Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a physical medical device (a nerve guidance conduit) and its performance testing, with no mention of software, algorithms, or AI/ML capabilities.

Therapeutic

Yes
The device is described as a "Rebuilder Nerve Guidance Conduit" indicated for the "reconstruction of a peripheral nerve discontinuity," and designed to "provide a protective environment for peripheral nerve repair after injury" and offer "guidance and protection for axonal growth." These actions are aimed at treating or alleviating a condition (nerve discontinuity/injury), fitting the definition of a therapeutic device.

Diagnostic

No

The device description indicates it is a "Nerve Guidance Conduit" designed to "serve as an interface between the nerve and the surrounding tissue, providing a protective environment for peripheral nerve repair after injury" and to offer "guidance and protection for axonal growth across a nerve gap." This describes a therapeutic or reparative function, not a diagnostic one.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a physical, bioresorbable tube made of poly(lactide-co-caprolactone), intended for surgical implantation. This is a hardware device, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states the device is for the "reconstruction of a peripheral nerve discontinuity." This is a surgical procedure performed in vivo (within the body) to repair damaged tissue.
Device Description: The description details a "permeable and bioresorbable poly(lactide-co-caprolactone) based tube" designed to be implanted to guide nerve growth. This is a physical implant, not a reagent or instrument used to test samples in vitro (outside the body).
Performance Studies: The performance studies involve non-clinical tests on the device itself (suture retention, compression, degradation) and in vivo animal testing to evaluate nerve repair and functional recovery. These are not studies related to analyzing biological samples for diagnostic purposes.

IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The Rebuilder Nerve Guidance Conduit does not perform this function. It is a therapeutic device used in a surgical setting.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes

JXI

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.

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

Non-Clinical Tests were conducted and performed on the subject device and predicate device, 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.

Key Metrics

Not Found

Predicate Device(s)

Neurolac Nerve guide, K112267, Neurolac Nerve guide, K050573

Reference Device(s)

NeuroGen Nerve Guide, K011168

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

0

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).

1

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

2

and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

3

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)

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."

4

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
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
Polyganics BV. |
|-----------------------------|-------------------------------------------------------------------|
| Additional Predicate Device | Neurolac Nerve guide, K050573
Polyganics BV. |
| Reference Device | NeuroGen Nerve Guide, K011168
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.

5

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

Summary/Comparison of Technical Characteristics

6

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,

7

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.