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 across 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 medical devices that are intended to be processed through 100 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. All the ouripented acomPel fabrics are dyed and treated with a fluorocarbon finish.

ComPel® Gowns will function as surgical attire when processed according to instructions through 100 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

This document describes the regulatory submission for the "ComPel 1-Ply Surgical Gowns." It focuses on demonstrating that the device is substantially equivalent to legally marketed predicate devices. The study conducted is a series of laboratory tests to confirm the physical properties and performance characteristics of the surgical gowns against established standards.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Test Name	Standard / Method	Reported Device Performance	Comments
Barrier Properties
Liquid Barrier (Hydrostatic) Test	AATCC #127-1980	Not explicitly quantified, but stated to meet the "Level 2 Barrier" classification.	Per ANSI/AAMI PB70:2003 standard, the 1-ply surgical gowns with flat felled seam design are classified as a Level 2 Barrier after successful testing.
Impact Penetration Test	AATCC 42-2000	Not explicitly quantified.	Successfully completed.
Durability
Durability through Processing	Through 100 processings (wash, dry and sterilization)	Gowns will function and perform as protective apparel through 100 complete cycles.	This indicates the gowns maintained their functional integrity after 100 cycles of washing, drying, and sterilization.
Material Strength
Strength Test	ASTM D-1682-75	Not explicitly quantified.	Successfully completed.
Other Properties
Flammability	Code of Federal Regulations 1610 (CS-191-53)	Not explicitly quantified.	Successfully completed.
Lint	IST 160.0-83	Not explicitly quantified.	Successfully completed.
Biocompatibility/Safety
Cytotoxicity (MEM Elution)	MG023	Not explicitly quantified.	Successfully completed.
Primary Skin Irritation	FHSA	Not explicitly quantified.	Successfully completed.
Sterilization Compatibility
Compatibility with Steam Sterilization	Not specified	Not explicitly quantified.	Successfully completed.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes used for each individual test. It refers to "the tests that have been successfully completed," implying that a sufficient number of samples were tested to demonstrate compliance.

Sample Size: Not specified in the provided text for individual tests.
Data Provenance: The data is generated from laboratory testing of the ComPel 1-Ply Surgical Gowns, conducted by the manufacturer (Standard Textile Company 1). This is prospective data generation for the purpose of regulatory submission. The country of origin for the data generation would be the United States, as the manufacturer is based in Ohio.

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

This type of information is not applicable for this device. The "ground truth" for a surgical gown is adherence to established industry standards and test methods for physical and biological properties. These standards themselves are developed by expert consensus, but the testing itself does not require expert adjudication of "ground truth" for individual samples in the way a diagnostic AI might. The results are objective measurements against predefined thresholds within the standards.

4. Adjudication Method for the Test Set

This is not applicable. The tests are objective laboratory measurements against predefined standards. There is no human "adjudication" in the sense of multiple reviewers making subjective decisions. The results of the tests are either within the acceptance criteria for the standard or they are not.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic or screening devices where human interpretation plays a significant role, often comparing AI-assisted human performance against unaided human performance. A surgical gown is a protective barrier, not a diagnostic tool requiring image interpretation or similar cognitive tasks.

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

No, a standalone algorithm performance study was not done. This device is a physical product (a surgical gown), not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on performance against established industry standards and test methods.

For barrier properties: Adherence to AATCC #127-1980 and AATCC 42-2000, which then correlates to a classification like "Level 2 Barrier" as per ANSI/AAMI PB70:2003.
For physical properties (strength, durability, flammability, lint): Meeting thresholds defined in ASTM D-1682-75, CFR 1610, IST 160.0-83, and manufacturer's internal durability specifications (lasting 100 cycles).
For biocompatibility: Meeting criteria in MEM Elution (MG023) and Primary Skin Irritation (FHSA).
For sterilization: Compatibility with steam sterilization implies the material structure and performance are not negatively affected.

These standards and methods represent a consensus of scientific and technical understanding for the performance of surgical attire.

8. The Sample Size for the Training Set

This is not applicable. This device is a physical product, not a machine learning model. Therefore, there is no "training set." The materials used in the gowns (100% Dacron, fluorocarbon finish) are known materials with established properties.

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

This is not applicable as there is no training set for this physical device.

Summary

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K04/653

STANDARD TEXT ! LI

JUL 0 1 2005

O HORI D HEADDIA P.O. BOX 371805 CINCINNATI, OHIO 45222-1805

Page 2

513-761-9255
513-761-0467 FAX
1-800-990-0400

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)

Standard Textile Company 1 -One Knollcrest Drive Cincinnati, Ohio 45237 Contact Person: Brad Bushman (513) 761-9256 Extension 455
ComPel® 1-Ply Surgical Gowns Device Name: 2. ComPel® 'O' Surgical Attire/Gowns Developmental Name: Surgical Attire Common/Usual Name: Surgical Attire Classification Name:
All the components used in these ComPel® Gowns are made from 100% Dacron 3. All the ouripented acomPel 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.
The tests that have been successfully completed include: ട്.
- Suter Hydrostatic Testing AATCC #127-1980 a.
- Impact Penetration Testing AATCC 42-2000 b.
- Flammability Code of Federal Regulations 1610 (CS-191-53) C.
- Durability through 100 processings (wash, dry and sterilization). d.
- Strength ASTM D-1682-75 e.
- Lint IST 160.0-83 f,
- Toxicity பு.
  - Cytotoxicity MEM Elution (MG023) ...
  - Primary Skin Irritation (FHSA) ii.
- 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

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with medicine and healthcare. The caduceus features a staff with two snakes entwined around it, topped by a pair of wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 0 1 2005

Mr. Bradley J. Bushman Standard Textile Company Incorporated One Knollcrest Drive P.O. Box 371805 Cincinnati, Ohio 45222-1805

Re: K041653

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: June 17, 2005 Received: June 20, 2005

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. Bradley J. 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 (OS) 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 vours,

Syllie H. Michaux M.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): K041653

ComPel 1-Ply Surgical Gowns Device Name:

Indications For Use:

ComPel 1-Ply Surgical gowns are medical devices that are intended to be wor by operating of light ComPel 1-Ply Surgical govers at included to protect them by inhibiting the migration of liquids
room personnel during surgical procedures to protect them by inhibiting the mi room persomici during surgritical areas of the gown.

When processed according to instructions, ComPel I-Ply Surgical gowns will function and When processed according to Institutions, Courselle through 100 wash, dry, and sterilization
perform as protective apparel. The gowns are resile mades that are intended to be perform as protective apparel. List gownload as non-sterily products that are intended to be cycles. They are manufactured and or contract laundry companies.

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

Over-The-Counter Use_ (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)

Shule A. Moyerkey P.

Page 1 of _

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

510(k) Number: K041653

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.