(462 days)
The Applied Wound Protector/Retractor is indicated for use to:
- Access the abdominal cavity during surgery through an atraumatically retracted incision.
- Deliver maximum exposure of the abdominal cavity with minimum incision size.
- Protect against wound contamination during laparoscopic and open surgery.
Applied Medical's Alexis O wound protector/retractors are disposable single-use surgical devices used to establish access to internal body cavities and spaces. The protector/retractors are designed for soft tissue retraction and provide 360 degrees of a circumferential retraction and 360 degrees of protection of the wound margins. The predicate Alexis devices are made in sizes ranging from Small to XLarge that accommodate incisions ranging from 2.5 to 17cm. This submission request clearance for adding an XXL and XXXL sizes to the product family. The XXL is for incisions ranging from 17 to 25cm; the XXXL is for incisions ranging from 25 to 30cm. The protector/retractors have a shelf life of three years and are delivered with a template that is used to determine the incision length for the corresponding retractor chosen for the procedure. Protector/retractors are packaged in a Tyvek pouch placed inside a carton.
The provided text describes the Alexis O Wound Protector/Retractor and its substantial equivalence to a predicate device. It does not contain information about an AI/ML powered device, therefore no information of the acceptance criteria and study that proves the device meets the acceptance criteria is described.
§ 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.