HEART SYNC, MODELS C-100 AND T-100 by HEART SYNC LLC

The Heart Sync Adult Radio Transparent Multi Function Electrodes and Heart Sync Adult Radiotranslucent Multifunction Electrodes are indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single patient use only. The electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the patient's skin. The electrode is intended for use on adult patients. When a patient requires defibrillation, cardioversion or external pacing, these electrodes will be applied to the patient and connected to the instrument. This device is intended for use on defibrillators whose output is classified as low power (360 joule maximum). Compatible with Medtronic Physio Control, Zoll, Hewlett-Packard, Philips Medical, and Welch-Allyn models of monophasic and bi-phasic defibrillators, external pacemakers.

Device Description

The electrodes are multifunction because they can be used for defibrillation, pacing, cardioversion, and monitoring. Heart Sync electrodes can be used on Physio Control, Zoll, Hewlett-Packard, Philips and Welch-Allyn makes and models of monophasic and bi-phasic defibrillator. Radiotransparent and or Radiotranslucent "One Pad System" enables the pads to stay with the patient as they move through departments. Heart Sync has an electrode for any clinical need or patient situation. Heart Sync can provide onsite conversion of current cables to accept the Heart Sync electrodes. The polymer adhesive gel provides contact for uniform current distribution and more effective defibrillation and pacing. All Heart Sync products are Latex free.

AI/ML Overview

The provided text is a 510(k) summary for the "Heart Sync" C-100 and T-100 Multifunction Electrodes. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a standalone study with specific performance metrics against acceptance criteria. Therefore, much of the requested information, such as detailed acceptance criteria, specific device performance data, sample sizes for test and training sets, expert qualifications, and adjudication methods for ground truth, is not available in the provided document.

The document states that the device is "identical in function to the PadPro (K020203), and Katecho (K981737) and identical in design." It primarily relies on demonstrating compliance with recognized standards and similarity to these predicate devices.

However, I can extract and infer some information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied to be compliance with relevant standards and functional equivalence to predicate devices. Specific performance metrics for the Heart Sync electrodes are not reported in a quantitative manner but are stated to be "SAME" as the predicate devices in comparison areas.

Acceptance Criteria (Implied)	Reported Device Performance
Indications for Use (monitoring, pacing, cardioversion, defibrillation)	SAME as predicate devices
Where used (Hospitals and Paramedic situations)	SAME as predicate devices
Basic features (Radiotransparent/translucent, non-sterile, latex-free, single patient use, self-adhesive, sealed in foil pouch)	SAME as predicate devices
Standard met (21CFR 898.12 Performance standard; ANSI/AAMI DF-80 2003 standard)	Heart Sync meets these standards (Stated in Conclusion)

2. Sample size used for the test set and the data provenance

Sample Size: Not specified. The submission relies on comparative analysis and compliance with standards rather than a specific clinical test set with a defined sample size for the Heart Sync device itself.
Data Provenance: Not applicable in the context of a clinical test set for the Heart Sync device. The comparison is made against existing predicate device specifications and recognized standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts: Not applicable. There is no mention of a test set requiring expert ground truth for the Heart Sync device in this document.
Qualifications of Experts: Not applicable.

4. Adjudication method for the test set

Adjudication method: Not applicable. No test set requiring adjudication is described.

5. 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

MRMC Study: No. This device is an electrode for defibrillation, pacing, and monitoring, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human readers improving with AI assistance is not relevant or described.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Standalone Performance: Not applicable. The device is a physical medical device (electrodes), not an algorithm or AI system. Its performance is inherent to its physical properties and electrical conductivity, tested against physical standards.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Type of Ground Truth: Not directly applicable to the Heart Sync device's evaluation in this document. The "ground truth" for the device's acceptable performance is defined by its compliance with industry standards (21CFR 898.12, ANSI/AAMI DF-80 2003) and its substantial equivalence to legally marketed predicate devices.

8. The sample size for the training set

Sample Size: Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

Ground Truth Establishment: Not applicable. This is not an AI/ML device that requires a training set.

Summary of the Study Proving Acceptance Criteria:

The "study" demonstrating the device meets acceptance criteria is primarily a comparative analysis against predicate devices and compliance with recognized standards.

Comparison: The Heart Sync electrodes are compared to PadPro (K020203) and Katecho (K981737). The document explicitly states they are "identical in function" and "identical in design" to these predicates. The comparison table confirms that indications for use, where used, and basic features are "SAME" as the predicate devices.
Standards Compliance: The Heart Sync electrodes are stated to meet the "Performance standard" 21CFR 898.12 and the "ANSI/AAMI DF-80 2003 standard, self-adhesive electrodes for monitoring and defibrillation."
Conclusion of Substantial Equivalence: Based on the comparison and standards compliance, the conclusion is that the Heart Sync System Defibrillator Electrodes are "substantially equivalent to other electrodes that are legally marketed for this purpose" and "The device meets the standards referenced above." This determination of substantial equivalence (as indicated by the FDA's letter) serves as the "proof" that the device meets the regulatory acceptance criteria for market clearance.

Summary

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Kosoyzl

EXHIBIT 2

Heart Sync

FEB 2 9 2008

LLC. 5643 Plymouth Rd. Ann Arbor, Mi 48105 Phone: 800-828-4681 Fax: 734-213-5640 Contact: Stephen Shulman, Managing Partner January 16, 2008 510(k) Summary of Safety and Effectiveness

Identification of the Device: 1. Proprietary-Trade Name: "Heart Sync" C-100 Adult Radiotransparent, Multifunction Electrodes and "Heart Sync" T-100 Adult Radiotranslucent Multifunction Electrodes
Classification Name: Electrode, Electrocardiograph, Multi-Function; MLN Common/Usual Name: Defibrillator Electrode
1. Equivalent legally marketed devices: This is identical in function to the PadPro (K020203), and Katecho (K981737) and identical in design.
1. Indications for Use: The Heart Sync Adult Radio Transparent and/or Translucent Multi Function Electrodes are indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single patient use only. The electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the patient's skin. The electrode is intended for use on adult patients. When a patient requires defibrillation, cardioversion or external pacing, these electrodes will be applied to the patient and connected to the instrument. This device is intended for use on defibrillators whose output is classified as low power (360 joule maximum).
1. Description of the Devices: Features & Benefits:

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Model differentiation:

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COLOR OF ANY	.Non-Amore, Andrew

1. Safety and Effectiveness, comparison to predicate device:

Comparison Areas	PadPro (K020203), and Katecho(K981737)	"Heart Sync" C-100and T-100 Electrodes
Indications for use	For use as disposable electrodes forautomatic and manual externaldefibrillators for monitoring, pacing,cardioversion, and defibrillation	SAME
Where used	Hospitals and Paramedic situations	SAME
Basic features	Radiotransparent and orRadiotranslucent, non sterile, latexfree, single patient use, selfadhesive, in sealed foil pouch.	SAME
Standard met	21CFR 898.12 Performancestandard; ANSI/AAMI DF-80 2003standard, self adhesive electrodes formonitoring and defibrillation	SAME

1. Conclusion In all respects, the Heart Sync System Defibrillator Electrodes are substantially equivalent to other electrodes that are legally marketed for this purpose. The device meets the standards referenced above.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is black and white, and the text is in a simple sans-serif font.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 9 2008

Heart Sync LLC Mr. Mark Job c/o Regulatory Technology Services 1394 25th Street, NW Buffalo, MN 55313

Re: K080421

Trade/Device Name: Heart Sync C-100 and Heart Sync T-100 Regulation Number: 21 CFR 870.2360 Regulation Name: Electrocardiograph electrode Regulatory Class: Class II (two) Product Code: MLN Dated: February 14, 2008 Received: February 15, 2008

Dear Mr. Job:

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, Drug, 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 such 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. Mark Job

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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Bfhimmer for

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

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: "Heart Sync" C-100 Adult Radiotransparent Multifunction Electrodes and "Heart Sync" T-100 Adult Radiotranslucent Multifunction Electrodes

Indications for Use:

Compatible with Medtronic Physio Control, Zoll, Hewlett-Packard, Philips Medical, and Welch-Allyn models of monophasic and bi-phasic defibrillators, external pacemakers.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Bhumumo
(Division Sign Off)

(Division Sign-Off) Division of Cardiovascular Deyices 510(k) Number

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 870.5310 Automated external defibrillator system.

(a)
Identification. An automated external defibrillator (AED) system consists of an AED and those accessories necessary for the AED to detect and interpret an electrocardiogram and deliver an electrical shock (e.g., battery, pad electrode, adapter, and hardware key for pediatric use). An AED system analyzes the patient's electrocardiogram, interprets the cardiac rhythm, and automatically delivers an electrical shock (fully automated AED), or advises the user to deliver the shock (semi-automated or shock advisory AED) to treat ventricular fibrillation or pulseless ventricular tachycardia.(b)
Classification. Class III (premarket approval)(c)
Date PMA or notice of completion of PDP is required. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED that was in commercial distribution before May 28, 1976. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976. Any other AED and AED accessory described in paragraph (a), shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.