(172 days)
Not Found
No
The description focuses on electrical stimulation and control, with no mention of AI/ML terms or capabilities.
No
The probes are used to stimulate nerves for identification and location during surgery, which is a diagnostic/monitoring function, not a therapeutic intervention.
No.
The device's intended use is to stimulate nerves for location and identification during surgery, and its description confirms it carries stimulation current, rather than detecting or analyzing conditions.
No
The device description explicitly states that the probes "carry stimulation current from the patient interface to the patient" and are "single use devices," indicating a physical hardware component.
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.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. They are performed outside of the living body.
- Device Description: The device description confirms it "carry stimulation current from the patient interface to the patient." This is a direct electrical stimulation of nerves within the patient's body.
The device is a surgical tool used for nerve stimulation and identification during surgery, not for analyzing samples taken from the body.
N/A
Intended 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.
Product codes (comma separated list FDA assigned to the subject device)
ETN
Device Description
The NIMTM 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, intraoperative
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™ Surgeon Control Probes 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(s) are as safe and effective as their predicate devices.
- . 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
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
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March 21, 2022
Medtronic Xomed, Inc. Alexandra Oliver Senior Regulatory Affairs Specialist 6743 Southpoint Drive North Jacksonville. Florida 32216
Re: K213246
Trade/Device Name: NIM™ Surgeon Control Probes Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical nerve stimulator/locator Regulatory Class: Class II Product Code: ETN Dated: February 23, 2022 Received: February 25, 2022
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 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 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for 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 (QS) 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 mediation-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/cdrh-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,
for 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
Enclosure
2
Indications for Use
510(k) Number (if known) K213246
Device Name NIM™ Surgeon Control Probes
Indications for Use (Describe)
The NIM™ Surgeon Control Probes are intended to stimulate cranial and peripheral motor nerves for location and identification during surgery, including spinal nerve roots.
| 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
510(k) Summary
| I. SUBMITTER | |
|---|---|
| Company (submitter): | Medtronic Xomed, Inc. |
| 6743 Southpoint Drive North | |
| Jacksonville, Florida 32216 USA | |
| Telephone Number: (904) 296-9600 | |
| Date Prepared: | March 15, 2022 |
| 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™ Surgeon Control Probes |
|---|---|
| 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 NIM™ Surgeon Control Probes are substantially equivalent in intended use and technological characteristics to the following predicate devices:
| 510(k) Number | 510(k) / Device Name | 510(k) Clearance Date |
|---|---|---|
| K873964 | Nicolet Disposable | |
| Prass Probe | November 20, 1987 | |
| K992869 | Xomed Monopolar | |
| Stimulator Probe | October 07, 1999 |
4
IV. DEVICE DESCRIPTION
Device Description
The NIMTM 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 NIM™ 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.
VI. SUBSTANTIAL EQUIVALENCE
Substantial Equivalence/Device Comparison (Subject Device(s) to Predicate Devices)
| Feature/Attribute | Surgeon Control
Probes
(Subject Device(s)) | Nicolet Disposable Prass
Probe / K873964
(Predicate Device) | Xomed Monopolar
Stimulator Probe /
K992869
(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 |
| 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 Prass Probes carry
stimulation current from
the console, via the
Patient Interface, to the
patient [...] The
incrementing prass probes
provide the surgeon with
the means to adjust the
stimulation current at the
surgical site. | The Monopolar Ball-Tip
Stimulating Probes
carry stimulation current
from the console, via the
Patient Interface, to the
patient [...] The
incrementing probes
provide the surgeon
with the means to adjust
the stimulation current
at the surgical site. |
| Intended Use | The NIM™ surgeon
control probes are
intended for use as
intraoperative nerve
stimulators | This device is intended
for use as an
intraoperative motor
nerve stimulator with the
Nerve Integrity Monitor
(NIM™) | To stimulate cranial and
peripheral motor nerves
for location and
identification during
surgery, including spinal
nerve roots |
| Indications for Use | The NIM™ surgeon
control probes are
intended to stimulate | This device is indicated
for intraoperative motor
nerve monitoring | The Ball-Tip Monopolar
Stimulating Probe is
intended to stimulate |
| Feature/Attribute | Surgeon Control
Probes
(Subject Device(s)) | Nicolet Disposable Prass
Probe / K873964
(Predicate Device) | Xomed Monopolar
Stimulator Probe /
K992869
(Predicate Device) |
| | cranial and peripheral
motor nerves for location
and identification during
surgery, including spinal
nerve roots | cranial and peripheral
motor nerves for location
and identification during
surgery, including spinal
nerve roots | cranial and peripheral
motor nerves for
location and
identification during
surgery, including spinal
nerve roots |
| 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 3.0 is
contraindicated for use
with paralyzing anesthetic
agents that will
significantly reduce, if
not completely eliminate,
EMG responses to direct
or passive nerve
stimulation. | The NIM 3.0 is
contraindicated for use
with paralyzing
anesthetic agents that
will significantly
reduce, if not
completely eliminate.
EMG responses to direct
or passive nerve
stimulation. |
| Operating
Principle | Electrical stimulation | Electrical stimulation | Electrical stimulation |
| Design | Offered in Prass-tip or
Ball-tip configurations | Prass-tip configuration | Ball-tip configuration |
| Probe tip (exposed
area) tissue
contact surface
geometry | Probe Prass Tip: Flat
•
Probe Ball Tip:
•
1mm ball | Flat (Prass) | 1mm ball |
| Probe working
length | Probe Prass: 3.76"
•
[9.6cm]
Probe Ball: 3.76"
•
[9.6cm] | 3.76" [9.6cm] | 3.76" [9.6cm] |
| Patient-contacting
Materials | 303 Stainless Steel with
Xylamed coating
insulation or Teflon
Polytetrafluoroethylene
(PTFE) coating
insulation | 303 Stainless Steel with
Xylamed coating
insulation | 303 Stainless Steel with
Teflon
Polytetrafluoroethylene
(PTFE) coating
insulation |
| Patient contact | Direct | Direct | Direct |
| Biocompatible | Yes | Not available | Yes |
| Sterile | Yes | Yes | Yes |
| Single-Use
Disposable | Yes | Yes | Yes |
| Duration of Use | Limited (