(171 days)
EURO DEFI PADS series of disposable multi-function electrodes are indicated for the following clinical applications:
- external defibrillation
- synchronized cardioversion
- cardiac stimulation
- ECG monitoring
EURO DEFI PADS series of disposable multi-function electrodes provide the conductive interface between the defibrillator and the patient's skin. These devices are available with different connectors compatible for use with different defibrillators. All devices are non-sterile and for single-use only.
The pediatric model of EURO DEFI PADS disposable multi-function electrodes is intended for use on pediatric patient under eight years of age, or weighting less than 25 kg, the device is designed to deliver a maximum of 100 joule.
The adult model of EURO DEFI PADS disposable multi-function electrodes is intended for use on adult patients and children older than eight years or greater than 25 kg, the device is designed to deliver a maximum of 360 joule.
The radio-transparent adult model EURO DEFI PADS disposable multi-function electrodes for adult patient use only, is well suited for certain clinical applications involving radiographic viewing.
FIAB EURO DEFI PADS series of disposable multi-function electrodes are made by a couple of pre-gelled self-adhesive pad-type electrodes consisting of foam backing, laminated metallic substrate, conductive hydrogel, cabling and molded connector. The electrodes are passive devices providing the conductive interface between the defibrillator and the patient's skin. Each couple of electrodes is permanently attached with lead wires that join together in a safety connector suitable for direct connection to devices - both monophasic and biphasic of the main defibrillators brands nowadays present on the market.
The products are packaged in pairs inside water-vapor proof, heat sealed, non-transparent, aluminum/PE pouches.
FIAB EURO DEFI PADS series of disposable multi-function electrodes are available in the following versions: adult, adult radiotransparent, pediatric.
This submission is for a medical device that is substantially equivalent to existing predicate devices, rather than a diagnostic AI algorithm. Therefore, the questions related to AI performance metrics, sample sizes for training/test sets, expert ground truth, and comparative effectiveness studies are not applicable in this context. The acceptance criteria and study detailed below refer to the substantial equivalence requirements for traditional medical devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | FIAB EURO DEFI PADS Performance |
|---|---|---|
| Intended Use | Same as predicate devices: external defibrillation, synchronized cardioversion, cardiac stimulation, ECG monitoring. | Meets: "FIAB EURO DEFI PAD electrodes have the same intended use as the predicate device." |
| Design, Materials, Packaging, Labeling | No technical differences compared to predicate devices. | Meets: "There are no technical differences in the design, materials, packaging, and labeling compared to the predicate." |
| Defibrillation Performance Standards | Meet 21 CFR 898.12 and ANSI/AAMI DF80:2003 standards. | Meets: "The defibrillation pads meet the standards referenced above." and "Testing was conducted to meet AAMI/ANSI standard DF80:2003. The FIAB Euro Defi Pads passed the tests related to defibrillation pads." |
| Biocompatibility | Pass ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation and delayed-type hypersensitivity). | Meets: "The results were reported as passing by the NAMSA organization and are congruent with the predicate device." |
| Component Compatibility | Ensure interoperability with listed defibrillators, pacers, and monitors (assessment of insertion/extraction forces, energy delivery, simulated heartbeat monitoring). | Meets: "Compatibility testing was conducted to ensure interoperability between the FIAB Euro Defi Pads and the listed defibrillators, pacers, and monitors." |
| Risk-Benefit Analysis | Risk must be deemed acceptable according to ISO 14971 standards. | Meets: "According to the risk-benefit analysis (ISO 14971 standards), the risk has been deemed acceptable." |
| Shelf-Life | Assure a shelf life of 30 months. | Meets: "Accelerated age testing was conducted to assure a shelf life of 30 months." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The submission does not specify a "test set" in the context of an AI algorithm or a clinical trial with a defined patient population. Rather, the "tests" refer to engineering and biological evaluations performed on the device itself.
- Sample size: Not explicitly stated for each test, but standard procedures for medical device testing within ISO and AAMI standards would involve a sufficient number of samples to ensure statistical validity for the specific test (e.g., adequate electrodes for biocompatibility, multiple units for electrical or compatibility testing).
- Data provenance: The testing was conducted by NAMSA (for biocompatibility) and likely by FIAB SpA or a contracted laboratory for other tests. The manufacturer is FIAB SpA, located in Florence, Italy. The data is prospective for these specific tests as they were performed to validate the device for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is not an AI diagnostic device where expert ground truth is established for image/data interpretation. Ground truth for device performance is established by adherence to recognized national and international standards (e.g., AAMI/ANSI, ISO) and laboratory testing protocols.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not an AI diagnostic device requiring human adjudication of performance outcomes. Device performance is determined by meeting predefined technical specifications and standards (e.g., passing electrical tests, biocompatibility results).
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. This is not an AI diagnostic device. No human-in-the-loop performance or MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm. The device, when used, is always "human-in-the-loop" as it requires a medical professional to apply and operate it with a defibrillator.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this medical device's performance is its adherence to established engineering, safety, and biocompatibility standards, and its functional equivalence to legally marketed predicate devices. This includes:
- Standard adherence: Compliance with 21 CFR 898.12, ANSI/AAMI DF80:2003, and ISO 10993 (biocompatibility).
- Predicate device comparison: Demonstrating that the device has the "same intended use," "no technical differences in the design, materials, packaging, and labeling" to the predicate, and performs as expected for its clinical applications.
- Laboratory testing results: Objective measurements from tests like biocompatibility, component compatibility (e.g., insertion/extraction forces, energy delivery), and electrical standards compliance.
8. The sample size for the training set
Not applicable. This is a medical device, not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is a medical device, not an AI algorithm that requires a training set.
§ 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.