(109 days)
Not Found
No
The summary describes a device for EMG monitoring and airway management, focusing on the physical components and basic electrical function. There is no mention of AI, ML, or any data processing beyond basic signal acquisition for EMG.
No.
The device is used for monitoring nerve activity and providing ventilation during surgery, not for treating a disease or condition.
Yes
Explanation: The device is used for "continuous EMG monitoring and status assessment of the nerves supplying the laryngeal musculature," which is a diagnostic function to assess the real-time condition of the nerves.
No
The device description explicitly states it is an "endotracheal tube with integrated electrodes," which are physical hardware components.
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 Neurovision Ink Printed Endotracheal Tube Electrode is a device used during surgery to monitor nerve activity (EMG) in vivo (within the living body) and provide an airway. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states "during surgery and parasurgical care only" for "continuous EMG monitoring and status assessment of the nerves supplying the laryngeal musculature." This is a direct interaction with the patient's body, not an analysis of a sample.
Therefore, this device falls under the category of a medical device used for monitoring and providing an airway during surgical procedures, 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 and status assessment of the nerves supplying the laryngeal musculature as well as providing an open airway for patient ventilation.
Product codes
ETN, PDO, BTR, GWF
Device Description
The Neurovision Ink Printed Endotracheal Tube Electrode is an endotracheal tube with integrated electrodes for electromyographic (EMG) monitoring during surgery. The ET tube is made of a flexible PVC material with an inflatable low pressure cuff. The Neurovision Ink Printed Endotracheal Tube Electrode is provided as a sterile, single use disposable accessory that connects to a compatible EMG monitor to provide an open airway for patient ventilation during EMG neuromonitoring of the Recurrent 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
During surgery and parasurgical care setting.
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)
Nonclinical testing, including valve functionality, electrode impedance and bend tests 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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.
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Image /page/0/Picture/1 description: The image shows the logo for Neurovision Medical. The word "neurovision" is in large, outlined letters on the top line. Below that, the word "MEDICAL" is in smaller, outlined letters with three lines above it.
Special 510k - Ink Printed Endotracheal Tube Electrode Modification
JUL 1 2 2013
510K Summary
Date: 5/1/2013
In accordance with Title 21 of the Code of Federal Requlations. Part 807 and in particular 21 CFR §807.92, the following summary of information is provided:
Applicant Information
Christine Vergely Regulatory Affairs Manager 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: Common or Usual Name:
Neurovision Ink Printed Endotracheal Tube Electrode. Endotracheal Tube with Electromyography (EMG) monitoring Electrodes. Class II
Device Class: Product Code:
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.:
- . K110989 Neurovision Ink Printed Endotracheal Tube Electrode
ETN
Device Description
The Neurovision Ink Printed Endotracheal Tube Electrode is an endotracheal tube with integrated electrodes for electromyographic (EMG) monitoring during surgery. The ET tube is made of a flexible PVC material with an inflatable low pressure cuff. The Neurovision Ink Printed Endotracheal Tube Electrode is provided as a sterile, single use disposable accessory that connects to a compatible EMG monitor to provide an open airway for patient ventilation during EMG neuromonitoring of the Recurrent Laryngel Nerve (RLN).
Intended 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 and status assessment of the nerves supplying the laryngeal musculature as well as providing an open airway for patient ventilation.
Technological Characteristics of Device in Relation to Predicate Devices
The Neurovision Ink Printed Endotracheal Tube Electrode is substantially equivalent to the predicated device in intended use and technological characteristics including design,
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Image /page/1/Picture/0 description: The image shows the logo for Neurovision Medical. The word "neurovision" is written in large, outlined letters. Below that, the word "MEDICAL" is written in smaller, block letters, underlined by three horizontal lines that are connected by a small, jagged line in the middle.
Special 510k - Ink Printed Endotracheal Tube Electrode Modification
material composition, function, packaging, and sterilization.
Comparison with the Predicate Device
| Predicate Device | Subject Device | |
|---|---|---|
| Device Name | Neurovision Ink Printed | |
| Endotracheal Tube Electrode | No Change | |
| Indicated 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 and status | ||
| assessment of the nerves | ||
| supplying the laryngeal | ||
| musculature as well as | ||
| providing an open airway for | ||
| patient ventilation. | No Change | |
| Operating Principle | Receives EMG signal | No Change |
| Shelf Life | 3 years | No Change |
| Laryngeal | ||
| Surface | ||
| Electrode | YES | No Change |
| Endotracheal | ||
| Location | YES | No Change |
| Number | ||
| of | ||
| Electrodes | 2 or 4 | No Change |
| Electrode | ||
| Surface | ||
| Material | Conductive Silver Ink | No Change |
| Tube | ||
| & | ||
| Cuff | ||
| Materials | PVC | No Change |
| Reinforcing Material | Dielectric coating | Dielectric coating attached |
| to tube by non-phthalate | ||
| PVC adhesive. | ||
| Tube Dimensions | Various Dimensions | No Change |
| Sterilization | ||
| and | ||
| Packaging | Sterile, Single Use Only | No Change |
| Labeling, | ||
| Instructions for Use, | ||
| Intended Use | See attachments 1 and 2 | No Change |
Nonclinical testing, including valve functionality, electrode impedance and bend tests 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.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three lines representing the branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 12, 2013
Neurovision Medical Product, Inc. Ms. Christine Vergely Regulatory Affairs Manager 2225 Sperry Avenue, Suite 1000 Ventura, CA 93003
Re: K130806
Trade/Device Name: Neurovision Ink Printed Endotracheal Tube Electrode Regulation Number: 21 CFR 874.1820 Regulation Name: Neurosurgical Nerve Locator Regulatory Class: Class II Product Code: PDO, ETN, BTR, GWF Dated: June 12, 2013 Received: June 13, 2013
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 }] (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.
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
3
Page 2 - Ms. Christine Vergely
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fdagov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 yours,
Victor Krauthamer -S
Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K130806
Device Name: Neurovision Ink Printed Endotracheal Tube Electrode
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 and status assessment of the nerves supplying the laryngeal musculature as well as for providing an open airway for patient ventilation.
Prescription Use _ × (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Victor Krauthamer: -S 2013.07.12 16:49:43 -04'00'
Division Sign Off) Division of Neurological and Physical Medicine Devices (DNPMD)
510(k) Number
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