STIMULUS/DISSECTION INSTRUMENTS

K090838 · Axon Systems, Inc. · ETN · Jul 20, 2009 · Ear, Nose, Throat

Device Facts

• Record ID: K090838
• Device Name: STIMULUS/DISSECTION INSTRUMENTS
• Applicant: Axon Systems, Inc.
• Product Code: ETN · Ear, Nose, Throat
• Decision Date: Jul 20, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.1820
• Device Class: Class 2

Intended Use

These instruments are intended to be used for pedicle preparation or access to the vertebral body. The instruments are used for screw placement in open and minimally invasive procedures to reduce the risk of nerve root injury and deficits from misplaced screws by providing early warning of pedicle breach.

Device Story

Disposable, sterile surgical instruments (needles, probes, dilators) used for tissue dissection and spinal nerve root stimulation. Devices feature stainless steel distal tips for stimulation and biocompatible electrical insulation on shafts; proximal connectors attach to external monopolar stimulators. Operated by surgeons in OR settings during spinal procedures (e.g., pedicle preparation, screw placement). Device provides physical access to vertebral body while enabling intraoperative nerve monitoring; electrical stimulation helps identify nerve proximity, providing early warning of pedicle breach to reduce risk of nerve root injury. Output is physical tissue interaction and electrical stimulation; clinical decision-making relies on surgeon interpretation of nerve response to stimulation.

Clinical Evidence

No clinical data. Bench testing only, including verification of electrical insulation and mechanical design requirements.

Technological Characteristics

Needles, probes, and dilators; stainless steel and aluminum alloy construction; biocompatible electrical insulation; proximal connectors for monopolar stimulator; non-insulated distal tips. Meets IEC 60601-1:1988/A1:1991/A2:1995 Clause 56.3(c) per 21 CFR 898.12. Supplied sterile in dual barrier trays.

Indications for Use

Indicated for tissue dissection and stimulation of spinal nerve roots for identification and location during surgery in patients undergoing open or minimally invasive spinal 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

• Stimulus Dissection Instruments (K031003)
• Disposable Stimulator Probes (K062996)
• Surgical Nerve Stimulator/Locator (K002677)

Submission Summary (Full Text)

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90238

#### Appendix J 510(k) Summary of Substantial Equivalence

JUL 20 2009

### 510k Summary of Safety and Effectiveness

Company Name: Axon Systems, Inc. 80-5 Davids Drive Hauppauge, NY 11788

Contact: Howard Bailin Vice President, C.O.O. Phone: [phone] Fax: [phone] Email: [e-mail]

Summary Date February 26, 2009

Proprietary Name: ХРАК ІІ ХРАК

Common Name:

Nerve Stimulator/Locator

Classification:

Class II (Performance Standards) Number: 874.1820 Nerve Stimulator/Locator Procode: ETN

Predicate Devices

Manufacturer: Medtronic Xomed Trade Name: Stimulus Dissection Instruments FDA number: K031003

Manufacturer: Axon Systems, Inc Trade Name: Disposable Stimulator Probes FDA number: K062996

Manufacturer: Nuvasive Trade Name: Surgical Nerve Stimulator/Locator FDA number: K002677

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#### Appendix J 510(k) Summary of Substantial Equivalence

#### Device Description

Axon Systems' Stimulus Dissection Instruments are disposable (for "Single Use Only"), sterile devices used for tissue dissection and stimulation of spinal nerve roots for location and identification during surgery.

These instruments consists of probes of differing shapes and sizes with biocompatible electrical insulation applied to select portions, and proximal connectors provided to attach the instruments to a monopolar stimulator. The distal surfaces of the instruments are non-insulated stainless steel to provide for probing and tissue stimulation. The probes are a protected pin design and meet the requirements of IEC 60601-1:1988 / A1:1991 / A2:1995 Clause 56.3(c) per 21 CFR 898.12

The instruments consist of needles, probes and dilators (expanding set of cannulas) designed to provide physicians with the ability to perform tissue dissection and stimulation intraoperatively.

The designs of the proposed Stimulus Dissection accessories are similar to Class I exempt surgical instruments such as those described in 21 CFR 888.4540 Orthopedic Manual Surgical Instrument. The instruments consists of stainless steel and aluminum alloy needles, probes and dilators with biocompatible electrical insulation applied to selected portions, proximal electrical connectors to attach the instruments to a monopolar electrical stimulator and in some cases, a proximal ABS handle. The distal surfaces of the instruments are non-insulated and provide for manual dissection / resection / probing and tissue stimulation.

#### Intended Use

These instruments are intended to be used for pedicle preparation or access to the vertebral body. The instruments are used for screw placement in open and minimally invasive procedures to reduce the risk of nerve root injury and deficits from misplaced screws by providing early warning of pedicle breach.

#### Technological Characteristics

These Stimulus Dissection Instruments consists of needles, probes and dilators of differing shapes and sizes with biocompatible electrical insulation applied to select portions, and proximal connectors provided to attach the instruments to a monopolar stimulator. The distal surfaces of the instruments are non-insulated stainless steel to provide for probing and tissue stimulation. The connector is specifically designed so that it cannot be plugged into AC power outlet. The Stimulus Dissection Instruments are supplied in dual barrier sterile trays. Materials used are the same as in the predicate devices.

#### Conclusions

Axon Systems' Stimulus Dissection Instruments are substantially equivalent to the predicate devices. No new questions of safety or effectiveness are raised or evident.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its wing and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUL 2 0 2009

Axon Systems, Inc. % Howard Bailin Vice President, C.O.O. 80-5 Davids Drive Hauppauge, NY 11788

Re: K090838

Trade Name: Axon Systems, Inc. Stimulus/dissection instruments Regulation Number: 21 CFR § 874.1820 Regulation Name: Surgical Nerve Stimulator/Locator Regulatory Class: Class II Product Code: ETN Dated: May 27, 2009 Received: June 9, 2009

Dear Mr. Bailin:

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 devicerelated 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/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 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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# Indications for Use

#### 510(k) Number: K090838

## Device Name: Axon Systems, Inc. Stimulus/dissection instruments

Indications For Use:

These instruments are 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 LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
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| Division of Ophthalmic, Neurological and Ear, | Page 1 of 1 |
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| 510(k) Number | K090838 |
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