(125 days)
The Heart Sync Pediatric 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 pediatric patients whose weight is less than 25 kg. 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. 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.
The provided text describes the 510(k) summary for the "Heart Sync" Pediatric Radiotranslucent Multifunction Electrodes, model # Pediatric-100. The device's acceptance criteria are based on its substantial equivalence to a legally marketed predicate device.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Heart Sync device are primarily based on its substantial equivalence to the predicate device, Pad Pro K020288. Therefore, the "performance" is demonstrated by meeting the same standards and having comparable features and indications for use.
| Acceptance Criteria (Based on Substantial Equivalence to Predicate K020288) | Reported Device Performance (Heart Sync Pediatric-100) |
|---|---|
| Indications for Use: For use as disposable electrodes for semi-automatic and manual external defibrillators for monitoring, pacing, cardioversion, and defibrillation. | SAME (as per "Comparison Areas" table) |
| Where used: Hospitals and Paramedic situations. | SAME (as per "Comparison Areas" table) |
| Basic features: Radiotranslucent, non-sterile, latex-free, single patient use, self-adhesive, in sealed foil pouch. | SAME (as per "Comparison Areas" table) |
| Standard Met: 21CFR 898.12 Performance standard; ANSI/AAMI DF-39 (3.3.19) standard, self-adhesive electrodes for monitoring and defibrillation. | SAME (as per "Comparison Areas" table). The device "meets the standards referenced above." |
| Functionality: Capable of defibrillation, pacing, cardioversion, and monitoring. | Multifunction electrodes capable of defibrillation, pacing, cardioversion, and monitoring. |
| Compatibility: Compatible with Medtronic Physio Control, Zoll, Hewlett-Packard, Philips Medical, and Welch-Allyn models of monophasic and bi-phasic defibrillators, external pacemakers. | Compatible with Medtronic Physio Control, Zoll, Hewlett-Packard, Philips Medical, and Welch-Allyn models of monophasic and bi-phasic defibrillators, external pacemakers. |
| Patient Population: Pediatric patients whose weight is less than 25 kg. | Intended for use on pediatric patients whose weight is less than 25 kg. |
| Defibrillator Output: Intended for use on defibrillators whose output is classified as low power (360 joule maximum). | Intended for use on defibrillators whose output is classified as low power (360 joule maximum). |
| Pad Conductive Area: Predicate has 36.9 sq cm. | Heart Sync has 35.3 sq cm. (This is a difference, but not presented as failing an acceptance criterion, rather as a model differentiation). |
2. Sample Size Used for the Test Set and the Data Provenance
The provided text does not describe an explicit "test set" in the context of a clinical performance study with a defined sample size. The submission for the Heart Sync device relies on demonstrating substantial equivalence to a predicate device (Pad Pro K020288). This means that its performance is argued to be equivalent because its design, materials, and intended use are similar to a device already cleared by the FDA, and it meets the same recognized standards.
Therefore, there is no mention of a specific sample size, country of origin, or retrospective/prospective nature of data for a "test set" for the Heart Sync device itself. The "data provenance" would refer to the standards cited (e.g., 21CFR 898.12, ANSI/AAMI DF-39) which are generally established through extensive research and validation studies in the broader medical device industry.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
As there is no described "test set" or clinical study with independent ground truth establishment, this information is not applicable or available in the provided document. The ground truth for the predicate device would have been established through its own clearance process, but that information is not detailed here.
4. Adjudication Method for the Test Set
Since there is no described "test set" requiring expert review for ground truth, an adjudication method is not applicable or mentioned in the provided document.
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
The device described is a physical medical device (defibrillator electrodes), not an Artificial Intelligence (AI) software. Therefore, an MRMC comparative effectiveness study involving AI assistance is not applicable to this submission.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is a physical medical device (defibrillator electrodes), not an algorithm or AI software. Therefore, a standalone performance study of an algorithm is not applicable to this submission.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context is implicitly established through compliance with recognized performance standards (21CFR 898.12, ANSI/AAMI DF-39) and the demonstrated substantial equivalence to a legally marketed predicate device. The predicate device's safety and effectiveness would have been established through its own clearance process, which likely involved pre-clinical testing, possibly some clinical data, and compliance with relevant standards. The provided document does not detail specific "ground truth" through direct clinical outcomes data for the Heart Sync device.
8. The Sample Size for the Training Set
As there is no described AI algorithm involved, a "training set" for machine learning is not applicable to this submission.
9. How the Ground Truth for the Training Set Was Established
As there is no described AI algorithm involved, the establishment of ground truth for a "training set" for machine learning is not applicable to this submission.
§ 870.5300 DC-defibrillator (including paddles).
(a)
Low-energy DC-defibrillator —(1)Identification. A low-energy DC-defibrillator is a device that delivers into a 50 ohm test load an electrical shock of a maximum of 360 joules of energy used for defibrillating (restoring normal heart rhythm) the atria or ventricles of the heart or to terminate other cardiac arrhythmias. This generic type of device includes low energy defibrillators with a maximum electrical output of less than 360 joules of energy that are used in pediatric defibrillation or in cardiac surgery. The device may either synchronize the shock with the proper phase of the electrocardiogram or may operate asynchronously. The device delivers the electrical shock through paddles placed either directly across the heart or on the surface of the body.(2)
Classification. Class II (performance standards).(b)
High-energy DC-defibrillator —(1)Identification. A high-energy DC-defibrillator is a device that delivers into a 50 ohm test load an electrical shock of greater than 360 joules of energy used for defibrillating the atria or ventricles of the heart or to terminate other cardiac arrhythmias. The device may either synchronize the shock with the proper phase of the electrocardiogram or may operate asynchronously. The device delivers the electrical shock through paddles placed either directly across the heart or on the surface of the body.(2)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any DC-defibrillator (including paddles) described in paragraph (b)(1) of this section that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a DC-defibrillator (including paddles) described in paragraph (b)(1) of this section that was in commercial distribution before May 28, 1976. Any other DC-defibrillator (including paddles) described in paragraph (b)(1) of this section shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.