(258 days)
Not Found
No
The device description focuses on the material composition and physical properties of a nerve conduit, with no mention of computational analysis, algorithms, or learning processes. The performance study describes a clinical trial evaluating the physical device's efficacy and safety.
Yes
The device is intended for the repair of peripheral nerve injuries and is described as providing "protection of the neural environment" and acting as an "interface between the nerve and the surrounding tissue," indicating a therapeutic function in aiding recovery from injury.
No
Explanation: The device description states that Nerbridge™ is a product composed of polyglycolic acid and collagen, described as a "flexible, resorbable and semipermeable tubular membrane matrix filled with porous collagen that provides a non-constricting encasement for injured peripheral nerves for protection of the neural environment." This indicates it is a therapeutic device for nerve repair, not for diagnosing conditions.
No
The device description clearly states it is a physical product composed of polyglycolic acid and collagen, a tubular membrane matrix, and is provided in a sterile pouch. This indicates a hardware 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 for the repair of peripheral nerve injuries. This is a therapeutic intervention, not a diagnostic test performed in vitro (outside the body) on biological specimens.
- Device Description: The device is a physical implant designed to encase and protect injured nerves. It is not a reagent, instrument, or system used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances, or providing diagnostic information based on in vitro testing.
The device is a medical device intended for surgical implantation to aid in nerve repair.
N/A
Intended Use / Indications for Use
Nerbridge™ is intended 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 (comma separated list FDA assigned to the subject device)
JXI
Device Description
Nerbridge™ is a product composed of polyglycolic acid and collagen derived from porcine skin. Nerbridge™ is a flexible, resorbable and semipermeable tubular membrane matrix filled with porous collagen that provides a non-constricting encasement for injured peripheral nerves for protection of the neural environment. Nerbridge™ is designed to be an interface between the nerve and the surrounding tissue. When hydrated, Nerbridge™ is a pliable, soft, non-friable, porous conduit. The resilience of Nerbridge allows the product to recover and maintain closure without constricting the nerve once the device is placed around the nerve. Nerbridge™ is manufactured using validated viral inactivation and removal processes for the collagen. The product is provided in a foil pouch, sterile, nonpyrogenic, for single use only, in a variety of sizes, and placed in an outer Tyvek header bag for added protection.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral nerve, nerve, hand
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
A multi-center joint randomized evaluator-blinded comparative clinical study was conducted on the Nerbridge™ device where the Nerbridge™ device was used in 60 subjects at 20 trial sites with hand injuries. The primary efficacy endpoint was evaluated on the Full Analysis Set (58 subjects) and the Per Protocol Set (54 subjects). The control group consisted of 6 subjects implanted with an autogenous free nerve graft.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical study: A multi-center joint randomized evaluator-blinded comparative clinical study was conducted on the Nerbridge™ device where the Nerbridge™ device was used in 60 subjects at 20 trial sites with hand injuries. The primary efficacy endpoint was evaluated on the Full Analysis Set (58 subjects) and the Per Protocol Set (54 subjects). The control group consisted of 6 subjects implanted with an autogenous free nerve graft. The mean percentage of improvement in primary evaluation in the sensory function test by the Semmes-Weinstein method for the Nerbridge™ device was higher than that in the autogenous free nerve grafting group. The incidence of adverse events were lower for the Nerbridge™ device than the control. Therefore, the Nerbridge "" device is safe and effective for its intended use and substantially equivalent to the predicate devices.
Animal Study: An animal study was conducted in rabbit model to evaluate the performance and safety (local tissue effects) of the Nerbridge™ after nerve section and direct suture in the rabbit sciatic nerve. Nerbridge™ resorbed by day 72, there was evidence of nerve regeneration, and the histological reactions at the site of introduction of the device were slight.
Non-Clinical Tests:
- Suture retention strength: Acceptance criteria met
- Mechanical compression and rebound: Acceptance criteria met
- Porosity: Acceptance criteria met
- Permeability: Acceptance criteria met
- In vitro degradation: Acceptance criteria met
- Tensile strength: Acceptance criteria met
- pH: Acceptance criteria met
- Swelling rate: Acceptance criteria met
- Visual inspection: Acceptance criteria met
- Bending stiffness: Acceptance criteria met
- Endotoxin: Acceptance criteria met
Biocompatibility Testing:
- Cytotoxicity: Non-cytotoxic
- Sensitization: No evidence of sensitization
- Acute intracutaneous Reactivity: No evidence of irritation
- Acute Systemic Toxicity: No mortality or evidence of systemic toxicity
- Rabbit Pyrogen Study: No evidence of material-mediated pyrogenicity
- Hemolysis: No hemolytic activity
- Genotoxicity (Ames Mutagenicity Assay): No evidence of mutagenicity
- Genotoxicity (Mouse bone marrow micronucleus): No evidence of clastogenicity
- Genotoxicity (CHL/IU cells): No evidence of inducing chromosomal aberrations or polyploid cells
- Implantation Absorption: Absorption of material by 13 weeks. No inflammation observed
- Implantation (safety and performance): Protection during nerve repair. No fibrous peri-nervous tissue was observed after 3, 30 or 90 days.
- Subchronic / Chronic toxicity: No adverse tissue reaction to the implant up to 13 weeks of implantation; No systemic toxicity
Viral Inactivation Study: It was demonstrated that the inactivation steps reduced down the final viral load to the limit of detection.
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
§ 882.5275 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/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract symbol that resembles a stylized caduceus or a representation of the human profile in triplicate.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 22, 2016
Toyobo Co., Ltd. % James A. Boiani, MS, JD Official Correspondent Epstein Becker & Green, P.C. 1227 25th St. NW, Suite 700 Washington, DC 20037
Re: K152967
Trade/Device Name: Nerbridge™ Regulation Number: 21 CFR 882.5275 Regulation Name: Nerve Cuff Regulatory Class: Class II Product Code: JXI Dated: May 20, 2016 Received: May 23, 2016
Dear Mr. Boiani:
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
1
the quality systems (OS) 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 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/A
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) K152967
Device Name Nerbridge™
Indications for Use (Describe)
Nerbridge™ is intended 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.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(K) SUMMARY
The assigned 510(k) number is: K152967
1. Submitter's Identification:
Tovobo Co., Ltd. 2-8 Dojima Hama 2-chome, Kita-ku, Osaka 530-8230 Japan Tel: 81-6-6348-3336 Fax: 81-6-6348-3696 Contact: Mr. Yuta Kawakatsu
Date Summary Revised: June 21, 2016
2. Name of the Device:
Nerbridge™ Device Common Name: Cuff, Nerve Device Classification Name: Nerve Cuff Product Regulation Number: 21 CFR Part 882.5275 Product Code: JXI Requlatory Class: II Classification Panel: Neurology
3. Predicate Device Information:
4. Device Description:
Nerbridge™ is a product composed of polyglycolic acid and collagen derived from porcine skin. Nerbridge™ is a flexible, resorbable and semipermeable tubular membrane matrix filled with porous collagen that provides a non-constricting encasement for injured peripheral nerves for protection of the neural environment. Nerbridge™ is designed to be an interface between the nerve and the surrounding tissue. When hydrated, Nerbridge™ is a pliable, soft, non-friable, porous conduit. The resilience of Nerbridge allows the product to recover and maintain closure without constricting the nerve once the device is placed around the nerve. Nerbridge™ is manufactured using validated viral inactivation and removal processes for the collagen. The product is provided in a foil pouch, sterile, nonpyrogenic, for single use only, in a variety of sizes, and placed in an outer Tyvek header bag for added protection.
5. Indications for Use:
Nerbridge™ is intended 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.
4
6. Comparison to Predicate Devices:
| Device Name | Nerbridge™ | Neurotube™ | Cova™ORTHO-NERVE | ||
|---|---|---|---|---|---|
| Manufacturer | TOYOBO CO., LTD. | Neuroregen, LLC | Biom'Up S.A. | ||
| 510(k) No. | K152967 | K983007 | K103081 | ||
| Intended Use and Indications | |||||
| for Use | Nerbridge™ is | ||||
| intended 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. | The Neurotube™ is | ||||
| intended for single | |||||
| use in patients with | |||||
| an injury to a | |||||
| peripheral nerve in | |||||
| which the nerve gap | |||||
| is more than or | |||||
| equal to 8mm, but | |||||
| less than or equal to | |||||
| 3 cm. The nerve | |||||
| gap may be created | |||||
| primarily at the time | |||||
| of injury or created | |||||
| secondarily at the | |||||
| time of exploration | |||||
| of failed primary | |||||
| repair. | 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 | |||||
| Material | Synthetic | ||||
| polyester | Polyglycolic acid | ||||
| (PGA) | PGA | Contains no | |||
| Synthetic Polyester | |||||
| material | |||||
| Collagen | Type | I and III | None | I | |
| Origin | Porcine | None | Porcine | ||
| Shape | Cylindrical | Cylindrical | Membrane, rollable | ||
| if needed | |||||
| Physical structure | PGA conduit whose | ||||
| outer surface is | |||||
| coated by collagen | |||||
| and with inner | |||||
| porous collagen | PGA conduit | Collagen | |||
| membrane | |||||
| Device Name | NerbridgeTM | NeurotubeTM | CovaTMORTHO- | ||
| NERVE | |||||
| Sizes | ID: 0.5, 1.0, 1.5, 2.0, | ||||
| 2.5, 3.0, 3.5, 4.0mm | |||||
| Length: 30, 50 mm | ID: 2.0,3.0, 4.0, | ||||
| 8.0mm | |||||
| Length: 20, 40mm | Rectangular sheets | ||||
| of 15 x 25 mm, 20 x | |||||
| 30 mm, 30 x 40 mm | |||||
| and 40 x 60 mm | |||||
| Sterilization | Ethylene oxide | Ethylene oxide | Gamma irradiation | ||
| Clinical testing | Yes | Yes | No | ||
| Non-clinical animal testing | Yes | Unknown | Yes | ||
| Biocompatibility | ISO 10993 | Unknown | ISO 10993 | ||
| Suture | |||||
| retention | |||||
| strength | Yes | Unknown | Yes | ||
| Mechanical | |||||
| compression | |||||
| and rebound | Yes | Yes | Yes | ||
| Porosity | Yes | Unknown | Unknown | ||
| Permeability | Yes | Yes | Unknown | ||
| In vitro | |||||
| degradation | Yes | Yes | Yes | ||
| Performance | Tensile | ||||
| strength | Yes | Unknown | Yes | ||
| pH | Yes | Unknown | Yes | ||
| Swelling rate | Yes | Unknown | Yes | ||
| Visual | |||||
| inspection | Yes | Unknown | Unknown | ||
| Bending | |||||
| stiffness | Yes | Yes | Unknown | ||
| Endotoxin | Yes | Unknown | Yes | ||
| Packaging | Foil pouch within | ||||
| protective outer | |||||
| pouch | Double peel | ||||
| packages | Double peel | ||||
| packages | |||||
| Shelf Life | 3 years | 5 years | 24 months |
5
6
The Nerbridge™ and the predicate devices have the same intended use: to act as a conduit to assist the nerve in repairing itself following damage.
The Nerbridge™ and the predicate devices are sutured to the nerve and nerve tissue and surround the damaged nerve to protect the damaged area, allowing it to heal. At a high level, the subject and predicate devices are based on the following same technological elements:
- Provided or can be made into a cylindrical shape
- Flexible ●
- Smooth ●
- Wettable ●
- Resorbable material .
Certain technological differences exist between the subject and predicate devices as detailed in the above. In particular, the subject device is a PGA tube with an outer coating and internal filling of a porous Type I and III collagen blend; the Neurotube is a PGA tube that does not contain collagen; the Cova Ortho-Nerve is a Type I collagen membrane. While having some technological differences with the predicates, the Clinical and Non-Clinical tests performed on the Nerbridge™ show that it is safe and effective for its intended use and substantially equivalent to the predicate devices.
7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence:
The following functional performance verification and product characterization testing was conducted on finished sterile Nerbridge™ devices using known standards and/or clinically relevant criteria:
- Suture retention strength ●
- . Mechanical compression and rebound
- Porositv ●
- Permeability .
- In vitro degradation
- Tensile strength ●
- pH ●
- Swelling rate
- Visual inspection ●
- Bending stifffness ●
- Endotoxin
The testing supports and further characterizes Nerbridge™ that was studied in the Nerbridge™ Clinical Study, and shown to be clinically safe and effective for its intended use as a nerve conduit, and supporting substantial equivalence to other nerve conduits with the same intended use.
| Test | Test Method Summary | Results |
|---|---|---|
| Test | Test Method Summary | Results |
| Suture retention | ||
| strength | Testing according to ISO 7198:1998 | |
| Acceptance criteria: Suture must fail before the | ||
| Nerbridge | Acceptance | |
| criteria met | ||
| Mechanical | ||
| compression and | ||
| rebound | Testing according to JIS T0401:2013 | |
| Acceptance criteria: Nerbridge must maintain | ||
| mechanical strength after continuous | ||
| compression and rebound loading | Acceptance | |
| criteria met | ||
| Porosity | Testing according to ISO 845:2006 and JIS | |
| Z8807:2012 | ||
| Acceptance criteria: Porosity of Nerbridge must | ||
| be greater than or equal to porosity of PGA tube | ||
| alone | Acceptance | |
| criteria met | ||
| Permeability | Devices were filled with protein solution and then | |
| immersed in saline. At periods of time up to 96 | ||
| hours, saline was measured for protein particles | ||
| Acceptance criteria: Protein must permeate the | ||
| wall of the Nerbridge | Acceptance | |
| criteria met | ||
| In vitro | ||
| degradation | Testing according to ISO 15814:1999 and ISO | |
| 527-1:2012 | ||
| Acceptance criteria: Nerbridge must maintain a | ||
| tensile strength greater than that of suture for 8 | ||
| weeks | Acceptance | |
| criteria met | ||
| Tensile strength | Testing according to ISO 527-1:2012 | |
| Acceptance criteria: Nerbridge tensile strength is | ||
| at least as much as the predicate | Acceptance | |
| criteria met | ||
| pH | Testing according to JIS T 3211:2011 | |
| Acceptance criteria: Nerbridge satisfies the | ||
| acceptance criteria as specified in JIS T | ||
| 3211:2011 | Acceptance | |
| criteria met | ||
| Swelling rate | Testing according to ISO 10545-3:1995 | |
| Acceptance criteria: Swelling rate of Nerbridge | ||
| must be greater than or equal to swelling rate of | ||
| PGA tube alone | Acceptance | |
| criteria met | ||
| Visual inspection | Visual inspection with a magnifying glass | |
| Acceptance criteria: No observation of significant | ||
| streaks, wrinkles, uneven, scratches and cracks, | ||
| bubbles or other abnormalities | Acceptance | |
| criteria met | ||
| Test | Test Method Summary | Results |
| Bending stiffness | Testing according to JIS T0401:2013 | |
| Acceptance criteria: Bending stiffness of | ||
| Nerbridge must be greater than or equal to | ||
| bending stiffness of PGA tube alone | Acceptance | |
| criteria met | ||
| Endotoxin | Testing according to Japanese Pharmacopoeia | |
| 16th edition and FDA Guidance for Industry: | ||
| Pyrogen and Endotoxin Testing: Questions and | ||
| Answers (June 2012) | ||
| Acceptance criteria: Endotoxin level is less than | ||
| or equal to 20 EU/device | Acceptance | |
| criteria met |
7
8
Biocompatibility Testing
The biocompatibility evaluation for the Toyobo Nerbridge device was performed according to ISO 10993 to demonstrate that the device was both safe for implantation and establish substantial equivalence among the predicate device.
| Test | Test Method Summary | 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 System 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 |
9
| Test | Test Method Summary | Results |
|---|---|---|
| Genotoxicity | ISO Mouse bone marrow micronucleus with device extracts (saline and sesame oil extracts) | No evidence of clastogenicity |
| Genotoxicity | CHL/IU cells with device extracts (MEM & 10%CS/MEM) | No evidence of inducing chromosomal aberrations or polyploid cells |
| 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, 30 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 device. For the validation, different viruses were selected according to their physio-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.
8. Clinical Tests Performed
A multi-center joint randomized evaluator-blinded comparative clinical study was conducted on the Nerbridge™ device where the Nerbridge™ device was used in 60 subjects at 20 trial sites with hand injuries. The primary efficacy endpoint was evaluated on the Full Analysis Set (58 subjects) and the Per Protocol Set (54 subjects). The control group consisted of 6 subjects implanted with an autogenous free nerve graft. The mean percentage of improvement in primary evaluation in the sensory function test by the Semmes-Weinstein method for the Nerbridge™ device was higher than that in the autogenous free nerve grafting group. The incidence of adverse events were lower for the Nerbridge™ device than the control. Therefore, the Nerbridge "" device is safe
10
and effective for its intended use and substantially equivalent to the predicate devices.
9. Animal Tests Performed
An animal study was conducted in rabbit model to evaluate the performance and safety (local tissue effects) of the Nerbridge™ after nerve section and direct suture in the rabbit sciatic nerve. Nerbridge™ resorbed by day 72, there was evidence of nerve regeneration, and the histological reactions at the site of introduction of the device were slight.
10. Conclusions
The subject device, the Nerbridge™, has the same intended use as the predicate devices, Biom'Up SA. Cova ™ ORTHO-NERVE (K103081) and Neuroregen LLC, Neurotube™ (K983007). The Clinical and Non-Clinical testing supplied within our submission demonstrates that there are not any significant differences in their technological characteristics thereby not raising any new questions of safety and effectiveness. Therefore, the Nerbridge™ is substantially equivalent to the predicate devices, Biom'Up SA. CovaT™ ORTHO-NERVE (K103081) and Neuroregen LLC, Neurotube™ (K983007).