(262 days)
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.
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.
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.
Here's an analysis of the provided text regarding the Indus Textiles O.R. Towels, focusing on acceptance criteria and the supporting study, while addressing your specific questions.
Based on the provided documents (510(k) summary), the "device" in question is a surgical towel. The acceptance criteria and "study" are related to demonstrating substantial equivalence to predicate devices, primarily through physical and performance testing, rather than clinical trials involving human subjects, multi-reader studies, or complex AI algorithms.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
For a surgical towel, "acceptance criteria" are typically defined by performance standards for physical properties. The document doesn't explicitly state quantitative acceptance criteria (e.g., "absorptive capacity must be > X ml"), but it lists the tests performed and the standards used, implying that meeting the requirements of these standards constitutes acceptable performance. The "reported device performance" is implicitly that the device passed these tests, thus demonstrating substantial equivalence to its predicates.
| Acceptance Criteria (Implied by Test and Standard) | Reported Device Performance |
|---|---|
| Absorptive Capacity (per IST 10.1 and ASTM D1117) | Met requirements of standards |
| Imbibition Test (per AATCC 8-1996 – Saline Crocking) | Met requirements of standard |
| Flammability (per 16 CFR 1610.4) | Met requirements of standard |
| Tearing Resistance (per ASTM D1424-96) | Met requirements of standard |
| Grab Tensile (per ASTM D1682) | Met requirements of standard |
| Biocompatibility (post-gamma and EtO sterilization) | Investigated and documented (implicitly acceptable as no adverse findings are noted) |
Notes:
- The document states: "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." This implies that for toxicology and general biocompatibility, the predicate's established safety profile is leveraged, with additional testing initiated for the specific sterilization methods used for the new device.
- The "reported device performance" is a high-level summary. The detailed results (e.g., specific absorption values, tear strength in newtons) are not provided in this 510(k) summary but would have been in the full submission.
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 physical test. These tests typically involve multiple samples to ensure statistical validity according to the respective ASTM, IST, and AATCC standards.
- Data Provenance: The tests were performed by or for Indus Textiles, Inc. (the manufacturer). The provenance is therefore the manufacturer's internal testing. The country of origin of the data is not explicitly stated but would typically be where the manufacturer's testing facilities are located or where contract labs were commissioned (likely within the U.S. or a country with comparable regulatory standards given the FDA submission). This is retrospective testing performed on the finished product to demonstrate compliance.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This question is not applicable to this type of device and study. The "ground truth" for a surgical towel's performance is established by objective physical and chemical testing against recognized standards, not by expert consensus or clinical interpretation.
4. Adjudication Method for the Test Set
This question is not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical studies or image-based diagnostic AI evaluations where expert interpretation is involved. For physical product testing, results are typically objective measurements against fixed criteria.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. These studies are relevant for diagnostic devices (especially in radiology) where human readers interpret medical data, and the effect of AI assistance on their performance is evaluated. A surgical towel does not involve human interpretation of data for diagnosis.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No, a standalone algorithm performance study was not done. This concept applies to AI algorithms. The "device" here is a physical product (a towel), not an algorithm.
7. Type of Ground Truth Used
The "ground truth" (or benchmark for performance) used for the Indus Textiles O.R. Towels is based on objective physical and chemical testing standards, such as ASTM, IST, AATCC, and CFR regulations. These standards define the accepted methods and performance parameters for textile products. The performance of the predicate devices also serves as a baseline for substantial equivalence.
8. Sample Size for the Training Set
This question is not applicable. There is no "training set" in the context of a physical surgical towel and its associated performance testing. Training sets are used to develop and train AI algorithms.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the same reasons as #8.
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Attachment A
.
| 9.0 | 510(k) Summary | K013958 |
|---|---|---|
| ----- | ---------------- | --------- |
INDUS TEXTILES O.R. TOWELS
| Manufacturer: | Indus Textiles, Inc.PMB # 1487723 Tylersville Place Blvd.Westchester, Ohio 45069 |
|---|---|
| Regulatory Affairs Contact: | Michele VovolkaP.O. Box 848Grayslake, 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. TowelsA Plus International O.R. TowelCom-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
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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 (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
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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
§ 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.