STIMULUS - DISSECTION INSTRUMENTS

K014165 · Medtronic Xomed, Inc. · ETN · Jan 22, 2002 · Ear, Nose, Throat

Device Facts

• Record ID: K014165
• Device Name: STIMULUS - DISSECTION INSTRUMENTS
• Applicant: Medtronic Xomed, Inc.
• Product Code: ETN · Ear, Nose, Throat
• Decision Date: Jan 22, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.1820
• Device Class: Class 2

Intended Use

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

Device Story

Stimulus-Dissection Instruments are manual surgical tools (scissors, forceps, retractors, hooks) used for tissue dissection and nerve stimulation. Devices consist of stainless steel with biocompatible electrical insulation on non-contact surfaces. Proximal connectors attach to a monopolar stimulator; distal non-insulated surfaces provide mechanical dissection and electrical stimulation. Used in surgery by clinicians to locate and identify cranial, peripheral motor, and spinal nerve roots. Benefits include combined mechanical dissection and nerve localization functionality in a single instrument. Steam autoclavable.

Clinical Evidence

No clinical data. Substantial equivalence is based on design, technological characteristics, and intended use comparisons to predicate devices.

Technological Characteristics

Stainless steel construction; biocompatible electrical insulation; monopolar stimulation capability; protected pin design per IEC 60601-1:1988/A1:1991/A2:1995 Clause 56.3(c); steam autoclavable; manual actuation.

Indications for Use

Indicated for tissue dissection and stimulation of cranial and 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

• Ball-Tip Monopolar Stimulating Probe (K992869)

Submission Summary (Full Text)

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

KO14163

# 510(k) Summary

JAN 2 2 2002

#### 1.0 Date Prepared

January 14, 2002

#### Submitter (Contact) 2.0

Martin D. Sargent Regulatory Affairs Manager Medtronic Xomed Jacksonville, FL [phone]

#### 3.0 Device Name

| Proprietary Name: | Stimulation / Dissection Instruments (Tradenames have not been<br>finalized at this time) |
|-------------------------|-------------------------------------------------------------------------------------------|
| Common Name(s): | Nerve Stimulator / Locator |
| Classification Name(s): | Surgical Nerve Stimulator / Locator |

#### Device Classification 4.0

| Classification Name: Surgical Nerve Stimulator / Locator and accessories | | |
|--------------------------------------------------------------------------|----------|-------------------|
| Procode 77ETN | Class II | 21 CFR § 874.1820 |
| Procode Various | Class I | 21 CFR § 874.4420 |
| Procode Various | Class I | 21 CFR § 878.4800 |

#### Device Description 5.0

The designs of the Stimulus - Dissection Instruments are similar to existing stainless steel manual surgical instruments. The instruments consist of scissors, forceps, retractors, and hooks with biocompatible electrical insulation applied to selected portions, and proximal connectors provided to attach the instruments to a monopolar stimulator. The distal surfaces of the instruments are noninsulated stainless steel to provide for mechanical, manually actuated dissection / resection, and tissue stimulation. The Stimulus - Dissection Instruments 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. Accessories include monopolar cables available in lengths up to 3 M.

#### 6.0 Indications for Use

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

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

## 510(k) Summary (continued)

### Substantial Equivalence 7.0

The design, technology, features, function, and intended use of the intraoperative neurological stimulation feature of the Stimulus-Dissection Instrument is substantially equivalent to Medtronic Xomed Monopolar Stimulator Probe originally described in K992869.

The design, technology, features, function, and intended use of the mechanical dissection feature is substantially equivalent to Class I exempt manual surgical instruments such as those described in 21 CFR § 874.4420 and 21 CFR § 878.4800.

| Characteristic | Stimulus - Dissection Instruments | Ball-Tip Monopolar<br>Stimulating Probe [K992869] |
|------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Indications For<br>Use | Tissue dissection and stimulation of<br>cranial and peripheral motor nerves<br>for location and identification<br>during surgery, including spinal<br>nerve roots. | To stimulate cranial and<br>peripheral motor nerves for<br>location and identification during<br>surgery, including spinal nerve<br>roots. |
| Stainless steel<br>construction | Yes | Yes |
| Electrical<br>insulation | Electrical insulation on all surfaces<br>not intended to provide electrical<br>contact with the patient | Electrical insulation on all<br>surfaces not intended to provide<br>electrical contact with the patient |
| Distal stainless<br>steel patient<br>contact surface | Yes | Yes |
| Proximal<br>stimulator<br>connector | Yes | Yes |
| IEC 60601-1<br>Protected Pin<br>design | Yes | Yes |
| Biocompatible | Yes | Yes |
| Steam<br>autoclavable | Yes | Yes |

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

Image /page/2/Picture/1 description: The image is a seal for the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 2 2002

Medtronic Xomed, Inc. c/o Martin D. Sargent 6743 Southpoint Dr. North Jacksonville, FL 32216

Re: K014165

Trade/Device Name: Stimulation/Dissection Instruments Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical Nerve Stimulator/Locator Regulatory Class: Class II Product Code: ETN Dated: December 18, 2002 Received: December 19, 2002

Dear Mr. Sargent:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally prematted predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

A. Ralph Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

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

16014165 510(k) Number (if known): __ Stimulus - Dissection Instruments Device Name: Indications for Use:

.

The Stimulus - Dissection Instruments are indicated for tissue dissection and stimulation of cranial and periph-I he Stimulus - Dissection insulance are indicated for about the research of the spinal nerve roots.

> (Please do not write below this line - continue on another page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Or

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Karen Bahr '41

(Division Sign-Off) Division of Ophthalmic Ea Nose and Throat Devis

510(k) Number K014165