INDUS TEXTILES TOWEL-STERILE AND NON-STERILE

K013958 · Indus Textiles, Inc. · KKX · Aug 19, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K013958
• Device Name: INDUS TEXTILES TOWEL-STERILE AND NON-STERILE
• Applicant: Indus Textiles, Inc.
• Product Code: KKX · General, Plastic Surgery
• Decision Date: Aug 19, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4370
• Device Class: Class 2

Intended Use

This is a single use disposable surgical towel intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The O.R. Towel is further used as a fluid-absorbing towel during surgery or as a device to dry hands of the O.R. personnel.

Device Story

Indus Textiles O.R. Towels are single-use, disposable, 100% cotton surgical towels. They are pre-washed and delinted, available in blue, and provided in both sterile and non-sterile configurations. Used in the operating room environment by surgical personnel, the towels serve as a protective barrier to isolate incision sites from microbial contamination, absorb surgical fluids, or dry hands. The device functions as a passive physical barrier and absorbent material. No electronic, software, or complex mechanical components are involved.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included absorptive capacity (IST 10.1, ASTM D1117), imbibition (AATCC 8-1996), flammability (16 CFR 1610.4), tearing resistance (ASTM D1424-96), and grab tensile strength (ASTM D1682). Biocompatibility testing was conducted post-gamma and EtO sterilization.

Technological Characteristics

Material: 100% cotton. Form factor: Surgical towel. Sterilization: Gamma and EtO. Standards: IST 10.1, ASTM D1117 (absorptive capacity), AATCC 8-1996 (imbibition), 16 CFR 1610.4 (flammability), ASTM D1424-96 (tearing resistance), ASTM D1682 (grab tensile).

Indications for Use

Indicated for use as a protective patient covering to isolate surgical incision sites from contamination, for the absorption of fluids (including blood and body fluids) during surgery, and as a general use towel for drying the hands of O.R. personnel.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Broadline O.R. Towels
• A Plus International O.R. Towel
• Com-Med O.R. Towel

Submission Summary (Full Text)

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### Attachment A

.

| 9.0 | 510(k) Summary | K013958 |
|-----|----------------|---------|
|-----|----------------|---------|

INDUS TEXTILES O.R. TOWELS

| Manufacturer: | Indus Textiles, Inc.<br>PMB # 148<br>7723 Tylersville Place Blvd.<br>Westchester, Ohio 45069 |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory Affairs Contact: | Michele Vovolka<br>P.O. Box 848<br>Grayslake, Illinois 60030 |
| Telephone: | [phone] |
| Date Summary Prepared: | November 20, 2001 |
| Product Trade Name: | Indus Textiles O.R. Towels |
| Common Name: | Surgical Towel |
| Classification: | Class II per 21 CFR §878.4370 |
| Predicate Devices: | Broadline O.R. Towels<br>A Plus International O.R. Towel<br>Com-Med O.R. Towel |
| Description: | The Indus Textiles O.R. Towels are made of 100% cotton that have been pre-<br>washed and delinted. The towels are offered sterile and non-sterile and are |

available in blue.

Intended Use: This is a single use disposable surgical towel intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The O.R. Towel is further used as a fluid-absorbing towel during surgery or as a device to dry hands of the O.R. personnel.

CONFIDENTIAL

age 4 of 6 Page 2 of

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## Attachment A

#### 510(k) Summary (Continued)

#### Substantial Equivalence:

The Indus Textiles O.R. Towels are substantially equivalent to the Broadline O.R. Towels, A Plus O.R. Towels, and Com-Med TO.R. Towels in that they provide the following characteristics:

- Intended use is the same
- Size, configuration, color are similar
- Made of 100% cotton
- Physical properties are similar

#### Summary of Testing:

The following tests were performed on the finished Indus Textiles O.R. Towels:

| Test Method | Standard Used |
|---------------------|--------------------------------|
| Absorptive Capacity | IST 10.1 and ASTM D1117 |
| Imbibition Test | AATCC 8-1996 – Saline Crocking |
| Flammability | 16 CFR 1610.4 |
| Tearing Resistance | ASTM D1424-96 |
| Grab Tensile | ASTM D1682 |

The material and blue dye are identical to the predicate devices listed above. The toxicology and biocompaibility have been thoroughly investigated and documented with these predicate devices. Biocompatibility testing was initiated for the towel post gamma and EtO sterilization.

### CONFIDENTIAL

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of what appears to be an abstract human form or symbol. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the graphic. The logo is black and white.

AUG 1 9 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Indus Textiles, Incorporated Ms. Michele H. Vovolka Vantage Consulting International, Limited P.O. Box 848 Grayslake, Illinois 60030

Re: K013958

Trade/Device Name: IndusTextiles O.R. Towel (Blue, Sterile and Non-Sterile) Regulation Number: 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: KKX Dated: June 28, 2002 Received: July 1, 2002

Dear Ms. Vovolka:

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.

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Page 2 – Ms. Vovolka

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Patricia Cuccinto for

Timothy A. Ulatowski 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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Page 1 of 1

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Indus Textiles O.R. Towel ( Blue, Steville / Non-Sterele Device Name:

Indications For Use:

This is a single use disposable surgical towel intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The O.R. towel is also to be used for the absorption of fluids, including blood and body fluids or as a general use towel for drying hands.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use OR (Per 21 CFR 801.109)

Over -The-Counter Use

Quim S. Lim

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

510(k) Number K013958