(108 days)
Not Found
No
The device description and performance studies focus on the material properties and biological response of the dural regeneration matrix, with no mention of AI or ML technologies.
Yes
The device is indicated as a dura substitute for the repair of dura mater, which is a therapeutic intervention for a medical condition.
No
Explanation: The device description and intended use clearly state that DuraGen® Secure Dural Regeneration Matrix is an implant used for the repair of dura mater, indicating its function as a therapeutic or restorative device, not one that diagnoses a condition.
No
The device is described as an absorbable implant comprised of collagen and HPMC, which are physical materials, not software. The description focuses on the material composition and physical properties of the implant.
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 on the patient's tissue.
- Device Description: The description details an "absorbable implant" comprised of collagen and HPMC, designed for surgical repair.
- 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, etc.) to provide information for diagnosis, monitoring, or screening. The device itself is the therapeutic intervention, not a tool for analyzing biological samples.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
DuraGen® Secure Dural Regeneration Matrix is indicated as a dura substitute for the repair of dura mater.
Product codes (comma separated list FDA assigned to the subject device)
GXQ
Device Description
DuraGen Secure Dural Regeneration Matrix is an absorbable implant for the repair of dura mater. This absorbable, sutureless onlay graft is comprised of a porous, highly purified collagen matrix and a thin layer of hydroxypropyl methyl cellulose (HPMC). HPMC is a non-cytotoxic, non-immunogenic, biocompatible plant-derived cellulosebased material. The addition of HPMC results in a dural graft which reduces the potential for the product to migrate, slide or displace during the surgical procedure, such as during irrigation of the surgical site or in a standing pool of fluid, without the use of sutures.
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)
Two animal studies were performed under GLP conditions comparing DuraGen Secure and the predicate device, DuraGen XS.
- A canine duraplasty study: results presented similarly in vivo. Both articles produced minimal inflammation, vascularization, and foreign body response. The products were mostly resorbed by 90-days and completely resorbed by 180-days. They were both completely integrated by 90-days. Both followed a similar time course for tissue reaction. There was no evidence of CSF leak through clinical, gross, or microscopic observation. There was also no evidence of infection or hydrocephalus. Under the conditions of this study, DuraGen Secure was considered substantially equivalent to DuraGen XS.
- A second canine efficacy study: results demonstrated the increased resistance to migration of DuraGen Secure when compared to the predicate. DuraGen XS, during irrigation and exposure to the conditions of standing fluid in a surgical site.
Biocompatibility testing according to standards set forth in ISO 10993 demonstrated no systemic toxicity and that the device was non-irritating, non-mutagenic, non-cytotoxic, non-hemolytic, and non-pyrogenicity was evaluated using the Limulus Amebocyte Lysate (LAL) test on the final sterilized DuraGen Secure device and found to be less than 0.06 EU/ml (Endotoxin Units / ml) per FDA 's Guidance Document for Dura Substitute Devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Endotoxin Units / ml (EU/ml) less than 0.06
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
JUN 1 5 2012
510(k) SUMMARY
A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92.
| 807.92(a)(1) - Submitter Information | |
|---|---|
| Name | Integra LifeSciences Corporation |
| Address | 311 Enterprise Drive |
| Plainsboro NJ 08536 | |
| Phone Number | (609) 936-5526 |
| Fax Number | (609) 275-9445 |
| Establishment | |
| Registration Number | 3003418325 |
| Name of Contact Person | Aakash Jain |
| Date Prepared | May 4, 2012 |
| 807.92(a)(2) - Name of device | |
| Trade or Propriety Name | DuraGen® Secure Dural Regeneration Matrix |
| Common or Usual Name | Dura substitute |
| Classification Name | Dura Substitute |
| Classification Panel | Neurology |
| Regulation | Class II, under 21 CFR 882.5910 |
| Product Code(s) | GXQ |
| 807.92(a)(3) - Legally marketed device(s) to which equivalence is claimed |
DuraGen XS " Dural Regeneration Matrix - K072207
807.92(a)(4) - Device description
DuraGen Secure Dural Regeneration Matrix is an absorbable implant for the repair of dura mater. This absorbable, sutureless onlay graft is comprised of a porous, highly purified collagen matrix and a thin layer of hydroxypropyl methyl cellulose (HPMC). HPMC is a non-cytotoxic, non-immunogenic, biocompatible plant-derived cellulosebased material. The addition of HPMC results in a dural graft which reduces the potential for the product to migrate, slide or displace during the surgical procedure, such as during irrigation of the surgical site or in a standing pool of fluid, without the use of sutures.
807.92(a)(5) - Intended Use of the device
DuraGen® Secure Dural Regeneration Matrix is indicated as Indications for Use a dura substitute for the repair of dura mater.
807.92(a)(6) Summary of the technological characteristics of the device compared to the predicate
DuraGen Secure Dural Regeneration Matrix is similar to the predicate device, DuraGen XS Dural Regeneration Matrix (Integra LifeSciences) in terms of intended use, physical properties, and mechanical properties. DuraGen Secure is manufactured using a collagen matrix, which is made from the same raw materials as those used to manufacture DuraGen XS, and has an added thin layer of HPMC to one side of the collagen matrix which reduces the potential for the product to migrate, slide or displace during the surgical procedure, such as during irrigation of the surgical site or in a standing pool of fluid, without the use of sutures.
Product
Comparision of DuraGen Secure to the predicate (DuraGen XS)
1
| Characteristics | |
|---|---|
| Mechanical | |
| Properties (Suture | |
| Retention and | |
| Tensile Strength) | Similar |
| Thickness | Similar |
| Porosity | Similar |
| Transition | |
| Temperature | Similar |
| Wetting Time | Similar |
| Material(s) | • DuraGen Secure: Bovine Type I Collagen and Plant-Derived |
| Hydroxypropyl Methylcellulose (HPMC) | |
| • DuraGen XS: Bovine Type I Collagen | |
| Resistance to | |
| migration | • DuraGen Secure: Meets Slip and Submersion Tests Criteria |
| • DuraGen XS: Does not meet Slip and Submersion Tests Criteria |
807.92(b)(1-2) - Nonclinical Tests Submitted
In addition to mechanical testing, two animal studies were performed under GLP conditions comparing DuraGen Secure and the predicate device, DuraGen XS.
The first animal study was a canine duraplasty study in which the results presented similarly in vivo. Both articles produced minimal inflammation, vascularization, and foreign body response. The products were mostly resorbed by 90-days and completely resorbed by 180-days. They were both completely integrated by 90-days. Both followed a similar time course for tissue reaction. There was no evidence of CSF leak through clinical, gross, or microscopic observation. There was also no evidence of infection or hydrocephalus. Under the conditions of this study, DuraGen Secure was considered substantially equivalent to DuraGen XS.
A second canine efficacy study was performed in which the results demonstrated the increased resistance to migration of DuraGen Secure when compared to the predicate. DuraGen XS, during irrigation and exposure to the conditions of standing fluid in a surgical site.
Biocompatibility testing according to standards set forth in ISO 10993 demonstrated no systemic toxicity and that the device was non-irritating, non-mutagenic. non-cytotoxic, non-hemolytic, and non-pyrogenicity was evaluated using the Limulus Amebocyte Lysate (LAL) test on the final sterilized DuraGen Secure device and found to be less than 0.06 EU/ml (Endotoxin Units / ml) per FDA 's Guidance Document for Dura Substitute Devices. All DuraGen Secure lots will be tested prior to release to ensure they are less than 0.06 EU/ml and will be labeled non-pyrogenic.
807.92(b)(3) - Conclusions drawn from non-clinical data
Testing confirmed that DuraGen Secure meets the product specifications and is biocompatible. Testing has confirmed that the product is substantially equivalent to the predicate device, DuraGen XS. The modifications expressed in this 510(k) Premarket Notification do not change the intended use or fundamental scientific technology of the device, and does not raise any new issues of safety or effectiveness.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three stripes representing health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle.
JUN 1 5 2012
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Integra LifeSciences Corporation c/o Mr. Aakash Jain Regulatory Affairs Associate 311 Enterprise Drive Plainsboro, New Jersey 08536
Re: K120600
Trade/Device Name: DuraGen® Secure Dural Regeneration Matrix Regulation Number: 21 CFR 882.5910 Regulation Name: Dura Substitute Regulatory Class: Class II Product Code: GXQ Dated: June 07, 2012 Received: June 08, 2012
Dear Mr. Jain:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
3
Page 2 - Mr. Aakash Jain
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Kesia Alexander
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Integra LifeSciences Corporation-Traditional 510(k) DuraGen Secure Dural Regeneration Matrix
Indications for Use
510(k) Number (if known):
Device Name:
DuraGen® Secure Dural Regeneration Matrix
Indications For Use:
DuraGen® Secure Dural Regeneration Matrix is indicated as a dura substitute for the repair of dura mater.
Prescription Use X (Per 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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K120600