HEART SYNC PEDIATRIC, MODEL PED-100 by HEART SYNC LLC

The Heart Sync Pediatric 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 pediatric patients whose weight is less than 25 kg. 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. 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.

AI/ML Overview

The provided text describes the 510(k) summary for the "Heart Sync" Pediatric Radiotranslucent Multifunction Electrodes, model # Pediatric-100. The device's acceptance criteria are based on its substantial equivalence to a legally marketed predicate device.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Heart Sync device are primarily based on its substantial equivalence to the predicate device, Pad Pro K020288. Therefore, the "performance" is demonstrated by meeting the same standards and having comparable features and indications for use.

Acceptance Criteria (Based on Substantial Equivalence to Predicate K020288)	Reported Device Performance (Heart Sync Pediatric-100)
Indications for Use: For use as disposable electrodes for semi-automatic and manual external defibrillators for monitoring, pacing, cardioversion, and defibrillation.	SAME (as per "Comparison Areas" table)
Where used: Hospitals and Paramedic situations.	SAME (as per "Comparison Areas" table)
Basic features: Radiotranslucent, non-sterile, latex-free, single patient use, self-adhesive, in sealed foil pouch.	SAME (as per "Comparison Areas" table)
Standard Met: 21CFR 898.12 Performance standard; ANSI/AAMI DF-39 (3.3.19) standard, self-adhesive electrodes for monitoring and defibrillation.	SAME (as per "Comparison Areas" table). The device "meets the standards referenced above."
Functionality: Capable of defibrillation, pacing, cardioversion, and monitoring.	Multifunction electrodes capable of defibrillation, pacing, cardioversion, and monitoring.
Compatibility: Compatible with Medtronic Physio Control, Zoll, Hewlett-Packard, Philips Medical, and Welch-Allyn models of monophasic and bi-phasic defibrillators, external pacemakers.	Compatible with Medtronic Physio Control, Zoll, Hewlett-Packard, Philips Medical, and Welch-Allyn models of monophasic and bi-phasic defibrillators, external pacemakers.
Patient Population: Pediatric patients whose weight is less than 25 kg.	Intended for use on pediatric patients whose weight is less than 25 kg.
Defibrillator Output: Intended for use on defibrillators whose output is classified as low power (360 joule maximum).	Intended for use on defibrillators whose output is classified as low power (360 joule maximum).
Pad Conductive Area: Predicate has 36.9 sq cm.	Heart Sync has 35.3 sq cm. (This is a difference, but not presented as failing an acceptance criterion, rather as a model differentiation).

2. Sample Size Used for the Test Set and the Data Provenance

The provided text does not describe an explicit "test set" in the context of a clinical performance study with a defined sample size. The submission for the Heart Sync device relies on demonstrating substantial equivalence to a predicate device (Pad Pro K020288). This means that its performance is argued to be equivalent because its design, materials, and intended use are similar to a device already cleared by the FDA, and it meets the same recognized standards.

Therefore, there is no mention of a specific sample size, country of origin, or retrospective/prospective nature of data for a "test set" for the Heart Sync device itself. The "data provenance" would refer to the standards cited (e.g., 21CFR 898.12, ANSI/AAMI DF-39) which are generally established through extensive research and validation studies in the broader medical device industry.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

As there is no described "test set" or clinical study with independent ground truth establishment, this information is not applicable or available in the provided document. The ground truth for the predicate device would have been established through its own clearance process, but that information is not detailed here.

4. Adjudication Method for the Test Set

Since there is no described "test set" requiring expert review for ground truth, an adjudication method is not applicable or mentioned in the provided document.

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

The device described is a physical medical device (defibrillator electrodes), not an Artificial Intelligence (AI) software. Therefore, an MRMC comparative effectiveness study involving AI assistance is not applicable to this submission.

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

The device is a physical medical device (defibrillator electrodes), not an algorithm or AI software. Therefore, a standalone performance study of an algorithm is not applicable to this submission.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" in this context is implicitly established through compliance with recognized performance standards (21CFR 898.12, ANSI/AAMI DF-39) and the demonstrated substantial equivalence to a legally marketed predicate device. The predicate device's safety and effectiveness would have been established through its own clearance process, which likely involved pre-clinical testing, possibly some clinical data, and compliance with relevant standards. The provided document does not detail specific "ground truth" through direct clinical outcomes data for the Heart Sync device.

8. The Sample Size for the Training Set

As there is no described AI algorithm involved, a "training set" for machine learning is not applicable to this submission.

9. How the Ground Truth for the Training Set Was Established

As there is no described AI algorithm involved, the establishment of ground truth for a "training set" for machine learning is not applicable to this submission.

Summary

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SEP 2 4 2008

EXHIBIT 2

Heart Sync Inc. 5643 Plymouth Rd. Ann Arbor, Mi 48105 Phone: 800-828-4681 Fax: 734-213-5640 Contact: Stephen Shulman, President May 22, 2008 510(k) Summarv

1. Identification of the Device: Proprietary-Trade Name: "Heart Sync" Pediatric Radiotranslucent Multifunction Electrodes, model # Pediatric-100.
  Classification Name: DC-defibrillator Common/Usual Name: Defibrillator Electrode
1. Equivalent legally marketed devices: This is identical in function to the Pad Pro K020288.
Indications for Use: The Heart Sync Pediatric Radiotranslucent Multifunction Electrodes 3. 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 pediatric patients whose weight is less than 25 kg. 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.

1. Description of the Devices: Features & Benefits:
  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. 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.

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Model differentiation:

Model	Feature/difference
Pediatric PEDIATRIC-100	Pad Conductive Area 35.3. sq cm.
Predicate K020288	Pad Conductive Area 36.9 sq cm

5. Safety and Effectiveness, comparison to predicate device:

Comparison Areas	PadPro K 020288	"Heart Sync"PediatricPEDIATRIC-100
Indications for use	For use as disposable electrodes forSemi-automatic and manual externaldefibrillators for monitoring, pacing,cardioversion, and defibrillation	SAME
Where used	Hospitals and Paramedic situations	SAME
Basic features	Radiotranslucent, non sterile, latexfree, single patient use, selfadhesive, in sealed foil pouch.	SAME
Standard met	21CFR 898.12 Performance standard;ANSI/AAMI DF-39 (3.3.19)standard, 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/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 24 L.

Heart Sync LLC c/o Mr. Stephen Shulman Managing Partner 5643 Plymouth Road Ann Arbor, MI 48105

Rc: K081442

Trade/Device Name: "Heart Sync" Pediatric Radiotranslucent Multifunction Electrodes Regulation Number: 21 CFR 870.5300 Regulation Name: DC-defibrillator (including paddles) Regulatory Class: Class II Product Code: LDD Dated: September 15, 2008 Received: September 16, 2008

Dear Mr. Shulman:

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.

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

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Page 2 -- Mr. Stephen Shulman

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.

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) 276-3464. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (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,

Qamee

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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j) Indications for Use

510(k) Number

Device Name: "Heart Sync" Pediatric Radiotranslucent Multifunction Electrodes

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

Over the Counter Use

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Per 21 CFR 801.109)

Qamel

ion Sianision of Cardiovascular Devices

KOS1442 510(k) Number.

Regulation Number and Section

§ 870.5300 DC-defibrillator (including paddles).

(a)
Low-energy DC-defibrillator —(1)Identification. A low-energy DC-defibrillator is a device that delivers into a 50 ohm test load an electrical shock of a maximum of 360 joules of energy used for defibrillating (restoring normal heart rhythm) the atria or ventricles of the heart or to terminate other cardiac arrhythmias. This generic type of device includes low energy defibrillators with a maximum electrical output of less than 360 joules of energy that are used in pediatric defibrillation or in cardiac surgery. The device may either synchronize the shock with the proper phase of the electrocardiogram or may operate asynchronously. The device delivers the electrical shock through paddles placed either directly across the heart or on the surface of the body.(2)
Classification. Class II (performance standards).(b)
High-energy DC-defibrillator —(1)Identification. A high-energy DC-defibrillator is a device that delivers into a 50 ohm test load an electrical shock of greater than 360 joules of energy used for defibrillating the atria or ventricles of the heart or to terminate other cardiac arrhythmias. The device may either synchronize the shock with the proper phase of the electrocardiogram or may operate asynchronously. The device delivers the electrical shock through paddles placed either directly across the heart or on the surface of the body.(2)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any DC-defibrillator (including paddles) described in paragraph (b)(1) of this section that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a DC-defibrillator (including paddles) described in paragraph (b)(1) of this section that was in commercial distribution before May 28, 1976. Any other DC-defibrillator (including paddles) described in paragraph (b)(1) of this section shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.