(22 days)
No
The summary describes a collagen implant for dura repair and contains no mention of AI or ML technology.
Yes
The device is indicated as a dura substitute for the repair of the dura mater, which is a therapeutic function.
No
Explanation: The device is described as a "dura substitute for the repair of the dura mater" and a "collagen implant," indicating it is a therapeutic device for repair, not a diagnostic device for identifying conditions.
No
The device description clearly states it is a "collagen implant" supplied in "sheet form," indicating a physical, non-software component.
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 in vivo (within the body) to repair tissue.
- Device Description: The description confirms it's a "collagen implant for the repair of defects in the dura mater," supplied in sheet form for surgical use.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples in vitro (outside the body), such as blood, urine, or tissue, to diagnose a condition or provide information about a patient's health status.
IVD devices are specifically designed for testing biological samples to provide diagnostic information. This device is a surgical implant for tissue repair.
N/A
Intended Use / Indications for Use
Durepair® is indicated as a dura substitute for the repair of the dura mater.
Product codes
GXO
Device Description
The 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 ropal. of act and sutured 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
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
Not Found
Key Metrics
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
/ l
NOV - 3 2006
4. 510(k) Summary
This summary of safety and effectiveness is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.87 .
| Address of Manufacturer: | TEI Biosciences Inc.
7 Elkins Street
Boston, MA 02127
(617) 268-1616
(617) 268-3282 (fax)
ERN 3004170064 |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jeffrey Henderson
Vice President, Quality and Regulatory Affairs
Medtronic Neurosurgery
125 Cremona Drive
Goleta CA, 93117
(805) 968-1546 ext. 1773
Fax: (805) 968-9336
ERN 2021898 |
| Date: | October 12, 2006 |
| Trade or Proprietary Name: | Durepair® Dura Regeneration Matrix |
| Common Usual or Classification Name: | Dura Substitute (882.5910) |
| Predicate Device Identification: | Durepair® Dura Regeneration Matrix
(K041000 and K052211) |
Description: The 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 ropal. of act and sutured by the surgeon to meet the individual patient's needs.
Intended Use: Durepair is a dura substitute for the repair of the dura mater.
Intended Use of Predicate Device(s): The predicate device, Durepair, is a dura substitute for the repair of the dura mater.
Technological Comparison: Medtronic Neurosurgery submits that the collagen material, fundamental scientific technological attributes, device labeling, and the matonal, familian homal vice are the same as the previously reviewed and cleared Intenair. Based upon the summary above, Medtronic Neurosurgery determines substantial equivalence, safety, and efficacy of the Durepair product compared to the predicate and currently marketed devices.
1
Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The seal is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 3 2006
Medtronic Neurosurgery % Mr. Jeffrey Henderson VP, Quality & Regulatory Affairs 125 Cremona Drive Goleta, California 93117-5500
Re: K063117
Trade/Device Name: Durcpair® Dura Regencration Matrix Regulation Number: 21 CFR 882.5910 Regulation Name: Dura substitute Regulatory Class: II Product Code: GXO Dated: October 12, 2006 Received: October 12, 2006
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, 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.
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.
2
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 (240) 276-0115. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/odrh/industry/support/index.html.
Sincerely yours,
Neil R.S. Dohm
Mark N. Melkerson (
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
II. Statement of Indications for Use
Indications for Use
510(k) Number (if known): KO63117
Device Name: Durepair® Dura Regeneration Matrix
Indications for Use:
Durepair® is indicated as a dura substitute for the repair of the dura mater.
Prescription Use ﺮ AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Per Division of General, Restorative, and Neurological Devices
510/12) Nimbor K 063 117