(552 days)
Not Found
No
The device description and performance studies focus on the material properties and biological integration of a collagen membrane for nerve repair. There is no mention of any computational analysis, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device provides a scaffold for nerve healing and protection, aiming to directly treat and repair peripheral nerve injuries.
No
Explanation: The device, the NervAlign® Nerve Cuff, is a collagen membrane matrix intended for the repair of peripheral nerve injuries. Its function is to provide a scaffold for nerve healing and protection, not to diagnose a condition.
No
The device description clearly states it is a collagen membrane matrix derived from porcine pericardium, which is a physical, implantable material, not software.
Based on the provided information, the NervAlign® Nerve Cuff is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the repair of peripheral nerve injuries by providing a scaffold and protection during healing. This is a therapeutic intervention performed in vivo (within the body).
- Device Description: The device is a collagen membrane matrix intended for implantation. This is a medical device used for structural support and tissue regeneration in vivo.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The NervAlign® Nerve Cuff does not perform any such function. It is implanted directly into the patient's body.
Therefore, the NervAlign® Nerve Cuff is a medical device used for surgical repair, not an IVD.
N/A
Intended Use / Indications for Use
The NervAlign® Nerve Cuff is indicated for the repair of peripheral nerve injuries in which there is no gap or where a gap closure is achieved by flexion of the extremity.
Product codes (comma separated list FDA assigned to the subject device)
JXI
Device Description
The NervAlign® Nerve Cuff is a collagen membrane matrix derived from porcine pericardium. It is a sterile, whitish to light beige colored, freeze-dried, pre-cut, flat sheet of acellular collagen. The NervAlign® Nerve Cuff is available in three (3) different sizes: 10x10mm, 20x30mm and 30x40mm.
The collagen material that comprises the Nerve Cuff is derived from the same species as that of the predicate nerve cuff (AxoGuard Nerve Protector; K132660) manufactured by Cook Biotech Incorporated.
Like the predicate, the NervAlign® Nerve Cuff is implanted providing a scaffold which becomes infiltrated by the patient's cells and is remodelled into native tissue. The Nerve Cuff provides protection of the damaged nerve while the nerve heals.
The NervAlign® Nerve Cuff is packaged in a dried state, is for single use and provided sterile.
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)
The following testing was performed on the ReNerve NervAlign® Nerve Cuff.
Suture retention strength
- Test Method Summary: A suture was placed through aged and unaged devices and the force required to pull free was measured.
- Results: Test was completed and met specification. Like predicate the device has sufficient strength for its intended use.
Thickness
- Test Method Summary: Direct measurement of the device with micrometer when hydrated according to IFU.
- Results: Thickness measurements of device showed substantially equivalent to predicate.
Tensile Strength
- Test Method Summary: Direct measurement of the device. Device placed between two grips and the separation force required to reach device failure was measured.
- Results: Test was completed and met specification. Like predicate device is suitable for intended use.
Cytotoxicity
- Test Method Summary: The device was evaluated for potential cytotoxic effects using a mammalian cell line following ISO 10993-5 guidelines.
- Results: The test article extract showed no cytotoxic potential.
Sensitization
- Test Method Summary: The device was evaluated for the potential to cause delayed dermal contact sensitization in guinea pigs based on ISO 10993-10.
- Results: Extracts of the test article showed no evidence of inducing delayed contact sensitization in the guinea pig.
Acute intracutaneous reactivity (Irritation)
- Test Method Summary: The device was evaluated for the potential to cause irritation following intracutaneous injection in rabbits based on ISO 10993-10.
- Results: Extracts of the test article show no evidence of irritation.
Acute systemic toxicity
- Test Method Summary: The device was evaluated for acute systemic toxicity in mice based on ISO 10993-11.
- Results: No mortality or evidence of systemic toxicity from both extracts, injected into mice.
Pyrogenicity
- Test Method Summary: The device was evaluated for the potential to induce a pyrogenic response following intravenous injection in rabbits. Study conducted according to the United States Pharmacopeia (USP 41 - NF36, General Chapter ).
- Results: The test article met the requirements and is judged non-pyrogenic.
Hemolysis
- Test Method Summary: The device was evaluated for hemolytic potential when in contact with blood based on ASTM F756 and requirements of ISO 10993-4.
- Results: The direct contact of the test article was slightly hemolytic. The extracts at 25, 12.5 and 6.25% were non-hemolytic. Device is suitable for intended indication.
Genotoxicity (AMES)
- Test Method Summary: The device was evaluated for the potential to induce reverse mutations in Salmonella typhimurium and Escherichia coli tester strains per ISO 10993-3.
- Results: Extracts of the device were considered to be non-mutagenic to tester strains.
Genotoxicity (mouse lymphoma assay)
- Test Method Summary: The device was evaluated to determine its mutagenic potential using the mouse lymphoma forward gene mutation assay per ISO 10993-3.
- Results: Test article considered non-mutagenic.
Endotoxin
- Test Method Summary: Bacterial endotoxin testing is conducted per USP 85 and European Pharmacopoeia 2.6.14
- Results: Device is produced and released with endotoxin level
§ 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/0 description: The image contains 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.
February 10, 2022
Renerve Ltd % Chris Sloan President Sloan Regulatory Consulting LLC 322 Hart Road Gaithersburg, Maryland 20878
Re: K202234
Trade/Device Name: NervAlign Nerve Cuff Regulation Number: 21 CFR 882.5275 Regulation Name: Nerve Cuff Regulatory Class: Class II Product Code: JXI Dated: January 10, 2022 Received: January 11, 2022
Dear Chris Sloan:
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,
Adam D. Pierce, Ph.D. 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
2
Indications for Use
510(k) Number (if known) K202234
Device Name NervAlign® Nerve Cuff
Indications for Use (Describe)
The NervAlign® Nerve Cuff is indicated for the repair of peripheral nerve injuries in which there is no gap closure is achieved by flexion of the extremity.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary NervAlign® Nerve Cuff K202234
Submitter
| Name | ReNerve Ltd |
|---|---|
| Address | Suite 3, 21 Vale Street |
| North Melbourne, Victoria 3051 | |
| Australia | |
| Contact Person | David Rhodes |
| Phone | +61 (0)418598835 |
| Email Address | drhodes@renerve.com.au |
| Date Prepared | February 2, 2022 |
Device
| Trade Name | NervAlign® Nerve Cuff |
|---|---|
| Common Name | Nerve Cuff |
| Classification Name | Nerve Cuff |
| Classification Number | 21 CFR 882.5275 |
| Product Code | JXI |
| Regulatory Class | II |
Predicate Device
| Name [510(k) Number] | AxoGuard Nerve Protector [K132660] |
|---|---|
| ---------------------- | ------------------------------------ |
Device Description
The NervAlign® Nerve Cuff is a collagen membrane matrix derived from porcine pericardium. It is a sterile, whitish to light beige colored, freeze-dried, pre-cut, flat sheet of acellular collagen. The NervAlign® Nerve Cuff is available in three (3) different sizes: 10x10mm, 20x30mm and 30x40mm.
The collagen material that comprises the Nerve Cuff is derived from the same species as that of the predicate nerve cuff (AxoGuard Nerve Protector; K132660) manufactured by Cook Biotech Incorporated.
Like the predicate, the NervAlign® Nerve Cuff is implanted providing a scaffold which becomes infiltrated by the patient's cells and is remodelled into native tissue. The Nerve Cuff provides protection of the damaged nerve while the nerve heals.
The NervAlign® Nerve Cuff is packaged in a dried state, is for single use and provided sterile.
4
Indications for Use
The NervAlign® Nerve Cuff is indicated for the repair of peripheral nerve injuries in which there is no gap or where a gap closure is achieved by flexion of the extremity.
Comparison of Technological Characteristics with the Predicate Device
The proposed device is substantially equivalent to the design and materials in the predicate device. The table below summarizes the comparison between the predicate device and the NervAlign® Nerve Cuff.
| Feature | NervAlign® Nerve Cuff
[Proposed Device] | AxoGuard Nerve Protector
[Predicate Device] |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | K202234 | K132660 |
| Device Class | Class II | Class II |
| Classification Name and
Number | Nerve Cuff; 21 CFR 882.5275 | Nerve Cuff; 21 CFR 882.5275 |
| Product Code | JXI | JXI |
| Indications for Use | The NervAlign® Nerve Cuff is
indicated for the repair of
peripheral nerve injuries in which
there is no gap or where a gap
closure is achieved by flexion of the
extremity. | The Nerve Cuff is indicated for
the repair of peripheral nerve
injuries in which there is no gap
or where a gap closure is
achieved by flexion of the
extremity. The device is provided
sterile and intended for one-time
use. |
| Principles of Operation | Collagen matrix intended to wrap
and repair damaged peripheral
nerves | Collagen matrix intended to wrap
and repair damaged peripheral
nerves |
| Material | Collagen Matrix - Porcine
Pericardium | Collagen Matrix – Porcine Small
Intestinal Submucosa (SIS) |
| Sterile/Single Use | Sterile; single use | Sterile; single use |
| Sterilization Method | Gamma Irradiation | Ethylene Oxide (EtO) |
NervAlign® Nerve Cuff Comparison to AxoGuard Nerve Protector
Performance Data
The following testing was performed on the ReNerve NervAlign® Nerve Cuff.
5
| Test | Test Method Summary | Results |
|---|---|---|
| Suture retention | ||
| strength | A suture was placed through aged and | |
| unaged devices and the force required to | ||
| pull free was measured. | Test was completed and met specification. | |
| Like predicate the device has sufficient | ||
| strength for its intended use. | ||
| Thickness | Direct measurement of the device with | |
| micrometer when hydrated according to | ||
| IFU. | Thickness measurements of device showed | |
| substantially equivalent to predicate. | ||
| Tensile Strength | Direct measurement of the device. | |
| Device placed between two grips and the | ||
| separation force required to reach device | ||
| failure was measured. | Test was completed and met specification. | |
| Like predicate device is suitable for | ||
| intended use. | ||
| Cytotoxicity | The device was evaluated for potential | |
| cytotoxic effects using a mammalian cell | ||
| line following ISO 10993-5 guidelines. | The test article extract showed no cytotoxic | |
| potential. | ||
| Sensitization | The device was evaluated for the | |
| potential to cause delayed dermal | ||
| contact sensitization in guinea pigs | ||
| based on ISO 10993-10. | Extracts of the test article showed no | |
| evidence of inducing delayed contact | ||
| sensitization in the guinea pig. | ||
| Acute intracutaneous | ||
| reactivity (Irritation) | The device was evaluated for the | |
| potential to cause irritation following | ||
| intracutaneous injection in rabbits based | ||
| on ISO 10993-10. | Extracts of the test article show no evidence | |
| of irritation. | ||
| Acute systemic | ||
| toxicity | The device was evaluated for acute | |
| systemic toxicity in mice based on ISO | ||
| 10993-11. | No mortality or evidence of systemic | |
| toxicity from both extracts, injected into | ||
| mice. | ||
| Pyrogenicity | The device was evaluated for the | |
| potential to induce a pyrogenic response | ||
| following intravenous injection in | ||
| rabbits. Study conducted according to | ||
| the United States Pharmacopeia (USP 41 |
- NF36, General Chapter ). | The test article met the requirements and is
judged non-pyrogenic. |
| Hemolysis | The device was evaluated for hemolytic
potential when in contact with blood
based on ASTM F756 and requirements
of ISO 10993-4. | The direct contact of the test article was
slightly hemolytic.
The extracts at 25, 12.5 and 6.25% were
non-hemolytic.
Device is suitable for intended indication. |
| Genotoxicity
(AMES) | The device was evaluated for the
potential to induce reverse mutations in
Salmonella typhimurium and | Extracts of the device were considered to be
non-mutagenic to tester strains. |
| Test | Test Method Summary | Results |
| Escherichia coli tester strains per ISO
10993-3. | | |
| Genotoxicity (mouse
lymphoma assay) | The device was evaluated to determine
its mutagenic potential using the mouse
lymphoma forward gene mutation assay
per ISO 10993-3. | Test article considered non-mutagenic. |
| Endotoxin | Bacterial endotoxin testing is conducted
per USP 85 and European
Pharmacopoeia 2.6.14 | Device is produced and released with
endotoxin level