(191 days)
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.
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.
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.
§ 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.