Rebuilder Nerve Guidance Conduit

K230794 · Celestray Biotech Company, LLC., · JXI · Jan 29, 2024 · Neurology

Device Facts

• Record ID: K230794
• Device Name: Rebuilder Nerve Guidance Conduit
• Applicant: Celestray Biotech Company, LLC.,
• Product Code: JXI · Neurology
• Decision Date: Jan 29, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5275
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Rebuilder Nerve Guidance Conduit is indicated for the reconstruction of a peripheral nerve discontinuity up to 20 mm in patients who have sustained a complete division of a nerve.

Device Story

Permeable, bioresorbable poly(lactide-co-caprolactone)-based tube; serves as interface between nerve and surrounding tissue; provides protective environment for peripheral nerve repair; guides axonal growth across nerve gaps. Used in surgical settings for nerve repair. Provided sterile, non-pyrogenic, single-use; various sizes (1.5mm to 10mm inner diameter). Surgeon implants conduit at site of nerve injury; facilitates nerve regeneration and functional recovery. Benefits patient by providing structural guidance for axonal regrowth across discontinuities.

Clinical Evidence

No human clinical data. Evidence based on non-clinical bench testing and in vivo animal study. Bench testing: mechanical strength, suture retention, compression, chemical analysis, degradation, and biocompatibility (ISO 10993-1:2018). Animal study: rat sciatic nerve transection model (n=not specified) compared subject device to Neurolac Nerve Guide. Evaluated at 1, 3, and 6 months. Endpoints: macroscopic tissue adhesion, clinical pathology, animal wellness, Sciatic Function Index (walking tracks), and histological assessment (inflammation, nerve fiber density, axonal myelination). Results demonstrated substantial equivalence in facilitating nerve repair and functional recovery.

Technological Characteristics

Bioresorbable tube composed of poly(lactide-co-caprolactone), poly(lactic-co-glycolic acid), and polylactic acid-b-polyethylene glycol. Permeable design; inner diameters 1.5mm–10mm; length 3cm. Sterilized via Ethylene Oxide to SAL 10^-6. Single-use. Biocompatibility per ISO 10993-1:2018.

Indications for Use

Indicated for reconstruction of peripheral nerve discontinuity up to 20 mm in patients with complete nerve division.

Regulatory Classification

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).

Predicate Devices

• Neurolac Nerve guide (K112267)
• Neurolac Nerve guide (K050573)

Reference Devices

• NeuroGen Nerve Guide (K011168)

Submission Summary (Full Text)

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January 29, 2024

Image /page/0/Picture/1 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white. To the right of the square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.

CelestRay Biotech Company, LLC Shanshan Xu CTO and Partner P.O. Box 341754 Bethesda, Maryland 20827-1754

Re: K230794

Trade/Device Name: Rebuilder Nerve Guidance Conduit Regulation Number: 21 CFR 882.5275 Regulation Name: Nerve Cuff Regulatory Class: Class II Product Code: JXI Dated: December 23, 2023 Received: December 29, 2023

Dear Shanshan Xu:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 ([e-mail]) or phone [phone] or 301-796-7100).

> Sincerely, Adam D. Digitally signed by Adam D. Pierce -S Digitally signed by Pierce -S 13:55:20 -05'00'

Adam Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological

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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) K230794

Device Name Rebuilder Nerve Guidance Conduit

Indications for Use (Describe)

Rebuilder Nerve Guidance Conduit is indicated for the reconstruction of a peripheral nerve discontinuity up to 20 mm in patients who have sustained a complete division of a nerve.

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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## 510(k) Summary K230794

### Applicant information

| Applicant Name: | CelestRay Biotech company, LLC |
|--------------------|----------------------------------------|
| Applicant Address: | PO BOX 341754, BETHESDA, MD 20827-1754 |
| Phone: | 202-808-5668 |
| Fax: | -- |
| Contact Person: | Shanshan Xu<br>CTO and Partner |
| Date Prepared: | January 25, 2024 |

#### Name of Device

| Device Common Name: | Nerve Guide |
|-----------------------------|----------------------------------|
| Device Trade Name: | Rebuilder Nerve Guidance Conduit |
| Device Classification Name: | Nerve Cuff |
| | 882.5275 |
| | Class II |
| | JXI |

#### Legally Marketed Devices to Which Substantial Equivalence is Claimed

| Primary Predicate Device | Neurolac Nerve guide, K112267<br>Polyganics BV. |
|-----------------------------|-------------------------------------------------------------------|
| Additional Predicate Device | Neurolac Nerve guide, K050573<br>Polyganics BV. |
| Reference Device | NeuroGen Nerve Guide, K011168<br>Integra LifeSciences Corporation |

#### Description of the device

The Rebuilder Nerve Guidance Conduit is designed to be a permeable and bioresorbable poly(lactide-co-caprolactone) based tube. It is designed to serve as an interface between the nerve and the surrounding tissue, providing a protective environment for peripheral nerve repair after injury. The Rebuilder Nerve Guidance Conduit offers guidance and protection for axonal growth across a nerve gap.

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The Rebuilder Nerve Guidance Conduit is provided sterile, non-pyrogenic, for single use only, in various sizes (with product inner diameter ranging from 1.5mm to 10 mm). The Rebuilder Nerve Guidance Conduit is provided in double peel package.

#### Indications for Use

Rebuilder Nerve Guidance Conduit is indicated for the reconstruction of a peripheral nerve discontinuity up to 20 mm in patients who have sustained a complete division of a nerve.

| Haracteristic | Subject Device | Predicate | Predicate | Reference |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | Device | Device | Device |
| Device Name | Rebuilder Nerve<br>Guidance<br>Conduit | Neurolac<br>Nerve Guide<br>(K112267) | Neurolac<br>Nerve Guide<br>(K050573) | Neurogen<br>Nerve Guide<br>(K01168) |
| Indications<br>for use | Rebuilder Nerve<br>Guidance<br>Conduit is<br>indicated for the<br>reconstruction of<br>a peripheral<br>nerve<br>discontinuity up<br>to 20 mm in<br>patients who<br>have sustained a<br>complete<br>division of a<br>nerve. | The Neurolac<br>nerve guide is<br>indicated for<br>the<br>reconstruction<br>of a peripheral<br>nerve<br>discontinuity<br>up to 20 mm in<br>patients who<br>have sustained<br>complete<br>a<br>division of a<br>nerve. | The Neurolac<br>nerve guide is<br>indicated for<br>the<br>reconstruction<br>of a peripheral<br>nerve<br>discontinuity<br>up to 20 mm in<br>patients who<br>have sustained<br>complete<br>a<br>division of a<br>nerve. | The Collagen<br>Nerve Cuff is<br>intended<br>for<br>use in repair of<br>peripheral<br>nerve<br>discontinuities<br>where<br>gap<br>closure can be<br>achieved<br>by<br>flexion of the<br>extremity. |
| Principle<br>of<br>Operation | To serve as an<br>interface<br>between the<br>nerve and the<br>surrounding<br>tissue, providing<br>a protective<br>environment for | To provide a<br>protective<br>environment<br>for peripheral<br>nerve<br>regeneration<br>after<br>injury<br>and to create a<br>conduit<br>to | To provide a<br>protective<br>environment<br>for peripheral<br>nerve<br>regeneration<br>after after<br>injury<br>and to create a<br>conduit<br>to | To provide a<br>protective<br>environment<br>for peripheral<br>nerve repair<br>after injury, to<br>be an interface<br>between<br>the<br>nerve<br>and |
| | peripheral nerve<br>repair after<br>injury, and to<br>offer guidance<br>and protection<br>for axonal<br>growth across a<br>nerve gap. | guide axonal<br>growth across<br>a nerve gap. | guide axonal<br>growth across<br>a nerve gap. | surrounding<br>tissue and to<br>create<br>a<br>conduit for<br>axonal growth<br>across a nerve<br>gap. |
| Design | A permeable tube<br>with inner<br>diameter ranging<br>from 1.5mm to<br>10 mm, and<br>length of 3 cm | A flexible and<br>transparent tube<br>with internal<br>diameter of 1.5-<br>3 mm, and<br>length of 3 cm. | A flexible and<br>transparent tube<br>with internal<br>diameter of 4-10<br>mm, and length<br>of 3 cm. | A porous tube<br>with inner<br>diameter of 2 -<br>7mm,<br>and<br>length of 2 cm<br>to 4 cm. |
| Material | poly(lactide-co-<br>caprolactone),<br>Poly<br>(lactic-co-<br>glycolic acid) and<br>Polylactic acid-b-<br>Polyethylene<br>glycol | poly(DL-<br>lactide-co-ε-<br>caprolactone) | poly(DL-<br>lactide-co-ε-<br>caprolactone) | Collagen |
| Resorbable<br>Material | Yes | Yes | Yes | Yes |
| Sterilization | Ethylene Oxide<br>to SAL of 10-6 | Ethylene<br>Oxide to SAL<br>of 10-6 | Ethylene<br>Oxide to SAL<br>of 10-6 | Ethylene<br>Oxide to SAL<br>of 10-6 |
| Single<br>Use<br>/Reuse | Single use only | Single<br>use<br>only | Single use<br>only | Single<br>use<br>only |
| Packaging | Tyvek paper-<br>plastic bag, and<br>an aluminum foil<br>bag | Single use,<br>polycarbonate<br>tray, single<br>Tyvek pouch,<br>cardboard box | Single use,<br>polycarbonate<br>tray, single<br>Tyvek pouch,<br>cardboard box | Double blister<br>packages |
| Product<br>Code | JXI | JXI | JXI | JXI |
| CFR Section | 882.5275 | 882.5275 | 882.5275 | 882.5275 |

# Summary/Comparison of Technical Characteristics

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## Performance Testing

The Rebuilder Nerve Guidance Conduit and its predicates have been characterized for performance with mechanical strength to demonstrate substantial equivalence. Non-Clinical Tests were conducted and performed on the subject device and predicate device,

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including suture retention strength, compression properties, as well as chemical analysis and degradation properties. The test demonstrates the proposed device is substantial equivalent to the legally marketed predicate device.

The biocompatibility testing of the product was performed according to ISO 10993-1:2018 Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process under the category of implant device, tissue/bone contact, permanent duration (>30 days), including Cytotoxicity, Sensitization, Intracutaneous reactivity, Systemic toxicity(acute), Genotoxicity, Implantation (with histology of the surrounding tissue). Hemolysis, Pyrogenicity, Subchronic systemic toxicity and Chronic systemic toxicity. All test results showed that the Rebuilder Nerve Guidance Conduit is biocompatible. The tests helped demonstrate that the device is substantially equivalent to its predicate.

In vivo animal testing was performed using a rat nerve sciatic nerve transection model. The transected nerves were implanted with either the Rebuilder Nerve Guidance Conduit (test article) to the Neurolac Nerve Guide (comparator control), and rats were evaluated at the 1-, 3- and 6-month evaluation time points for healing responses. Outcome measures included macroscopic assessment of the nerve implant sites for tissue adhesions, clinical pathology (hematology and serum chemistry), in-life assessments of animal wellness, functional recovery as assessed using a Sciatic Function Index of walking tracks, and semiquantitative histological assessments for inflammation, nerve fiber density, axonal myelination. The results demonstrate the substantial equivalence of the Rebuilder Nerve Guidance Conduit to the Neurolac Nerve Guide in facilitating nerve repair and functional recovery.

#### Conclusion of Non-clinical test

The results of the mechanical performance, biocompatibility and animal testing demonstrated that the Rebuilder Nerve Guidance Conduit is substantially equivalent to Neurolac Nerve Guide, K112267.