(91 days)
Not Found
No
The summary describes a device that delivers electrical stimulation and allows for current adjustment, with no mention of AI or ML technologies.
No.
The device is indicated to stimulate nerves for location and identification during surgery, not for therapeutic treatment.
No
The device is used for stimulating and locating nerves during surgery, which is an intraoperative procedure and not a diagnostic process performed externally or prior to treatment for diagnosis.
No
The device description explicitly states that the device "carry stimulation current from the patient interface to the patient" and mentions "Electromechanical, dimensional, and visual design performance" and "Electrical safety & EMC testing to IEC 60601" in the performance studies, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "stimulate cranial and peripheral motor nerves for location and identification during surgery." This is a direct interaction with the patient's body during a surgical procedure.
- Device Description: The device "carry stimulation current from the patient interface to the patient." This confirms it's applying a stimulus to the patient.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) outside of the body to provide information about a physiological state, health, or disease.
IVD devices are specifically designed to perform tests on samples taken from the body to diagnose or monitor conditions. This device is used in vivo (within the living body) for nerve stimulation and identification during surgery.
N/A
Intended Use / Indications for Use
The NIM™ surgeon control probes are indicated to stimulate cranial and peripheral motor nerves for location and identification during surgery, including spinal nerve roots via minimally invasive Transoral endoscopic thyroidectomy via vestibular approach - TOETVA.
Product codes
ETN
Device Description
The NIM™ surgeon control probes carry stimulation current from the patient interface to the patient. It also enables the user to adjust stimulation current and key functions from the surgical site. All probes are single use devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cranial and peripheral motor nerves, spinal nerve roots
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon, surgical site
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)
Design performance testing was completed to ensure the functionality and intended use of the NIM™ 35cm long surgeon control probe was met in accordance with external standards, and device specifications via pre-defined acceptance criteria. Bench engineering test samples were subjected to simulated real-life conditions during functional testing to establish baseline data and accelerated aging data. The testing included in this submission provides objective evidence through passing results that key technological characteristics such as the ones listed below are proven to be safe and effective. This performance testing was used to support substantial equivalence, proving the subject device is as safe and effective as its predicate device.
- Electromechanical, dimensional, and visual design performance
- Sterilization validation to ISO 11135:2014
- Electrical safety & EMC testing to IEC 60601
- Biocompatibility testing and risk analysis to ISO 10993-1:2018
- Stability testing of proposed shelf life
- Packaging performance of environmental conditioning to ISTA 3A and distribution simulation to ASTM D4169
- Usability testing to IEC 62366-1:2015
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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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August 30, 2023
Medtronic Xomed, Inc. Alexandra Oliver Senior Regulatory Affairs Specialist 6743 Southpoint Drive North Jacksonville, Florida 32216
Re: K231580
Trade/Device Name: NIM™ 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35) Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical Nerve Stimulator/Locator Regulatory Class: Class II Product Code: ETN Dated: May 30, 2023 Received: May 31, 2023
Dear Alexandra Oliver:
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 app roval 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 located 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.
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 803) for
1
devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K231580
Device Name NIM™ 35cm long Surgeon Control Probe
Indications for Use (Describe)
The NIM™ surgeon control probes are indicated to stimulate cranial and peripheral motor nerves for location and identification during surgery, including spinal nerve roots via minimally invasive Transoral endoscopic thyroidectomy via vestibular approach - TOETVA.
| 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) |
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510(k) Summary - K231580
I. SUBMITTER
| Company (submitter): | Medtronic Xomed, Inc.
6743 Southpoint Drive North
Jacksonville, Florida 32216 USA
Telephone Number: (904) 296-9600 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | May 19, 2023 |
Contact Person: Alexandra Oliver Senior Regulatory Affairs Specialist Telephone: (904) 332-8936 Email Address: Alexandra.j.oliver@medtronic.com
II. DEVICE
| Proprietary (Trade) Name: | NIM™ 35cm long Surgeon Control Probe |
|---|---|
| Common Name: | Stimulator, nerve |
| Regulation Name: | Surgical nerve stimulator/locator |
| Regulation Number: | 21 CFR 874.1820 |
| Product Code: | ETN |
| Classification: | II |
| Panel: | 77 (Ear, Nose, & Throat) |
III. PREDICATE DEVICE(s)
The 35cm long NIM™ Surgeon Control Probe is substantially equivalent in intended use and technological characteristics to the following predicate device:
| 510(k) Number | 510(k) / Device
Name | 510(k) Clearance
Date |
|---------------|---------------------------------|--------------------------|
| K213246 | NIMTM Surgeon
Control Probes | March 21, 2022 |
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IV. DEVICE DESCRIPTION
Device Description
The NIM™ surgeon control probes carry stimulation current from the patient interface to the patient. It also enables the user to adjust stimulation current and key functions from the surgical site. All probes are single use devices.
Intended Use
The NIMTM surgeon control probes are intended for use as intraoperative nerve stimulators.
V. INDICATIONS FOR USE
Indications for Use
The NIM™ surgeon control probes are intended to stimulate cranial and peripheral motor nerves for location and identification during surgery, including spinal nerve roots via minimally invasive Transoral endoscopic thyroidectomy via vestibular approach - TOETVA.
VI. SUBSTANTIAL EQUIVALENCE
Substantial Equivalence/Device Comparison (Subject Device(s) to Predicate Devices)
| Feature/Attribute | 35cm long Surgeon Control Probe
(Subject Device(s)) | Surgeon Control Probes, K213246
(Predicate Device) | Comparison |
|-------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | ETN | ETN | SAME |
| Regulation Number | 21 CFR 874.1820 | 21 CFR 874.1820 | SAME |
| Regulation Description | Surgical nerve stimulator/locator | Surgical nerve stimulator/locator | SAME |
| Classification | Class II | Class II | SAME |
| Common Name | Nerve Stimulator | Nerve Stimulator | SAME |
| Device Description | The NIM™ surgeon control probes carry stimulation current from the patient interface to the patient. It also enables the user to adjust stimulation current and key functions from the surgical site. All probes are single use devices. | The NIM™ surgeon control probes carry stimulation current from the patient interface to the patient. It also enables the user to adjust stimulation current and key functions from the surgical site. All probes are single use devices. | SAME |
| Intended Use | The NIM™ surgeon control probes are intended for use as intraoperative nerve stimulators | The NIM™ surgeon control probes are intended for use as intraoperative nerve stimulators | All probes are intended for the SAME use, as an intraoperative nerve stimulator. |
| Indications for Use | The NIM™ surgeon control probes are intended to stimulate cranial and peripheral motor nerves for location and identification during surgery, including | The NIM™ surgeon control probes are intended to stimulate cranial and peripheral motor nerves for location and identification during surgery, including spinal nerve roots | The subject device's extended length is to accommodate TOETVA as a minimally invasive approach. The |
| Feature/Attribute | 35cm long Surgeon Control Probe
(Subject Device(s)) | Surgeon Control Probes, K213246
(Predicate Device) | Comparison |
| | spinal nerve roots via
minimally invasive Transoral
endoscopic thyroidectomy via
vestibular approach -
TOETVA | | usability study on the
NIM 35cm long probe
shows this probe
length is suitable for
use in a TOETVA
approach. |
| Contraindications | The NIM™ surgeon control
probes are contraindicated for
use with paralyzing anesthetic
agents when monitoring a
motor nerve as these may
reduce or eliminate the
patient's EMG response. | The NIM™ surgeon control
probes are contraindicated for
use with paralyzing anesthetic
agents when monitoring a
motor nerve as these may
reduce or eliminate the
patient's EMG response. | SAME |
| Operating
Principle | Electrical stimulation | Electrical stimulation | SAME |
| Design | Offered in a ball-tip
configuration with insulated
shaft and permanently molded
incrementing (stim) handle for
use in the sterile field | Offered in prass-tip or ball-tip
configurations; both with
insulated shaft and
permanently molded
incrementing (stim) handle for
use in the sterile field | SAME |
| Probe tip (exposed
area) tissue
contact surface
geometry | 1mm ball | 1mm ball | SAME (for ball-tip
geometries
respectively) |
| Probe working
length | 13.78" [35.0 cm] | 3.76" [9.6cm] | The 35 cm Ball Tip
probe has a longer
length for extended
reach. The patient
contacting surfaces
and stimulation
performance is
unaffected by this
modification to the
length. |
| Patient-contacting
Materials | 303 Stainless Steel with Teflon
Polytetrafluoroethylene
(PTFE) coating insulation | 303 Stainless Steel with
Xylamed coating insulation or
Teflon Polytetrafluoroethylene
(PTFE) coating insulation | SAME (for ball-tip
materials respectively) |
| Patient contact | Direct | Direct | SAME |
| Biocompatible | Yes | Yes | SAME |
| Sterile | Yes | Yes | SAME |
| Single-Use
Disposable | Yes | Yes | SAME |
| Duration of Use | Limited (