(55 days)
Kimberly-Clark* Corporation intends to market the sterile Kimberly-Clark* Surgical Drapes with AAMI Liquid Barrier Level 4 claim 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. The Kimberly-Clark* Surgical Drapes with AAMI Liquid Barrier Level 4 claim meet the Level 4 requirements of the AAMI Liquid Barrier classifications.
The Kimberly-Clark* Surgical Drapes with AAMI Liquid Barrier Level 4 claim are also sold as bulk non-sterile, single use items, to repackager/relabeler establishments for further packaging and Ethylene Oxide (EtO) sterilization.
The Kimberly-Clark* Surgical Drapes with AAMI Liquid Barrier Level 4 claim are constructed with various base sheet and reinforcement fabric types, provided in various sizes and shapes, and may contain fluid collection pouches or clear film panels as components. The base sheet fabric is a three layer laminate comprised of polypropylene spunbond/polypropylene meltblown/polypropylene spunbond. Layers are thermally embossed together producing a single layer with various basis weights. Fabric is topically treated to enhance water repellency and to assure static dissipation.
The drape reinforcement fabrics are constructed of various configurations of spunbond, meltblown and film. The reinforcement materials are either CONTROL PLUS*, a spunbond/meltblown/film laminate or SURROUND*, a spunbond/film laminate. The primary component of these materials is polypropylene with surfactant and blue pigment.
The Kimberly-Clark* Surgical Drapes with AAMI Liquid Barrier Level 4 claim were evaluated through performance testing to ensure compliance with the "Level 4 liquid barrier performance of ANSI/AAMI PB70: 2003 'Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities.'"
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Level 4 liquid barrier performance of ANSI/AAMI PB70: 2003 | All results of testing met acceptance criteria. |
| Biocompatibility (cytotoxicity, primary skin irritation, and sensitization tests) | All results of testing met acceptance criteria. |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the sample size used for the test set or the country of origin for the data. The testing was described as "performance testing in accordance with industry recognized test methods" and "biocompatibility using cytotoxicity, primary skin irritation tests and sensitization testing." This suggests a prospective testing methodology performed specifically for the device's premarket notification.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable to the submitted document. The ground truth for this medical device (surgical drapes) is established through standardized performance tests and material biocompatibility tests, not through expert consensus on medical images or diagnoses.
4. Adjudication method for the test set:
This information is not applicable. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, such as those with medical imaging. For the performance of surgical drapes, the results are determined by objective laboratory tests against predefined standards.
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 information is not applicable. The device in question is a surgical drape, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable. The device is a physical product (surgical drape), not an algorithm.
7. The type of ground truth used:
The ground truth used for this device is based on objective performance standards and material safety requirements. Specifically:
- Performance: Adherence to "Level 4 liquid barrier performance of ANSI/AAMI PB70: 2003".
- Biocompatibility: Results from cytotoxicity, primary skin irritation, and sensitization tests.
8. The sample size for the training set:
This information is not applicable. Surgical drapes are not developed or evaluated using machine learning algorithms that require training sets. The "training" of such a device involves product design, material selection, and manufacturing processes, followed by validation through standardized physical and biological testing.
9. How the ground truth for the training set was established:
This information is not applicable as there is no "training set" in the context of an AI algorithm for this type of medical device. The "ground truth" for the device's design and manufacturing is established through adherence to recognized industry standards (like ANSI/AAMI PB70: 2003) and regulatory requirements for material biocompatibility and safety.
§ 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.