HEART SYNC

K131550 · Heart Sync, Inc. · MKJ · Dec 6, 2013 · Cardiovascular

Device Facts

• Record ID: K131550
• Device Name: HEART SYNC
• Applicant: Heart Sync, Inc.
• Product Code: MKJ · Cardiovascular
• Decision Date: Dec 6, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5310
• Device Class: Class 3
• Attributes: Therapeutic

Intended Use

The Heart Sync Sterile Adult Radio Transparent Multi Function Electrodes are indicated for use in external pacing, defibrillation and monitoring applications as a 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 Physio Control, Zoll, and "Anderson" adapted models of monophasic and bi-phasic defibrillators.

Device Story

Single-use, sterile, self-stick, radiotransparent defibrillator electrodes; conductive hydrogel interface; connects patient skin to external defibrillator or transcutaneous pacemaker. Used in clinical settings for adult patients requiring defibrillation, cardioversion, or pacing. Device facilitates energy delivery from defibrillator to patient; enables ECG monitoring. Operator (clinician) applies pads to patient chest; connects to compatible defibrillator (Physio Control, Zoll, Anderson). Benefits include sterile application for patient safety and radiotransparency for imaging compatibility.

Clinical Evidence

Bench testing only. Testing included AAMI standards for DC offset instability, AC small signal impedance, AC large signal impedance, and defibrillator overload. Biocompatibility testing performed on patient contact material. Shelf-life validated via 30-month accelerated aging. Sterilization validated per ANSI/AAMI/ISO 11137-2. Performance compared to non-sterile predicate showed excellent correlation.

Technological Characteristics

Conductive adhesive hydrogel patient contact material; radiotransparent construction. Connectors meet FDA performance standards for touch-proof ECG connectors. Complies with ANSI/AAMI DF80:2003. Sterilization via radiation per ANSI/AAMI/ISO 11137-2. No software or active electronic components.

Indications for Use

Indicated for adult patients requiring external pacing, defibrillation, or cardioversion. Used as a conductive interface between the patient's skin and a low-power (max 360J) defibrillator or noninvasive cardiac pacemaker.

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

• Heart Sync C-100/T-100 (K080421)

Submission Summary (Full Text)

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## 510(k) Summary K131550

(1) Submitter: Heart Sync, Inc. 5643 Plymouth Road Ann arbor, MI 48105 TEL [phone] FAX [phone] Contact: Stephen Shulman, President Date prepared: May 20, 2013

DEC 0 6 2013

- (2) The name of the device: Sterile Defibrillator Pads, STERILE-C100; STERILE-C100-PHYSIO: STERILE-C100-ZOLL. Common or usual name: Single Use Sterile Defibrillator Pad
Classification name:/Product Code MKJ/MLN, Class III

- (3) Predicate devices: Identical to K080421, Heart Sync C-100/T-100 in materials and construction, except now available sterile.
- (4) Description of the device: These are single use, sterile, self stick defibrillator electrodes packaged in pairs. Effective electrode area = Conductive Area: 195.98 Sq.cm. They are radiotransparent. They come in three connector styles to match the specific defibrillator. The construction and materials employed are identical to the predicate. The patient contact material is a conductive adhesive hydrogel identical to the material used in the predicate devices. These pads meet the AAMI Standard ANSI/AAMI DF80:2003 and the connectors meet the FDA performance standard for touch proof ECG connectors.
- (5) Statement of the intended use of the Heart Sync Sterile Adult Radio Transparent Multi Function Electrodes are indicated for use in external pacing, defibrillation and monitoring applications as a 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 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 Physio Control, Zoll, and "Anderson" adapted models of monophasic and bi-phasic defibrillators.
- (6) This device has the same technological characteristics (i.e., design, material, chemical composition, energy source) as the predicate device. The defibrillator pads meet the AAMI and FDA performance standards for this type of device.
- (7) Discussion of the nonclinical tests submitted, referenced, or relied on in the premarket notification submission for a determination of substantial equivalence: Bench testing summary: Various different lots containing multiple samples each were subjected to the AAMI tests for DC offset instability, AC small signal impedance, AC large signal impedance, defibrillator overload. All units passed these testing routine was applied to a 30 month accelerated age shelf life test. All units passed the tests. Biocompatibility testing was performed on the patient contact material passed biocompatibility testing. Compliance with the FDA performance standard was verified by inspection of the connectors. (Connectors must be "touch-proof."). Performance testing on the attenuator system for both types of pads was performed and testing compared performance directly with the attenuator predicates showing excellent correlation of results. Testing was conducted post-sterilization was validated per ANSI/AAMI/ISO ISO 11137-2 ANSI/AAMI/ISO Sterilization of Heath Care Products - Radiation - Establishing the sterilization dose
- (8) Conclusion: Based on the results of the nonclinical tests (that demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device) we conclude that these defibrillator pads are as safe and effective as the predicates identified in paragraph (3). Furthermore, the materials and construction methods are identical to the predicate.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Public Health Service

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

December 6, 2013

Heart Sync Inc. % Daniel Kamm, P.E. Kamm & Associates 8870 Ravello Ct Naples, FL 34114 US

Re: K131550

> Trade/Device Name: Sterile C-100 family of multi-function electrodes Regulation Number: 21 CFR 870.5310 Regulation Name: Automated External Defibrillators (Non-Wearable) Regulatory Class: Class III Product Code: MKJ Dated: November 9, 2013 Received: November 13, 2013

Dear Mr. Daniel Kamm:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 - Daniel Kamm

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Owen P. Earis -S

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): K131550

Device Name: Sterile Defibrillator Pads, STERILE-C100; STERILE-C100-PHYSIO; STERILE-C100-ZOLL.

#### Indications for Use:

The Heart Sync Sterile Adult Radio Transparent Multi Function Electrodes are indicated for use in external pacing, defibrillation and monitoring applications as a 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 Physio Control, Zoll, and "Anderson" adapted models of monophasic and bi-phasic defibrillators.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (Part 21 CFR 807 Subpart C)

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

### Concurrence of CDRH, Office of Device Evaluation (ODE)

Digitally signed by Owen P. Faris -5
Date: 2013.12.06 12:18:09 -05'00'

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