iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe (NTX-9006); iD3 Nav Ball Tip Probe (NTX-9007)

K260992 · Neuralytix · PDQ · Jun 25, 2026 · Ear, Nose, Throat

Device Facts

• Record ID: K260992
• Device Name: iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe (NTX-9006); iD3 Nav Ball Tip Probe (NTX-9007)
• Applicant: Neuralytix
• Product Code: PDQ · Ear, Nose, Throat
• Decision Date: Jun 25, 2026
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.1820
• Device Class: Class 2

Indications for Use

This device is intended for use in surgical procedures to assist in locating and mapping motor nerves through the use of mechanomyographic (MMG) signals and electrical stimulus of nerves. The device provides information directly to the surgeon to help assess a patient's neurophysiologic status by measuring and comparing MMG signals throughout a surgical procedure. The device is intended to identify relative changes in the conduction and neural transmission ability of the nerve throughout a surgical procedure by measuring and comparing the minimum amount of electrical stimulation current (mA) required to induce a measurable MMG response (MMG nerve response threshold). Examples of surgical applications which may require mechanomyographic (MMG) monitoring: • Minimally invasive and open spinal surgery involving spinal fusion cages, screws, rods, plates, discs and biologic • Minimally invasive, open and endoscopic, direct and indirect nerve decompressions, discectomies, laminectomies, laminotomies, facetectomies, foraminotomies • Treatment of nerve compression, stenosis, degenerative disc disease, disc herniation, spondylolisthesis

Device Story

iD3 Stimulation Probes (NTX-9005, NTX-9006, NTX-9007) are sterile, single-use accessories for the iD3 MMG System; used in OR during spinal/nerve surgery. Probes deliver electrical stimulus to nerves; system records resulting mechanomyographic (MMG) signals from innervated muscles. Device measures nerve response thresholds (minimum mA to elicit MMG response); tracks changes in conduction/neural transmission throughout surgery. Surgeon uses probe to map nerves; system provides real-time feedback via control unit display. Enables surgeon to assess neurophysiologic status; helps identify nerve health changes during intervention. Benefits include improved nerve identification and monitoring during complex procedures.

Clinical Evidence

No clinical data. Bench testing only. Performance validated via clinically relevant MMG signal simulation to demonstrate high agreement with predicate device. Testing included electrical safety (IEC 60601-1 series), EMC (IEC TR 60601-4-2), biocompatibility, sterilization (ISO 11137/11138), and mechanical integrity (retention force, package integrity).

Technological Characteristics

Materials: 316L stainless steel, Parylene C coating. Sensing/Actuation: Electrical nerve stimulation and MMG signal acquisition. Connectivity: USB-B or 1.5mm touchproof connectors. Sterilization: Ethylene Oxide (NTX-9005/9007) or Gamma Radiation (NTX-9006). Form factor: Probes (200-225mm length). Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-40, ISO 11607, ASTM F88, ASTM F2096.

Indications for Use

Indicated for adolescents and adults undergoing surgical procedures (e.g., spinal surgery, nerve decompressions) to assist in locating/mapping motor nerves and assessing neurophysiologic status via mechanomyographic (MMG) signals and electrical nerve stimulation.

Regulatory Classification

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.

Predicate Devices

• iD3 MMG System (K243636)

Submission Summary (Full Text)

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**FDA** **U.S. FOOD & DRUG**
ADMINISTRATION

June 25, 2026

Neuralytix
Brian Dean
VP, Quality/Compliance
138 S Park Sq.
Suite 203
Fruita, Colorado 81521

Re: K260992

Trade/Device Name: iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe (NTX-9006); iD3 Nav Ball Tip Probe (NTX-9007)

Regulation Number: 21 CFR 874.1820

Regulation Name: Surgical Nerve Stimulator/Locator

Regulatory Class: Class II

Product Code: PDQ, ETN

Dated: March 25, 2026

Received: March 26, 2026

Dear Brian Dean:

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.

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K260992 - Brian Dean

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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).

Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).

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 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-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ('UDI Rule'). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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

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K260992 - Brian Dean

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the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Patrick Antkowiak -S

for

Jay Gupta

Assistant Director

DHT5A: Division of Neurosurgical,

Neurointerventional, and

Neurodiagnostic Devices

OHT5: Office of Neurological and

Physical Medicine Devices

Office of Product Evaluation and Quality

Center for Devices and Radiological Health

Enclosure

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# Indications for Use

| Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | | K260992 | ? |
| --- | --- | --- | --- |
| Please provide the device trade name(s). | | | ? |
| iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe (NTX-9006); iD3 Nav Ball Tip Probe (NTX-9007) | | | |
| Please provide your Indications for Use below. | | | ? |
| This device is intended for use in surgical procedures to assist in locating and mapping motor nerves through the use of mechanomyographic (MMG) signals and electrical stimulus of nerves. The device provides information directly to the surgeon to help assess a patient's neurophysiologic status by measuring and comparing MMG signals throughout a surgical procedure. | | | |
| The device is intended to identify relative changes in the conduction and neural transmission ability of the nerve throughout a surgical procedure by measuring and comparing the minimum amount of electrical stimulation current (mA) required to induce a measurable MMG response (MMG nerve response threshold). | | | |
| Examples of surgical applications which may require mechanomyographic (MMG) monitoring: | | | |
| • Minimally invasive and open spinal surgery involving spinal fusion cages, screws, rods, plates, discs and biologic • Minimally invasive, open and endoscopic, direct and indirect nerve decompressions, discectomies, laminectomies, laminotomies, facetectomies, foraminotomies • Treatment of nerve compression, stenosis, degenerative disc disease, disc herniation, spondylolisthesis | | | |
| Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | | ? |
| Please select the age group(s) for which the device(s) is to be used. | ☐ Neonates/Newborns (Birth to < 29 days old) ☐ Infants (29 days old to < 2 years old) ☐ Children (2 years old to < 12 years old) ☑ Adolescents (12 years old to < 22 years old) ☑ Adults (22 years old and greater) | | ? |

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# 510(K) SUMMARY

### A. Submitter Information

Manufacturer/Submitter: Neuralytix, LLC
138 S Park Square, STE 203
Fruita, CO 81521

Contact Person: Brian Dean
[phone]
[e-mail]

**B. Date Prepared** March 16, 2026

### C. Device Name

Trade/Proprietary Name: iD3 Stimulation Probes (NTX-9005, NTX-9006, NTX-9007)
Common/Usual Name: Surgical Nerve Stimulator/Locator
Device Classification: Class II per 21 CFR §874.1820
Product Code/Description: PDQ; Neurosurgical Nerve Locator
ETN; Stimulator, Nerve

### D. Predicate Device Name

The subject iD3 Stimulation Probes are substantially equivalent to the following primary predicate device:

- K243636 iD3 MMG System

### E. Device Description

The Neuralytix iD3 Stimulation Probes are accessory devices to the Neuralytix iD3 MMG System, designed to allow surgeon-directed control of the system within the sterile field. The iD3 MMG System is a multichannel device for locating, mapping and assessing the status of motor nerves during surgical procedures. Neuralytix alerts the user of recorded mechanical activity (termed mechanomyography, or MMG) from muscles innervated by affected nerves, which may originate from operator-applied electrical stimulus. The device assists with nerve identification and assessment by alerting the surgeon when monitored nerves are activated. The device also assists with tracking the status of monitored nerves throughout the course of surgical intervention. Neuralytix is especially useful in helping assess a patient’s neurophysiologic status by measuring and identifying nerve response thresholds, or the minimum amount of electrical current (mA) necessary to elicit an MMG response. Neuralytix enables intuitive controls for measuring, recording and comparing nerve response thresholds throughout a surgical procedure to provide insights to the user as to how nerve health, or the conduction and neural transmission ability of a nerve, may change throughout surgery.

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# F. Technological Characteristics

| Attribute | Subject Device NTX-9005 | Subject Device NTX-9006 | Subject Device NTX-9007 | Primary Predicate: iD3 MMG System | Substantially Equivalent |
| --- | --- | --- | --- | --- | --- |
| Length | 200 mm | 225 mm | 225 mm | 200 mm | Yes |
| Stimulation Surface Area | 14.5 mm² | 10.0 mm² | 10.0 mm² | 14.5 mm² | Yes |
| Maximum Charge Density | 13.79 uC/cm² | 20.00 uC/cm² | 20.00 uC/cm² | 13.79 uC/cm² | Yes |
| Maximum RMS Current Density | 3.9 mA/cm² | 5.6 mA/cm² | 5.6 mA/cm² | 3.9 mA/cm² | Yes |
| Maximum Power Density | 22.07 W/cm² | 32.00 W/cm² | 32.00 W/cm² | 22.07 W/cm² | Yes |
| Electrical Insulation | Parylene C | Parylene C | Parylene C | Parylene C | Yes |
| Proximal Connector | USB-B | 1.5mm touchproof | USB-B | 1.5mm touchproof | Yes |
| Patient Contacting Material | 316L Stainless Steel; Parylene C | 316L Stainless Steel; Parylene C | 316L Stainless Steel; Parylene C | 316L Stainless Steel; Parylene C | Yes |
| Stimulation Control | Touch Screen via Control Unit or with buttons on handle | Touch Screen via Control Unit | Touch Screen via Control Unit or with buttons on handle | Touch Screen via Control Unit | Yes |
| Sterilization | Sterile via Ethylene Oxide; Single Use | Sterile via Gamma Radiation; Single Use | Sterile via Ethylene Oxide; Single Use | Sterile via Gamma Radiation; Single Use | Yes |

# G. Indications for Use/Intended Use

This device is intended for use in surgical procedures to assist in locating and mapping motor nerves through the use of mechanomyographic (MMG) signals and electrical stimulus of nerves. The device provides information directly to the surgeon to help assess a patient's neurophysiologic status by measuring and comparing MMG signals throughout a surgical procedure.

The device is intended to identify relative changes in the conduction and neural transmission ability of the nerve throughout a surgical procedure by measuring and comparing the minimum amount of electrical stimulation current (mA) required to induce a measurable MMG response (MMG nerve response threshold).

Examples of surgical applications which may require mechanomyographic (MMG) monitoring:

- Minimally invasive and open spinal surgery involving spinal fusion cages, screws, rods, plates, discs and biologic
- Minimally invasive, open and endoscopic, direct and indirect nerve decompressions, discectomies, laminotomies, facetectomies, foraminotomies
- Treatment of nerve compression, stenosis, degenerative disc disease, disc herniation, spondylolisthesis

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## H. Summary of Similarities and Differences in Technological Characteristics, Performance and Intended Use

| Attribute | Substantial Equivalence Evaluation |
| --- | --- |
| Indications for Use | The indications for use statement of the subject device is identical to the primary predicate device |
| Stimulation Probe | Substantially equivalent to predicate device in terms of conductive materials, dielectric properties, exposed stimulation surface areas and intended function. |

## I. Materials / Contact Classification

The contact classification for the patient-contacting components of all probes under this 510(k) submission (NTX-9005, Nav Decompression Stim Probe; NTX-9006, Ball Tip Stim Probe; and NTX-9007, Nav Ball Tip Probe) is externally communicating with tissue and bone and cerebrospinal fluid contact for a limited duration ($\leq 24$ hours). The patient contacting materials of the subject device are biocompatible 316L stainless steel with Parylene C conformal coating.

## J. Summary of Performance Testing

Non-clinical testing was conducted in accordance with Design Controls and Risk Management to confirm device performance for its intended use. The test results demonstrate that the device performs as well as the predicate device and/or conforms to recognized consensus standards for the compared design inputs, including, but not limited to: operating conditions, electrical safety, electromagnetic compatibility, hardware and disposable device functionality, signal acquisition equivalence, biocompatibility, shelf-life, sterilization, packaging integrity and software validations. Additionally, a substantially equivalent comparative performance evaluation was performed using clinically relevant MMG signal simulation to capture a statistically significant sample for demonstration of high agreement with respect to performance of the predicate device.

| Test | Test Method Summary | Results/Conclusions |
| --- | --- | --- |
| Plug and Wire Disconnect Force Testing | Plug-to-Connector connections (Probe Wire to Control Unit) must provide at least 2.2N of retention force to withstand inadvertent disconnection when pulled normal to plug. | Substantially Equivalent |
| Probe to Probe Handle Disconnect Force Testing | Probe-to-Handle connection must provide at least 2.2N of retention force to withstand inadvertent disconnection when pulled normal to plug. | Substantially Equivalent |
| Sterility | Sterilization for NTX-9005 and NTX-9007 were validated per ISO 11138-1:2017 and ISO 11138-2:2017 using Ethylene Oxide at a sterility assurance level of $10^{-6}$. Sterilization for the NTX-9006 was validated per ISO 11137-1, ISO 11137-, and ISO 11137-32 using gamma irradiation at a sterility assurance level of $10^{-6}$. | Substantially Equivalent |
| Sterile Package Integrity | Sterile Packaging was validated per ISO 11607-1 and ISO 11607-2, including Seal Strength Testing | Substantially Equivalent |

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| | per ASTM F88/F88M-21, Bubble-Leak Testing per ASTM F2096-19 (Reapproved 2019) | |
| --- | --- | --- |
| Accelerated Aging – Sterile | Sterile Packaging was maintained for an accelerated aging cycle representative of 1 year of Real Time and then subjected to Seal Strength Testing per ASTM F88/F88M-21, Bubble-Leak Testing per ASTM F2096-19 (Reapproved 2019) | Substantially Equivalent |
| Environmental and Transport Stability | All devices were subjected, in packaging, to environmental preconditioning at stated transportation conditions per ASTM D4332 and then subjected to Transport Stability Testing per ASTM D4169 Cycle 13. Functional Testing of Devices performed afterwards per internal protocol. Sterile Packages subjected to Seal Strength Testing per ASTM F88/F88M-21, Bubble-Leak Testing per ASTM F2096-19 (Reapproved 2019) | Substantially Equivalent |
| EMC and Electrical Safety | System was tested for compliance with the requirements of IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, and IEC 60601-2-40. Evaluation of EMC performance to IEC TR 60601-4-2 was completed | Substantially Equivalent |
| Biocompatibility | The Stimulation Probes were assessed as externally communicating devices with tissue/bone and cerebrospinal fluid contact for limited duration (<24hr) for endpoints of cytotoxicity, sensitization, intracutaneous irritation, acute systemic toxicity, material-mediated pyrogenicity, and indirect [extract] hemolysis. | Substantially Equivalent |

### K. Conclusion

The indications for use and intended use of the subject device are consistent with those of the predicate devices. Comparison of technological characteristics and results of performance testing demonstrate substantial equivalence between the subject device and predicate device.