Foothills Surgical Drapes are devices made from natural and synthetic materials intended to be used by medical professionals as protective coverings, such as a patient covering to isolate a site for surgical incision from contamination and to cover accessories in the operating room.

These disposable single-use drapes are designed to be repackaged and sterilized before use by the user using a 100% EtO cycle that has been validated to achieve a SAL of 10-6 in accordance with ANSI/AAMI/ISO 11135:1994. Sterilization residual limits should meet the requirements of the ANSI/AAMI/ISO 10993-9:1995.

Device Description

Foothills Industries disposable surgical drapes and utility covers are devices made from natural and synthetic materials intended to be used by medical professionals as protective coverings.

AI/ML Overview

The provided text describes the submission for a 510(k) premarket notification for "Foothills Surgical Drapes" and confirms their substantial equivalence to existing predicate devices. However, it does not include information about specific acceptance criteria or a study designed to prove the device meets such criteria as would typically be found for AI/ML-driven devices with performance metrics like accuracy, sensitivity, or specificity.

The document focuses on the technological characteristics and intended use of the surgical drapes being substantially equivalent to legally marketed predicate devices. The "study" mentioned relates to the sterilization validation, which is a process validation, not a performance study in the context of an AI/ML device.

Therefore, many of the requested sections (Table of acceptance criteria, sample sizes, expert involvement, MRMC study, standalone performance, ground truth types and establishment, and training set details) are not applicable to this particular document, as it concerns a traditional medical device (surgical drapes) and not an AI/ML-driven device.

Here's the information that can be extracted or inferred from the provided text, acknowledging the limitations for an AI/ML context:

1. Table of Acceptance Criteria and the Reported Device Performance

As this device is a traditional surgical drape, the "acceptance criteria" revolve around its material properties, intended use, and ability to be sterilized, rather than performance metrics common for AI/ML devices (e.g., sensitivity, specificity). The document indicates substantial equivalence based on these characteristics.

Acceptance Criteria Category	Specific Criteria/Standard	Reported Device Performance (Foothills Surgical Drapes)
Material & Design	Same as currently marketed surgical drapes.	Made from the same materials and designs as other currently marketed surgical drapes.
Absorbency	Same as currently marketed surgical drapes.	Provides the same absorbency as other currently marketed surgical drapes.
Packaging	Same as currently marketed surgical drapes.	Has the same packaging as other currently marketed surgical drapes.
Other Performance Characteristics	Same as currently marketed surgical drapes.	Possesses the same "other performance characteristics" as other currently marketed surgical drapes.
Sterilization Process	Designed to be sterilized by the user using a 100% EtO cycle achieving a SAL of 10-6.	Designed for user sterilization via a 100% EtO cycle validated to achieve a SAL of 10-6 in accordance with ANSI/AAMI/ISO 11135:1994.
Sterilization Residuals	Residual limits should meet requirements of ANSI/AAMI/ISO 10993-9:1995.	Sterilization residual limits should meet the requirements of ANSI/AAMI/ISO 10993-9:1995.
Labeling	Similarly labeled as disposable and non-sterile.	Similarly labeled as disposable and non-sterile.
Intended Use	Protective coverings, patient covering, covering accessories in OR.	Intended for the same uses as predicate devices (protective coverings, isolating surgical site, covering accessories).

The "study" that proves the device meets (or is equivalent to devices meeting) these criteria is the 510(k) premarket notification review process, which determined substantial equivalence to predicate devices (3M Steri Drape (K031287) and Alcon (K830822)). The sterilization aspect relies on the validation of a 100% EtO cycle designed to achieve a specified Sterility Assurance Level (SAL) and meet residual limits.

The following information is not present in the provided text, as it pertains to AI/ML device performance studies, which are not relevant for a traditional surgical drape 510(k) submission:

Sample size used for the test set and the data provenance: Not applicable. No test set in the context of an AI/ML performance study is described. The "test" here refers to demonstrating manufacturing and material equivalence, and sterilization validation.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No expert ground truth establishment for a diagnostic/interpretive task.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable. This is not an AI-assisted device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. "Ground truth" in this context would relate to the material specifications, absorbency values, and successful sterilization, not diagnostic outcomes.
The sample size for the training set: Not applicable. No training set for an AI/ML model.
How the ground truth for the training set was established: Not applicable.

Summary

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FEB - 3 2005

K041224

Summary of Safety and Effectiveness

Submitted by:

Jov Shuford Foothills Industries 172 Lukfin Street Marion, NC 28752

Date Summary Prepared: December 6, 2004

Proposed Devices: Surgical drapes and utility drapes

Classification Name: Surgical Drape and Drape Accessories

Comparison Devices:

Foothills Industries surgical drapes and utility drapes are substantially equivalent to surgical drapes and utility drapes currently marketed by 3M Steri Drape (K031287) and Alcon (K830822).

Description of Device:

Foothills Industries disposable surgical drapes and utility covers are devices made from natural and synthetic materials intended to be used by medical professionals as protective coverings.

Intended Use:

Foothills Industries disposable surgical drapes and utility covers are devices made from natural and synthetic materials intended to be used by medical professionals as protective coverings, such as patient covering to isolate a site for surgical incision from contamination and to cover accessories in the operating room.

Technological Characteristics:

Foothills Industries surgical and utility drapes are made from the same materials and designs as other currently marketed surgical drapes. They provide the same absorbency, packaging, and other performance characteristics and are similarly labeled as disposable and non-sterile.

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Image /page/1/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. In the center of the seal is a stylized caduceus, a symbol of medicine and health, with a double helix representing DNA.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 3 2005

Ms. Joy Shuford Chief Executive Foothills Industries, Incorporated 172 Lukin Street Marion, North Carolina 28752

Re: K041224

Trade/Device Name: Foothills Surgical Drapes Regulation Number: 21 CFR 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: KKX Dated: January 19, 2005 Received: January 21, 2005

Dear Ms. Shuford:

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.

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Page 2 - Ms. Shuford

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 vou desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. 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/industry/support/index.html.

Sincerely yours,

Chiu Lin, Ph.D.

Chiu Lin, Ph.D. 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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Indications for Use

510(k) Number (if known): K041224

Device Name: Foothills Surgical Drapes

Indications For Use:

Cichosio D.P. for Loretta Michael 2/1/05, Acting Branch Chief

on Figh-6 Ston of Anesthesiology, General Hospital, Interior Control, Dental Devices

Number: K041224

AND/OR Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use X (21 CFR 807 Subpart C)

(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.