XOMED BALL-TIP MONOPOLAR STIMULATOR PROBE

K992869 · Xomed, Inc. · ETN · Oct 7, 1999 · Ear, Nose, Throat

Device Facts

• Record ID: K992869
• Device Name: XOMED BALL-TIP MONOPOLAR STIMULATOR PROBE
• Applicant: Xomed, Inc.
• Product Code: ETN · Ear, Nose, Throat
• Decision Date: Oct 7, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.1820
• Device Class: Class 2

Intended Use

The Ball-Tip Monopolar Stimulating Probe is intended to stimulate cranial and peripheral motor nerves for location and identification during surgery, including spinal nerve roots.

Device Story

The Xomed Ball-Tip Monopolar Stimulator Probe is a surgical instrument used to locate and identify cranial and peripheral motor nerves, including spinal nerve roots, during surgery. The device consists of a metal ball tip, an insulated flexible metal shaft, and a protected pin electrical connector. It is designed to be connected to an external nerve stimulator. During surgical procedures, a surgeon uses the probe to deliver electrical stimulation to tissues; the resulting nerve response helps the surgeon identify nerve locations. The device is intended for prescription use only.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and intended use comparisons.

Technological Characteristics

Device consists of a metal ball tip, insulated flexible metal shaft, and a protected pin electrical connector. It is a passive surgical instrument designed for use with an external nerve stimulator. No software or electronic processing components are present.

Indications for Use

Indicated for the stimulation of cranial and peripheral motor nerves, including spinal nerve roots, for location and identification during 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

• Magstim/Neurosign Pedicle Hole Probe (K980148)

Submission Summary (Full Text)

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# 510(k) Summary

## 1.0 Date Prepared

August 24, 1999

### Submitter (Contact) 2.0

Martin D. Sargent Xomed Surgical Products Jacksonville, FL [phone]

#### Device Name 3.0

| Proprietary Name: | Xomed Ball-Tip Monopolar Stimulator Probe |
|-------------------------|-------------------------------------------|
| Common Name(s): | Monopolar Stimulator Probe |
| Classification Name(s): | Surgical Nerve Stimulator/Locator |

#### 5.0 Device Classification

Surgical Nerve Stimulator/Locator: Procode ETN Class II 21 CFR 874.1820

#### 6.0 Device Description

The probe includes a metal ball tip, an insulated, flexible metal shaft, and a protected pin electrical connector to attach the probe to a stimulator.

#### 7.0 Intended Use

The Ball-Tip Monopolar Stimulating Probe is intended to stimulate cranial and peripheral motor nerves for location and identification during surgery, including spinal nerve roots.

#### 8.0 Substantial Equivalence

The Xomed Ball-Tip Monopolar Stimulator Probe is substantially equivalent to the Magstim/Neurosign Pedicle Hole Probe as described in K980148 in its intended use, materials, and overall design.

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

Public Health Service

7 1999 OCT

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Martin D. Sargent Sr. Regulatory Affairs Specialist XOMED 6743 Southpoint Dr. N. Jacksonville, Florida

Re: K992869 Trade Name: Xomed Monopolar Stimulator Probe Regulatory Class: II Product Code: 77 ETN Dated: August 25, 1999 Received: August 26, 1999

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 .

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Page 2 - Mr. Martin D. Sargent

· This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

A Roerl Rosenthal

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

Enclosure

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510(k) Number (if known): Ball-Tip Monopolar Stimulator Probe Device Name: _ Indications for Use:

> The Ball-Tip Monopolar Stimulating Probe is intended to stimulate cranial and peripheral The Dail-Tip Honopolar Summandig cation during surgery, including spinal nerve roots.

(Division Sign-Off)
Division of Ophthalmic Devices
10(k) Number k992869

(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)

Prescription Use
(Per 21 CFR 801.109) ✓

Or

Over-the-Counter Use***_***_

(Optional Format 1-2-96)