(81 days)
Medline Band Bags and Equipment Covers are intended to be used to cover medical equipment in order to maintain the sterile field and as an aid in the clean up of equipment after surgery. These covers are not intended to be used as patient drapes and have no patient contact.
Not Found
The provided text does not contain information about acceptance criteria or a study proving device performance for "Medline Band Bags and Equipment Covers." The document is a 510(k) clearance letter from the FDA, indicating that the device is substantially equivalent to a legally marketed predicate device.
Specifically, the letter from the FDA (Pages 0-1) and the "Indications for Use" section (Page 2) discuss the following:
- Device Name: Medline Band Bags and Equipment Covers
- Regulation Number: 878.4370
- Regulation Name: Surgical Drape and Drape Accessories
- Regulatory Class: II
- Product Code: MMP
- Indications for Use: "Medline Band Bags and Equipment Covers are intended to be used to cover medical equipment in order to maintain the sterile field and as an aid in the clean up of equipment after surgery. These covers are not intended to be used as patient drapes and have no patient contact."
The document focuses on regulatory clearance based on substantial equivalence, not on a detailed performance study with acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, ground truth, and expert qualifications is not available 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.