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.

Device Description

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.

AI/ML Overview

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 cellGL625: 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.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

November 16, 2021

Alexander Mfg. Co. Stacey Hippen Design And Development Team Leader 1511 S Garfield Pl Mason City, Iowa 50401

Re: K963305

Trade/Device Name: Alexander Box, Battery, Rechargeable Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: BWA

Dear Stacey Hippen:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated April 17, 1997. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product code BWA.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Jennifer Shih, OHT2: Office of Cardiovascular Devices, 301-796-5813, Jennifer.Shih(@fda.hhs.gov.

Sincerelv.

Jennifer W. Shih -S

Jennifer Shih Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 7 1997

Mr. Stacey Hippen Alexander Manufacturing Company P.O. Box 1508 1511 South Garfield Place Mason City, Iowa 50401

K963305 Re : Replacement Batteries: Models MS5R225, MS501, H132, MS8400, and GL625 Regulatory Class: II (two) Product Code: 74 MOX Dated: December 19, 1996 Received: January 21, 1997

Dear Mr. Hippen:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is che device is a resultations for use stated in the enclosure) to devices marketed in interstate commerce prior to encioure, 30 actional date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls may , is of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 920) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Stacey Hippen

This letter will allow you to begin marketing your device as described Inis fected will driow you oo acgain. The FDA finding of substantial in your 510 (x) promastice to a legally marketed predicate device equivalence of your device of your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling If you desire bpcorrio and additionally 809.10 for in vitro regures: (evices), please contact the Office of Compliance at diagnobere actroom, for questions on the promotion and (301) 354 4646. Indresses, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, (301) 39 4037. Internal to premarket notification" (21 CFR 807.97). firstranding by rerormed on your responsibilities under the Act may ocher general introduction of Small Manufacturers Assistance at its be obcarned from 2000) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number: K963305

MS5R225 Device Name:

Indications for Use:

Power the ANTEK Medical Telemetry. �

PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

over-the-counter use (optional Form 1-2-96)

Sion Sign-Off) of Cardiovascular, Re eurological Devices Ak) Number ___________________________________________________________________________________________________________________________________________________________________

362

{4}------------------------------------------------

Device Name: MS501

Indications for Use:

Power the BIQ-TEK Safety Analyzer Model 501. .

PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OVER-THE-COUNTER USE _________________________________________________________________________________________________________________________________________________________ (optional Form 1-2-96)

் கிராம்.

விளையும்
இங்கி

ാന Sign-Off) - of Cardiovascular, Respira agrological Devices (k) Number __

363

{5}------------------------------------------------

Device Name: 上一篇: 上一篇:
上一篇: 上一篇: 上一篇: 上一篇: 上一篇: 上一篇: 上一篇: 上一篇: 上一篇: 上一篇: 上一篇: 上一篇: 上一篇: 上一篇: 上一篇: 上一篇: 上一篇: 上一篇: 上一篇: 上一篇: 上一篇: 上一篇: 上一篇: 上一篇: 上一篇: 上一篇: 上一篇: 上一篇: 上一篇: 上一篇: 上一篇: 上一篇: 上一篇

Indications for Use:

Power the Corometrics Medical PH Meter. .

PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OVER-THE-COUNTER USE (optional Form 1-2-96)

(Dialeann Sian Off) D. Same and ardiovascular, Respiratory
ar

{6}------------------------------------------------

Device Name: MS8400

Indications for Use:

Power the International Technidyne Corp. Hemochron 400 and Blood . Coagulator Timer.

PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _____________________________________________________________________________________________________________________________________________________________

ાર

OVER-THE-COUNTER USE _ (optional Form 1-2-96)

پورٽينٽ

-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------or Sign-Off)

of Cardiovascular, Respire
of Cardiovascular, Respire of Cardio Cardio Cardio Carological Devices
Carological Devices ി ()(k) Number -

365

{7}------------------------------------------------

Device Name: GL625

Indications for Use:

Power the Syborn Corp. ACT Blood Pressure Monitor and Portable Blood . Coagulator

PLEASE DO NOT WRITE BELOW THIS LINE --CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OVER-THE-COUNTER USE __ (optional Form 1-2-96)

il in Mar ada

(Division Sign-Off) Division of Cardiovascular, and Neurological Devices 510(k) Number _

{8}------------------------------------------------

Not Used
See TAX
April 16, 97
K963305

A. Summary

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 Saft and Sanyo manuals are located in Appendices B and C, respectively. The H132 is a mercury cell produced by Alexander Manufacturing. The specifications for the H132 are in Appendix H. Part number GL625 is a lead-acid battery. Gates (lead-acid) cell information is in Appendix S.

Alexander Manufacturing Company is ISO registered by the National Standards Authority of Ireland (NSAI). Appendix D contains a copy of our registration.

Each of Alexander Manufacturing part nos. MS5R225, MS501, H132, MS8400 and GL625 is substantially equivalent to its respective OEM. The MS5R225 is equivalent to the battery pack in the ANTEK Medical Telemetry. The MS501 is equivalent to the BIO-TEK Safety Analyzer Model 501. The H132 is equivalent to the Corometrics Medical PH Meter. The MS8400 is equivalent to the International Technidyne Corp. Hemochron 400 and Blood Coagulator Timer, and the GL625 is equivalent to the Syborn Corp. ACT Blood Pressure Monitor and Portable Blood Coagulator

B. Submitter

Alexander Manufacturing Company 1511 South Garfield Place Mason City, IA 50401

j Contact Person

Stacey Hippen

D. Date of Application:

August 5, 1996

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Trade Names E.

MS5R225 ﺮ ﻣﺠﻤﻮﻋﺔ ﺍﻟﻤﺴﺘﻮﻳﺔ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﺘﻲ ﺗﻘﺮﻳﺒﺎ ﺍﻟﻤﺴﺘﻮﻳﺘﻴﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﺘﻲ ﺗﺴﺘﺨﺪﻡ ﺍﻟﻤﺴﺘﻮﻳﺘﺮ ﺍﻟﻤﺴﺘﻮﻳﺘﺮ ﺍﻟﻤﺴﺘﻮﻳﺘﺮ ﺍﻟﻤﺴﺘﻮﻳﺘﺮ ﺍﻟﻤﺴﺘﻮﻳﺘﺮ ﺍﻟﻤﺴﺘﻮﻳﺘﺮ ﺍﻟﻤﺴﺘﻮﻳﺘﺮ ﺍﻟﻤﺴﺘﻮﻳﺘﺮ ﺍﻟﻤﺴﺘﻮﻳﺘﺮ ﺍﻟﻤﺴﺘﻮ
MS501 ri
H132 ﺮﺟﺎ
MS8400 ব .
GL625 发

Common Name F.

Rechargeable Battery

Substantially Equivalent To: G.

ANTEK Medical Telemetry. ﺎ .
BIO-TEK Safety Analyzer Model 501. 2.
Corometrics Medical PH Meter. ా
International Technidyne Corp. Hemochron 400 and Blood Coagulator Timer री
Syborn Corp. ACT Blood Pressure Monitor and Portable Blood Coagulator. ਪਾ

Description: H.

MS5R225 is a 6.0V/2.5 Ah battery pack for use with the ANTEK Medical 1 . Telemetry
MS501 is a 4.8V/1.2 Ah battery pack for use with the BIO-TEK Safety 2. Analyzer Model 501.
H132 is a 2.8V/1.0 Ah battery pack for use with the Corometrics Medical PH 3. Meter
MS8400 is a 6.0V/1.2 Ah battery pack for use with the International র্ব 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 న్. Blood Pressure Monitor and Portable Blood Coagulator.

As previously stated, Alexander Manufacturing Company is ISO registered and utilizes a three-tiered structure: Foundation (mission, policy and beliefs), Operational Control (manual, SOPs, and work instructions), and Management Review/ Assessment.

{10}------------------------------------------------

An uncontrolled copy of the Quality System Manual #05 is located in Appendix E.

Job Work Instructions (JWI) and drawings for each applicable part number can be found in Appendices F, G, H, I and J.

Indications for Use [.

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.

Indications for Use Form J.

Indications for Use form(s) utilizing the format provided by the Central for Devices and Radiological Health are found in Appendix K.

Summary of Safety and Effectiveness K.

Alexander Manufacturing Company is submitting a 510(k) Statement in lieu of a Alexander Manufacturing Company is This 510(k) Statement can be found in Appendix L.

Truthful and Accurate Statement L.

A Truthful and Accurate Statement as required by 21 CFR 807.87(j) is located in Appendix M.

Regulation Number and Section

§ 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.