(62 days)
The Klinidrape® Surgical Drapes are devices intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination.
The Klinidrape® Surgical Drapes are composed of a 3-laminate or 2- laminate composed of nonwoven, polyethylene film and white tissue.
The document describes the acceptance criteria and the summary of testing for the Klinidrape® Surgical Drapes.
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Characteristic | Acceptance Criteria (Standard Assessed) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Non-toxic and non-irritant (ISO 10993, Part I: Biological Evaluation of Medical Devices) | Found non-toxic and non-irritant |
| Barrier | Resistance to Penetration by Synthetic Blood (ASTM-F1670-98) | Determined to pass |
| Barrier | Viral Penetration Testing (ASTM-F1671-97b) | Determined to pass |
| Flammability | Meets Class 1 (16 CFR 1610) | Meets Class 1 |
| Physical Strength | Tensile Strength and Elongation (ASTM D 882) | Tested and pass |
| Physical Strength | Breaking Strength (ASTM D 5034) | Tested and pass |
Regarding the study proving the device meets the acceptance criteria:
The document states that the Klinidrape® Surgical Drapes have been found non-toxic and non-irritant when tested by the above biological tests in accordance with the ISO 10993, Part I: Biological Evaluation of Medical Devices. It also mentions that the materials used... have been tested in accordance with applicable standards and was determined to pass the specified ASTM and CFR standards.
The document does not provide details about a "study" in the traditional sense of a clinical trial or comparative effectiveness study. Instead, it refers to product testing against established material and performance standards relevant to Class II medical devices like surgical drapes.
The following information is not provided in the document:
- Sample sizes used for the test set and the data provenance: The document mentions "the above biological tests" and "materials were tested" but does not specify sample sizes for each test or the origin of the data (country, retrospective/prospective).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for material testing against standards.
- Adjudication method for the test set: Not applicable for material testing against standards.
- 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 an AI/software device; therefore, an MRMC study is not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This is not an AI/software device; therefore, standalone performance is not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" here is compliance with established international and national standards for material properties and performance for surgical drapes.
- The sample size for the training set: Not applicable, as this is a physical medical device undergoing material and performance testing, not a machine learning model.
- How the ground truth for the training set was established: Not applicable for the same reason as above.
§ 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.