LARYNGEAL SURFACE ELECTRODE

K093373 · Spes Medica Srl · ETN · Aug 24, 2010 · Ear, Nose, Throat

Device Facts

• Record ID: K093373
• Device Name: LARYNGEAL SURFACE ELECTRODE
• Applicant: Spes Medica Srl
• Product Code: ETN · Ear, Nose, Throat
• Decision Date: Aug 24, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.1820
• Device Class: Class 2

Intended Use

The Dragonfly Laryngeal Surface Electrode is intended to be used as disposable, self-adhesive electrode attached to an endotracheal tube and positioned for continuous EMG monitoring of the larynx during surgical procedures. It is intended for use only by a licensed physician and in conjunction with these listed below medical grade electromyographic monitors: Neurovision Medical Products Nerveana Axon Eclipse Medtronic - NIM XLTEK EP Works Nicolet Viking Cadwell Cascade Neurosign Avalanche

Device Story

Dragonfly Laryngeal Surface Electrodes are single-use, self-adhesive electrodes; designed for attachment to endotracheal tubes. Electrodes capture EMG signals from laryngeal muscles during surgery; signals transmitted to external medical-grade electromyographic monitors. Two configurations: Family A (silver ink on polyester film) and Family B (silver ink on carbon-loaded vinyl). Device enables continuous intraoperative EMG monitoring; assists physicians in nerve localization/monitoring during procedures. Used in clinical/surgical settings; operated by physicians. Benefits include non-invasive monitoring of laryngeal nerves; facilitating nerve preservation during surgery.

Clinical Evidence

No clinical data provided. Substantial equivalence based on bench testing and comparison of technological characteristics to predicate devices.

Technological Characteristics

Single-use, self-adhesive electrodes. Family A: silver conductive ink on polyester film. Family B: silver conductive ink on carbon-loaded vinyl. Non-invasive. Sterilized via ETO. Connects to external EMG monitors. No active electronic components; passive electrode interface.

Indications for Use

Indicated for continuous EMG monitoring of the larynx during surgical procedures in patients requiring endotracheal intubation. Intended for use by licensed physicians only.

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

• LARYNGEAL SURFACE ELECTRODE-ENDOTRACHEAL TUBE (K003745)
• NEUROSIGN LARYNGEAL ELECTRODES (K071349)
• XOMED-TREACE EMG ENDOTRACHEAL TUBEEN (K925640)

Submission Summary (Full Text)

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Spes Medica s.r.l.

510(k)NOTIFICATION Dragonfly Laryngeal Surface Electrodes

K093375

# 510 (k) Summary of safety and effectiveness

AUG 2 4 2010

## SUBMITTER INFORMATION

- A. Company Name:
B. Company Address:

- C. Company Phone: Company Fax:
D. Contact Person:

Spes Medica s.r.l.

Via Europa - Zona industriale Battipaglia (SA) - Italy 84091

+ 39 0828 614191 + 39 0828 341788

Alfredo Spadavecchia Quality Assurance Manager Spes Medica s.r.l. e-mail: [e-mail]

- E. Date Summary Prepared:
October 21, 2009

## DEVICE IDENTIFICATION

| A. Device name: | Dragonfly Laryngeal Surface Electrodes |
|----------------------------|------------------------------------------------------|
| B. Trade/Proprietary name: | Dragonfly Laryngeal Surface Electrodes |
| C. Classification name: | Surgical nerve stimulator/locator (21 CFR §874.1820) |
| D. Product code: | ETN |

# LEGALLY MARKETED DEVICES (PREDICATE DEVICES)

| Predicate device | 510(k) Holder/Applicant | 510(k) number |
|--------------------------------------------------|-----------------------------|---------------|
| LARYNGEAL SURFACE<br>ELECTRODE-ENDOTRACHEAL TUBE | RLN SYSTEM, INK | K003745 |
| NEUROSIGN LARYNGEAL<br>ELECTRODES | THE MAGSTIM COMPANY<br>LTD. | K071349 |
| XOMED-TREACE EMG<br>ENDOTRACHEAL TUBEEN | XOMED-TREACE, INC. | K925640 |

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### DEVICE DESCRIPTION

Spes Medica Dragonfly Laryngeal Surface Electrode are single used electrodes for evoked EMG monitoring of the larynx and it to be inserted and retained in position against the larvngeal muscle by use of an endotracheal tube. The Electrodes are intended to be used as disposable, self-adhesive electrodes attached to an endotracheal tube and positioned for continuous EMG monitoring of the larynx during surgical procedures. Spes Medica produces two different families of electrodes: Family A and Family B.

The family A and B mentioned above are the same product because, have been developed with same intended use, design, materials, packaging and other technological characteristics. The manufacturing processes are the same for both configurations (Family A and Family B) but the substrates and the shape of the electrodes are different. Indeed, for the family A the substrate for the Silver ink is a polyester film and for the family B the substrate for the Silver ink is carbon loaded vinyl. Furthermore, both families use the same connection to the EMG unit.

### INTENDED USE

The Dragonfly Laryngeal Surface Electrode is intended to be used as disposable, selfadhesive electrode attached to an endotracheal tube and positioned for continuous EMG monitoring of the larynx during surgical procedures. It is intended for use only by a licensed physician and in conjunction with these listed below medical grade electromyographic monitors:

| Manufacturer and Device name | | | COMPARISON CHART LARYNGEAL SURFACE ELECTRODES<br>DRAGONFLY LARYNGEAL SURFACE ELECTRODES<br>(Submitted Product) | | | | | | |
|------------------------------|--|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|--|--|
| Neurovision Medical Products | | | FAMILY A<br>New Device | FAMILY B<br>New Device | LEGALLY MARKETED<br>PREDICATE DEVICES OF<br>RLN System Inc.<br>K003745 | LEGALLY MARKETED<br>PREDICATE DEVICES OF<br>Xomed Treace Inc.<br>K925640 | LEGALLY MARKETED<br>PREDICATE DEVICES OF<br>The Magstim Company Ltd.<br>K071349 | | |
| Nerveana | | Code | Yes | Yes | Yes | Yes | Yes | | |
| Axon Eclipse | | EMG units | Yes | Yes | Yes | Yes | Yes | | |
| Medtronic - NIM | | Electrode attachment | Attached to the surface of the endotracheal tube | Attached to the surface of the endotracheal tube | Attached to the surface of the endotracheal tube | Embedded within the endotracheal tube<br>Stainless Steel Wire | Attached to the surface of the endotracheal tube<br>Conductive ink on a polyester substrate | | |
| XLTEK EP Works | | | Silver conductive ink on a polyester substrate | Carbon w/Ag | Carbon w/Ag | | | | |
| Nicolet Viking | | | Trachea/larynx | Trachea/larynx | Trachea/larynx | Trachea/larynx | Trachea/larynx | | |
| Cadwell Cascade | | | Continuous EMG monitoring | Continuous EMG monitoring | Continuous EMG monitoring | Continuous EMG monitoring | Continuous EMG monitoring | | |
| Neurosign Avalanche | | | Yes | Yes | Yes | Yes | Yes | | |
| | | ETO | ETO | ETO | ETO | ETO | | | |
| | | Non-invasive | Non-invasive | Non-invasive | Non-invasive | Non-invasive | | | |
| | | The Laryngeal Surface Electrodes is intended<br>to be used as disposable, self-adhesive<br>electrode attached to an endotracheal tube<br>and positioned for continuous EMG<br>monitoring of the larynx during surgical<br>procedures.<br>It is intended for use only by a licensed<br>physician and in conjunction with these listed<br>below medical grade electromyographic<br>monitors:<br>Neurovision Medical Products<br>Nerveana<br>Axon Eclipse<br>Medtronic - NIM<br>XLTEK EP Works<br>Nicolet Viking<br>Cadwell Cascade | The Laryngeal Surface Electrodes is intended to<br>be used as disposable, self-adhesive electrode<br>attached to an endotracheal tube and<br>positioned for continuous EMG monitoring of<br>the larynx during surgical procedures.<br>It is intended for use only by a licensed<br>physician and in conjunction with these listed<br>below medical grade electromyographic<br>monitors:<br>Neurovision Medical Products<br>Nerveana<br>Axon Eclipse<br>Medtronic - NIM<br>XLTEK EP Works<br>Nicolet Viking<br>Cadwell Cascade | The Laryngeal Surface Electrodes<br>is intended to be used as<br>disposable, self-adhesive<br>electrode attached to an<br>endotracheal tube and positioned<br>for continuous EMG monitoring of<br>the larynx during surgical<br>procedures. It is intended for use<br>only by a licensed physician and<br>in conjunction with a commercially<br>available, medical grade<br>electromyographic monitor | The Xomed EMG<br>Endotracheal Tube is intended<br>for use as a tracheal tube for<br>the administration of<br>anesthesia gases and to<br>maintain an open airway for<br>the patient during the surgery.<br>The EMG electrodes are<br>intended to serve as contact<br>electrodes with the vocal<br>cords of the patient and when<br>connected to an EMG monitor,<br>the wire electrodes facilitate<br>the intra-operative monitoring<br>of the vocal cords for locating<br>and mapping the Recurrent<br>Laryngeal Nerve and its | The non-invasive Laryngeal<br>Electrode is intended for use<br>as an intraoperative method of<br>monitoring the laryngeal<br>nerves during thyroid surgery,<br>and of the Xth cranial nerve<br>during skull-base surgery | | | |

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Spes Medica s.r.l

0(k)NOTIFICATION Dragonfly Laryngeal Surface Electrodes

SUBSTANTAL EQUIVALENCE
The Dragonify Laryngel Surface are similar in intended use, design, materials, packaging and other technological characteristics and

Section 9

Page 9-4

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# CONCLUSION

The Dragonfly Laryngeal Surface Electrodes are similar in intended use, design, materials, packaging and other technological characteristics to the predicate devices. After analyzing performance and safety testing, it is the conclusion of Spes Medica s.r.l. that the Dragonfly Laryngeal Surface Electrodes are safe and effective as the predicate devices and introduce no new questions concerning safety and effectiveness

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) in the USA. The logo features a stylized depiction of an eagle or bird with three wing-like shapes extending upwards and to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" are arranged in a circular fashion around the bird symbol.

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

Spes Medica s.r.l. %Alfredo Spadavecchia Viale Europa - Zona Industriale 84091 Battipaglia SA, Italy 0828 342168

AUG 2 4 2010

Re: K093373

> Trade Name: Dragonfly Laryngeal Surface Electrodes Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical nerve stimulator/locator Regulatory Class: Class II Product Code: ETN Dated: July 19, 2010 Received: July 21, 2010

Dear Mr. Spadavecchia:

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

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# Page 2 - Mr. Alfredo Spadavecchia

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 devicerelated 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.

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/vcm115809.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/MedicalDevices/Safety/ReportaProblem/default.htm 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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Srinivas Nandkumar, Ph.D.

Branch Chief, Ear. Nose, and Throat Devices Branch 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

### K093373

510(k) Number (if known):

Device Name:

Dragonfly Laryngeal Surface Electrodes

Indications for Use:

The Dragonfly Laryngeal Surface Electrode is intended to be used as disposable, self-adhesive electrode attached to an endotracheal tube and positioned for continuous EMG monitoring of the larynx during surgical procedures. It is intended for use only by a licensed physician and in conjunction with these listed below medical grade electromyographic monitors:

| Manufacturer and Device name |
|------------------------------|
| Neurovision Medical Products |
| Nerveana |
| Axon Eclipse |
| Medtronic - NIM |
| XLTEK EP Works |
| Nicolet Viking |
| Cadwell Cascade |
| Neurosign Avalanche |

Prescription Use × (21 CFR 801 Subpart C) AND/OR

Over-The-Counter Use (Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Sr. Nani

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

umber k093373

510(k) Number

(Per 21 CFR 801.109)