(227 days)
Exact Medical Manufacturing Surgical Drape AAMI Level 4 are sterile or non-sterile single use devices 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 EMM Surgical Drapes AAMI Level 4 are also sold as bulk non-sterile, single use items, to repackager/relabeler establishments for further packaging and ethylene oxide sterilization according to ISO 11135-1:2007
Exact Medical Manufacturing Surgical Drape AAMI Level 4 are sterile or non-sterile single use devices 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.
Exact Medical Manufacturing Surgical Drape with AAMI Liquid Barrier Level The base sheet fabric is a three layer composite comprised of polypropylene spunbond and a co-extruded PE film. Layers are thermally bonded together producing a single layer with various basis weights. The outer layers are non woven fabric, the inner layer is AAMI PB:70 Level 4 capable PE film.
The provided document K121919 describes a surgical drape, not an AI/ML powered medical device. Therefore, many of the requested categories for AI/ML devices (e.g., sample sizes for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance) are not applicable.
However, I can extract the acceptance criteria and performance data for this physical medical device based on the information provided.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Predicate Device K102666) | Reported Device Performance (Exact Medical Manufacturing Surgical Drape with AAMI Liquid Barrier Level IV) |
|---|---|---|
| Barrier Performance | AAMI PB70: Level 4 | AAMI PB70: Level 4 |
| Biocompatibility | Cytotoxicity, Primary Skin Irritation, Sensitization tests | ISO 10993-5:2009 Cytotoxicity, ISO 10993-10:2002 Skin Irritation, ISO 10993-10:2002 Sensitization |
| Tear Strength (ASTM 5587-08) | Unknown/Equivalent to Predicate | 19.4 lbs & 9.7 lbs |
| Breaking Strength (ASTM D5034-09) | Unknown/Equivalent to Predicate | 24.4 lbs & 15.9 lbs |
| Flammability (16CFR1610:2007) | Class 1 | Class 1 |
| Linting (ISO 9073-10:2003) | Unknown/Equivalent to Predicate | Reported as 'Substantially Equivalent' to predicate, implying it met predicate's (unknown) criteria |
| Sterility | Sterile via EO Gas | Sterile (via EO Gas) ISO 11135-1:2007 |
Study Proving Device Meets Acceptance Criteria:
The study proving the device meets the acceptance criteria is a "Summary of Testing" described in the 510(k) submission. It states:
"Exact Medical Manufacturing Surgical Drape with AAMI Liquid Barrier Level IV is substantially equivalent and meets the same acceptance criteria as the predicate device/Drape in K102666 Non-clinical performance testing includes: Biocompatibility (cytotoxicity, irritation, sensitization) in compliance with the methods of ISO 10993, Barrier properties- AAMI PB:70 Level 4, tensile, tear strength, flammability, linting and sterility. All results of the testing met acceptance criteria."
Regarding AI/ML Specific Information (Categories 2-9):
As this is a physical surgical drape, the following categories are not applicable and no information is provided in the document:
- Sample size used for the test set and the data provenance: Not applicable for a physical device undergoing non-clinical performance testing.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Material properties and performance are measured against standards, not expert consensus.
- Adjudication method for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For a physical device, the "ground truth" or reference for acceptance is established by recognized international and national standards (e.g., AAMI PB70, ISO 10993, ASTM, 16CFR1610).
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
§ 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.