(184 days)
Light Drapes are designed to cover and enhance the outer appearance of phototherapy light fixtures.
Light Drape (accessory to Neonatal Phototherapy Light)
The provided text is a 510(k) premarket notification letter from the FDA regarding a device called "Light Drape." This document does not contain any information about acceptance criteria, device performance, studies, ground truth establishment, or sample sizes.
The letter explicitly states: "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... You may, therefore, market the device." This indicates that the FDA has found the device to be substantially equivalent to a predicate device, which means it likely does not require extensive new clinical studies or detailed performance metrics to be established for market approval.
The "Indications for Use" section (Image/page/2) merely states: "Light Drapes are designed to cover and enhance the outer appearance of phototherapy light fixtures." This is a functional description, not a performance claim that would necessitate specific acceptance criteria or a study with the details requested.
Therefore, I cannot populate the requested information from the provided document.
§ 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.