(60 days)
The DURAFORM Dural Graft Implant is intended for use in procedures where the repair or substitution of the patient's dura mater is needed.
The DURAFORM Dural Graft Implant is a single use, sterile collagen implant manufactured from processed bovine tendons. The Duraform Dural Graft Implant is designed to be a sutureless, onlay graft, but tensionless sutures can be used if preferred by the surgeon.
This document describes the performance testing for the DURAFORM Dural Graft Implant, specifically to support an extended shelf life from 12 months to 30 months. The testing focuses on device stability and packaging stability.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Category | Test | Test Method Summary | Acceptance Criteria (Implied from Results) | Reported Device Performance |
|---|---|---|---|---|
| Device | Compressibility (Time-Zero & 30-Month) | Quantifies the ability of a device to be compressed by comparing the compressed thickness to the original thickness after 120 seconds of compression. | Passed (device behaves as expected for its intended use) | Both time-zero and 30-month real-time tests passed the acceptance criterion, demonstrating substantial equivalence to the predicate device and no new safety/effectiveness issues. |
| Device | Resilience (Time-Zero & 30-Month) | Quantifies the capability of a device returning to its original state by comparing the recovered thickness after compression (30 minutes recovery after 120 seconds compression) to the original thickness. | Passed (device returns to original state as expected) | Both time-zero and 30-month real-time tests passed the acceptance criterion, demonstrating substantial equivalence to the predicate device and no new safety/effectiveness issues. |
| Device | Imbibition (Time-Zero & 30-Month) | Measures how much fluid a material absorbs. Determined by the ratio of dry weight to wet weight after 10 seconds of irrigation, representing clinical use. | Passed (device absorbs fluid appropriately for clinical use) | Both time-zero and 30-month real-time tests passed the acceptance criterion, demonstrating substantial equivalence to the predicate device and no new safety/effectiveness issues. |
| Device | Apparent Density (Time-Zero & 30-Month) | Measures the density of the dural substitute material using the dry weight of the device. | Passed (density remains within acceptable limits) | Both time-zero and 30-month real-time tests passed the acceptance criterion, demonstrating substantial equivalence to the predicate device and no new safety/effectiveness issues. |
| Device | Visual Inspection (Time-Zero & 30-Month) | Samples are inspected to be white in color with no visible stains. | Passed (device remains white with no stains) | Both time-zero and 30-month real-time tests passed the acceptance criterion, demonstrating substantial equivalence to the predicate device and no new safety/effectiveness issues. |
| Device | Tensile Strength (Time-Zero & 30-Month) | Performed according to FDA guidance for dura substitutes. Samples are wetted, placed in an Instron instrument, re-wetted, and then pulled to capture peak load at failure. | Time-zero passed, 30-month results deemed acceptable (device maintains sufficient strength over time) | Time-zero testing passed the acceptance criteria; 30-month testing results were deemed acceptable, demonstrating substantial equivalence to the predicate device and no new safety/effectiveness issues. |
| Packaging | Visual Inspection (120-Month & 132-Month) | Performed for any damage to the packaging. | Passed (no damage to packaging) | Both 120-month and 132-month tests passed the acceptance criterion, indicating packaging integrity will be maintained for the proposed 30-month shelf life. |
| Packaging | Seal Integrity (Dye Penetration) (120-Month & 132-Month) | Tested in accordance with ASTM F1929-12 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration. | Passed (no dye penetration, indicating seal integrity) | Both 120-month and 132-month tests passed the acceptance criterion, indicating packaging integrity will be maintained for the proposed 30-month shelf life. |
| Packaging | Seal Strength (120-Month & 132-Month) | Tested in accordance with ASTM F88/F88M-09 Standard Test Method for Seal Strength of Flexible Barrier Materials. | Passed (seal strength maintained within acceptable limits) | Both 120-month and 132-month tests passed the acceptance criterion, indicating packaging integrity will be maintained for the proposed 30-month shelf life. |
2. Sample Sizes Used for the Test Set and Data Provenance:
The document does not explicitly state the exact sample sizes for each test. However, it indicates that "All testing was performed on final sterile devices unless otherwise specified" for device stability tests. For packaging stability, tests were performed at "120 months and 132 months of real-time aging."
- Sample Size: Not explicitly stated as numerical values for each specific test. Implied to be sufficient for demonstrating statistical significance for shelf-life extension.
- Data Provenance: The data is generated from laboratory testing of the device and its packaging. There is no mention of country of origin of the data, but it's generated by Codman & Shurtleff, Inc., based in Raynham, MA, USA. The testing is retrospective in the sense that it's performed on samples aged for specific durations to simulate shelf life (real-time aging).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Experts:
Not applicable. This is a performance study for physical and material properties, not an AI or diagnostic study requiring expert ground truth for interpretation. The "ground truth" for these tests are the established physical and material property standards and specifications of the device.
4. Adjudication Method for the Test Set:
Not applicable. This is not a study requiring adjudication of expert opinions. The results are objective measurements from laboratory tests against predetermined criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. This study is focused on the physical and material performance of a medical implant and its packaging over time to justify a shelf-life extension, not on the interpretative accuracy of human readers with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This product is a physical medical implant, not an algorithm or AI-driven device.
7. The Type of Ground Truth Used:
The ground truth used for these performance tests is based on:
- Established physical and chemical properties of the device: The inherent properties the Dural Graft Implant is expected to maintain for its function.
- Regulatory guidance: The tensile strength testing, for example, is performed "per FDA's guidance on physical and mechanical properties testing for dura substitutes."
- Industry standards: For packaging, ASTM F1929-12 and ASTM F88/F88M-09 are cited.
- Predicate device characteristics: The new device (DURAFORM) is explicitly compared to the predicate device (CODMAN Dural Graft Implant) to ensure "substantial equivalence" and that it "does not raise new issues in safety and effectiveness." The predicate device's established performance serves as a comparative benchmark.
8. The Sample Size for the Training Set:
Not applicable. This is not an AI/machine learning study requiring a training set.
9. How the Ground Truth for the Training Set was Established:
Not applicable. There is no training set for this type of performance study.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an emblem featuring a stylized depiction of three human profiles facing to the right, layered on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 30, 2015
Codman & Shurtleff, Inc. Ms. Jennifer Siu Regulatory Affairs Specialist 325 Paramount Drive Raynham, Massachusetts 02767
Re: K152481
Trade/Device Name: DURAFORM Dural Graft Implant Regulation Number: 21 CFR 882.5910 Regulation Name: Dura Substitute Regulatory Class: Class II Product Code: GXQ Dated: October 1, 2015 Received: October 2, 2015
Dear Ms. Siu:
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.
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 of medical devicerelated 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.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Carlos L. Pena -S
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name DURAFORM Dural Graft Implant
Indications for Use (Describe)
The DURAFORM Dural Graft Implant is intended for use in procedures where the repair or substitution of the patient's dura mater is needed.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X | Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
| I. Submitter | Codman & Shurtleff, Inc.325 Paramount DriveRaynham, MA 02767 | ||
|---|---|---|---|
| Establishment Registration Number: 1226348 | |||
| Primary Contact: | Jennifer Siu(508) 828-3288(508) 977-6979 | ||
| Secondary Contact: | Jocelyn Raposo(508) 828-3421(508) 977-6979 | ||
| Date of Submission: | August 28, 2015 | ||
| II. Device | Device Proprietary Name | DURAFORM™ Dural Graft Implant | |
| Common Name | Dura Substitute | ||
| Classification Name | Dura Substitute (21 CFR 882.5910) | ||
| Regulatory Classification | II | ||
| Product Code | GXQ | ||
| III. Predicate Device | The predicate device for this submission is the CODMAN Dural GraftImplant (K033395), which was cleared on February 25, 2004. | ||
| IV. Device Description | The DURAFORM Dural Graft Implant is a single use, sterile collagenimplant manufactured from processed bovine tendons. The DuraformDural Graft Implant is designed to be a sutureless, onlay graft, buttensionless sutures can be used if preferred by the surgeon. | ||
| V. Indications for Use | The DURAFORM Dural Graft Implant is intended for use in procedureswhere the repair or substitution of the patient's dura mater is needed. | ||
| VI. Comparison to Predicate Device | The DURAFORM Dural Graft Implant is identical to the predicatedevice, formerly known as Codman Dural Graft Implant (K033395), withregard to indications for use, design, materials, manufacturing process, |
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| VI. Comparisonto PredicateDevice (Cont.) | clinical utility, packaging, and sterilization; only the shelf life is different.Codman is extending the shelf life for the DURAFORM Dural GraftImplant from 12 months to 30 months. The appropriate spectrum ofstability testing has been performed to demonstrate substantialequivalence to the CODMAN Dural Graft Implant with a 12-month shelflife. |
|---|---|
| VII.PerformanceData | There were no changes made that affect the DURAFORM Dural GraftImplant's indications for use, design, materials, manufacturing process,clinical utility, packaging, and sterilization. |
| Device and packaging stability testing for device and packagingcharacteristics that may be affected by an extended shelf life wasperformed. All testing was performed on final sterile devices unlessotherwise specified. |
The following device stability testing was performed at time-zero and after 30 months of real-time aging:
| Test | Test Method Summary | Results |
|---|---|---|
| Compressibility(Time-Zero and30-Month) | Compressibility quantifies theability of a device to be compressed.Compressibility is measured bycomparing the compressedthickness to the original thickness ofthe device. The compressedthickness is measured with athickness gage after compression at120 seconds. | Both time-zero and30-month real-time testspassed the acceptancecriterion. Therefore, theproposed device issubstantially equivalent tothe predicate device anddoes not raise new issues insafety and effectiveness. |
| Resilience(Time-Zero and30-Month) | Resilience quantifies the capabilityof a device returning back to itsoriginal state. Resilience ismeasured by comparing therecovered thickness aftercompression to the originalthickness of the device. Therecovered thickness is measuredafter the device has beencompressed for 120 seconds and leftto recover to its original state for30 minutes. | Both time-zero and30-month real-time testspassed the acceptancecriterion. Therefore, theproposed device issubstantially equivalent tothe predicate device anddoes not raise new issues insafety and effectiveness. |
| Test | Test Method Summary | Results |
| Imbibition(Time-Zero and30-Month) | The imbibition quotient measureshow much fluid a material is able toabsorb. In order to determineimbibition quotient, the dividend ofthe dry weight of a DURAFORMDural Graft Implant sample is takenfrom wet weight of the sample after10 seconds of irrigation, theprocedure representing clinical use. | Both time-zero and30-month real-time testspassed the acceptancecriterion. Therefore, theproposed device issubstantially equivalent tothe predicate device anddoes not raise new issues insafety and effectiveness. |
| ApparentDensity(Time-Zero and30-Month) | Apparent density measures thedensity of a dural substitutematerial. Apparent density ismeasured using the dry weight ofthe device. | Both time-zero and30-month real time testspassed the acceptancecriterion. Therefore, theproposed device issubstantially equivalent tothe predicate device anddoes not raise new issues insafety and effectiveness. |
| VisualInspection(Time-Zero and30-Month) | A visual inspection is performed forthe samples to be white in colorwith no stains visible. | Both time-zero and30-month real-time testspassed the acceptancecriterion. Therefore, theproposed device issubstantially equivalent tothe predicate device anddoes not raise new issues insafety and effectiveness. |
| TensileStrength(Time-Zero and30-Month) | Tensile strength testing is performedon the DURAFORM Dural GraftImplant per FDA's guidance onphysical and mechanical propertiestesting for dura substitutes, asoutlined in the Guidance Documentfor Dura Substitute Devices:Guidance for Industry.In order to test tensile strength, eachsample is wetted with water, placedinto an Instron instrument, andrewetted to ensure the sample hasnot dried out. Then, the instrumentpulls the sample and captures thepeak load when failure occurs. | Time-zero testing passedthe acceptance criteria;30-month testing resultswere deemed acceptable.Therefore, the proposeddevice is substantiallyequivalent to the predicatedevice and does not raisenew issues in safety andeffectiveness. |
| Test | Test Method Summary | Results |
| VisualInspection(120-Monthand132-Month) | A visual inspection is performedfor any damage to the packaging. | Both 120-month and132-month tests passed theacceptance criterion.Therefore, packaging integritywill be maintained for theduration of the proposed shelflife at 30 months. |
| Seal Integrity(DyePenetration)(120-Monthand132-Month) | Seal integrity (dye penetration)testing was tested in accordancewith ASTM F1929-12 StandardTest Method for Detecting SealLeaks in Porous MedicalPackaging by Dye Penetration. | Both 120-month and132-month tests passed theacceptance criterion.Therefore, packaging integritywill be maintained for theduration of the proposed shelflife at 30 months. |
| Seal Strength(120-Monthand132-Month) | Seal strength testing was testedin accordance with ASTMF88/F88M-09 Standard TestMethod for Seal Strength ofFlexible Barrier Materials. | Both 120-month and132-month tests passed theacceptance criterion.Therefore, packaging integritywill be maintained for theduration of the proposed shelflife at 30 months. |
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VII.
Performance Data (Cont.)
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VII. Performance Data (Cont.)
The following packaging stability testing, performed at 120 months and 132 months of real-time aging, was leveraged to support packaging integrity for the proposed shelf life at 30 months:
Animal Testing:
No animal studies were performed as appropriate validation of the shelf life extension was achieved based on the comparison to the predicate device and from the results of the device and packaging stability studies.
Clinical Testing:
No clinical studies were performed as appropriate validation of the shelf life extension was achieved based on the comparison to the predicate device and from the results of the device and packaging stability studies.
Conclusion:
Based upon the indications for use, design, materials, packaging, comparison to the currently marketed device, and shelf life testing performed by Codman, it is concluded that the DURAFORM Dural Graft Implant with a 30-month shelf life is substantially equivalent to the predicate CODMAN Dural Graft Implant with a 12-month shelf life and therefore, does not raise any new issues of safety and effectiveness.
§ 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).