(62 days)
The Klinidrape® Surgical Drapes are devices intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination.
The Klinidrape® Surgical Drapes are composed of a 3-laminate or 2- laminate composed of nonwoven, polyethylene film and white tissue.
The document describes the acceptance criteria and the summary of testing for the Klinidrape® Surgical Drapes.
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Characteristic | Acceptance Criteria (Standard Assessed) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Non-toxic and non-irritant (ISO 10993, Part I: Biological Evaluation of Medical Devices) | Found non-toxic and non-irritant |
| Barrier | Resistance to Penetration by Synthetic Blood (ASTM-F1670-98) | Determined to pass |
| Barrier | Viral Penetration Testing (ASTM-F1671-97b) | Determined to pass |
| Flammability | Meets Class 1 (16 CFR 1610) | Meets Class 1 |
| Physical Strength | Tensile Strength and Elongation (ASTM D 882) | Tested and pass |
| Physical Strength | Breaking Strength (ASTM D 5034) | Tested and pass |
Regarding the study proving the device meets the acceptance criteria:
The document states that the Klinidrape® Surgical Drapes have been found non-toxic and non-irritant when tested by the above biological tests in accordance with the ISO 10993, Part I: Biological Evaluation of Medical Devices. It also mentions that the materials used... have been tested in accordance with applicable standards and was determined to pass the specified ASTM and CFR standards.
The document does not provide details about a "study" in the traditional sense of a clinical trial or comparative effectiveness study. Instead, it refers to product testing against established material and performance standards relevant to Class II medical devices like surgical drapes.
The following information is not provided in the document:
- Sample sizes used for the test set and the data provenance: The document mentions "the above biological tests" and "materials were tested" but does not specify sample sizes for each test or the origin of the data (country, retrospective/prospective).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for material testing against standards.
- Adjudication method for the test set: Not applicable for material testing against standards.
- 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 an AI/software device; therefore, an MRMC study is not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This is not an AI/software device; therefore, standalone performance is not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" here is compliance with established international and national standards for material properties and performance for surgical drapes.
- The sample size for the training set: Not applicable, as this is a physical medical device undergoing material and performance testing, not a machine learning model.
- How the ground truth for the training set was established: Not applicable for the same reason as above.
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JUN 1 0 2003
510(k) SUMMARY
长031131
| Applicant: | Mölnlycke Health Care, Inc.826 Newtown-Yardley RoadNewtown, PA 18940 |
|---|---|
| Contact Person: Miguel A. NegronVice President,Quality & Regulatory Affairs - North AmericaTel.: 267-685-2078Fax: 267-685-2010 | |
| Device Name: | Proprietary Name: Klinidrape® Surgical DrapesCommon/Usual Name: Surgical DrapesDevice Classification: Class II – 21 CFR 878.4370 |
| SubstantialEquivalence: | For the purpose of Section 510(k) of the Federal Food, Drug andCosmetic Act, Mölnlycke Health Care considers the new Klinidrape®Surgical Drapes are substantially equivalent in function and intendeduse to our original Klinidrape® Surgical Drapes (K000906). |
| Intended Use: | The Klinidrape® Surgical Drapes are devices intended to be used as aprotective patient covering, such as to isolate a site of surgical incisionfrom microbial and other contamination. |
| Description: | The Klinidrape® Surgical Drapes are composed of a 3-laminate or 2-laminate composed of nonwoven, polyethylene film and white tissue. |
| Summary ofTesting: | The Klinidrape® Surgical Drapes have been found non-toxic and non-irritant when tested by the above biological tests in accordance withthe ISO 10993, Part I: Biological Evaluation of Medical Devices. Thematerials used in the manufacturing of Klinidrape® Surgical Drapeshave been tested in accordance with applicable standards and wasdetermined to pass the Resistance of Materials Used in ProtectiveClothing to Penetration by Synthetic Blood (ASTM-F1670-98) and theViral Penetration testing (ASTM-F1671-97b). These materials weretested in accordance with 16 CFR 1610 and meet Class 1. TheKlinidrape® Surgical Drapes have been tested and pass TensileStrength and Elongation (ASTM D 882) and Breaking Strength(ASTM D 5034). |
:
Mõlnlycke Health Care, Inc.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Public Health Service
JUN 1 0 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Miguel A. Negron Vice President Mölnlycke Health Care, Incorporated 826 Newtown-Yardley Road Newtown, Pennsylvania 18940
Re: K031131
Trade/Device Name: Klinidrape® Surgical Drapes Regulation Number: 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: KKX Dated: April 14, 2003 Received: April 15, 2003
Dear Mr. Negron:
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.
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Page 2 - Mr. Negron
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. 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 (OS) 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). please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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.
Susan Runoe
Susan Runner, DDS, MA Interim 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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Indications for Use Statement Section 9:
PREMARKET NOTIFICATION
INDICATIONS FOR USE STATEMENT
KO31131 Unassigned
510(k) Number:
Mölnlycke Health Care, Inc.
Device Name:
Klinidrape® Surgical Drapes
Indications for Use:
The Klinidrape® Surgical Drapes are devices intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
| Division of Anesthesiology, General Hospital, | |
| Infection Control, Dental Devices | |
| 510(k) Number: | K031131 |
Prescription Use (Per 21 CFR 801.109) Or Over-The-Counter Use
0
§ 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.