HEART SYNC PEDIATRIC, MODEL PED-100

K081442 · Heart Sync, LLC · LDD · Sep 24, 2008 · Cardiovascular

Device Facts

• Record ID: K081442
• Device Name: HEART SYNC PEDIATRIC, MODEL PED-100
• Applicant: Heart Sync, LLC
• Product Code: LDD · Cardiovascular
• Decision Date: Sep 24, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5300
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

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 Story

Heart Sync Pediatric Radiotranslucent Multifunction Electrodes serve as conductive interface between patient skin and external defibrillators/pacemakers. Device consists of disposable, self-adhesive pads with polymer adhesive gel for uniform current distribution. Used in hospitals and paramedic settings for defibrillation, pacing, cardioversion, and monitoring. Radiotranslucent design allows pads to remain on patient during imaging procedures. Clinicians apply electrodes to patient and connect to compatible monophasic or bi-phasic defibrillator/pacemaker units. Facilitates effective energy delivery for cardiac therapy.

Clinical Evidence

No clinical data. Substantial equivalence based on design, intended use, and adherence to performance standards (21 CFR 898.12; ANSI/AAMI DF-39).

Technological Characteristics

Non-sterile, disposable, self-adhesive electrodes. Features polymer adhesive gel for current distribution. Radiotranslucent construction. Compatible with monophasic and bi-phasic defibrillators/pacemakers. Meets 21 CFR 898.12 and ANSI/AAMI DF-39 standards.

Indications for Use

Indicated for pediatric patients weighing less than 25 kg requiring external pacing, defibrillation, cardioversion, or monitoring. Compatible with low-power (max 360J) monophasic and bi-phasic defibrillators and external pacemakers.

Regulatory Classification

Identification

Low-energy DC-defibrillator: 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. High-energy DC-defibrillator: 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.

Predicate Devices

• Pad Pro (K020288)

Submission Summary (Full Text)

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SEP 2 4 2008

## EXHIBIT 2

Heart Sync Inc. 5643 Plymouth Rd. Ann Arbor, Mi 48105 Phone: [phone] Fax: [phone] 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

- 2. 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.

- 4. 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"<br>Pediatric<br>PEDIATRIC-100 |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|
| Indications for use | For use as disposable electrodes for<br>Semi-automatic and manual external<br>defibrillators for monitoring, pacing,<br>cardioversion, and defibrillation | SAME |
| Where used | Hospitals and Paramedic situations | SAME |
| Basic features | Radiotranslucent, non sterile, latex<br>free, single patient use, self<br>adhesive, in sealed foil pouch. | SAME |
| Standard met | 21CFR 898.12 Performance standard;<br>ANSI/AAMI DF-39 (3.3.19)<br>standard, self adhesive electrodes for<br>monitoring and defibrillation | SAME |

- 6. 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 [phone]. 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 [phone] or [phone] 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

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.

Prescription Use X

OR

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.