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 Description

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. 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.

AI/ML Overview

This document describes the premarket notification for the "Rebuilder Nerve Guidance Conduit" (K230794). It is a medical device intended for the reconstruction of peripheral nerve discontinuities.

Here's an analysis of the provided information, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by demonstrating substantial equivalence to the predicate device, Neurolac Nerve Guide (K112267). The study aimed to show that the Rebuilder Nerve Guidance Conduit performs similarly to the predicate across various characteristics.

Acceptance Criteria (Derived from Equivalence)	Reported Device Performance (Summary of Findings)
Mechanical Properties:	Mechanical Properties:
No significant difference in suture retention strength compared to predicate.	Demonstrated substantial equivalence in suture retention strength.
No significant difference in compression properties compared to predicate.	Demonstrated substantial equivalence in compression properties.
Material Properties:	Material Properties:
No significant difference in chemical analysis and degradation properties compared to predicate.	Demonstrated substantial equivalence in chemical analysis and degradation properties.
Biocompatibility:	Biocompatibility:
Biocompatible according to ISO 10993-1:2018 for implant device, tissue/bone contact, permanent duration (>30 days).	All tests (Cytotoxicity, Sensitization, Intracutaneous reactivity, Systemic toxicity (acute), Genotoxicity, Implantation (with histology), Hemolysis, Pyrogenicity, Subchronic systemic toxicity, Chronic systemic toxicity) showed the device is biocompatible.
In Vivo Performance (Nerve Repair & Functional Recovery):	In Vivo Performance (Nerve Repair & Functional Recovery):
Comparable healing responses (macroscopic assessment, clinical pathology, animal wellness) to predicate.	Comparable healing responses observed.
Comparable functional recovery (Sciatic Function Index) to predicate.	Comparable functional recovery demonstrated.
Comparable histological assessments (inflammation, nerve fiber density, axonal myelination) to predicate.	Comparable histological assessments observed.

2. Sample Size Used for the Test Set and Data Provenance

Mechanical and Chemical Testing: The document does not specify the exact sample sizes for these tests. It generally states that "Non-Clinical Tests were conducted and performed on the subject device and predicate device."
Biocompatibility Testing: The sample sizes for individual biocompatibility tests (e.g., cytotoxicity assays) are not provided in this summary.
In Vivo Animal Testing:
- Sample Size: Not explicitly stated as a number of animals, but refers to "a rat nerve sciatic nerve transection model." This implies a group of rats for the test article and a group for the comparator control.
- Data Provenance: Prospective animal study conducted in a laboratory setting (rat model). Country of origin is not specified.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is generally not applicable to a device like a nerve guidance conduit, as the "ground truth" is established through objective performance measures (mechanical, chemical, biological, and functional outcomes) rather than expert interpretation of images or clinical reports. Therefore, no experts were used for establishing ground truth in the traditional sense of diagnostic AI.

4. Adjudication Method for the Test Set

Not applicable, as ground truth was established through objective measurements and not subjective expert evaluation requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a physical implant, not an AI software intended to assist human readers in diagnostic tasks.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical implant.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The ground truth for evaluating the device's performance was established using a combination of:

Objective Laboratory Measurements: Suture retention strength, compression properties, chemical analysis, degradation properties, and various in vitro biocompatibility assays.
Pathology/Histology: Histological assessments of implantation sites for inflammation, nerve fiber density, and axonal myelination in the animal study.
Outcomes Data (Animal Functional Outcomes): Sciatic Function Index using walking tracks in the rat model.
Macroscopic Assessments: Observation of nerve implant sites for tissue adhesions in the animal study.
Clinical Pathology (Animal): Hematology and serum chemistry in the animal study.

8. The Sample Size for the Training Set

Not applicable. This device is a physical implant, not an AI model requiring a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for a physical device.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 XuCTO 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, K112267Polyganics BV.
Additional Predicate Device	Neurolac Nerve guide, K050573Polyganics BV.
Reference Device	NeuroGen Nerve Guide, K011168Integra LifeSciences Corporation

Description of the device

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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 NerveGuidanceConduit	NeurolacNerve Guide(K112267)	NeurolacNerve Guide(K050573)	NeurogenNerve Guide(K01168)
Indicationsfor use	Rebuilder NerveGuidanceConduit isindicated for thereconstruction ofa peripheralnervediscontinuity upto 20 mm inpatients whohave sustained acompletedivision of anerve.	The Neurolacnerve guide isindicated forthereconstructionof a peripheralnervediscontinuityup to 20 mm inpatients whohave sustainedcompleteadivision of anerve.	The Neurolacnerve guide isindicated forthereconstructionof a peripheralnervediscontinuityup to 20 mm inpatients whohave sustainedcompleteadivision of anerve.	The CollagenNerve Cuff isintendedforuse in repair ofperipheralnervediscontinuitieswheregapclosure can beachievedbyflexion of theextremity.
PrincipleofOperation	To serve as aninterfacebetween thenerve and thesurroundingtissue, providinga protectiveenvironment for	To provide aprotectiveenvironmentfor peripheralnerveregenerationafterinjuryand to create aconduitto	To provide aprotectiveenvironmentfor peripheralnerveregenerationafter afterinjuryand to create aconduitto	To provide aprotectiveenvironmentfor peripheralnerve repairafter injury, tobe an interfacebetweenthenerveand
	peripheral nerverepair afterinjury, and tooffer guidanceand protectionfor axonalgrowth across anerve gap.	guide axonalgrowth acrossa nerve gap.	guide axonalgrowth acrossa nerve gap.	surroundingtissue and tocreateaconduit foraxonal growthacross a nervegap.
Design	A permeable tubewith innerdiameter rangingfrom 1.5mm to10 mm, andlength of 3 cm	A flexible andtransparent tubewith internaldiameter of 1.5-3 mm, andlength of 3 cm.	A flexible andtransparent tubewith internaldiameter of 4-10mm, and lengthof 3 cm.	A porous tubewith innerdiameter of 2 -7mm,andlength of 2 cmto 4 cm.
Material	poly(lactide-co-caprolactone),Poly(lactic-co-glycolic acid) andPolylactic acid-b-Polyethyleneglycol	poly(DL-lactide-co-ε-caprolactone)	poly(DL-lactide-co-ε-caprolactone)	Collagen
ResorbableMaterial	Yes	Yes	Yes	Yes
Sterilization	Ethylene Oxideto SAL of 10-6	EthyleneOxide to SALof 10-6	EthyleneOxide to SALof 10-6	EthyleneOxide to SALof 10-6
SingleUse/Reuse	Single use only	Singleuseonly	Single useonly	Singleuseonly
Packaging	Tyvek paper-plastic bag, andan aluminum foilbag	Single use,polycarbonatetray, singleTyvek pouch,cardboard box	Single use,polycarbonatetray, singleTyvek pouch,cardboard box	Double blisterpackages
ProductCode	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.

Regulation Number and Section

§ 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).