(77 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, PHYSIOCONTROL, 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. Effective electrode area = 98 cm2 (15.2 in2). They are radiotransparent. They come in various 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.
Acceptance Criteria and Device Performance Study for Cardio Med Defibrillation/Cardioversion/Monophasic or Biphasic Pacing/ECG Electrodes (K103154)
1. Table of Acceptance Criteria and Reported Device Performance
The Cardio Med Defibrillation/Cardioversion/Monophasic or Biphasic Pacing/ECG Electrodes were tested against the AAMI Standard ANSI/AAMI DF80:2003 for defibrillator pads.
| Test | Acceptance Criteria (Pre-Pacing Limits) | Acceptance Criteria (Post-Pacing Limits) | Reported Device Performance (Pre-Pacing) | Reported Device Performance (Post-Pacing) |
|---|---|---|---|---|
| DC Offset | $\leq$ 100 mV | $\leq$ 100 mV | Passed | Passed |
| Offset Instability and Noise | $\leq$ 150 μV | $\leq$ 150 μV | Passed | Passed |
| AC Small Signal Impedance (10 Hz) | $\leq$ 2,000 Ohms | $\leq$ 2,000 Ohms | Passed | Passed |
| AC Small Signal Impedance (30 kHz) | $\leq$ 5 Ohms | $\leq$ 5 Ohms | Passed | Passed |
| AC Large Signal Impedance | $\leq$ 2 Ohms | $\leq$ 2 Ohms | Passed | Passed |
| Defib Overload Recovery (at 4 seconds) | $\leq$ 400 mV | $\leq$ 400 mV | Passed | Passed |
| Defib Overload Recovery (at 60 seconds) | $\leq$ 300 mV | $\leq$ 300 mV | Passed | Passed |
| Biocompatibility | Passed Biocompatibility Testing | N/A | Passed | N/A |
| Connector Compliance | "Touch-proof" (FDA Performance Standard) | N/A | Passed | N/A |
2. Sample size used for the test set and the data provenance
Sample Size: For the AAMI bench tests, three different lots were used, with six samples from each lot subjected to the tests. Additionally, the same testing routine (three lots, two samples each) was applied to a 36-month accelerated age shelf life test.
Data Provenance: The data is reported from nonclinical bench testing performed by the manufacturer, Cardio Medical Products, Inc. This is prospective data generated specifically for the premarket notification. The country of origin of the data is not explicitly stated in the provided text but is implied to be within the United States, given the FDA submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This study involved bench testing against established engineering standards (AAMI, FDA performance standard). It did not involve human interpretation or subjective assessment of medical images or patient data. Therefore, there were no experts used to establish ground truth in the context of medical diagnosis or interpretation for this specific type of device testing. The "ground truth" was the objective measurement against the specified engineering limits.
4. Adjudication method for the test set
Not applicable. As this was bench testing against objective engineering standards, there was no subjective judgment or adjudication required. Each test result was either within the specified limits ("Passed") or not.
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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a defibrillator electrode and does not involve AI or human interpretation of medical data in its primary function.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical device (defibrillator electrode), not an algorithm or AI software. Therefore, no standalone algorithm-only performance study was conducted.
7. The type of ground truth used
The ground truth used was based on objective engineering and performance standards established by the Association for the Advancement of Medical Instrumentation (AAMI Standard ANSI/AAMI DF80:2003) and FDA performance standards for ECG connectors. For biocompatibility, the ground truth was meeting established biocompatibility testing protocols for patient contact materials.
8. The sample size for the training set
Not applicable. This is a physical medical device. There was no machine learning or AI algorithm that required a "training set."
9. How the ground truth for the training set was established
Not applicable, as there was no training set for this device.
§ 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.