(24 days)
BARRIER® surgical drapes are intended for single use to be used as a protective patient covering, such as to isolate a site on a surgical incision from microbial and other contamination.
The BARRIER® Surgical Drapes have been designed with an assortment of fabrics, films and other materials and have been on the market for a number of years, cleared under multiple 510(k) notifications. BARRIER® surgical drapes, drape components and assorted surgical drape packs have been developed for a variety of surgical procedures including: Angiography, Cardiovascular/Thoracic, ENT/Plastic Surgery, OB/Gynecology. Laparascopic. Laparotomy, Orthopaedic, Urology, Cranial, Nephroscopy, Pediatric and other general surgical procedures. BARRIER® Surgical Drapes have been designed with materials. which provide increased protection to help prevent possible exposure to bloodborne pathogens and other potentially infectious materials.
The Barrier® Surgical Drapes are categorized into the following product groups: Patient Drapes, Equipment Drapes and Drape Components. All Barrier Drapes are categorized into ANSI/AAMI Level 2 or Level 4 based on material selection and construction.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the BARRIER® Surgical Drapes:
Disclaimer: The provided document is a 510(k) summary from 2005 for a medical device (surgical drapes). The nature of this document means it focuses on demonstrating equivalence to existing products and meeting regulated standards, rather than providing a detailed clinical study report typically associated with AI/ML-based devices. Therefore, many of the requested categories for AI/ML device studies will not be applicable or explicitly stated in this type of document.
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Acceptance Criteria (from text) | Reported Device Performance (from text) |
|---|---|---|
| Liquid Barrier Performance | Evaluated using the ANSI/AAMI PB-70:2003 Standard. | All BARRIER® drapes are categorized into ANSI/AAMI Level 2 or Level 4 based on material selection and construction, demonstrating compliance with the standard's requirements for these levels. (The specific criteria for Level 2 and Level 4 would be defined within the ANSI/AAMI PB-70:2003 standard itself, which is referenced but not detailed in this summary.) |
| Device Classification | Classified as Class II - 21 CFR 878.4370 (Surgical Drape and Drape Accessories). | The device meets this classification. |
| Intended Use | Single use as a protective patient covering to isolate a surgical incision site from microbial and other contamination. | The device's design and materials are stated to "provide increased protection to help prevent possible exposure to bloodborne pathogens and other potentially infectious materials," aligning with the intended use. The historical clearance under multiple 510(k) notifications and design for various surgical procedures (Angiography, Cardiovascular/Thoracic, ENT/Plastic Surgery, OB/Gynecology, Laparascopic, Laparotomy, Orthopaedic, Urology, Cranial, Nephroscopy, Pediatric and other general surgical procedures) supports its fitness for this purpose. |
| Material/Construction | Designed with an assortment of fabrics, films, and other materials. | The device is explicitly described as "designed with an assortment of fabrics, films and other materials." |
| Biocompatibility | (Not explicitly stated, but implied for medical devices in direct patient contact) | (Not explicitly stated in the provided text.) |
| Sterility | (Not explicitly stated, but implied for surgical drapes) | (Not explicitly stated in the provided text.) |
Study Details (as far as discernible from the provided text)
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated. The summary mentions evaluation of "Barrier® Surgical Drapes," "Barrier Drapes," "Patient Drapes, Equipment Drapes and Drape Components." This implies testing was performed on representative samples of different product variations within the Barrier® line.
- Data Provenance: Not specified. Standardized testing for medical devices would typically be conducted by accredited laboratories.
- Retrospective or Prospective: N/A for this type of materials performance testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This is not applicable as the study described is a technical performance evaluation against a published standard (ANSI/AAMI PB-70:2003), not a clinical study requiring expert ground truth for interpretation (like assessing medical images). The "ground truth" is established by the specifications of the standard itself.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. This was materials testing against a standard, not a clinical interpretation study.
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
- No. This is a 510(k) summary for surgical drapes, which are physical medical devices, not AI/ML software. Therefore, an MRMC study comparing human readers with/without AI assistance is not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No. This device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The ground truth for this evaluation is defined by the metrics and pass/fail criteria within the ANSI/AAMI PB-70:2003 Standard, specifically for "Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities."
8. The sample size for the training set
- Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable.
Summary of the Study Mentioned:
The primary study mentioned to demonstrate compliance is an evaluation of the BARRIER® Surgical Drapes using the ANSI/AAMI PB-70:2003 Standard (Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities).
This standard assesses the liquid barrier performance of protective apparel and drapes, categorizing them into different levels based on their resistance to liquid penetration. The study showed that "All Barrier Drapes are categorized into ANSI/AAMI Level 2 or Level 4 based on material selection and construction." This compliance with a recognized standard demonstrates that the drapes meet established performance criteria for fluid resistance, which is critical for their intended use in preventing contamination during surgery.
The context of this 510(k) summary is to demonstrate substantial equivalence to previously marketed surgical drapes, building on a history of pre-amendment devices and multiple clearance notifications since 1976. The testing against ANSI/AAMI PB-70:2003 serves to confirm that the current iterations of the BARRIER® drapes maintain or exceed the performance characteristics necessary for their intended use and regulatory classification.
§ 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.