(30 days)
Not Found
No
The summary describes a collagen implant and does not mention any computational or algorithmic components, let alone AI/ML.
Yes
The device is a dura substitute for the repair of the dura mater, which is a therapeutic function.
No
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 structural repair, not for diagnosing conditions.
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 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 examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVDs are used in vitro (outside the body) to analyze samples. This device is used in vivo (inside 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 (comma separated list FDA assigned to the subject device)
GXQ
Device Description
The Durepair Dura Regeneration Matrix is a collagen implant for the repair of defects in the dura mater. Du epair is supplied sterile in sheet form in a variety of sizes to be trimmed and sutu red 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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
KOSzz11
7. 510(k) Summary
This summary of safety and effectiveness is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 307.87.
| Address of Manufacturer: | TEI Biosciences Inc.
7 Elkins Street
Boston, MA 02127
(317) 268-1616
(317) 268-3282 (fax)
ERN 3004170064
Lyophilization Services of New England, Inc.
One Sundial Ave., Suite 112
Manchester, NH 03103
ERN 1225991 |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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: | August 10, 2005 |
| 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) |
Description: The Durepair Dura Regeneration Matrix is a collagen implant for the repair of defects in the dura mater. Du epair is supplied sterile in sheet form in a variety of sizes to be trimmed and sutu red by the surgeon to meet the individual patient's needs.
Intended Use: Durepair is a dura subs titute 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.
1
KOSZZ11
2/2
Technological Comparison: Medtronic Ne រrosurgery submits that the collagen
t and comparison anasification, fundamental scientific technological attitibutes, Technological Comparison: Nedronic Ne irosurgery submiss matributes, device
material, sourcing specification, fundamerial scientific technological attributes, device rechnique intended use of the device are the same as the previously reviewed
Iabeling, and the intended use of the device are the same as the previously reviewed hateling, and the intended use of the device are the same as the provinces of the morgery
and cleared Durepair. Based upon the summary above, Medicological product haboling and determines substantial equivalence, surently marketed devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged in a circular fashion around the symbol. The caduceus is depicted in a simple, abstract style, with three vertical lines representing the staff and curved lines representing the snakes.
Public Health Service
SEP 1 4 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Jeffrey Henderson Vice President, Quality and Regulatory Affairs Medtronic Neurosurgery 125 Cremona Drive Goleta, California 93117
Re: K052211
Trade/Device Name: Durepair® Dura Regeneration Matrix Regulation Number: 21 CFR 882.5910 Regulation Name: Dura substitute Regulatory Class: II Product Code: GXQ Dated: August 10, 2005 Received: August 16, 2005
Dear Mr. Henderson:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 310(t) premained is substantially equivalent (first indications referenced above and nave cetermined a vices and a sevices marketed in interstate for use stated in the electosule) to legally management date of the Medical Device American be and Food. Days commerce proof to May 20, 1978, the excordance with the provisions of the Federal Food. Drug. devices that have been recuire approval of a premarket approval application (PMA). and Cosmetic Act (Act) that do not require appears appear al controls provisions of the Act. The r ou may, merciolo, market the act include requirements for annual registration, listing of general controls provisions of the tice, 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 If your device is classified (600 a0070) als. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations on may be subject to submittenal connections, Title 21, Parts 800 to 898. In addition, FDA may be found in the OULS announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Frease be advised that I Dri of ibseants of our device complies with other requirements of the Act that I DA has made a determinations administered by other Federal agencies. You must of ally it collar statures and regaranents and limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CTN in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quanty bytvelles (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) I his letter will anow you to ocgin manceing your antial equivalence of your device to a legally premarket nothication. The PDA midning of backantial vour 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 Pairt 801), please If you desire specific advice for your active of your access note the regulation entitled, contact the Office of Comphanes at (217) =if =ation" (21CFR Part 807.97). You may obtain "Misbranding by reference to premantee so premantee for from the Division of Small other general information on your responsible in the toll-free number (800) 638-2041 or Manufacturers, micritational and Octass http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Barbara Buchud
tv
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
II. Statement of Indications for Use
Indicati >ns 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.
X Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Otfice of Device Evaluation (ODE)
Barbara Buchholz for Myivi
Division Sign-Off) Offision big
Division of General, Restorative, and Neurological Devices
510(k) Number K052211