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510(k) Data Aggregation
(428 days)
To power the functions of various devices for which batteries or battery packs are configured.
Since 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.
Battery Packs are is shipped only to customers who request a replacement battery for a particular device or to replace a competitor's battery. The biomedical equipment technician therefore knows the intended use is as a replacement battery.
Batteries have become a critical component in many medical devices. As more devices are computerized and more have become mobile, batteries play an important part in system performance and reliability. Medical batteries are treated as a piece of medical equipment, they are entered as an asset into the facilities equipment database and our included in the preventative maintenance schedule. The end use of the equipment is used to establish the frequency for preventative maintenance. Both the recommendation of the manufacturer of the medical device and the battery spec sheet from the battery manufacturer help establish the maintenance protocol.
Anybattery C2 Rechargeable batteries and 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.
Anybattery C2 Rechargeable batteries and battery packs either the primary or secondary source of power and they retain critical parameters and data in the event of power disruption. These batteries range in size, while they are mostly 12-volt, they range in capacity from two-amp hour right up to 36-amp hour batteries.
The performance and life span of a rechargeable battery depends on several factors. Battery operating conditions of temperature, current drain, and charge/discharge method. are taken into account in the design of such batteries. Anybattery's goal is to develop a battery that maintains its battery capacity as high as possible and as long as possible.
There are several types of rechargeable batteries introduced and marketed for medical uses. In this submission are batteries in the Nickel-Based Rechargeable Battery Product Family and the Valve-Regulated Lead-Acid (VRLA) Rechargeable Battery Product Family.
The document provided is a 510(k) premarket notification letter and summary for the Anybattery C2 Rechargeable Battery, with a list of 28 models. It seeks to demonstrate substantial equivalence to existing predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't present a formal table of acceptance criteria with specific numerical thresholds for each battery model. Instead, it describes general performance benchmarks against predicate devices. The primary acceptance criterion appears to be: "meet or exceed the benchmark results consistently" set by OEM Battery Packs (predicate devices).
Here's a summary of the performance aspects described:
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Target Capacity (Pass/Fail for Design Acceptance) | "Our batteries must meet or exceed a required threshold of 90%, or higher, prior to final design control acceptance." This is measured using Vencon UBA Battery Analyzers in "Test Mode" after 3 full charge/discharge cycles for Nickel-based and 2 full cycles for VRLA. Any samples not meeting the criteria are rejected. Batch build sheets require 100% > then cutoff voltage, and polarity testing. The entire lot is tested and documented. |
| Life Cycle (Number of charge/discharge cycles) | "The replacement battery must provide as many or more charge and discharge cycles as the original." This is described as an ongoing process, not part of standard QC final inspection. Cycle life is based on IEC61951-2 (Nickel-Metal hydride) and IEC 61056-1 (lead-acid batteries). |
| Temperature Range (Functionality) | "The replacement battery must function correctly over the same temperature range as compared to the original." Testing is done at 0, 25, and 40℃ (32, 77, and 104°F respectively). |
| Mechanical & Electrical Component Integrity (Drop Tests) | "Normal testing would involve 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 should any damage occur." There's no specific pass/fail rate mentioned for these tests, only that issues would lead to root cause analysis. |
| Correct Voltage and Polarity (100% testing prior to shipment) | "All Battery Packs are tested 100% for correct voltage and polarity prior to shipment. Those devices that fail are rejected and quarantined." |
| Overall Substantial Equivalence | "Anybattery C2 Rechargeable batteries and battery packs met or exceed the predicate devices in design and functionality, material, safety and performance, packing protocol, principal of operation, mechanical capacity, and physical properties, i.e., dimension, weight, voltage, discharge capacity, impedence and storage and device life." This is a general statement rather than specific performance metrics against defined criteria. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document implies that all cells, samples, and entire lots are tested at various stages ("All cells are inspected...", "Any samples that do not meet the criteria are rejected", "Subsequently, the entire lot is tested and documented", "All Battery Packs are tested 100%"). However, specific numerical sample sizes for formal "test sets" (e.g., number of batteries subjected to lifecycle or temperature testing) are not specified.
- Data Provenance: The data provenance is prospective, as the testing described ("Incoming Inspection," "Vencon Testing," "Voltage Testing," "Safety and Performance") appears to be conducted by Anybattery, Inc. as part of their manufacturing and quality control process for the C2 Rechargeable Batteries. The country of origin of the data is implied to be the United States, where Anybattery, Inc. is located (Rosemount, Minnesota).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
- Not Applicable. This document describes the testing of physical medical devices (rechargeable batteries) against established engineering and performance benchmarks, not the establishment of a "ground truth" for diagnostic or AI-driven interpretations. Therefore, there are no "experts" involved in establishing a ground truth in the way one would for clinical image analysis or disease diagnosis. The "benchmark" is set by the OEM predicate devices.
4. Adjudication Method for the Test Set:
- Not Applicable. As per point 3, there's no clinical "ground truth" adjudication required for this type of device testing. Performance is measured against physical specifications and benchmarks.
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 document concerns physical batteries, not AI software or diagnostic tools that involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This document concerns physical batteries, not AI algorithms. The performance testing described is of the battery device itself.
7. The Type of Ground Truth Used:
- The "ground truth" or benchmark used for the Anybattery C2 Rechargeable Batteries is the performance and specifications of the OEM (Original Equipment Manufacturer) predicate devices. The document explicitly states: "In comparison analysis, OEM Battery Packs (Predicate devices) set the benchmark and the Anybattery batteries replacement devices met and/or exceed the benchmark." This "ground truth" is based on established engineering and functional characteristics of legally marketed medical device batteries.
8. The Sample Size for the Training Set:
- Not Applicable. This document is about the physical testing and substantial equivalence of medical device batteries, not an AI model. Therefore, there is no "training set."
9. How the Ground Truth for the Training Set was Established:
- Not Applicable. As per point 8, there is no training set mentioned or implied.
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