(379 days)
No
The device description and performance studies focus on the material properties and clinical outcomes of a collagen matrix for dural repair, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes.
The device is a dura substitute intended for the repair of dura mater, which is a therapeutic intervention.
No
Explanation: The device description and intended use clearly state that DuraGen™ Dural Graft Matrix is an absorbable implant used as a dura substitute for repair, not for diagnosis. Diagnostic devices are used to identify or detect medical conditions.
No
The device description clearly states it is an "absorbable implant" made from "porous collagen matrix" derived from "bovine achilles tendon." This is a physical, material-based 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 dura mater." This describes a surgical implant used directly in the body for structural repair.
- Device Description: The description details a collagen matrix derived from bovine tissue, designed to be implanted.
- 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.
IVD devices are used outside the body to analyze samples and provide diagnostic information. This device is an implant used inside the body for surgical repair.
N/A
Intended Use / Indications for Use
DuraGen™ Dural Graft Matrix is indicated as a dura substitute for the repair of dura mater.
Product codes
GXQ
Device Description
DuraGen™ Dural Graft Matrix is an absorbable implant for repair of dura mater. DuraGen [M is an easy to handle, soft, white, pliable, nonfriable, porous collagen matrix. DuraGen™ is supplied sterile, nonpyrogenic, for single use in double peel packages in a variety of sizes.
DuraGen™ is manufactured from bovine achilles tendon, which is classified by European Standards as Class IV material, no detectable infectivity for Bovine Spongiform Encephalopathy (BSE). The bovine tendon is known to be one of the purest sources of Type I Collagen that is commercially available. The collagen used to manufacture DuraGen™ is currently used in the manufacture of an artificial skin, absorbable hemostatic sponges, and absorbable wound dressings. The manufacturing process for DuraGen134 meets the United States Food and Drug Administration's Guidance document and European Standards for animal tissue sourcing, handling and inactivation of BSE. This process involves a treatment with sodium hydroxide that is a recognized method of inactivation of Spongiform Encephalopathy (SE). The bovine tendon is only obtained from facilities in the United States of America that have been inspected by the United States Department of Agriculture (USDA). Bovine Spongiform Encephalopathy (BSE) is not known to exist in the United States of America, therefore, the United States of America is considered by the European Union as a low risk country for bovine sourced materials.
A viral inactivation study for the DuraGen™ manufacturing process was conducted by an independent certified laboratory. In this study, the sodium hydroxide treatment was evaluated for its ability to inactivate the following viral strains: I luman Immunodeficiency Virus Type I (HIV), Bovine Viral Diarrhea (BVD), Infectious Bovine Rhinotracheitis (IBR), Parainfluenza Virus Type 3 (P13). Vesicular Stomatitis (VSV). For these viruses, the sodium hydroxide treatment reduced the viral titer to non-detectable levels.
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
DuraGen™ Dural Graft Matrix has been evaluated by a number of tests for safety, biocompatibility, toxicity, pyrogenicity, sterility and preclinical and clinical evaluations. Summaries and reports of all data are contained in the Premarket Notification submission.
The biocompatibility studies have demonstrated DuraGen™ Dural Graft Matrix to be: noncytotoxic, nonpyrogenic, nonmutagenic, nonsensitizing and be absorbed with no cellular or allergic responses. The following studies were conducted:
- Cytotoxicity Irritation/Intracutaneous Reactivity Pyrogenicity Genotoxicity Sensitization Study Chronic Toxicity Study Implantation Studies Intramuscular Toxicity Study Subcutaneous Implantation Study Immunological/Sensitivity Studies Mcchanical Testing
The collagen sponge was evaluated in a long-term clinical study to examine its suitability as a dural graft. Clinical evaluations involving more than 1,000 patients demonstrated that DuraGen™ Dural Graft Matrix performed safely and effectively as a dura substitute. During the course of the study, biopsies of the collagen implant were available from 100 patients for macroscopic and histological examination. There were no incidences of graft encapsulation, neomembrane formation, delayed hemorrhage, or foreign body reactions.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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
K.982180
JUL - 6 1999
Integra LifeSciences Corporation 510(k) K982180 DuraGen™ Dural Graft Matrix
510(k) PREMARKET NOTIFICATION SUMMARY OF SAFETY AND EFFECTIVENESS In Accordance with the Safe Medical Device Act of 1990
DuraGen™ Dural Graft Matrix
- Submitted by: 1.
Integra LifeSciences Corporation 105 Morgan Lane Plainsboro, NJ 08536 USA 609-275-0500 Telephone: 609-799-3297 Fax:
Contact Person:
Judith E. O'Grady, RN, MSN, RAC Sr. Vice President, Regulatory Affairs (609) 936-2311
- Date Prepared: June 1, 1999 2.
Name of the Medical Device: 3.
DuraGen™ Dural Graft Matrix Proprietary Name: Classification Name: Dura Substitute
Device Classification: 4.
- Class II Regulation Number 21 CFR 882.5910
ડ. Indications for Use
- DuraGen™ Dural Graft Matrix is indicated as a dura substitute for the repair ◆ of dura mater.
Statement of Substantial Equivalence Q-
DuraGen™ Dural Graft Matrix is substantially equivalent in function and intended use to the following devices:
- I yoplant Dura Substitute, (Bovine Pericardium), 510(k) K970851 તે. Manufactured for AESCULAP, Inc.
- Dura-Guard® Dural Repair Patch, (Bovine Pericardium), 510(k) K973706 b. Manufactured by BioVascular, Inc.
- Preclude® Dura Substitute, (Expanded polytetrafluroethylene), C. 510(k) K953967. Manufactured by W.L. Gore & Associates
1
:
Integra LifeSciences Corporation 510(k) K982180 DuraGen™ Dural Graft Matrix
- TutoPlast® Processed Dura Mater, (Human Dura Mater), 510(k) K910555 d. Manufactured by Biodynamics International, Inc.
- Lyodura®, (Human Dura Mater) e. Manufactured for AESCULAP, Inc.
7. Device Description
DuraGen™ Dural Graft Matrix is an absorbable implant for repair of dura mater. DuraGen [M is an easy to handle, soft, white, pliable, nonfriable, porous collagen matrix. DuraGen™ is supplied sterile, nonpyrogenic, for single use in double peel packages in a variety of sizes.
DuraGen™ is manufactured from bovine achilles tendon, which is classified by European Standards as Class IV material, no detectable infectivity for Bovine Spongiform Encephalopathy (BSE). The bovine tendon is known to be one of the purest sources of Type I Collagen that is commercially available. The collagen used to manufacture DuraGen™ is currently used in the manufacture of an artificial skin, absorbable hemostatic sponges, and absorbable wound dressings. The manufacturing process for DuraGen134 meets the United States Food and Drug Administration's Guidance document and European Standards for animal tissue sourcing, handling and inactivation of BSE. This process involves a treatment with sodium hydroxide that is a recognized method of inactivation of Spongiform Encephalopathy (SE). The bovine tendon is only obtained from facilities in the United States of America that have been inspected by the United States Department of Agriculture (USDA). Bovine Spongiform Encephalopathy (BSE) is not known to exist in the United States of America, therefore, the United States of America is considered by the European Union as a low risk country for bovine sourced materials.
A viral inactivation study for the DuraGen™ manufacturing process was conducted by an independent certified laboratory. In this study, the sodium hydroxide treatment was evaluated for its ability to inactivate the following viral strains: I luman Immunodeficiency Virus Type I (HIV), Bovine Viral Diarrhea (BVD), Infectious Bovine Rhinotracheitis (IBR), Parainfluenza Virus Type 3 (P13). Vesicular Stomatitis (VSV). For these viruses, the sodium hydroxide treatment reduced the viral titer to non-detectable levels.
8. Performance Data
DuraGen™ Dural Graft Matrix has been evaluated by a number of tests for safety, biocompatibility, toxicity, pyrogenicity, sterility and preclinical and clinical evaluations. Summaries and reports of all data are contained in the Premarket Notification submission.
2
Integra LifeSciences Corporation 510(k) K982180 DuraGen™ Dural Graft Matrix
Biocompatibility
The biocompatibility studies have demonstrated DuraGen™ Dural Graft Matrix to be: noncytotoxic, nonpyrogenic, nonmutagenic, nonsensitizing and be absorbed with no cellular or allergic responses. The following studies were conducted:
- Cytotoxicity Irritation/Intracutaneous Reactivity Pyrogenicity Genotoxicity Sensitization Study Chronic Toxicity Study Implantation Studies Intramuscular Toxicity Study Subcutaneous Implantation Study Immunological/Sensitivity Studies Mcchanical Testing
Clinical Studies
The collagen sponge was evaluated in a long-term clinical study to examine its suitability as a dural graft. Clinical evaluations involving more than 1,000 patients demonstrated that DuraGen™ Dural Graft Matrix performed safely and effectively as a dura substitute. During the course of the study, biopsies of the collagen implant were available from 100 patients for macroscopic and histological examination. There were no incidences of graft encapsulation, neomembrane formation, delayed hemorrhage, or foreign body reactions.
Summary/Comparison of Technological Characteristics 9.
Technological Characteristics
DuraGen™ and its predicates have similar technological characteristics.
The technological differences between DuraGen™ and the predicate devices do not raise new types of safety or effectiveness issues. The technological differences have been assessed by valid scientific and clinical methods. Physical, laboratory, animal and human clinical test methods have been performed and have proven the ability of DuraGen™ to function as a dura substitute.
Table 1 describes the properties of DuraGen™ Dural Graft Matrix compared to properties of the predicate devices.
10. Manufacturing
DuraGen™ Dural Graft Matrix is manufactured by Integra LifeSciences Corporation at its facility in Plainsboro, NJ in compliance with FDA Quality System Regulations. The facility is registered as a United States Food and Drug Administration Medical Device manufacturing facility. The Integra LifeSciences facility is also ISO 9001/EN 46001/Medical Device Directive certified.
3
Integra LifeSciences Corporation 510(k) K982180 DuraGen™ Dural Graft Matrix
The collagen used to manufacture DuraGen™ is used in other implantable medical devices manufactured by Integra LifeSciences such as hemostatic sponges, implantable wound dressings, and artificial skin.
Quality Assurance 11.
DuraGen™ is fully tested according to an established Quality Control procedure and is only released if the product conforms to specifications.
The test data from extensive in vivo preclinical testing and extensive human clinical studies presented in this submission establish that DuraGen™ Dural Graft Matrix is equivalent to predicate devices in biocompatibility and safety and effectiveness as a dura substitute.
4
| Feature | DuraGen™
Dural Graft Matrix | Lyoplant Dura
Substitute¹ | Lyodura®¹ | Dura-Guard®
Dural Repair
Patch¹ | Preclude Dura
Substitute¹ | Tutoplast®
Dura
Substitute¹ |
|------------------------------|----------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|------------------------------------------------------------------------|
| Manufacturer/
Distributor | Integra LifeSciences
Corporation | B. Braun /Aesculap | B. Braun/Aesculap | Bio-Vascular, Inc. | W.L. Gore &
Associates, Inc. | Biodynamics,
Inc. |
| Indications for
Use | Dura Substitute
Used as a dura
substitute for the repair
of dura mater. | Dura Substitute
Used as a dura mater
substitute in
neurological
procedures for soft
tissue reconstruction
of damaged,
impaired, or missing
tissue. | Dura Substitute
Indicated for the
replacement and
enlargement of
connective-tissue
structures. | Dura Substitute
Used as a dural
substitute for the
closure of dura
mater during
neurosurgery. | Dura Substitute
Used as a dura
substitute and for
spinal membrane | Dura Substitute
Used as a
substitute for
human dura
mater. |
| Materials | Bovine Type I Collagen | Bovine pericardium | Human Dura Mater | Bovine
pericardium | Expanded
polytetrafluoro-
ethylene | Human Dura
Mater |
| Absorption
Time | Gradual biodegradation | Gradual
biodegradation | Information not
available | Gradual
biodegradation | Non-resorbable | Gradual
biodegradation |
| Non-Pyrogenic | YES | YES | YES | Not claimed | YES | YES |
TABLE 1: Substantial Equivalence Comparison Chart
'Based on information from company brochure
5
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized depiction of a human figure with outstretched arms, resembling an eagle or bird-like shape.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 6 1999
Ms. Judith E. O'Grady, RN, MSN Senior Vice President Regulatory Affairs, Quality Assurance and Clinical Affairs Integra Life Sciences Corporation 105 Morgan Lane · Plainsboro, New Jersey 08536
Re: K982180
Trade Name: DuraGen™ Dural Graft Matrix Regulatory Class: II Product Code: GXQ Dated: June 1, 1999 Received: June 3, 1999
Dear Ms. O'Grady:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
6
Page 2 - Ms. Judith E. O'Grady, RN, MSN
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
.
:
Page 1 of 1
510(k) Number: K982180 Device Name: DuraGen™ Dural Graft Matrix
Indications for Use:
- DuraGen™ Dural Graft Matrix is indicated as a dura substitute for the . repair of dura mater.
(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 | |
| Optional Format 1-2-96) | |
| Or | |
| Over-the-Counter Use | ________________ |
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | K982180 |