(124 days)
No
The description focuses on the physical characteristics and function of a disposable electrode for nerve monitoring, with no mention of AI or ML algorithms for data analysis or interpretation.
No.
The device's stated intended use is "Non-invasively monitoring of the laryngeal nerves during thyroid surgery, and of the Xth cranial nerve during skull-base surgery," which means it is a diagnostic/monitoring device, not one that treats a condition. Its function is to lower risk of damage, not to treat existing damage or a condition itself.
No
The device is used for "monitoring" the laryngeal nerves during thyroid surgery and the Xth cranial nerve during skull-base surgery, specifically to "lower the risk of damage" to these nerves. While it provides real-time information, its primary purpose is to guide the surgeon during the procedure to prevent injury, rather than to diagnose a condition or disease.
No
The device description explicitly details physical components like electrodes, a polyethylene substrate, a polyester connector, and a cable assembly. It also mentions different sizes of the electrode and sterilization, which are characteristics of hardware devices, not software-only devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: This device is used for monitoring nerve activity during surgery. It is applied externally (non-invasively) and does not analyze samples taken from the body.
- Intended Use: The intended use is to "monitor" laryngeal and cranial nerves, not to diagnose a condition based on analyzing biological samples.
The device is a surgical accessory used for nerve monitoring during specific procedures.
N/A
Intended Use / Indications for 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.
Non-invasively monitoring of the laryngeal nerves during thyroid surgery, and of the Xth cranial nerve during skull-base surgery.
Product codes (comma separated list FDA assigned to the subject device)
ETN
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
larynx, Xth cranial nerve (Vagus nerve)
Indicated Patient Age Range
different sexes and age groups.
Intended User / Care Setting
licensed physician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
:
,
-
- 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
- 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