(60 days)
Not Found
No
The 510(k) summary describes a collagen implant for dural repair and does not mention any AI or ML components, image processing, or data-driven performance metrics typically associated with AI/ML devices.
Yes
The device is intended for the repair or substitution of the patient's dura mater, which is a therapeutic purpose.
No
The device description clearly states "The DURAFORM Dural Graft Implant is intended for use in procedures where the repair or substitution of the patient's dura mater is needed." This indicates it's a therapeutic implant, not a diagnostic tool used for identifying conditions.
No
The device description clearly states it is a "single use, sterile collagen implant manufactured from processed bovine tendons," indicating it is a physical implant, 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 the "repair or substitution of the patient's dura mater," which is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a "single use, sterile collagen implant manufactured from processed bovine tendons." This describes a surgical implant, not a device used to examine specimens from the body.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze samples (blood, urine, tissue, etc.) from the human body to provide information about a physiological state, disease, or condition.
IVD devices are used in vitro (outside the body) to examine specimens. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
The DURAFORM Dural Graft Implant is intended for use in procedures where the repair or substitution of the patient's dura mater is needed.
Product codes (comma separated list FDA assigned to the subject device)
GXQ
Device Description
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.
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
Prescription Use
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 and packaging stability testing for device and packaging characteristics that may be affected by an extended shelf life was performed. All testing was performed on final sterile devices unless otherwise specified.
The following device stability testing was performed at time-zero and after 30 months of real-time aging:
- Compressibility (Time-Zero and 30-Month)
- Test Method Summary: Compressibility quantifies the ability of a device to be compressed. Compressibility is measured by comparing the compressed thickness to the original thickness of the device. The compressed thickness is measured with a thickness gage after compression at 120 seconds.
- Results: Both time-zero and 30-month real-time tests passed the acceptance criterion. Therefore, the proposed device is substantially equivalent to the predicate device and does not raise new issues in safety and effectiveness.
- Resilience (Time-Zero and 30-Month)
- Test Method Summary: Resilience quantifies the capability of a device returning back to its original state. Resilience is measured by comparing the recovered thickness after compression to the original thickness of the device. The recovered thickness is measured after the device has been compressed for 120 seconds and left to recover to its original state for 30 minutes.
- Results: Both time-zero and 30-month real-time tests passed the acceptance criterion. Therefore, the proposed device is substantially equivalent to the predicate device and does not raise new issues in safety and effectiveness.
- Imbibition (Time-Zero and 30-Month)
- Test Method Summary: The imbibition quotient measures how much fluid a material is able to absorb. In order to determine imbibition quotient, the dividend of the dry weight of a DURAFORM Dural Graft Implant sample is taken from wet weight of the sample after 10 seconds of irrigation, the procedure representing clinical use.
- Results: Both time-zero and 30-month real-time tests passed the acceptance criterion. Therefore, the proposed device is substantially equivalent to the predicate device and does not raise new issues in safety and effectiveness.
- Apparent Density (Time-Zero and 30-Month)
- Test Method Summary: Apparent density measures the density of a dural substitute material. Apparent density is measured using the dry weight of the device.
- Results: Both time-zero and 30-month real time tests passed the acceptance criterion. Therefore, the proposed device is substantially equivalent to the predicate device and does not raise new issues in safety and effectiveness.
- Visual Inspection (Time-Zero and 30-Month)
- Test Method Summary: A visual inspection is performed for the samples to be white in color with no stains visible.
- Results: Both time-zero and 30-month real-time tests passed the acceptance criterion. Therefore, the proposed device is substantially equivalent to the predicate device and does not raise new issues in safety and effectiveness.
- Tensile Strength (Time-Zero and 30-Month)
- Test Method Summary: Tensile strength testing is performed on the DURAFORM Dural Graft Implant per FDA's guidance on physical and mechanical properties testing for dura substitutes, as outlined in the Guidance Document for Dura Substitute Devices: Guidance for Industry. In order to test tensile strength, each sample is wetted with water, placed into an Instron instrument, and rewetted to ensure the sample has not dried out. Then, the instrument pulls the sample and captures the peak load when failure occurs.
- Results: Time-zero testing passed the acceptance criteria; 30-month testing results were deemed acceptable. Therefore, the proposed device is substantially equivalent to the predicate device and does not raise new issues in safety and effectiveness.
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:
- Visual Inspection (120-Month and 132-Month)
- Test Method Summary: A visual inspection is performed for any damage to the packaging.
- Results: Both 120-month and 132-month tests passed the acceptance criterion. Therefore, packaging integrity will be maintained for the duration of the proposed shelf life at 30 months.
- Seal Integrity (Dye Penetration) (120-Month and 132-Month)
- Test Method Summary: Seal integrity (dye penetration) testing was tested in accordance with ASTM F1929-12 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration.
- Results: Both 120-month and 132-month tests passed the acceptance criterion. Therefore, packaging integrity will be maintained for the duration of the proposed shelf life at 30 months.
- Seal Strength (120-Month and 132-Month)
- Test Method Summary: Seal strength testing was tested in accordance with ASTM F88/F88M-09 Standard Test Method for Seal Strength of Flexible Barrier Materials.
- Results: Both 120-month and 132-month tests passed the acceptance criterion. Therefore, packaging integrity will be maintained for the duration of 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.
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
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.
1
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
2
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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3
510(k) Summary
| I. Submitter | Codman & Shurtleff, Inc.
325 Paramount Drive
Raynham, 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 Graft
Implant (K033395), which was cleared on February 25, 2004. | | |
| IV. Device Description | 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. | | |
| V. Indications for Use | The DURAFORM Dural Graft Implant is intended for use in procedures
where 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 predicate
device, formerly known as Codman Dural Graft Implant (K033395), with
regard to indications for use, design, materials, manufacturing process, | | |
4
| VI. Comparison
to Predicate
Device (Cont.) | clinical utility, packaging, and sterilization; only the shelf life is different.
Codman is extending the shelf life for the DURAFORM Dural Graft
Implant from 12 months to 30 months. The appropriate spectrum of
stability testing has been performed to demonstrate substantial
equivalence to the CODMAN Dural Graft Implant with a 12-month shelf
life. |
|--------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| VII.
Performance
Data | There were no changes made that affect the DURAFORM Dural Graft
Implant's indications for use, design, materials, manufacturing process,
clinical utility, packaging, and sterilization. |
| | Device and packaging stability testing for device and packaging
characteristics that may be affected by an extended shelf life was
performed. All testing was performed on final sterile devices unless
otherwise 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 and | ||
| 30-Month) | Compressibility quantifies the | |
| ability of a device to be compressed. | ||
| Compressibility is measured by | ||
| comparing the compressed | ||
| thickness to the original thickness of | ||
| the device. The compressed | ||
| thickness is measured with a | ||
| thickness gage after compression at | ||
| 120 seconds. | Both time-zero and | |
| 30-month real-time tests | ||
| passed the acceptance | ||
| criterion. Therefore, the | ||
| proposed device is | ||
| substantially equivalent to | ||
| the predicate device and | ||
| does not raise new issues in | ||
| safety and effectiveness. | ||
| Resilience | ||
| (Time-Zero and | ||
| 30-Month) | Resilience quantifies the capability | |
| of a device returning back to its | ||
| original state. Resilience is | ||
| measured by comparing the | ||
| recovered thickness after | ||
| compression to the original | ||
| thickness of the device. The | ||
| recovered thickness is measured | ||
| after the device has been | ||
| compressed for 120 seconds and left | ||
| to recover to its original state for | ||
| 30 minutes. | Both time-zero and | |
| 30-month real-time tests | ||
| passed the acceptance | ||
| criterion. Therefore, the | ||
| proposed device is | ||
| substantially equivalent to | ||
| the predicate device and | ||
| does not raise new issues in | ||
| safety and effectiveness. | ||
| Test | Test Method Summary | Results |
| Imbibition | ||
| (Time-Zero and | ||
| 30-Month) | The imbibition quotient measures | |
| how much fluid a material is able to | ||
| absorb. In order to determine | ||
| imbibition quotient, the dividend of | ||
| the dry weight of a DURAFORM | ||
| Dural Graft Implant sample is taken | ||
| from wet weight of the sample after | ||
| 10 seconds of irrigation, the | ||
| procedure representing clinical use. | Both time-zero and | |
| 30-month real-time tests | ||
| passed the acceptance | ||
| criterion. Therefore, the | ||
| proposed device is | ||
| substantially equivalent to | ||
| the predicate device and | ||
| does not raise new issues in | ||
| safety and effectiveness. | ||
| Apparent | ||
| Density | ||
| (Time-Zero and | ||
| 30-Month) | Apparent density measures the | |
| density of a dural substitute | ||
| material. Apparent density is | ||
| measured using the dry weight of | ||
| the device. | Both time-zero and | |
| 30-month real time tests | ||
| passed the acceptance | ||
| criterion. Therefore, the | ||
| proposed device is | ||
| substantially equivalent to | ||
| the predicate device and | ||
| does not raise new issues in | ||
| safety and effectiveness. | ||
| Visual | ||
| Inspection | ||
| (Time-Zero and | ||
| 30-Month) | A visual inspection is performed for | |
| the samples to be white in color | ||
| with no stains visible. | Both time-zero and | |
| 30-month real-time tests | ||
| passed the acceptance | ||
| criterion. Therefore, the | ||
| proposed device is | ||
| substantially equivalent to | ||
| the predicate device and | ||
| does not raise new issues in | ||
| safety and effectiveness. | ||
| Tensile | ||
| Strength | ||
| (Time-Zero and | ||
| 30-Month) | Tensile strength testing is performed | |
| on the DURAFORM Dural Graft | ||
| Implant per FDA's guidance on | ||
| physical and mechanical properties | ||
| testing for dura substitutes, as | ||
| outlined in the Guidance Document | ||
| for Dura Substitute Devices: | ||
| Guidance for Industry. | ||
| In order to test tensile strength, each | ||
| sample is wetted with water, placed | ||
| into an Instron instrument, and | ||
| rewetted to ensure the sample has | ||
| not dried out. Then, the instrument | ||
| pulls the sample and captures the | ||
| peak load when failure occurs. | Time-zero testing passed | |
| the acceptance criteria; | ||
| 30-month testing results | ||
| were deemed acceptable. | ||
| Therefore, the proposed | ||
| device is substantially | ||
| equivalent to the predicate | ||
| device and does not raise | ||
| new issues in safety and | ||
| effectiveness. | ||
| Test | Test Method Summary | Results |
| Visual | ||
| Inspection | ||
| (120-Month | ||
| and | ||
| 132-Month) | A visual inspection is performed | |
| for any damage to the packaging. | Both 120-month and | |
| 132-month tests passed the | ||
| acceptance criterion. | ||
| Therefore, packaging integrity | ||
| will be maintained for the | ||
| duration of the proposed shelf | ||
| life at 30 months. | ||
| Seal Integrity | ||
| (Dye | ||
| Penetration) | ||
| (120-Month | ||
| and | ||
| 132-Month) | Seal integrity (dye penetration) | |
| testing was tested in accordance | ||
| with ASTM F1929-12 Standard | ||
| Test Method for Detecting Seal | ||
| Leaks in Porous Medical | ||
| Packaging by Dye Penetration. | Both 120-month and | |
| 132-month tests passed the | ||
| acceptance criterion. | ||
| Therefore, packaging integrity | ||
| will be maintained for the | ||
| duration of the proposed shelf | ||
| life at 30 months. | ||
| Seal Strength | ||
| (120-Month | ||
| and | ||
| 132-Month) | Seal strength testing was tested | |
| in accordance with ASTM | ||
| F88/F88M-09 Standard Test | ||
| Method for Seal Strength of | ||
| Flexible Barrier Materials. | Both 120-month and | |
| 132-month tests passed the | ||
| acceptance criterion. | ||
| Therefore, packaging integrity | ||
| will be maintained for the | ||
| duration of the proposed shelf | ||
| life at 30 months. |
5
VII.
Performance Data (Cont.)
6
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.