(212 days)
Not Found
No
The device description focuses on the physical components and intended use for nerve monitoring, with no mention of AI or ML technologies.
No
The device is used for non-invasive monitoring of nerves to lower the risk of damage during surgery, which is a diagnostic/monitoring function rather than a therapeutic one.
Yes
The device is used for non-invasively monitoring laryngeal and Xth cranial nerves, which implies it provides information about the state of these nerves during surgery, thus aiding in identifying potential issues.
No
The device description explicitly details hardware components including a single-use electrode, a connector, and a cable assembly.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Neurosign® Laryngeal Electrode is used for non-invasively monitoring nerve activity during surgery. It is applied externally or internally within the body (via an endotracheal tube) to detect electrical signals from nerves and muscles.
- Lack of Sample Analysis: The device does not analyze samples taken from the body. It directly interacts with the body to measure physiological signals.
Therefore, the device falls under the category of a medical device used for monitoring during surgical procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The non-invasive Laryngeal Electrode is intended for use as an intraoperative method of monitoring the laryngeal nerves during thyroid surgery, and of the Xth cranial nerve during skull-base surgery. The monitoring is performed by a surface electrode held in position against the vocal cords through an attachment to a normal endotracheal tube. The electrode is then connected to a Neurosign® machine for readout. A connector allows the cable to connect with the Neurosign® Nerve Monitor Pre-Amplifier Pod. The electrode detects EMG in the vocalis or the posterior cricoarvenoid muscles and will also detect stimulation of the superior laryngeal nerves during radical neck dissections.
The Neurosign® Laryngeal Electrode is indicated for use when it is necessary to continuously monitor the laryngeal nerves, the Xth cranial nerve or the laryngeal musculature during surgery. The device will mainly be used in adults, as thyroidectory is very rarely undertaken in children.
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
The Neurosign® Laryngeal Electrode, which was specially developed for use with the Neurosign® 100, 400 and 800 models, consists of: a single-use electrode constructed from medical-grade inks suspended in a polyester substrate; a connector made of polypropylene; and a cable assembly. The electrode is available in two sizes to suit different sexes and age groups. 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 tube. The cable assembly is available separately and will have a long life if it is not abused and is stored appropriately.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
laryngeal nerves, Xth cranial nerve, vocal cords, vocalis, posterior cricoarvenoid muscles
Indicated Patient Age Range
The device will mainly be used in adults, as thyroidectory is very rarely undertaken in children.
Intended User / Care Setting
Not Found
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)
Not Found
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
Neurosign® Laryngeal Electrode: FDA 510(k) Submission
Confidential
Section 5: 510(k) Summary or 510(k) Statement
Image /page/0/Picture/4 description: The image shows the word "magstim" in a bold, sans-serif font. The letters are black, and the word is presented in a simple, straightforward manner. The dot on the "i" is a circle.
Spring Gardens . Whitland Carmarthenshire · Wales · UK SA34 OHR
+44 (0) 1994 240798 +44 (0) 1994 240061 info@magstim.com www.magstim.com
SECTION 5: 510(k) SUMMARY
DEC ] 2 2007
Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850 04 May 2007
Contact information:
Anwen Evans The Magstim Company Ltd Spring Gardens, Whitland Carmarthenshire, Wales, UK SA34 OHR Tel: +44 (0) 1994 242902 Fax: +44 (0) 1994 240061 E-mail: anwen.evans@magstim.com
The product information is as follows:
Product: Laryngeal Electrode for use with the Neurosign® 100, 400 and 800 nerve monitors Class: Class II CFR $874.1820 Surgical Nerve Stimulator and Locator Panel: Ear, Nose and Throat Product Code: ETN
Classification name: Nerve Stimulator (Class II) Common or usual names: Laryngeal Electrode Proprietary name: Neurosign® Laryngeal Electrode
1
Section 5: 510(k) Summary or 510(k) Statement
Description of the Device 5.1
The Neurosign® Laryngeal Electrode, which was specially developed for use with the Neurosign® 100, 400 and 800 models, consists of: a single-use electrode constructed from medical-grade inks suspended in a polyester substrate; a connector made of polypropylene; and a cable assembly. The electrode is available in two sizes to suit different sexes and age groups. 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 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.
5.2 Intended Use of the Device
The non-invasive Laryngeal Electrode is intended for use as an intraoperative method of monitoring the laryngeal nerves during thyroid surgery, and of the Xth cranial nerve during skull-base surgery. The monitoring is performed by a surface electrode held in position against the vocal cords through an attachment to a normal endotracheal tube. The electrode is then connected to a Neurosign® machine for readout. A connector allows the cable to connect with the Neurosign® Nerve Monitor Pre-Amplifier Pod. The electrode detects EMG in the vocalis or the posterior cricoarvenoid muscles and will also detect stimulation of the superior laryngeal nerves during radical neck dissections.
The Neurosign® Laryngeal Electrode is indicated for use when it is necessary to continuously monitor the laryngeal nerves, the Xth cranial nerve or the laryngeal musculature during surgery. The device will mainly be used in adults, as thyroidectory is very rarely undertaken in children.
5.3 Predicate Devices
The predicate devices used in this submission are:
- � Neurovision LSE500 Laryngeal Surface Electrodes (reference K003745); and
- Medtronic NIM™ EMG Endotracheal Tube (reference K925640). �
2
Neurosign® Laryngeal Electrode: FDA 510(k) Submission
.
Section 5: 510(k) Summary or 510(k) Statement
5.3.1 Comparison with the predicate devices
| | NeurosignⓇ
Laryngeal
Electrode
(Subject Device) | Medtronic NIMTM
EMG
Endotracheal Tube
(Predicate Device) | Neurovision
LSE500 Laryngeal
Surface Electrode
(Predicate Device) |
|-------------------------------------------------|----------------------------------------------------------|-------------------------------------------------------------------|----------------------------------------------------------------------------|
| Laryngeal surface
electrode | Yes | Yes | Yes |
| Monitoring site | Trachea/larynx | Larynx | Oesophagus |
| Monitoring type | Continuous EMG
monitoring | Continuous EMG
monitoring | Continuous EMG
monitoring |
| May be used with
all commercial
EMG units | Yes | Yes | Yes |
| Method of
electrode
attachment | Attached to the
surface of the
endotracheal tube | Embedded within
the endotracheal
tube | Attached to the
surface of the
endotracheal tube |
| Number of
electrodes utilised | 2 | 4 | 2 |
| Number of
channels | 2 | 2 | 1 |
| Surface of
electrode | Conductive ink on a
polyester substrate | Stainless steel wire | Carbon w/Ag |
| Single-use only | Yes | Yes | Yes |
| Safety
characteristics | Non-invasive | Non-invasive | Non-invasive |
5.4 Conclusions
The Neurosign® Laryngeal Electrode is both safe and is similar in its risks and benefits, as well as its manner of performance, to the predicate devices listed above (see Section 12 for further discussion).
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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three stripes forming its body and wing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
The Magstim Company, LTD. c/o Anwen Evans Spring Gardens Whitland Carmarthenshire, Wales United Kingdom, SA34 OHR
Re: K071349
Trade/Device Name: Neurosign® Laryngeal Electrode Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical nerve stimulator and locator Regulatory Class: Class II Product Code: ETN Dated: May 4, 2007 Received: May 14, 2007
Dear Mr. Evans:
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.
DEC 1 2 2007
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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); 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.
4
Page 2 - Mr. Anwen Evans
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
M.B. Eylerhs, MD
Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Section 4: Indications for Use Statement
SECTION 4: INDICATIONS FOR USE STATEMENT
Indications for Use
510(k) Number (if known): K944902
Device Name: Laryngeal Electrodes
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 X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kaua H. bota
(Off)
hthalmic Ear Throat Devise
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