COMPE1 1 -PLY SURGICAL GOWNS by STANDARD TEXTILE CO., INC.

ComPel 1-Ply Surgical gowns are medical devices that are intended to be worn by operating room personnel during surgical procedures to protect them by inhibiting the migration of liquids through the surface of the critical areas of the gown.

When processed according to instructions, ComPel 1-Ply Surgical gowns will function and perform as protective apparel. The gowns are reusable through 125 wash, dry, and sterilization cycles. They are manufactured and distributed as non-sterile products that are intended to be processed by health care facilities and/or contract laundry companies.

Device Description

All the components used in these ComPel® Gowns are made from 100% Dacron polyester filaments. ComPel fabrics are dyed and treated with a fluorocarbon finish.

ComPel® Gowns will function as surgical attire when processed according to instructions through 125 complete cycles - wash, dry and sterilization. These products will be manufactured and distributed as non-sterile gowns that are intended to be processed by health care facilities and/or contract sterilization/laundry companies.

AI/ML Overview

Here's an analysis of the provided information regarding the ComPel® 1-Ply Surgical Gowns, formatted to address your request:

Acceptance Criteria and Device Performance Study

The provided document describes the safety and effectiveness summary for ComPel® 1-Ply Surgical Gowns. This submission is for a medical device (surgical gowns) and the "device performance" refers to the gowns' physical properties and durability, rather than a diagnostic algorithm or AI. Therefore, concepts like "test set," "training set," "experts," and "ground truth" as they apply to AI/algorithm performance are not directly relevant in the context of this document. However, I can extract the acceptance criteria (standards/tests performed) and the reported device performance (successful completion of these tests).

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Test/Standard)	Reported Device Performance
Suter Hydrostatic Testing (AATCC #127-1980)	Successfully completed
Impact Penetration Testing (AATCC 42-2000)	Successfully completed
Flammability (CFR 1610 (CS-191-53))	Successfully completed
Durability (through 125 processings)	Successfully completed (wash, dry, and sterilization cycles)
Strength (ASTM D-1682-75)	Successfully completed
Lint (IST 160.0-83)	Successfully completed
Toxicity: Cytotoxicity (MEM Elution (MG023))	Successfully completed
Toxicity: Primary Skin Irritation (FHSA)	Successfully completed
Compatibility with Steam Sterilization	Successfully completed
ANSI/AAMI PB70:2003 Standard	Classified as a Level 2 Barrier (for 1-ply gowns with flat felled seam design)

2. Sample Size for the Test Set and Data Provenance

Sample Size: Not explicitly stated in the provided document for each specific test. However, the tests are applied to the "ComPel® 1-Ply Surgical Gowns" product. For durability, the claim is "through 125 complete cycles – wash, dry and sterilization," implying a sample of gowns was subjected to this number of cycles.
Data Provenance: The document does not specify the country of origin where the tests were conducted. It is a submission by an American company (Standard Textile Company, Cincinnati, Ohio) to the U.S. FDA. The data is retrospective in the sense that the tests were completed prior to the 510(k) submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This is not applicable for this type of medical device submission. The "ground truth" is defined by the established standards and test methodologies (e.g., AATCC #127-1980, ASTM D-1682-75). The "experts" would be the accredited laboratories and technicians performing these standardized tests, who follow the documented procedures to determine if the product meets the specified criteria. Their qualifications are in conducting these specific material science and safety tests accurately.

4. Adjudication Method for the Test Set

Not applicable in the context of product testing against material standards. The tests have defined pass/fail criteria, and results are typically determined by measurements and observations against those criteria, not by expert adjudication of subjective interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This type of study is relevant for diagnostic devices or AI algorithms where human readers' performance is compared with and without AI assistance. This document describes physical product performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No. This concept is not applicable. The device is a surgical gown, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is objectively defined by established engineering and material science standards and test methods. For example, a Suter Hydrostatic Test has a quantifiable pressure reading that determines barrier performance. Toxicity tests have specific indicators for cytotoxicity or irritation.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/algorithm. There is no concept of a "training set" for a physical product like a surgical gown.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set for a physical product, the method for establishing its "ground truth" is irrelevant in this context.

Summary

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STANDARD TE

MAR 7 2006

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COMPEL® 1-PLY SURGICAL GOWNS SAFETY AND EFFECTIVNESS SUMMARY

The following information is being supplied in accordance with the Safe Medical Device Act of 1990.

807.92(a)

1. Standard Textile Company One Knollcrest Drive Cincinnati, Ohio 45237 Contact Person: Brad Bushman (513) 761-9256 Extension 455
1. Device Name: ComPel® 1-Ply Surgical Gowns ComPel® 'O' Surgical Attire/Gowns Developmental Name: Common/Usual Name: Surgical Attire Classification Name: Surgical Attire
1. All the components used in these ComPel® Gowns are made from 100% Dacron polyester filaments. ComPel fabrics are dyed and treated with a fluorocarbon finish.

ComPel® Surgical Gowns are intended to be used as surgical attire in an operating 4. theater. The liquid barrier properties will inhibit the migration of liquids across its surface. Per ANSI/AAMI PB70:2003 standard, the 1-ply surgical gowns with the flat felled seam design are classified as a Level 2 Barrier.
ട്. The tests that have been successfully completed include:
- a. Suter Hydrostatic Testing AATCC #127-1980
- b. Impact Penetration Testing AATCC 42-2000
- Flammability Code of Federal Regulations 1610 (CS-191-53) C.
- d. Durability through 125 processings (wash, dry and sterilization).
- Strength ASTM D-1682-75 e.
- f. Lint IST 160.0-83
- Toxicity ದು.
  - . -Cytotoxicity MEM Elution (MG023)
  - Primary Skin Irritation (FHSA) 11.
- Compatibility with Steam Sterilization h.

To the best of my knowledge, all data and information in the 510(k) are truthful and accurate, and that no material fact has been omitted.

Bradley J. Bushman

INCINNATI, OH C

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus, which is a staff with two snakes entwined around it, and a bowl. The text reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA".

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 7 2006

Mr. Bradley Bushman Vice President, Technical Affairs Standard Textile Company, Incorporated One Knollcrest Drive PO Box 371805 Cincinnati, Ohio 45237

Re: K060181

Trade/Device Name: ComPel® 1-Ply Surgical Gowns Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FYA Dated: January 19, 2006 Received: January 23, 2006

Dear Mr. Bushman:

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 – Mr. Bushman

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 (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,

Susan Ruoner
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):

Device Name:

ComPel 1-Ply Surgical Gowns

Indications For Use:

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

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)

Shirl. L. Murphy, R. 3/4/64

May, General Hospital

Services

Regulation Number and Section

§ 878.4040 Surgical apparel.

(a)
Identification. Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.(b)
Classification. (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.