(238 days)
Each battery pack is a replacement for the OEM battery pack. Each is used in the Each battery pack is a replacement for the original batteries supplied with the original equipment.
In summary, the indication for use is to power the device to which the battery pack is configured.
Alexander Manufacturing Company battery part nos. MS5R225, MS501 and MS8400 are all nickel-cadmium (NiCad) battery packs comprised of cells produced by either Saft or Sanyo. The H132 is a mercury cell produced by Alexander Manufacturing. Part number GL625 is a lead-acid battery.
Each battery pack is rechargeable (except for H132) just as the original equipment manufacturer's (OEM) battery packs are. The cells are assembled into battery packs at Alexander Manufacturing Company's facility in Mason City, Iowa. The packs are assembled under the auspices of 21 CFR Part 820 Good Manufacturing Practice for Medical Devices (GMP) and ISO 9001.
- MS5R225 is a 6.0V/2.5 Ah battery pack for use with the ANTEK Medical Telemetry
- MS501 is a 4.8V/1.2 Ah battery pack for use with the BIO-TEK Safety Analyzer Model 501.
- H132 is a 2.8V/1.0 Ah battery pack for use with the Corometrics Medical PH Meter
- MS8400 is a 6.0V/1.2 Ah battery pack for use with the International Technidyne Corp. Hemochron 400 and Blood Coagulator Timer.
- GL625 is a 6.0V/2.5 Ah battery pack for use with the Syborn Corp. ACT Blood Pressure Monitor and Portable Blood Coagulator.
This document is a 510(k) premarket notification for replacement batteries manufactured by Alexander Manufacturing Company. It primarily argues for substantial equivalence to existing OEM batteries rather than providing a study demonstrating specific device performance against acceptance criteria in the traditional sense of a clinical trial for diagnostic or therapeutic devices.
Therefore, many of the requested categories for acceptance criteria and study details are not directly applicable or are not explicitly stated in this type of submission.
However, based on the provided text, we can infer the "acceptance criteria" through the claim of substantial equivalence and identify the "study" as a comparison to the predicate devices.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from Substantial Equivalence Claim) | Reported Device Performance (Claimed) |
|---|---|
| Output / Functionality: The ability to power the indicated medical device. | Each battery pack powers its respective OEM medical device. |
| Specifications: Match the voltage and mAh capacity of the OEM battery. | MS5R225: 6.0V/2.5 Ah (for ANTEK Medical Telemetry) |
| MS501: 4.8V/1.2 Ah (for BIO-TEK Safety Analyzer Model 501) | |
| H132: 2.8V/1.0 Ah (for Corometrics Medical PH Meter) | |
| MS8400: 6.0V/1.2 Ah (for International Technidyne Corp. Hemochron 400 and Blood Coagulator Timer) | |
| GL625: 6.0V/2.5 Ah (for Syborn Corp. ACT Blood Pressure Monitor and Portable Blood Coagulator) | |
| Material: Comprised of suitable battery cell types (e.g., NiCad, mercury, lead-acid). | MS5R225, MS501, MS8400: Nickel-cadmium (NiCad) |
| H132: Mercury cell | |
| GL625: Lead-acid battery | |
| Manufacturing Standards: Manufactured under Good Manufacturing Practice (GMP) and ISO 9001. | Alexander Manufacturing is ISO registered by the NSAI and manufactures under the auspices of 21 CFR Part 820 GMP and ISO 9001. |
| Intended Use: Used as a replacement battery for the original OEM battery in the specific medical device. | Each battery pack is a "replacement for the OEM battery pack" and "is used in the original equipment." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- There is no explicit "test set" in the context of a clinical performance study described. The submission focuses on design equivalence and manufacturing process adherence. The "data" provenance would be internal manufacturing records and specifications of the OEM and replacement batteries, and potentially supplier documentation for battery cells. This would be a retrospective comparison of specifications and existing manufacturing practices.
3. 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. No "experts" were used to establish ground truth for a test set in a clinical evaluation sense. The "ground truth" here is the specifications and performance of the OEM batteries, which are inherently known by the manufacturers and assumed to be functionally benchmarked for the specific medical devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. There was no test set requiring expert adjudication.
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 device (rechargeable battery) is not a diagnostic device and does not involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a physical accessory (battery), not a software algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The "ground truth" used for this submission is the specifications and documented performance of the legally marketed OEM batteries and the intended functionality of the medical devices they power. The manufacturer claims direct equivalence in function and form.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device that requires a training set. The "training" for the manufacturing process would involve internal quality control and adherence to documented procedures.
9. How the ground truth for the training set was established
- Not applicable. No training set for an AI/ML algorithm is involved. The "ground truth" for manufacturing quality is established through adherence to established quality management systems (21 CFR Part 820 GMP and ISO 9001), which dictate manufacturing processes, inspections, and control.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.