(65 days)
Disposable sterile drapes are intended for use for :
- patient protective covering used to isolate incision sites and protect . against contamination during surgical procedures.
- cover a variety of surgical and non-surgical equipment in various settings . throughout the clinical setting. These drapes are used protect surgical and non-surgical equipment from contamination during surgical procedures
Drapes provided as sterile and non-sterile surgical drapes are to be sold to OEMs for EtO sterilization according to ISO 11135. Sterile Surgical Drapes are to be sold directly to users after EtO sterilization validation to ISO 1135.
The document lists the following disposable surgical drape types and model numbers included in the submission:
| MATERIAL | DRAPE STYLE | STERILE | DRAPE TYPE | MODEL # |
|---|---|---|---|---|
| SMS | Non | |||
| Reinforced | Sterile | Top | JHSAD 150-240E | |
| Bottom | JHSAD 180-175E | |||
| Non Sterile | Top | JHSAD 150-240NS | ||
| Bottom | JHSAD 180-175NS |
I am sorry but this document is a 510(k) premarket notification decision letter from the FDA to a medical device manufacturer. It certifies that the device, a surgical and equipment drape, is substantially equivalent to a legally marketed predicate device.
The document does not contain information related to acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement for evaluating an AI-powered device. It is a regulatory approval document for a non-AI medical device.
Therefore, I cannot provide the requested information based on 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.