(325 days)
Not Found
No
The device description and performance studies focus on the material composition, physical properties, and clinical equivalence to existing dura repair patches, with no mention of AI or ML.
No
This device is an implantable patch used to repair defects in the dura mater, which is a structural repair rather than a therapeutic treatment of a disease or condition.
No
The device is described as an "absorbable, synthetic implant for bridging defects of the dura mater," indicating it is a therapeutic or reconstructive device, not one used for diagnosis.
No
The device description clearly states it is a physical implant made of composite fleece fabric and film, provided sterile and ready for implantation. It is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "bridging defects of the dura mater," which is a surgical implant procedure performed directly on a patient.
- Device Description: The device is described as a "synthetic, absorbable implant" and is "provided sterile and ready for implantation." This aligns with a surgical device, not a diagnostic test performed on samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health status. The device's function is structural repair.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
GXQ
Device Description
The CODMAN ETHISORB™ Dura Patch is composed of a composite fleece fabric of polyglactin 910 and polydioxanone yarns, 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
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)
Device Testing Summary:
- Biocompatibility Testing: Although all materials used in the device have been shown to be bicompatible implant materials, additional tests were performed on final Dura Patch product, including pyrogenicity, cytocoxicity, 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
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.
1
6. Device Testing Summary
| Testing Performed | Comments |
|---|---|
| Biocompatibility | |
| Testing | Although all materials used in the device have been shown to |
| be bicompatible implant materials, additionaltests were | |
| performed on final Dura Patch product, including pyrogenicity, | |
| cytocoxicity, 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. |
2
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.
3
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
4
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)