(168 days)
No
The summary describes a device with integrated electrodes for EMG monitoring, but there is no mention of AI or ML being used for data analysis or interpretation. The performance studies focus on bench testing and biocompatibility, not algorithmic performance.
No
The device is described as an accessory for continuous EMG neurological monitoring and status assessment of nerves, and for providing an open airway for patient ventilation during surgery, rather than for treating a disease or condition.
Yes
Explanation: The device is intended for "continuous EMG neurological monitoring and status assessment of the nerves supplying the laryngeal musculature," which is a diagnostic function. It provides data for assessing the status of nerves.
No
The device description clearly states it is an endotracheal tube made of flexible PVC material with integrated electrodes and an inflatable cuff, indicating it is a physical hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The NuVasive EMG Endotracheal Tube is used in vivo (inside the body) during surgery. It provides an airway and monitors nerve activity directly within the patient. It does not analyze samples taken from the patient.
Therefore, based on the provided information, the NuVasive EMG Endotracheal Tube is a surgical device used for monitoring and ventilation within the body, not an IVD.
N/A
Intended Use / Indications for Use
The NuVasive 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
PDQ, ETN, GWX, BSK, BTR
Device Description
The NuVasive® EMG Endotracheal (ET) Tube is an endotracheal tube with integrated electrodes for electromyographic (EMG) monitoring surgery. The ET tube is made of a flexible PVC material with an inflatable low pressure cuff. The 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 NuVasive 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 – MEM Elution: Results: Discrete intracytoplasmic granules; no cell lysis (Grade 0). Conclusion: Pass Non-cytotoxic.
- Intracutaneous testing – NS and CSO: Results: No erythema (Score 0) No edema (Score 0). Conclusion: Pass Requirements met.
- Sensitization testing – NS and CSO: Results: No sensitization observed (Score 0). Conclusion: Pass Non-sensitizer.
- Systemic toxicity – NS and CSO: Results: No signs or symptoms of systemic toxicity observed. Conclusion: Pass Requirements met.
- 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)
K094054 - NuVasive NV 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.
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Image /page/0/Picture/1 description: The image shows the logo for "NUVASIVE". The logo consists of a stylized graphic to the left of the company name. Below the company name is the tagline "Speed of Innovation" in a smaller font.
510(k) Summary
MAY 0 2 2014
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:
Submitted by: A.
Jeremy Markovich Associate Manager, Regulatory Affairs NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: (858) 909-1800
Date Prepared: April 25, 2014
B. Device Name
| Trade or Proprietary Name: | NuVasive® EMG Endotracheal Tube |
|---|---|
| Common or Usual Name: | Neurosurgical Nerve Locator; |
| Endotracheal Tube with Electromyography (EMG) | |
| monitoring Electrodes | |
| Classification Name: | Surgical nerve stimulator/locator; |
| Tracheal Tube; | |
| Inflatable Cuff: | |
| Device Class: | Class II |
| Classification: | §874.1820, §882.1820, §868.5730 and §868.5750 |
| Product Code: | PDQ, ETN, GWX, BSK and BTR |
Predicate Devices C.
The subject NuVasive EMG Endotracheal Tube is substantially equivalent to the following predicate devices currently distributed commercially in the U.S .:
- . K094054 - NuVasive NV EMG Endotracheal Tube
Device Description D.
The NuVasive® EMG Endotracheal (ET) Tube is an endotracheal tube with integrated electrodes for electromyographic (EMG) monitoring surgery. The ET tube is made of a flexible PVC material with an inflatable low pressure cuff. The 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).
E. Intended Use
The NuVasive EMG Endotracheal Tube is intended for use with any compatible monitoring system during surgical procedures for continuous EMG neurological monitoring and status
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Image /page/1/Picture/0 description: The image shows the logo for Nuvasive. The logo consists of a stylized graphic to the left of the company name, "NUVASIVE," in bold, sans-serif font. Below the company name is the tagline "Speed of Innovation" in a smaller font size. The logo is simple and modern, with a focus on the company name and tagline.
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 NuVasive 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. This device does not contain software. See the table below for a detailed comparison:
| Predicate Devices | Subject Device | |
|---|---|---|
| NuVasive NV EMG Endotracheal | ||
| Tube (K094054) | NuVasive EMG Endotracheal | |
| Tube | ||
| Laryngeal Surface | ||
| Electrode | YES | YES |
| Endolaryngeal | ||
| Location | YES | YES |
| Number of | ||
| Electrodes | 2 bipolar | 2 bipolar |
| Electrode | ||
| Surface Material | Conductive | |
| Silver Ink | Conductive | |
| Silver Ink with PVC Base | ||
| Tube & Cuff | ||
| Materials | PVC | PVC (Non-DEHP) |
| Reinforcing | ||
| Material | None | None |
| Tube Dimensions | Various Dimensions | Various Dimensions |
| Sterilization & | ||
| Packaging | Sterile, single use only | Sterile, single use only |
G. Performance Data
Nonclinical testing was performed to demonstrate that the subject NuVasive EMG Endotracheal Tube is substantially equivalent to other predicate devices. The following testing was performed:
- Biocompatibility testing per ISO 10993-1 requirements, including: .
| Test Name | Results | Conclusion |
|---|---|---|
| Cytotoxicity testing – | ||
| MEM Elution | Discrete intracytoplasmic granules; | |
| no cell lysis (Grade 0) | Pass | |
| Non-cytotoxic | ||
| Intracutaneous testing – | ||
| NS and CSO | No erythema (Score 0) | |
| No edema (Score 0) | Pass | |
| Requirements met | ||
| Sensitization testing – | ||
| NS and CSO | No sensitization observed | |
| (Score 0) | Pass | |
| Non-sensitizer | ||
| Systemic toxicity – | ||
| NS and CSO | No signs or symptoms of systemic | |
| toxicity observed | Pass | |
| Requirements met |
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Image /page/2/Picture/1 description: The image shows the Nuvasive logo. The logo consists of a stylized leaf-like shape on the left, followed by the word "NUVASIVE" in bold, sans-serif font. Below "NUVASIVE" is the tagline "Speed of Innovation" in a smaller font size.
- 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 NuVasive EMG Endotracheal Tube has been shown to be substantially equivalent to legally marketed predicate devices for its intended use.
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol. The logo is black and white.
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
May 2, 2014
NuVasive, Incorporated Mr. Jeremy Markovich Associate Manager, Regulatory Affairs 7475 Lusk Blvd. San Diego, California 92121
Re: K133530
Trade/Device Name: NuVasive® EMG Endotracheal Tube Regulation Number: 21 CFR 874.1820 Regulation Name: Neurosurgical Nerve Locator Regulatory Class: Class II Product Code: PDQ, BSK and BTR Dated: March 31, 2014 Received: April 1, 2014
Dear Mr. Markovich:
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.
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
4
Page 2 - Mr. Jeremy Markovich
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 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.fda.gov/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Felipe Aquel -S
Carlos L. Peña, PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K133530
Device Name Nu Vasive EMG Endotracheal Tube
Indications for Use (Describe)
The NuVasive EMG Endoracheal Tube is intended for use with any compatible monitoring surgical procedures for continuous EMG neurological monitoring and status assessment of the laryngeal musculature as well as for providing an open airway for patient ventilation.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
... .
er for Devices and Radiological Health (CDRH) (Signature)
Date: 2014.05.02 11:22:42 -04'00'
FORM FDA 3881 (1/14)
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
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