(226 days)
The Surgical Drape is intended for external use only and is used as a protective patient covering, such as to isolate a site of surgical incisions from microbial and other contamination. They are provided sterile using ethylene oxide.
Surgical drapes are intended to provide protection from microbial and other contamination. The Lucas surgical drapes described in this submission are one-piece, single use disposable sheets designed to provide an absorbent sterile barrier during surgical procedures. The drapes cover the patient and are made of an absorbent nonwoven fabric backed with a protective film that stops fluid strike-through. There are various sizes to meet the surgeon's needs. In general, the surgeon delineates with proposed field of surgery and charges the nursing team with the responsibility of draping the patient suing different types of drapes, with & without fenestration.
Lucas surgical drapes are made of nonwoven fabric composes of a three-layer composite comprised of a top layer, middle layer and bottom layer, they passed the industry standard tests that measure fluid and synthetic blood penetration, they are classified as a level 4 device under the AAMI PB 70 for barrier performance.
The document describes the acceptance criteria and the study conducted for the Surgical Drape, models 42526 and 42527, manufactured by GRIFFITH-LUCAS LLC.
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Performance Measure) | Reported Device Performance (Lucas Surgical Drape) |
|---|---|
| Barrier Properties | AAMI PB70 Barrier Level 4 |
| Liquid Barrier Performance | AAMI PB70 Barrier Level 4 |
| Flammability | Meets CFR Part 1610 Standard |
| Resistance to Penetration by Synthetic Blood | Meets ASTM F 1670-08 Standard |
| Seal Leaks in Porous Medical Packaging | Meets ASTM F1929 Standard |
| Internal Pressurization Failure Resistance | Meets ASTM F1140 Standard |
| Biocompatibility | Non-cytotoxic, non-sensitizing, non-irritating, no pyrogen |
2. Sample Size Used for the Test Set and Data Provenance:
The document states "bench tests to demonstrate that the proposed device performs within its specifications" and provides a list of standards met for various tests. However, it does not explicitly state the specific sample sizes used for each of these bench tests.
The data provenance is from non-clinical (bench) testing performed by GRIFFITH-LUCAS LLC. There is no information regarding the country of origin of the data beyond the manufacturer being in China, but the tests performed are based on international standards (AAMI, CFR, ASTM). The studies are prospective in the sense that they were conducted specifically for the purpose of demonstrating the device's performance against established standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not applicable as the ground truth for this device's performance is established through adherence to standardized non-clinical test methods and specified acceptance criteria (e.g., AAMI PB70 Barrier Level 4, ASTM standards) rather than expert consensus on a test set of data.
4. Adjudication Method for the Test Set:
This information is not applicable. The performance is evaluated against defined physical and chemical standards, not through expert adjudication of subjective assessments. The tests have pass/fail criteria based on objective measurements.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "The subject of this premarket submission, SURGICAL DRAPE, did not require clinical studies to support substantial equivalence."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This question is not applicable as the device is a physical surgical drape, not an AI algorithm or software. The "standalone performance" refers to the device's functional characteristics (e.g., barrier properties, biocompatibility) when tested independently according to established standards.
7. The Type of Ground Truth Used:
The ground truth used for performance validation is based on established industry standards and regulatory criteria. These include:
- AAMI PB70 (liquid barrier performance and classification)
- CFR Part 1610 (flammability)
- ASTM F 1670-08 (resistance to penetration by synthetic blood)
- ASTM F1929 (seal leaks in porous medical packaging)
- ASTM F1140 (internal pressurization failure resistance)
- Biocompatibility standards (cytotoxicity, irritation, sensitization, pyrogenicity)
8. The Sample Size for the Training Set:
This information is not applicable. This submission is for a physical medical device (surgical drape), not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established:
This information is not applicable for the same reason as point 8.
§ 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.