(90 days)
Rechargeable batteries are utilized in portable medical equipment as a primary d-c power source or as a stand-by or backup d-c power source for portable as well as stationary medical equipment with a-c providing the primary power.
Rechargeable batteries are utilized in portable medical equipment as a primary d-c power source or as a stand-by or backup d-c power source for portable as well as stationary medical equipment with a-c providing the primary power. These devices are copies of Original Equipment Manufacturer (OEM) or After-Market battery packs currently on the market. A sample is generally submitted by Hospitals, Medical Centers, and Biomedical or Clinical Engineering Service Professionals for duplication. Battery packs are "device specific" and are designed to operate and fit into those OEM devices for which they were manufactured.
The provided document is a 510(k) premarket notification letter from the FDA regarding a rechargeable battery (Models: MLA6153, MNC 847L) for perinatal monitoring systems. This document does not contain the acceptance criteria or a study proving the device meets those criteria, nor does it typically include clinical study details as it concerns a battery, an accessory for a medical device.
The letter states that the device is substantially equivalent to legally marketed predicate devices. The "Indications for Use Statement" (Page 2) describes how the rechargeable batteries are utilized in portable medical equipment as a primary or stand-by/backup DC power source. It also mentions that "The end-user provides feedback and assists in qualifying the device as to its performance, form, fit or function although we incorporate all available resources to assist us in producing a device that meets or exceeds OEM specifications." This statement suggests that acceptance criteria would likely relate to battery performance metrics (e.g., voltage, current, duration, cycle life, safety standards) and would be compared against the original equipment manufacturer's (OEM) specifications or industry standards for similar batteries.
Therefore, I cannot provide the specific information requested in the prompt based on the provided document. The document is a regulatory approval letter, not a study report.
To answer your request, I would need a different type of document, such as a test report, a clinical investigation report, or a detailed technical specification document for the battery and its performance evaluation.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 4 2003
Mr. Alexander B. Henderson Technical Manager ACCESS Battery, Inc 5357 Highway 86 ELIZABETH CO 80107
Re: K030261
Trade/Device Name: Battery, Rechargeable Models: MLA6153, MNC 847L Regulation Number: 21 CFR 884.2740 Regulation Name: Perinatal monitoring system with accessories Regulatory Class: II Product Code: 85 HGM Dated: January 23, 2003 Received: January 24, 2003
Dear Mr. Henderson:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxX | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Power When It Matters Most!™
Page 1 of 1
INDICATIONS FOR USE STATEMENT
030261 510(K) Number:
Device Name: Battery, Rechargeable
Indications for Use:
Rechargeable batteries are utilized in portable medical equipment as a primary d-c power source or as a stand-by or backup d-c power source for portable as well as stationary medical equipment with a-c providing the primary power.
These devices are copies of Original Equipment Manufacturer (OEM) or After-Market battery packs currently on the market. A sample is generally submitted by Hospitals, Medical Centers, and Biomedical or Clinical Engineering Service Professionals for duplication.
There is no direct contact with the OEM's or access to their equipment for testing purposes. The end-user provides feedback and assists in qualifying the device as to its performance, form, fit or function although we incorporate all available resources to assist us in producing a device that meets or exceeds OEM specifications. It is this process that the majority of after-market manufacturers utilize in order to duplicate battery packs for sale as replacements for the original or predicate device.
Battery packs are "device specific" and are designed to operate and fit into those OEM devices for which they were manufactured. Therefore, only qualified personnel should evaluate, test, or install these devices.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
Smthell MD m dan
(Division Sign-Off) Division of Reproductive. Abdomi and Radiological Device 510(k) Number
§ 884.2740 Perinatal monitoring system and accessories.
(a)
Identification. A perinatal monitoring system is a device used to show graphically the relationship between maternal labor and the fetal heart rate by means of combining and coordinating uterine contraction and fetal heart monitors with appropriate displays of the well-being of the fetus during pregnancy, labor, and delivery. This generic type of device may include any of the devices subject to §§ 884.2600, 884.2640, 884.2660, 884.2675, 884.2700, and 884.2720. This generic type of device may include the following accessories: Central monitoring system and remote repeaters, signal analysis and display equipment, patient and equipment supports, and component parts.(b)
Classification. Class II (performance standards).