(184 days)
The PRECLUDE® MVP Dura Substitute is intended for use as a temporary or permanent prosthesis for repair of dura mater during neurosurgery.
The applicant PRECLUDE® MVP Dura Substitute includes substantially equivalent materials and designs as the predicate PRECLUDE® Dura Substitute devices. The microstructure on the dural side of the applicant device is slightly altered to permit enhanced biological fixation and sealing. The neural side of the material is unchanged from the predicate PRECLUDE® Dura Substitutes. Side orientation is rendered apparent to the surgeon by means of texturing the open microstructure side with a visually and tactilely distinct "ridges and valleys" or "corduroy" pattern.
This document describes the PRECLUDE® MVP Dura Substitute, a device intended for use as a temporary or permanent prosthesis for repair of dura mater during neurosurgery.
However, based on the provided text, there is no information available regarding acceptance criteria or a specific study that proves the device meets such criteria. The document is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than presenting a detailed study with specific performance metrics and acceptance criteria.
The information provided covers:
- Applicant and Contact Information
- Date Prepared
- Trade/Proprietary Name, Common Name, and Classification Name
- Device Predicates:
- Device Description: The PRECLUDE® MVP Dura Substitute has "substantially equivalent materials and designs as the predicate PRECLUDE® Dura Substitute devices." Key features include a slightly altered microstructure on the dural side for enhanced biological fixation and sealing, an unchanged neural side, and a textured open microstructure side ("ridges and valleys" or "corduroy" pattern) for side orientation.
- Statement of Intended Use: "The PRECLUDE® MVP Dura Substitute is intended for use as a temporary or permanent prosthesis for repair of dura mater during neurosurgery."
- Statement of Substantial Equivalence: "A variety of tests, assessments, and comparisons demonstrate that the PRECLUDE® MVP Dura Substitute is substantially equivalent to the cited predicate devices in terms of composition, design, intended use, and performance attributes." The FDA letter confirms the substantial equivalence determination.
Therefore, I cannot provide the requested table or answer the other questions as the necessary data is not present in the provided text. The document describes the regulatory pathway (510(k)) and the basis for market clearance (substantial equivalence), which does not typically include a detailed performance study with explicit acceptance criteria as would be found for novel devices requiring clinical trials.
The emphasis here is on demonstrating that the new device is as safe and effective as existing legally marketed devices, rather than establishing de novo performance benchmarks.
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KO21477
Summary of Information Regarding Safety and Effectiveness
Page 1 of 2
III. Summary of Information Regarding Safety & Effectiveness
Applicant:
8 2002 NOV
WL Gore & Associates, Inc. 3450 West Kiltie Lane P. O. Box 500 Flagstaff, AZ 86002-0500
Contact:
Mike Johnson Regulatory Affairs Associate
Date Prepared:
October 28, 2002
Trade or Proprietary Name:
PRECLUDE® MVP Dura Substitute
Common or Usual Name:
Dura Substitute
Classification Name:
Dura Substitute
.. ..
Device Predicates:
- WL Gore & Associates, Inc. -- PRECLUDE® ACUSEAL Dura Substitute (K984534) .
- WL Gore & Associates, Inc. PRECLUDE® Dura Substitute (K953969) ●
- WL Gore & Associates, Inc. SEAMGUARD Staple Line Reinforcement Material ● (K010936)
- Integra Life Sciences Corp. DuraGen Dural Graft Matrix (K982180) ●
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Summary of Information Regarding Safety and Effectiveness
KO21477
Page 2 of 2
Device Description:
The applicant PRECLUDE® MVP Dura Substitute includes substantially equivalent materials and designs as the predicate PRECLUDE® Dura Substitute devices. The microstructure on the dural side of the applicant device is slightly altered to permit enhanced biological fixation and sealing. The neural side of the material is unchanged from the predicate PRECLUDE® Dura Substitutes. Side orientation is rendered apparent to the surgeon by means of texturing the open microstructure side with a visually and tactilely distinct "ridges and valleys" or "corduroy" pattern.
Statement of Intended Use:
The PRECLUDE® MVP Dura Substitute is intended for use as a temporary or permanent prosthesis for repair of dura mater during neurosurgery.
Substantial Equivalence:
A variety of tests, assessments, and comparisons demonstrate that the PRECLUDE® MVP Dura Substitute is substantially equivalent to the cited predicate devices in terms of composition, design, intended use, and performance attributes.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/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 a stylized image of three human figures in profile, one behind the other, with flowing lines representing movement or connection.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 8 2002
Mr. Timothy J. Rynn Regulatory Affairs W. L. Gore & Associates, Inc. 3450 West Kiltie Lane Flagstaff, Arizona 86002-0500
Re: K021477
Trade/Device Name: Preclude® MVP Dura Substitute Regulation Number: 21 CFR 882.5910 Regulation Name: Dura Substitute Regulatory Class: Class II Product Code: GXQ Dated: August 14, 2002 Received: August 15, 2002
Dear Mr. Rynn:
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 vour 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. 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.
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Page 2 - Mr. Timothy J. Rynn
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) 594-4659. 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.
Miriam C. Provost
for Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K02/477
Statement of Intended Use · III.
Page _ of _
510(k) Number (if known)
Device Name: PRECLUDE® MVP Dura Substitute
INDICATIONS FOR USE:
The PRECLUDE® MVP Dura Substitute is intended for use as a temporary or permanent prosthesis for repair of dura mater during neurosurgery.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X (per 21 CFR 801.109)
OR
Over-The-Counter Use __
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K02/477
§ 882.5910 Dura substitute.
(a)
Identification. A dura substitute is a sheet or material that is used to repair the dura mater (the membrane surrounding the brain).(b)
Classification. Class II (performance standards).