(151 days)
The TIDIShield Curing Light Sleves are indicated for used as an accessory to dental instrument. These sleves are non-sterile and are intended for single patient use only.
Not Found
This is a 510(k) premarket notification for a dental barrier/sleeve device (TIDIShield™ Curing Light Sleeve), not an AI/ML device. Therefore, the concepts of "acceptance criteria," "study," "test set," "training set," "ground truth," "MRMC study," "standalone performance," and "experts" as they relate to AI/ML device evaluations are not applicable to this document.
The document discusses the regulatory review and approval of a physical medical device. It confirms that the device is "substantially equivalent" to legally marketed predicate devices and is subject to general controls.
Therefore, I cannot provide the requested information as it is not present or relevant in the provided text.
§ 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.