(177 days)
No
The device description and performance studies focus on the material properties and biological response of a bovine pericardial patch, with no mention of AI or ML.
No.
The device is intended to function as a surgical patch material to close dura mater, which is a structural repair rather than a therapeutic treatment.
No.
The device is a surgical patch material intended to close dura mater during neurosurgery, which is a therapeutic function rather than a diagnostic one.
No
The device description clearly states it is a physical patch made of bovine pericardial tissue, treated and packaged. There is no mention of software as a component or the primary function of the device.
Based on the provided information, the DuraSure Biologic Patch is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "close dura mater during neurosurgery." This is a surgical procedure performed in vivo (within the living body).
- Device Description: The device is a physical patch made of bovine pericardial tissue, designed to be implanted to repair a natural organ.
- Lack of In Vitro Testing: The performance studies described involve physical property testing (tensile, burst, suture retention, thickness) and an in vivo animal study. There is no mention of testing biological samples (blood, tissue, etc.) outside the body to diagnose or monitor a condition.
- No Mention of Diagnostic Purpose: The device's function is to physically repair tissue, not to provide information about a patient's health status through analysis of biological samples.
IVD devices are typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The DuraSure Biologic Patch does not fit this description.
N/A
Intended Use / Indications for Use
The DuraSure Biologic Patch is intended for use as a surgical patch material to close dura mater during neurosurgery.
Product codes (comma separated list FDA assigned to the subject device)
GXQ
Device Description
The DuraSure consists of one piece of bovine pericardial tissue that has been selected for minimal tissue blemishes. The tissue is treated with a glutaraldehyde process which crosslinks the collagen fibers and minimizes antigenicity. The DuraSure is liquid chemical sterilized and packaged in a plastic jar containing sterile glutaraldehyde storage solution. The DuraSure is designed to repair the body's natural organs.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
dura mater (during neurosurgery)
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)
Functional/Safety Testing: The verification activities conducted indicate that DuraSure biologic patch meets the product performance requirements of the device specifications and does not raise any additional safety issues.
Sterilization: DuraSure biologic patch is chemically sterilized according to ISO14160: 2011, "Sterilization of health care products -- Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives -- Requirements for characterization, development, validation and routine control of a sterilization process for medical devices".
Biocompatibility: The material for DuraSure Biologic Patch is bovine pericardium. It is identical to that in the predicate device and the reference device which have established biocompatibility. This submission is to expand the indication with no change to product design, materials, or manufacturing processes.
Summary of Product Testing: The following tests have been completed to evaluate the safety and performance of the DuraSure Biologic Patch when compared with the predicate device:
• Tensile test
• Burst strength test
• Suture retention test
• Thickness measurement
Summary of Pre-clinical Study:
Study type: Animal Study (in-vivo rabbit model)
Sample size: Forty nine (49) rabbits
Description: The purpose of this animal study was to assess the local tissue response to implantation following 1, 8, and 26-week brain dural repair/neural implantation in rabbits compared to a predicate control to satisfy ISO 10993-6, Annex D, Tests for local effects after implantation and US-FDA Guidance Document for Dura Substitutes Devices, Section XI, 2000.
Forty nine (49) rabbits received single dural defects of approximately 0.6 cm x 0.6 cm. Test or control article were sutured in place to cover each dural defect. The bone flap was replaced, the dermal incisions were surgically closed, and animals were recovered and returned to standard housing. Animals were observed closely and weighed weekly to as one measure of general clinical health. After 1, 8, or 26 weeks post-surgery, animals were humanely euthanized and draining lymph nodes and the whole skull with brain was excised and placed in formalin. The formalin-fixed lymph nodes and implant sites were processed by histopathology techniques, using decalcification (as needed) and paraffin embedding. Resulting lymph node slides were stained with H&E. The dura/brain sections were treated with H&E, Fluoro-Jade, Luxol Fast Blue, anti-GFAP (glial fibrillary acidic protein) and anti-Iba-1 immunostaining on slides. All slides were evaluated by a veterinary pathologist for neuropathological changes in brain tissue, dural integrity, neoduralization and local tissue reaction according to ISO 10993-6 and FDA Guidance.
Key Results: The overall conclusion of the control and test article brain dural repair local effect evaluation based on in vivo and terminal evaluations, including an extensive histopathological evaluation of the implantation site, adjoining areas and draining lymph nodes, is that the implantation and dural repair surgery was successful and the test article is locally non-toxic. This applies to evaluations of animals exposed for 1, 8 or 26-weeks. General clinical evaluations/cageside observations, neurophysiological evaluations and body weights provide no evidence supporting an adverse effect of the surgery, control material or test article. These conclusions are supported by macroscopic evaluations and microscopic evaluations with scoring. Resorption of the test article or control article was minimal at the last exposure time evaluated. Adhesions at or near the repair site were noted, especially at one week exposure, and evidence of hydrocephaly was also noted, especially at 1 and 8 week exposure, however neither were associated with any pathology or adverse effects. From this investigation, it appears that the test and control articles performed equivalently in the in-vivo rabbit model of dural repair.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Tensile: All DuraSure patches passed the acceptance criteria of ≥ 2 MPa. The mean of tensile strength of DuraSure patch was measured as 11.9 MPa.
Elongation: All DuraSure patches passed the acceptance criteria of 550% elongation. The mean of elongation of DuraSure patch was measured as 25%.0.75 mm.
Burst strength: All DuraSure patches passed the acceptance criteria of ≥ 12 PSI. The mean of burst strength of DuraSure patch was measured as 127 PSI.
Suture retention: All DuraSure patches passed the acceptance criteria of ≥ 300 gf. The mean of suture retention of DuraSure patch was measured as 970 gf.
Thickness: All DuraSure patches passed acceptance criteria of 0.35
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.
Dura-Guard Dura Repair Patch K973706
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.
XenoSure Biologic Patch K040835
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).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 13, 2019
LeMaitre Vascular Inc. Xiang Zhang Vice President of Regulatory Affairs 63 Second Ave Burlington, Massachusetts 01803
Re: K183513
Trade/Device Name: DuraSure Biologic Patch Regulation Number: 21 CFR 882.5910 Regulation Name: Dura Substitute Regulatory Class: Class II Product Code: GXQ Dated: May 8, 2019 Received: May 14, 2019
Dear Xiang Zhang:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Matthew Krueger, M.S.E Assistant Director DHT5A: Division of Neurosurgical. Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K183513
Device Name DuraSure Biologic Patch
Indications for Use (Describe)
The DuraSure Biologic Patch is intended for use as a surgical patch material to close dura mater during neurosurgery.
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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510k Summary K183513
| Submitter's Information | |
|---|---|
| Name: | LeMaitre Vascular, Inc. |
| Address: | 63 Second Avenue, Burlington, MA 01803 |
| Phone: | 781-425-1706 |
| Fax: | 781-425-5049 |
| Contact Person: | Xiang (Vic) Zhang |
| VP of Regulatory Affairs | |
| LeMaitre Vascular, Inc. | |
| Email: xzhang@lemaitre.com | |
| Date Prepared: | May 8, 2019 |
| Device Name: | DuraSure Biologic Patch |
| Trade Name: | DuraSure Biologic Patch |
| Common Name: | Dura Substitute |
| Regulation Number: | 21CFR §882.5910 |
| Classification Panel: | Neurology |
| Class: | II (2) |
| Product Code: | GXQ |
| Establishment | |
| Registration: | 1220948 |
| Establishment: | 63 Second Avenue |
| Burlington, MA 01803 | |
| Predicate Device: | Dura-Guard Dura Repair Patch K973706 |
| Reference Device: | XenoSure Biologic Patch K040835 |
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| Device Description: | The DuraSure consists of one piece of bovine pericardial tissue that has been selected for minimal tissue blemishes. The tissue is treated with a glutaraldehyde process which crosslinks the collagen fibers and minimizes antigenicity. The DuraSure is liquid chemical sterilized and packaged in a plastic jar containing sterile glutaraldehyde storage solution. The DuraSure is designed to repair the body's natural organs. | ||
|---|---|---|---|
| Indication for Use: | The DuraSure Biologic Patch is intended for use as a surgical patch material to close dura mater during neurosurgery. | ||
| Summary of Technological | |||
| Characteristics: | Comparisons of the DuraSure Biologic Patch with the predicate Dura-Guard Patch show that technological characteristics such as materials, biocompatibility, performance, and sterilization of the proposed device are substantially equivalent to the predicate device. The difference between the proposed device and the predicate device is: The DuraSure biologic patch is stored in glutaraldehyde solution and the Dura-Guard is stored in propylene oxide solution. This difference does not raise additional risk concern because DuraSure biologic patch has satisfactory biocompatibility results and in-vivo animal study results. | ||
| Proposed Device | Predicate Device | Comparison | |
| Product Name: | |||
| DuraSure Biologic Patch | Product Name: | ||
| Dura-Guard Patch | |||
| Manufacturer | LeMaitre Vascular Inc. | Synovis/Baxter | |
| Clearance | This submission | K973706 | |
| Indications for | |||
| Use | The XenoSure Dura Biologic | ||
| Patch is intended for use as a | |||
| surgical patch material to | |||
| close dura mater during | |||
| neurosurgery. | For use as a dura | ||
| substitute for the | |||
| closure of dura mater | |||
| during neurosurgery. | Same | ||
| Common Name | Dura Substitute | Dura Substitute | Same |
| Classification | II (2) | II (2) | Same |
| Regulation | |||
| Number | 882.5910 | 882.5910 | Same |
| Product Code | GXQ | GXQ | Same |
| Materials | Bovine pericardium | Bovine pericardium | Same |
| Sterility | Chemical sterilization with 106 SAL | Chemical sterilization with 10-6 SAL | Same |
| Single Use | Yes | Yes | Same |
| Medical | |||
| Specialists | Neurology | Neurology | Same |
| Packaging | Jar/Lid | Jar/Lid | Same |
| Storage solution | 0.2% glutaraldehyde | 1% propylene oxide | Different |
| Functional/Safety Testing: | The verification activities conducted indicate that DuraSure biologic patch meets the product performance requirements of the device specifications and does not raise any additional safety issues. | ||
| Sterilization: | DuraSure biologic patch is chemically sterilized according to ISO14160: 2011, "Sterilization of health care products -- Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives -- Requirements for characterization, development, validation and routine control of a sterilization process for medical devices". | ||
| Biocompatibility: | The material for DuraSure Biologic Patch is bovine pericardium. It is identical to that in the predicate device and the reference device which have established biocompatibility. This submission is to expand the indication with no change to product design, materials, or manufacturing processes. | ||
| Summary of Product Testing: | The following tests have been completed to evaluate the safety and performance of the DuraSure Biologic Patch when compared with the predicate device: | ||
| • Tensile test | |||
| • Burst strength test | |||
| • Suture retention test | |||
| • Thickness measurement | |||
| Test | Test method summary | Results | |
| Tensile | Use Instron pull the sample until it fails. Record the ultimate tensile strength in MPa. | All DuraSure patches passed the acceptance criteria of ≥ 2 MPa. The mean of tensile strength of the predicate device was | |
| of tensile strength of DuraSure | |||
| patch was measured as 11.9 | |||
| MPa. | |||
| Elongation | Use Instron pull the sample until it | ||
| fails. Record the elongation at the | |||
| failure as percent of the original sample | |||
| length. | All DuraSure patches passed the | ||
| acceptance criteria of 5~50% | |||
| elongation. The mean of | |||
| elongation of the predicate | |||
| device was measured as 32%. | |||
| The mean of elongation of | |||
| DuraSure patch was measured as | |||
| 25%. | |||
| Burst strength | Sample is secured in the testing fixture | ||
| as a membrane between two chambers. | |||
| One side of the sample is slowly | |||
| pressurized using water. Record the | |||
| pressure at the time of burst or leak. | All DuraSure patches passed the | ||
| acceptance criteria of ≥ 12 PSI. | |||
| The mean of burst strength of | |||
| the predicate device was | |||
| measured as 59 PSI. The mean | |||
| of burst strength of DuraSure | |||
| patch was measured as 127 PSI. | |||
| Suture retention | Make sutures on the edge of the patch. | ||
| Pull the suture using Instron until either | |||
| patch or suture fail. Record the force at | |||
| the failure. | All DuraSure patches passed the | ||
| acceptance criteria of ≥ 300 gf. | |||
| The mean of suture retention of | |||
| the predicate device was | |||
| measured as 978 gf. The mean | |||
| of suture retention of DuraSure | |||
| patch was measured as 970 gf. | |||
| Thickness | Measure the thickness of the patch | ||
| using a thickness gauge | All DuraSure patches passed | ||
| acceptance criteria of 0.35~0.75 | |||
| mm. The thickness of the | |||
| predicate device was measured | |||
| between 0.32~0.71 mm. |
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7
| Summary of Pre-clinical Study: | The purpose of this animal study was to assess the local tissue response to implantation following 1, 8, and 26-week brain dural repair/neural implantation in rabbits compared to a predicate control to satisfy ISO 10993-6, Annex D, Tests for local effects after implantation and US-FDA Guidance Document for Dura Substitutes Devices, Section XI, 2000.
Forty nine (49) rabbits received single dural defects of approximately 0.6 cm x 0.6 cm. Test or control article were sutured in place to cover each dural defect. The bone flap was replaced, the dermal incisions were surgically closed, and animals were recovered and returned to standard housing. Animals were observed closely and weighed weekly to as one measure of general clinical health. After 1, 8, or 26 weeks post-surgery, animals were humanely euthanized and draining lymph nodes and the whole skull with brain was excised and placed in formalin. The formalin-fixed lymph nodes and implant sites were processed by histopathology techniques, using decalcification (as needed) and paraffin embedding. Resulting lymph node slides were stained with H&E. The dura/brain sections were treated with H&E, Fluoro-Jade, Luxol Fast Blue, anti-GFAP (glial fibrillary acidic protein) and anti-Iba-1 immunostaining on slides. All slides were evaluated by a veterinary pathologist for neuropathological changes in brain tissue, dural integrity, neoduralization and local tissue reaction according to ISO 10993-6 and FDA Guidance.
The overall conclusion of the control and test article brain dural repair local effect evaluation based on in vivo and terminal evaluations, including an extensive histopathological evaluation of the implantation site, adjoining areas and draining lymph nodes, is that the implantation and dural repair surgery was successful and the test article is locally non-toxic. This applies to evaluations of animals exposed for 1, 8 or 26-weeks. General |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion: | clinical evaluations/cageside observations, neurophysiological evaluations and body weights provide no evidence supporting an adverse effect of the surgery, control material or test article. These conclusions are supported by macroscopic evaluations and microscopic evaluations with scoring. Resorption of the test article or control article was minimal at the last exposure time evaluated. Adhesions at or near the repair site were noted, especially at one week exposure, and evidence of hydrocephaly was also noted, especially at 1 and 8 week exposure, however neither were associated with any pathology or adverse effects. From this investigation, it appears that the test and control articles performed equivalently in the in-vivo rabbit model of dural repair. LeMaitre Vascular has demonstrated that DuraSure Biologic Patch is substantially equivalent to the predicate devices based on its intended use and fundamental scientific technology. |
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