TRIMAX by STANDARD TEXTILE CO., INC.

TriMax Surgical Gown are intended to be worn by operating room personnel during surgical Procedures to protect both the surgical patients and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.

TriMax Surgical Gown will function as surgical gowns when processed according to instructions. The TriMax Surgical Gown are reusable through 75 wash, dry and sterilization cycles. They are manufactured and distributed as non-sterile surgical gowns that are intended to be sterilized and processed by health care facilities and/or contract sterilization/laundry companies.

Device Description

All fabric components used in TriMax Surgical Gowns are made from 100% polyester. TriMax Surgical Gown will function as surgical gowns when processed according to instructions through 75 complete wash, dry and sterilization cycles. These products will be manufactured and distributed as non-sterile surgical gowns that are intended to be sterilized and processed by health care facilities and/or contract sterilization/laundry companies.

AI/ML Overview

The provided text is a 510(k) summary for the TriMax Surgical Gown. It outlines the device, its intended use, and the testing conducted to demonstrate its safety and effectiveness. However, it does not describe acceptance criteria in quantifiable terms or a comparative study as typically performed for diagnostic or AI-driven medical devices.

The document focuses on claiming substantial equivalence to a predicate device (ComPel XTR® Surgical Gowns #K922753) based on the performance of the gown materials and the gown itself after undergoing a specified number of processing cycles. The "acceptance criteria" here are implied through successful completion of standardized material and product performance tests.

Here's an attempt to extract the requested information, acknowledging that some fields may not be directly applicable or fully detailed given the nature of a 510(k) for a surgical gown:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test/Standard	Acceptance Criteria (Implied by success)	Reported Device Performance
Barrier Performance	Viral Resistance ASTM #1671-97b	Pass	Successfully completed
	Suter Hydrostatic Testing AATCC #127-1989	Pass	Successfully completed
	Mullens Hydrostatic Testing ASTM D751-95 Procedure A	Pass	Successfully completed
Flammability	16 CFR Part 1610	Pass	Successfully completed
Strength	ASTM #D-1682-87	Pass	Successfully completed
Lint	EDANA 220.0-96	Pass	Successfully completed
Toxicity	Cytotoxicity MEM Elution (MG023)	Non-cytotoxic	Successfully completed
	Acute Systemic Toxicity (ISO 10993)	Non-toxic	Successfully completed
	Primary Skin Irritation (ISO 10993)	Non-irritating	Successfully completed
Sterilization	Prevacuum steam cycles (for non-sterile gown)	Compatible with sterilization	Successfully completed (product sold non-sterile, compatible with prevacuum steam cycles)
Durability	Through 75 processing (wash, dry, sterilization)	Maintain performance	Successfully completed (functions as surgical gown through 75 cycles)
Colorfastness	To Commercial Laundering AATCC #61-1993(4A)	Pass	Successfully completed
Overall Function	Function as surgical gown	Functions as intended	Performed as intended when used as labeled

Explanation of "Acceptance Criteria (Implied by success)": For a 510(k) of this nature, the demonstration of "success" in meeting the requirements of recognized standards is the primary form of acceptance criterion. The document states "The tests that have been successfully completed include:", indicating that the device met the performance thresholds defined by each respective standard.

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

Sample Size: The document does not specify the exact sample sizes used for each individual test (e.g., number of gowns tested for viral resistance or durability). It broadly states that the gown "will function as surgical gowns... through 75 complete wash, dry and sterilization cycles," implying a test sample was put through this process, but the number of units is not quantified.
Data Provenance: Not specified. However, the tests are against international (ISO) and US (ASTM, AATCC, CFR) standards, suggesting the testing was performed in compliance with these regulations. It does not mention country of origin for the data or if it was retrospective or prospective, as these are typically not relevant for material performance tests of this type.

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

Not Applicable. This type of information (experts establishing ground truth) is typically relevant for diagnostic devices where human interpretation is involved. For a surgical gown, the "ground truth" is based on objective, standardized physical and material performance tests. The standards themselves are generally developed by expert committees, but there isn't a "ground truth" established by individual experts for this specific test set.

4. Adjudication Method for the Test Set

Not Applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements in human expert interpretations, typically in diagnostic or imaging studies. For objective material performance tests, the outcome is determined by the test protocol and measurement, not by expert consensus or adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. An MRMC study is relevant for evaluating the impact of a system (often AI) on human reader performance in tasks like diagnosis or detection. This is not applicable to a surgical gown, which is a physical barrier device. The document does not describe any human reader involvement.

6. If a Standalone Study (algorithm only without human-in-the-loop performance) was done

Yes, in spirit, but not in the context of an algorithm. The tests described are "standalone" in the sense that they evaluate the gown's material properties and performance objectively, without human intervention in the outcome assessment (beyond conducting the test and recording results). There is no "algorithm" involved, as this is a physical medical device, not a software or AI product.

7. The Type of Ground Truth Used

The ground truth used is primarily objective physical and chemical testing against established industry and regulatory standards. This includes:
- Material properties: Flammability, strength, lint.
- Barrier performance: Viral resistance, hydrostatic pressure.
- Biocompatibility: Cytotoxicity, systemic toxicity, skin irritation.
- Durability and integrity: Performance after repeated processing cycles.
- The "ground truth" is defined by the passing criteria of the specific ASTM, AATCC, EDANA, ISO, and CFR standards cited.

8. The Sample Size for the Training Set

Not Applicable. This device is a physical product, not an AI/ML algorithm or software. Therefore, there is no "training set" in the computational sense. The product's design and manufacturing processes are refined through engineering and material science, not through machine learning.

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

Not Applicable. As there is no training set for an algorithm, there is no ground truth established for it. The performance of the gown itself is proven through the testing detailed in Section 7.

Summary

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Page 93

HEALTHCARE TEXTILE COMPANY

DEC 0 3 2001

vorld headquarter NE KNOLLCREST D O BOX 371805 CINCINNATI, OHIO 5222-1805 13-761-9255 3-761-0467 FA

012268

510(k) Summary

This summary of 510(k) safety and effectiveness is being supplied in accordance with the Safe Medical Device Act of 1990 and 21 C.F.R.

807.92(a)

1.	Standard Textile Co., Inc.One Knollcrest DriveCincinnati, Ohio 45237	Contact Person: Brad Bushman(513) 761-9255 Ext. 455Summary Prepared on 6/29/01
2.	Device Name:TriMax Surgical Gown, non-sterile (75X reusable)Common/Usual Name:Surgical GownClassification Name:Surgical Apparel 21 C.F.R. § 878.4040	Device Name:	TriMax Surgical Gown, non-sterile (75X reusable)	Common/Usual Name:	Surgical Gown	Classification Name:	Surgical Apparel 21 C.F.R. § 878.4040
Device Name:	TriMax Surgical Gown, non-sterile (75X reusable)
Common/Usual Name:	Surgical Gown
Classification Name:	Surgical Apparel 21 C.F.R. § 878.4040
3.	Predicate Device:	ComPel XTR® Surgical Gowns #K922753

All fabric components used in TriMax Surgical Gowns are made from 100% polyester. 4.
TriMax Surgical Gown will function as surgical gowns when processed according to instructions These products will be manufactured and through 75 complete wash, dry and sterilization cycles. distributed as non-sterile surgical gowns that are intended to be sterilized and processed by health care facilities and/or contract sterilization/laundry companies
TriMax Surgical Gown are intended to be worn by operating room personnel during surgical procedures ર. to protect both the surgical patients and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.
There are no critical differences in the use of this product from currently marketed ComPel XTR® Surgical Gowns except for higher liquid resistance claims, additional viral resistance claims and sleeve seam performance claims. TriMax Surgical Gown have demonstrated that they will perform as intended when used as labeled.
The tests that have been successfully completed include: 6.
- Flammability 16 CFR Part 1610. a.
- Barrier Performance b.
  - Viral Resistance ASTM #1671-97b i.
  - Suter Hydrostatic Testing AATCC #127-1989 ii.
  - Mullens Hydrostatic Testing ASTM D751-95 Procedure A iii.
- Strength ASTM #D-1682-87 C.
- Lint EDANA 220.0-96 d.
- Toxicity Cytotoxicity MEM Elution (MG023) e. Acute Systemic Toxicity (ISO 10993)
- Primary Skin Irritation (ISO 10993)) f.
- Sterilization Product sold non-sterile; can be sterilized using prevacuum steam cycles. g.
- Durability through 75 processing (wash, dry and sterilization). h.
- Colorfastness to Commercial Laundering AATCC #61-1993(4A). i.

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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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three parallel lines that curve and resemble a human figure in motion or flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Bradley J. Bushman Director, Technical Resources Standard Textile Company, Incorporated One Knollcrest Drive P.O. Box 371805 Cincinnati, Ohio 45237-1600

Re: K012268

Trade/Device Name: Trimax Regulation Number: 878.4040 Regulation Name: Surgical Gown Regulatory Class: II Product Code: FYA Dated: October 15, 2001 Received: October 19, 2001

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.

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

DEC 0 3 2001

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of the Act or any Federal statutes and regulations administered by other Federal agencies. or the rict of any I outh all the Act's requirements, including, but not limited to: registration r od listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and insting (2) roquicellents as lectronic 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 This letter with and w you're cognification. 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the and additionally of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

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To be issued KO12268 510(k) NUMBER:

TriMax Surgical Gown DEVICE NAME:

INDICATIONS FOR USE:

Chis tom

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Device 510(k) Number _

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) Over-The-Counter-Use (Optional Format 1)

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.