(134 days)
Not Found
No
The summary describes a physical device (endotracheal tube with electrodes) for EMG monitoring and airway management. There is no mention of AI or ML in the device description, intended use, or performance studies. The focus is on the physical properties and electrical functionality of the tube.
No.
The device is described as being for "continuous EMG neurological monitoring and status assessment of the nerves" and to provide an "open airway for patient ventilation", indicating diagnostic/monitoring and assistive functions, but not direct therapeutic effect.
Yes
The device is used for "continuous EMG neurological monitoring and status assessment of the nerves supplying the laryngeal musculature," which is a diagnostic function.
No
The device description explicitly states it is an "endotracheal tube with integrated electrodes" made of "flexible PVC material with an inflatable low pressure cuff," 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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The NeuroVision EMG Endotracheal Tube is a device that is inserted into the body (in vivo) to provide an airway and to monitor electrical activity of nerves (EMG) during a surgical procedure. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for "continuous EMG neurological monitoring and status assessment of the nerves supplying the laryngeal musculature" and "providing an open airway for patient ventilation" during surgical procedures. This is an in-vivo application.
Therefore, the NeuroVision EMG Endotracheal Tube is a medical device used for in-vivo monitoring and airway management, not an in-vitro diagnostic test.
N/A
Intended Use / Indications for Use
The NeuroVision® EMG Endotracheal Tube is intended for use with any compatible monitoring system during surgical procedures for continuous EMG neurological monitoring and status assessment of the nerves supplying the laryngeal musculature as well as for providing an open airway for patient ventilation.
Product codes (comma separated list FDA assigned to the subject device)
ETN, GWF
Device Description
The NuVasive® NeuroVision® EMG Endotracheal (ET) Tube 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 EMG ET Tube 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 Laryngeal 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
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)
Nonclinical testing was performed to demonstrate that the subject NeuroVision® EMG Endotracheal Tube is substantially equivalent to other predicate devices. The following testing was performed:
- . Biocompatibility testing per ISO 10993-1 requirements, including:
- cytotoxic testing (per ISO 10993-5)
- intracutaneous testing (per ISO 10993-10)
- sensitization testing (per ISO 10993-10)
- Functional bench testing, including:
- Functional testing per ISO 5361
- inflation valve functionality
- leak test
- electrode resistance test
- system integration test
- bending test
- . Stability Testing
- . Sterilization & Packaging Validations
The results of these studies showed that the modified device meets the same specifications and criteria as the predecessor predicate device, and the device was therefore found to be substantially equivalent.
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
§ 882.1870 Evoked response electrical stimulator.
(a)
Identification. An evoked response electrical stimulator is a device used to apply an electrical stimulus to a patient by means of skin electrodes for the purpose of measuring the evoked response.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo for Nuvasive. The logo consists of the word "NUVASIVE" in bold, sans-serif font. Below the word "NUVASIVE" is the phrase "Creative Spine Technology" in a smaller, italicized font. To the left of the word "NUVASIVE" is a stylized graphic.
サイ
510(k) 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:
A. Submitted by:
Sheila Bruschi Senior Regulatory Affairs Associate NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: (858) 320-4515 Fax: (858) 320-4615 Date Prepared: May 13, 2010
MAY 1 4 2010
B. Device Name
| Trade or Proprietary Name: | NuVasive® NeuroVision® EMG Endotracheal Tube |
|---|---|
| Common or Usual Name: | Endotracheal Tube with Electromyography (EMG) |
| monitoring Electrodes. | |
| Classification Name: | Tracheal Tube |
| Inflatable Cuff | |
| Surgical nerve stimulator/locator | |
| Device Class: | Class II |
| Classification: | §874.1820, §882.1870, §868.5730 and §868.5750 |
| Product Code: | ETN, GWF |
C. Predicate Devices
The subject NeuroVision® EMG Endotracheal Tube is substantially equivalent to the following predicate devices currently distributed commercially in the U.S .:
- . K090298 - NuVasive NeuroVision EMG Endotracheal Tube
- K032491 ECOM™ CV4 Endotracheal Cardiac Output Monitor .
- K050162 Contact™ EMG Rotatable Endotracheal Tube .
D. Device Description
The NuVasive® NeuroVision® EMG Endotracheal (ET) Tube 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 EMG ET Tube 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 Laryngeal Nerve (RLN).
1
Image /page/1/Picture/0 description: The image shows the logo for NUVASIVE. The logo consists of the word "NUVASIVE" in a bold, sans-serif font. Below the word "NUVASIVE" is the phrase "Creative Spine Technology" in a smaller, italicized font. To the left of the word "NUVASIVE" is a stylized graphic.
E. Intended Use
The NeuroVision® EMG Endotracheal Tube is intended for use with any compatible monitoring system during surgical procedures for continuous EMG neurological monitoring and status assessment of the nerves supplying the laryngeal musculature as well as for providing an open airway for patient ventilation.
F. Technological Characteristics
As was established in this submission, the subject NeuroVision® EMG Endotracheal Tube is substantially equivalent to other predicate devices cleared by the FDA for commercial distribution in the United States. The subject device was shown to be substantially equivalent and have the same technological characteristics to its predicate devices through comparison in areas including design, intended use, material composition, function, packaging, and sterilization. See the table below for a detailed comparison:
| Subject Device | Predicate Devices | |||
|---|---|---|---|---|
| NeuroVision | ||||
| EMG | ||||
| Endotracheal | ||||
| Tube | NeuroVision EMG | |||
| Endotracheal Tube | ||||
| (K090298) | ECOM CV4 | |||
| Endotracheal | ||||
| Cardiac Output | ||||
| Monitor (K032491) | Contact™ EMG | |||
| Rotatable | ||||
| Endotracheal Tube | ||||
| (K050162) | ||||
| Laryngeal Surface | ||||
| Electrode | YES | YES | YES | YES |
| Endolaryngeal | ||||
| Location | YES | YES | YES | YES |
| Number of | ||||
| Electrodes | 4 | 4 | unknown | 4 |
| Electrode | ||||
| Surface Material | Conductive | |||
| Silver Ink | Stainless Steel Wire | Conductive | ||
| Silver Ink | Stainless Steel Wire | |||
| Tube & Cuff | ||||
| Materials | PVC | Silicone | PVC | Silicone |
| Reinforcing | ||||
| Material | None | Stainless Steel Wire | None | Stainless Steel Wire |
| Tube Dimensions | Various | |||
| Dimensions | Various Dimensions | unknown | Various Dimensions | |
| Sterilization & | ||||
| Packaging | Sterile, single use | |||
| only | Sterile, single use | |||
| only | Sterile, single use | |||
| only | Sterile, single use | |||
| only |
--
2
G. Performance Data
Nonclinical testing was performed to demonstrate that the subject NeuroVision® EMG Endotracheal Tube is substantially equivalent to other predicate devices. The following testing was performed:
- . Biocompatibility testing per ISO 10993-1 requirements, including:
- · cytotoxicity testing (per ISO 10993-5)
- · intracutaneous testing (per ISO 10993-10)
- · sensitization testing (per ISO 10993-10)
- Functional bench testing, including: ●
- · Functional testing per ISO 5361
- inflation valve functionality
- leak test
- electrode resistance test
- system integration test
- " bending test
- . Stability Testing
- . Sterilization & Packaging Validations
The results of these studies showed that the modified device meets the same specifications and criteria as the predecessor predicate device, and the device was therefore found to be substantially equivalent.
H. Conclusions
Based on the indications for use, technological characteristics, performance testing, and comparison to predicate devices, the subject NeuroVision® EMG Endotracheal Tube has been shown to be substantially equivalent to legally marketed predicate devices, and safe and effective for its intended use.
3
Image /page/3/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a serif font. The text is centered on the image and is the only element present.
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling an emblem. The emblem is a stylized representation of a bird or abstract design, possibly symbolizing health and well-being.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
NuVasive, Inc. c/o Ms. Sheila Bruschi Senior Regulatory Affairs Associate 7475 Lusk Blvd. San Diego, CA 92121
MAY. 1 4, 2010
Re: K094054
Trade/Device Name: NuVasive® NeuroVision EMG Endotracheal Tube Regulation Number: 21 CFR 882.1870 Regulation Name: Evoked Response Electrical Stimulator Regulatory Class: Class II Product Code: GWF, ETN Dated: April 12, 2010 Received: April 13, 2010
Dear Ms. Bruschi:
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.
4
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/ucm11.5809.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 yours.
Qula. Kumm, wo fr
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
| 510(k) Number (if known): | K |
|---|---|
| --------------------------- | --- |
Device Name:
Indications For Use:
The NeuroVision EMG Endotracheal Tube is intended for use with any compatible monitoring system during surgical procedures for continuous EMG neurological monitoring and status assessment of the nerves supplying the laryngeal musculature as well as for providing an open airway for patient ventilation.
Prescription Use X (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 CDRH, Office of Device Evaluation (ODE)
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(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K094054