(262 days)
Not Found
No
The description focuses on the physical design and function of an endotracheal tube with electrodes for EMG monitoring. There is no mention of AI or ML in the device description, intended use, or performance studies.
No.
The device is for monitoring laryngeal musculature (diagnostic/monitoring), not for treating a condition (therapeutic).
No
Explanation: The device is an EMG tube designed to facilitate electromyographic (EMG) monitoring of laryngeal musculature during surgery. While EMG monitoring provides information, the tube itself is an accessory for monitoring and not directly performing a diagnostic function of identifying a disease or condition. The monitoring is used to avoid nerve damage during surgery.
No
The device description clearly states that the device is a physical endotracheal tube made of silicone elastomer with embedded electrodes. This is a hardware device, not software only.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is for continuous monitoring of laryngeal musculature during surgical procedures. This involves direct interaction with the patient's body for physiological monitoring.
- Device Description: The device is an endotracheal tube with electrodes designed to contact laryngeal muscles for electromyographic (EMG) monitoring. This is a physical device used for in-vivo measurement.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (blood, tissue, urine, etc.) outside of the body. IVDs are specifically designed for testing samples in vitro (in glass).
The device is clearly intended for direct physiological monitoring within the patient's body during surgery, which falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The EMG tube is indicated for use where continuous monitoring of the laryngeal musculature is required during surgical procedures. The EMG tube is not intended for postoperative use.
Product codes (comma separated list FDA assigned to the subject device)
ETN
Device Description
Medtronic Xomed, Inc.'s NIM™ Standard Reinforced and NIM CONTACT™ Reinforced Endotracheal Tubes are flexible, reinforced endotracheal tubes with inflatable cuffs. The NIM EMG ET Tubes are made from silicone elastomer. Each tube is fitted with electrodes on the main shaft, which are exposed only for a short distance, slightly superior to the cuff. The electrodes are designed to make contact with the laryngeal muscles around the patient's vocal cords to facilitate electromyographic (EMG) monitoring of the laryngeal musculature during surgery when connected to an EMG monitoring device. Both the tube and cuff are manufactured from material that allows the tube to conform readily to the shape of the patient's trachea with minimal trauma to tissues.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
laryngeal musculature, vocal cords, trachea
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Anesthesiologist/Nurse Anesthetist, Surgical procedures
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)
The following nonclinical testing was performed to establish substantial equivalence to the predicates: Summative Usability Validation and Labeling Design Validation. The Objective of this Summative Usability Validation testing was to accomplish:
-
- Achieve the Usability Goal: The Anesthesiologist/Nurse Anesthetist shall be able to intubate the patient and maintain the airway without introducing any unrealized use errors or critical tasks;
-
- Confirm the Critical tasks were completed without any unacceptable Use Error that may have resulted in unmitigated potential hazards; and
-
- To show the risk mitigations were effective in regard to labeling and training.
Additionally, the objective of the Labeling Design Validation was to validate that the NIM EMG Tube IFU and product labels met the User Need which was that the product labeling was to be understandable and provide needed information for proper safe and effective use of the device.
The results of these validations with the modified proposed labeling demonstrated that the usability goal was achieved, all critical tasks were completed without introducing any additional unmitigated hazards, the user need and risk control measures were met and the training mitigations proposed were effective. This nonclinical testing demonstrated that the subject device is substantially equivalent to the predicate device.
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 26, 2023
Medtronic Xomed, Inc. Emily Davis Principal Regulatory Affairs Specialist 6743 Southpoint Drive North Jacksonville, Florida 32216
Re: K230320
Trade/Device Name: NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal Tube Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical nerve stimulator/locator Regulatory Class: Class II Product Code: ETN Dated: August 29, 2023 Received: August 30, 2023
Dear Emily Davis:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies.combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100. Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrl-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Shuchen Peng -S
Shu-Chen Peng, Ph.D. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K230320
Device Name
NIM™ Standard Reinforced EMG Endotracheal Tube and NIM CONTACT™ Reinforced EMG Endotracheal Tube
Indications for Use (Describe)
The EMG tube is indicated for use where continuous monitoring of the laryngeal musculature is required during surgical procedures. The EMG tube is not intended for postoperative use.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Medtronic
Medtronic Xomed, Inc. 6743 Southpoint Drive N. Jacksonville, FL 32216 United States of America www.medtronic.com Tel. 904-296-9600
510(k) Summary
This 510(k) Summary was prepared in accordance with 21 CFR 807.92.
| Submitted By: | Medtronic Xomed, Inc.
6743 Southpoint Drive North
Jacksonville, Florida 32216 USA
Telephone Number: (904) 296-9600 |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number: | K230320 |
| Date Prepared: | 10/26/2023 |
| Official Correspondent: | Alexandra Oliver
Regulatory Affairs Manager
Telephone: (904) 332-8936
Email Address:
Alexandra.j.oliver@medtronic.com |
| Alternate Contact: | Emily Davis
Principal Regulatory Affairs Specialist
Telephone: (949) 636-4621
Email Address:
emily.r.davis@medtronic.com |
| I. DEVICE | |
| Proprietary (Trade) Names: | NIMTM Standard Reinforced EMG Endotracheal Tube,
NIM CONTACTTM Reinforced EMG Endotracheal Tube
Stimulator |
| Common Name: | Surgical nerve stimulator/locator |
| Regulation Name: | 21 CFR 874.1820 |
| Regulation Number: | ETN |
| Product Code: | II |
| Device Classification: | Ear, Nose, & Throat (ENT) |
| Review Panel: | |
II. PREDICATE DEVICE(S)
The NIM™ Standard Reinforced EMG Endotracheal Tube and NIM CONTACT™ EMG Reinforced Endotracheal Tube are substantially equivalent in intended use and technological characteristics to the following predicate device(s):
| 510(k) Number | 510(k) Device Name | Product
Code | Regulation
Number | 510(k)
Clearance Date |
|---------------|---------------------------------------------|-----------------|----------------------|--------------------------|
| K925640 | Xomed-Treace EMG
Endotracheal Tube | ETN | 21 CFR 874.1820 | August 17, 1993 |
| K050162 | CONTACT™ EMG
Rotatable Endotracheal Tube | ETN | 21 CFR 874.1820 | March 3, 2005 |
4
Medtronic
III. DEVICE DESCRIPTION
Device Description
Medtronic Xomed, Inc.'s NIM™ Standard Reinforced and NIM CONTACT™ Reinforced Endotracheal Tubes are flexible, reinforced endotracheal tubes with inflatable cuffs. The NIM EMG ET Tubes are made from silicone elastomer. Each tube is fitted with electrodes on the main shaft, which are exposed only for a short distance, slightly superior to the cuff. The electrodes are designed to make contact with the laryngeal muscles around the patient's vocal cords to facilitate electromyographic (EMG) monitoring of the laryngeal musculature during surgery when connected to an EMG monitoring device. Both the tube and cuff are manufactured from material that allows the tube to conform readily to the shape of the patient's trachea with minimal trauma to tissues.
Intended Use
The 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 intrinsic laryngeal musculature when connected to an appropriate EMG monitor.
IV. INDICATIONS FOR USE
Indications for Use
The EMG tube is indicated for use where continuous monitoring of the nerves supplying the laryngeal musculature is required during surgical procedures. The EMG tube is not intended for postoperative use.
V. TECHNOLOGICAL COMPARISON TO THE PREDICATE DEVICE(S)
The EMG Endotracheal tube is substantially equivalent to the predicate devices based on comparison of indications for use and technological characteristics where additions to the subject devices instructions for use were made being the only difference. Technological Characteristics of our device compared to each predicate is shown in the following table and in the Substantial Equivalence section of this submission.
5
Medtronic
| Feature/Attribute | NIM™ Standard
Reinforced EMG
Endotracheal Tube
& NIM
CONTACT™
Reinforced EMG
Endotracheal Tube
(Subject Device(s)) | Xomed-Treace EMG
Endotracheal Tube /
K925640
(Predicate Device) | CONTACT TM EMG
Rotatable ET Tube / K050162
(Predicate Device) |
|----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | ETN | ETN | ETN |
| Regulation Number | 21 CFR 874.1820 | 21 CFR 874.1820 | 21 CFR 874.1820 |
| Regulation
Description | Surgical nerve
stimulator/locator | Surgical nerve
stimulator/locator | Surgical nerve stimulator/locator |
| Classification | Class II | Class II | Class II |
| Common Name | Nerve Stimulator | Nerve Stimulator | Nerve Stimulator |
| Indications for Use | The EMG tube is
indicated for use where
continuous monitoring
of the nerves supplying
the laryngeal
musculature is required
during surgical
procedures. The EMG
tube is not intended or
postoperative use. | Intraoperative
electromyographic
monitoring of the vocal
cords to facilitate locating
and mapping of the
recurrent laryngeal nerve
in surgical procedures
involving the laryngeal
region of the throat. | The CONTACTTM EMG
Rotatable 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 intrinsic laryngeal
musculature when connected to an
appropriate EMG monitor.
The EMG Tube is indicated
for use where continuous
monitoring of the integrity
of the nerves supplying the
laryngeal musculature is
required during surgical
procedures. |
| Tube Lengths | Approximately 12.8
inches | Approximately 12.8
inches | Approximately 12.8 inches |
| Tube Inner
Diameter (ID) | 6mm-8mm | 4mm-8mm | 6mm-8mm |
| Number of
Laryngeal Surface
Electrodes | 4 | 4 | 4 |
| Electrode Surface | Stainless steel wire | Stainless steel wire | Stainless steel wire |
| Tube Material | Silicone | Silicone | Silicone |
| Cuff Material | Silicone | Silicone | Silicone |
| Reinforcing
Material | Stainless Steel | Stainless Steel | Stainless Steel |
| Sterilization Method | EtO | EtO | EtO |
6
Substantial Equivalence Discussion
The purpose of this submission is to gain clearance for proposed modifications to the labeling (Instructions for Use (IFU) and product labels) for the NIM™ Standard Reinforced and NIM CONTACT™ Reinforced Endotracheal Tubes. The NIM™ EMG ET Tubes are intended for use as a means of providing both an open airway for patient ventilation and for intraoperative monitoring of EMG activity of the intrinsic laryngeal musculature when connected to an appropriate EMG monitor. As the intended use remains the differences in labeling between the subject and predicate devices are additional warnings and precautions in the IFU for actions to be taken if airway obstruction is encountered, with additional symbols on product labeling for clarification on EMG ET Tube material and recommended tool for cuff inflation. These modified labeling differences are critical to the intended surgical use of the device when used as labeled and have been evaluated by Human Factors Testing and a Labeling Design Validation study which were found to improve the safety and efficacy. Both the subject device(s) and the predicate device(s) share similar characteristics (design, materials, operating principle, energy source, and performance).
VI. PERFORMANCE DATA
Performance Testing Discussion
The following nonclinical testing was performed to establish substantial equivalence to the predicates: Summative Usability Validation and Labeling Design Validation. The Objective of this Summative Usability Validation testing was to accomplish:
-
- Achieve the Usability Goal: The Anesthesiologist/Nurse Anesthetist shall be able to intubate the patient and maintain the airway without introducing any unrealized use errors or critical tasks;
-
- Confirm the Critical tasks were completed without any unacceptable Use Error that may have resulted in unmitigated potential hazards; and
-
- To show the risk mitigations were effective in regard to labeling and training.
Additionally, the objective of the Labeling Design Validation was to validate that the NIM EMG Tube IFU and product labels met the User Need which was that the product labeling was to be understandable and provide needed information for proper safe and effective use of the device.
The results of these validations with the modified proposed labeling demonstrated that the usability goal was achieved, all critical tasks were completed without introducing any additional unmitigated hazards, the user need and risk control measures were met and the training mitigations proposed were effective. This nonclinical testing demonstrated that the subject device is substantially equivalent to the predicate device.
Clinical Testing
No clinical test data is required of the proposed device.
7
VII. CONCLUSION
The NIM™ Standard Reinforced and NIM CONTACT™ Reinforced Endotracheal Tubes is concluded to be substantially equivalent to the predicates as the identified differences do not raise new or different concerns or questions of safety and effectiveness relative to the predicate device(s). Therefore, it is the opinion of the submitter that the NIM™ Standard Reinforced and NIM CONTACT™ Reinforced Endotracheal Tubes are as safe, as effective and performs as well as the legally marketed predicated devices.