(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.
§ 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).