The SaluTunnel™ Nerve Protector is indicated for the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue.

Device Description

The SaluTunnel Nerve Protector is a flexible tubular sheath developed to provide a protective environment for peripheral nerve repair after injury. The wall of the sheath has a longitudinal slit that allows SaluTunnel to be spread open for easy placement at the site of injury. The SaluTunnel Nerve Protector is designed to be interfaced between the nerve and its bed and, if necessary, to create a conduit for axonal growth across a nerve gap. SaluTunnel Nerve Protector is available in 2 through 10 mm inner diameter sizes. Each SaluTunnel device must be secured in place to prevent migration. Each SaluTunnel device should be chosen to be size appropriate. The device is manufactured from Salubria biomaterial. Salubria is made from a polymer (polyvinyl alcohol) and saline. Each SaluTunnel is provided sterile, hydrated in saline for presentation onto the operative field, for single use only.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the SaluTunnel™ Nerve Protector, based on the provided text:

Key Takeaways from the Document:

This 510(k) submission is for the SaluTunnel™ Nerve Protector.
The primary method for demonstrating safety and effectiveness, and thus meeting acceptance criteria, is through substantial equivalence to existing predicate devices (SaluBridge Nerve Cuff, NeuroWrap™ Nerve Protector, NeuroMend™ Collagen Nerve Wrap).
The studies conducted are primarily non-clinical (bench-top and biocompatibility)
The device's biocompatibility leans heavily on the SaluBridge Nerve Cuff, which is stated to be made from the exact same material and manufacturing process, differing only in a longitudinal slit.

1. Table of Acceptance Criteria and Reported Device Performance

Test/Category	Acceptance Criteria (Implied/Stated)	Reported Device Performance
Biocompatibility	No evidence of cytotoxicity, sensitization, irritation, mutagenicity, clastogenicity, or local/systemic toxicity.	Cytotoxicity: No evidence of cytotoxicity (for SaluBridge and aged SaluTunnel). Sensitization: No evidence of sensitization. Intracutaneous Reactivity: No evidence of irritation. Genotoxicity (Ames): No evidence of mutagenicity. Genotoxicity (Chromosomal Aberration): No evidence of clastogenicity. Implantation/Chronic Toxicity: No evidence of local or systemic toxicity compared to silicone control implant.
Design Verification (Bench-Top Testing)	Device must meet all established requirements for physical and mechanical properties.	Dimensional/Visual Inspection: Met requirements. Simulated Use: Met requirements. Suture Retention Strength (SaluBridge): Met requirements. Sterilization Validation: Met requirements. Packaging Verification: Met requirements. Shelf Life Determination: Met requirements.
Substantial Equivalence	Device must be substantially equivalent in function and intended use to predicate devices and satisfy safety and effectiveness requirements.	Demonstrated through detailed comparison to predicate devices (K002098, K041620, K060952) in intended use, material, design, sizes, sterilization, shelf life, and packaging. Non-clinical testing supports this.

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

Test Set (Biocompatibility): Not explicitly stated in terms of number of devices or animals, but refers to ISO standard methods (MEM Elution, Kligman Maximization, Intracutaneous Injection, Ames Mutagenicity, Chromosomal Aberration Assay) and a Rat Subcutaneous Implantation Study.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The studies are non-clinical, so geographical provenance for human data isn't applicable.
Test Set (Design Verification): Refers to "units which were sterilized and met finished goods release requirements" and "all sizes" for dimensional/visual inspection. No specific number is provided.

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

This type of information is generally not applicable for non-clinical (bench-top and biocompatibility) studies. The "ground truth" is established through adherence to standardized laboratory methods and measurements.
For the overall substantial equivalence claim, the "ground truth" is the established safety and efficacy of the predicate devices.

4. Adjudication Method for the Test Set

Not applicable as the studies described are non-clinical (biocompatibility and bench-top testing) and do not involve human readers/experts for adjudication in the context of diagnostic performance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The submission focuses on non-clinical testing and substantial equivalence, not on human interpretive performance of an AI.

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

No, this device is a physical medical device (nerve protector), not a software algorithm or AI. Therefore, "standalone" performance in the context of an algorithm is not applicable.

7. The Type of Ground Truth Used

Biocompatibility: Ground truth is established by standardized international (ISO) testing methods and comparison to known negative controls (e.g., silicone control implant in the rat study).
Design Verification: Ground truth is established by engineering specifications, material properties, and functional requirements.
Overall Equivalence: The primary "ground truth" for substantial equivalence is the established safety and effectiveness of the legally marketed predicate devices.

8. The Sample Size for the Training Set

Not applicable. This submission describes a physical medical device, not an AI/machine learning algorithm that requires a "training set." The materials and manufacturing processes are established for the SaluBridge Nerve Cuff (the "parent" device).

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

Not applicable. As stated above, there is no "training set" in the context of an AI algorithm for this device. The properties and performance characteristics of the SaluTunnel Nerve Protector are derived from testing the device itself and leveraging the established data of its substantially equivalent predecessor, the SaluBridge Nerve Cuff.

Summary

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K100382

AUG - 5 2010

SaluTunnel™ Nerve Protector

510(k) Summary

(as required by 21 CFR 807.92)

Submitter's Name and Address:

SaluMedica, LLC 931 E. Ponce de Leon Avenue, NE Atlanta, GA 30306

Contact Person and Telephone Number:

Tom Shields President (404) 876-6432 Tel: (404) 876-5950 Fax:

Date Summary was Prepared:

August 2, 2010

Name of the Device:

SaluTunnel™ Proprietary Name: Common Name: Nerve Protector Classification Name: 21 CFR 882.5275 Device Classification: Class II, 84 Neurology Product Code: JXI

Substantial Equivalence:

SaluTunnel Nerve Protector is substantially equivalent in function and intended use to the following products which have been cleared to market under Premarket Notifications 510(k): SaluBridge Nerve Cuff (fka SaluMedica Nerve Cuff, K002098), Integra Lifesciences Corporation NeuroWrap™ Nerve Protector (K041620), and Collagen Matrix, Inc., NeuroMend™ Collagen Nerve Wrap (K060952). The basis for equivalence is demonstrated by the comparisons in the following table:

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	SaluTunnelNerve Protector(K100382)	SaluBridge NerveCuff (K002098)	NeuraWrapNerve Protector(K041620)	NeuroMendCollagen NerveWrap (K060952)
Intended Use	Repair ofperipheral nervediscontinuities inwhich there hasbeen nosubstantial lossof nerve tissue	Repair ofperipheral nervediscontinuities inwhich there hasbeen nosubstantial lossof nerve tissueand where gapclosure can beachieved byflexion of theextremity	Management ofperipheral nerveinjuries in whichthere has beenno substantialloss of nervetissue	Management ofperipheral nerveinjuries in whichthere has beenno substantialloss of nervetissue and wheregap closure canbe achieved byflexion of theextremity
Material	Salubriabiomaterial	Salubriabiomaterial	Collagen	Collagen
Design	Tube withlongitudinal slit	Tube	Tube withlongitudinal slit	Tube withlongitudinal slit
Sizes	2-10mm ID6.35cm length	2, 5, 10mm ID6.35cm length	3, 5, 7 mm2, 4 cm length	4, 6, 12mm ID2.5, 5 cm length
Sterilization	Irradiation	Irradiation	Unknown	Unknown
Shelf Life	3 years	3 years	Unknown	Unknown
Packaging	Single device,hydrated,contained inpreformedplastic tray withfoil laminate lidin single unitcarton	Single device,hydrated,contained inpreformedplastic tray withfoil laminate lidin single unitcarton	Unknown	Unknown

Device Description:

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The device is manufactured from Salubria biomaterial. Salubria is made from a polymer (polyvinyl alcohol) and saline. Each SaluTunnel is provided sterile, hydrated in saline for presentation onto the operative field, for single use only.

Intended Use:

SaluTunnel Nerve Protector is indicated for the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue.

Summary of Non-Clinical Data:

As required under Section 12, Part (a)(i)(3A) of the Safe Medical Devices Act of 1990, a summary of any information regarding safety and effectiveness of the device follows. Included in this section are descriptions of the testing, substantiating the safe and effective performance of the SaluTunnel Nerve Protector as well as its substantial equivalence to the predicate devices:

Biocompatibility
Design Verification (Bench-Top Testing)

The SaluTunnel Nerve Protector met all established requirements.

Biocompatibility:

Biocompatibility for SaluTunnel Nerve Protector is based on the biocompatibility of the SaluBridge Nerve Cuff. The two devices are manufactured from the exact material formulation using the exact manufacturing process. The devices differ only in the presence of a longitudinal slit in SaluTunnel Nerve Protector. The biocompatibility testing conducted for SaluBridge Nerve Cuff directly represents the biocompatibility of SaluTunnel Nerve Protector. Test results are summarized in the following table:

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Test	Device	Method	Result
Cytotoxicity	SaluBridge	ISO MEM Elution	No evidence of cytotoxicity
Cytotoxicity	SaluTunnel -after 4 yrs RTaging	ISO MEM Elution	No evidence of cytotoxicity
Sensitization	SaluBridge	ISO KligmanMaximization	No evidence of sensitization
Intracutaneous Reactivity	SaluBridge	ISO IntracutaneousInjection	No evidence of irritation
Genotoxicity	SaluBridge	ISO AmesMutagenicity	No evidence of mutagenicity
Genotoxicity	SaluBridge	ISO ChromosomalAberration Assay	No evidence of clastogenicity
Implantation / ChronicToxicity	SaluBridge	Rat SubcutaneousImplantation Study- 4 and 13 week	No evidence of local or systemictoxicity comparedto silicone controlimplant

Design Verification (Bench-Top Testing):

Design Verification testing was conducted to evaluate the physical and mechanical properties of the SaluTunnel Nerve Protector. All testing was performed using units which were sterilized and met finished goods release requirements. Some testing, as noted below references testing conducted on the SaluBridge Nerve Cuff. The tests performed included:

- Dimensional / Visual Inspection (all sizes)

Simulated Use
Suture Retention Strength Test (SaluBridge)
Sterilization Validation
Packaging Verification: Ship Testing, Peel Strength, Vacuum Leak Analysis (SaluBridge)
Shelf Life Determination: Accelerated and Real-Time Aging (SaluBridge)

The SaluTunnel Nerve Protector met all acceptance criteria for the tests conducted.

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Conclusion:

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SaluTunnel Nerve Protector is safe and effective under the proposed conditions of use and is substantially equivalent to its predicate devices. Safety and efficacy are supported through physician experience with the equivalent SaluBridge product, biocompatibility testing, and design verification testing.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

SaluMedica, LLC c/o Mr. Bob Braden 931 E Ponce De Leon Avenue Atlanta. GA 30306

Re: K100382

Trade/Device Name: SaluTunnel™M Nerve Protector Regulation Number: 21 CFR 882.5275 Regulation Name: Nerve cuff Regulatory Class: Class II Product Code: JXI Dated: July 15, 2010 Received: July 19, 2010

AUG - 5 2010

Dear Mr. Braden:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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,

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K100382

Indications for Use

510(k) Number (if known): K100382

AUG - 5 2010

Device Name: SaluTunnel™ Nerve Protector

Indications For Use:

The SaluTunnel™ Nerve Protector is indicated for the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Signature

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K100382

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).