(34 days)
The 700-F series electrodes are disposable electrodes for external cardiac stimulation and monitoring. Electrodes of this design are suitable for external pacing, external defibrillation, synchronized cardioversion and ECG monitoring. The expected patient population for the use of these devices includes adults and children. The environment for use includes all areas of the hospital, ambulance, and prehospital (paramedic) situations. The duration for use is to be less than 24 hours. Individual catalog numbers are labeled for more specific use based primarily on the Interface connector and cable system which defines the host external device, such as an external defibrillator.
The devices covered by this premarket notification provide an interface from the skin to a number diagnostic or therapeutic devices and are labels with one or more of the following intended uses:
External Defibrillation
External Pacing
ECG Monitoring
Synchonized Cardioversion
The 700-F Series electrodes consist of a foam backing material, a laminated metallic substrate which is covered by a conductive adhesive (hydrogel). This hydrogel is then surrounded by an adhesive coated foam ring and covered by a removable release liner. The electrodes have an integral lead wire for attachment to the interface cable of the defibrillator/pacemaker/monitor.
Upon use, the release liner is removed from the electrode, exposing the hydrogel and adhesive areas. Each electrode of the set is then applied to the patient's chest in the selected set and pressed to ensure adhesion. The electrode is then attached to the host device via the interface cable and treatment is new accordance with established protocols.
The 700-F Series electrodes are produced in two basic styles; Adult and Child. Leadwire sets having various lengths and interface connectors are added to the basic electrode styles to obtain many combinations of end product design. The product line is further differentiated through trade name and OEM identification.
The provided text is a 510(k) summary for the Cardiotronics Systems 700-F Series Disposable Cardiac Stimulation/Monitoring Electrodes. This document describes the device, its intended use, and substantial equivalence to a predicate device, focusing on bench testing, biocompatibility, and limited animal testing.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly list acceptance criteria in a quantitative table format. Instead, it states that the device's performance was evaluated against specific standards and general suitability.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Electrical Performance | Conformance to ANSI/AAMI DF-39 subsection 3.3.19. The text states: "These test show the 700-F series electrodes to be suitable for the uses and environment specified." and "Substantial equivalence has been determined primarily on the basis of electrical performance results in conformance to the AAMI standard DF39 (Subsection 3.3.19)". |
| Mechanical Performance | "A number of mechanical performance parameters developed by the manufacturer." The text states: "These test show the 700-F series electrodes to be suitable for the uses and environment specified." |
| Biocompatibility (Hydrogel) | Cytotoxicity: Passed. |
| Primary Skin Irritation: Passed. | |
| Delayed Contact Sensitization: Passed. | |
| The text states: "These tests showed all materials which contact the skin to be biocompatible." | |
| Biocompatibility (Foam Ring) | Primary Skin Insult Patch test: Passed. |
| The text states: "These tests showed all materials which contact the skin to be biocompatible." | |
| Animal Study (Live Pigs) | Effectiveness at delivering energy: Demonstrated. |
| Ability to sense clear ECG signal: Demonstrated. | |
| No significant skin changes during or after energy delivery: Ensured. | |
| The text states: "to demonstrate effectiveness at delivering energy, ability to sense clear ECG signal and to ensure that these electrodes do not contribute to any significant skin changes during or ofter the delivery of energy." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document mentions "a limited number of electrodes were tested on live pigs" for the animal study. For bench testing (electrical and mechanical), biocompatibility, the specific number of units tested is not provided.
- Data Provenance: The animal study was conducted on "live pigs." The location (country of origin) is not specified. The studies appear to be prospective, specifically designed to test the new device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable and therefore not provided in the document. The studies described are technical performance evaluations (bench and animal) rather than human-expert-driven evaluations requiring ground truth establishment by experts in the context of diagnostic interpretations.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
Not applicable. As described above, the studies involve direct measurement of device performance, not interpretation by human experts.
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
Not applicable. The device is a physical electrode, not an AI or diagnostic tool that would involve human readers or AI assistance in interpretation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an electrode, not an algorithm. However, the bench and animal tests can be considered "standalone" in the sense that they evaluate the device's technical performance directly, without human "in-the-loop" interpretation for the ground truth establishment.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for these studies is based on:
- Established Standards: Conformance to ANSI/AAMI DF-39 for electrical performance.
- Manufacturer-Developed Parameters: For mechanical performance.
- Biocompatibility Standards: Implicitly, standard methods for cytotoxicity, irritation, and sensitization tests.
- Direct Observation/Measurement: In the animal study, effectiveness in energy delivery, ECG signal sensing, and absence of skin changes would be directly observed or measured against expected physiological responses.
8. The Sample Size for the Training Set
Not applicable. This device is an electrode, not an AI model that requires a "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable for the same reason as point 8.
§ 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.