(325 days)
The CODMAN ETHISORB™ Dura Patch is a synthetic, absorbable implant intended for bridging defects of the dura mater.
The CODMAN ETHISORB™ Dura Patch is an absorbable, synthetic implant for bridging defects of the dura mater.
The CODMAN ETHISORB™ Dura Patch is composed of a composite fleece fabric of polyglactin 910 and polydioxanone yams, with a polydioxanone film dyed with D&C Violet No. 2 on one surface. The porous structure of the fleece allows tissue on-growth while the PDS film coating minimizes leakage of cerebrospinal fluid (CSF). The device is provided sterile and ready for implantation in a foil pouch. Animal and clinical trials have demonstrated that the device is suitable for its intended use. The implant material is fully biocompatible and absorbable over time
The provided document is a 510(k) summary for the CODMAN ETHISORB™ Dura Patch. It describes the device, its intended use, and a summary of testing performed to demonstrate its substantial equivalence to predicate devices. However, the document does not contain specific acceptance criteria, detailed study results, or the other requested information for a medical device AI, CADe, or CADx system.
The "Device Testing Summary" section indicates:
- Biocompatibility Testing: "additional tests were performed on final Dura Patch product, including pyrogenicity, cytotoxicity, and implant studies of tissue reaction."
- Performance Testing: "Performance testing was conducted in the target tissue to confirm device suitability for its intended use as a dura substitute."
- Clinical Evaluation: "A prospective non-randomized clinical trial was conducted to demonstrate the clinical performance characteristics of the device. Results of all testing demonstrate that the ETHISORB™ Dura Patch is equivalent to currently marketed products in its performance as a safe and effective dura substitute."
Given the information provided in the document, it is not possible to complete the requested table and details because:
- Acceptance Criteria and Reported Device Performance: No specific quantitative acceptance criteria (e.g., sensitivity, specificity, AUC, non-inferiority margins) or their corresponding performance metrics are listed. The document generically states that "Results of all testing demonstrate that the ETHISORB™ Dura Patch is equivalent to currently marketed products in its performance as a safe and effective dura substitute." This is a qualitative statement, not a numerical performance metric against a defined criterion.
- Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Set): The document mentions a "prospective non-randomized clinical trial" but provides no details on its methodology, sample size, data provenance, ground truth establishment, or any role of experts or AI. This device is a physical implant, not an AI/CADe/CADx system, so many of the requested fields (like AI performance, training set, experts for ground truth) are not applicable.
Conclusion: The provided 510(k) summary for the CODMAN ETHISORB™ Dura Patch does not contain the detailed, quantitative information typically found in submissions for AI/CADe/CADx devices regarding acceptance criteria and study results. Therefore, I cannot populate the requested table and answer the specific questions directly from the given text.
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MAR 1 3 2000
510K Summarv CODMAN ETHISORB™ Dura Patch
March 8, 2000
K991413
1. Submitter
Codman & Shurtleff, Inc. 325 Paramount Drive Ravnham. MA 02767 Deana Boushell, Manager Regulatory Affairs, (508) 828-3107
Device Name 2.
Proprietary Name: Common Name: Classification Name: Regulatory Class:
CODMAN ETHISORB™ Dura Patch Dura Substitute Dura Substitute Class II by 21 CFR §882.5910
3. Intended Use
The CODMAN ETHISORB™ Dura Patch is a synthetic, absorbable implant intended for bridging defects of the dura mater.
Device Description 4.
The CODMAN ETHISORB™ Dura Patch is composed of a composite fleece fabric of polyglactin 910 and polydioxanone yams, with a polydioxanone film dyed with D&C Violet No. 2 on one surface. The porous structure of the fleece allows tissue on-growth while the PDS film coating minimizes leakage of cerebrospinal fluid (CSF). The device is provided sterile and ready for implantation in a foil pouch. Animal and clinical trials have demonstrated that the device is suitable for its intended use. The implant material is fully biocompatible and absorbable over time
5. Predicate Device Comparison
The CODMAN ETHISORB™ Dura Patch is similar to other dura substitutes with respect to its design as a thin, flexible, impermeable sheet of material which is both biocompatible and sufficiently strong enough to bridge the dural defect until healing occurs. Examples of predicate products with these same characteristics include the Dura-Guard™ Dural Repair Patch by Bio-Vascular, Inc., (K950956) and the Neuro-Patch by Aesculap®, Inc. (K960470). The Dura Patch differs from the predicate devices only in that once it has fulfilled its function and is no longer needed to cover the defect, it is hydrolyzed and absorbed slowly over time.
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6. Device Testing Summary
| Testing Performed | Comments |
|---|---|
| BiocompatibilityTesting | Although all materials used in the device have been shown tobe bicompatible implant materials, additionaltests wereperformed on final Dura Patch product, including pyrogenicity,cytocoxicity, and implant studies of tissue reaction. |
| Performance Testing | Performance testing was conducted in the target tissue toconfirm device suitability for its intended use as a durasubstitute. |
| Clinical Evaluation | A prospective non-randomized clinical trial was conducted todemonstrate the clinical performance characteristics of thedevice. Results of all testing demonstrate that theETHISORB™ Dura Patch is equivalent to currently marketedproducts in its performance as a safe and effective durasubstitute. |
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Image /page/2/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three horizontal lines extending from its body, representing feathers or wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 3 2000
Ms. Deana Boushell, RAC Team Leader, Regulatory Affairs Codman & Shurtleff, Inc. 325 Paramount Drive Raynham. Massachusetts 02767
Re: K991413 Trade Name: ETHISORB™ Dura Patch Regulatory Class: II Product Code: GXQ Dated: January 10, 2000 Received: January 11, 2000
Dear Ms. Boushell:
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.
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Page 2 - Ms. Deana Boushell, RAC
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,
Neil R.P. Ogden
James E. Dillard III
ames E. નીન Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications For Use Device Name: CODMAN ETHISORB™ Dura Patch
K99143
The CODMAN ETHISORB™ Dura Patch is an absorbable, synthetic implant for bridging defects of the dura mater.
(Please do not write below this line - Continue on another page if necessary) Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number. K991413
Prescription Use (Per 21 CFR §801.109)
OR
Over-the-Counter Use
(Optional Format 1-2-96)
§ 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).