(142 days)
Kimberly-Clark Corporation intends to market the sterile KC100 Surgical Drapes as devices made of natural or synthetic material intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. Kimberly-Clark intends to market the sterile KC100 Surgical Equipment Covers which are protective barrier covers that are intended to be used to cover surgical equipment and provide a protective barrier for that equipment.
The surgical drapes and equipment covers described in this 510(k) submission are identical in all specifications to the predicate device models identified in K080629 except for minor variations in the widths and lengths of three models.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility | Met acceptance criteria |
| Barrier properties | Met acceptance criteria |
| Tensile strength | Met acceptance criteria |
| Tear strength | Met acceptance criteria |
| Alcohol repellency | Met acceptance criteria |
| Flammability | Met acceptance criteria |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes used for the test set for each individual criterion. It only states that "All results of testing met acceptance criteria."
The data provenance is not explicitly mentioned. However, since this is a 510(k) submission to the FDA, it is highly likely that the testing was conducted by or on behalf of the manufacturer (Kimberly-Clark Corporation) to demonstrate compliance with US regulations. The nature of the tests (biocompatibility, barrier properties, strength, etc.) suggests these would be laboratory-based studies, likely prospective in nature (i.e., conducted specifically for this submission).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
This information is not provided in the document. For device performance testing (like material properties), "ground truth" is typically established by standardized testing methods and analytical instruments, not by expert consensus in the same way it would be for diagnostic image interpretation.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided. Adjudication methods (like 2+1, 3+1) are relevant for studies where human interpretation or judgment is involved, especially in medical image analysis or clinical trials to resolve discrepancies. For material property testing, the results are typically objectively measured against predefined standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
This information is not applicable and therefore not provided. The device (surgical drapes and equipment covers) is a medical device, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human readers with and without AI assistance would not be relevant.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done
This information is not applicable and therefore not provided. As mentioned above, the device is a physical sterile barrier product, not a software algorithm.
7. The Type of Ground Truth Used
The ground truth used for this testing would be based on objective measurements and predefined material specifications/standards. For example:
- Biocompatibility: Established by reference to ISO 10993 standards and their associated test methods and acceptable limits (e.g., cell viability percentages, irritation scores).
- Barrier properties: Measured against standardized test methods for fluid penetration, microbial penetration, etc., with defined acceptable levels.
- Tensile and tear strength: Measured using force-testing equipment against specified minimum strength requirements.
- Alcohol repellency & Flammability: Measured according to relevant industry standards and acceptable criteria.
8. The Sample Size for the Training Set
This information is not applicable and therefore not provided. As the device is a physical product and not an AI/machine learning model, there is no "training set" in the context of algorithm development. The testing conducted is to verify the physical properties of the manufactured product.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and therefore not provided 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.