(73 days)
Incubator Capes are designed to cover and enhance the outer appearance of an incubator.
Incubator Cover (accessory to Incubators)
The provided text is a 510(k) clearance letter from the FDA for an "Incubator Cape." This document does not contain information about acceptance criteria or a study proving device performance as described in your request.
The letter explicitly states: "we have determined the device is substantially equivalent... to legally marketed predicate devices." This means the FDA found the device to be similar enough to existing devices that it does not require a new study to prove its safety or effectiveness. The purpose of a 510(k) notification is to demonstrate substantial equivalence, not to provide new performance data against specific acceptance criteria.
Therefore, I cannot provide the requested information from the given text.
If you have a different document that details performance studies and acceptance criteria for a medical device, please provide it, and I will do my best to extract the information you need.
§ 878.4370 Surgical drape and drape accessories.
(a)
Identification. A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy.(b)
Classification. Class II (special controls). The device, when it is an ear, nose, and throat surgical drape, a latex sheet drape with self-retaining finger cot, a disposable urological drape, a Kelly pad, an ophthalmic patient drape, an ophthalmic microscope drape, an internal drape retention ring (wound protector), or a surgical drape that does not include an antimicrobial agent, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.