STIMULATION/DISSECTION INSTRUMENTS

K112709 · Nu Vasive, Incorporated · ETN · Feb 9, 2012 · Ear, Nose, Throat

Device Facts

• Record ID: K112709
• Device Name: STIMULATION/DISSECTION INSTRUMENTS
• Applicant: Nu Vasive, Incorporated
• Product Code: ETN · Ear, Nose, Throat
• Decision Date: Feb 9, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.1820
• Device Class: Class 2

Intended Use

The Stimulation/Dissection Instruments are indicated for tissue dissection and stimulation of peripheral motor nerves for location and identification during surgery, including spinal nerve roots.

Device Story

NuVasive Stimulation/Dissection Instruments are manual surgical tools including retractors, dilators, stimulating electrodes, taps, drills, probes, needles, and screwdrivers. Devices feature proximal connectors for attachment to a monopolar stimulator and insulating sheaths for electrical safety. Distal surfaces are non-insulated to allow for mechanical tissue dissection, resection, probing, and nerve stimulation. Used by surgeons during surgical procedures to locate and identify peripheral motor nerves, including spinal nerve roots. The device facilitates nerve identification by delivering electrical stimulation to tissues, helping the surgeon avoid nerve damage during dissection. Some instruments are provided sterile for single use, while others are reusable and non-sterile.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included stimulation and insulation impedance, current density determination, biocompatibility per ISO 10993-1, and sterilization validation per ISO 11135-1.

Technological Characteristics

Manual surgical instruments (retractors, dilators, electrodes, etc.). Materials: Anodized Aluminum, Stainless Steel, Radel. Biocompatible. Electrical insulation provided via sheaths or accessories. Sterilization: Sterile for single use or non-sterile reusable. Energy: Monopolar electrical stimulation. Connectivity: Proximal connector for external stimulator.

Indications for Use

Indicated for tissue dissection and stimulation of peripheral motor nerves for location and identification during surgery, including spinal nerve roots.

Regulatory Classification

Identification

A surgical nerve stimulator/locator is a device that is intended to provide electrical stimulation to the body to locate and identify nerves and to test their excitability.

Predicate Devices

• Medtronic Stimulation/Dissection Instruments (K031003)
• NuVasive Disposable Stimulating Electrode (K111597)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo for Nuvasive. The logo consists of a stylized, incomplete circle on the left, followed by the word "NUVASIVE" in capital letters. Below the word "NUVASIVE" is the tagline "Speed of Innovation" in a smaller font.

# 510(k) Summary

In accordance with Title 21 of the Code of Federal Regulations. Part 807, and in particular 21 CFR §807.92. the following summary of information is provided:

## Submitted by: A.

Elias Ketchum Senior Associate. Regulatory Affairs NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Contact: [phone]

Date Prepared: September 2, 2011

## B. Device Name

| Trade or Proprietary Name: | <i>NuVasive</i> ® Stimulation/Dissection Instrument |
|----------------------------|-----------------------------------------------------|
| Common or Usual Name: | Nerve Stimulator/Locator |
| Classification Name: | Surgical Nerve Stimulator/Locator |

| Device Class: | Class II |
|-----------------|-------------------|
| Classification: | 21 CFR § 874.1820 |
| Product Code: | ETN |

## C. Predicate Devices

The subject Stimulation/Dissection Instruments are substantially equivalent to the following predicate devices currently distributed commercially in the U.S .:

- K031003 Medtronic Stimulation/Dissection Instruments �
- K111597 NuVasive Disposable Stimulating Electrode .

## D. Device Description

The NuVasive Stimulation/Dissection Instruments are similar to existing Class I exempt manual surgical instruments described in 21 CFR 88.4540 Orthopedic Manual Surgical Instruments. The instruments consist of retractors, dilators (expanding set of cannula), a stimulating electrode, taps, drills, probes, needles, and screw drivers with proximal connectors to attach the instruments to a monopolar stimulator, and insulating sheaths to provide biocompatible electrical insulation to selected portions of the instruments. The distal surfaces of the instruments are selectively noninsulated and manufactured from durable biocompatible materials to provide for mechanical, manual dissection/resection, probing, and tissue stimulation.

## E. Intended Use

The Stimulation/Dissection Instruments are indicated for tissue dissection and stimulation of peripheral motor nerves for location and identification during surgery, including spinal nerve roots.

{1}------------------------------------------------

# hnological Characterist ت

wa established in this subject Similation Instruments are substantaly equivalent to ol
dicate devices de the PDA for commercial distribution in the subject device was shown a

| Predicate Device | | Subject Device | Substantially<br>Equivalent |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Stimulation/Dissection Instruments<br>K031003 | | NuVasive® Stimulation/Dissection Instruments<br>K112709 | |
| The Stimulation/Dissection Instruments are<br>indicated for tissue dissection and stimulation of<br>cranial and peripheral motor nerves for location<br>and identification during surgery, including<br>spinal nerve roots. | | The Stimulation/Dissection Instruments are indicated<br>for tissue dissection and stimulation of peripheral<br>motor nerves for location and identification during<br>surgery, including spinal nerve roots. | Yes |
| ETN | | ETN | Yes |
| 874.1820 | | 874.1820 | Yes |
| Electrical insulation on all surfaces not intended<br>to provide electrical contact with the patient and<br>connection | | Some instruments have electrical insulation on surfaces<br>not intended to provide electrical contact with the<br>patient and connection while others are used with an<br>insulating accessory that provides electrical insulation<br>on surfaces not intended to provide electrical contact<br>with the patient and connection. | Yes |
| Yes | | Yes | Yes |
| Biocompatible | | Biocompatible:<br>Anodized Aluminum<br>Stainless Steel<br>Radel | Yes |
| Sterile for single use | | Some instruments are provided sterile for single use<br>only while others are provided as non-sterile reusable<br>instruments. | Yes |

# Predicate and Subject Device Comparison 1

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the logo for Nuvasive. The logo consists of a stylized, incomplete circle on the left, followed by the word "NUVASIVE" in a sans-serif font. Below the word "NUVASIVE" is the tagline "Speed of Innovation" in a smaller font.

## G. Performance Data

Nonclinical testing was performed to demonstrate that the subject Stimulation/Dissection Instruments are substantially equivalent to other predicate devices. The following testing was performed:

- . Stimulation and Insulation Impedance
- . Current Density Determination
- . Biocompatibility testing per ISO 10993-1
- . Sterilization validation per ISO 11135-1

The results of these studies showed that the subject Stimulation/Dissection Instruments meets or exceeds the performance of the predicate device, and the device was therefore found to be substantially equivalent.

## Conclusions H.

Based on the indications for use, technological characteristics, performance testing, and comparison to predicate devices, the subject Stimulation/Dissection Instruments has been shown to be substantially equivalent to legally marketed predicate devices, and do not raise new questions of safety or effectiveness.

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image is a logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird-like figure.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

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

NuVasive, Inc. c/o Mr. Elias Ketchum Senior Associate, Regulatory Affairs 7475 Lusk Blvd. San Diego, California 92121

FEB - 9 2012

Re: K112709

Trade/Device Name: NuVasive Stimulation/Dissection Instruments Regulation Number: 21 CFR 874.1820 Regulation Name: Nerve Stimulator/Locator Regulatory Class: Class II Product Code: ETN Dated: January 6, 2012 Received: January 9, 2012

Dear Mr. Ketchum:

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.

{4}------------------------------------------------

# Page 2 - Mr. Elias Ketchum

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

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 vours.

signature

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

{5}------------------------------------------------

K112709

# Indications for Use

510(k) Number (if known): K112709

Device Name: NuVasive® Stimulation and Dissection Instruments

Indications For Use:

The Stimulation/Dissection Instruments are indicated for tissue dissection and stimulation of peripheral motor nerves for location and identification during surgery, including spinal nerve roots.

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 THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

R. Mathe

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

| 510(k) Number | K112709 |
|---------------|---------|
|---------------|---------|

Prescription Use (Per 21 CFR 801.109)

Page 1 of 1