(158 days)
To power the functions of various devices for which batteries or battery packs are configured.
Since non-rechargeable batteries and battery packs are "device specific" and are designed to operate and fit into the equipment for which they were manufactured, only qualified personnel should evaluate, test, or install these devices.
This battery is shipped only to customers who request a replacement battery for a PhysioControl LP500 AED (OEM P/N: 3005380-026, 11141-00013) or to replace a competitor's replacement battery for the same AED.
Biomedical equipment service professionals therefore know that the intended use is as a replacement battery.
Non-rechargeable battery packs are utilized as a primary direct current (d-c) power source or as a standby or backup d-c power source for portable as well as stationary medical equipment. These devices provide a means of supplying electrical power through chemical reaction. The energy provided depends upon the voltage and capacity rating of a particular pack and the amount of current used by the device into which they are installed. The performance and life span of these batteries depends on operating conditions of temperature, current drain, and the discharge method. These parameters are taken into account in designing such batteries. The goal is to develop battery packs that maintain capacity for as high and as long as possible under a specified range of environmental conditions.
This document is a 510(k) summary for a replacement battery pack, not a comparative effectiveness study or a standalone AI algorithm performance study. Therefore, it does not contain the detailed information requested regarding acceptance criteria, study design for proving equivalence, and information about AI model testing.
Here's a breakdown of what can be gleaned from the provided text, and what cannot:
What can be extracted (though not in the format requested as it's not a performance study):
- Device: R & D Battery Pack P/N 6019
- Intended Use: To power functions of various devices, specifically as a replacement battery for a PhysioControl LP500 AED.
- Predicate Device: AMCO Battery Pack P/N 5L500, also used in the PhysioControl LP500 AED.
- Basis of Equivalence: The document states "The design components and functionality of the R & D Batteries Inc. P/N 6019 battery pack is identical to the predicate device. Cell chemistry and type are identical. Sealed (Vented) Lithium / Sulphur Dioxide (Li/SO2)."
Information that is NOT available in this document:
Since this is a 510(k) premarket notification for a battery pack, not a medical device driven by an algorithm or intended for diagnostic/therapeutic functions requiring complex performance metrics, the following information is not applicable or not provided:
- A table of acceptance criteria and the reported device performance: While there would be internal specifications and performance targets for the battery, this document does not present them as "acceptance criteria" for a primary efficacy or diagnostic study. The equivalence is based on being "identical" to a predicate, not necessarily meeting a specific set of clinical performance cutoffs.
- Sample size used for the test set and the data provenance: Not applicable. Equivalence is primarily demonstrated through design and material identity, along with bench testing.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There's no ground truth in the context of expert consensus for a battery's performance in this type of submission.
- Adjudication method: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This is not an AI-assisted diagnostic or therapeutic device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a battery, not an algorithm.
- The type of ground truth used: Not applicable in the context of clinical outcomes or expert consensus. For a battery, "ground truth" relates to its physical and electrical properties meeting specifications.
- The sample size for the training set: Not applicable. This is not an AI device.
- How the ground truth for the training set was established: Not applicable.
What performance/safety testing was done (as per the document):
- Type of Study: Bench tests
- Equipment used: Medtronic's/PhysioControl LP500 AED and a NETECH Model Delta 2200 Defibrillator Analyzer.
- Tests conducted:
- Life Cycle
- Temperature
- Mechanical & Electrical Component Integrity
- Reference: The document refers to "013 Performance Testing for procedures and results," which is an internal document not provided here.
In summary, this document is a regulatory submission demonstrating substantial equivalence of a replacement battery pack to an existing one, based on identical design, materials, and bench testing, rather than a clinical study evaluating diagnostic or therapeutic efficacy of a complex medical device or AI system.
§ 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.