(75 days)
Replacement battery for Sabretek 6060 Homerun Volumetric Infusion Pump (K941984) (and other non-rechargeable 8.4 volt (9-volt) applications).
This battery is shipped only to customers who request a replacement battery for a particular device or to replace a competitor's replacement battery. The biomedical equipment technician therefore knows the intended use is as a replacement battery.
This document pertains to a 510(k) premarket notification for a battery, not an AI/ML medical device. Therefore, the requested information regarding acceptance criteria, study details, expert involvement, MRMC studies, standalone performance, training set, and ground truth establishment is not applicable to this submission.
The document is primarily focused on demonstrating substantial equivalence of the "Alexander Manufacturing Company battery Part Number MC146X" to a legally marketed predicate device (Sabretek 6060 Homerun Part Number Volumetric Infusion Pump battery K941984, and other 8.4-volt applications batteries).
The key elements discussed are:
- Device Description: MC146X is an 8.4 volt/800 mAh battery pack.
- Intended Use: Replacement battery for the Sabretek 6060 Homerun Volumetric Infusion Pump (K941984) and other non-rechargeable 8.4-volt (9-volt) applications.
- Substantial Equivalence: Claimed equivalence to the Sabretek 6060 Homerun Volumetric Infusion Pump battery (K941984) and other 8.4 volt (9-volt) applications batteries.
- Compliance: Alexander Manufacturing Company operates under 21 CFR Part 820 Good Manufacturing Practice for Medical Devices (GMP) and is ISO 9001 registered.
- Testing: "Testing data is located in Appendix C" (though Appendix C is not provided in the prompt). The document mentions the MC146X meets "all US Government ANSI/NEDA specs."
Without Appendix C, specific performance data or acceptance criteria related to battery function (e.g., voltage, capacity, cycle life, safety standards) cannot be detailed. However, the existing information does not describe an AI/ML-driven device or a study involving human readers or ground truth as typically understood in AI/ML performance evaluation.
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Alexander Manufacturing
K 98/776
A. Summary
Alexander Manufacturing Company battery Part Number MC146X is a battery comprised of 6 mercuric oxide cell(s). Testing data is located in Appendix C. Alexander MC146X is substantially equivalent to Sabretek 6060 Homerun Part Number Volumetric Infustion Pump (K941984) and other 8.4 volt (9-volt) applications battery.
Cells are assembled into batteries at Alexander Manufacturing Company's facility in Mason City, lowa. They 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 9001 registered by the National Standards Authority of Ireland (NSAI). Appendix A contains a copy of our registration.
B. Submitter
Alexander Manufacturing Company 1511 South Garfield Place Mason City, lowa 50401
- C. Contact Person Ken Heimendinger
- D. Date of Application 5/14/98
- E. Trade Name MC146X
F. Common Name - Primary Battery
(K941984) Sabretek 6060 Homerun Volumetric G. Substantially Equivalent to -Infustion Pump (K941984) and other 8.4 volt (9-volt) applications battery.
H. Description - MC146X is a 8.4 volt/800 mAh battery pack which replaces Sabretek 6060 Homerun Volumetric Infustion Pump (K941984) and other 8.4 volt (9-volt) (K941984). applications battery
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. The MC146X meets all US Government ANSI/NEDA specs, so is therefore a replacement for the common "9-volt" battery.
J. Indications for Use form(s) utilizing the format provided by the Center for Devices and Radiological Health are found in Section III, Page 3.
K. 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 B.
L. Truthful and Accurate Statement - A Truthful and Accurate Statement as required by 21 CFR 807.87(j) is located in Appendix D.
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
3 1698 AUG
Mr. Ken Heimendinger 'Alexander Manufacturing Company 1511 South Garfield Place Mason City, Iowa 50401
Re : K981776 Alexander Manufacturing Co. Battery Part Trade Name: Number MC146X Requlatory Class: II Product Code: FRN May 14, 1998 Dated: May 20, 1998 Received:
Dear Mr. Heimendinger:
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 Requlations, Title 21, Parts 800 to 895. ਸ 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 Failure to comply with the GMP verity such assumptions. 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
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Page 2 - Mr. Heimendinger
the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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) 594-4692. 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,
S. Putman for
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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14981776 510(k) Number:
Device Name: MC146X
Indications for Use:
Replacement battery for Sabretek 6060 Homerun Volumetric Infusion Pump (K941984) (and other non-rechargeable 8.4 volt (9-volt) applications).
This battery is shipped only to customers who request a replacement battery for a particular device or to replace a competitor's replacement battery. The biomedical equipment technician therefore knows the intended use is as a replacement battery.
PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Patricia Caucenite
(Division Sign-Off) Division of Demal, Infection Control, and General Hospit
510(k) Number K981776
Prescription Use
OR
OVER-THE-COUNTER USE__
(optional Form 1-2-96)
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).