DISPOSABLE STIMULATING ELECTRODE

K111597 · Nuvasive, Inc. · ETN · Oct 13, 2011 · Ear, Nose, Throat

Device Facts

• Record ID: K111597
• Device Name: DISPOSABLE STIMULATING ELECTRODE
• Applicant: Nuvasive, Inc.
• Product Code: ETN · Ear, Nose, Throat
• Decision Date: Oct 13, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.1820
• Device Class: Class 2

Intended Use

The NuVasive Disposable Stimulating Electrode is indicated for tissue dissection and stimulation of spinal nerve roots for identification and location during surgery.

Device Story

Single-use, sterile stimulating electrode; composed of polyphenylsulfone (PPSU) and conductive silver. Features dielectric-coated shaft and non-insulated distal tip for tissue stimulation; proximal connector attaches to compatible neuromonitoring stimulators. Used by surgeons during spinal procedures to identify and locate nerve roots via electrical stimulation. Device facilitates safe tissue dissection by providing feedback to the surgeon regarding proximity to neural structures, thereby reducing risk of nerve injury.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated through non-clinical bench testing: impedance and durability testing, biocompatibility (ISO 10993 series), sterilization validation (ISO 11135-1, AAMI TIR 28), bioburden analysis (ISO 11737-1), EO residual analysis (ISO 10993-7), and shelf-life validation (ASTM F1980, D4332, F2096, F88; ISO 11607).

Technological Characteristics

Single-use, sterile electrode. Materials: Polyphenylsulfone (PPSU) and conductive silver. Dielectric coating for insulation. Connectivity: Non-insulated proximal connector for neuromonitoring stimulators. Sterilization: Ethylene Oxide (EO). Standards: ISO 10993 (biocompatibility), ISO 11135-1 (sterilization), ASTM F1980/D4332/F2096/F88 (shelf life).

Indications for Use

Indicated for tissue dissection and stimulation of spinal nerve roots for identification and location during surgery in patients undergoing surgical procedures.

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

• Cadwell Disposable Stimulator Probe (K103128)
• Axon Systems Stimulus/dissection Instruments (K090838)
• Medtronic Xomed Stimulus / Dissection Instruments (K031003)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for Nuvasive. The logo consists of a stylized letter N on the left and the word "NUVASIVE" on the right. Below the word "NUVASIVE" is the tagline "Speed of Innovation".

# 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.

Sheila Bruschi Associate Manager, Regulatory Affairs NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121

Date Prepared: September 29, 2011

### Device Name B.

| Trade or Proprietary Name: | <i>NuVasive</i> ® Disposable Stimulating Electrode |
|----------------------------|----------------------------------------------------|
| 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 Disposable Stimulating Electrode is substantially equivalent to the following predicate devices currently distributed commercially in the U.S.:

- K103128 Cadwell Disposable Stimulator Probe ●
- K090838 Axon Systems Stimulus/dissection Instruments ●
- K031003 Medtronic Xomed Stimulus / Dissection Instruments .

#### Device Description D.

The Disposable Stimulating Electrode is a single-use; sterile stimulating electrode composed of polyphenylsulfone (PPSU) and a conductive silver. The Disposable Stimulating Electrode is insulated along its length with a dielectric coating, a non-insulated proximal connector to attach to any compatible neuromonitoring stimulator, and a non-insulated distal tip to deliver tissue stimulation.

## E. Intended Use

The NuVasive Disposable Stimulating Electrode is indicated for tissue dissection and stimulation of spinal nerve roots for identification and location during surgery.

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Image /page/1/Picture/1 description: The image shows the logo for Nuvasive. The logo consists of a stylized graphic to the left of the company name. Below the company name is the tagline "Speed of Innovation".

## Technological Characteristics F.

As was established in this submission. the subject Disposable Stimulating Electrode is substantially equivalent to other predicate devices cleared by the FDA for commercial distribution in the United States. The subject device was shown to be substantially equivalent and have the same technological characteristics to its predicate devices through comparison in areas including design, intended use, material composition, pyrogenicitylabeling, and functions. The device is not labeled as non-pyrogenic. The shelf life of the device is

## Performance Data G.

Nonclinical testing was performed to demonstrate that the subject Disposable Stimulating Electrode is substantially equivalent to other predicate devices. The following testing was performed:

- Impedance and Durability Testing
- 트 Biocompatibility testing per:
- ISO 10993-1:2009, ISO 10993-10:2002/Amd. 1:2006(E), ISO 10993-11:2006, ISO 10993-5:2009
- Sterilization assessment and adoption per AAMI TIR 28: 2009
- Sterilization validation on a master device per ISO 11135-1: 2007
- 트 Bioburden analysis per ISO 11737-1:2006
- EO sterilization residual analysis per ISO 10993-7:2008
- I Shelf life validation per:

ASTM F1980: 2007. ASTM D4332-01: 2006. ISO 11607: 2006. ASTM F2096: 2004, and ASTM F88:2009.

The results of these studies showed that the subject Disposable Stimulating Electrode meets or exceeds the performance of the predicate device, and the device was therefore found to be substantially equivalent.

## H. Conclusions

Based on the indications for use, technological characteristics, performance testing, and comparison to predicate devices, the subject Disposable Stimulating Electrode has been shown to be substantially equivalent to legally marketed predicate devices, and safe and effective for its intended use.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter of the circle. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

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

NuVasive, Inc. c/o Ms. Sheila Bruschi 7475 Lusk Boulevard San Diego, CA 92121

OCT 1 3 2011

Re: K111597

Trade/Device Name: Disposable Stimulating Electrode Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical Nerve Stimulator/Locator Regulatory Class: Class II Product Code: ETN Dated: September 20, 2011 Received: September 21, 2011

Dear Ms. Bruschi:

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.

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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.

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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Q. A. Peterson L

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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# Indications for Use

510(k) Number (if known):_K111597

Device Name: NuVasive® Disposable Stimulating Electrode

Indications For Use:

The NuVasive® Disposable Stimulating Electrode is indicated for tissue dissection and stimulation of spinal nerve roots for identification and location during surgery.

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)

B. Nall

Division Sign-Off) Division of Ophthalmic, Neurological and Ear, ·Jose and Throat Devices

Prescription Use
X
(Per 21 CFR 801.109)

510(k) Number K111597

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