STIMULUS/DISSECTION INSTRUMENTS, BALL-TIP PROBES

K031003 · Medtronic Xomed, Inc. · ETN · Apr 11, 2003 · Ear, Nose, Throat

Device Facts

• Record ID: K031003
• Device Name: STIMULUS/DISSECTION INSTRUMENTS, BALL-TIP PROBES
• Applicant: Medtronic Xomed, Inc.
• Product Code: ETN · Ear, Nose, Throat
• Decision Date: Apr 11, 2003
• Decision: SESE
• Submission Type: Special
• 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

Manual surgical instruments (scissors, retractors, awls, taps, needles, probes, hooks) used for tissue dissection and nerve stimulation; stainless steel construction with biocompatible electrical insulation on non-contact surfaces; proximal connectors attach to external monopolar stimulator; used by surgeons in operating room; distal non-insulated tip delivers electrical current to stimulate motor nerves; enables intraoperative nerve identification and location; helps prevent nerve damage during dissection.

Clinical Evidence

No clinical data; bench testing only. Device design conforms to IEC 60601-1:1988/A1:1991/A2:1995 Clause 56.3(c) for protected pin design.

Technological Characteristics

Stainless steel manual surgical instruments; biocompatible electrical insulation; protected pin design per IEC 60601-1:1988/A1:1991/A2:1995; monopolar stimulation capability; accessories include cables up to 3M.

Indications for Use

Indicated for patients undergoing surgery requiring tissue dissection and cranial or peripheral motor nerve (including spinal nerve roots) location and identification.

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

• Medtronic Xomed Stimulus Dissection Instruments (K014165)
• Medtronic Xomed Monopolar Stimulator Probes (K992869)

Submission Summary (Full Text)

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K031003

## 510(k) Summary

#### 1.0 Date Prepared

APR 1 1 2003

March 28, 2003

### 2.0 Submitter (Contact)

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

## 3.0 Device Name

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

#### 4.0 Device Classification

| 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 | |

## 5.0 Device Description

The designs of the Stimulus - Dissection Instruments are similar to existing stainless steel manual surgical instruments. The instruments consist of scissors, retractors, awls, taps, needles, probes, 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 non-insulated stainless steel to provide for mechanical, manual 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.

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# 510(k) Summary (continued)

## 7.0 Substantial Equivalence

The design, technology, features, function, and intended use of the Stimulus-Dissection Instrument is substantially equivalent to Medtronic Xomed Stimulus Dissection Instruments cleared via K014165 and Medtronic Xomed Monopolar Stimulator Probes originally described in K992869.

| Characteristic | Stimulus - Dissection<br>Instruments<br>[Proposed Device] | Stimulus / Dissection Instruments<br>[K014165] |
|------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications For<br>Use | Tissue dissection and stimulation<br>of cranial and peripheral motor<br>nerves for location and<br>identification during surgery,<br>including spinal nerve roots. | Tissue dissection and stimulation<br>of cranial and peripheral motor<br>nerves for location and<br>identification during surgery,<br>including spinal nerve 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 surfaces<br>not intended to provide electrical<br>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 |
| Single Use,<br>Sterile | Yes | Yes<br>[K992869] |

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## APR 11 2003

Medtronic Xomed, Inc. c/o Mr. Martin D. Sargent Regulatory Affairs Manager 6743 Southpoint Drive North Jacksonville, FL 32216

Re: K031003

Trade/Device Name: Stimulus/Dissection Instruments, Ball-Tip Probes Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical nerve stimulator/locator Regulatory Class: Class II Product Code: ETN Dated: March 28, 2003 Received: March 31, 2003

Dear Mr. Sargent:

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 such 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); 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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Page 2 - Mr. Martin D. Sargent

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 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/dsma/dsmamain.html

Sincerely vours,

A. halpi 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

Enclosure

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K031003 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 peripheral motor nerves for location and identification during surgery, including 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 H. Baker
(Division Sign-Off)

Division of Ophthalmic Ear, Nose and Throat Devises

510(k) Number_ K031003