MERTEX-PLUS REUSABLE SURGICAL DRAPE by MERCAN AB

The Sewing Source Custom Reusable Surgical Drapes, based on the both the Maxima ESD-AT and Mertex-Plus E5533-R materials, are reusable protective patient covering for isolating sites of surgical incisions from microbial or other contamination. For manufacturing, processing, or repackaging, these drapes must be reprocessed and packaged.

Device Description

reusable protective patient covering for isolating sites of surgical incisions from microbial or other contamination.

AI/ML Overview

The provided text is related to a 510(k) premarket notification for a non-sterile reusable surgical drape, Mertex-Plus Nonsterile Reuseable Surgical Drape (K012237). The acceptance criteria and the study that proves the device meets them are not explicitly detailed in the provided document.

This document is a marketing clearance letter from the FDA stating that the device is "substantially equivalent" to legally marketed predicate devices, which means it doesn't need to demonstrate novel performance characteristics or undergo new clinical trials for effectiveness in the same way a new drug or novel device might. The substantial equivalence is based on the device's technical characteristics and intended use being similar to existing cleared devices.

Therefore, the specific quantitative details requested in your questions (e.g., performance metrics, sample sizes, expert qualifications, effect sizes, etc.) are not present in this type of FDA clearance letter. Such information would typically be found in the manufacturer's 510(k) submission, which is not publicly available in this excerpt.

However, I can infer what might have been considered based on the nature of a reusable surgical drape and the regulatory context of a 510(k) submission:

Acceptance Criteria and Reported Device Performance: Instead of performance metrics like sensitivity/specificity for diagnostic AI, for a reusable surgical drape, acceptance criteria would likely relate to:
- Material properties: Tensile strength, tear resistance, fluid repellency, linting, microbial barrier effectiveness (after multiple reprocessing cycles).
- Biocompatibility: Confirmation that the material is not irritating or sensitizing.
- Reprocessing efficacy: Demonstration that the drape can be effectively cleaned, disinfected/sterilized, and maintained for a specified number of cycles without degradation of its protective properties.
- Substantial Equivalence to Predicate: The primary "performance" metric here is demonstrating that the Mertex-Plus drape performs similarly to existing legally marketed reusable surgical drapes.
Sample Size and Data Provenance: Not applicable in the context of a 510(k) for substantial equivalence based on material properties and reprocessing. The "test set" would be the Mertex-Plus material and reprocessed drapes. The provenance would be the manufacturer's lab tests.
Number of Experts and Qualifications: Not applicable. Material testing and reprocessing validation are usually done by engineers and microbiologists, not clinical experts for "ground truth" in the diagnostic sense.
Adjudication Method: Not applicable.
Multi Reader Multi Case (MRMC) Comparative Effectiveness Study: Not applicable. This type of study is for evaluating diagnostic performance of AI with human readers.
Standalone Algorithm Performance: Not applicable. This is not an AI device.
Type of Ground Truth: For this type of device, "ground truth" would be established through:
- Standardized material testing: e.g., ASTM or ISO standards for textile properties, fluid resistance, breathability.
- Microbiological barrier testing: To demonstrate efficacy against microbial penetration.
- Reprocessing validation studies: Showing that the cleaning and sterilization protocols achieve the desired level of cleanliness and sterility while maintaining material integrity over multiple cycles.
- Biocompatibility testing: Following ISO 10993 standards.
Sample Size for Training Set: Not applicable. This product does not involve machine learning.
How Ground Truth for Training Set was Established: Not applicable.

In summary, the provided document is an FDA clearance letter for a device that received a 510(k) substantial equivalence determination. It does not contain the detailed performance study information typically associated with AI/diagnostic devices and the "acceptance criteria" here would be tied to material and reprocessing standards rather than clinical performance metrics.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 5 2001

Mercan AB C/O Mr. Jeffrey O Stull International Personal Protection, Incorporated 10907 Wareham Court Austin, Texas 78739

Re: K012237

Trade/Device Name: Mertex-Plus Nonsterile Reuseable Surgical Drape Regulation Number: 878.4370 Regulation Name: Nonsterile Surgical Drape; Sterilization Wrappers Regulatory Class: II Product Code: KKX Dated: July 15, 2001 Received: July 17, 2001

Dear Mr. Stull:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.

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You must comply with all the Act's requirements, including, but not limited to: registration 1 ou inust comply with and and (21 CFR Part 801); good manufacturing practice and ilsuing (21 es ready in the quality systems (QS) regulation (21 CFR Part 820); and if requirements the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Kunroe

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Sewing Source Custom Reusable Surgical Drapes based on the both the Maxima ESD-AT and Mertex-Plus E5533-R Materials

Reference: K012237

Statement of Intended Use

Qutin S. lin

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number .

Regulation Number and Section

§ 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.