INOMED ADHESIVE LARYNGEAL ELECTRODES, MODELS 530655, 530656

K091874 · Inomed Medizintechnik GmbH · ETN · Nov 18, 2009 · Ear, Nose, Throat

Device Facts

• Record ID: K091874
• Device Name: INOMED ADHESIVE LARYNGEAL ELECTRODES, MODELS 530655, 530656
• Applicant: Inomed Medizintechnik GmbH
• Product Code: ETN · Ear, Nose, Throat
• Decision Date: Nov 18, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.1820
• Device Class: Class 2

Intended Use

The Inomed Adhesive Laryngeal Electrodes are intended to be used as a disposable, selfadhesive electrode attached to an endotracheal tube and positioned for continuous EMG monitoring of the larynx during surgical procedures.

Device Story

Inomed Adhesive Laryngeal Electrodes are single-use, self-adhesive surface electrodes designed for continuous EMG monitoring of laryngeal nerves. The device consists of medical-grade conductive ink on a polyester substrate, a polypropylene connector, and a cable assembly. During surgery, the electrode is attached to an endotracheal tube positioned at the vocal cords; a neutral adhesive electrode is placed on the patient's shoulder. Both electrodes connect to a reusable recording cable and an external nerve monitor. The device captures EMG signals from the larynx, which are processed by the nerve monitor to provide real-time feedback to the surgeon. This monitoring helps identify and protect the recurrent laryngeal nerve and vagus nerve during procedures such as thyroidectomies, carotid endarterectomies, and skull-base surgeries. By providing continuous nerve activity data, the device assists clinicians in avoiding nerve injury, potentially improving patient outcomes by reducing the risk of vocal cord paralysis or other nerve-related complications.

Clinical Evidence

Bench testing only. The device was evaluated for electrical safety and biocompatibility (ISO 10993-1). No clinical data was provided.

Technological Characteristics

Materials: medical-grade conductive ink, polyester substrate, polypropylene connector. Sensing: surface EMG electrode. Connectivity: compatible with commercial EMG units via cable assembly. Sterilization: ETO. Electrical: touch-proof connector, adhesive insulation on electrode head.

Indications for Use

Indicated for continuous EMG monitoring of the larynx during surgical procedures, including thyroid, anterior cervical, carotid endarterectomy, and skull-base surgeries, via attachment to an endotracheal tube.

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 Laryngeal electrodes (K071349)
• Laryngeal surface Electrode - Endotracheal Tube (K003745)

Submission Summary (Full Text)

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K091874
P. 1 of 3

# 510(k) Summary 807.92(c)

SPONSOR Company Name:

Company Address

807.92(a)(1)

Inomed Medizintechnik GmbH

Tullastrasse Sa Teningen, Germany 79331

Telephone: Fax:

49-7641-9414-0 49-7641-9414-94

Contact Person: Telephone:

Sascha Busch 049-7641-9414-87

Summary Preparation Date: March 23, 2009

# DEVICE NAME

Trade Name: Common/Usual Name: Classification Name: Regulation Number: Product Code: Device Class:

### PREDICATE DEVICE

Legally Marketed Equivalent Device Company Magstim Co.,Ltd. RLN Systems. Inc.

# DEVICE DESCRIPTION

Inomed Adhesive Laryngeal Electrode Laryngeal Electrode. Stimulator, Nerve CFR §874.1820 ETN Class II

807.92(a)(3)

510(k) # K071349 K003745

807.92(a)(4)

The Inomed Adhesive Laryngeal Electrodes are single used electrodes constructed from an medical grade ink with a conductive polymer film covered by an insulating coating, a connector made of polypropylene: and a cable assembly. The electrodes are designed to monitor the recurrent nerve during thyroid, anterior cervical, carotid endartecrectomy surgery and vagus nerve monitoring during brain surgery. The monitoring is performed with a surface electrode that is attached to an endotracheal tube placed on the vocal cord. A neutral adhesive electrode is placed on the patient's shoulder. Both adhesive electrodes are connected to a reusable recording cable and to the nerve monitor

Product

Neurosign Laryngeal electrodes Laryngeal Surface Electrode

NOV 1 8 2009

807.92(a)(2)

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# DEVICE INTENDED USE

#### 807.92(a)(5)

The Inomed Adhesive Laryngeal Electrodes are intended to be used as a disposable, selfadhesive electrode attached to an endotracheal tube and positioned for continuous EMG monitoring of the larynx during surgical procedures.

#### COMPARISON OF TECHNICAL CHARACTERISTICS 807.92(a)(6)

| Parameters... | New Device | Predicate Device | Predicate Device |
|----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device | Inomed Laryngeal<br>Electrode | Neurosign Laryngeal<br>Electrodes | Laryngeal surface<br>Electrode -<br>Endotracheal Tube |
| Manufacturer | Inomed | Magstim Co., Ltd. | RLN Systems, Inc.<br>(Neurovision Medical) |
| 510(k) | N/A | K071349: | K003745 |
| Product Code | ETN | ETN | ETN |
| Intended Use | The Laryngeal Surface<br>Electrode-Endotracheal<br>Tube is intended to be<br>used as a disposable,<br>self-adhesive electrode<br>attached to an<br>endotracheal tube and<br>positioned for<br>continuous EMG<br>monitoring of the larynx<br>during surgical<br>procedures. | Laryngeal electrodes<br>intended for non-<br>invasively monitoring<br>the laryngeal nerves<br>during thyroid surgery,<br>and of the Xth cranial<br>nerve during skull-base<br>surgery | The Laryngeal Surface<br>Electrode-Endotracheal<br>Tube is intended to be<br>used as a disposable,<br>self-adhesive electrode<br>attached to an<br>endotracheal tube and<br>positioned for<br>continuous EMG<br>monitoring of the larynx<br>during surgical<br>procedures. |
| Monitoring site | Trachea/larynx | Trachea/larynx | Trachea/larynx |
| Monitoring type | Continuous EMG<br>monitoring | Continuous EMG<br>monitoring | Continuous EMG<br>monitoring |
| May be used with all<br>commercial EMG units | yes | Yes | Yes |
| Method of electrode<br>attachment | Attached to the surface<br>of the endotracheal tube | Attached to the surface<br>of the endotracheal tube | Attached to the surface<br>of the endotracheal tube |
| Number of electrodes<br>utilized | 2 | 2 | 2 |
| Number of channels | 2 | 2 | 2 |
| Device design | -Medical grade inks<br>suspended in a polyester<br>substrate<br>-polypropylene<br>connector<br>- cable assembly | -Medical grade inks<br>suspended in a polyester<br>substrate<br>-polypropylene<br>connector<br>- cable assembly | -Two-plate laryngeal<br>electrode<br>-adhesive on back<br>surface |
| Electrical insulation | -Adhesive back surface<br>Electrical insulation on | -Adhesive back surface<br>Electrical insulation on | Two plate laryngeal<br>electrode |
| | head of the electrode | head of the electrode | head of the electrode |
| Single use only | Yes | Yes | Yes |
| Safety characteristics | Non-invasive | Non-invasive | |
| Biocompatibility ISO<br>10993-1 | Yes | | Yes |
| IEC 60601-1 Protected | Connector touch proof | Unknown | Unknown |
| Pin design | | | |
| Sterilization | ETO | ETO | ETO |

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0918574
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# Conclusions:

The Inomed Adhesive Laryngeal Electrodes are similar to the predicate device in intended use and technological characteristics. After analyzing performance and safety testing, it is the conclusion of Inomed that the inomed adhesive laryngeal electrodes are as safe and effective as the predicate devices and introduce no new questions concerning safety and effectiveness.

# NONCLINICAL AND CLINICAL TEST

### 807.92(b)

# SAFETY and EFFECTIVENESS

The Inomed adhesive electrodes have been tested to the appropriate electrical testing standard and biocompatibility standards and have been found safe for their intended use

# CONCLUSION

# 807.92(b)(3)

#### Conclusions:

The Inomed Adhesive Laryngeal Electrodes are similar to the predicate device in intended use and technological characteristics. After analyzing performance and safety testing, it is the conclusion of Inomed that the inomed adhesive laryngeal electrodes are as safe and effective as the predicate devices and introduce no new questions concerning safety and effectiveness.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The background is white.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

# NOV 1 8 2009

Inomed Medizintechnik GmbH c/o Ms. Yolanda Smith Smith Associates 1468 Harwell Avenue Crofton, MD 21114

Re: K091874

Trade/Device Name: Inomed Adhesive Laryngeal Electrode Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical Nerve Stimulator/Locator Regulatory Class: II Product Code: ETN Dated: October 2, 2009 Received: October 5, 2009

Dear Ms. Smith:

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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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,

Eile. then, m

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, 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): KO91874

Device Name: Inomed Adhesive Laryngeal Electrodes

Indications for Use:

The Inomed Adhesive Laryngeal Electrodes are intended to be used as a disposable, selfadhesive electrode attached to an endotracheal tube and positioned for continuous EMG monitoring of the larynx during surgical procedures.

Prescription Use V (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use.
(Per 21 CFR 801.109)

*John Doucet*
(Division Sign-On)
Division of Ophthalmic, Neurological and Ear,
and Tatum Devices

510(k) Number:
K091874

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