Who is the manufacturer of LARYNGEAL ELECTRODE?

Technomed Europe filed the 510(k) submission for LARYNGEAL ELECTRODE (K121257).

What is the FDA product code for LARYNGEAL ELECTRODE?

ETN. It is classified under 21 CFR 874.1820 as a Class 2 device in the Ear, Nose, Throat panel.

What is the regulatory pathway for LARYNGEAL ELECTRODE?

510(k) clearance (submission type: Traditional).

What are the predicate devices for LARYNGEAL ELECTRODE?

Dragonfly Laryngeal Surface Electrode (K093373); Neurosign Laryngeal Electrode (K071349).

Who can help prepare an FDA 510(k) submission like LARYNGEAL ELECTRODE?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

LARYNGEAL ELECTRODE

K121257 · Technomed Europe · ETN · Aug 28, 2012 · Ear, Nose, Throat

Device Facts

Record ID	K121257
Device Name	LARYNGEAL ELECTRODE
Applicant	Technomed Europe
Product Code	ETN · Ear, Nose, Throat
Decision Date	Aug 28, 2012
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 874.1820
Device Class	Class 2

Intended Use

The Disposable Laryngeal Electrodes are intended for non-invasive use attached to a endotracheal tube and positioned for continuous EMG monitoring of the larynx during surgical procedures with recording and monitoring equipment, (active and reference), of Electromyography (EMG). The electrodes are designed for single-patient application use. The electrodes are intended for use only by a licensed physician.

Device Story

Disposable Laryngeal Electrode is a non-invasive, single-patient use device designed for continuous EMG monitoring of the larynx during surgical procedures. The device consists of medical-grade conductive ink electrodes on a polyethylene substrate, attached to an endotracheal tube via an adhesive backing. It connects to external, commercially available electromyographic (EMG) monitoring equipment via a polyester connector and cable assembly. Used in clinical settings (e.g., OR) by licensed physicians, the device captures EMG signals from the laryngeal area. By providing continuous nerve monitoring, it assists surgeons in identifying and avoiding damage to the laryngeal or Vagus (Xth cranial) nerves during thyroidectomy or parathyroidectomy. The non-invasive nature of the electrode reduces infection risk compared to invasive alternatives. The healthcare provider interprets the EMG output from the connected monitor to guide surgical decision-making and nerve preservation.

Clinical Evidence

Bench testing only. No clinical data provided. Performance characteristics, including impedance, dimensions, and design, were verified through bench testing in comparison to predicate devices.

Technological Characteristics

Disposable, non-invasive electrode. Materials: medical-grade conductive ink on polyethylene (PE) substrate. Connectivity: polyester connector with cable assembly (DIN 42802). Sterilization: EtO. Shelf-life: 3 years. Biocompatibility: ISO 10993-1:2009 compliant. Available in three sizes (4/5mm, 6/7mm, 8/9mm) for different endotracheal tube diameters.

Indications for Use

Indicated for non-invasive monitoring of laryngeal nerves during thyroid surgery and the Xth cranial nerve during skull-base surgery.

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

Dragonfly Laryngeal Surface Electrode (K093373)
Neurosign Laryngeal Electrode (K071349)

Related Devices

K232888 — Disposable Laryngeal Electrodes · Suzhou Haishen Medical Device Associates Co., Ltd. · Dec 21, 2023
K091874 — INOMED ADHESIVE LARYNGEAL ELECTRODES, MODELS 530655, 530656 · Inomed Medizintechnik GmbH · Nov 18, 2009
K071349 — NEUROSIGN LARYNGEAL ELECTRODES · The Magstim Company , Ltd. · Dec 12, 2007
K122040 — INVOTEC LARYNGEAL ELECTRODE · Invotec International, Inc. · Oct 31, 2013
K110989 — NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODE · Neurovision Medical Products, Inc. · Nov 3, 2011

Submission Summary (Full Text)

{0}------------------------------------------------ : , - 6. 510(k) Summary or 510(k) Statement ## AUG 2 8 2012 : | 510(k) Summary | | |--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer: | Technomed Europe Amerikalaan 71 6199 AE Maastricht Airport The Netherlands | | Submitted by: | Technomed Europe Amerikalaan 71 6199 AE Maastricht Airport The Netherlands Tel.: (+31) 43-408 6868 Fax: (+31) 43-408 6888 | | Contact person: | Mr. Pierre Vreuls Manager Regulatory Affairs & Quality Assurance E-mail: pvreuls@technomed.nl | | Date: | April 19, 2012 | | Proprietary Name: | Laryngeal Electrode | | Common/usual Name: | Laryngeal Electrode | | Classification Name: | Disposable Laryngeal Electrode is classified as class II per 21 CFR section 874.1820. Product code ETN. | | Substantial Equivalence: | K093373: Dragonfly Laryngeal Surface Electrode K071349: Neurosign Laryngeal Electrode | | Device description: | Disposable Laryngeal Electrodes are non-invasive. The disposable device is constructed using a medical grade ink as electrode material suspended on a polyethylene substrate; a polyester connector with a separate available cable assembly or DIN 42802 connectors; The electrode is available in three sizes to suit different sexes and age groups. The 4/5mm electrode should be used with an 4 or 5mm endotracheal tube; the 6/7mm electrode should be used with a 6 or 7mm endotracheal tube; the 8/9mm electrode should be used with an 8 or 9mm endotracheal tube. The cable assembly is available separately and will have a long life if it is not abused and is stored appropriately. Using the laryngeal electrode lowers the risk of damage to the laryngeal or Xth cranial nerve (the Vagus nerve) during thyroidectomy or parathyroidectomy and, since it is noninvasive, it also lessens the risk of infection during the monitoring procedure. | | Intended Use: | The Disposable Laryngeal Electrodes are intended for non- invasive use attached to a endotracheal tube and positioned for continuous EMG monitoring of the larynx during surgical procedures with recording and monitoring equipment, (active and reference), of Electromyography (EMG). The electrodes are designed for single-patient application use. The electrodes are intended for use only by a licensed physician. | {1}------------------------------------------------ ## Comparison to predicates: . The design, materials, chemical composition, packaging and other technological characteristics of the subject device is equivalent to those of the predicate devices. . | Manufacturer | Spes Medica s.r.l. | The Magstim Company Inc. | Technomed Europe | Comments to differences | |------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------| | Device | Dragonfly Laryngeal Surface Electrode | Neurosign Laryngeal Electrode | Laryngeal Electrode | -- | | 510(k) number | K093373 Predicate device | K071349 Predicate device | This notification | -- | | Laryngeal Surface Electrode | Yes | Yes | Yes | Same | | Endolaryngeal location | Yes | Yes | Yes | Same | | Function with commercial EMG units | Neurovision Medical Products Nerveana Axon Eclipse Medtronic - NIM XLTEK EP Works Nicolet Viking Cadwell Cascade Neurosign Avalanche | Yes | Yes | Same | | Method of electrode attachment | Attached to the surface of the endotracheal tube using adhesive backside | Attached to the surface of the endotracheal tube using adhesive backside | Attached to the surface of the endotracheal tube using adhesive backside | Same | | Electrode surface | Silver conductive ink on polyester substrate | Conductive ink on polyester substrate | Conductive ink on soft PE substrate | Using a softer substrate material (PE) (see §12.4) | | Electrical insulation | On all surfaces except electrodes | On all surfaces except electrodes | On all surfaces except electrodes | Same | | Product code | ETN | ETN | ETN | Same | | Intended Use/ Indication of 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. | Laryngeal electrodes for non-invasively monitoring of the laryngeal nerves during thyroid surgery, and of the Xth cranial nerve during skull- base surgery. | The Laryngeal 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 a commercially available, medical grade electromyographic monitor. | Same | | Sterilization | EtO | Gamma | EtO | Same | | Shelf-life (expiry date) | 3 years | 3 years | 3 years | Same | | Uses | Disposable | Disposable | Disposable | Same | | Method of electrode attachment | Attached to the surface of the endotracheal tube with adhesive | Attached to the surface of the endotracheal tube with adhesive | Attached to the surface of the endotracheal tube with medical grade adhesive | Same | | Number of electrodes utilized | 4 | 2 | 2 | Same | | Number of channels | 2 | 2 + grounding electrode | 2 + grounding electrode | Same | | Connector | 1.5 mm safety connector DIN 42 802 | Polypropylene connector with extension lead to DIN 42 802 safety connector | Polypropylene connector with extension lead to DIN 42 802 safety connector | Same | | Safety characterization | Non invasive | Non invasive | Non invasive | Same | | Biocompatible according ISO 10993-1:2009 | Yes | Yes | Yes | Same | Page 2 of 3 {2}------------------------------------------------ Non-clinical data: Technomed Europe has been bench testing the Laryngeal Electrodes to confirm performance characteristics of this device. The Technomed Europe Laryngeal electrodes are being bench tested in comparison to the predicated devices, K093373: Dragonfly Laryngeal Surface Electrode and K071349: Neurosign Laryngeal Electrode. The electrode surface, method of electrode attachment to endotracheal tube, electrical insulation, sterilization, shelf-life, intended use, number of electrodes utilized, number of channels, connector, safety characterization, design characterization, impedance, dimensions will be tested. ## Conclusion: The comparison to the predicate devices demonstrate that the Disposable Laryngeal Electrode is safe and effective and is substantially equivalent to the predicate devices. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol. The logo is black and white. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Technomed Europe c/o Mr. Pierre Vreuls Manager Regulatory Affairs & Quality Assurance Amerikalaan 71 6199 AE Maastricht Airport The Netherlands AUG 2 8 2012 Re: K121257 Trade/Device Name: Laryngeal Electrode Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical Nerve Stimulator/Locator Regulatory Class: Class II Product Code: ETN Dated: August 7, 2012 Received: August 10, 2012 Dear Mr. Vreuls: 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. 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. {4}------------------------------------------------ Page 2 - Mr. Pierre Vreuls 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 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. 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/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. Da Thumson Jr. 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 {5}------------------------------------------------ 5. Indications for Use Statement ## Indications for Use 510(k) Number (if known): K121257 Laryngeal Electrodes Device Name: _ Indications for Use: Non-invasively monitoring of the laryngeal nerves during thyroid surgery, and of the Xth cranial nerve during skull-base surgery. Prescription Use __ × (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) Concurrence of CDRH, Office of Device Evaluation (ODE) Tog Malik (Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices . Prescription Use X (Per 21 CFR 801.109) 510(k) Number K121257