Neuralytix iD3 System (NTX-9001)

K243636 · Neuralytix, LLC · PDQ · Jun 26, 2025 · Ear, Nose, Throat

Device Facts

• Record ID: K243636
• Device Name: Neuralytix iD3 System (NTX-9001)
• Applicant: Neuralytix, LLC
• Product Code: PDQ · Ear, Nose, Throat
• Decision Date: Jun 26, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.1820
• Device Class: Class 2

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 biologics. • 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

Neuralytix iD3 System is a multichannel surgical nerve stimulator/locator; inputs include mechanomyographic (MMG) signals from accelerometer sensors placed on muscles and operator-applied electrical stimulation; device transforms inputs by measuring MMG response to electrical current; outputs include real-time MMG signal graphs and nerve response thresholds (mA) displayed on a touchscreen; used in OR by surgeons during spinal/nerve decompression procedures; provides objective data on nerve conduction/transmission status; assists surgeons in identifying nerves and monitoring neural integrity; helps prevent nerve injury during surgery.

Clinical Evidence

Bench testing only. No clinical data. Performance validated via comparative performance evaluation using clinically relevant MMG signal simulation (positive/negative waveforms) showing >99% agreement with predicate. Biocompatibility testing (ISO 10993) confirmed non-cytotoxic, non-sensitizing, and non-irritant status for patient-contacting components.

Technological Characteristics

Multichannel (max 8) nerve stimulator; constant current (0-20 mA) monophasic rectangular pulse (100μs); accelerometer-based MMG sensing; 7-inch touchscreen interface; 316L stainless steel and Parylene C probe materials; hydrogel adhesive patches; gamma radiation sterilization; IEC 60601-1/1-2/2-40 compliant; connectivity via 1.5mm touchproof connectors.

Indications for Use

Indicated for use in surgical procedures to assist in locating and mapping motor nerves in patients undergoing spinal or nerve decompression surgeries (e.g., discectomy, laminectomy, fusion) by monitoring MMG signals and nerve response thresholds.

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

• Sentio MMG Gen 2 (K173526)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

June 26, 2025

Neuralytix, LLC
Christopher Wybo
CEO
138 S Park Square
Ste 203
Fruita, Colorado 81521

Re: K243636
Trade/Device Name: Neuralytix iD3 System (NTX-9001)
Regulation Number: 21 CFR 874.1820
Regulation Name: Surgical Nerve Stimulator/Locator
Regulatory Class: Class II
Product Code: PDQ, ETN
Dated: May 27, 2025
Received: May 27, 2025

Dear Christopher Wybo:

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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K243636 - Christopher Wybo
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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 System (QS) 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 (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 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.

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 the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-

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K243636 - Christopher Wybo
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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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FORM FDA 3881 (6/20)
Page 1 of 1
PSC Publishing Services [phone]
EF

| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K243636 | |
| Device Name Neuralytix iD3 System | |
| Indications for Use (Describe) 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 biologics. • 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. | |
| 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) | |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* | |
| The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail] | |
| "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | |

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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: Christopher Wybo
[phone]
[e-mail]

B. Date Prepared
June 24, 2025

C. Device Name

Trade/Proprietary Name: Neuralytix iD3 System
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 Neuralytix iD3 System is substantially equivalent to the following primary predicate device:
- K173526 Sentio MMG Gen 2

E. Device Description

The Neuralytix iD3 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 will assist with nerve identification and assessment by alerting the surgeon when monitored nerves are activated. The device will also assist 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 the conduction and neural transmission ability of a nerve may change throughout surgery.

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F. Technological Characteristics

| Attribute | Subject Device Neuralytix iD3 System | Predicate Device Sentio MMG Gen 2 | Substantially Equivalent |
| --- | --- | --- | --- |
| Capital Equipment: Control Unit/Display | | | |
| Number of Channels | Max 8 | Max 10 | Yes |
| Display Size | 20cm x 13cm x 4cm | 32cm x 22cm x 3cm | Yes |
| Weight | 0.72 kg | 2.0 kg | Yes |
| Screen Size | 7.0 inch | 9.8 inch | Yes |
| System Stimulation | | | |
| Type Constant | Constant current (mA) | Constant current (mA) | Yes |
| Stimulus Range | 0-20 mA Standard Mode
0.3-4 mA Hi-Res Mode | 0-20 mA Nerve Mapping
0-2 mA Bipolar Mode | Yes |
| Control | Digitally controlled, adjusted in increments as follows per mode:
1mA Standard Mode
0.1mA Hi-Res Mode | Digitally controlled, adjusted in increments as follows per mode:
1mA Nerve Mapping
0.1mA Bipolar Mode | Yes |
| Maximum Stimulation Voltage | 160V | 115V | Yes |
| Waveform | Monophasic rectangular pulse | Monophasic rectangular pulse | Yes |
| Pulse Width | 100μs | 100μs | Yes |
| Stimulation Rate | 4Hz, 8Hz | 2Hz, 4Hz | Yes |
| Sensors | | | |
| Function | Mechanomyographic (MMG) | Mechanomyographic (MMG) | Yes |
| Type | Accelerometer | Accelerometer | Yes |
| Size | 2-inch round | 2-inch round | Yes |
| Ground Patch | | | |
| Attachment Mode | Hydrogel Adhesive | Hydrogel Adhesive | Yes |
| Size | 2 x 4 inch | 2 x 4 inch | Yes |
| Connector Type | 1.5 mm touchproof | 1.5 mm touchproof | Yes |
| Stimulation Instruments | | | |

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| Attribute | Subject Device Neuralytix iD3 System | Predicate Device Sentio MMG Gen 2 | Substantially Equivalent |
| --- | --- | --- | --- |
| Length | 200 mm | 200 mm | Yes |
| Stimulation Diameter | 2.0 mm | 2.2 mm | Yes |
| Stimulation Surface Area | 14.5 mm² | 14.7 mm² | Yes |
| Maximum charge density | 13.79 uC/cm² | 13.61 uC/cm² | Yes |
| Maximum RMS current density | 3.9 mA/cm² | 2.72 mA/cm² | Yes |
| Maximum power density | 22.07 W/cm² | 15.65 W/cm² | Yes |
| Electrical Insulation | Parylene C | Parylene C | Yes |
| Proximal Connector | 1.5mm touchproof | 1.5mm touchproof | Yes |
| Patient Contacting Material | 316L Stainless Steel; Parylene C | 316L Stainless Steel; Parylene C | Yes |
| Delivery | Sterile via Gamma Radiation; Single Use | Sterile via Ethylene Oxide 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 biologics.
- 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.

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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 substantially equivalent to the primary predicate device, with additional language provided for clarifying how the device is used intraoperatively and what MMG signals are measured and recorded for helping surgeons assess a patient's neurophysiological status. The clarifying language and differences in indications for use do not change the intended use as a surgical nerve stimulator / locator, nor raise new questions of safety or effectiveness, as demonstrated by results of the risk-based verification and validation testing. |
| Capital Equipment: Control Unit/Display | Sensor Channel Display - Live streaming graphs for each sensor channel is substantially equivalent to the predicate device. Stimulation Output Display - Real time display of active stimulation current (mA) is substantially equivalent to the predicate device. Alerts - Substantially equivalent - Subject device meets the same acceptance criteria and conforms to the same consensus standards as the primary predicate device for visually and audibly alerting the user of device activity. User Interface - Touchscreen graphical user interface control is substantially equivalent to the predicate device. Display Size - Substantially equivalent - Subject device meets the same acceptance criteria and conforms to the same consensus standards as the primary predicate device for displaying relevant and critical device information to the user on the touchscreen display. Weight - Substantially equivalent - Subject device meets the same acceptance criteria and conforms to the same consensus standards as the primary predicate device. |
| Event Detection Algorithm | Enhanced signal acquisition and MMG event detection is substantially equivalent to the predicate device, as evidenced by the comparative performance evaluation. |
| System Stimulation | Stimulation Output - Cathodic constant current (mA) stimulation output via rectangular waveform pulse is substantially equivalent to the predicate device. Stimulus Range - Standard (0-20 mA) and Hi-Res (0.3-4 mA) stimulation ranges are substantially equivalent to the predicate device and have the same intended function. Stimulation Pulse Width - Substantially equivalent to the predicate device. Stimulation Pulse Rate - User selectable and continuous; substantially equivalent to the predicate device. |

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| | Control - Digitally controlled, incremental adjustment for Standard (0-20 mA in 1 mA increments) and Hi-Res (0.3-4 mA in 0.1 mA increments) stimulation modes via touchscreen display is substantially equivalent to the predicate device.
Maximum Stimulation Voltage - Maximums are within the limit settings and substantially equivalent to the predicate device. |
| --- | --- |
| Stimulation Instruments | Substantially equivalent to predicate device in terms of conductive materials, dielectric properties, exposed stimulation surface areas and intended function. |
| Sensors | Signal (electromechanical) - same as predicate device.
Technology - Digital, same as predicate device.
Configuration - 4-channels per harness/connector, simplified usability while substantially equivalent performance requirements as predicate device.
Usability - Increased robustness for multi-use applications; substantially equivalent performance requirements as predicate device.
Size - substantially equivalent to predicate device.
Connector Type - Simplified for usability, substantially equivalent performance requirements as predicate device.
Operating Voltage - 1.8V; substantially equivalent to predicate device. |
| Sensor Patches | Single-use sensor patches configured for application with multi-use sensor harness. Substantially equivalent size, materials and intended function and performance requirements as predicate device for adhering sensors to patient. |
| Ground Patch | Substantially equivalent size, materials, biocompatibility and performance requirements as predicate device. |
| Materials | All components are comprised of materials evidenced to be suited for their intended purpose, with applicable biocompatible components and intended function substantially equivalent to the predicate device. |

# I. Materials / Contact Classification

The contact classification for the patient contacting components of the NTX-9003 Decompression Stim Probe is externally communicating with tissue/bone and cerebrospinal fluid contact for a limited duration $(<= 24$ hours). The patient contacting materials of the subject device are biocompatible 316L stainless steel with Parylene C conformal coating.

The contact classification for the patient contacting components of the Sensor Patch and Ground Patch (NTX-9004/NTX-9004) is skin contacting for a limited duration $(<= 24$ hours). The patient contacting material of the subject device is biocompatible hydrogel adhesive.

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J. Biocompatibility

A Biocompatibility Evaluation was performed on the Neuralytix iD3 System to support the Substantial Equivalence. A Summary of Biocompatibility Testing is provided below

NTX-9003, iD3 Decompression Stim Probe: Biocompatibility Testing performed on the subject device; NTX-0301, iD3 Decompression Stim Probe

| Test | Results | Conclusions |
| --- | --- | --- |
| Cytotoxicity – MEM Elution | No cytotoxicity or cell lysis was noted in any of the test wells. No pH shift was observed at 48 hours. The reagent control, negative control and the positive control performed as anticipated. | Non-Cytotixic |
| Sensitization – GPMT | All animals were observed with the expected dermal reactions associated with intradermal injection of FCA and were clinically normal throughout the study. No evidence of sensitization was observed. | Non-sensitizer |
| Intracutaneous Reactivity | All animals appeared normal throughout the study. All injection sites appeared normal immediately following injection. No difference was noted between the Test and Control means. | Non-Irritant |
| Acute Systemic Toxicity | There was no mortality or evidence of systemic toxicity from the extracts injected into mice. Each test article extract met the requirements of the study. | Non-Toxic |
| Material-Mediated Pyrogenicity, USP-Rabbit | No single animal showed a temperature rise of 0.5°C or more above its baseline temperature. The total rise of the rabbits' temperature during 3 hours was 0.0°C. | Non-Pyrogenic |
| Hemolysis – Extract | The test article extract had a hemolytic index of -0.1% | Non-Hemoyltic |

NTX-9004, iD3 Sensor/Ground Kit (4-ch) & NTX-9008, iD3 Sensor/Ground Kit (8-ch): Biocompatibility Testing was performed on the subject device; NTX-0400, Sensor Patch.

| Test | Results | Conclusions |
| --- | --- | --- |
| Cytotoxicity – Direct Contact method | The test article showed evidence of causing mild reactivity when exposed to L-929 cells directly. The test article met the requirements of the test and is considered to not elicit a cytotoxic effect. Risk Assessment has been performed which identified no indications of biological risk during intended clinical use. | Non-Cytotoxic |
| Sensitization – Buehler (closed patch) | The test article showed no evidence of causing delayed dermal contact sensitization in the guinea pig. | Non-sensitizer |
| Skin Irritation in Rabbits | There was no to well-defined erythema and no edema observed on the skin of the animals treated with the test article. The Primary Irritation Index for the test article was calculated to be 0.1. The response of the test article was categorized as negligible. | Non-Irritant |

K. Summary of Performance Testing

Non-clinical testing was conducted in accordance with Design Controls and Risk Management to confirm

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device performance for its intended use. The test results demonstrate that the device performs as well as the predicate device and/or conform 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 | Wire to plug connections (Probe-Probe Wire, Control Unit-Probe Wire, Control Unit-Ground Patch) must provide at least 2.2N of retention force (to withstand inadvertent disconnection) when pulled normal to plug). Instron Test at 300mm/min. | All samples passed the acceptance criteria. Design inputs satisfied. Substantially Equivalent. |
| Hydrogel Patch Adhesion Testing | Adhesive Sensor Patch and Ground Patches must provide at least 4N of retention force to HDPE (skin-approximating) test surface when pulled normal from surface by Sensor Wire or Ground Wire, respectively. Testing performed per PSTC 101 Type F. | All samples passed the acceptance criteria. Design inputs satisfied. Substantially Equivalent. |
| Sterility | Sterilization was validated per ISO 11137-1, ISO 11137-, and ISO 11137-32 using gamma irradiation at a sterility assurance level of 10-6. | All samples passed the acceptance criteria. Design inputs satisfied. Substantially Equivalent. |
| Sterile Package Integrity | Sterile Packaging was validated per ISO 11607-1 and ISO 11607-2, including Seal Strength Testing per ASTM F88/F88M-21, Bubble-Leak Testing per ASTM F2096-19 (Reapproved 2019) | All samples passed the acceptance criteria. Design inputs satisfied. Substantially Equivalent. |
| Real Time Aging – Sterile | Sterile Packaging was maintained for 3 years of Real Time Aging and then subjected to Seal Strength Testing per ASTM F88/F88M-21, Bubble-Leak Testing per ASTM F2096-19 (Reapproved 2019) | All samples passed the acceptance criteria. Design inputs satisfied. Substantially Equivalent. |
| Accelerated Aging – Non-Sterile | Adhesive Sensor Patch and Ground Patches must provide at least 4N of retention force to HDPE (skin-approximating) test surface when pulled normal from surface by Sensor Wire or Ground Wire, respectively. Patches were subjected to 1 year of Accelerated Aging per ASTM F1980-21 and pull testing per PSTC 101 Type F. | All samples passed the acceptance criteria. Design inputs satisfied. 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, | All samples passed the acceptance criteria. Design inputs satisfied. Substantially Equivalent. |
| | Bubble-Leak Testing per ASTM F2096-19 (Reapproved 2019) | |

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| | Bubble-Leak Testing per ASTM F2096-19 (Reapproved 2019) | |
| --- | --- | --- |
| EMC and Electrical Safety | System was tested for compliance to the requirements of IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, and IEC 60601-2-40. Additional Evaluation of EMC performance to IEC TR 60601-4-2 was completed | All samples passed the acceptance criteria. Design inputs satisfied. Substantially Equivalent. |
| Biocompatibility | Biocompatibility testing was conducted on the tissue contacting components of the system:
The Hydrogel Patches were evaluated per requirements for intact skin contacting (≤24hr) devices: ISO 10993-1, ISO 10993-5, ISO 10993-10, and ISO 10993-23 (cytotoxicity, sensitization, irritation).

The Stimulation Probe as evaluated per requirements for Externally communicating devices with tissue/bone and cerebrospinal fluid contact for limited duration (≤24hr). Testing was performed in accordance with 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-11, ISO 10993-23, and ISO 10993-4 (cytotoxicity, sensitization, intracutaneous irritation, acute systemic toxicity, material-mediated pyrogenicity, and indirect [extract] hemolysis). | All samples passed the acceptance criteria. Design inputs satisfied. Substantially Equivalent. |
| Sensor Characterization | The subject device measurements were compared to NIST traceable reference accelerometer at multiple frequencies to confirm performance was within specification with respect to low-pass filtering and % error. | All samples passed the acceptance criteria. Design Inputs satisfied. Substantially Equivalent. |
| Comparative Performance Evaluation | MMG-detection performance of subject device was compared to predicate device by subjecting both devices to MMG-positive and MMG-negative waveforms. Overall correlation was evaluated and confirmed to be >99% agreement. | All samples passed the acceptance criteria. Design Inputs satisfied. Substantially Equivalent. |

L. Conclusion

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