(108 days)
DuraGen® Secure Dural Regeneration Matrix is indicated as a dura substitute for the repair of dura mater.
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.
This document describes the 510(k) summary for the DuraGen® Secure Dural Regeneration Matrix. It focuses on demonstrating substantial equivalence to a predicate device, DuraGen XS, rather than providing a detailed study proving the device meets acceptance criteria in the way one might for an AI/ML device (e.g., sensitivity, specificity, AUC).
Instead, the study demonstrates substantial equivalence through a comparison of physical properties, material composition, and biological performance in animal studies. The acceptance criteria here are implicitly demonstrating "similarity" or "no significant difference" in key performance characteristics, with the added benefit of improved migration resistance.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Characteristic/Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Material Composition | Bovine Type I Collagen (similar to predicate) | Bovine Type I Collagen and Plant-Derived Hydroxypropyl Methylcellulose (HPMC) |
| Mechanical Properties | Similar to predicate (DuraGen XS) | Similar (Suture Retention and Tensile Strength) |
| Thickness | Similar to predicate (DuraGen XS) | Similar |
| Porosity | Similar to predicate (DuraGen XS) | Similar |
| Transition Temperature | Similar to predicate (DuraGen XS) | Similar |
| Wetting Time | Similar to predicate (DuraGen XS) | Similar |
| Resistance to Migration | Meets Slip and Submersion Tests Criteria (improved over predicate) | Meets Slip and Submersion Tests Criteria (DuraGen XS does not) |
| In Vivo Performance (Canine Duraplasty Study) | Minimal inflammation, vascularization, foreign body response, resorption by 180 days, integration by 90 days, no CSF leak, infection, or hydrocephalus (similar to predicate) | Minimal inflammation, vascularization, foreign body response; Mostly resorbed by 90-days, completely resorbed by 180-days; Completely integrated by 90-days; No evidence of CSF leak, infection, or hydrocephalus |
| Biocompatibility (ISO 10993) | Non-systemic toxicity, non-irritating, non-mutagenic, non-cytotoxic, non-hemolytic, non-pyrogenic | Demonstrated no systemic toxicity, non-irritating, non-mutagenic, non-cytotoxic, non-hemolytic |
| Endotoxin Level (LAL Test) | Less than 0.06 EU/ml (per FDA Guidance) | Less than 0.06 EU/ml |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Mechanical Testing: Not specified.
- Canine Duraplasty Study: Two animal studies were performed. The exact number of animals is not specified, but the text mentions "in vivo" and "under GLP conditions."
- Canine Efficacy Study (Migration Resistance): The exact number of animals is not specified.
- Biocompatibility Testing: Not specified.
- Data Provenance: Not specified, but animal studies were conducted "under GLP conditions," implying controlled, prospective animal studies. Country of origin not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This section is not applicable as the document describes a medical device (dural regeneration matrix) and its substantial equivalence to a predicate, not an AI/ML device requiring expert ground truth for interpretation of images or data. Ground truth here is established through scientific testing (mechanical, biocompatibility, animal studies).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in clinical studies involving human interpretation (e.g., radiology reads). The studies described here are focused on physical and biological properties.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This section is not applicable. This describes a physical medical device, not an AI/ML system, and therefore no MRMC study or assessment of human reader improvement with AI assistance was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. This concerns a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the device's performance is established through:
- Predicate Device Comparison: DuraGen XS, an already legally marketed device, serves as a benchmark for comparison.
- Mechanical Testing Standards: Implicit industry standards for suture retention, tensile strength, thickness, porosity, transition temperature, and wetting time.
- Specific Test Criteria: "Slip and Submersion Tests Criteria" for migration resistance.
- Histopathological & Clinical Observations in Animal Studies: For inflammation, vascularization, foreign body response, resorption, integration, CSF leak, infection, hydrocephalus.
- Biocompatibility Standards (ISO 10993): Criteria for systemic toxicity, irritation, mutagenicity, cytotoxicity, hemolysis.
- LAL Test Standards: For endotoxin levels (less than 0.06 EU/ml).
8. The sample size for the training set
This section is not applicable. This document describes a medical device, not an AI/ML system that requires a "training set."
9. How the ground truth for the training set was established
This section is not applicable. (See point 8).
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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 DrivePlainsboro NJ 08536 |
| Phone Number | (609) 936-5526 |
| Fax Number | (609) 275-9445 |
| EstablishmentRegistration 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)
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| Characteristics | |
|---|---|
| MechanicalProperties (SutureRetention andTensile Strength) | Similar |
| Thickness | Similar |
| Porosity | Similar |
| TransitionTemperature | Similar |
| Wetting Time | Similar |
| Material(s) | • DuraGen Secure: Bovine Type I Collagen and Plant-DerivedHydroxypropyl Methylcellulose (HPMC)• DuraGen XS: Bovine Type I Collagen |
| Resistance tomigration | • 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.
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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.
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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
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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
§ 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).