(14 days)
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.
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.
The provided text is a 510(k) summary for the "Heart Sync" C-100 and T-100 Multifunction Electrodes. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a standalone study with specific performance metrics against acceptance criteria. Therefore, much of the requested information, such as detailed acceptance criteria, specific device performance data, sample sizes for test and training sets, expert qualifications, and adjudication methods for ground truth, is not available in the provided document.
The document states that the device is "identical in function to the PadPro (K020203), and Katecho (K981737) and identical in design." It primarily relies on demonstrating compliance with recognized standards and similarity to these predicate devices.
However, I can extract and infer some information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally implied to be compliance with relevant standards and functional equivalence to predicate devices. Specific performance metrics for the Heart Sync electrodes are not reported in a quantitative manner but are stated to be "SAME" as the predicate devices in comparison areas.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Indications for Use (monitoring, pacing, cardioversion, defibrillation) | SAME as predicate devices |
| Where used (Hospitals and Paramedic situations) | SAME as predicate devices |
| Basic features (Radiotransparent/translucent, non-sterile, latex-free, single patient use, self-adhesive, sealed in foil pouch) | SAME as predicate devices |
| Standard met (21CFR 898.12 Performance standard; ANSI/AAMI DF-80 2003 standard) | Heart Sync meets these standards (Stated in Conclusion) |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. The submission relies on comparative analysis and compliance with standards rather than a specific clinical test set with a defined sample size for the Heart Sync device itself.
- Data Provenance: Not applicable in the context of a clinical test set for the Heart Sync device. The comparison is made against existing predicate device specifications and recognized standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. There is no mention of a test set requiring expert ground truth for the Heart Sync device in this document.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set
- Adjudication method: Not applicable. No test set requiring adjudication is described.
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
- MRMC Study: No. This device is an electrode for defibrillation, pacing, and monitoring, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human readers improving with AI assistance is not relevant or described.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance: Not applicable. The device is a physical medical device (electrodes), not an algorithm or AI system. Its performance is inherent to its physical properties and electrical conductivity, tested against physical standards.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Type of Ground Truth: Not directly applicable to the Heart Sync device's evaluation in this document. The "ground truth" for the device's acceptable performance is defined by its compliance with industry standards (21CFR 898.12, ANSI/AAMI DF-80 2003) and its substantial equivalence to legally marketed predicate devices.
8. The sample size for the training set
- Sample Size: Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Ground Truth Establishment: Not applicable. This is not an AI/ML device that requires a training set.
Summary of the Study Proving Acceptance Criteria:
The "study" demonstrating the device meets acceptance criteria is primarily a comparative analysis against predicate devices and compliance with recognized standards.
- Comparison: The Heart Sync electrodes are compared to PadPro (K020203) and Katecho (K981737). The document explicitly states they are "identical in function" and "identical in design" to these predicates. The comparison table confirms that indications for use, where used, and basic features are "SAME" as the predicate devices.
- Standards Compliance: The Heart Sync electrodes are stated to meet the "Performance standard" 21CFR 898.12 and the "ANSI/AAMI DF-80 2003 standard, self-adhesive electrodes for monitoring and defibrillation."
- Conclusion of Substantial Equivalence: Based on the comparison and standards compliance, the conclusion is that the Heart Sync System Defibrillator Electrodes are "substantially equivalent to other electrodes that are legally marketed for this purpose" and "The device meets the standards referenced above." This determination of substantial equivalence (as indicated by the FDA's letter) serves as the "proof" that the device meets the regulatory acceptance criteria for market clearance.
§ 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.