(37 days)
Promax Surgical Drapes and Covers are intended to be used in health care facilities on patients or surfaces during surgical procedures where protection from liquid migration is needed. The liquid barrier will inhibit migration of liquid through its surface.
ProMax™ Surgical Drapes and Covers can be constructed utilizing one or more types of filament polyester fabrics based on the intended use of the product. The specific fabrics include ProMax™, WrapPel®, ComPel® and Zorwick®. ProMax™ Surgical Drapes and Covers will meet performance standards as a surgical drape and cover when processed according to instructions through 75 complete wash, dry and sterilization cycles. These products will be manufactured and distributed as nonsterile surgical drapes and covers that are intended to be sterilized and processed by health care facilities and/or contract sterilization/laundry companies.
This document is a 510(k) summary for ProMax™ Surgical Drapes and Covers, seeking to demonstrate substantial equivalence to a predicate device (ComPel® Surgical Drapes #K923811). It outlines the device's characteristics, intended use, and performance testing.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by successful completion of various standardized tests, indicating that ProMax™ Surgical Drapes and Covers meet the performance standards required for surgical drapes and covers. The reported device performance is that ProMax™ successfully completed all listed tests.
| Acceptance Criteria (Test) | Reported Device Performance (Outcome) |
|---|---|
| Flammability: | Successfully completed |
| - Code of Federal Regulations 1610 Standard for the Flammability of Clothing Textiles (CS-191-53) | |
| - NFPA 702-1975 (Flammability of Wearing Apparel) | |
| Barrier Performance: | Successfully completed |
| - Mullens Hydrostatic Resistance for liquid "proof" fabrics (ASTM #D-751-79 Method A) | |
| - Suter Hydrostatic Resistance for liquid resistant fabrics (AATCC #127-1989) | |
| Colorfastness: | Successfully completed |
| - Colorfastness to Commercial Laundering (AATCC #61-1996-4A) | |
| Strength: | Successfully completed |
| - Tensile Strength for woven fabrics (ASTM #D-1682) | |
| - Bursting Strength for knitted and coated fabrics | |
| Biocompatibility (ISO 10993-1): | Successfully completed |
| - Cytotoxicity (MEM Elution - NamSA Laboratories) | |
| - Primary Skin Irritation (FHSA - NamSA Laboratories) | |
| - Systemic Toxicity (Saline - USP - NamSA Laboratories) | |
| - Systemic Toxicity (Cottonseed Oil - USP - NamSA Laboratories) | |
| - Systemic Toxicity (Saline/Alcohol - USP - NamSA Laboratories) | |
| - Sensitization (ISO - NamSA Laboratories) | |
| - Hemolysis (ASTM MGP72-100 - NamSA Laboratories) | |
| Sterilization: | Successfully completed |
| - ANSI/AAMI ST 25-1987 "Guideline for Industrial Moist Heat Sterilization of Medical Products" |
The document states that these tests were successfully completed "through 75 complete wash, dry and sterilization cycles," indicating the durability of the performance.
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify the exact sample sizes used for each test. The provenance of the data is from non-clinical tests conducted by "NamSA Laboratories" for biocompatibility tests, and by Standard Textile Co., Inc. (implied for other material performance tests). The tests are performed on the ProMax™ fabric and products. The nature of these tests suggests they are prospective in the sense that they are conducted on new prototypes or manufactured samples to demonstrate compliance with standards. There is no mention of country of origin for the data directly, other than the location of Standard Textile Co., Inc. in Cincinnati, Ohio, USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This type of information is not applicable to this submission. The "ground truth" for the performance of the surgical drapes is established by the successful completion of standardized material and biological tests, not by expert interpretation of clinical cases or data. The standards themselves (e.g., ASTM, AATCC, ISO, NFPA, CFR) represent a consensus of expert knowledge in their respective fields.
4. Adjudication Method for the Test Set
This is not applicable as the evaluation relies on objective, standardized tests with predefined pass/fail criteria, not on subjective assessments that would require adjudication.
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 is not applicable. This is a submission for surgical drapes and covers, which are physical medical devices, not diagnostic software or AI-assisted technologies. Therefore, MRMC studies, human reader performance, or AI assistance are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device is based on established industry and regulatory standards and specifications for medical textiles and biocompatibility. Successful adherence to these standards, as verified by quantitative and qualitative laboratory tests, constitutes the "ground truth" for performance.
8. The Sample Size for the Training Set
This is not applicable. This submission is for a physical medical device (surgical drapes), not a machine learning model. Therefore, there is no "training set."
9. How the Ground Truth for the Training Set was Established
This is not applicable as there is no training set for a physical medical device.
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Image /page/0/Picture/0 description: The image shows a logo with a shield on the left and the word "STANDARD" on the right. The shield has a letter "S" in the middle. The word "STANDARD" is written in a bold, sans-serif font.
THE HEALTHCARE TEXTILE COMPANY
FR 2 6 1998
Image /page/0/Picture/3 description: The image shows a sequence of handwritten characters, which appear to be a combination of letters and numbers. The sequence reads 'K980183'. The characters are written in a cursive style, with some connections between the letters and numbers. The writing is in black ink on a white background.
WORLD
HEADQUARTERS
ONE KNOLLCREST DR.
P.O. BOX 371805
CINCINNATI, OHIO
45222-1805
513-761-9255
513-761-0467 FAX
1-800-999-0400
Section VI - 510(k) Summary of Safety and Effectiveness
The following information is being supplied in accordance with the Safe Medical Device Act of 1990. 807.92(a)
- Standard Textile Co., Inc. 1. One Knollcrest Drive Cincinnati. Ohio 45237 FDA Registration No. 1527185 Contact Person: Brad Bushman (513)761-9255 Ext. 455 Summary Prepared on 12-08-97
- Device Name: ProMax™ Surgical Drapes and Covers 2.
Common/Usual Name: Non-Sterile Surgical Drapes and Covers
Classification Name: Drape, Surgical - Fenestrated and Non-Fenestrated
-
- Predicate Device: ComPel® Surgical Drapes #K923811
- ProMax™ Surgical Drapes and Covers can be constructed utilizing one or more types of 4. filament polyester fabrics based on the intended use of the product. The specific fabrics include ProMax™, WrapPel®, ComPel® and Zorwick®.
ProMax™ Surgical Drapes and Covers will meet performance standards as a surgical drape and cover when processed according to instructions through 75 complete wash, dry and sterilization cycles. These products will be manufactured and distributed as nonsterile surgical drapes and covers that are intended to be sterilized and processed by health care facilities and/or contract sterilization/laundry companies.
-
- ProMax™ Surgical Drapes and Covers are intended to be used in health care facilities on patients or surfaces during surgery where protection from liquid migration is needed. The location and level of liquid protection as well as the size and location of a fenestration will vary. The liquid barrier properties will inhibit migration of liquids through its surface.
- ProMax™ Surgical Drapes and Covers are identical to ComPel® Surgical Drapes and 6. Covers in design, intended use and function, but differ in material. ProMax™ drapes and covers can utilize a vinyl coated polyester knitted fabric (ProMax™ fabric), and ComPel drapes and covers can utilize a silicone coated polvester woven fabric (ComPel XTR®) for areas within the design of these products which require higher levels of liquid resistance.
-
- Non-clinical tests demonstrate that the performance of ProMax™ Surgical Drapes and Covers is comparable to ComPel® Surgical Drapes and Covers.
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- The following tests have been successfully completed on ProMax™: 8.
- Flammability Code of Federal Regulations 1610 Standard for the Flammability of a. Clothing Textiles (CS-191-53) - NFPA 702-1975 (Flammability of Wearing Apparel).
- Barrier Performance b.
-
- Mullens Hydrostatic Resistance for liquid "proof" fabrics American Society for Testing & Materials #D-751-79 Method A.
-
- Suter Hydrostatic Resistance for liquid resistant fabrics American Association for Textile Chemists and Colorists #127-1989.
-
- Colofastness to Commercial Laundering American Association of Textile Chemist C. and Colorist #61-1996-4A.
- Strength 1) Tensile Strength for woven fabrics ASTM #D-1682. ರ.
- 2) Bursting Strength for knitted and coated fabrics.
- Biocompatability ISO 10993-1 Biological Evaluation of Medical Devices e.
- Cytotoxicity NamSA Laboratories MEM Elution 1.
- Primary Skin Irritation NamSA Laboratories FHSA 2.
- Systemic Toxicity (Saline) NamSA Laboratories USP 3.
- Systemic Toxicity (Cottonseed Oil) NamSA Laboratories USP ব
-
- Systemic Toxicity (Saline/Alchol) NamSA Laboratories USP
-
- Sensitization NamSA Laboratories ISO
-
- Hemolysis NamSA Laboratories ASTM MGP72-100
- Sterilization Association for the Advancement of Medical Instrumentation American ি করে National Standard - "Guideline for Industrial Moist Heat Sterilization of Medical Products" - ANSI/AAMI ST 25 1987
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of a caduceus, which is a traditional symbol of medicine. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 6 1998
Mr. Bradley J. Bushman Director, Technical Resources Standard Textile Company, Incorporated One Knollcrest Drive P.O. Box 371805 Cincinnati, Ohio 45222-1805
Re : K980183 ProMax Surgical Drapes and Covers Trade Name: Requlatory Class: II Product Code: KKX January 12, 1998 Dated: Received: January 20, 1998
Dear Mr. Bushman:
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 The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895 - A - -- -substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements " action. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
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Page 2 - Mr. Bushman
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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 (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page l of 1
510 (k) NUMBER (if KNOWN) :
ProMax Surgical Drapes and Covers DEVICE NAME:
INDICATIONS FOR USE:
Promax Burgical Drapes and Covers are intended to be used in health care facilities on patients or surfaces during surgical procedures where protection from liquid migration is needed. The liquid barrier will inhibit migration of liquid through its surface.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED. }
Chin S. Lam
Office of Device Evaluation (ODE) (Division Sign Division of Dental, In and General He 510(k) Number
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter-Use
(Optional Format 1-2-96)
§ 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.