NICOLET ELECTROCAUTERY DETECTOR

K020955 · Nicolet Biomedical, Inc. · ETN · Apr 17, 2002 · Ear, Nose, Throat

Device Facts

• Record ID: K020955
• Device Name: NICOLET ELECTROCAUTERY DETECTOR
• Applicant: Nicolet Biomedical, Inc.
• Product Code: ETN · Ear, Nose, Throat
• Decision Date: Apr 17, 2002
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 874.1820
• Device Class: Class 2

Intended Use

The intended use of the Nicolet Electrocautery Detector is as an accessory device supporting muting of external audible outputs when electrocautery interference is detected.

Device Story

Nicolet Electrocautery Detector functions as an accessory interface between a nerve monitor's auditory signal output and its external speaker. Device monitors for electrocautery radio frequency (RF) energy; upon detection of interference, it automatically mutes the nerve monitor's speaker to prevent loud, distracting noise for the surgical team. Used in hospitals and clinics where nerve monitors are employed. Sensitivity is user-selectable. Device provides faster recovery time from muted state compared to predicate. Benefits include improved auditory environment for clinicians during procedures involving electrocautery.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence is based on technological comparison and performance specifications regarding electrocautery detection and muting functionality.

Technological Characteristics

Accessory device; detects electrocautery RF energy; provides user-selectable sensitivity; supports up to 2 antenna probe inputs; recovery time ≤ 1 second. Operates as an interface between nerve monitor signal output and speaker.

Indications for Use

Indicated for use as an accessory to nerve monitors and stimulators in clinical environments (hospitals/clinics) to automatically mute external audible outputs upon detection of electrocautery interference.

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

• Nerve Integrity Monitor-2 (NIM-2 XL) (K934426)

Submission Summary (Full Text)

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K020955

# APR 1 7 2002

## Summary of Safety and Effectiveness

| Company Name: | Nicolet Biomedical<br>5225 Verona Road<br>Madison, WI 53711 |
|----------------------------|-------------------------------------------------------------------------------------|
| Contact:<br>Phone:<br>Fax: | Glen Hermanson, Manager of Standards and Compliance<br>608 441-2065<br>608 441-2007 |
| Summary Date: | March 20, 2002 |
| Trade Name: | Electrocautery Detector |
| Common Name: | Nerve Stimulator |
| Classification Name: | 21 CFR 874.1820; Product Code: ETN |
| Predicate Device: | 510(k) Number: K934426<br>Manufacture: XOMED-TREACE, Inc. |

Nerve Integrity Monitor-2 (NIM-2 XL) Trade Name:

#### Description of Device 1.0

The Nicolet Electrocautery Detector interfaces between the auditory signal output from a nerve monitor and the nerve monitor's external speaker. The Electrocautery Detector automatically mutes the nerve monitor speaker when electrocautery interference is detected.

#### 2.0 Intended Use

The intended use of the Nicolet Electrocautery Detector is as an accessory device supporting muting of external audible outputs when electrocautery interference is detected.

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Image /page/1/Picture/0 description: The image shows the logo for Nicolet Biomedical. The word "Nicolet" is in a large, bold, sans-serif font. A thick black line is underneath the word "Nicolet". Below the line, the word "BIOMEDICAL" is in a smaller, sans-serif font, with a space between each letter.

#### Technological 3.0

The technology of the Electrocautery Detector is equivalent to the electrocautery mute feature in the predicate device. Both devices detect the presence of electrocautery RF energy as an interference signal and mute the speaker.

#### Conclusions 4.0

The intended use and technology of the Nicolet Electrocautery Detector device is substantially equivalent to the predicate device, electrocautery mute feature. No new questions of safety or effectiveness are raised.

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Specifications/Comparison to Predicates 5.0

Table 5.0-1 compares features and specifications of the Nicolet Electrocautery Detector to the predicate device

:

| Feature | Nicolet Electrocautery Detector Device<br>(Under Review) | XOMED NIM-2 XL<br>(Predicate K934426) | Substantial Equivalence Comments |
|-----------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| Indication for Use | The Nicolet Electrocautery Detector is an<br>accessory device supporting muting of external<br>audible outputs when electrocautery interference<br>is detected. | As a feature of nerve monitoring, an<br>electrocautery detection and muting feature is<br>provided. | Same features with regard to electrocautery<br>detection and muting of audible output. |
| Environment of<br>Use | Wherever nerve monitors and stimulators are<br>used. Typically hospitals and clinics. | Hospitals and clinics | Used in the same clinical environments. |
| Number of<br>electrocautery<br>detector inputs | 2 | 4 | Up to 2 electrocautery antenna probe inputs are<br>supported on the Electrocautery Detector. |
| Technology | Detection of electrocautery Radio Frequency<br>energy and muting of audible output. | Detection of electrocautery Radio Frequency<br>energy and muting of audible output. | Same |
| Recovery Time<br>After Mute | ≤ 1 second | ≤ 5 seconds | The Nicolet Electrocautery Detector has a faster<br>recovery time from a muted condition. |
| Electrocautery<br>Detector<br>Sensitivity<br>Adjustment | Yes - User selectable | Yes - User Selectable | Same |
| Adjustable<br>Sensitivity to<br>Electrocautery<br>Interference<br>Detection | Yes | Yes | Same |

CONFIDENTIAL

Electrocautery Mute 510(k)

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Electrocautery Mute 510(k)

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CONFIDENTIAL

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human form or a bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# APR 1 7 2002

Nicolet Biomedical, Inc c/o Gary Syring, Principal Consultant Ouality and Regulatory Associates, LLC 800 Levanger Lane Stoughton, WI 53589

Re: K020955

Trade/Device Name: Nicolet Electrocautery Detector Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical Nerve Stimulator/Locator Regulatory Class: Class II Product Code: ETN Dated: March 20, 2002 Received: March 25, 2002

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, Principal Consultant

This letter will allow you to begin marketing your device as described in your Section 510(k) r market notification. The FDA finding of substantial equivalence of your device to a legally promated 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 vours,

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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10209 510(k) Number (if known):

Device Name: Nicolet Electrocautery Detector

Indications For Use:

The Nicolet Electrocautery Detector is an accessory device supporting muting of external audible outputs when electrocautery interference is detected.

(PLEASE: DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

Prescription Use yes ✓
(Per 21 CFR 801.109)

Vann Biller

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

02 510(k) Number.