(169 days)
Not Found
No
The summary describes a collagen implant for dura repair and does not mention any AI or ML components or functionalities.
Yes
Explanation: The device is a collagen implant used for the repair of dura mater defects, directly treating a medical condition or assisting in the healing process.
No
The device is described as a "dura substitute" and a "collagen implant for the repair of defects in the dura mater," indicating it is a therapeutic device for structural repair, not for diagnosing conditions.
No
The device description clearly states it is a "collagen implant" and a "dura substitute," indicating a physical, material-based medical device, 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 "as a dura substitute for the repair of the dura mater." This describes a surgical implant used directly in the body to repair tissue.
- Device Description: The description details a "collagen implant" that is "supplied sterile" and "intended for single (one-time) use-only." This further reinforces its nature as a surgical device.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any interaction with bodily specimens for diagnostic purposes.
Therefore, Durepair is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Durepair is indicated as a dura substitute for the repair of the dura mater.
Product codes (comma separated list FDA assigned to the subject device)
GXQ
Device Description
Durepair® Dura Regeneration Matrix is a collagen implant for the repair of defects in the dura mater. Durepair is supplied sterile, in a double-peel package, and is intended for single (one-time) use-only. Durepair is available in a variety of sizes intended to be cut by the surgeon to the desired shape.
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)
Bench Top Testing:
- Sizes: Measured with digital calipers and were inspected 100%. All samples met acceptance criteria, demonstrating no concerns regarding physical attributes.
- Tensile Strength: All skins sampled at the two thinnest corners, representing worst case. All samples met acceptance criteria, demonstrating no concerns regarding strength and stiffness.
- Tensile Stiffness: All skins sampled at the two thinnest corners, representing worst case. All samples met acceptance criteria, demonstrating no concerns regarding strength and stiffness.
- Suture Retention Strength: 3 mm suture bite using polypropylene 4-0 suture, two samples taken from thinnest (weakest) areas of each skin. All samples met acceptance criteria, demonstrating no concerns regarding suture retention.
- Wet Shrink Temperature: Hydrated specimens tested with a Differential Scanning Colorimeter. All samples met acceptance criteria, demonstrating no concerns regarding scaffold damage during processing.
- Pore Size: No visible through pores should be seen. All samples met acceptance criteria, demonstrating no concerns regarding material porosity.
- Hydration Rate: Time to hydrate. All samples met acceptance criteria, demonstrating no concerns regarding hydration rate time.
- Histology (Wet EBM): To demonstrate EBM is free of cells and cellular/nuclear debris. All samples met acceptance criteria, demonstrating no concerns regarding contents.
- Safety: Must be non-pyrogenic. All samples met acceptance criteria, demonstrating no concerns regarding contents.
- Bioburden: No bioburden observed in final rinse water. All samples met acceptance criteria, demonstrating no concerns regarding contents.
Biocompatibility Testing:
- Calcification: Samples implanted into weanling rats for 4 weeks. Pass. No calcification was present in the samples.
- Cytotoxicity: Per ISO 10993-5, mouse fibroblasts exposed to a MEM elution of product. Pass. None of the cultures showed greater than grade 2 of reactivity.
- Skin Sensitization Study (Saline & Cottonseed Oil Extraction): Per ISO 10993-10, guinea pig maximization test. Pass. All test animals scored a 0 and had no significant dermal contact sensitization.
- Irritation Study, Intracutaneous Injection (Saline & Cottonseed Oil Extraction): Per ISO 10993-10, rabbits. Pass. Mean reaction scores for the test articles were
§ 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).
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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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles facing right, suggesting a sense of community and care.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 2, 2016
Medtronic Neurosurgery Manas Lele Senior Regulatory Affairs Specialist 125 Cremona Drive Goleta, California 93117
Re: K161370
Trade/Device Name: Durepair Dura Regeneration Matrix Regulation Number: 21 CFR 882.5910 Regulation Name: Dura Substitute Regulatory Class: Class II Product Code: GXQ Dated: September 27, 2016 Received: September 28, 2016
Dear Mr. Lele:
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 (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, Michael J. Hoffmann -A
Carlos L. Peña. PhD, MS for 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) K161370
Device Name Durepair Dura Regeneration Matrix
Indications for Use (Describe) Durepair is indicated as a dura substitute for the repair of the dura mater.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
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
This 510(k) summary is submitted in accordance with the requirements of 21 CFR 807.92.
| 510(k) Owner: | Medtronic Neurosurgery
125 Cremona Drive
Goleta, CA 93117-5503 USA |
|----------------------------|----------------------------------------------------------------------------------------------------------------------|
| Contact Name: | Manas Lele
Senior Regulatory Affairs Specialist
Telephone: (805) 571-8956
Email: Manas.M.Lele@Medtronic.com |
| Date Summary Prepared: | October 31, 2016 |
| Trade or Proprietary Name: | Durepair Dura Regeneration Matrix |
| Common Name: | Dura Substitute |
| Classification Name: | Dura Substitute
(21 CFR §882. 882.5910, Product Code GXQ) |
| Predicate Device: | Durepair Dura Regeneration Matrix (K063117
K041000 and K052211) |
Device Description:
Durepair® Dura Regeneration Matrix is a collagen implant for the repair of defects in the dura mater. Durepair is supplied sterile, in a double-peel package, and is intended for single (one-time) use-only. Durepair is available in a variety of sizes intended to be cut by the surgeon to the desired shape.
Indications for Use:
Durepair is indicated as a dura substitute for the repair of the dura mater.
Summary of Technological Characteristics Compared to the Predicate Device:
The proposed Durepair Dura Regeneration Matrix incorporates the same basic technological characteristics as the predicate device. The manufacturing process change relative to the predicate device did not affect the device design, indications of use, material or the fundamental technology of the device.
4
| Table 1 - Summary of Technological Characteristics Comparison between Predicate | ||||
|---|---|---|---|---|
| Durepair Device and Proposed Durepair Device |
| Technological
| Characteristic | Predicate Durepair Device | Proposed Durepair Device |
|---|---|---|
| Fundamental | ||
| Technology | Collagen implant for the repair of | |
| the defects in the dura mater | Same. The Fundamental Technology has | |
| not changed. | ||
| Sizes | Durepair is available in different | |
| sizes | ||
| 1" x 1" | ||
| 1" x 3" | ||
| 2" x 2" | ||
| 3" x 3" | ||
| 4" x 5" | ||
| 5" x 8" | Same. The length or width sizes or | |
| tolerances have not changed | ||
| Suturability | Use of suture allowed to secure | |
| device | Same. This characteristic has not | |
| changed. | ||
| Material | Collagen matrix harvested from | |
| processed fetal bovine materials | Same. The proposed device is made | |
| from the collagen matrix | ||
| Cut product to size | Durepair can be cut ot size based | |
| on user need | Same. This characteristic has not | |
| changed. | ||
| Manufacturing | ||
| Process (Use of | ||
| Solvents) | Use of organic solvents | No use of organic solvents. Replacement |
| with equivalent processing step. |
Table 2 – Summary of Bench Top Testing:
The following bench testing was submitted in support of substantial equivalence.
| Test | Test Method Summary for Proposed Durepair device | Results for Proposed Durepair device |
|---|---|---|
| Sizes | The specified length or width had a tolerance of $\pm$ 5%. Measured with digital calipers and were inspected 100%. | All samples met the acceptance criteria, demonstrating that there are no concerns regarding the physical attributes of the proposed device in comparison to the predicate device. |
| Tensile | ||
| Strength | Tensile Strength must be an average 5 MPa minimum. All skins were sampled at the two thinnest corners of each skin representing worst case. | All samples met the acceptance criteria, demonstrating that there are no concerns regarding the strength and stiffness attributes of the proposed device in comparison to the predicate device. |
| Tensile | ||
| Stiffness | Tensile Stiffness must have an average 225 MPa maximum. All skins were sampled at the two thinnest corners of each skin representing worst case. | All samples met the acceptance criteria, demonstrating that there are no concerns regarding the strength and stiffness attributes of the proposed device in comparison to the predicate device. |
| Test | Test Method Summary for | |
| Proposed Durepair device | Results for Proposed Durepair device | |
| Suture | ||
| Retention | ||
| Strength | At a pull rate of 20mm/min, 3 mm | |
| suture bite using polypropylene 4-0 | ||
| suture, suture strength must be a | ||
| Minimum of 5 N. Two suture retention | ||
| samples were taken from the thinnest | ||
| (weakest) areas of each skin. | All samples met the acceptance criteria, | |
| demonstrating that there are no concerns | ||
| regarding the ability to maintain a suture | ||
| on the proposed device in comparison to | ||
| the predicate device. | ||
| Wet Shrink | ||
| Temperature | Wet shrink Temperature - Hydrated | |
| specimens must be 58° - 67° C (an in | ||
| process specification). A Differential | ||
| Scanning Colorimeter was used. | ||
| Indicator that the scaffold has not | ||
| been damaged during processing. | All samples met the acceptance criteria, | |
| demonstrating that there are no concerns | ||
| regarding the ability to maintain a suture | ||
| on the proposed device in comparison to | ||
| the predicate device. | ||
| Pore Size | No visible through pores should be | |
| seen and this test helps determine | ||
| the material porosity | All samples met the acceptance criteria, | |
| demonstrating that there are no concerns | ||
| regarding the physical attributes of | ||
| proposed device in comparison to the | ||
| predicate device. | ||
| Hydration Rate | Time to hydrate must be less than or | |
| equal to 3 minutes. Saline solution is | ||
| used to hydrate at room temperature | All samples met the acceptance criteria, | |
| demonstrating that there are no concerns | ||
| regarding the hydration rate time of | ||
| proposed device in comparison to the | ||
| predicate device. | ||
| Histology (Wet | ||
| EBM) | No cells or cellular/nuclear debris | |
| evident. | ||
| To demonstrate the EBM is free of | ||
| cells and cellular/nuclear debris | All samples met the acceptance criteria, | |
| demonstrating that there are no concerns | ||
| regarding the contents of the proposed | ||
| device in comparison to the predicate | ||
| device. | ||
| Safety | Must be non-pyrogenic (Less than or | |
| equal to 2.15 EU/device) | ||
| No bacterial endotoxins verified per | ||
| each production lot. | All samples met the acceptance criteria, | |
| demonstrating that there are no concerns | ||
| regarding the contents of the proposed | ||
| device in comparison to the predicate | ||
| device. | ||
| Bioburden | No bioburden observed in the final | |
| rinse water, 0 CFUs for each lot. | ||
| Final rinse water samples collected | ||
| for each lot. | All samples met the acceptance criteria, | |
| demonstrating that there are no concerns | ||
| regarding the contents of the proposed | ||
| device in comparison to the predicate | ||
| device. | ||
| Test | Test Method Summary | Result |
| Calcification | No calcification. Samples implanted into | |
| weanling rats for 4 weeks, explants were | ||
| examined grossly and microscopically. | ||
| Samples were tested for potential for calcification. | Pass. | |
| No calcification was | ||
| present in the | ||
| samples. | ||
| Cytotoxicity | Per ISO 10993-5 | |
| Test item considered non-cytotoxic if none of | ||
| cultures exposed to test item show greater than | ||
| mild reactivity (grade 2) | ||
| Lots tested for biological reactivity by exposing | ||
| mouse fibroblasts to a MEM elution of product. | Pass. | |
| None of the cultures | ||
| showed greater than | ||
| grade 2 of reactivity. | ||
| Skin Sensitization Study | ||
| (Saline & Cottonseed Oil | ||
| Extraction) | Per ISO 10993-10 | |
| No significant dermal contact sensitization. | ||
| Extract of EBM was tested for allergenic potential | ||
| via the guinea pig maximization test | Pass. | |
| All test animals | ||
| scored a 0 and had | ||
| no significant dermal | ||
| contact sensitization. | ||
| Irritation Study, | ||
| Intracutaneous Injection | ||
| (Saline & Cottonseed Oil | ||
| Extraction) | Per ISO 10993-10 | |
| Mean reaction scores for the test articles must be |