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 Description

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.

AI/ML Overview

The provided 510(k) summary for K131550 describes Sterile Defibrillator Pads. This submission focuses on demonstrating substantial equivalence to a predicate device (K080421, Heart Sync C-100/T-100) for a sterile version of an already marketed product. Therefore, the "study" described is primarily a non-clinical bench testing and biocompatibility study to confirm that the new sterile version performs equivalently to the non-sterile predicate and meets relevant standards.

Here's an analysis of the provided information, addressing your specific questions:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Standard / Test)	Reported Device Performance
AAMI Standard ANSI/AAMI DF80:2003	"All units passed these testing routine was applied to a 30 month accelerated age shelf life test. All units passed the tests."
- DC offset instability	Passed (implied by above)
- AC small signal impedance	Passed (implied by above)
- AC large signal impedance	Passed (implied by above)
- Defibrillator overload	Passed (implied by above)
FDA Performance Standard for Touch-Proof ECG Connectors	"Compliance with the FDA performance standard was verified by inspection of the connectors."
Biocompatibility Testing (on patient contact material)	"Biocompatibility testing was performed on the patient contact material passed biocompatibility testing."
Sterilization Validation (ANSI/AAMI/ISO 11137-2)	"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"
Performance Testing on Attenuator System (compared to predicate)	"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."
Accelerated Age Shelf Life (30 months)	"All units passed these testing routine was applied to a 30 month accelerated age shelf life test. All units passed the tests."

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

The document states, "Various different lots containing multiple samples each were subjected to the AAMI tests..." It does not specify an exact numerical sample size for the test set.

Data Provenance: The testing appears to be prospective bench testing conducted by Heart Sync, Inc. The country of origin for the data is not explicitly stated but can be inferred as the United States, given the company's location and FDA submission.

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

Not applicable (N/A). This submission pertains to a medical device (defibrillator pads), not an AI or diagnostic imaging device that requires expert ground truth establishment for a test set. The "ground truth" here is defined by objective engineering standards (AAMI, FDA, ISO) and laboratory measurements, not human interpretation.

4. Adjudication Method for the Test Set

Not applicable (N/A). Since the testing involves objective measurements against engineering standards, there is no need for adjudication by multiple human experts. The pass/fail criteria are defined by the standards themselves.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a MRMC comparative effectiveness study was not done. This type of study is typically conducted for AI-powered diagnostic tools to assess the impact of AI on human reader performance. Defibrillator pads are a therapeutic device, not a diagnostic one that involves human image or data interpretation.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable (N/A). This device does not involve an algorithm. Its performance is assessed through physical and electrical bench testing, and its function is to provide a conductive interface for defibrillation and pacing, not to perform an algorithmic function.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on objective engineering and biocompatibility standards.

AAMI Standard ANSI/AAMI DF80:2003: Performance criteria for defibrillator electrodes.
FDA Performance Standard for Touch-Proof ECG Connectors: Safety and performance criteria for connectors.
ANSI/AAMI/ISO 11137-2: Sterilization validation standard.
Biocompatibility testing against established biological safety criteria.
Direct comparison to the predicate device for attenuator system performance.

8. The Sample Size for the Training Set

Not applicable (N/A). This device is not an AI or machine learning algorithm, so there is no concept of a "training set."

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

Not applicable (N/A). As there is no training set for an algorithm, there is no ground truth to establish for it.

Summary

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510(k) Summary K131550

(1) Submitter: Heart Sync, Inc. 5643 Plymouth Road Ann arbor, MI 48105 TEL 800-828-4681 FAX 734-213-5640 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 (800) 638-2041 or (301) 796-7100 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 (800) 638 2041 or (301) 796-7100 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:

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'

Page 1 of 1

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.