(102 days)
The 6L785 Sealed Manganese Dioxide (MnO2) life+cel (or lifecel) is a replacement disposable battery pack, for use in the Philips Medical Systems FR2 Series AED, specifically OEM Part Number M3863A. This battery pack has a shelf life of 5 years from the date of manufacture.
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. The Amco 6L785 battery chemistry is Manganese Dioxide (MnO2) based and is non rechargeable.
This document describes the acceptance criteria and the study conducted for the Amco International Manufacturing & Design, Inc. Replacement Battery Pack 6L785.
The information primarily focuses on the technical testing and performance of the battery pack, not on a medical device with AI components or human-in-the-loop performance studies. Therefore, many of the requested categories (e.g., MRMC studies, effect size of human readers with AI, ground truth for training set) are not applicable to this submission.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Incoming Inspection: Cells inspected for correct specification, visible damage, voltage. Cases inspected for form, fit, function, and aesthetics. | All cells are inspected and randomly voltage tested prior to acceptance. Lot numbers are recorded. Cases are also inspected. Failed items are rejected. |
| CADEX Testing (Non-Rechargeable Packs): Tested to depletion. Target capacity must meet or exceed a required threshold of 90% of nominal capacity. | Non-Rechargeable packs are tested to depletion on a random lot sample basis using a Cadex Electronics Battery Analyzer Model C7400ER in "Auto Mode" with custom test parameters (C-Rates, delta V, volts-per-cell). The target capacity threshold is stated as 90% or higher. Samples not meeting the criteria are rejected, and the entire lot is subsequently tested. |
| Voltage Testing - Completed Packs: 100% testing for correct voltage/polarity. | All Battery Packs are tested 100% for correct voltage/polarity prior to shipment. Devices that fail are rejected and quarantined. |
| Defibrillator Testing: Meet the expected number of shocks as specified by the OEM. | Independent testing (Beta Tests) and random tests on finished packs are performed using NETECH Model Delta 2000 Defibrillator Analyzers to ensure they meet the expected number of shocks as specified by the OEM's. |
| Life Cycle: Replacement battery must provide as many or more charge and discharge cycles as the original (for rechargeable). | Stated that this is an "ongoing process and is not part of the standard QC final inspection protocol" for replacement batteries. (Note: The product 6L785 is non-rechargeable, so this criterion is framed generally for battery packs. For the specific non-rechargeable 6L785, shelf life is based on the original cell manufacturer's specification sheets and Certificates of Conformance. The stated shelf life is 5 years from the date of manufacture). |
| Temperature Performance: Function correctly over the same temperature range as the original. | Testing is done at 0, 25, and 50℃ (32, 77, and 122°F respectively) to ensure correct function over the specified temperature range. |
| Mechanical & Electrical Component Integrity: Withstand drop tests, no case cracks, cell separation, or component damage. | Normal testing involves drop tests from a predetermined height (usually 2-3 feet) onto a hard, uniform surface. Battery packs are inspected for case cracks, cell separation, and electrical/electronic component damage. Root cause analysis is performed for any damage. If no visible damage, the battery is tested for form, fit, and function. Active Safety devices are inspected and tested before use and after installation. |
| Overall Performance & Safety: Replacement devices must meet or exceed OEM benchmark results consistently. | Comparison Analysis: OEM Battery Packs set the benchmark, and replacement devices must meet or exceed these benchmark results consistently to ensure safety and performance meet all functional requirements and performance specifications. The Amco 6L785 is stated to be "identical to those of their predicate devices" in design components and functionality. It is designed to maintain capacity for as high and as long as possible. The Amco 6L785 battery chemistry (Manganese Dioxide) is non-rechargeable and cell specifications are included. |
Study Details:
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size:
- CADEX Testing (Non-Rechargeable): "random lot sample basis" for testing to depletion. No specific number is provided, but it implies a statistical sampling approach for batches. If a sample from a lot fails, the entire lot is tested.
- Defibrillator Testing: "random tests on finished packs." No specific number provided.
- Voltage Testing: 100% of completed packs are tested.
- Temperature & Mechanical Testing: Not specified as lot-based; implies testing of representative samples during development and quality control.
- Data Provenance: Not explicitly stated, but the company is based in the USA. The testing is conducted internally by Amco International Manufacturing & Design, Inc. (and Phoenix Technology), and involves external independent testing ("Beta Tests") for defibrillator performance. This is prospective testing performed on manufactured battery packs.
- Test Set Sample Size:
-
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 a battery component, not a diagnostic medical device that requires expert interpretation for ground truth. The "ground truth" is established by technical specifications and performance benchmarks of the OEM battery pack.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. This is a technical product testing, not a clinical study involving human judgment that requires adjudication. Pass/fail criteria are based on defined technical specifications and measurements.
-
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 device is a battery pack, not an AI-enabled diagnostic system. No human reader or AI assistance is involved.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a battery pack, not an algorithm or AI system.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for the battery pack's performance is established by technical specifications and performance benchmarks of the legally marketed predicate devices' OEM batteries. The goal is for the replacement battery to "meet or exceed OEM benchmark results consistently." Key aspects include voltage, capacity, number of defibrillator shocks, temperature range, and mechanical integrity, all compared to the original specifications.
-
The sample size for the training set
- Not Applicable. This is traditional product manufacturing and testing, not a machine learning or AI-based system that requires a "training set."
-
How the ground truth for the training set was established
- Not Applicable. As above, no training set for an AI/ML algorithm 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.