(286 days)
Not Found
No
The summary describes a standard endotracheal tube with electrodes for EMG monitoring, and there is no mention of AI or ML in the device description, intended use, or performance studies.
No.
The device is used for monitoring electromyographic (EMG) activity of the laryngeal musculature rather than directly treating a condition. Its primary function is diagnostic and monitoring during surgical procedures.
Yes
The device is described as providing "intraoperative monitoring of EMG activity of the laryngeal musculature" and facilitating "electromyographic (EMG) monitoring of the laryngeal musculature during surgery." Monitoring typically involves collecting data to assess a condition, which aligns with the purpose of a diagnostic device, especially when used to understand the integrity of nerves.
No
The device description clearly states it is a physical endotracheal tube made of PVC with conductive silver electrodes, indicating it is a hardware device.
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 Next Generation EMG Endotracheal Tube is a device that is inserted into the patient's airway in vivo (within the living body). Its primary function is to maintain an open airway and to monitor electrical activity (EMG) of the laryngeal muscles directly from within the body.
- Lack of Sample Analysis: The device does not analyze samples taken from the patient. It is a direct monitoring tool used during surgery.
Therefore, the device's function and intended use clearly fall outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Next Generation EMG Endotracheal Tube is intended for use as a means of providing both an open airway for patient ventilation and for intraoperative monitoring of EMG activity of the laryngeal musculature when connected to an appropriate EMG monitor.
The EMG Tube is indicated for use when continuous monitoring of the integrity of the nerves supplying the laryngeal musculature is required during surgical procedures.
Product codes (comma separated list FDA assigned to the subject device)
ETN
Device Description
The Next Gen EMG Endotracheal Tube is a standard-size PVC (DEHP-free polyvinyl chloride) endotracheal tube with inflatable high volume, low pressure cuffs. Each tube is imprinted with four (two pairs) conductive silver electrodes. The conductive silver is printed on the PVC of the main shaft of the endotracheal tube and exposed only for a short distance, approximately 40 mm, slightly superior to the cuff, for contacting the vocal cords. The electrodes are designed to make contact with the patient's vocal cords to facilitate electromyographic (EMG) monitoring of the laryngeal musculature during surgery when connected to a multi-channel EMG neuromonitoring device.
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)
In house laboratories conducted studies verifying the design of the proposed device. Studies followed scientific protocols. The data were determined to be scientifically valid under 21 CFR 860.7.
Nonclinical testing was performed to demonstrate that the proposed Next Gen EMG Tube is substantially equivalent to the predicate devices.
The following testing was performed:
- Biocompatibility testing per ISO 10993-1 requirements, including: .
- cytotoxicity testing (per ISO 10993-5:2009)
- intracutaneous reactivity testing (per ISO 10993-10:2010)
- sensitization testing (per ISO 10993-10:2010)
- Functional testing, including:
- compliance testing per ISO 5361:1999
- electrode impedance test
- wire harness test
- product integration testing
- marking ink adhesion test.
Functional testing was performed using an animal model. The animal study provided evidence that the proposed device performed substantially equivalent to the predicate devices during monitoring of nerve integrity during surgical procedures.
The data presented in this Premarket Notification support that the subject device is safe and effective and performs in the same manner as the predicate devices when used in accordance with the labeled directions for use and for the specified indication(s).
The risks of the subject device, as well as the benefits to the patient, are the same as those . attributed to the use of the predicate devices.
A direct comparison of key technological characteristics demonstrates that the proposed Next Gen EMG Endotracheal Tube is substantially equivalent to the predicate devices in areas including design, material composition, function, packaging and sterilization.
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
§ 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
JUN 2 7 2012
Medtronic Xomed, Inc. Section 5.0 510(k) Summary
Traditional 510(k) Submission, Next Gen EMG Endotracheal Tube
Section 5.0 510(k) Summary
A. 510(k) Owner
Medtronic Xomed, Inc 6743 Southpoint Drive North Jacksonville, Florida 32216-0980 USA 904-279-7586 904-296-2386 (FAX)
B. Contact Information
Marek Pawlowski Senior Regulatory Affairs Specialist Medtronic Xomed, Inc marek.pawlowski@medtronic.com
Next Gen EMG Endotracheal Tube
C. Date Summary Prepared
D. Proprietary Name
E. Device Name
Trade name:
Common/Usual Name: Classification Name:
Next Gen EMG Endotracheal Tube (final name TBD) EMG ET Tube, EMG Endotracheal Tube Surgical nerve stimulator/locator (21 CFR 874.1820, Product Code ETN, Class II)
F. Predicate Devices:
| Trade Name: | NuVasive® NeuroVision® EMG Endotracheal Tube |
|---|---|
| Common/Usual Name: | EMG ET Tube |
| Classification Name: | Surgical nerve stimulator/locator |
| (21 CFR 874.1820, Product Code ETN, Class II) | |
| Premarket Notification: | K094054 |
November 10, 2011
Xomed EMG Endotracheal Tube Trade Name: EMG ET Tube Common/Usual Name: Classification Name: Surgical nerve stimulator/locator (21 CFR 874.1820, Product Code ETN, Class II) K925640 Premarket Notification:
G. Purpose of Submission:
:
Design change in the material of the tube from silicone in the predicate device Xomed EMG Tube to PVC in the proposed device and design change of electrodes from stainless steel wire in the predicate device to conductive silver ink in the proposed device.
1
Traditional 510(k) Submission, Next Gen EMG Endotracheal Tube Medtronic Xomed, Inc. Section 5.0 510(k) Summary
H. Device Description
The Next Gen EMG Endotracheal Tube is a standard-size PVC (DEHP-free polyvinyl chloride) endotracheal tube with inflatable high volume, low pressure cuffs. Each tube is imprinted with four (two pairs) conductive silver electrodes. The conductive silver is printed on the PVC of the main shaft of the endotracheal tube and exposed only for a short distance, approximately 40 mm, slightly superior to the cuff, for contacting the vocal cords. The electrodes are designed to make contact with the patient's vocal cords to facilitate electromyographic (EMG) monitoring of the laryngeal musculature during surgery when connected to a multi-channel EMG neuromonitoring device.
I. Intended Use/Indications for Use:
Indications for Use:
The EMG Tube is indicated for use when continuous monitoring of the integrity of the nerves supplying the laryngeal musculature is required during surgical procedures.
Intended Use:
The Next Generation EMG Endotracheal Tube is intended for use as a means of providing both an open airway for patient ventilation and for intraoperative monitoring of EMG activity of the laryngeal musculature when connected to an appropriate EMG monitor.
J. Substantial Equivalence
The subject device: Next Gen EMG Endotracheal Tube is substantially equivalent to predicate devices cleared by FDA for commercial distribution in the United States. A comparison of technological characteristics in areas including design, material composition, function, packaging and sterilization is presented in the table below:
| | Subject Device
Next Gen EMG
Endotracheal Tube | Predicate Device(s) | |
|--------------------------------|-----------------------------------------------------|-----------------------------------------------------------------|---------------------------------------------|
| | | NuVasive®
NeuroVision® EMG
Endotracheal Tube
(K094054) | Xomed EMG Endotracheal
Tube
(K925640) |
| Laryngeal Surface
Electrode | Yes | Yes | Yes |
| Endolaryngeal
Location | Yes | Yes | Yes |
| Number of
Electrodes | 4 | 4 | 4 |
| Electrode Surface
Material | Conductive Silver Ink | Conductive Silver Ink | Stainless Steel Wire |
| Tube & Cuff
Material | PVC | PVC | Silicone |
| Reinforcing Material | None | None | Stainless Steel Wire |
| Tube Dimensions | Various Dimensions | Various Dimensions | Various Dimensions |
| Sterilization &
Packaging | Sterile, single use only | Sterile, single use only | Sterile, single use only |
2
-k 112 686
Traditional 510(k) Submission, Next Gen EMG Endotracheal Tube Medtronic Xomed, Inc. Section 5.0 510(k) Summary
K. Conclusion
In house laboratories conducted studies verifying the design of the proposed device. Studies followed scientific protocols. The data were determined to be scientifically valid under 21 CFR 860.7.
Nonclinical testing was performed to demonstrate that the proposed Next Gen EMG Tube is substantially equivalent to the predicate devices.
The following testing was performed:
- Biocompatibility testing per ISO 10993-1 requirements, including: .
- cytotoxicity testing (per ISO 10993-5:2009) O
- intracutaneous reactivity testing (per ISO 10993-10:2010) o
- sensitization testing (per ISO 10993-10:2010) o
- Functional testing, including:
- o compliance testing per ISO 5361:1999
- electrode impedance test O
- wire harness test o
- product integration testing o
- o marking ink adhesion test.
Functional testing was performed using an animal model. The animal study provided evidence that the proposed device performed substantially equivalent to the predicate devices during monitoring of nerve integrity during surgical procedures.
The data presented in this Premarket Notification support that the subject device is safe and effective and performs in the same manner as the predicate devices when used in accordance with the labeled directions for use and for the specified indication(s).
The risks of the subject device, as well as the benefits to the patient, are the same as those . attributed to the use of the predicate devices.
A direct comparison of key technological characteristics demonstrates that the proposed Next Gen EMG Endotracheal Tube is substantially equivalent to the predicate devices in areas including design, material composition, function, packaging and sterilization.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like bird with three stripes forming its body and wings. The bird is positioned to the right of a circular text element that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged around the circumference of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Medtronic Xomed c/o Mr. Marek Pawlowski Senior Regulatory Affairs Specialist 6743 Southpoint Dr. North Jacksonville, FL 32216
JUN 2 7 2012
Re: K112686
Trade/Device Name: Next Generation EMG Endotracheal Tube Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical nerve stimulator/locator Regulatory Class: Class II Product Code: ETN Dated: June 15, 2012 Received: June 18, 2012
Dear Mr. Pawlowski:
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
Page 2 - Mr. Marek Pawlowski
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 (OS) 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.fdagov/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 yours,
E.L. Rummell MD
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
5
K112 686
Traditional 510(k) Submission, Next Gen EMG Endotracheal Tube Medtronic Xomed, Inc. Section 4.0 Indications for Use Statement
Section 4.0 Indications for Use Statement
Indications for Use
510(k) Number (if known): KIIQ 660
Next Generation EMG Endotracheal Tube (Final name to be Device Name: _ determined).
Intended Use/Indications for Use:
The Next Generation EMG Endotracheal Tube is intended for use as a means of providing both an open airway for patient ventilation and for intraoperative monitoring of EMG activity of the laryngeal musculature when connected to an appropriate EMG monitor.
The EMG Tube is indicated for use when continuous monitoring of the integrity of the nerves supplying the laryngeal musculature is required during surgical procedures.
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)
John Doucett
(Division Sign-Off)
Division of Ophthalmic, Neurological and Ear,
Division of Ophthalmic, Neurologices (Division Sign-Off) Division of Opinal
510(k) Number.
Image /page/5/Picture/18 description: The image shows the text "Prescription Use (Per 21 CFR 801.109)" in a bold, sans-serif font. The text is oriented diagonally from the bottom left to the upper right of the image. A dark line crosses out the text.