(500 days)
No
The device description and performance studies focus on the material properties and biological interactions of a collagen membrane, with no mention of AI or ML algorithms for analysis, diagnosis, or treatment.
Yes.
The device is intended for the repair of peripheral nerve injuries by acting as a barrier to guide healing, indicating a therapeutic purpose.
No
Explanation: The device is a resorbable collagen membrane indicated for the repair of peripheral nerve injuries. Its function is to act as a barrier for guided healing, not to diagnose a condition.
No
The device description clearly states it is a "pure collagen membrane" and describes its physical properties and manufacturing process, indicating it is a physical medical device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Description: The description of Cova™ORTHO-NERVE clearly states it is a "pure collagen membrane designed to be used as a barrier to allow guided healing along distinct anatomical planes." It is intended for the repair of peripheral nerve injuries within the body.
- Intended Use: The intended use is for the "repair of peripheral nerve injuries," which is a surgical or therapeutic intervention, not a diagnostic test performed on a sample.
The device is an implantable medical device used for surgical repair, not for diagnosing a condition by testing samples.
N/A
Intended Use / Indications for Use
Cova™ORTHO-NERVE is indicated for the repair of peripheral nerve injuries in which there is no gap or where a gap closure can be achieved by flexion of the extremity.
Product codes
JXI
Device Description
Cova™ORTHO-NERVE is a pure collagen membrane designed to be used as a barrier to allow guided healing along distinct anatomical planes. It is completely resorbable within a time frame that is compatible with healing. The membrane is obtained by standardized, controlled manufacturing processes. Cova™ORTHO-NERVE is further sterilized in double-pouches by gamma-irradiation.
Cova™ORTHO-NERVE membranes are designed to be resorbable, non inflammatory and biocompatible for uses to treat peripheral nerve injuries. When wetted, the membrane is conformable, elastic and easy to handle. It can be used alone or, if needed, it can be sutured in place. Cova™ORTHO-NERVE is provided in rectangular sheets of 15 x 25 mm, 20 x 30 mm, 30 x 40 mm and 40 x 60 mm. Furthermore, the device can be easily trimmed or shaped to the appropriate size, without tearing or fragmenting, to fit the zone to be treated.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral nerve
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)
Summary of Non-Clinical Data
Biocompatibility
Biocompatibility tests were selected in accordance with ISO-10993 - 1 (Biological Evaluation of Medical Devices) guidelines for a permanent implant in contact with tissue/bone. All studies were conducted pursuant to 21 CFR, Part 58, Good Laboratory Practices.
- Cytotoxicity: ISO Direct contact Cytotoxicity Assay - Non-cytotoxic
- Sensitization: ISO Guinea pig Maximization Test with device extracts (saline and sesame oil extracts) - No evidence of sensitization
- Acute Intracutaneous Reactivity: ISO Acute Intracutaneous Reactivity Test in rabbits with device extracts (saline and sesame oil extracts) - No evidence of irritation
- Acute Systemic Toxicity: ISO Acute Systemic Toxicity in Mice with device extracts (saline and sesame oil extracts) - No mortality or evidence of systemic toxicity
- Rabbit Pyrogen Study: USP Material-mediated Rabbit Pyrogen Test with saline extract of the device - No evidence of material-mediated pyrogenicity
- Hemolysis: Hemolysis Test by direct contact with human red blood cells - No hemolytic activity
- Genotoxicity: ISO Ames Mutagenicity Assay with device extracts (saline and ethanol extracts) - No evidence of mutagenicity
- Genotoxicity: ISO Mouse bone marrow micronucleus with device extracts (saline and sesame oil extracts) - No evidence of clastogenicity
- Implantation/Absorption: Subcutaneous implantation in rats - Absorption of material by 13 weeks, No inflammation observed
- Implantation (safety and performance): In vivo safety and performance study in rats after 3, 30 and 90 days - Protection during nerve repair, No fibrous peri-nervous tissue was observed after 3, 60 or 90 days.
- Subchronic / chronic toxicity: 13-Week systemic toxicity and local Tolerance Study in rats following subcutaneous implantation - No adverse tissue reaction to the implant up to 13 weeks of implantation, No systemic toxicity
Viral Inactivation Study
Viral Inactivation steps were validated for collagen extracted from tissues used in the manufacture of the membranes. For the validation, different viruses were selected according to their physico-chemical resistance and representativeness. The viral inactivation steps are routinely performed in process using appropriate treatment. It was demonstrated that the inactivation steps reduced down the final viral load to the limit of detection.
Bench Test
In vitro bench tests were conducted on final product to demonstrate the safety and effectiveness of the device, and to demonstrate that the device performs as it is intended. The following tests were performed and were found to meet the similar specifications as a predicate.
- -Color, odor, feel Inspection
- -Dimensional Inspection
- -Edge Verification
- Suture strength Verification -
- -Tensile strength Verification
- pH Verification
- UV Spectra Verification to determine the purity of the raw material -
- Enzymatic Degradation Verification .
- -Swelling Rate Verification
- -Compression and Kinking
Moreover, Endotoxin (Limulus Amebocyte Lysate Test) testing is routinely performed on the final device to conform to the endotoxin limit of 20 EU/device.
Animal Study
An animal study was conducted in rat model to evaluate the performance and safety (local tissue effects) of the Cova™ORTHO-NERVE membrane after nerve section and direct suture in the rat peroneal nerve. No fibrous peri-nervous tissue was observed after 3, 60 or 90 days. The membrane also demonstrated its ability to confer a protective environment for the repaired nerve. Time for re-intervention was also lowered.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Collagen Nerve Wrap (K060952), NeuraWrap™ (K041620), NeuroGen™ (K011168)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5275 Nerve cuff.
(a)
Identification. A nerve cuff is a tubular silicone rubber sheath used to encase a nerve for aid in repairing the nerve (e.g., to prevent ingrowth of scar tissue) and for capping the end of the nerve to prevent the formation of neuroma (tumors).(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/21 description: The image shows the logo for Biom'up Advanced Biomaterials. The logo features the word "biom'up" in a bold, sans-serif font, with the "up" portion slightly smaller and raised. Above the word is a wavy line composed of small, vertical bars. Below the word is the text "ADVANCED BIOMATERIALS" in a smaller, sans-serif font.
MAR - 2 2012
510(k) Summary
Submitter's name and address: Biom'Up S.A. 8. Allee Irene Joliot-Curie 69800, Saint-Priest, France
Contact person:
Valerie Centis. R&D Project Manager and Regulatory Affairs
Biom'Up S.A.S 8, Allee Irene Joliot-Curie 69800, Saint-Priest, France Phone: +33 (0)4 86 57 36 10 Fax: +33 (0)4 37 69 00 84 Email: regulatory.affairs@biomup.com
Date Summary was prepared:
Trade/Proprietary Name:
Classification Name: Product Code: Regulation Number: Device Classification:
Predicate Devices
March 2nd, 2012
Cova™ORTHO-NERVE
Nerve Cuff JXI 21 CFR 882.5275 Class II
Collagen Nerve Wrap (K060952) NeuraWrap™ (K041620) NeuroGen™ (K011168)
Device Description
Cova™ORTHO-NERVE is a pure collagen membrane designed to be used as a barrier to allow guided healing along distinct anatomical planes. It is completely resorbable within a time frame that is compatible with healing. The membrane is obtained by standardized, controlled manufacturing processes. Cova™ORTHO-NERVE is further sterilized in double-pouches by gamma-irradiation.
Cova™ORTHO-NERVE membranes are designed to be resorbable, non inflammatory and biocompatible for uses to treat peripheral nerve injuries. When wetted, the membrane is conformable, elastic and easy to handle. It can be used alone or, if needed, it can be
1
Image /page/1/Picture/0 description: The image shows the logo for "biom'up ADVANCED BIOMATERIALS". Above the company name is a graphic of a wave made up of small dots. The company name is in bold, and the words "ADVANCED BIOMATERIALS" are in a smaller font size.
sutured in place. Cova™ORTHO-NERVE is provided in rectangular sheets of 15 x 25 mm, 20 x 30 mm, 30 x 40 mm and 40 x 60 mm. Furthermore, the device can be easily trimmed or shaped to the appropriate size, without tearing or fragmenting, to fit the zone to be treated.
Intended Use
Cova™ORTHO-NERVE is indicated for the repair of peripheral nerve injuries in which there is no gap or where a gap closure can be achieved by flexion of the extremity.
Basis for Substantial Equivalence
The intended use, product design, composition, physical structure and target population of Cova™ORTHO-NERVE resorbable collagen membranes are substantially equivalent to the FDA cleared and legally marketed predicate devices Collagen Nerve Wrap (K060952), NeuraWrap™ (K041620) and NeuroGen™ (K011168). Similarities are presented in Table 1.
2
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Table 1. Comparison of Cova™ORTHO-NERVE with the predicate devices
| Medical Device | Cova™ ORTHO-NERVE | Collagen Nerve Wrap | NeuraWrap™ Nerve Protector | NeuroGen™ Nerve Guide |
|---|---|---|---|---|
| 510(k) | ||||
| Class | K103081 (tbd) | |||
| JXI | K060952 | |||
| JXI | K041620 | |||
| JXI | K011168 | |||
| JXI | ||||
| Composition | ||||
| Origin | Type I Collagen | |||
| Porcine | Type I collagen | |||
| Bovine | Type I collagen | |||
| Bovine | Type I collagen | |||
| Bovine | ||||
| Intended use | Indicated for the repair of peripheral | |||
| nerve injuries in which there is no gap | ||||
| or where a gap closure can be achieved | ||||
| by flexion of the extremity. | Indicated for the management of peripheral nerve | |||
| injuries in which there has been no substantial loss of | ||||
| nerve tissue and where gap closure can be achieved | ||||
| by flexion of the extremity. | Indicated for the management of peripheral | |||
| nerve injuries in which there has been no | ||||
| substantial loss of nerve tissue. | Indicated for the repair of peripheral nerve | |||
| discontinuities where gap closure can be | ||||
| achieved by flexion of the extremity. | ||||
| Characteristics | Membrane, rollable if needed | |||
| Easy to manipulate | ||||
| Flexible | ||||
| Smooth | ||||
| Wettable | ||||
| Hemostatic | ||||
| Cell-occlusive | Pre-rolled membrane | |||
| Easy to manipulate | ||||
| Flexible | ||||
| Smooth | ||||
| Wettable | ||||
| Hemostatic | ||||
| Cell-occlusive | Pre-rolled membrane | |||
| Easy to manipulate | ||||
| Flexible | ||||
| Smooth | ||||
| Wettable | ||||
| Hemostatic | ||||
| Cell-occlusive | Tubular | |||
| Easy to manipulate | ||||
| Flexible | ||||
| Smooth | ||||
| Wettable | ||||
| Hemostatic | ||||
| Cell-occlusive | ||||
| Biocompatibility | Established | Established | Established | Established |
| Non-pyrogenic | Yes | Yes | Yes | Yes |
| Resorbable | Yes | Yes | Yes | Yes |
| Suturable | Yes | Yes | Yes | Yes |
| Sterilization | Gamma irradiation | Gamma irradiation | Ethylene Oxide (EtO) | Ethylene Oxide (EtO) |
| Reusable | Single-use | Single-use | Single-use | Single-use |
| Shelf-life | 24 months | 36 months | 36 months | 36 months |
| Packaging | Double-peel packages | Double-peel packages | Double-peel packages | Double-peel packages |
ಗಾ
3
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Any differences in technological characteristics between the Cova™ORTHO-NERVE and the predicate devices do not raise any new issues of safety or efficacy. The performance and safety of the material used was evaluated. The collective results have demonstrated that the Cova™ORTHO-NERVE is substantially equivalent to the respective predicate devices with regard to safety and efficacy.
Summary of Non-Clinical Data
Biocompatibility
Biocompatibility tests were selected in accordance with ISO-10993 - 1 (Biological Evaluation of Medical Devices) guidelines for a permanent implant in contact with tissue/bone. All studies were conducted pursuant to 21 CFR, Part 58, Good Laboratory Practices. The table 2 provides a summary of the biocompatibility test results and conclusions.
| Test | Test Method | Results |
|---|---|---|
| Cytotoxicity | ISO Direct contact Cytotoxicity | |
| Assay | Non-cytotoxic | |
| Sensitization | ISO Guinea pig Maximization Test | |
| with device extracts (saline and | ||
| sesame oil extracts) | No evidence of sensitization | |
| Acute Intracutaneous | ||
| Reactivity | ISO Acute Intracutaneous | |
| Reactivity Test in rabbits with | ||
| device extracts (saline and | ||
| sesame oil extracts) | No evidence of irritation | |
| Acute Systemic Toxicity | ISO Acute Systemic Toxicity in | |
| Mice with device extracts (saline | ||
| and sesame oil extracts) | No mortality or evidence of systemic | |
| toxicity | ||
| Rabbit Pyrogen Study | USP Material-mediated Rabbit | |
| Pyrogen Test with saline extract | ||
| of the device | No evidence of material-mediated | |
| pyrogenicity | ||
| Hemolysis | Hemolysis Test by direct contact | |
| with human red blood cells | No hemolytic activity | |
| Genotoxicity | ISO Ames Mutagenicity Assay | |
| with device extracts (saline and | ||
| ethanol extracts) | No evidence of mutagenicity | |
| Genotoxicity | ISO Mouse bone marrow | |
| micronucleus with device extracts | ||
| (saline and sesame oil extracts) | No evidence of clastogenicity |
Table 2: Biocompatibility Testing Summary for Cova™ORTHO-NERVE
4
Image /page/4/Picture/0 description: The image shows the logo for "biom'up ADVANCED BIOMATERIALS". Above the word "biom'up" is a graphic of a series of vertical lines that are arranged in a wave-like pattern. The word "biom'up" is in a bold, sans-serif font, and the words "ADVANCED BIOMATERIALS" are in a smaller, sans-serif font below the word "biom'up".
| Implantation/Absorption | Subcutaneous implantation in
rats | Absorption of material by 13 weeks
No inflammation observed |
|------------------------------------------|----------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|
| Implantation (safety and
performance) | In vivo safety and performance
study in rats after 3, 30 and 90
days | Protection during nerve repair
No fibrous peri-nervous tissue was
observed after 3, 60 or 90 days. |
| Subchronic / chronic
toxicity | 13-Week systemic toxicity and
local Tolerance Study in rats
following subcutaneous
implantation | No adverse tissue reaction to the
implant up to 13 weeks of
implantation
No systemic toxicity |
Viral Inactivation Study
Viral Inactivation steps were validated for collagen extracted from tissues used in the manufacture of the membranes. For the validation, different viruses were selected according to their physico-chemical resistance and representativeness. The viral inactivation steps are routinely performed in process using appropriate treatment. It was demonstrated that the inactivation steps reduced down the final viral load to the limit of detection.
Bench Test
In vitro bench tests were conducted on final product to demonstrate the safety and effectiveness of the device, and to demonstrate that the device performs as it is intended. The following tests were performed and were found to meet the similar specifications as a predicate.
- -Color, odor, feel Inspection
- -Dimensional Inspection
- -Edge Verification
- Suture strength Verification -
- -Tensile strength Verification
- pH Verification
- UV Spectra Verification to determine the purity of the raw material -
- Enzymatic Degradation Verification .
- -Swelling Rate Verification
- -Compression and Kinking
Moreover, Endotoxin (Limulus Amebocyte Lysate Test) testing is routinely performed on the final device to conform to the endotoxin limit of 20 EU/device.
5
Image /page/5/Picture/0 description: The image shows the logo for Biom'up Advanced Biomaterials. The logo features the word "biom'up" in a bold, sans-serif font, with the apostrophe slightly raised. Above the word is a wavy line made up of small, vertical lines that get progressively shorter towards the ends. Below the word is the text "ADVANCED BIOMATERIALS" in a smaller, sans-serif font.
Animal Study
An animal study was conducted in rat model to evaluate the performance and safety (local tissue effects) of the Cova"*ORTHO-NERVE membrane after nerve section and direct suture in the rat peroneal nerve. No fibrous peri-nervous tissue was observed after 3, 60 or 90 days. The membrane also demonstrated its ability to confer a protective environment for the repaired nerve. Time for re-intervention was also lowered.
Conclusion
Cova™ORTHO-NERVE Resorbable Collagen Membrane is substantially equivalent to its predicate devices: Collagen Nerve Wrap, NeuraWrap™ and NeuroGen™.
6
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is positioned to the right of a circular seal that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Biom'up Sas c/o Valerie Centis, Ph.D. R&D Project Manager and Regulatory Affairs 8, Allee Irene Joliot-Curie St-Priest, France 69800
MAR - 2 2012
Re: K103081
Trade/Device Name: Cova™ ORTHO-NERVE Regulation Number: 21 CFR 882.5275 Regulation Name: Nerve Cuff Regulatory Class: Class II Product Code: JXI Dated: December 21, 2011 Received: December 22, 2011
Dear Dr. Centis:
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 1 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.
7
Page 2 - Valerie Centis, Ph.D.
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 device-related 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance 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,
Quchan for
Malvina B. Eydelman, I Director Division of Ophthalmic, Neurological, and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
8
Indications for Use
510(k) Number (if known): 长 | 0 3 0 8 |
Cova™ORTHO-NERVE Device Name:
Indications for Use:
Indicated for the repair of peripheral nerve injuries in which there is no gap or where a gap closure can be achieved by flexion of the extremity.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) ૮ ઉન
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K103081
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