(26 days)
DuraMatrix™ Collagen Dura Substitute Membranes are indicated as dural substitutes for the repair of dura mater.
The Collagen Dura Substitute Membrane are white, nonfriable, conformable, resorbable, membrane matrices engineered from highly purified type I collagen derived from bovine Achilles tendon. The devices have thicknesses similar to that of native dura. They are flexible and conform to the contours of the defect site. The Collagen Dura Substitute Membranes are supplied sterile, non-pyrogenic, in various sizes, and for single use only.
The provided document describes a 510(k) premarket notification for a medical device, the DuraMatrix™ Collagen Dura Substitute Membranes. This submission process focuses on establishing substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a detailed clinical study with reported performance metrics.
Therefore, many of the requested details about acceptance criteria, specific study designs, sample sizes for test and training sets, and expert involvement are not explicitly stated in this type of regulatory document.
However, based on the information provided, here's an attempt to answer the questions:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not provide a table of acceptance criteria with corresponding device performance metrics in the way one would see for a diagnostic device or a device with quantifiable outputs. Instead, it states that the device was evaluated for safety and effectiveness by demonstrating substantial equivalence to a predicate device.
| Acceptance Criteria Category | Reported Device Performance (Summary from Document) |
|---|---|
| Safety | "Collagen Dura Substitute Membrane equivalent has been evaluated by a number of tests to assess its safety/biocompatibility. The device passed all applicable FDA Blue Book Memorandum G95-1 and ISO 10993-1 testing for the biological evaluation of medical devices." This implies the acceptance criteria were compliance with these established biocompatibility standards. The reported performance is that the device "passed all applicable" tests. |
| Effectiveness | "The results of a large-scale animal study and clinical study of the equivalent product support the effectiveness of using a membrane material as a dura substitute in the repair of dura mater. The characteristics of the modified Collagen Dura Substitute Membranes meet the design requirements for an effective dura substitute." This implies the acceptance criteria for effectiveness were demonstrated through the "equivalent product" (likely the predicate device) and that the modified device's characteristics "meet the design requirements." Specific performance metrics are not given. |
| Equivalence | "The results of the in vitro product characterization studies show that the device modifications of the Collagen Dura Substitute Membrane are safe and substantially equivalent to the original device." The acceptance criterion is demonstrated substantial equivalence, with performance being that it was found substantially equivalent. |
2. Sample size Used for the Test Set and Data Provenance
- Sample Size: Not specified for the animal or clinical studies mentioned. The clinical study was for an "equivalent product," suggesting it was not directly performed on the current device being cleared.
- Data Provenance: The document does not specify the country of origin. The data is retrospective in the sense that the clinical and animal studies were performed on an "equivalent product" (predicate) and the current device's characteristics were compared. The "in vitro product characterization studies" are likely specific to the new device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The document refers to "evaluations" and "studies" but doesn't detail the involvement of specific experts in establishing ground truth, as would be common for AI/diagnostic device validation.
4. Adjudication Method for the Test Set
Not applicable/Not specified. This type of regulatory submission doesn't typically detail adjudication methods as it's not assessing diagnostic accuracy requiring expert consensus.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size
No. This is a physical medical device, not an AI or imaging diagnostic device where MRMC studies are typically performed.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not an algorithm or software device, so "standalone performance" in that context is not applicable. The device itself (the membrane) has standalone performance as a dura substitute, which was evaluated for safety and effectiveness as described above.
7. The Type of Ground Truth Used
- For safety: Likely biological endpoints (e.g., inflammation, biocompatibility markers) from in vivo animal studies and in vitro tests, compared against established standards (FDA Blue Book G95-1, ISO 10993-1). "Ground truth" here is compliance with these standards.
- For effectiveness: Based on the statement "support the effectiveness of using a membrane material as a dura substitute in the repair of dura mater," the ground truth for effectiveness would likely be successful dural repair in the animal and clinical studies (e.g., absence of CSF leakage, successful integration, neurological outcomes). This was established for the "equivalent product."
- For equivalence: In vitro product characterization studies (e.g., physical integrity, pore structure, conformability) comparing the new device to the predicate. The ground truth is the measured characteristics of the predicate and whether the new device's characteristics fall within acceptable ranges.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that utilizes training sets.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this type of device.
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K061487 Page 1/2
510(k) Summary of Safety and Effectiveness
| Applicant Name and Address: | Collagen Matrix, Inc.509 Commerce StreetFranklin Lakes, New Jersey 07417 | JUN 26 2006 |
|---|---|---|
| Contact Person: | Peggy Hansen, RACDirector, Clinical, Regulatory, and Quality AssuranceTel: (201) 405-1477Fax: (201) 405-1355 | |
| Date of Summary: | May 30, 2006 | |
| Device Common Name: | Collagen Dura Substitute Membranes | |
| Device Trade Name: | DuraMatrix™ Collagen Dura Substitute Membranes | |
| Device Classification Name: | Dura substituteClass II882.5910GXQ | |
| Predicate Device(s): | DuraMatrix™ Collagen Dura Substitute Membrane,K040888 |
Description of the Device
The Collagen Dura Substitute Membrane are white, nonfriable, conformable, resorbable, membrane matrices engineered from highly purified type I collagen derived from bovine Achilles tendon. The devices have thicknesses similar to that of native dura. They are flexible and conform to the contours of the defect site. The Collagen Dura Substitute Membranes are supplied sterile, non-pyrogenic, in various sizes, and for single use only.
Intended Use
The Collagen Dura Substitute Membranes are indicated for use as a dural substitute for the repair of dura mater.
Summary/Comparison of Technical Characteristics
Collagen Dura Substitute Membranes and their predicate have similar technological characteristics. In particular, the Collagen Dura Substitute Membrane and its predicates are similar with respect to intended use, material, form, sizes, thickness, physical integrity, pore structure and conformability.
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Safety
Collagen Dura Substitute Membrane equivalent has been evaluated by a number of tests to assess its safety/biocompatibility. The device passed all applicable FDA Blue Book Memorandum G95-1and ISO 10993-1 testing for the biological evaluation of medical devices.
Effectiveness
The results of a large-scale animal study and clinical study of the equivalent product support the effectiveness of using a membrane material as a dura substitute in the repair of dura mater. The characteristics of the modified Collagen Dura Substitute Membranes meet the design requirements for an effective dura substitute.
Conclusion
The results of the in vitro product characterization studies show that the device modifications of the Collagen Dura Substitute Membrane are safe and substantially equivalent to the original device.
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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 circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, with flowing lines representing hair or clothing.
JUN 26 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Collagen Matrix, Inc. c/o Peggy Hansen, RAC Director, Clinical, Regulatory, and Quality Assurance 509 Commerce Street Franklin Lakes, New Jersey 07417
Re: K061487
Trade/Device Name: DuraMatrix™ Collagen Dura substitute Membranes Regulation Number: 21 CFR 882.5910 Regulation Name: Dura Substitute Regulatory Class: Class II Product Code: GXQ Dated: June 7, 2006 Received: June 8, 2006
Dear Ms. Hansen:
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 idecations 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 1 clity. general controls pro sions of the Act include requirements for annual registration, isting 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. In the way 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. Younny of 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 lectronic product radiation control provisions (Sections 531-542 of the Actil 11 CFR 100-0.000.
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Page 2 - Peggy Hansen
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 (240) 276-0115. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours
Oabara Bneem
Mark Melkerson Director Division of General, Restorative And Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
| 510(k) Number (if known): | K061487 |
|---|---|
| --------------------------- | --------- |
Device Name: DuraMatrix™ Collagen Dura Substitute Membranes
Indications for Use:
DuraMatrix™ Collagen Dura Substitute Membranes are indicated as dural substitutes for the repair of dura mater.
Prescription Use X (Part 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)
Cladia, Philip, Joseph
(Doris, Sister)
Div neral, Restorative. and Neurological Devices
Page 1 of _1
510(k) Number
§ 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).