(99 days)
Not Found
No
The summary describes a collagen implant for dura repair and does not mention any computational or algorithmic components, let alone AI/ML.
Yes
Durepair® is a collagen implant for the repair of dura mater defects, which is a therapeutic intervention. It is indicated for use by a surgeon to treat a specific medical condition.
No
The device, Durepair®, is described as a "dura substitute" and a "collagen implant for the repair of defects in the dura mater." Its intended use is for "repair of the dura mater," indicating a therapeutic or reconstructive purpose rather than a diagnostic one.
No
The device description clearly states it is a "collagen implant" supplied in "sheet form," indicating it is a physical, hardware-based medical device, 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 "as a dura substitute for the repair of the dura mater." This describes a surgical implant used directly in the body to repair tissue.
- Device Description: The description details a "collagen implant" supplied in sheet form to be "trimmed and sutured or onlayed by the surgeon." This is a physical device used during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide information about a patient's health, diagnosis, or condition.
IVD devices are used in vitro (in glass, or outside the body) to analyze samples. This device is used in vivo (in the body) as a surgical implant.
N/A
Intended Use / Indications for Use
Durepair® is indicated as a dura substitute for the repair of the dura mater.
Product codes
GXQ
Device Description
Durepair® Dura Regeneration Matrix is a collagen implant for the repair of defects in the dura mater. Durepair® is supplied sterile in sheet form in a variety of sizes to be trimmed and; sutured or onlayed by the surgeon to meet the individual patient's needs.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
dura mater
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Safety of the Durepair® device to the predicate products was demonstrated in biocompatibility studies in accordance with ISO 10993, in vitro testing, animal studies, and clinical data.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
JUL 27 2004
41000
510(k) Summary
This 510(k) summary for Dura Regeneration Matrix is being submitted in accordance with the requirements of 21 CFR 807.92.
Submitted by:
Medtronic Neurosurgery 125 Cremona Drive Goleta, CA 93117
Contact Person:
Jeffrey Henderson Vice President, Quality & Requlatory Affairs Tel: (805) 968-1546 Ext. 1770 or 1-800-826-5603 Fax: (805) 968-9336
Date Prepared:
April 16, 2004
Device Information:
| Proprietary name: | Durepair® Dura Regeneration Matrix |
|---|---|
| Classification name: | Dura substitute |
| Device classification: | Class II (21CFR882.5910) |
Device Description:
Durepair® Dura Regeneration Matrix is a collagen implant for the repair of defects in the dura mater. Durepair® is supplied sterile in sheet form in a variety of sizes to be trimmed and; sutured or onlayed by the surgeon to meet the individual patient's needs.
Indications for Use:
Durepair® is indicated as a dura substitute for the repair of the dura mater.
1
KO411e C
Statement of Substantia! Equivalence:
Durepair® is substantially equivalent in function and intended use to:
| Predicate
| Devices | Manufacturer | 510(k) Number |
|---|---|---|
| Dura-Guard® | Bio-Vascular | K982282 |
| DuraGen™ | Integra Life Sciences | K982180 |
Summary of Technological Characteristics:
Safety of the Durepair® device to the predicate products was demonstrated in biocompatibility studies in accordance with ISO 10993, in vitro testing, animal studies, and clinical data.
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 horizontal lines forming its body and wings. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 27 2004
Mr. Jeffrey Henderson Vice President, Quality & Regulatory Affairs Medtronic Neurosurgery 125 Cremona Drive Goleta, California 93117-5500
Re: K041000
Trade/Device Name: Durepair® Dura Regeneration Matrix Regulation Number: 21 CFR 882.5910 Regulation Name: Dura Substitute Regulatory Class: II Product Code: GXQ Dated: June 18, 2004 Received: June 21, 2004
Dear Mr. Henderson:
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. Iisting 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.
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.
3
Page 2 - Mr. Jeffrey Henderson
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) 594-4659. 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,
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
4
K041000
Indications for Use
510(k) Number (if known):
Device Name:
Durepair® Dura Regeneration Matrix
Indications for Use:
Durepair® is indicated as a dura substitute for the repair of the dura mater.
Muriam C. Provost
Division Sign-Division of General, Restorative, and Neurological Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Medtronic Neurosurgery Durepair® 510(K) 04/16/04