The Kepler MedTec Single Patient Use ECG Lead Wire is a electrode cable system used to transmit signals from patient electrodes to various electrocardiograph recorders / monitors for both diagnostic and monitoring purposes. Use is limited by the indications for use of the connected monitoring or diagnostic equipment. The Single Patient Use ECG Lead Wire Set is intended to be used by trained operators in a medical professional's environment.

Device Description

The Single Patient Use ECG Lead Wire is a single patient, electrode cable system used to transmit signals from patient surface electrodes to various electrocardiograph recorders/monitors for both diagnostic and monitoring purposes. This type of device is common to both industry and to most medical establishments. The system is designed to provide a family of lead wires that will link the patient and the compatible patient trunk cable system.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided 510(k) summary for the Single Patient Use ECG Lead Wire Set:

This submission is for an ECG Lead Wire Set, which is a fairly straightforward electromechanical device. Unlike AI/ML-driven software, its performance is primarily evaluated through adherence to established engineering standards and physical testing, not through clinical efficacy studies involving human readers or extensive AI model training. Therefore, many of the requested elements (like sample sizes for test/training sets, expert ground truth, MRMC studies, and standalone AI performance) are not applicable in the context of this device and typical regulatory submissions for such products.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Connector Retention Force	Meets ANSI/AMMI EC 53A standard. The device design for connector retention force is comparable to the predicate devices, which also meet this standard.
Electrical Performance	Meets ANSI/AMMI EC 53A standard. The device's electrical performance is comparable to the predicate devices, which also meet this standard.
Biological Evaluation	Meets EN/ISO 10993-1:2003 (Part I: Guidance on selection of tests). This standard addresses biocompatibility, indicating the materials used are safe for patient contact.
General Safety (Electrical)	Meets IEC 601-1 (1998) subclause 56.3(c). This standard pertains to general requirements for safety of medical electrical equipment.
Product Markings	Meets ANSI/AAMI EC13:2002 (chapter 4.1.1.5). This standard covers product markings for cardiac monitors, heart rate meters, and alarms, ensuring appropriate labeling for the lead wire set.
Quality Systems	Complies with Good Manufacturing Practice (GMP) requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). (Implied by FDA's substantial equivalence determination, as compliance with general controls is a prerequisite for marketing).
Registration and Listing	Complies with annual registration and listing requirements (21 CFR Part 807). (Implied by FDA's substantial equivalence determination).
Labeling	Complies with labeling requirements (21 CFR Part 801) and "Misbranding by reference to premarket notification" (21CFR Part 807.97). (Implied by FDA's substantial equivalence determination, and explicit mention of labeling in FDA letter).
Medical Device Reporting	Complies with medical device reporting (MDR) (21 CFR 803). (Implied by FDA's substantial equivalence determination).
Intended Use Match	Intended use is substantially equivalent to predicate devices. The device's intended use ("transmit signals from patient electrodes to various electrocardiograph recorders / monitors for both diagnostic and monitoring purposes") is the same as the predicate devices. This is a functional rather than a performative acceptance criterion in this context.

Note: The document primarily outlines the standards met rather than providing specific raw performance data. The "reported device performance" is the statement of compliance with these standards, implying that the device successfully passed the tests required by each standard.

Study Details (Applicability for ECG Lead Wires)

Sample Size used for the test set and the data provenance:
- Sample Size: Not explicitly stated in the summary. For electrical and mechanical performance testing (e.g., connector retention force, electrical integrity, biocompatibility), sample sizes are typically determined by the respective standards (e.g., ANSI/AAMI EC53A, ISO 10993). These are usually small, representative batches or a statistically significant number of units to ensure consistency.
- Data Provenance: Not explicitly stated. Such testing is typically conducted in designated test laboratories, either in-house or by third-party contractors. The location (country) of these labs is not specified. The testing is prospective for the device under review.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. For an ECG lead wire set, "ground truth" as it relates to clinical diagnosis or interpretation by experts (e.g., radiologists) is not relevant. The device's performance is objectively measured against engineering specifications and physical standards. Expert consensus would not be used to assess, for example, connector retention force.
Adjudication method for the test set:
- Not Applicable. Adjudication methods (like 2+1 or 3+1) are for resolving discrepancies in expert interpretations, typically in clinical studies or image analysis. This is not how an ECG lead wire's compliance with engineering standards is assessed. Compliance is determined by objective measurements meeting predefined thresholds.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, not applicable. MRMC studies are designed for assessing the impact of diagnostic aids (often AI-powered) on human reader performance. An ECG lead wire is a passive component for signal transmission, not a diagnostic aid that assists a human reader in interpretation. Therefore, such a study would not be performed.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, not applicable. "Standalone performance" refers to the performance of an algorithm without human intervention, typically for AI/ML software. An ECG lead wire is a physical device that transmits electrical signals, not an algorithm.
The type of ground truth used:
- Objective Engineering Standards / Physical Measurements: The "ground truth" for this device's performance relies entirely on objective measurements against established engineering standards (e.g., force in Newtons for retention, electrical resistance/impedance values, biocompatibility profiles) and visual inspection where applicable. There is no subjective ground truth or clinical outcome data used directly for this type of device's regulatory review in this context.
The sample size for the training set:
- Not Applicable. "Training set" refers to data used to train an AI/ML model. This device is not an AI/ML product; it is an electromechanical accessory.
How the ground truth for the training set was established:
- Not Applicable. As there is no AI/ML model, there is no training set or ground truth establishment for a training set. The device's "ground truth" for its design and manufacturing is based on adherence to the listed industry standards and specifications.

Summary

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510(k) Summary

K101660

A) SUBMITTED BY : Kepler MedTec 223 Avenue D Willston, VT 05495 (facility registration # 3008160705)

CONTACT:

MEDIcept Inc. 200 Homer Ave Ashland, MA 01721 F. David Rothkopf 508-231-8842 508-231-8861 Fax

AUG 1 1 2010

B) DEVICE NAME:	Single Patient Use ECG Lead Wire Set
COMMON NAME:	ECG Patient Cable
DEVICE CLASS:	Class II
PRODUCT CODE:	DSA, 870.2900 Cable, transducer and electrode, patient (including connector)

C) PREDICATES:

K980582 Marquette Medical Systems: ECG Lead Wire and Cable System

Intended use: Multi-Link Cable and Lead Wire Systems are reusable electrode cable system used to transmit signals from patient electrodes to various electrocardiograph recorders/monitors fro both diagnostic and monitoring purposes. Multi-Link Cable and Lead Wire Systems are limited to indications for use of the connected monitoring or diagnostic equipment. Such equipment is commonly located in hospitals, doctor's offices, and emergency vehicles, as well as in home use.

K082851 GE Medical Systems: Multi-Link Cable and Lead Wire System Intended use: Multi-Link Cable and Lead Wire Systems are electrocardiograph cable systems used to transmit signals from patient surface electrodes to various . electrocardiograph recorders/monitors for both diagnostic and monitoring purposes. Use is limited by the indications for use of the connected monitoring or diagnostic equipment. Multi-Link Cable and Lead Wire Systems are intended to be used by trained operators in a medical professional environment.

Kepler MedTec

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D) DEVICE DESCRIPTION:

E) INTENDED USE:

The Single Patient Use ECG Lead Wire is an electrode cable systems used to transmit signals from patient electrodes to various electrocardiograph recorders / monitors for both diagnostic and monitoring purposes. Use is limited by the indications for use of the connected monitoring or diagnostic equipment. The Single Patient Use ECG Lead Wire set is intended to be used by trained operators in a medical professional's environment.

Device Features	Single Patient Use ECGLead Wire Set	Predicate	Predicate
		K980582 MarquetteMedical Systems:ECG Lead Wire andCable System	K082851 GE MedicalSystems: Multi-Link Cableand Lead Wire System
Intended Use	Transmit signals frompatient electrodes tovarious electrocardiographrecorders / monitors forboth diagnostic andmonitoring purposes	Same	Same
Patient Usage	Reusable	Reusable	Reusable
Anatomical Sites	Attached to electrodes placedat standard specifiedlocations on the chest wall	Same	Same
Sterilization	Provided non-sterile	Provided non-sterile	Provided non-sterile
Wire Material/ConnectorDesignConstruction	Flexible, Shielded multi-connector electrical cablekeyed to fit specific monitorsand snap for electrodes	Same but additionallymay use Grabber andBanana electrodeterminationconfiguration	Same but additionally may useGrabber, Banana, or Mactrodeelectrode terminationconfiguration
Instrumentinterfaceconnector	Compatible to MultiLinkyoke design	Compatible toMultiLink yoke design	Compatible to MultiLink yokedesign
ConnectorRetention Force	ANSI/AMMI EC 53A	Same	Same
ElectricalPerformance	ANSI/AMMI EC 53A	Same	Same

F) COMPARISON TO PREDICATE DEVICES(s):

The Single Patient Use ECG Lead Wire has a similar intended use, target population, clinical setting, and technology as its predicate devices.

Kepler MedTec

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G) STANDARDS MET:

. ANSI/AMMI EC53-1995 (R)2001, R(2008) ECG Cables and Leadwires (except 4.3.1)
ANSI/AAMI EC13:2002 Cardiac monitors, heart rate meters and alarms (only ● product markings, chapter 4.1.1.5)
21 CFR 898: Guidance Document on the Performance Standard for Electrode Lead . Wires and Patient Cables, May 11, 1998 IEC 601-1 (1998), "Medical Electrical Equipment - Part 1: General Requirements for Safety, " (R)1995 subclause 56.3(c)
EN/ISO 10993-1:2003 Biological evaluation of Medical Devices, Part I: Guidance ● on selection of tests

H) CONCLUSION:

Kepler MedTec believes that the Single Patient Use ECG Lead Wire Set is as safe and effective and is substantially equivalent to the predicate devices based on intended usage, technology comparison and system performance.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized, curved lines.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Kepler MedTec c/o Mr. F. David Rothkopf MEDIcept, Inc. 200 Homer Ave. Ashland, MA 01721

AUG 1 1 2010

Re: K101660

Trade/Device Name: Single Patient Use ECG Lead Wire Set Regulatory Number: 21 CFR 870.2900 Regulation Name: Patient Transducer and Electrode Cable (Including Connector) Regulatory Class: Class II (Two) Product Code: DSA Dated: June 8, 2010 Received: June 14, 2010

Dear Mr. F. David Rothkopf:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Or ve and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. F. David Rothkopf

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

[signature]

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Form

510(k) Number (if known):

KIDIGGO

Device Name: Single Patient Use ECG Patient Lead Wire Set

AUG 1 1 2010

Indications for Use:

Prescription Use X 21CFR 801, Subpart D OR Over-the-Counter Use_21CFR 801.109

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

W. M.

510(k) Number

Kepler MedTec

June 8, 2010

Page 12

Regulation Number and Section

§ 870.2900 Patient transducer and electrode cable (including connector).

(a)
Identification. A patient transducer and electrode cable (including connector) is an electrical conductor used to transmit signals from, or power or excitation signals to, patient-connected electrodes or transducers.(b)
Classification. Class II (performance standards).