BAXANO NEURO CHECK DEVICE

K092729 · Baxano, Inc. · ETN · Oct 2, 2009 · Ear, Nose, Throat

Device Facts

• Record ID: K092729
• Device Name: BAXANO NEURO CHECK DEVICE
• Applicant: Baxano, Inc.
• Product Code: ETN · Ear, Nose, Throat
• Decision Date: Oct 2, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 874.1820
• Device Class: Class 2

Intended Use

The Baxano, Inc. Neuro Check Device is for use with Baxano cutting and biting devices for localization of motor nerves in settings where visualization is compromised.

Device Story

The Neuro Check Device is a surgical nerve stimulator/locator used during spinal column surgery. It is designed to be placed in the neural foramen to assist surgeons in locating motor nerves when visualization is compromised. The device functions by directing energy from a commercial EMG system to electrodes on the probe; a switch allows the surgeon to toggle between bipolar and monopolar stimulation modes. By providing feedback regarding the relative location of a nerve root to the device, it helps surgeons avoid nerve damage without requiring additional bone removal. It is used in the operating room by surgeons.

Clinical Evidence

No clinical data provided. Evidence consists of mechanical and electrical performance testing to verify design specifications and animal studies.

Technological Characteristics

Surgical nerve stimulator/locator; probe form factor for placement in neural foramen; electrodes for energy delivery; supports both bipolar and monopolar stimulation; connects to commercial EMG systems.

Indications for Use

Indicated for localization of motor nerves during spinal column surgery in patients where visualization is limited, as an alternative to removing additional bone for direct visualization.

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

• Baxano Neural Localization Probe (K081742)

Submission Summary (Full Text)

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K092729

# BAXAN

OCT - 2 2009

## 510(K) SUMMARY (21 CFR 807.92)

### NEURO CHECK DEVICE

510(k) Owner:

ﻘ

Baxano, Inc. 2660 Marine Way, Suite B Mountain View, CA 94043 Tel: [phone] Fax: [phone]

September 3, 2009

(21 CFR 874.1820)

etn, hae

Baxano Neuro Check Device

Surgical nerve stimulator/locator

Class II, Surgical nerve stimulator/locator

Contact Person:

Cindy Domecus Tel: [phone] E-mail: [e-mail]

Date Prepared:

Trade Name:

Common Name:

Classification:

Product Code:

Predicate Device Information:

The modified Baxano Neural Localization Probe (now referred to as the Baxano Neuro Check Device) is substantially equivalent to the Baxano Neural Localization Probe, which was determined substantially equivalent on Sept 17, 2008 (K081742).

The modified device allows for addition of monopolar stimulation. Device Description: A switch directs the stimulus signal so that the nerve can be located relative to the Neuro Check Device. The Neuro Check Device assists in the localization of nerve roots during spinal column surgery where visualization is limited as an alternative to removing additional bone for direct visualization.

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Intended Use:

Technological

Characteristics:

The Baxano, Inc. Neuro Check Device is for use with Baxano cutting and biting devices for localization of motor nerves in settings where visualization is compromised.

The Neuro Check Device is designed to be placed in the neural foramen to enable the surgeon to direct energy from a commercial EMG system to electrodes on the device enabling feedback regarding relative location of a nerve root to the device. The modification allows for the use of both bipolar and monopolar stimulation. The fundamental scientific technology is unchanged from the predicate.

Mechanical and electrical performance tests were conducted to verify that the device meets design specifications and performance characteristics, based upon the intended use. The modified Neuro Check Device is equivalent to the predicate Neural Localization Probe.

The Neuro Check Device is substantially equivalent to the Neural Localization Probe, which was determined substantially equivalent on Sept 17, 2008 (K081742). The Neuro Check Device has the same indications for use and fundamental scientific technology as its predicate. Based upon the indications for use, technological characteristics and performance test results, changes to the Neuro Check Device do not raise new questions of safety or effectiveness.

Baxano has determined, based on the performance testing and animal studies that the Neuro Check Device conforms to the design specifications and is substantially equivalent to the predicate device.

Any statement regarding "substantial equivalence" made in this 510(k) submission and summary only relates to whether the product addressed in this submission may be lawfully morketed without premarket approval or reclassification, and is not intended to be interpreted as an admission or any other type of evidence in any patent proceeding, including potent infringement, litigation or proceeding before any Patent Office. The present submission and statements therein therefore should not be construed as affecting to the scope of any patent or patent or patent application, or to whether the product addressed in this submission, or its use, may be considered indistinct, from a patentability perspective, from any of the other devices referenced in this filing.

Performance Data:

Non-Clinical

Substantial Equivalence:

Conclusions:

\$

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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVIC" in all capital letters. The text is black and appears to be printed on a white background. The text is horizontally oriented and evenly spaced.

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

Baxano, Inc. c/o Ms. Patty Hevey Director of Clinical and Regulatory Affairs 2660 Marine Way Suite B Mountain View, CA 94043

OCT - 2 2009

Re: K092729

Trade/Device Name: Baxano Neuro Check Device Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical Nerve Stimulator/Locator Regulatory Class: II Product Code: ETN Dated: September 3, 2009 Received: September 4, 2009

Dear Ms. Hevey:

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.

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/CDRH0ffices/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/cdrh/mdr/ 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/cdrh/industry/support/index.html.

Sincerely vours.

Robe. Thm. m k

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 STATEMENT

K092729 510(k) Number (if known):

Device Name: Neuro Check Device

Indications for Use: The Baxano, Inc. Neuro Check Device is for use with Baxano cutting and biting devices for localization of motor nerves in settings where visualization is compromised.

Over-The-Counter Use Prescription Use _ × AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

#### Concurrence of CDRH, Office of Device Evaluation (ODE)

Kristen Bowsher
(Division Sign-Off)

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Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number_Kog_23229