BARRIER® surgical drapes are intended for single use to be used as a protective patient covering, such as to isolate a site on a surgical incision from microbial and other contamination.

Device Description

The BARRIER® Surgical Drapes have been designed with an assortment of fabrics, films and other materials and have been on the market for a number of years, cleared under multiple 510(k) notifications. BARRIER® surgical drapes, drape components and assorted surgical drape packs have been developed for a variety of surgical procedures including: Angiography, Cardiovascular/Thoracic, ENT/Plastic Surgery, OB/Gynecology. Laparascopic. Laparotomy, Orthopaedic, Urology, Cranial, Nephroscopy, Pediatric and other general surgical procedures. BARRIER® Surgical Drapes have been designed with materials. which provide increased protection to help prevent possible exposure to bloodborne pathogens and other potentially infectious materials.

The Barrier® Surgical Drapes are categorized into the following product groups: Patient Drapes, Equipment Drapes and Drape Components. All Barrier Drapes are categorized into ANSI/AAMI Level 2 or Level 4 based on material selection and construction.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the BARRIER® Surgical Drapes:

Disclaimer: The provided document is a 510(k) summary from 2005 for a medical device (surgical drapes). The nature of this document means it focuses on demonstrating equivalence to existing products and meeting regulated standards, rather than providing a detailed clinical study report typically associated with AI/ML-based devices. Therefore, many of the requested categories for AI/ML device studies will not be applicable or explicitly stated in this type of document.

Acceptance Criteria and Device Performance

Acceptance Criteria Category	Acceptance Criteria (from text)	Reported Device Performance (from text)
Liquid Barrier Performance	Evaluated using the ANSI/AAMI PB-70:2003 Standard.	All BARRIER® drapes are categorized into ANSI/AAMI Level 2 or Level 4 based on material selection and construction, demonstrating compliance with the standard's requirements for these levels. (The specific criteria for Level 2 and Level 4 would be defined within the ANSI/AAMI PB-70:2003 standard itself, which is referenced but not detailed in this summary.)
Device Classification	Classified as Class II - 21 CFR 878.4370 (Surgical Drape and Drape Accessories).	The device meets this classification.
Intended Use	Single use as a protective patient covering to isolate a surgical incision site from microbial and other contamination.	The device's design and materials are stated to "provide increased protection to help prevent possible exposure to bloodborne pathogens and other potentially infectious materials," aligning with the intended use. The historical clearance under multiple 510(k) notifications and design for various surgical procedures (Angiography, Cardiovascular/Thoracic, ENT/Plastic Surgery, OB/Gynecology, Laparascopic, Laparotomy, Orthopaedic, Urology, Cranial, Nephroscopy, Pediatric and other general surgical procedures) supports its fitness for this purpose.
Material/Construction	Designed with an assortment of fabrics, films, and other materials.	The device is explicitly described as "designed with an assortment of fabrics, films and other materials."
Biocompatibility	(Not explicitly stated, but implied for medical devices in direct patient contact)	(Not explicitly stated in the provided text.)
Sterility	(Not explicitly stated, but implied for surgical drapes)	(Not explicitly stated in the provided text.)

Study Details (as far as discernible from the provided text)

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

Sample Size: Not explicitly stated. The summary mentions evaluation of "Barrier® Surgical Drapes," "Barrier Drapes," "Patient Drapes, Equipment Drapes and Drape Components." This implies testing was performed on representative samples of different product variations within the Barrier® line.
Data Provenance: Not specified. Standardized testing for medical devices would typically be conducted by accredited laboratories.
Retrospective or Prospective: N/A for this type of materials performance testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is not applicable as the study described is a technical performance evaluation against a published standard (ANSI/AAMI PB-70:2003), not a clinical study requiring expert ground truth for interpretation (like assessing medical images). The "ground truth" is established by the specifications of the standard itself.

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

Not applicable. This was materials testing against a standard, not a clinical interpretation study.

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

No. This is a 510(k) summary for surgical drapes, which are physical medical devices, not AI/ML software. Therefore, an MRMC study comparing human readers with/without AI assistance is not relevant.

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

No. This device is not an algorithm.

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

The ground truth for this evaluation is defined by the metrics and pass/fail criteria within the ANSI/AAMI PB-70:2003 Standard, specifically for "Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities."

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable.

Summary of the Study Mentioned:

The primary study mentioned to demonstrate compliance is an evaluation of the BARRIER® Surgical Drapes using the ANSI/AAMI PB-70:2003 Standard (Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities).

This standard assesses the liquid barrier performance of protective apparel and drapes, categorizing them into different levels based on their resistance to liquid penetration. The study showed that "All Barrier Drapes are categorized into ANSI/AAMI Level 2 or Level 4 based on material selection and construction." This compliance with a recognized standard demonstrates that the drapes meet established performance criteria for fluid resistance, which is critical for their intended use in preventing contamination during surgery.

The context of this 510(k) summary is to demonstrate substantial equivalence to previously marketed surgical drapes, building on a history of pre-amendment devices and multiple clearance notifications since 1976. The testing against ANSI/AAMI PB-70:2003 serves to confirm that the current iterations of the BARRIER® drapes maintain or exceed the performance characteristics necessary for their intended use and regulatory classification.

Summary

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K051625

510(k) SUMMARY

JUL 1 4 2005

Applicant:	Mölnlycke Health Care826 Newtown Yardley Rd.Newtown, PA 18940
Contact Person:	John ClayRegulatory Affairs Officer
Tel.:	267-685-2078
Fax:	267-685-2010
Device Name:	Proprietary Name: Barrier® Surgical DrapesCommon/Usual Name: Surgical DrapesDevice Classification: Class II - 21 CFR 878.4370 (KKX)
Substantial Equivalence:	For the purpose of Section 510(k) of the Federal Food, Drug andCosmetic Act, Mölnlycke Health Care considers the BARRIER®Surgical Drape are substantially equivalent in composition,function and intended use to the previously marketed BARRIER®Surgical Drapes. The original BARRIER® Brand surgical drapeswere pre-amendment devices manufactured by Johnson andJohnson Medical.
	The first premarket notifications (K760807, K760902, K760933,K760937) were submitted in 1976 to cover the products already onthe market. In 1978, additional submissions (K780282,K780839A, K780840A, K780841A, K780842A, K780843A,K780844A, K780856A) were made for modifications to the fabricin various surgical drape configurations to the Fabric 450® non-woven fabric used in the pre-amendment surgical gowns. Since1978, several modifications and additions to the drape familieshave been made to the Barrier® drapes and packs, which havebeen cleared through multiple 510(k) submissions.
Intended Use:	BARRIER® surgical drapes are intended for single use to be usedas a protective patient covering, such as to isolate a site on asurgical incision from microbial and other contamination.

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BARRIER® Surgical Drapes 510(k) Summary, Page 2

The BARRIER® Surgical Drapes have been designed with an Description: assortment of fabrics, films and other materials and have been on the market for a number of years, cleared under multiple 510(k) notifications. BARRIER® surgical drapes, drape components and assorted surgical drape packs have been developed for a variety of surgical procedures including: Angiography, Cardiovascular/Thoracic, ENT/Plastic Surgery, OB/Gynecology. Laparascopic. Laparotomy, Orthopaedic, Urology, Cranial, Nephroscopy, Pediatric and other general surgical procedures. BARRIER® Surgical Drapes have been designed with materials. which provide increased protection to help prevent possible exposure to bloodborne pathogens and other potentially infectious materials.

Summary of BARRIER® Surgical Drapes have been evaluated using the Testing: ANSI/AAMI PB-70:2003 Standard. (Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities)

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its wings or body. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 4 2005

Mr. John Clay Regulatory Affairs Officer Molnlycke Health Care, Incorporated 826 Newton-Yardley Road Newton, Pennsylvania 18940

Re: K051625

Trade/Device Name: BARRIER® Surgical Drapes Regulation Number: 21 CFR 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: KKX Dated: June 17, 2005 Received: June 21, 2005

Dear Mr. Clay:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave rottowed your sected 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 Intersule conmisers prices 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 the rederal I vou, Drag, Drag, therefore, market the device, subject to the general approvisions 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 If your dovice is classified (oss as additional controls. Existing major regulations affecting (111), it may of bund in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device A may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Clay

Please be advised that FDA's issuance of a substantial equivalence determination does not I tease be ad rised that 22 a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. of the Act of all , I out of the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and ibsing (21 Cr 11 the quality systems (QS) regulation (21 CFR Part 820); and if requirents as 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) rms leter 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), n you donto 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 entitied, "Miserantial information on your responsibilities under the Act from the may 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.

Clare

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): < 05/625

Device Name: BARRIER® Surgical Drapes

Indications for Use:

BARRIER® surgical drapes are intended for single use to be used as a protective patient covering, such as to isolate a site on a surgical incision from microbial and other contamination.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use X (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Shula H. Murphy, R. 2/2/05

(Division Sign-Off) Division of Anesthesiology, General Hospital. Infection Control. Dental Devices

510(k) Number. A053625

Page __ of ___________________________________________________________________________________________________________________________________________________________________

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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.