(62 days)
Not Found
No
The device description and performance studies focus on the physical properties and barrier performance of surgical drapes, with no mention of AI or ML.
No
The device is described as a protective patient covering to isolate a surgical site from contamination, which is a barrier function, not a therapeutic intervention.
No
Explanation: The device is described as surgical drapes intended to be a protective patient covering and isolate a surgical incision. Its purpose is to physically bar contamination, not to detect, diagnose, or monitor a medical condition.
No
The device description clearly states the device is composed of physical materials (nonwoven, polyethylene film, white tissue) and is a surgical drape, which is a physical product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a "protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination." This describes a physical barrier used during surgery, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details the materials used to construct a surgical drape (nonwoven, polyethylene film, white tissue). This aligns with the description of a physical barrier.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information. The performance studies focus on the physical properties of the drape (toxicity, penetration resistance, strength), which are relevant to its function as a barrier.
Therefore, the Klinidrape® Surgical Drapes are classified as a surgical drape, which is a medical device but not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
KKX
Device Description
The Klinidrape® Surgical Drapes are composed of a 3-laminate or 2-laminate composed of nonwoven, polyethylene film and white tissue.
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
Not Found
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 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. The materials used in the manufacturing of Klinidrape® Surgical Drapes have been tested in accordance with applicable standards and was determined to pass the Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood (ASTM-F1670-98) and the Viral Penetration testing (ASTM-F1671-97b). These materials were tested in accordance with 16 CFR 1610 and meet Class 1. The Klinidrape® Surgical Drapes have been tested and pass Tensile Strength and Elongation (ASTM D 882) and Breaking Strength (ASTM D 5034).
Key Metrics
Not Found
Predicate Device(s)
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
JUN 1 0 2003
510(k) SUMMARY
长031131
| Applicant: | Mölnlycke Health Care, Inc.
826 Newtown-Yardley Road
Newtown, PA 18940 |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Person: Miguel A. Negron
Vice President,
Quality & Regulatory Affairs - North America
Tel.: 267-685-2078
Fax: 267-685-2010 |
| Device Name: | Proprietary Name: Klinidrape® Surgical Drapes
Common/Usual Name: Surgical Drapes
Device Classification: Class II – 21 CFR 878.4370 |
| Substantial
Equivalence: | For the purpose of Section 510(k) of the Federal Food, Drug and
Cosmetic Act, Mölnlycke Health Care considers the new Klinidrape®
Surgical Drapes are substantially equivalent in function and intended
use to our original Klinidrape® Surgical Drapes (K000906). |
| Intended 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. |
| Description: | The Klinidrape® Surgical Drapes are composed of a 3-laminate or 2-
laminate composed of nonwoven, polyethylene film and white tissue. |
| Summary of
Testing: | 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. The
materials used in the manufacturing of Klinidrape® Surgical Drapes
have been tested in accordance with applicable standards and was
determined to pass the Resistance of Materials Used in Protective
Clothing to Penetration by Synthetic Blood (ASTM-F1670-98) and the
Viral Penetration testing (ASTM-F1671-97b). These materials were
tested in accordance with 16 CFR 1610 and meet Class 1. The
Klinidrape® Surgical Drapes have been tested and pass Tensile
Strength and Elongation (ASTM D 882) and Breaking Strength
(ASTM D 5034). |
:
Mõlnlycke Health Care, Inc.
1
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.
2
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
3
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