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 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.

AI/ML Overview

I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) premarket notification for the "Dragonfly Laryngeal Surface Electrodes," focusing on demonstrating substantial equivalence to previously marketed devices. It describes the device, its intended use, and compares it to predicate devices but does not include details on specific performance metrics, clinical study designs, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot fulfill your request to provide:

A table of acceptance criteria and reported device performance.
Sample size, data provenance for the test set.
Number and qualifications of experts for ground truth.
Adjudication method.
MRMC comparative effectiveness study results.
Standalone performance study details.
Type of ground truth used.
Sample size for the training set.
How training set ground truth was established.

Summary

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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: a.spadavecchia@spesmedica.com

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 SURFACEELECTRODE-ENDOTRACHEAL TUBE	RLN SYSTEM, INK	K003745
NEUROSIGN LARYNGEALELECTRODES	THE MAGSTIM COMPANYLTD.	K071349
XOMED-TREACE EMGENDOTRACHEAL TUBEEN	XOMED-TREACE, INC.	K925640

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DEVICE DESCRIPTION

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 ELECTRODESDRAGONFLY LARYNGEAL SURFACE ELECTRODES(Submitted Product)
Neurovision Medical Products		FAMILY ANew Device	FAMILY BNew Device	LEGALLY MARKETEDPREDICATE DEVICES OFRLN System Inc.K003745	LEGALLY MARKETEDPREDICATE DEVICES OFXomed Treace Inc.K925640	LEGALLY MARKETEDPREDICATE DEVICES OFThe Magstim Company Ltd.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 tubeStainless Steel Wire	Attached to the surface of the endotracheal tubeConductive 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 intendedto be used as disposable, self-adhesiveelectrode attached to an endotracheal tubeand positioned for continuous EMGmonitoring of the larynx during surgicalprocedures.It is intended for use only by a licensedphysician and in conjunction with these listedbelow medical grade electromyographicmonitors:Neurovision Medical ProductsNerveanaAxon EclipseMedtronic - NIMXLTEK EP WorksNicolet VikingCadwell Cascade	The Laryngeal Surface Electrodes is intended tobe used as disposable, self-adhesive electrodeattached to an endotracheal tube andpositioned for continuous EMG monitoring ofthe larynx during surgical procedures.It is intended for use only by a licensedphysician and in conjunction with these listedbelow medical grade electromyographicmonitors:Neurovision Medical ProductsNerveanaAxon EclipseMedtronic - NIMXLTEK EP WorksNicolet VikingCadwell Cascade	The Laryngeal Surface Electrodesis intended to be used asdisposable, self-adhesiveelectrode attached to anendotracheal tube and positionedfor continuous EMG monitoring ofthe larynx during surgicalprocedures. It is intended for useonly by a licensed physician andin conjunction with a commerciallyavailable, medical gradeelectromyographic monitor	The Xomed EMGEndotracheal Tube is intendedfor use as a tracheal tube forthe administration ofanesthesia gases and tomaintain an open airway forthe patient during the surgery.The EMG electrodes areintended to serve as contactelectrodes with the vocalcords of the patient and whenconnected to an EMG monitor,the wire electrodes facilitatethe intra-operative monitoringof the vocal cords for locatingand mapping the RecurrentLaryngeal Nerve and its	The non-invasive LaryngealElectrode is intended for useas an intraoperative method ofmonitoring the laryngealnerves during thyroid surgery,and of the Xth cranial nerveduring 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 (800) 638-2041 or (301) 796-7100 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:

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)

Regulation Number and Section

§ 874.1820 Surgical nerve stimulator/locator.

(a)
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.(b)
Classification. Class II.