(84 days)
Not Found
No
The summary describes a biological graft material for dural repair and does not mention any computational or analytical functions that would typically involve AI/ML.
No
The device is a dural substitute for repairing dura mater, which is a structural repair rather than a therapeutic treatment for a disease or condition.
No
Explanation: The device is a Dural Substitute for repairing dura mater, indicating it is a therapeutic device, not a diagnostic one.
No
The device description clearly states it is a physical material (porcine small intestinal submucosa) supplied in various sizes, indicating it is a hardware 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 repairing dura mater." This is a surgical implant used directly in the body to repair tissue.
- Device Description: The device is a physical patch made from porcine tissue, intended for surgical implantation.
- Lack of IVD Characteristics: IVD devices are used in vitro (outside the body) to examine specimens (like blood, urine, or tissue samples) to provide information for diagnosis, monitoring, or screening. This device does not perform any such function.
The device is a surgical implant, not a diagnostic tool used with biological samples.
N/A
Intended Use / Indications for Use
Durasis® Dural Substitute is intended for use as a dura substitute for repairing dura mater. The device is intended for one-time use.
Product codes (comma separated list FDA assigned to the subject device)
84GXQ, GXQ
Device Description
Durasis® Dural Substitute is manufactured from porcine small intestinal submucosa and is supplied in various sizes ranging up to 140 cm². The device is packaged in sterile, sealed double pouches.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The material comprising Durasis® Dural Substitute was subjected to in vitro, in vivo, and clinical evaluation to assess biocompatibility, mechanical properties, performance characteristics, and safety. The material met the criteria, providing reasonable assurance of device performance for its intended use and supporting substantial equivalence.
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.
K950956, K910555, K991413, K980431, K982180
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
S-I
510(k) Summary
SEP - 8 2003
Mark Bleyer, President Submitted By: Cook Biotech Incorporated 3055 Kent Avenue West Lafavette, IN 47906 (765) 497-3355 June 13, 2003
Names of Device:
| Trade Name: | Durasis® Dural Substitute |
|---|---|
| Common/Usual Name: | Dural substitute, dural graft, dural repair patch |
| Classification Name: | Dura Substitute |
| 21 CFR § 882.5910 (84GXQ) |
Intended Use:
Durasis® Dural Substitute is intended for use as a dura substitute for repairing dura mater. The device is intended for one-time use.
Predicate Devices:
Predicate devices are Dura-Guard® Dural Repair Patch (K950956), manufactured by Bio-Vascular, Inc., Tutoplast® Processed Dura Mater (K910555), marketed by Biodynamics International, Inc., CODMAN ETHISORB™ Dura Patch (K991413), marketed by Johnson & Johnson, Surgisis Soft Tissue Graft (K980431), manufactured by Cook Biotech Incorporated, and DuraGen Dural Matrix (K982180) manufactured by Integra Neurosciences.
Device Description:
Durasis® Dural Substitute is manufactured from porcine small intestinal submucosa and is supplied in various sizes ranging up to 140 cm². The device is packaged in sterile, sealed double pouches.
Substantial Equivalence:
Durasis" Dural Substitute is comparable with respect to intended use, materials of composition, and technical characteristics to predicate devices in terms of 510(k) substantial equivalence.
Discussion of Tests and Test Results:
The material comprising Durasis® Dural Substitute was subjected to in vitro, in vivo, and clinical evaluation to assess biocompatibility, mechanical properties, performance characteristics, and safety. The material met the criteria, providing reasonable assurance of device performance for its intended use and supporting substantial equivalence.
Conclusions Drawn from Tests:
Outcomes from the evaluation of Durasis® Dural Substitute provide evidence of its suitability for dura mater replacement and of substantial equivalency to predicate devices in terms of intended use and technological characterstics.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle with its wings spread, enclosed within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the upper portion of the circle. The eagle is drawn in a simple, bold style, and the overall design is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 8 2003
Mr. Mark Bleyer President Cook Biotech, Inc. 3055 Kent Avenue West Lafayette, Indiana 47906
Re: K031850
Trade/Device Name: Durasis® Dural Substitute Regulation Number: 21 CFR 882.5910 Regulation Name: dura substitute Regulatory Class: II Product Code: GXQ Dated: June 13, 2003 Received: June 19, 2003
Dear Mr. Bleyer:
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. Mark Bleyer
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
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
3
1031800
510(k) Number (if known): K031850
Durasis® Dural Substitute Device Name:
Indications For Use:
Durasis Dural Substitute is intended for use as a dura substitute for repairing dura mater. The device is provided sterile and intended for one-time use.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K031850
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use