(124 days)
Non-invasively monitoring of the laryngeal nerves during thyroid surgery, and of the Xth cranial nerve during skull-base surgery.
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.
The provided 510(k) summary for the Technomed Europe Laryngeal Electrode describes the device's characteristics and compares it to predicate devices to demonstrate substantial equivalence, rather than providing acceptance criteria and a detailed study report. This submission does not contain a study that demonstrates device performance against specific acceptance criteria in the way typically found for AI/ML-enabled devices or performance studies with quantitative metrics.
Instead, the document focuses on establishing substantial equivalence based on design, materials, chemical composition, packaging, and other technological characteristics.
Here's an analysis of what information is present or absent based on your request:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics (e.g., sensitivity, specificity, accuracy, F1-score) or clinical outcomes. The "acceptance" is implicitly defined by demonstrating equivalence to the predicate devices across various design and functional characteristics.
- Reported Device Performance: Not reported in quantitative terms. The document states that "Technomed Europe has been bench testing the Laryngeal Electrodes to confirm performance characteristics of this device" and that "The Technomed Europe Laryngeal electrodes are being bench tested in comparison to the predicated devices..." The characteristics to be tested include impedance and dimensions, among others. However, the results of these bench tests, or any performance metrics derived from them, are not provided in the summary. The "performance" is concluded to be "safe and effective" and "substantially equivalent" based on qualitative comparison.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. This submission does not describe a clinical performance study with a test set of patient data. The "testing" mentioned is bench testing of the electrode characteristics.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. No ground truth establishment by experts is described as there is no human-interpreted test set data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set requiring expert adjudication is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This device is a laryngeal electrode, not an AI/ML-enabled device. Therefore, no MRMC study or AI assistance is relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a hardware device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. There is no ground truth data in the context of clinical performance described. The "ground truth" for the bench testing would be established by validated measurement standards and equipment against the defined physical and electrical properties of the electrodes.
8. The sample size for the training set
- Not applicable. This is a hardware device, not an AI/ML system requiring a training set.
9. How the ground truth for the training set was established
- Not applicable. This is a hardware device, not an AI/ML system requiring a training set.
Summary of the Document's Approach:
The provided 510(k) summary is for a traditional medical device (laryngeal electrode), not an AI/ML-enabled diagnostic or therapeutic device. The "study" referenced is a bench testing comparison to predicate devices, focusing on demonstrating that the new device has "equivalent" design, materials, and functional characteristics to devices already on the market. The FDA's letter confirms substantial equivalence based on this comparison and the declared intended use.
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- 510(k) Summary or 510(k) Statement
AUG 2 8 2012
:
| 510(k) Summary | |
|---|---|
| Manufacturer: | Technomed EuropeAmerikalaan 716199 AE Maastricht AirportThe Netherlands |
| Submitted by: | Technomed EuropeAmerikalaan 716199 AE Maastricht AirportThe NetherlandsTel.: (+31) 43-408 6868Fax: (+31) 43-408 6888 |
| Contact person: | Mr. Pierre VreulsManager Regulatory Affairs & Quality AssuranceE-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 per21 CFR section 874.1820. Product code ETN. |
| Substantial Equivalence: | K093373: Dragonfly Laryngeal Surface ElectrodeK071349: Neurosign Laryngeal Electrode |
| Device description: | Disposable Laryngeal Electrodes are non-invasive. Thedisposable device is constructed using a medical grade ink aselectrode material suspended on a polyethylene substrate; apolyester connector with a separate available cable assembly orDIN 42802 connectors; The electrode is available in three sizesto suit different sexes and age groups. The 4/5mm electrodeshould be used with an 4 or 5mm endotracheal tube; the 6/7mmelectrode should be used with a 6 or 7mm endotracheal tube; the8/9mm electrode should be used with an 8 or 9mm endotrachealtube. The cable assembly is available separately and will have along life if it is not abused and is stored appropriately. Using thelaryngeal electrode lowers the risk of damage to the laryngeal orXth cranial nerve (the Vagus nerve) during thyroidectomy orparathyroidectomy and, since it is noninvasive, it also lessens therisk 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 forcontinuous EMG monitoring of the larynx during surgicalprocedures with recording and monitoring equipment, (activeand reference), of Electromyography (EMG). The electrodes aredesigned for single-patient application use. The electrodes areintended for use only by a licensed physician. |
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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 CompanyInc. | Technomed Europe | Comments todifferences |
|---|---|---|---|---|
| Device | Dragonfly Laryngeal SurfaceElectrode | Neurosign LaryngealElectrode | Laryngeal Electrode | -- |
| 510(k)number | K093373Predicate device | K071349Predicate device | This notification | -- |
| Laryngeal SurfaceElectrode | Yes | Yes | Yes | Same |
| Endolaryngeallocation | Yes | Yes | Yes | Same |
| Function withcommercial EMGunits | Neurovision Medical ProductsNerveanaAxon EclipseMedtronic - NIMXLTEK EP WorksNicolet VikingCadwell CascadeNeurosign Avalanche | Yes | Yes | Same |
| Method of electrodeattachment | Attached to the surface of theendotracheal tube usingadhesive backside | Attached to the surface ofthe endotracheal tube usingadhesive backside | Attached to the surface ofthe endotracheal tube usingadhesive backside | Same |
| Electrode surface | Silver conductive ink onpolyester substrate | Conductive ink on polyestersubstrate | Conductive ink on soft PEsubstrate | Using a softersubstrate material(PE) (see §12.4) |
| Electrical insulation | On all surfaces exceptelectrodes | On all surfaces exceptelectrodes | On all surfaces exceptelectrodes | Same |
| Product code | ETN | ETN | ETN | Same |
| Intended Use/Indication of Use | The Dragonfly LaryngealSurface Electrode is intendedto be used as disposable, self-adhesive electrode attached toan endotracheal tube andpositioned for continuousEMG monitoring of the larynxduring surgical procedures.It is intended for use only by alicensedphysician and in conjunctionwith these listed belowmedical gradeelectromyographic monitors. | Laryngeal electrodes fornon-invasively monitoringof the laryngeal nervesduring thyroid surgery, andof the Xthcranial nerve during skull-base surgery. | The Laryngeal Electrode isintended to be used asdisposable, self-adhesiveelectrode attached to anendotracheal tube andpositioned for continuousEMG monitoring of thelarynx during surgicalprocedures. It is intended foruse only by a licensedphysician and inconjunction with acommercially available,medical gradeelectromyographic 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 electrodeattachment | Attached to the surface of theendotracheal tube withadhesive | Attached to the surface ofthe endotracheal tube withadhesive | Attached to the surface ofthe endotracheal tube withmedical grade adhesive | Same |
| Number ofelectrodes utilized | 4 | 2 | 2 | Same |
| Number of channels | 2 | 2 + grounding electrode | 2 + grounding electrode | Same |
| Connector | 1.5 mm safety connector DIN42 802 | Polypropylene connectorwith extension lead to DIN42 802 safety connector | Polypropylene connectorwith extension lead to DIN42 802 safety connector | Same |
| Safetycharacterization | Non invasive | Non invasive | Non invasive | Same |
| Biocompatibleaccording ISO10993-1:2009 | Yes | Yes | Yes | Same |
Page 2 of 3
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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.
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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.
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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
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- 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
§ 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.