(64 days)
The Cardio Med DEFIBRILLATION/CARDIOVERSION/MONOPHASIC OR BIPHASIC PACING/ ECG 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 Cardiac Science (ANDERSON connectors), PHILIPS MEDICAL, PHYSIO-CONTROL, and ZOLL MEDICAL models of monophasic and bi-phasic defibrillators, external pacemakers.
These are single use, non-sterile, self stick defibrillator electrodes packaged in pairs. 104 cm² (16.1 in²) They are radiotranslucent. They come in various connector styles to match the specific defibrillator. (See intended use statement below.) 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.
Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and study proving device performance:
1. Table of Acceptance Criteria and Reported Device Performance
The device (Cardio Med DEFIBRILLATION/CARDIOVERSION/MONOPHASIC OR BIPHASIC PACING/ECG ELECTRODES) was tested against the AAMI Standard ANSI/AAMI DF80:2003.
| Test | Acceptance Criteria (Pre-Pacing Limits) | Acceptance Criteria (Post-Pacing Limits) | Reported Device Performance |
|---|---|---|---|
| DC Offset | ≤100 mV | ≤650 mV | All units passed |
| Offset Instability and Noise | ≤100 μV | ≤100 μV | All units passed |
| AC Small Signal Impedance (10 Hz) | ≤3,000 Ohms | ≤3,000 Ohms | All units passed |
| AC Small Signal Impedance (30 kHz) | ≤5 Ohms | ≤5 Ohms | All units passed |
| AC Large Signal Impedance | ≤3 Ohms | ≤3 Ohms | All units passed |
| Defib Overload Recovery (At 4 seconds) | ≤400 mV | ≤650 mV | All units passed |
| Defib Overload Recovery (At 60 seconds) | ≤300 mV | ≤500 mV | All units passed |
Additionally, the device was subjected to an accelerated age shelf life test:
- Acceptance Criteria: Maintain compliance with the above AAMI tests after 36 months of accelerated aging.
- Reported Device Performance: All units passed the tests after the accelerated age shelf life test.
Furthermore, Biocompatibility testing was performed on the patient contact material Hydrogel, and the material passed.
Finally, Compliance with the FDA performance standard for touch-proof ECG connectors was verified by inspection.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set:
- For the AAMI electrical performance tests: Three different lots, with six samples each (total of 18 samples).
- For the 36-month accelerated age shelf life test: Three different lots, with two samples each (total of 6 samples).
- For Biocompatibility testing: Not specified, but performed on the patient contact material (hydrogel).
- For Connector compliance: Verified by inspection of the connectors (number of units not specified).
- Data Provenance: The nature of these tests (bench testing, accelerated aging, biocompatibility) indicates that the data is prospective and generated in a laboratory setting, rather than being collected from patients. The country of origin for the data is not explicitly stated in the provided text.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of submission is for a medical device (defibrillator electrodes) and primarily relies on bench testing against established industry standards (AAMI Standard ANSI/AAMI DF80:2003) and conformance to FDA performance standards for connectors.
- Experts for Ground Truth: There is no mention of human expert consensus being used to establish a "ground truth" for the performance of these basic electrical and material properties tests. The "ground truth" is defined by the objective, quantifiable limits set forth in the AAMI standard itself and FDA regulations for connectors. The testing would be conducted by qualified laboratory personnel, but their role is to measure and report, not to interpret complex clinical data for ground truth establishment.
4. Adjudication Method for the Test Set
Not applicable. As described above, the determination of "passing" is based on objective measurements against pre-defined numerical limits in a standard, not on the subjective interpretation of expert reviewers that would require an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI Improvement
No. This submission is for a physical medical device (defibrillator electrodes), not an AI algorithm. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant and was not performed.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No. This is not an AI algorithm.
7. The Type of Ground Truth Used
The ground truth used for proving the device meets acceptance criteria is based on:
- Industry Standards: Specifically, the AAMI Standard ANSI/AAMI DF80:2003 for electrical performance characteristics of defibrillator electrodes.
- FDA Regulations/Performance Standards: For "touch-proof" ECG connectors and biocompatibility.
- Objective Measurements: These standards define quantifiable limits (e.g., ≤100 mV for DC Offset, ≤3,000 Ohms for AC Small Signal Impedance) against which the device's measured performance is compared.
8. The Sample Size for the Training Set
Not applicable. As this is not an AI/algorithm-based device, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device 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.