(159 days)
The MBSS charging station is used to charge NiCd or SLA batteries of the Lifepak®, Fastpak® and Fastpak 2® series manufactured by Medtronic - Physio Control.
The MBSS overall dimensions are 30 cm x 20 cm x 10 cm. It is available either as a table top model or wall mount unit. The table top model has a standard power cord which plugs into a 110 volt wall outlet and non-slip rubberized feet. The wall mount model has a bracket for mounting the charger on a vertical surface. For mounting and use in an automobile (ambulance or rescue vehicle), the wall mount bracket is used. Power requirements are either standard mains at 120 volts or standard automotive 12 volts. The charger is only used for charging specific batteries. The batteries are removed from the defibrillator and inserted into the MBSS charging bays. The MBSS is not attached to the defibrillator during operation.
The provided text describes a 510(k) premarket notification for the Mobile Battery Service Station (MBSS), a battery charging station for defibrillator batteries. It focuses on demonstrating substantial equivalence to predicate devices rather than a typical clinical study evaluating a diagnostic or therapeutic AI device.
Therefore, many of the requested categories (like sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable or directly derivable from this type of regulatory submission. The document primarily reports engineering and safety testing.
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance (as stated in the document) |
|---|---|
| Electrical Safety Standards | Complies with EN60601-1 |
| Electromagnetic Compatibility (EMC) Standards | Complies with EN60601-1-2 |
| UL Safety Standards | Complies with UL 60950 |
| Product Specification Conformance | Tests included: Operation of the charger, Battery recognition, Charge times, Appropriate displays, Impedance, Electrical safety, Electromagnetic interference. In all cases, the product test results met specification. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for specific tests (e.g., how many chargers, how many batteries, how many charge cycles). The testing appears to be product-level validation rather than a statistical sampling of a large population.
- Data Provenance: The testing was conducted by the manufacturer, AD Elektronik GmbH, likely at their facilities or through certified testing laboratories. The country of origin for the testing is implied to be Germany (where the submitter is located). The testing is prospective in the sense that it evaluates the newly manufactured device, but it is not a clinical study on human subjects or patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- Not applicable/Not mentioned. This is not a study requiring expert-established ground truth for performance evaluation (e.g., diagnosing a condition). The "ground truth" here is compliance with engineering standards and predefined product specifications.
4. Adjudication Method for the Test Set
- None. This concept is not relevant to the engineering and safety testing described. The tests are pass/fail based on meeting predefined technical specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. This is not a clinical or diagnostic imaging device studied with human readers.
6. Standalone Performance Study (Algorithm only without human-in-the-loop performance)
- Yes (inherently). The described testing focuses solely on the performance of the MBSS device itself (e.g., charging function, safety compliance) as a standalone unit. There is no human interaction element in the performance evaluation described, beyond technicians operating the test equipment and assessing results against specifications.
7. Type of Ground Truth Used
- Engineering Specifications and Regulatory Standards. The "ground truth" for this device's performance is its ability to meet documented technical specifications (e.g., charge times, impedance) and adhere to established electrical safety (EN60601-1, UL 60950) and electromagnetic compatibility (EN60601-1-2) standards.
8. Sample Size for the Training Set
- Not applicable. This device is a hardware charging station, not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As above, no training set is involved.
§ 870.5310 Automated external defibrillator system.
(a)
Identification. An automated external defibrillator (AED) system consists of an AED and those accessories necessary for the AED to detect and interpret an electrocardiogram and deliver an electrical shock (e.g., battery, pad electrode, adapter, and hardware key for pediatric use). An AED system analyzes the patient's electrocardiogram, interprets the cardiac rhythm, and automatically delivers an electrical shock (fully automated AED), or advises the user to deliver the shock (semi-automated or shock advisory AED) to treat ventricular fibrillation or pulseless ventricular tachycardia.(b)
Classification. Class III (premarket approval)(c)
Date PMA or notice of completion of PDP is required. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED that was in commercial distribution before May 28, 1976. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976. Any other AED and AED accessory described in paragraph (a), shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.