MODIFICATION TO: COMPEL SURGICAL DRAPES by STANDARD TEXTILE CO., INC.

ComPel Surgical Drapes are intended to cover patients or working surfaces during surgical procedures. ComPel Surgical Drapes and Covers are made of synthetic materials intended to be used as protective other of Dargious such as to isolate a site of surgical incision from microbial and other contamination.

ComPel Surgical Drapes will function as a surgical drape when processed according to instructions. Com of Dargical Drapes are reusable through 75 wash, dry and sterilization cycles. They are manufactured and distributed as non-sterile surgical drapes that are intended to be sterilized and processed by health care facilities and/or contract sterilization/laundry companies.

Device Description

All base fabrics used in the construction of ComPel Surgical Drapes are made from 100% polyester, knitted or woven into fabric and then dyed. WrapPel and ComPel fabrics are fluorocarbon treated, XTR fabric is silicone coated, COMBOsafe fabric is laminated with a urethane film and Zorwik is treated to be hydrophilic. ComPel Surgical Drapes will function as a surgical drape when processed according to instructions through 75 complete wash, dry and sterilization cycles. These products will be manufactured and distributed as non-sterile surgical drapes that are intended to be sterilized and processed by health care facilities and/or contract sterilization/laundry companies.

AI/ML Overview

The provided text describes a 510(k) summary for "ComPel Surgical Drapes and Covers," a non-sterile, reusable surgical drape. The document outlines various performance tests and does not focus on a standalone algorithm or a multi-reader multi-case (MRMC) comparative effectiveness study. Therefore, sections related to AI performance, sample sizes for test and training sets, expert qualifications, and adjudication methods are not applicable to this document.

Here's an analysis of the provided information, focusing on the acceptance criteria and supporting studies where applicable:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria / Test	Reported Device Performance
Flammability (16 CFR Part 1610)	Successfully completed
Barrier Performance:
* Suter Hydrostatic Testing (AATCC #127-1989)	Successfully completed
* Mullens Hydrostatic Testing (ASTM D751-95 Procedure A)	Successfully completed
Strength (ASTM #D-1682-87 & ASTM #D-3786-87)	Successfully completed
Lint (EDANA 220.0-96)	Successfully completed
Toxicity:
* Cytotoxicity MEM Elution (MG023)	Successfully completed
* Acute Systemic Toxicity (ISO 10993)	Successfully completed
* Primary Skin Irritation (ISO 10993)	Successfully completed
Sterilization (pre-vacuum steam cycles)	Product sold non-sterilized, intended for sterilization by healthcare facilities.
Durability (through 75 processing cycles: wash, dry, and sterilization)	Successfully completed (ComPel Surgical Drapes will function as a surgical drape when processed according to instructions through 75 complete wash, dry and sterilization cycles.)
Colorfastness to Commercial Laundering (AATCC #61-1993(4A))	Successfully completed

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: The document does not specify the exact sample sizes used for each individual test. It merely states that the tests were "successfully completed."
Data Provenance: Not explicitly stated, but the tests refer to established international and national standards (e.g., AATCC, ASTM, ISO, CFR) which imply laboratory testing rather than data from human subjects or retrospective studies from specific countries.

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

This information is not applicable. The device's performance is measured against established scientific and engineering standards and test methods, not against expert consensus on medical images or diagnoses.

4. Adjudication method for the test set:

This information is not applicable. Adjudication typically refers to resolving discrepancies in expert interpretations in medical studies, which is not relevant for physical and chemical performance testing of a medical device like a surgical drape.

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:

This information is not applicable. This document describes a physical medical device (surgical drape), not an AI-powered diagnostic or assistive tool.

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

This information is not applicable. This document describes a physical medical device, not an algorithm.

7. The type of ground truth used:

The ground truth in this context is defined by the established performance specifications and limits within the referenced national and international standards (e.g., specific hydrostatic pressures for barrier performance, acceptable lint levels, non-toxic classifications, strength thresholds, and functional integrity after a certain number of processing cycles).

8. The sample size for the training set:

This information is not applicable. There is no machine learning or AI component described that would require a training set.

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

This information is not applicable. There is no machine learning or AI component described.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows a black and white emblem. The emblem is in the shape of a shield with a thick black border. Inside the shield are the letters 'S' and 'C' intertwined, also in black. The 'S' is in the foreground, partially overlapping the 'C'.

STANDARD TEXTILE

OCT 1 1 2001

012807

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:	ComPel Surgical Drapes and Covers, non-sterile (75X reusable)
	Common/Usual Name:	Non-sterile Surgical Drapes and Covers
	Classification Name:	Fenestrated Surgical Drapes/CoversNon-fenestrated Surgical Drapes/CoversRegulation #878.4370
3.	Predicate Device:	ComPel Surgical Drapes #K923811

All base fabrics used in the construction of ComPel Surgical Drapes are made from 100% polyester, 4. knitted or woven into fabric and then dyed. WrapPel and ComPel fabrics are fluorocarbon treated, XTR fabric is silicone coated, COMBOsafe fabric is laminated with a urethane film and Zorwik is treated to be hydrophilic.
ComPel Surgical Drapes will function as a surgical drape when processed according to instructions through 75 complete wash, dry and sterilization cycles. These products will be manufactured and distributed as non-sterile surgical drapes that are intended to be sterilized and processed by health care facilities and/or contract sterilization/laundry companies.
ComPel Surgical Drapes are intended to be used on patients or surfaces where protection from liquid ર. migration is needed. The location and level of liquid protection as well as the size and location of a fenestration is defined by the surgical staff. The liquid barrier properties will inhibit the migration of liquids across its surface.
There are no critical differences in the use of this product from currently marketed ComPel Surgical Drapes (K923811) except for the use of the COMBOsafe fabric. ComPel Surgical Drapes 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.

Suter Hydrostatic Testing AATCC #127-1989 i,
Mullens Hydrostatic Testing ASTM D751-95 Procedure A ii.
Strength ASTM #D-1682-87 & ASTM #D-3786-87 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-sterilized using prevacuum steam cycles. ದ್ದು
h. Durability through 75 processing (wash, dry and sterilization).
i. Colorfastness to Commercial Laundering - AATCC #61-1993(4A).

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

Bradley J. Bushman

... Page 56.

VORI D HEADQUARTE

ONE KNOLLCREST D CINCINNATI OHIO

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird with three curved lines representing its wings or feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 1 2001

Mr. Bradley J. Bushman Director, Technical Resources Standard Textile Company, Incorporated One Knollcrest Drive Cincinnati, Ohio 45237

Re: K012807

Trade/Device Name:ComPel Surgical Drapes Regulation Number: 878.4370 Regulation Name: Nonsterile Surgical Drapes and Covers Regulatory Class: II Product Code: KKX Dated: September 14, 2001 Received: September 18, 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 of the Act or any Federal statutes and regulations administered by other Federal agencies.

{2}------------------------------------------------

Page 2 - Mr. Bushman

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office 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,

Ti. A. Uhtomskii

Tin Directo: Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

K012807 510(k) NUMBER:

ComPel Surgical Drapes DEVICE NAME:

INDICATIONS FOR USE:

(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)

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

Over-The-Counter-Use (Optional Format 1)

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.