(37 days)
Promax Surgical Drapes and Covers are intended to be used in health care facilities on patients or surfaces during surgical procedures where protection from liquid migration is needed. The liquid barrier will inhibit migration of liquid through its surface.
ProMax™ Surgical Drapes and Covers can be constructed utilizing one or more types of filament polyester fabrics based on the intended use of the product. The specific fabrics include ProMax™, WrapPel®, ComPel® and Zorwick®. ProMax™ Surgical Drapes and Covers will meet performance standards as a surgical drape and cover when processed according to instructions through 75 complete wash, dry and sterilization cycles. These products will be manufactured and distributed as nonsterile surgical drapes and covers that are intended to be sterilized and processed by health care facilities and/or contract sterilization/laundry companies.
This document is a 510(k) summary for ProMax™ Surgical Drapes and Covers, seeking to demonstrate substantial equivalence to a predicate device (ComPel® Surgical Drapes #K923811). It outlines the device's characteristics, intended use, and performance testing.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by successful completion of various standardized tests, indicating that ProMax™ Surgical Drapes and Covers meet the performance standards required for surgical drapes and covers. The reported device performance is that ProMax™ successfully completed all listed tests.
| Acceptance Criteria (Test) | Reported Device Performance (Outcome) |
|---|---|
| Flammability: | Successfully completed |
| - Code of Federal Regulations 1610 Standard for the Flammability of Clothing Textiles (CS-191-53) | |
| - NFPA 702-1975 (Flammability of Wearing Apparel) | |
| Barrier Performance: | Successfully completed |
| - Mullens Hydrostatic Resistance for liquid "proof" fabrics (ASTM #D-751-79 Method A) | |
| - Suter Hydrostatic Resistance for liquid resistant fabrics (AATCC #127-1989) | |
| Colorfastness: | Successfully completed |
| - Colorfastness to Commercial Laundering (AATCC #61-1996-4A) | |
| Strength: | Successfully completed |
| - Tensile Strength for woven fabrics (ASTM #D-1682) | |
| - Bursting Strength for knitted and coated fabrics | |
| Biocompatibility (ISO 10993-1): | Successfully completed |
| - Cytotoxicity (MEM Elution - NamSA Laboratories) | |
| - Primary Skin Irritation (FHSA - NamSA Laboratories) | |
| - Systemic Toxicity (Saline - USP - NamSA Laboratories) | |
| - Systemic Toxicity (Cottonseed Oil - USP - NamSA Laboratories) | |
| - Systemic Toxicity (Saline/Alcohol - USP - NamSA Laboratories) | |
| - Sensitization (ISO - NamSA Laboratories) | |
| - Hemolysis (ASTM MGP72-100 - NamSA Laboratories) | |
| Sterilization: | Successfully completed |
| - ANSI/AAMI ST 25-1987 "Guideline for Industrial Moist Heat Sterilization of Medical Products" |
The document states that these tests were successfully completed "through 75 complete wash, dry and sterilization cycles," indicating the durability of the performance.
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify the exact sample sizes used for each test. The provenance of the data is from non-clinical tests conducted by "NamSA Laboratories" for biocompatibility tests, and by Standard Textile Co., Inc. (implied for other material performance tests). The tests are performed on the ProMax™ fabric and products. The nature of these tests suggests they are prospective in the sense that they are conducted on new prototypes or manufactured samples to demonstrate compliance with standards. There is no mention of country of origin for the data directly, other than the location of Standard Textile Co., Inc. in Cincinnati, Ohio, USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This type of information is not applicable to this submission. The "ground truth" for the performance of the surgical drapes is established by the successful completion of standardized material and biological tests, not by expert interpretation of clinical cases or data. The standards themselves (e.g., ASTM, AATCC, ISO, NFPA, CFR) represent a consensus of expert knowledge in their respective fields.
4. Adjudication Method for the Test Set
This is not applicable as the evaluation relies on objective, standardized tests with predefined pass/fail criteria, not on subjective assessments that would require adjudication.
5. 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
This is not applicable. This is a submission for surgical drapes and covers, which are physical medical devices, not diagnostic software or AI-assisted technologies. Therefore, MRMC studies, human reader performance, or AI assistance are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device is based on established industry and regulatory standards and specifications for medical textiles and biocompatibility. Successful adherence to these standards, as verified by quantitative and qualitative laboratory tests, constitutes the "ground truth" for performance.
8. The Sample Size for the Training Set
This is not applicable. This submission is for a physical medical device (surgical drapes), not a machine learning model. Therefore, there is no "training set."
9. How the Ground Truth for the Training Set was Established
This is not applicable as there is no training set for a physical medical device.
§ 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.