(238 days)
Not Found
Not Found
No
The device description and intended use clearly define the device as a replacement battery pack. There is no mention of any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
No
The device is a battery pack, which is explicitly stated to power other medical devices rather than directly providing therapy.
No.
The device is a battery pack, which is explicitly stated to power other devices. While some of the devices it powers might be diagnostic (e.g., blood pressure monitor, pH meter, safety analyzer), the battery pack itself is not performing any diagnostic function.
No
The device description clearly states that the devices are physical battery packs comprised of cells, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as providing power to medical devices. It does not mention any use in the examination of specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description details battery packs and their components. It does not describe any reagents, instruments, or systems intended for use in vitro.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing diagnostic information
- Mentioning any specific tests or assays
The battery packs are accessories that power medical devices, some of which might be IVDs (like the Hemochron or Blood Coagulator Timer), but the battery itself is not performing an in vitro diagnostic function.
N/A
Intended Use / Indications for Use
- Power the ANTEK Medical Telemetry.
- Power the BIQ-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.
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.
Product codes (comma separated list FDA assigned to the subject device)
BWA, MOX
Device Description
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.
- 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
1
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.
2
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
3
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
OR
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
OR
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
OR
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
OR
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.
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
j Contact Person
Stacey Hippen
D. Date of Application:
August 5, 1996
9
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.