ALEXANDER BOX, BATTERY, RECHARGEABLE
Device Facts
| Record ID | K963305 |
|---|---|
| Device Name | ALEXANDER BOX, BATTERY, RECHARGEABLE |
| Applicant | Alexander Mfg. Co. |
| Product Code | BWA · General, Plastic Surgery |
| Decision Date | Apr 17, 1997 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4400 |
| Device Class | Class 2 |
Indications for Use
Power the ANTEK Medical Telemetry. Power the BIO-TEK Safety Analyzer Model 501. Power the Corometrics Medical PH Meter. Power the International Technidyne Corp. Hemochron 400 and Blood Coagulator Timer. Power the Syborn Corp. ACT Blood Pressure Monitor and Portable Blood Coagulator.
Device Story
Replacement battery packs for medical equipment; includes nickel-cadmium (NiCad), mercury cell, and lead-acid chemistries. Assembled by Alexander Manufacturing Company; intended to replace original equipment manufacturer (OEM) batteries. Provides electrical power to specific clinical devices: telemetry units, safety analyzers, PH meters, and blood coagulation timers. Used in clinical settings where the host medical device is operated. No active electronic processing or software components; purely power-delivery accessories.
Clinical Evidence
No clinical data; bench testing only. Equivalence established through comparison of electrical specifications and physical compatibility with OEM host devices.
Technological Characteristics
Battery packs: NiCad (MS5R225, MS501, MS8400), mercury cell (H132), lead-acid (GL625). Voltages: 2.8V to 6.0V. Capacities: 1.0 Ah to 2.5 Ah. Assembled per 21 CFR Part 820 (GMP) and ISO 9001 standards. No software or electronic circuitry.
Indications for Use
Indicated for use as replacement battery packs to power specific medical devices: ANTEK Medical Telemetry, BIO-TEK Safety Analyzer Model 501, Corometrics Medical PH Meter, International Technidyne Corp. Hemochron 400 and Blood Coagulator Timer, and Syborn Corp. ACT Blood Pressure Monitor and Portable Blood Coagulator.
Regulatory Classification
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.
Predicate Devices
- ANTEK Medical Telemetry
- BIO-TEK Safety Analyzer Model 501
- Corometrics Medical PH Meter
- International Technidyne Corp. Hemochron 400 and Blood Coagulator Timer
- Syborn Corp. ACT Blood Pressure Monitor and Portable Blood Coagulator
Submission Summary (Full Text)
{0}
FDA U.S. FOOD & DRUG ADMINISTRATION
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.
Sincerely,
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
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
{1}
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850
APR 17 1997
Mr. Stacey Hippen
Alexander Manufacturing Company
P.O. Box 1508
1511 South Garfield Place
Mason City, Iowa 50401
Re: K963305
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 substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment 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 provisions 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 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) 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.
{2}
Page 2 - Mr. Stacey Hippen
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for *in vitro* diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahan, Ph.D.
Director
Division of Cardiovascular,
Respiratory, and Neurological Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
{3}
510(k) Number: K963305
Device Name: MS5R225
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 _______________ OR OVER-THE-COUNTER USE _______________
(optional Form 1-2-96)
Version Sign-Off)
Person of Cardiovascular, Respiratory,
Neurological Devices
K963305
(K) Number _______________
{4}
510(k) Number:
Device Name: MS501
Indications for Use:
- Power the BIO-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 ________ OR OVER-THE-COUNTER USE ________
(optional Form 1-2-96)
363
3605
{5}
510(k) Number:
Device Name: H132
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 _____
OR
OVER-THE-COUNTER USE _____
(optional Form 1-2-96)
(Describe S. on Off)
D. cardiovascular, Respiratory,
ar. surgical Devices
K963305
364
{6}
510(k) Number:
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 _____
OR
OVER-THE-COUNTER USE _____
(optional Form 1-2-96)
Susan Sign-Off)
First Cardiovascular, Respiratory,
Neurological Devices
K963305
510(k) Number _____
365
{7}
510(k) Number:
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 _________
OR
OVER-THE-COUNTER USE _________
(optional Form 1-2-96)
(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number _________ K963305
3/do
{8}
Not Used
Dec TAX on
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.
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.
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
# C. Contact Person
Stacey Hippen
# D. Date of Application:
August 5, 1996
-5-
{9}
E. Trade Names:
1. MS5R225
2. MS501
3. H132
4. MS8400
5. GL625
F. Common Name:
Rechargeable Battery
G. Substantially Equivalent To:
1. ANTEK Medical Telemetry.
2. BIO-TEK Safety Analyzer Model 501.
3. Corometrics Medical PH Meter.
4. International Technidyne Corp. Hemochron 400 and Blood Coagulator Timer
5. Syborn Corp. ACT Blood Pressure Monitor and Portable Blood Coagulator.
H. Description:
1. MS5R225 is a 6.0V/2.5 Ah battery pack for use with the ANTEK Medical Telemetry.
2. MS501 is a 4.8V/1.2 Ah battery pack for use with the BIO-TEK Safety Analyzer Model 501.
3. H132 is a 2.8V/1.0 Ah battery pack for use with the Corometrics Medical PH Meter.
4. MS8400 is a 6.0V/1.2 Ah battery pack for use with the International Technidyne Corp. Hemochron 400 and Blood Coagulator Timer.
5. GL625 is a 6.0V/2.5 Ah battery pack for use with the Syborn Corp. ACT 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.
-6-
{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.
## I. Indications for Use
Each battery pack is a replacement for the OEM battery pack. Each is used in the same indications as that of 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.
## J. Indications for Use Form
Indications for Use form(s) utilizing the format provided by the Central for Devices and Radiological Health are found in Appendix K.
## K. Summary of Safety and Effectiveness
Alexander Manufacturing Company is submitting a 510(k) Statement in lieu of a Summary of Safety and Effectiveness. This 510(k) Statement can be found in Appendix L.
## L. Truthful and Accurate Statement
A Truthful and Accurate Statement as required by 21 CFR 807.87(j) is located in Appendix M.
-7-
