(122 days)
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.
The NeuroVision® EMG Endotracheal (ET) Tube is a low pressure cuff endotracheal tube with integrated electrodes for electromyographic (EMG) monitoring during surgery.
The provided text is a 510(k) summary for the NuVasive® NeuroVision® EMG Endotracheal Tube. It primarily focuses on demonstrating substantial equivalence to existing predicate devices based on design, materials, and intended use.
Crucially, this document does not contain information about specific acceptance criteria or a study that rigorously proves the device meets such criteria through performance metrics like sensitivity, specificity, or accuracy. Instead, the substantial equivalence argument relies on comparing the device's characteristics to already-cleared devices.
Therefore, most of the requested information cannot be extracted from this document. However, I can provide what is available:
1. Table of Acceptance Criteria and Reported Device Performance:
- No specific acceptance criteria (e.g., performance thresholds) are explicitly stated in this document.
- No quantitative device performance metrics (e.g., sensitivity, specificity, accuracy) are reported.
- The document states that "Engineering specifications and labeling have demonstrated that the subject device is substantially equivalent, if not identical, to its predicate devices in terms of design, materials of composition, indications for use, and such other characteristics as may be associated with the manufacture of any medical device." This describes the basis for equivalence rather than performance against defined criteria.
2. Sample Size Used for the Test Set and Data Provenance:
- Not applicable. This document describes a 510(k) submission based on substantial equivalence, not a clinical study with a test set of data.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Not applicable. Ground truth establishment by experts for a test set is not described.
4. Adjudication Method for the Test Set:
- Not applicable. No test set or adjudication method is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. This document does not mention any MRMC comparative effectiveness study comparing AI assistance with human readers. The device itself is an endotracheal tube with EMG monitoring capabilities, not an AI diagnostic tool.
6. Standalone (Algorithm Only) Performance Study:
- Not applicable. The device is a physical endotracheal tube with integrated electrodes; it is not an algorithm or AI system for which standalone performance would be assessed in this context.
7. Type of Ground Truth Used:
- Not applicable. Ground truth for a performance study is not described. The "ground truth" in this context is the understanding of the predicate devices' safety and effectiveness, which is assumed.
8. Sample Size for the Training Set:
- Not applicable. No training set for an algorithm is described.
9. How Ground Truth for the Training Set Was Established:
- Not applicable. No training set or ground truth establishment for it is described.
In summary, this 510(k) submission focuses on demonstrating substantial equivalence through a comparison of device characteristics and intended use with predicate devices, rather than through a study proving performance against defined acceptance criteria.
{0}------------------------------------------------
VII. 510(k) Summary
In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular $807.92, the following summary of information is provided:
Submitted by: A.
Ms. Han Fan Regulatory Affairs Associate NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: (858) 909-1868 Fax: (858) 909-2068
JUN - 8 2009
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 TubeInflatable CuffSurgical 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 Xomed EMG Endotracheal Tube and the Arcadia Medical Tube currently distributed commercially in the U.S ..
D. Device Description
The NeuroVision® EMG Endotracheal (ET) Tube is a low pressure cuff endotracheal tube with integrated electrodes for electromyographic (EMG) monitoring during surgery.
Intended Use E.
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.
{1}------------------------------------------------
Substantial Equivalence F.
As was established in this submission, the subject device is substantially equivalent to other devices cleared by the agency for commercial distribution in the United States.
Engineering specifications and labeling have demonstrated that the subject device is substantially equivalent, if not identical, to its predicate devices in terms of design, materials of composition, indications for use, and such other characteristics as may be associated with the manufacture of any medical device.
{2}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The background is white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NuVasive, Inc. c/o Han Fan Regulatory Affairs Associate 7475 Lusk Blvd. San Diego, CA 92121
JUN - 8 2009
Re: K090298
Trade/Device Name: NuVasive® NeuroVision® EMG Endotracheal Tube Regulation Numbers: 21 CFR 882.1870 Regulation Name: Evoked Response Electrical Stimulator Regulatory Class: II Product Code: GWF Dated: May 21, 2009 Received: May 22, 2009
Dear Ms. Fan:
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.
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.
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.
{3}------------------------------------------------
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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
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
{4}------------------------------------------------
Indications for Use
510(k) Number (if known): K090298
Device Name: NuVasive NeuroVision EMG Endotracheal Tube
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 (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)
CG
Page 1 of 1
(Division Sign-Off) Division of Ophthalmic and Ear, Nose and Throat Devices
510(k) Number K090298
§ 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).