(209 days)
No
The summary describes a passive electrode device for EMG monitoring and airway management, with no mention of AI or ML in its function or processing.
No
The device is described as an accessory for monitoring and providing an airway during surgery, not for treating a disease or condition. It's a diagnostic/monitoring tool, not a therapeutic one.
Yes.
The device is used for continuous EMG monitoring and assessment of nerves, which is a diagnostic function to provide information about the patient's physiological state.
No
The device description clearly states it is a physical, sterile, single-use disposable accessory made of flexible PVC with an inflatable cuff, indicating it is a hardware device, not software-only.
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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Neurovision Ink Printed Endotracheal Tube Electrode is a device used during surgery to provide an airway and monitor nerve activity (EMG) of the laryngeal muscles. It is a physical device inserted into the body, not a test performed on a sample taken from the body.
- Intended Use: The intended use clearly states it's for "continuous EMG monitoring and assessment of the nerves supplying the laryngeal musculature" and "providing an open airway for patient ventilation." This is a monitoring and support function, not a diagnostic test on a biological sample.
Therefore, this device falls under the category of a surgical accessory and monitoring device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Neurovision Ink Printed Endotracheal Tube Electrode is intended for use during surgery and parasurgical care only, with any compatible monitoring system, for continuous EMG monitoring, assessment of the nerves supplying the laryngeal musculature as well as providing an open airway for patient ventilation.
Product codes
ETN, BTR, GWF
Device Description
The Nedrovision This Thise Chucklashic (EMG) monitoring during surgery. The ET tube is made of a flexible PVC material with an inflatable low pressure cuff. The Neurovision Ink made of a liexble I VO matonal with browided as a sterile, single use disposable accessory Printed Endonatible EMG monitor to provide an open airway for patient ventilation that connects to a a a current Laryngel Nerve (RLN).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
laryngeal musculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgery and parasurgical care
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
Nonclinical testing, including wire pull, abrasion, submersion and bend tests as well as impedance measurements demonstrated that the subject Neurovision Ink Printed Endotracheal Tube Electrode is substantially equivalent to the predicate.
Biocompatibility testing included ISO 10993-11 Systemic Toxicity, ISO 10993-10 Intracutaneous Sensitivity and ISO 10993-10 Irritation and Skin Sensitization.
Sterilization Validation was by VDMax method and Porous Packaging Validation was conducted according to ISO 11607.
Key Metrics
Not Found
Predicate Device(s)
K094054 NuVasive EMG Endotracheal Tube
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
neurovision
MEDICAL
K110989
NOV - 3 2011 p.1/2
Traditional 510k Neurovision Ink Printed Endotracheal Tube Electrode
510K Summary
. -
In accordance with Title 21 of the Code of Federal Regulations, Part 807 and in particular 21 CFR §807.92, the following summary of information is provided:
Applicant Information
Christine Vergely Neurovision Medical Products, Inc. 2225 Sperry Ave., Suite 1000 Ventura, CA 93003 PH 805-866-6999 Fax: 413-410-4579 christie@neurovisionmedical.com
Device Identification:
| Trade or Proprietary Name: | Neurovision Ink Printed Endotracheal Tube Electrode.
LETEIP-1, LETEIP-2 |
|----------------------------|----------------------------------------------------------------------------|
| Common or Usual Name: | Endotracheal Tube with Electromyography (EMG)
monitoring Electrodes. |
| Device Class: | Class II |
| Product Code: | ETN |
Predicate Device
The subject Neurovision Ink Printed Endotracheal Tube Electrode is substantially equivalent to the following predicate devices concurrently distributed commercially in the U.S.:
- K094054 NuVasive EMG Endotracheal Tube .
Device Description
Device Description The Nedrovision This Thise Chucklashic (EMG) monitoring during surgery. The ET tube is made of a flexible PVC material with an inflatable low pressure cuff. The Neurovision Ink made of a liexble I VO matonal with browided as a sterile, single use disposable accessory Printed Endonatible EMG monitor to provide an open airway for patient ventilation that connects to a a a current Laryngel Nerve (RLN).
Intended Use
The Neurovision Ink Printed Endotracheal Tube Electrode is intended for use atinyoung EMC The Neurovision This Frinted Endottachear Tube Elocatoring system, for continuous EMG
and parasurgerical care only, with any compatible monitoring system, for continuous en w and parasungencal care only, with any only compansion musculature as well as providing an open airway for patient ventilation.
Technological Characteristics of Device in Relation to Predicate Devices
Technological Characterisatis of Deville in heat the Electrode is substantially equivalent to
The subject Neurovision Ink Printed Endotracheal Tube Electrode in the United St The subject Neurovision ink Philed Endoration in the United States. The the predicated device cleared by the rechnically equivalent and have the same technological
1
neurovision
MEDICAL
p. 2/2
Traditional 510k Neurovision Ink Printed Endotracheal Tube Electrode
characteristics to its predicate device through comparison in areas including design, intended use, material composition, function, packaging, and sterilization.
| Characteristics | Predicate Device | Subject Device | |
|---|---|---|---|
| Laryngeal Surface | |||
| Electrode | NuVasive EMG Endotracheal | ||
| Tube | |||
| (K094054) | Neurovision Ink Printed | ||
| Endotracheal Tube Electrode | |||
| YES | YES | ||
| Endotracheal | |||
| Location | YES | YES | |
| Number of | |||
| Electrodes | 4 | 2 or 4 | |
| Electrode Surface | |||
| Material | Conductive Silver Ink | ||
| Tube & Cuff | |||
| Materials | PVC | ||
| Reinforcing Material | None | ||
| Tube Dimensions | Various Dimensions | Various Dimensions | |
| Sterilization and | |||
| Packaging | Sterile, Single Use Only | Sterile, Single Use Only |
Nonclinical testing, including wire pull, abrasion, submersion and bend tests as well as impedance measurements demonstrated that the subject Neurovision Ink Printed Endotracheal Tube Electrode is substantially equivalent to the predicate.
Biocompatibility testing included ISO 10993-11 Systemic Toxicity, ISO 10993-10 Intracutaneous Sensitivity and ISO 10993-10 Irritation and Skin Sensitization.
Sterilization Validation was by VDMax method and Porous Packaging Validation was conducted according to ISO 11607.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all capital letters and is evenly spaced around the circular border.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Neurovision Medical Products, Inc. c/o Ms. Christine Vergely Regulatory Manager 2225 Sperry Ave., Suite 1000 Ventura, CA 93003
NOV - 3 2011
~ Re: K110989
Trade/Device Name: Neurovision Ink Printed Endotracheal Tube Electrode Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical Nerve Stimulator/Locator Regulatory Class: Class II Product Code: ETN, BTR, GWF Dated: October 17, 2011 Received: October 19, 2011
Dear Ms. Vergely:
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.
3
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 (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.
Malvina R. Eydelman, M.D.
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
4
Indications for Use
510(k) Number (if known): K110989
Device Name: Neurovision Ink Printed Endotracheal Tube Electrode
Indications for Use:
The Neurovision Ink Printed Endotracheal Tube Electrode is intended for use during The Nouronolon mit a care only, with any compatible monitoring system, for surgery and paraourgiour sale of the ensessment of the nerves supplying the lanyngeal musculature as well as providing an open airway for patient ventilation.
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) JOE HUTTER
510(k) Number.
(Division Sign-Off) : Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices