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510(k) Data Aggregation
(132 days)
LIFE+CEL OR LIFECEL BATTERY PACK, MODEL 5L500
The 5L500 Lithium life+cel or lifecel is a replacement battery pack for the Medtronic LifePak 500 AED.
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, charge, or install these devices.
This battery is shipped only to customers who request a replacement battery for a particular device or to replace a competitor's replacement battery. Biomedical equipment service professionals, EMT's, etc. therefore know that the intended use is as a replacement battery.
The replacement battery pack in this submission, Amco Part Number 5L500, is to be provided by prescription only.
The AMCO 5L500 life+cel™ Non-rechargeable battery pack is 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 provided documents are a 510(k) premarket notification and subsequent administrative change letter for the Amco International Manufacturing & Design, Inc. Life+cel Or Lifecel Battery Pack, Model 51500. This device is a replacement battery pack for the Medtronic LifePak 500 AED.
The information provided primarily focuses on the substantial equivalence argument, comparing the replacement battery pack to its predicate device (the battery pack used in the Medtronic LifePak 500 AED cleared under 510(k) notification K052057). It outlines the general testing protocols used for quality control and provides some information regarding safety and performance testing for the replacement battery pack itself, aiming to meet or exceed OEM battery pack benchmarks.
However, the document does not contain a detailed "study that proves the device meets the acceptance criteria" in the format of a clinical trial or a formal comparative effectiveness study as would be seen for a new diagnostic or therapeutic device. Instead, it describes internal testing procedures to ensure the replacement battery pack functions comparably to the original.
Based on the available information, here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and the Reported Device Performance
The document describes general testing protocols and targets, rather than specific, quantified acceptance criteria with corresponding performance metrics for clinical outcomes. The "acceptance criteria" appear to be internal quality control thresholds.
| Acceptance Criteria (Internal QC/Benchmark) | Reported Device Performance (Internal QC/Benchmark) |
|---|---|
| Incoming Inspection: | |
| - Correct cell specification | - Cells inspected for correctness |
| - No visible damage | - Cells inspected for visible damage |
| - Random voltage test acceptance | - Random voltage tested prior to acceptance |
| Cadex Testing (Non-rechargeable): | |
| - Target capacity ≥ 90% of nominal capacity | - Batteries meet or exceed 90% threshold |
| Voltage Testing (Completed Packs): | |
| - 100% correct voltage/polarity | - Packs tested 100% for correct voltage/polarity |
| Defibrillator Testing (Random): | |
| - Meet expected number of shocks (OEM spec) | - Tests performed to ensure meeting OEM shock specs |
| Life Cycle (Ongoing process): | |
| - As many or more charge/discharge cycles than original | - Stated goal; "ongoing process," not part of standard QC final inspection. Shelf life based on original cell manufacturer's specs. |
| Temperature Functionality: | |
| - Correct function at 0, 25, 40°C | - Testing done at 0, 25, and 40°C |
| Mechanical Integrity (Drop Tests): | |
| - No case cracks, cell separation, electrical/electronic component damage after drop from 2-3 feet | - Battery packs inspected for damage; root cause analysis if damage occurs. |
| Form, Fit, Function (After Drop Test if no visible damage): | - Battery tested for form, fit, and function |
| Active Safety Devices: | |
| - Inspected and tested before use and after installation | - Inspected and tested |
Note: The performance described is primarily based on internal quality control and bench testing, aiming to match or exceed the predicate device's characteristics. There are no clinical performance metrics reported.
2. Sample Size Used for the Test Set and the Data Provenance
- Test Set Description: The "test set" in this context refers to batches of manufactured battery packs undergoing internal quality control and bench testing, not a clinical trial test set.
- Sample Size:
- Cadex Testing: "Non-Rechargeable packs are tested to depletion on a random lot sample basis." If samples do not meet criteria, "the entire lot is tested in this manner."
- Defibrillator Testing: "Independent testing (Beta Tests), as well as random tests on finished packs, are performed."
- Voltage Testing: "All Battery Packs are tested 100% for correct voltage / polarity prior to shipment."
- Incoming Inspection: "All cells are inspected," "randomly voltage tested."
- Data Provenance: The data provenance is internal to Amco International Manufacturing & Design, Inc. and its contracted testing facilities (like Phoenix Technology for the 510(k) summary). There is no mention of country of origin of the data or whether it's retrospective or prospective in a clinical sense. It's prospective in a manufacturing quality control sense.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This section is not applicable in the traditional sense for this type of device and submission. The "ground truth" for the performance characteristics of a replacement battery pack is its ability to power the intended medical device (Medtronic LifePak 500 AED) according to original equipment manufacturer (OEM) specifications, which are established engineering and performance criteria. No human experts are described as establishing "ground truth" in the way radiologists establish cancer diagnoses. The "experts" would be the engineers and technicians performing the quality control and bench testing, comparing to established OEM and internal specifications.
4. Adjudication Method for the Test Set
The concept of an "adjudication method" (like 2+1 or 3+1) is typically used in clinical studies, particularly for subjective assessments where multiple readers provide independent interpretations.
For this device, the "adjudication" is essentially based on:
- Pre-defined engineering specifications and thresholds (e.g., ≥90% capacity, correct voltage, meeting OEM shock count).
- Pass/fail criteria based on objective measurements from instruments like the Cadex Electronics Battery Analyzer and NETECH Model Delta 2000 Defibrillator Analyzers.
- Visual inspections for damage after mechanical stress tests.
There is no mention of a formal adjudication process involving multiple human reviewers for subjective assessments.
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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic aids that assist human readers (e.g., radiologists interpreting images). The submitted device is a replacement battery pack, which is a hardware component, not an AI diagnostic tool. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
No, a standalone performance study in the context of an algorithm or AI system was not done. The device is a battery pack, a physical component, not an algorithm. Its performance is inherent in its electrical and mechanical properties, not in an "algorithm only" mode.
7. The type of ground truth used
The "ground truth" for the battery pack's performance is tied to engineering specifications, OEM performance benchmarks, and industry standards for battery characteristics (voltage, capacity, life cycle, temperature range, mechanical integrity). This is primarily objective, measurable physical and electrical properties.
8. The sample size for the training set
This device does not involve a "training set" in the context of machine learning or AI. As a manufactured hardware component, it does not learn or get trained from data. The manufacturing process involves quality control, testing, and adherence to design specifications.
9. How the ground truth for the training set was established
Since there is no training set for this hardware device, this question is not applicable. The "ground truth" for manufacturing a battery pack is defined by its design specifications and the performance requirements of the device it powers (Medtronic LifePak 500 AED).
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