(262 days)
Broadline O.R. Towels, A Plus International O.R. Towel, Com-Med O.R. Towel
Not Found
No
The device description and intended use are for a simple surgical towel made of cotton, with no mention of any computational or analytical capabilities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is described as a surgical towel used for protection, fluid absorption, and drying, which are supportive functions during surgery, not therapeutic interventions for a disease or condition.
No
The device is a surgical towel used for protective covering, fluid absorption, and drying, not for diagnosing medical conditions.
No
The device description explicitly states the device is made of 100% cotton and is a physical towel, indicating it is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a surgical towel for patient covering, fluid absorption, and hand drying. These are all external, non-diagnostic uses.
- Device Description: The description focuses on the material (cotton) and physical characteristics (pre-washed, delinted, sterile/non-sterile, color). There is no mention of reagents, assays, or any components used to analyze biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes)
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition.
The device is a surgical accessory used during procedures, not a tool for in vitro analysis of biological specimens.
N/A
Intended Use / 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.
Product codes
KKX
Device Description
The Indus Textiles O.R. Towels are made of 100% cotton that have been pre-washed and delinted. The towels are offered sterile and non-sterile and are available in blue.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
O.R. personnel (implied from "drying hands of the O.R. personnel")
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The following tests were performed on the finished Indus Textiles O.R. Towels:
- Test Method: Absorptive Capacity, Standard Used: IST 10.1 and ASTM D1117
- Test Method: Imbibition Test, Standard Used: AATCC 8-1996 – Saline Crocking
- Test Method: Flammability, Standard Used: 16 CFR 1610.4
- Test Method: Tearing Resistance, Standard Used: ASTM D1424-96
- Test Method: Grab Tensile, Standard Used: ASTM D1682
Key Metrics
Not Found
Predicate Device(s)
Broadline O.R. Towels, A Plus International O.R. Towel, Com-Med O.R. Towel
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Attachment A
.
| 9.0 | 510(k) Summary | K013958 |
|---|---|---|
| ----- | ---------------- | --------- |
INDUS TEXTILES O.R. TOWELS
| Manufacturer: | Indus Textiles, Inc.
PMB # 148
7723 Tylersville Place Blvd.
Westchester, Ohio 45069 |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory Affairs Contact: | Michele Vovolka
P.O. Box 848
Grayslake, Illinois 60030 |
| Telephone: | (847) 856-0355 |
| 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
A Plus International O.R. Towel
Com-Med O.R. Towel |
| Description: | The Indus Textiles O.R. Towels are made of 100% cotton that have been pre-
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
1
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
2
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.
3
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 (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,
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
4
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