HILGER DUAL-STIM NERVE STIMULATOR

K063560 · Wr Medical Electronics Co. · ETN · Jan 5, 2007 · Ear, Nose, Throat

Device Facts

• Record ID: K063560
• Device Name: HILGER DUAL-STIM NERVE STIMULATOR
• Applicant: Wr Medical Electronics Co.
• Product Code: ETN · Ear, Nose, Throat
• Decision Date: Jan 5, 2007
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 874.1820
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Hilger Dual-Stim Nerve Stimulator provides electrical stimulation to nerves during diagnostic and surgical procedures.

Device Story

Hilger Dual-Stim Nerve Stimulator is a battery-powered (with optional AC) device used in hospitals, operating rooms, and clinics. It provides electrical stimulation to nerves to assist physicians in nerve location during diagnostic and surgical procedures. The device features two operational modes: Clinical Mode (6 Hz, 0.0006 ms pulse width) and Surgical Mode (5 Hz, 0.0002 ms pulse width), both delivering up to 10 mA current. The device is operated by clinicians who apply various probe configurations (bipolar, remote surgical, monopolar) to the patient. The device provides the stimulation, while the clinician observes and interprets the patient's nerve response to guide clinical decision-making. It benefits patients by facilitating accurate nerve identification during procedures.

Clinical Evidence

No clinical data provided. Evidence consists of bench testing, including software verification and validation, and declaration of compliance with safety standards (EN/IEC 60601-1, 60601-1-2, 60601-2-10, 60601-2-40).

Technological Characteristics

Battery-powered (4 C-cells) or optional AC line-operated nerve stimulator. Features two modes: Clinical (6 Hz, 0.0006 ms pulse) and Surgical (5 Hz, 0.0002 ms pulse). Output current up to 10 mA. Compatible with bipolar, remote surgical, and monopolar probes. Complies with EN/IEC 60601-1, 60601-1-2, 60601-2-10, and 60601-2-40 safety standards.

Indications for Use

Indicated for patients undergoing diagnostic or surgical procedures requiring nerve stimulation to aid in nerve location. No specific age or gender restrictions provided.

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

• Hilger Facial Nerve Stimulator (Preamendment)
• Brackman EMG Monitoring System (K895838)
• Gyrus ENT Nerve Stimulator (K021595)

Submission Summary (Full Text)

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5063567

# First Ronkes CO

/ORTH SECOND STREET, STILLWATER, MN 55082 ■ 651-430-1200 ■ TOLL-FREE 800-321-6387 ■ TAX 651-4.9-9733 ■ WWW.WWWFD C CM

## 510(k) Summary

| Company Name: | WR Medical Electronics CO. | | | |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--------------|
| Device Name: | Hilger Dual-Stim Nerve Stimulator | | | |
| | | | | JAN - 5 2007 |
| 510(k) Sponsor, Contact: | WR Medical Electronics CO.<br>123 North 2nd Street<br>Stillwater, MN 55082<br>Jack Blais, President<br>Phone: [phone]<br>Fax: [phone] | | | |
| Summary Date: | November 21, 2006 | | | |
| Common Name: | Nerve Stimulator | | | |
| Classification Name: | Nerve Stimulator 21 CFR 874.1820, Product Code: ETN, Class II | | | |
| Predicate Device(s): | Preamendment - Hilger Facial Nerve Stimulator<br>K895838 - Brackman EMG Monitoring System<br>K021595 - Gyrus ENT Nerve Stimulator | | | |

#### 1.0 Description of Device

The Hilger Dual-Stim Nerve Stimulator is a self contained, battery powered device. There is an option to provide a line powered option in the future.

Two modes of nerve stimulation are provided, a Clinical Mode and a Surgical Mode. Table 1.0-1 summarizes the differences in these stimulation modes.

| Feature | Clinical Mode | Surgical Mode |
|-------------------------|---------------------|---------------------|
| Stimulation Current | Up to 10 mA | Up to 10 mA |
| Stimulation Pulse Width | 0.0006 micro second | 0.0002 micro second |
| Stimulation Frequency | 6 Hz | 5 Hz |

### File: Hilger Dual Stim 510k 11-21-2006 final

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#### 1.1 Variations and Accessories

The only variations of the Hilger Dual-Stim Nerve Stimulator are a battery powered device and a future optional AC line operated device. The safety standards that these two variations meet are the same.

Accessories applied to the Hilger Dual-Stim Nerve Stimulator are probe configurations compatible with the two different stimulation modes:

- 1. Bipolar Clinical Probe
- 2. Remote Surgical Probe
- Monopolar Disposable Probe 3.
- 4. Silverstein Adapter for Continuous Stimulation (SACS Kit)
- 5. Hilger Dual-Stim Adapter.

The Hilger Dual-Stim Nerve Stimulator is used in hospitals, operating rooms and clinical environments to support clinical evaluation of nerves. The Hilger Dual-Stim Nerve Stimulator provides the nerve stimulation; the user provides the interpretation of appropriate nerve response.

#### 2.0 Intended use of Device

The intended use of the Hilger Dual-Stim Nerve Stimulator is:

The Hilger Dual-Stim Nerve Stimulator provides electrical stimulation to nerves during diagnostic and surgical procedures.

#### 3.0 Technological Characteristics

The technical characteristics of the Hilger Dual-Stim Nerve Stimulator are equivalent to those of the predicate devices. The following table summarizes significant feature comparisons.

File: Hilger Dual Stim 510k 11-21-2006 final

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| | Feature | Hilger Dual-Stim<br>Nerve Stimulator<br>Under Review | Predicate<br>Hilger<br>(Preamendment) | Predicate<br>Brackman<br>(K895838) | Predicate<br>Gyrus ENT Nerve<br>Stimulator<br>(K021595) |
|----|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. | Intended Use,<br>Indications for<br>Use | The Hilger Dual-Stim<br>Nerve Stimulator<br>provides electrical<br>stimulation to nerves<br>during diagnostic and<br>surgical procedures. | The Hilger Facial<br>Nerve Stimulator<br>provides electrical<br>stimulation to nerves<br>to aid in nerve location<br>during diagnostic and<br>surgical procedures. | The Brackman EMG<br>Monitor/Stimulator is<br>used to stimulate and<br>monitor cranial nerves | The Gyrus ENT Nerve<br>Stimulator is intended<br>to provide electrical<br>stimulation to cranial<br>and peripheral motor<br>nerves to aid in nerve<br>location during<br>surgical procedures. |
| 2. | Environment<br>of Use | Hospital, Operating<br>Room, Clinic | Hospital, Operating<br>Room, Clinic | Hospital, Operating<br>Room, Clinic | Hospital, Operating<br>Room, Clinic |
| 3. | Stimulation<br>Modes | Two<br>Clinical Mode<br>Surgical Mode | One<br>Same as Hilger Dual-<br>Stim Clinical Mode | One<br>Same as Hilger Dual-<br>Stim Surgical Mode | One |
| 4. | Stimulation<br>Probes | Bipolar Clinical Probe<br>Remote Surgical Probe<br>Monopolar Disposable<br>Probe | Bipolar Stimulator<br>Probe | Bipolar Stimulator<br>Probe<br>Monopolar Surgical<br>Stimulating Probe<br>Needle and Hook Wire<br>Electrodes | Monopolar and<br>Bipolar |
| 5. | Stimulation<br>Current | 0 to 10 mA | 0 to 10 mA | 0.01 to 4 mA | 0 to 5 mA |
| 6. | Stimulation<br>Pulse Width | Clinical Mode:<br>0.0006 seconds<br>Surgical Mode:<br>0.0002 seconds | 0.0006 seconds | 0.002 seconds | Unknown |
| 7. | Stimulation<br>Frequency | Clinical Mode: 6 Hz<br>Surgical Mode: 5 Hz | 6 Hz | 5 Hz | 3, 10, 30 Hz |
| 8. | Power | Battery 6 VDC<br>(4 – "C" Cells)<br>Option for AC Power | Battery 6 VDC<br>(4 -- "C" Cells) | Battery<br>(Lead Acid)<br>Battery Charger<br>Accessory option | AC Power |
| 9. | Safety<br>Standards<br>Compliance | EN/IEC 60601-1<br>EN/IEC 60601-1-2<br>EN/IEC 60601-2-10<br>EN/IEC 60601-2-40 | EN/IEC 60601-1<br>EN/IEC 60601-1-2 | EN/IEC 60601-1<br>EN/IEC 60601-1-2 | IEC 601-1<br>IEC 601-1-2 |

#### 4.0 Data Summary

Testing of the Hilger Dual-Stim Nerve Stimulator was performed in compliance with the WR Medical Electronics CO. design control process. Testing included:

- 1. Software verification and validation, and
- 2. Declaration of safety standard compliance prior to commercial distribution.

### File: Hilger Dual Stim 510k 11-21-2006 final

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#### 5.0 Conclusions

The safety and effectiveness of the Hilger Dual-Stim Nerve Stimulator was demonstrated by testing in compliance with the Design Control process. The intended use and technology of the Hilger Dual-Stim Nerve Stimulator is the same as the predicate devices. No new questions of safety or effectiveness are raised.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings. The eagle is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

WR Medical Electronics Co. c/o Gary Syring Principal Consultant Quality & Regulatory Associates 800 Lavanger Lane Stoughton. WI 53589

JAN - 5 2007

Re: K063560

Trade/Device Name: Hilger Dual-Stim Nerve Stimulator Regulation Number: 21 CFR 874:1820 Regulation Name: Surgical Nerve Stimulator/Locator Regulatory Class: Class II Product Code: ETN Dated: November 21, 2006 Received: November 27, 2006

Dear Mr. Syring:

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 - Gary Syring

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/industry/support/index.html.

Sincerely yours,

M.B. Egelmisi MD

Malvina B Eydelman, 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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Indications for Use 510(k) Number (if known): KOR3560

Device Name: Hilger Dual-Stim Nerve Stimulator

Indications for Use:

The Hilger Dual-Stim Nerve Stimulator provides electrical stimulation to nerves during diagnostic and surgical procedures.

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 THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Karen H. Baker

(Division Sign-Off) Division of Ophthalmic Ear, Nose and Throat Devises

KOGSSLA 510(k) Number.

Prescription Use
(Per 21 CFR 801.109) X