3M Steri-Drape™ Surgical Fabric Drapes are used to create a sterile field for a surgical procedure. They are provided sterile using ethylene oxide or gamma irradiation, and intended for external use only.

3M Steri-Drape™ non-sterile fabric drapes are provided to other manufacturers for further processing using ethylene oxide. 3M provides information on compatibility with ethylene oxide processing.

Device Description

The Steri-Drape™ Fabric Drapes described in this submission are onepiece, 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.

Steri-Drape™ Fabric Drapes are provided in various sizes and shapes to meet the surgeon's needs. In general, the surgeon delineates the proposed field of surgery and charges the nursing team with the responsibility of draping the patient using different types of drapes.

AI/ML Overview

The provided text describes a medical device, "Steri-Drape™ Fabric Drape," and its summary of safety and effectiveness, leading to FDA clearance (K031287). However, the document does NOT contain the specific details required to answer many of the questions about acceptance criteria and the study that proves the device meets those criteria, especially in the context of AI/ML performance evaluation.

This document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to a predicate device, rather than detailed performance study results with specific acceptance criteria that would be typical for an AI/ML device.

Here's an attempt to answer the questions based only on the provided text, highlighting what is missing:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Explicitly stated in the document)	Reported Device Performance (Explicitly stated in the document)
Biocompatibility (Cytotoxicity, Primary Skin Irritation, Sensitization)	"All testing indicated that the drapes described above were biocompatible and acceptable for the intended use."
(Performance testing in accordance with industry recognized test methods)	(Results not specified beyond general statement of testing performed)
Substantial Equivalence to predicate device	Stated as substantially equivalent to currently marketed Steri-Drape™ fabric drapes.
Intended Use: Create a sterile field for surgical procedure	Device has the same intended use as predicate device.

Missing Information: Specific quantitative acceptance criteria (e.g., specific thresholds for irritation indices, specific performance metrics for barrier function, etc.) and their corresponding quantitative performance results are not detailed. The document states "performance testing in accordance with industry recognized test methods" but does not elaborate on the specific tests, their criteria, or the outcomes.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Missing Information: The document does not specify the sample size for any test set (e.g., number of drapes tested for biocompatibility or performance). It also does not mention the data provenance (country of origin, retrospective/prospective). This type of detail is usually found in detailed test reports, not a 510(k) summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Missing Information: This question is not applicable to the type of device and testing described. The "ground truth" concept, especially involving expert consensus, is typically associated with diagnostic or image-analysis AI/ML devices where human expert interpretation is the standard. For a surgical drape, "ground truth" would be established through laboratory testing (e.g., chemical analysis, physical property measurements) and clinical observation of material safety and performance, not expert review of interpretative data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Missing Information: This question is not applicable for the reasons stated in point 3. Adjudication methods are relevant for resolving discrepancies in expert interpretations, which is not the nature of testing for a surgical drape.

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

Missing Information: This question is not applicable. An MRMC study is relevant for evaluating the clinical utility and impact of AI assistance on human reader performance, typically for diagnostic tasks (e.g., radiologists interpreting images). This device is a surgical drape, not an AI or diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Missing Information: This question is not applicable. The device is a physical surgical drape, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

As discussed in point 3, the concept of "ground truth" in the AI/ML context doesn't directly apply here. For this device, the "truth" or validation relies on:

Biocompatibility testing results: (cytotoxicity, primary skin irritation, sensitization testing) indicating safety for human contact.
Performance testing: "in accordance with industry recognized test methods" to ensure the drape functions as intended (e.g., barrier properties, absorbency – though specific details are withheld).
Predicate device comparison: Demonstrating substantial equivalence to an already legally marketed device with a known safety and effectiveness profile.

8. The sample size for the training set

Missing Information: Not applicable. This device is a physical product, not an AI model, so there is no "training set."

9. How the ground truth for the training set was established

Missing Information: Not applicable, as there is no training set for this type of device.

Summary of Document Limitations:

The provided document is a 510(k) summary for a physical medical device (surgical drape). Its purpose is to demonstrate substantial equivalence to a predicate device, focusing on intended use, technology, safety, and effectiveness. It is not a detailed scientific study report for an AI/ML device. Therefore, the specific criteria and study details requested, particularly those related to AI/ML performance evaluation (e.g., sample sizes for test/training sets, expert ground truth, MRMC studies), are not present in this document. The information available pertains to the biocompatibility and general performance claims of a physical product.

Summary

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SEP 1 0 2003

Image /page/0/Picture/1 description: The image shows a handwritten sequence of characters, seemingly a combination of letters and numbers. The sequence reads 'K031287'. The characters are written in a bold, somewhat uneven style, giving it a casual, handwritten appearance.

Steri-Drape™ Fabric Drape Summary of Safety and Effectiveness

General Information

Manufacturer:

Requlatory Contact:

3M Health Care 3M Center St. Paul, MN 55144-1000 (651) 733-1110

Scott Sardeson Sr. Regulatory Affairs Associate

Date:

Dietary Name:

Steri-Drape™ Fabric Surgical Drape Proprietary Name:

March 21, 2003

Common Name: Sterile and Non-Sterile Surgical Drape

Steri-Drape™ Fabric Surgical Drapes Predicate Device: (Class II, KKX)

Device Description

Indication for Use

3M Steri-Drape™ non-sterile fabric drapes are provided to other manufacturers for further processing using ethylene oxide. 3M provides information on compatibility with ethylene oxide processing.

Substantial Equivalence

The Steri-Drape™ fabric drapes described in this submission are substantially equivalent to the currently marketed Steri-Drape™ fabric drapes. These drapes have the same intended use as the currently marketed Steri-Drape™ Fabric Drapes.

Description of Testing

In addition to performance testing in accordance with industry recognized test methods, these drapes were tested for biocompatibility using

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cytotoxicity, primary skin irritation tests, and sensitization testing. All testing indicated that the drapes described above were biocompatible and acceptable for the intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three horizontal lines above two curved lines, resembling an abstract representation of the human form.

Public Health Service

SEP 1 0 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Scott S. Sardeson Senior Regulatory Affairs Associate 3M Center, Bldg. 275-5W-06 Street Paul, Minnesota 55144-1000

Re: K031287

Trade/Device Name: Steri- Drape Surgical Drapes Regulation Number: 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: KKX Dated: July 24, 2003 Received: July 28, 2003

Dear Mr. Sardeson:

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 vour 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.

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Page 2 -Mr. Sardeson

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. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, 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), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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 Russe

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K031287

Device Name: 3M Steri-Drape™ Surgical Fabric Drapes

Indications for Use:

3M Steri-Drape™ non-sterile fabric drapes are provided to other manufacturers for further processing using ethylene oxide. 3M provides information on compatibility with ethylene oxide processing.

Susabunne

(Division Sian-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental D

510(k) Number: K031287

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

concurrence of CDRH, Office of Device Evaluation (ODE)

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.