Abstract

Underground power lines are increasingly being used due to security concerns and greater dependability in circulation systems. These cables are secure and unaffected by severe weather conditions, but they pose challenges in detecting faults and fault locations. The main issue in electrical engineering is determining the fault's location and nature. Repairing faulty cables becomes difficult due to a lack of a proper system for tracking fault locations. Fortunately, advancements in technology and detection schemes are improving fault detection methods in underground cable systems. This scheme focuses on locating faults and identifying phase lines in damaged underground cables. Its tracking system consists of a microcontroller, LCD display, fault-sensing circuit module, and proper power supply arrangement with regulated power output. The current in the circuit is sensed by interconnected relays, and the fault is detected and precisely located.

Introduction

Power transmission and distribution were traditionally done through OHL (overhead lines), but OHL are susceptible to damage due to environmental factors such as heavy wind and lightning. Extended power outages can result in significant financial losses for power utilities, substantial production disruptions for industries, and considerable inconvenience for customers. To overcome the limitations of OH lines, underground (UG) cables are employed for power distribution.

The transition from OH power lines to underground cables involves burying electrical lines for improved aesthetics, reduced environmental impact, and enhanced reliability. It often requires significant infrastructure changes and can be more expensive but minimizes visual clutter and reduces susceptibility to weather-related disruptions. The major drawback of underground cables is identifying and repairing faults. This can result in longer outages and increased inconvenience for consumers.

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Detecting Faults in UG Cables

Deployment of the underground power link is growing because of security considerations and upgraded dependability in the circulation frameworks. Underground cables have been of vital importance because of security threats and the need for high-voltage power in populated areas. They offer the advantage of security and are less susceptible to severe weather conditions such as high winds, lightning strikes, or heavy snowfall compared to OHL. The challenge is promptly identifying the location and nature of faults in underground cable lines. Cable failures and the precise detection of cable faults are key issues in underground cable systems.

Conventional systems

Conventional underground fault detection systems employ techniques such as monitoring insulation resistance, measuring cable parameters, or using specialized equipment to locate faults when they occur. The following are some of the conventional methods that are majorly employed for fault detection.

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Visual Inspection

Technicians may visually inspect the area above ground for signs of damage to the cable, such as exposed wires, melted insulation, or scorched ground. While this method can sometimes indicate the general area of the fault, it is not precise enough for accurate fault localization.

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Cable Testing

Technicians use cable testing equipment, such as insulation resistance testers or TDRs, to assess the condition of the underground cable. These tests measure parameter like insulation resistance, capacitance, or impedance to identify abnormalities that could indicate a short circuit fault.

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Thumping

Thumping involves applying a high voltage pulse to the cable and listening for the distinctive sound by the discharge at the fault location. This method can help technicians narrow down the fault location by listening for the distinctive sound produced by the discharge.

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Cable Fault Locators

Cable fault locators are specialized instruments that can help pinpoint the location of a short circuit fault along the length of the cable. These devices typically use techniques such as time domain refectory (TDR) or pulse reflection to analyze the electrical characteristics of the cable and determine the distance of the fault.

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Excavation

In some cases, if the fault cannot be precisely located using the methods, technicians may need to excavate the area around the suspected fault location to visually inspect the cable and perform further testing.

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Cons of conventional methods:

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Limited Sensitivity:

Traditional methods lack the sensitivity to detect small or intermittent faults, leading to delayed detection and potential service interruptions.

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Limited Coverage:

Some conventional techniques only provide localized monitoring, making it challenging to detect faults in larger underground cable networks.

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Time Consuming:

Fault identification and localization using traditional methods can be time consuming, leading to longer outage durations and increased downtime for repairs.

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Precise Fault Location:

They have limitations in precisely locating the fault location within the underground cable network.

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Proposed System

The proposed system helps to determine the distance of the underground cable fault from the base station in kilometers using an Arduino board. This system comprises an Arduino microcontroller, buzzer, and LCD. This reduces time and operates effectively. When a fault occurs, it is difficult to dig out the faulty underground cable without knowing its exact location of the fault. Programs uploaded to the Arduino UNO kit help detect faults in the underground cables. When a fault occurs in the underground cables, we can locate them through the Arduino controller kit. LCD display is used to display the fault distance in km.

In this proposed system, we created faults manually to test its efficacy. Every cable has a unique resistance value, which depends on the material used. The value of the resistance depends on the length of the cable. Resistance is the main function in determining the fault location. If any deviation occurs in the resistance, the value of the voltage changes at that point. Using this system, we were able to accurately locate the fault.

This project uses Ohms Law concept. When a low-voltage DC is applied to the feeder end through a series resistor, the current would differ based on the location of the fault in the cable. If there is a short circuit from line to ground, the voltage across the series resistor alters accordingly. The relay senses it, Arduino recognizes the change in voltage, and then the fault distance is displayed on LCD (16*2) display.

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Simulations and Results

Design:

  • The circuit consists of a power supply, LCD display, Arduino, and relay. To induce faults manually, fault switches are used.
  • About twelve fault switches are used, which can be organized in three rows, with every row having four switches. These switches are placed in their respective rows to create a fault. The three rows represent the three phases, namely R, Y, and B, respectively.
  • The fault switches have two positions: no fail (switch open condition) and fail (switch close condition).
  • Resistors are placed in their respective rows to represent the internal voltage drop in the cable. These cables are connected across the relays, which detect the change in current flowing through the respective cables.
  • ULN2003A connects a relay to Arduino. Arduino operates at low current, and the relay operates at high current. ULN2003A acts as a bridge between the relay and Arduino to detect abnormal conditions.
  • Arduino receives the signal from ULN2003A and is connected to an LCD, which displays the condition in the respective line and the distance to the fault location in case of a fault.
  • A buzzer is connected to Arduino, which produces the sound in case of a fault. LEDs relate to a resistor in series; resistors oppose the overflow of current through LEDs.
  • Three LEDs are connected to represent faults in each phase. The circuit above is designed in Proteus software, and the source code is compiled in Arduino software.
  • The location of the code (.hex file) is copied to the program file location. Then run the project. By closing any switch, the respective fault line and distance will be displayed on the LCD.
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The following faults are created manually by closing the switches:

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These fault locations are detected by the proposed system and distance and fault phase will be showed in LCD display. The expected results are obtained in the simulation software. Thus, by using the proposed system, the drawbacks of the conventional systems can be overcome.

Toward Enhanced Reliability

In conclusion, the escalating use of underground power links for heightened security and improved reliability faces a critical challenge in promptly detecting and locating faults within the cable lines. The paper has thoroughly examined the causes of faults in underground cables, emphasizing manufacturing defects, poor workmanship, external damage, and environmental factors. Traditional fault detection methods have been scrutinized for their limitations.

The proposed system, featuring a microcontroller, LCD display, and fault-sensing circuit module, offers a promising solution.

Utilizing the Ohm’s Law concept and Arduino technology, it accurately determines the distance of underground cable faults from the base station. Simulations demonstrate the system's effectiveness in overcoming conventional drawbacks. In practical scenarios, the proposed system successfully identifies faults in distinct phases and distances. Also using the proposed system as basis custom sensing and monitoring solutions can be developed. Overall, the system presents a reliable solution for efficient underground cable fault detection, contributing to minimized downtime and enhanced reliability in power distribution systems.

About the Author

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Adilakshmi, Himasri, Daveedu, and Jaya Baily share a common background in and passion for electrical engineering. Their BTech degrees in electrical and electronics engineering provide a solid foundation in the principles and applications of electrical engineering. With their combined experience in electrical schematics, they possess a wealth of knowledge and expertise in interpreting and creating detailed diagrams essential for electrical systems' design and analysis.

Their shared enthusiasm drives continuous learning and exploration of innovative technologies, methodologies, and industry trends. They are committed to pushing the boundaries of innovation in electrical engineering, contributing to advancements that positively impact society and industry.

As authors, Adilakshmi, Himasri, Daveedu, and Jaya Baily’s combined knowledge, practical experience, and passion for electrical engineering make them valuable contributors to the discourse surrounding electrical technologies and innovations in the field.

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About Cyient

Cyient (Estd: 1991, NSE: CYIENT) partners with over 300 customers, including 40% of the top 100 global innovators of 2023, to deliver intelligent engineering and technology solutions for creating a digital, autonomous, and sustainable future. As a company, Cyient is committed to designing a culturally inclusive, socially responsible, and environmentally sustainable Tomorrow Together with our stakeholders.

For more information, please visit www.cyient.com

How to Submit a De Novo Request

The submission is done either through the eSTAR Program or through email.

The eSTAR Program, or Electronic Submission Template and Resource Program, is a USFDA initiative aimed at enhancing the efficiency and consistency of electronic submissions for regulatory review. It provides standardized templates and resources to streamline the submission process for various types of regulatory submissions, including premarket submissions for medical devices. The program offers structured templates for key submission documents, such as investigational device exemptions (IDEs), premarket approval applications (PMAs), and De Novo requests, ensuring consistency and completeness in submissions. Additionally, eSTAR provides guidance documents, training materials, and technical support to assist stakeholders in navigating the electronic submission process effectively. By promoting standardized electronic submissions, the eSTAR Program facilitates faster review timelines, improves data quality, and enhances communication between stakeholders and the FDA, ultimately supporting timely market access for safe and effective medical devices.

De Novo requests can also be submitted in an electronic format (eCopy) through email to the appropriate Document Control Center (DCC). The current mailing address for CDRH's Document Control Center and a link to the Center for Biologics Evaluation and Research's (CBER) Document Control Center's mailing address is provided on the eCopy Program for Medical Device Submissions webpage.

It is recommended to use the eSTAR submission program.

De Novo Request Medical Device User Fee Amendments (MDUFA)

De Novo requests are subject to user fees. The latest/current applicable fee amounts can be found on the USFDA official website, in the Medical Device User Fee Amendments (MDUFA) User Fees section.

FDA’s Final Actions on a De Novo Request

After review of the De Novo request, the FDA will make a final decision to either grant or decline. FDA will also consider the De Novo request to be withdrawn in certain situations.

  • Grant De Novo Request (21 CFR 860.260)

    If the data and information provided to the FDA demonstrate that general controls or general and special controls are adequate to provide reasonable assurance of safety and effectiveness, and the probable benefits of the device outweigh the probable risks, then the FDA may grant the De Novo request and establish a new classification regulation for the new device type.

  • Decline De Novo Request (21 CFR 860.260)

    De Novo request is declined by the FDA if –

    • General controls or general and special controls are insufficient to provide reasonable assurance of safety and effectiveness of the device
    • The data provided in the De Novo request are insufficient to determine whether general controls or general and special controls can provide a reasonable assurance of safety and effectiveness of the device
    • The probable benefits of the device do not outweigh the probable risks

    If the De Novo request is declined, the device remains in Class III and the requester may not legally market the device. The FDA will issue a written order to the requester identifying the reasons, which can include lack of performance data that warrant declining the De Novo request. The requester should generally either submit an application for premarket approval under Section 515 of the FD&C Act or collect additional information to address the issues and submit a new De Novo request that includes the additional information.

  • Withdrawal of a De Novo Request (21 CFR 860.250)

    The FDA will consider a De Novo classification request to be withdrawn if—

    • The requester submits a written notice to the FDA that the requester is withdrawing the De Novo request;
    • The requester fails to provide a complete response to a request for additional information (21 CFR 860.240), or deficiencies identified by the FDA (21 CFR 860.230) are not addressed within 180 days after the date the FDA issues such request; or
    • The requester does not permit an authorized FDA employee an opportunity to inspect the facilities (21 CFR 860.240), at a reasonable time and in a reasonable manner, and to have access to copy and verify all records pertinent to the De Novo request.

    If the FDA considers a De Novo request to be withdrawn, the FDA notifies the requester with reference to the De Novo request number and the date the FDA considered the De Novo request withdrawn.

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Challenges in De Novo Submission for Medical Device Manufacturers

Medical device manufacturers encounter several challenges during the De Novo submission process, stemming from the complexity of regulatory requirements, resource constraints, and evolving technological landscapes. Some of the key challenges include:

Regulatory Complexity

Navigating the regulatory landscape is a daunting task due to the intricate requirements and guidelines set forth by the FDA. Understanding and interpreting these regulations accurately is critical for a successful submission.

Resource Constraints

De Novo submissions require substantial investments of time, money, and manpower. Small and medium-sized manufacturers, in particular, may face resource constraints that hinder their ability to gather necessary data, conduct studies, or engage regulatory consultants.

Data Requirements

Generating sufficient clinical and non-clinical data to demonstrate the safety and effectiveness of the device can be challenging. Conducting clinical trials, gathering real-world evidence, and meeting statistical requirements demand significant resources and expertise.

Timeline Uncertainty

The timeline for De Novo review and decision-making can vary widely, depending on factors such as the FDA's workload, the complexity of the device, and the quality of the submission. Uncertainty surrounding review timelines can disrupt product development plans and market entry strategies.

Lack of Predicate Device

De Novo submissions are unique as they involve devices without predicate counterparts. Manufacturers must establish a comprehensive argument for the novelty and uniqueness of their device, which can be challenging without a comparable reference point.

Interactive Review Process

Addressing deficiencies identified during the FDA's substantive review often involves iterative communication and data exchanges. Managing this interactive review process effectively requires clear communication and strategic decision-making.

Post-Market Obligations

Obtaining De Novo classification is just the beginning; manufacturers must also fulfill post-market obligations, such as post-market surveillance, labeling updates, and quality management. Maintaining compliance with these requirements is an ongoing challenge.

Market Access Delays

Delays in obtaining FDA clearance or approval for a De Novo submission can impede market access, resulting in missed opportunities and competitive disadvantages. Timely approval is crucial for manufacturers to capitalize on market demand and secure a competitive position.

Addressing these challenges requires proactive planning, resource allocation, regulatory expertise, and strategic collaboration with regulatory consultants and stakeholders. By understanding the nuances of the De Novo submission process and effectively navigating regulatory requirements, medical device manufacturers can overcome obstacles and achieve successful market entry for their innovative products.

FDA's Review Process and Timeline for De Novo Submission Request

    • Acceptance review (21 CFR 860.230)

      Upon receipt of a De Novo request, the FDA will conduct an acceptance review. The acceptance review is an administrative review to assess the completeness of the application and whether it meets the minimum threshold of acceptability. If any of the acceptance elements are not included, a justification has to be provided for the omission.

      To aid in the acceptance review, it is recommended to submit an Acceptance Checklist as per the guidance document with the De Novo request that identifies the location of supporting information for each checklist element.

      The De Novo request will not be accepted and will receive a Refuse to Accept (RTA) designation if one or more of the elements noted as RTA items in the Acceptance Checklist are not present and no explanation is provided for the omission(s). However, during the RTA review, the FDA staff has the discretion to determine whether the missing checklist elements are needed to ensure the De Novo request is administratively complete to allow the De Novo request to be accepted.

      Within 15 calendar days of the Document Control Center receiving the De Novo request, the FDA will notify the requester electronically of the acceptance review result as one of the following:

      • The De Novo request has been accepted for substantive review;
      • The De Novo request has not been accepted for review (i.e., considered RTA) and the requester has 180 calendar days to fully address the RTA notification; or
      • The De Novo request is under substantive review and the FDA did not complete the acceptance review within 15 calendar days.
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    • Substantive review

      Once the De Novo request is accepted for substantive review, the FDA conducts a classification review of legally marketed device types and analyzes whether an existing legally marketed device of the same type exists. This information is used to confirm that the device is eligible for De Novo classification.

      During the substantive review of a De Novo request, the FDA may identify deficiencies that can be adequately addressed through interactive review and not require a formal request for additional information.

      If the issues and deficiencies cannot be addressed through interactive review, an Additional Information letter will be sent to the requester. If an Additional Information letter is sent, then the De Novo request will be placed on hold. The requester has 180 calendar days from the date of the Additional Information letter to submit a complete response to each item in the Additional Information letter.

      Note: The response must be sent to the DCC within 180 calendar days of the date of the Additional Information letter. No extensions beyond 180 days are granted. If the FDA does not receive a complete response to all deficiencies in the Additional Information letter within 180 days of the date of the letter, the request will be considered withdrawn and deleted from the FDA's review system. If the De Novo request is deleted, the De Novo requester will need to submit a new request to pursue the FDA's marketing authorization for that device.

      The requester must submit their response to an Additional Information letter in electronic format (eCopy), to the DCC of the appropriate center. The response should—

      • Include the requester's name;
      • Identify the De Novo number;
      • Include the requester's name;
      • Identify the submission as a response to the Additional Information letter;
      • Identify the date of the FDA's request for additional information; and
      • Provide the requested information in an organized manner.

      The final step is the De Novo request decision. Under MDUFA IV, the FDA's goal is to decide about a De Novo request in 150 review days. Review days are calculated as the number of calendar days between the date the De Novo request was received by the FDA and the date of the FDA's decision, excluding the days a request was on hold for an Additional Information request.

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CyARC—Accelerated Regulatory Platform

Cyient offers a one-stop solution, CyARC–Accelerated Regulatory Platform, for helping medical device companies to ensure regulatory compliance. Empowered by Quality Assurance and Regulatory Affairs (QARA) CoE, Cyient has certified professionals across all the functions who have the required skillsets and expertise to support medical device companies throughout the life-cycle of their medical devices.

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About Cyient

Cyient (Estd: 1991, NSE: CYIENT) partners with over 300 customers, including 40% of the top 100 global innovators of 2023, to deliver intelligent engineering and technology solutions for creating a digital, autonomous, and sustainable future. As a company, Cyient is committed to designing a culturally inclusive, socially responsible, and environmentally sustainable Tomorrow Together with our stakeholders.

For more information, please visit www.cyient.com

Conclusion

The De Novo submission pathway offers an important regulatory mechanism for launching novel medical devices in the United States market. By understanding the key components of De Novo submission, strategic considerations, and post-market obligations, medical device manufacturers can navigate the regulatory pathway effectively and obtain market clearance for innovative technologies that address unmet clinical needs and improve patient care. While most medical device companies face challenges in their De Novo submissions, collaboration, resource allocation, and strategic planning are essential for achieving successful market entry through the De Novo pathway.