HEART SYNC, MODELS C-100 AND T-100

K080421 · Heart Sync, LLC · MKJ · Feb 29, 2008 · Cardiovascular

Device Facts

• Record ID: K080421
• Device Name: HEART SYNC, MODELS C-100 AND T-100
• Applicant: Heart Sync, LLC
• Product Code: MKJ · Cardiovascular
• Decision Date: Feb 29, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5310
• Device Class: Class 3
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

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).

Device Story

Heart Sync C-100 (radiotransparent) and T-100 (radiotranslucent) are disposable, non-sterile, self-adhesive multifunction electrodes. They serve as the conductive interface between a patient's skin and external defibrillators or transcutaneous pacemakers. The electrodes utilize a polymer adhesive gel to ensure uniform current distribution during defibrillation, cardioversion, or pacing. Designed for use in hospitals and paramedic settings, they are compatible with various monophasic and bi-phasic defibrillator models from manufacturers including Physio Control, Zoll, Hewlett-Packard, Philips, and Welch-Allyn. The radiotransparent/translucent design allows the electrodes to remain on the patient during diagnostic imaging. The device is intended for single-patient use on adults.

Clinical Evidence

Bench testing only. The device demonstrates compliance with 21 CFR 898.12 and ANSI/AAMI DF-80 2003 standards for self-adhesive electrodes used in monitoring and defibrillation.

Technological Characteristics

Multifunction electrodes featuring polymer adhesive gel for current distribution. Radiotransparent (C-100) and radiotranslucent (T-100) variants. Latex-free. Compliant with ANSI/AAMI DF-80 2003 and 21 CFR 898.12. Compatible with monophasic and bi-phasic defibrillators up to 360 joules.

Indications for Use

Indicated for adult patients requiring external pacing, defibrillation, cardioversion, or ECG monitoring. Used as a conductive interface between the patient's skin and external defibrillators or transcutaneous pacemakers (max 360 joules).

Regulatory Classification

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.

Predicate Devices

• PadPro (K020203)
• Katecho (K981737)

Submission Summary (Full Text)

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Kosoyzl

## EXHIBIT 2

Heart Sync

FEB 2 9 2008

LLC. 5643 Plymouth Rd. Ann Arbor, Mi 48105 Phone: [phone] Fax: [phone] 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

- 2. Equivalent legally marketed devices: This is identical in function to the PadPro (K020203), and Katecho (K981737) and identical in design.
- 3. 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).
- 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. 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.

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Model differentiation:

| vioder | But the designed and the contraction of the contribution of the contribution of the comments of the contribution of the contribution of the contribution of the contribution o<br>. Feature/difference | |
|--------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| ( | ransparent to x-ray | |
| | ranslucent to x-ray<br>Status Canadian Career Station Company of Children Company of | |
| COLOR OF ANY | .<br>Non-Amore, Andrew | |

- 5. Safety and Effectiveness, comparison to predicate device:

| Comparison Areas | PadPro (K020203), and Katecho<br>(K981737) | "Heart Sync" C-100<br>and T-100 Electrodes |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|
| Indications for use | For use as disposable electrodes for<br>automatic and manual external<br>defibrillators for monitoring, pacing,<br>cardioversion, and defibrillation | SAME |
| Where used | Hospitals and Paramedic situations | SAME |
| Basic features | Radiotransparent and or<br>Radiotranslucent, non sterile, latex<br>free, single patient use, self<br>adhesive, in sealed foil pouch. | SAME |
| Standard met | 21CFR 898.12 Performance<br>standard; ANSI/AAMI DF-80 2003<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/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 [phone]. 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 [phone] or [phone] 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:

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.

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

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