(85 days)
For use in hospitals, clinics, laboratories or other facilities where absorbent toweling may be used.
For use as absorbent toweling for cleanup, preparation or squaring off a surgical incision site. For use during surgical procedures to provide extra absorption of blood and body fluids.
For use a) to dry off surgeons, doctor or nurses hands after scrubbing, (b) to square off a surgical incision site, and (c) to absorb blood or body fluids during a surgical procedure.
Not intended for use as surgical packing.
Operating Room Towels are a 100% cotton woven towel. The are generally available in white (undyed), green or blue colors. O.R. Towels have been used throughout the Healthcare industry for a variety of purposes. These absorbent towels are utilized for hand drying, cleanup, and also for squaring off the surgical incision site, and to provide increased absorbency of blood and bodily fluids.
The provided document describes the 510(k) premarket notification for "Sterile O.R. Towels" by International Medsurg Connection. This submission is for a medical device that is a commodity product (surgical drapes/towels) and as such, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are focused on demonstrating substantial equivalence to predicate devices already on the market, primarily through physical performance characteristics and biocompatibility testing, rather than a clinical study involving human readers or sophisticated algorithms.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility: | |
| - Cytotoxicity | Met USP test requirements for cytotoxicity (all three colors tested). |
| - Primary Skin Irritation | Acceptable. |
| - Dermal Sensitization | Acceptable. |
| Physical Performance: | |
| - Tear Strength | Tested per ASTM D5034. Results showed substantial equivalence to legally marketed devices. |
| - Tensile Strength | Tested per ASTM D1424 (Note: Standard withdrawn Jan 1995). Results showed substantial equivalence to legally marketed devices. |
| - Absorbency | Tested per USP. Results showed substantial equivalence to legally marketed devices. |
| General Characteristics: | |
| - Weight | Similar to predicate devices (minor differences may occur). |
| - Dimension | Similar to predicate devices (minor differences may occur). |
| - Size | Similar to predicate devices (minor differences may occur). |
| - Color | Generally available in white (undyed), green, or blue. Must be colorfast. |
| - Thread Count | Similar to predicate devices (minor differences may occur). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document does not specify the exact sample sizes used for the biocompatibility or physical performance tests (e.g., how many towels were tested for tear strength, absorbency). It only states that "testing" was done.
- Data Provenance: Not specified, but given the context of a 510(k) submission in the US, it's implied the testing was conducted either internally by International Medsurg Connection or by a contracted lab, with the results provided to the FDA. The tests are standard industry tests (USP, ASTM).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This question is not applicable to this device. For a sterile O.R. towel, "ground truth" is established through standardized laboratory testing (e.g., chemical assays for cytotoxicity, physical measurements for strength and absorbency) rather than expert interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This question is not applicable to this device. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving multiple human readers to resolve discrepancies in diagnoses or interpretations. The testing for O.R. towels involves direct measurement against established standards.
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 question is not applicable to this device. This is a commodity medical device (surgical towel), not an AI-powered diagnostic or assistive technology. Therefore, no MRMC study or AI-related comparative effectiveness was performed or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable to this device. This is not an algorithmic or software-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the performance of these surgical towels is based on established industry standards and tests:
- Biocompatibility: USP (United States Pharmacopeia) test requirements for cytotoxicity, and standard methods for Primary Skin Irritation and Dermal Sensitization.
- Physical Performance: ASTM (American Society for Testing and Materials) standards for a Tear Strength (ASTM D5034) and Tensile Strength (ASTM D1424), and USP standards for Absorbency.
8. The sample size for the training set
- This question is not applicable to this device. As a traditional medical product and not an AI/ML system, there is no "training set."
9. How the ground truth for the training set was established
- This question is not applicable to this device. There is no training set for this type of medical device.
{0}------------------------------------------------
International Medsurg Connection
1000 E. Woodfield Road, Suite 117 Schaumburg, IL 60173
Omi Bhati, M.D. President
JUN 24 1997 Ph (847) 517-6325 Fax (847) 517-1447
l
I. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
International Medsurg Connection 1000 E. Woodfield Road, Suite 117 Schaumburg, IL 60173 Phone #: (847) 517-6325 Fax #: (847) 517-1447 Omi Bhati, M.D. President
Date Prepared: May 6, 1997
Device Name
Proprietary: N/A Common: Sterile O.R. Towels Classification Name: Surgical Drapes
Product Description:
Operating Room Towels are a 100% cotton woven towel. The are generally available in white (undyed), green or blue colors. O.R. Towels have been used throughout the Healthcare industry for a variety of purposes. These absorbent towels are utilized for hand drying, cleanup, and also for squaring off the surgical incision site, and to provide increased absorbency of blood and bodily fluids.
Comparison to Legally Marketed Devices
These O.R. Towels are similar to those already on the market as described below:
| Medline Industries, Inc.Sterile OR Towels | A Plus InternationalSterile and Non-SterileOR Towels | Ulti-Med InternationalAbsorbent Fiber OperatingRoom Towels |
|---|---|---|
| ----------------------------------------------- | -------------------------------------------------------------- | -------------------------------------------------------------------- |
Technological Characteristics
A. Similarities
The towels packaged and sold by International Medsurg Connection are substantially equivalent to those distributed by Medline Industries, Inc., A Plus International and Ulti-Med International. They are similar in weight, dimension, size, color, and thread count. All towels must be colorfast and must pass biocompatibility requirements. Since the towels are 100% cotton and the
l
{1}------------------------------------------------
biocompatibility of cotton as a medical product is well established, testing only was done to illustrate the biocompatibility of the dyed product. All three colors were tested and all three met the USP test requirements for cytotoxicity. In addition, testing for Primary Skin Irritaiton and Dermal Sensitization was Both test results were acceptable. conducted.
- B. Differences
International Medsurg Connection towels differ from the predicate devices in that there may be minor differences in weight, absorbency, thread count, or size.
Intended Use:
For use in hospitals, clinics, laboratories or other facilities where absorbent toweling may be used.
For use as absorbent toweling for cleanup, preparation or squaring off a surgical incision site. For use during surgical procedures to provide extra absorption of blood and body fluids.
For use a) to dry off surgeons, doctor or nurses hands after scrubbing, (b) to square off a surgical incision site, and (c) to absorb blood or body fluids during a surgical procedure.
Not intended for use as surgical packing.
Performance Data:
These towels were tested for Tear Strength per ASTM D5034. Tensile Strength per ASTM D1424** and Absorbency (USP). The results of this testing showed that the device was substantially equivalent to the current legally marketed devices.
** Standard withdrawn by ASTM, January 1995
2
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUM SERVICES - USA" are arranged around the eagle in a circular fashion.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 4 1997
Ms. Lara N. Simmons Corporate Requlatory Affairs Manager International Medsurq Connection 1000 E. Woodfield Road, Suite 117 Schaumberq, Illinois 60173
- Re : K971159 Trade Name: Surqical Drapes Requlatory Class: II Product Code: KKX Dated: May 6, 1997 Received: May 7, 1997
Dear Ms. Simmons:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 reqistration, 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 (Premarket Approval), 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 895. ਖ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
{3}------------------------------------------------
Page 2 - Ms. Simmons
This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597.
Sincerely yours,
Timothy A. Ulatowski
Timot Ny A. Ulatowsk Director
Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
{4}------------------------------------------------
Page 1 __ of __ of __
510(k) Number (if known): N/A K 971159
Device Name: Sterile Operating Room Towels
Indications for Use:
For use in hospitals, clinics, laboratories or other facilities where absorbent toweling may be used.
For use as absorbent toweling for cleanup, preparation or squaring off a surgical incision site. For use during surgical procedures to provide extra absorption of blood and body fluids.
For use a) to dry off surgeons, doctor or nurses hands after scrubbing, (b) to square off a surgical incision site, and (c) to absorb blood or body fluids during a surgical procedure.
Not intended for use as surgical packing.
Cli
PLEASE DO WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
(Division Sign-Off)
ivision of Dental, Infection Connectie of CDRH, Office of Device Evaluation (ODE) d General Hospital Pese firtit Over-The-Counter Use OR
Per 21 CFR 801.109
Over-The-Counter Use X
(Optional Format 1-2-96)
8
§ 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.