SALUTUNNEL NERVE PROTECTOR, MODEL ED-20329, ED-20330, ED-20331

K100382 · Salumedica, LLC · JXI · Aug 5, 2010 · Neurology

Device Facts

• Record ID: K100382
• Device Name: SALUTUNNEL NERVE PROTECTOR, MODEL ED-20329, ED-20330, ED-20331
• Applicant: Salumedica, LLC
• Product Code: JXI · Neurology
• Decision Date: Aug 5, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5275
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

SaluTunnel Nerve Protector is a flexible tubular sheath used to provide a protective environment for peripheral nerve repair. The device features a longitudinal slit allowing it to be spread open for placement around the nerve injury site. It is placed between the nerve and its bed to act as a conduit for axonal growth. The device is used in an operative setting by a surgeon. It must be secured in place to prevent migration. The device is manufactured from Salubria, a polyvinyl alcohol and saline biomaterial. It is provided sterile and hydrated for single use. By protecting the nerve site, it facilitates healing and nerve regeneration.

Clinical Evidence

No clinical data. Evidence consists of bench-top testing and biocompatibility studies. Biocompatibility was established via testing on the predicate SaluBridge Nerve Cuff (cytotoxicity, sensitization, intracutaneous reactivity, genotoxicity, and 4/13-week rat subcutaneous implantation). Design verification included dimensional inspection, simulated use, suture retention, sterilization validation, packaging verification, and shelf-life testing.

Technological Characteristics

Flexible tubular sheath with longitudinal slit. Material: Salubria (polyvinyl alcohol and saline). Dimensions: 2-10 mm ID, 6.35 cm length. Sterilization: Irradiation. Shelf life: 3 years. Single-use, hydrated. No software or electronic components.

Indications for Use

Indicated for management of peripheral nerve injuries in patients with no substantial loss of nerve tissue.

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

• SaluBridge Nerve Cuff (K002098)
• Integra Lifesciences Corporation NeuroWrap™ Nerve Protector (K041620)
• Collagen Matrix, Inc., NeuroMend™ Collagen Nerve Wrap (K060952)

Submission Summary (Full Text)

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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 [phone] Tel: [phone] 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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| | SaluTunnel<br>Nerve Protector<br>(K100382) | SaluBridge Nerve<br>Cuff (K002098) | NeuraWrap<br>Nerve Protector<br>(K041620) | NeuroMend<br>Collagen Nerve<br>Wrap (K060952) |
|---------------|--------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Repair of<br>peripheral nerve<br>discontinuities in<br>which there has<br>been no<br>substantial loss<br>of nerve tissue | Repair of<br>peripheral nerve<br>discontinuities in<br>which there has<br>been no<br>substantial loss<br>of nerve tissue<br>and where gap<br>closure can be<br>achieved by<br>flexion of the<br>extremity | Management of<br>peripheral nerve<br>injuries in which<br>there has been<br>no substantial<br>loss of nerve<br>tissue | Management of<br>peripheral nerve<br>injuries in which<br>there has been<br>no substantial<br>loss of nerve<br>tissue and where<br>gap closure can<br>be achieved by<br>flexion of the<br>extremity |
| Material | Salubria<br>biomaterial | Salubria<br>biomaterial | Collagen | Collagen |
| Design | Tube with<br>longitudinal slit | Tube | Tube with<br>longitudinal slit | Tube with<br>longitudinal slit |
| Sizes | 2-10mm ID<br>6.35cm length | 2, 5, 10mm ID<br>6.35cm length | 3, 5, 7 mm<br>2, 4 cm length | 4, 6, 12mm ID<br>2.5, 5 cm length |
| Sterilization | Irradiation | Irradiation | Unknown | Unknown |
| Shelf Life | 3 years | 3 years | Unknown | Unknown |
| Packaging | Single device,<br>hydrated,<br>contained in<br>preformed<br>plastic tray with<br>foil laminate lid<br>in single unit<br>carton | Single device,<br>hydrated,<br>contained in<br>preformed<br>plastic tray with<br>foil laminate lid<br>in single unit<br>carton | Unknown | Unknown |

#### 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.

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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 -<br>after 4 yrs RT<br>aging | ISO MEM Elution | No evidence of cytotoxicity |
| Sensitization | SaluBridge | ISO Kligman<br>Maximization | No evidence of sensitization |
| Intracutaneous Reactivity | SaluBridge | ISO Intracutaneous<br>Injection | No evidence of irritation |
| Genotoxicity | SaluBridge | ISO Ames<br>Mutagenicity | No evidence of mutagenicity |
| Genotoxicity | SaluBridge | ISO Chromosomal<br>Aberration Assay | No evidence of clastogenicity |
| Implantation / Chronic<br>Toxicity | SaluBridge | Rat Subcutaneous<br>Implantation Study<br>- 4 and 13 week | No evidence of local or systemic<br>toxicity compared<br>to silicone control<br>implant |

## 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:

্ধ

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 [phone] or [phone] 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