GYRUS ENT NERVE STIMULATOR

K021595 · Gyrus Ent LLC · ETN · Oct 24, 2002 · Ear, Nose, Throat

Device Facts

• Record ID: K021595
• Device Name: GYRUS ENT NERVE STIMULATOR
• Applicant: Gyrus Ent LLC
• Product Code: ETN · Ear, Nose, Throat
• Decision Date: Oct 24, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.1820
• Device Class: Class 2

Intended Use

The Gyrus ENT Nerve Stimulator is intended to provide electrical stimulation to cranial and peripheral motor nerves to aid in nerve location during surgical procedures.

Device Story

Gyrus ENT Nerve Stimulator provides electrical stimulation to cranial and peripheral motor nerves; aids surgeons in nerve location and identification during surgical procedures. Device operates via 100-240VAC power supply; supports monopolar and bipolar probes. User interface includes touch pad for frequency selection (3, 10, 30Hz), current adjustment (0.1-5.0 mA), and visual indicators for frequency and current confirmation. Surgeon uses device intraoperatively to test nerve excitability; output helps identify nerve proximity, potentially reducing risk of nerve damage during surgery.

Clinical Evidence

Bench testing only. Device safety verified through UL2601/IEC 601 testing for electrical safety and IEC 601-1-2 for electromagnetic compatibility.

Technological Characteristics

Electrical nerve stimulator; 100-240VAC, 50/60Hz power source. Supports monopolar and bipolar probes. Features digital display for current settings and frequency/current confirmation indicators. Safety standards: UL2601/IEC 601, IEC 601-1-2.

Indications for Use

Indicated for use by clinicians during surgical procedures to provide electrical stimulation to cranial and peripheral motor nerves to aid in nerve location and identify nerves and test their excitability.

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

• Neurosign Model 100

Submission Summary (Full Text)

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OCT 2 4 2002

# 510(k) Summary of Safety and Effectiveness

| Trade Name: | Gyrus ENT Nerve Stimulator |
|----------------------|-----------------------------------------------------------------------------------------------------------------|
| Common Name: | Surgical nerve stimulator/locator |
| Classification Name: | Surgical nerve stimulator/locator (§ 874.1820) |
| Official Contact: | Gregory Sredin<br>Sr. Regulatory Affairs Specialist<br>Gyrus ENT LLC<br>2925 Appling Road<br>Bartlett, TN 38133 |
| Telephone: | [phone] |
| Telefax: | [phone] |
| Date Prepared: | May 13, 2002 |

The Gyrus ENT Nerve Stimulator is intended to provide electrical stimulation to cranial and peripheral motor nerves to aid in nerve location during surgical procedures.

The Gyrus ENT Nerve Stimulator that is described in this notification has the same technological characteristics, power modality and mode of operation as the predicate device. The intended use is substantially equivalent to the described predicate Neurosign Model 100. The Gyrus ENT Nerve Stimulator is designed to meet:

- UL2601/IEC 601 safety testing for 100Vac, 50/60 Hz. .
- UL2601/IEC 601 safety testing for 120Vac, 50/60 Hz. .
- UL2601/IEC 601 safety testing for 220Vac, 50/60 Hz. .
- UL2601/IEC 601 safety testing for 240Vac, 50/60 Hz. .
- EMC Testing, IEC 601-1-2. .

Conclusion: As a nerve stimulator only the Gyrus ENT Nerve Stimulator has the same intended use and the same basic technological characteristics as the Neurosion Model 100 Neural Tissue Stimulator and does not raise any new issues of safety or effectiveness.

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#

| | Gyrus ENT Nerve Monitor | Neurosign 100 Nerve Monitor |
|------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Gyrus ENT Nerve Stimulator is intended<br>to provide electrical stimulation to the body to<br>locate and identify nerves and to test their<br>excitability. | The device is intended to stimulate and monitor<br>cranial motor nerves. |
| Power Supply | 100-240VAC; 50-60Hz, features power<br>on LED. | 100-240VAC; 50-60Hz |
| Frequency | 3, 10, 30Hz, touch pad and frequency<br>confirm indicator. | 3, 30Hz, 2-position switch, no<br>frequency confirm indicator. |
| Current | 0.1 - 5.0 ma, in 0.1 ma increments<br>with display to show setting and<br>current confirm indicator. | 0.15 - 5.0 ma, variable settings, but no<br>display to show actual setting. Does<br>feature current confirm indicator, |
| Probes supported | Monopolar and Bipolar | Monopolar and Bipolar |

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Gyrus ENT c/o Greg Sredin Sr. Regulatory Affairs Specialist 2925 Appling Road Bartlett, TN 38133

Re: K021595

Trade/Device Name: Gyrus ENT Nerve Stimulator Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical Nerve Stimulator/locator Regulatory Class: Class II Product Code: ETN Dated: September 17, 2002 Received: September 18, 2002

Dear Mr. Sredin:

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.

OCT 24 2002

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### Page 2 – Greg Sredin

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 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

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Food and Drug Administration 510(k) Notification - Gyrus ENT Nerve Stimulator May 13, 2002

510(k) Number: Device Name:

:

KO215-95

Gyrus ENT Nerve Stimulator

### Indications for Use:

The Gyrus ENT Nerve Stimulator is intended to provide electrical stimulation to cranial and peripheral motor nerves to aid in nerve location during surgical procedures.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use . (Per 21 CFR 801.109)

(Optional Format 1-2-96)

| Prescription Use<br>(Per 21 CFR 801.109) | ✓ |
|------------------------------------------|---|
|------------------------------------------|---|

OR

| Over-the-Counter | |
|--------------------------|--|
| (Optional Format 1-2-96) | |

(Division Sign-Off)Division of Onhthalmic Ear, Nose a: .. session

510(k) Number K021595

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