(476 days)
Not Found
Not Found
No
The summary describes a passive electrode for EMG monitoring and contains no mention of AI, ML, or related concepts.
No
The device is described as an electrode for EMG monitoring during surgery, which indicates a diagnostic or monitoring function rather than a therapeutic one.
Yes
The device is used for continuous EMG monitoring, which measures electrical activity in muscles. Gathering this physiological data during a surgical procedure for monitoring purposes is inherently diagnostic, as it provides information about the state or function of the larynx.
No
The device is described as a physical electrode attached to an endotracheal tube, indicating it is a hardware component, not software-only.
Based on the provided information, the Invotec Laryngeal Electrodes are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for continuous EMG monitoring of the larynx during a surgical procedure. This involves measuring electrical activity within the body (in vivo), not analyzing samples taken from the body (in vitro).
- Device Description (or lack thereof): While the description is "Not Found," the intended use clearly points to a device that interacts directly with the patient's body during a procedure.
- Anatomical Site: The device is applied to the larynx, which is an internal anatomical structure.
IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a physiological state, health, or disease. The Invotec Laryngeal Electrodes are used to monitor a physiological function in situ during a surgical procedure.
N/A
Intended Use / Indications for Use
The Invotec Laryngeal Electrodes are intended to be used as a sterile, single use, selfadhesive electrode attached to an endotracheal tube and positioned for continuous ` EMG monitoring of larynx during surgical procedure.
This electrode is not to be adhesively attached to silicone endotracheal tubes.
Product codes
ETN
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
larynx
Indicated Patient Age Range
Not Found
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.
Not Found
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
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
October 31, 2013
Invotec International, Inc. c/o Mr. Jeffrey L. Aull President 6833 Phillips Industrial Blvd. Jacksonville, FL 32256
Re: K122040
Trade/Device Name: Invotec laryngeal electrode Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical Nerve Stimulator Regulatory Class: Class II Product Code: ETN Dated: October 4, 2013 Received: October 9, 2013
Dear Mr. Aull:
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. Jeffrey L. Aull
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/ReportalProblem/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 yours,
Eric A. Mann -S
for 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
2
Indications for Use
510(k) Number (if known): K122040
Device Name: Invotec Laryngeal Electrode
Indications For Use:
The Invotec Laryngeal Electrodes are intended to be used as a sterile, single use, selfadhesive electrode attached to an endotracheal tube and positioned for continuous ` EMG monitoring of larynx during surgical procedure.
This electrode is not to be adhesively attached to silicone endotracheal tubes.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
Sunny Park
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