Axon Therapy

K233364 · Neuralace Medical, Inc. · QPL · Jan 10, 2024 · Neurology

Device Facts

• Record ID: K233364
• Device Name: Axon Therapy
• Applicant: Neuralace Medical, Inc.
• Product Code: QPL · Neurology
• Decision Date: Jan 10, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Axon Therapy is intended to stimulate peripheral nerves for relief of chronic intractable pain, post-surgical pain and/or for relief of chronic painful diabetic peripheral neuropathy in the lower extremities. The Axon Therapy is for use on patients 18 and older.

Device Story

Axon Therapy is a magnetic stimulator system for non-invasive peripheral nerve stimulation to treat chronic pain. Used in pain management and physical therapy clinics by clinicians. System comprises a magnetic stimulation coil, liquid cooling unit, and cart. Device delivers brief, focused biphasic magnetic pulses (0-2 Hz, 290 µsec pulse width) to target areas (e.g., limbs, back). Thermal shutdown feature monitors coil temperature (45°C limit or 41°C for 9 minutes). Clinicians operate the device via LED interface to manage pain, potentially reducing reliance on pain medications and improving patient quality of life.

Clinical Evidence

Clinical study evaluated Axon Therapy for painful diabetic peripheral neuropathy (PDN). Randomized trial compared Axon Therapy plus conventional medical management (CMM) vs. Sham plus CMM. Primary endpoint: proportion of responders (≥50% reduction in VAS pain score at Day 30). Results showed -57.6% VAS reduction for treatment vs. -12.5% for sham (p < 0.00001). Secondary endpoints (QoL-DN, PGIC) showed statistically significant improvements in quality of life.

Technological Characteristics

Magnetic stimulator; biphasic waveform; 0-2 Hz frequency; 290 µsec pulse width. Materials: Stimulator housing (AL sheet EN AW 5754 H111), Coil (ABS). Cooling: Liquid cool unit. Safety: Thermal shutdown (45°C limit). Power: 110-240V AC. Connectivity: LED display. Standards: IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), IEC 62304 (software), IEC 62366-1 (usability).

Indications for Use

Indicated for patients 18+ with chronic intractable pain, post-traumatic pain, post-surgical pain, or chronic painful diabetic peripheral neuropathy in lower extremities.

Regulatory Classification

Identification

A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.

Predicate Devices

• Axon Therapy (K210021)

Submission Summary (Full Text)

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January 10, 2024

NeuraLace Medical Inc. % Allison Komivama, PhD, RAC VP, MedTech Innovation ROM+ 2251 San Diego Ave, Suite B-257 San Diego, California 92110

Re: K233364

Trade/Device Name: Axon Therapy Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: QPL, IPF Dated: September 29, 2023 Received: October 2, 2023

Dear Dr. Komiyama:

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.

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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 (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/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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Lauren E. Woodard -S

for Amber Ballard, Ph.D. Assistant Director DHT5B: Division of Neuromodulation

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and Rehabilitation 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

510(k) Number (if known) K233364

Device Name Axon Therapy

Indications for Use (Describe)

The Axon Therapy is intended to stimulate peripheral nerves for relief of chronic intractable pain, post-surgical pain and/or for relief of chronic painful diabetic peripheral neuropathy in the lower extremities. The Axon Therapy is for use on patients 18 and older.

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| <span style="font-family: Arial, sans-serif;">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> | <span style="font-family: Arial, sans-serif;">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> |

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## 510(k) SUMMARY K233364

#### DATE PREPARED

January 10, 2024

#### MANUFACTURER AND 510(k) OWNER

NeuraLace Medical, Inc. 16990 Goldentop Road, San Diego, CA 92127 Telephone: [phone] Official Contact: Joe Milkovits, CTO Email: [e-mail]

#### REPRESENTATIVE/CONSULTANT

Allison C. Komiyama, Ph.D., RAC, VP, MedTech Innovation Charles Neitzel, Principal Consultant RQM+ Telephone: [phone] Email: [e-mail]

#### DEVICE INFORMATION

| Proprietary Name/Trade Name: | Axon Therapy |
|------------------------------|------------------------------------------------------------|
| Common Name: | Electromagnetic stimulator, pain relief |
| Regulation Number: | 21 CFR 882.5890 |
| Regulation Name: | Transcutaneous Electrical Nerve Stimulator for Pain Relief |
| Class: | Class II |
| Product Code: | QPL<br>IPF |
| Review Panel: | Neurology<br>Physical Medicine |

#### PREDICATE DEVICE IDENTIFICATION

The Axon Therapy is substantially equivalent to the following predicates:

| 510(k) Number | Predicate Device Name / Manufacturer | Primary Predicate |
|---------------|--------------------------------------|-------------------|
| K210021 | Axon Therapy / NeuraLace | ✓ |

The predicate device has not been subject to a design related recall.

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#### DEVICE DESCRIPTION

The Axon Therapy is a magnetic stimulator system that provides brief and focused magnetic pulses in order to non-invasively stimulate peripheral nerves and provide chronic nerve pain relief. The subject device is intended to be used in clinics such as pain management clinics and physical therapy clinics. The device consists of Magnetic Stimulation Coil, Liquid Cool Unit, and a Cart. The Axon Therapy includes a thermal shutdown feature which is activated once the inside temperature of the stimulation coil either: (A) reaches 45°C or (B) exceeds 41°C for a total of nine minutes during a 20-minute session.

#### INDICATIONS FOR USE

The Axon Therapy is intended to stimulate peripheral nerves for relief of chronic intractable pain, post-traumatic pain, post-surgical pain and/or for relief of chronic painful diabetic peripheral neuropathy in the lower extremities. The Axon Therapy is for use on patients 18 and older.

#### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

NeuraLace believes that the Axon Therapy is substantially equivalent to the predicate device based on the information summarized here:

The subject device has an identical design and dimensions, and uses identical materials as the device cleared in K210021. The subject device has the same intended use and identical technological characteristics to the device cleared in K210021. The device has identical instrumentation to the device cleared in K210021.

| Comparison Topic | Subject Device | Predicate Device | Statement of Equivalence |
|--------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Name<br>/ Device Name | NeuraLace Medical Inc.<br>Axon Therapy | NeuraLace Medical Inc.<br>Axon Therapy | N/A |
| Indications for Use | The Axon Therapy is intended<br>to stimulate peripheral<br>nerves for relief of chronic<br>intractable pain, post-<br>traumatic pain, post-surgical<br>pain and/or for relief of<br>chronic painful diabetic<br>peripheral neuropathy in the<br>lower extremities. The Axon<br>Therapy is for use on patients<br>18 and older. | The Axon Therapy is intended<br>to stimulate peripheral nerves<br>for relief of chronic<br>intractable, post-traumatic<br>and post-surgical pain for<br>patients 18 and older. | Substantially equivalent<br>to the predicate device.<br>Clinical testing<br>demonstrates that there<br>is no impact on safety and<br>effectiveness for<br>expanded indication. |
| Product Codes / Regulation<br>Numbers | QPL / 21 CFR 882.5890<br>IPF / 21 CFR 890.5850 | QPL / 21 CFR 882.5890<br>IPF / 21 CFR 890.5850 | Identical to predicate<br>device with no impact on<br>safety and effectiveness. |
| Technological Characteristics | | | |
| Power Source | Power Supply: 110V to 240V<br>ac, 50/60Hz<br>Power consumption: 800VA<br>maximum, 115W idle | Power Supply: 110V to 240V<br>ac, 50/60Hz<br>Power consumption: 800VA<br>maximum, 115W idle | Identical to predicate<br>device with no impact on<br>safety and effectiveness. |
| Comparison Topic | Subject Device | Predicate Device | Statement of Equivalence |
| Company Name<br>/ Device Name | NeuraLace Medical Inc.<br>Axon Therapy | NeuraLace Medical Inc.<br>Axon Therapy | N/A |
| User Interface | LED display | LED display | Identical to predicate device with no impact on safety and effectiveness. |
| Waveform | Biphasic wave | Biphasic wave | Identical to predicate device with no impact on safety and effectiveness. |
| Software / Firmware /<br>Microprocessor Control? | Yes | Yes | Identical to predicate device with no impact on safety and effectiveness. |
| Indication Functions | On/off status<br>Ready status | On/off status<br>Ready status | Identical to predicate device with no impact on safety and effectiveness. |
| Time Range | 800 seconds (400 pulses at 0.5 Hertz) | 800 seconds (400 pulses at 0.5 Hertz) | Identical to predicate device with no impact on safety and effectiveness. |
| Housing Materials Construction | Stimulator: AL sheet EN AW 5754 H111<br>Coil: ABS | Stimulator: AL sheet EN AW 5754 H111<br>Coil: ABS | Identical to predicate device with no impact on safety and effectiveness. |
| Applied Part(s) | Coil 60BF-NL | Coil 60BF-NL | Identical to predicate device with no impact on safety and effectiveness. |
| Applied Part Area | 16 cm² | 16 cm² | Identical to predicate device with no impact on safety and effectiveness. |
| Treatment Area | Any area, such as Hand, Arm, Chest, Waist, Buttock, Thigh, Calf, Back and low back etc. | Any area, such as Hand, Arm, Chest, Waist, Buttock, Thigh, Calf, Back and low back etc. | Identical to predicate device with no impact on safety and effectiveness. |
| Weight | Stimulator: 17 kg<br>Coil: 3.2 kg<br>Full system (with cart): 54 kg | Stimulator: 17 kg<br>Coil: 3.2 kg<br>Full system (with cart): 54 kg | Identical to predicate device with no impact on safety and effectiveness. |
| Unit Dimensions | 485 x 380 x 165 mm | 485 x 380 x 165 mm | Identical to predicate device with no impact on safety and effectiveness. |
| Pulse Frequency | 0-2 Hz | 0-2 Hz | Identical to predicate device with no impact on safety and effectiveness. |
| Pulse Amplitude | 0 to 100%<br>A maximum of 80% intensity is recommended to reduce the risk of coil overheating | 0 to 100%<br>A maximum of 80% intensity is recommended to reduce the risk of coil overheating | Identical to predicate device with no impact on safety and effectiveness. |
| On-Cycle Duty Period | 2-800 seconds | 2-800 seconds | Identical to predicate device with no impact on safety and effectiveness. |
| Maximum Repetition Rate | 2 pulses per second (pps) | 2 pulses per second (pps) | Identical to predicate device with no impact on safety and effectiveness. |
| Pulse Mode | Standard | Standard | Identical to predicate device with no impact on safety and effectiveness. |
| Comparison Topic | Subject Device | Predicate Device | Statement of Equivalence |
| Company Name<br>/ Device Name | NeuraLace Medical Inc.<br>Axon Therapy | NeuraLace Medical Inc.<br>Axon Therapy | N/A |
| Pulse Width | Biphasic (290 µsec) | Biphasic (290 µsec) | Identical to predicate device with no impact on safety and effectiveness. |
| Maximum Output Power | 100% at 2 pps | 100% at 2 pps | Identical to predicate device with no impact on safety and effectiveness. |
| Testing | | | |
| Non-Clinical Testing | Electrical safety per IEC 60601-1<br>EMC testing per IEC 60601-1-2<br>Software testing per IEC 62304<br>Usability testing per IEC 62366-1 | Electrical safety per IEC 60601-1<br>EMC testing per IEC 60601-1-2<br>Software testing per IEC 62304<br>Usability testing per IEC 62366-1 | Identical to predicate device, no new elements proposed for subject device requiring new non-clinical testing. No impact to safety and effectiveness. |
| Clinical Testing | Three previous studies that evaluated the effectiveness and safety of the subject device.<br><br>One additional study for patients with diabetic peripheral neuropathy (PDN) for the subject device. | Three studies that evaluated the effectiveness and safety of the subject device. | Substantially equivalent to the predicate device. Performance and clinical testing demonstrate that there are no new questions of safety and effectiveness. |

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### SUMMARY OF NON-CLINICAL TESTING

The Axon Therapy subject device had no design changes from the predicate device cleared in K210021 that required additional non-clinical testing for this submission to demonstrate safety and effectiveness:

Software Verification: The subject device did not undergo any new software verification testing due to substantial equivalence of the predicate device and no new questions of safety and effectiveness.

Electromagnetic Compatibility and Electrical Safety: The subject device did not undergo any new electromagnetic compatibility and electrical safety testing due to substantial equivalence of the predicate device and no new questions of safety and effectiveness.

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Usability: The subject device did not undergo any new usability testing due to substantial equivalence of the predicate device and no new questions of safety and effectiveness.

Performance Testing: The subject device did not undergo any new performance testing due to substantial equivalence of the predicate device and no new questions of safety and effectiveness.

### SUMMARY OF CLINICAL TESTING

The goal of the Axon Therapy PDN clinical study was to expand the indications to include painful diabetic peripheral neuropathy. Axon Therapy was demonstrated to be effective and safe in the original clinical studies for chronic intractable post-traumatic and post-surgical pain. The primary efficacy objective of this trial was to compare the proportion of responders in the Axon Therapy plus CMM group, (responder is defined as a subject who experiences 50% or greater reduction from baseline in neuropathic pain intensity as measured by an in-clinic visual analog score (VAS) for the primary area of pain at Day 30, with no increase over baseline pain medications within four weeks of the Day 30 visit), to the Sham plus CMM group.

The results of the study demonstrate effectiveness of this non-invasive Treatment at statistically significant levels. The % reduction in VAS pain scores showed a -57.6% reduction for Treatment vs -12.5% for Sham at a p value of <0.00001. The -45.1% VAS pain reduction from Sham supports the argument that these are statistically significant improvements in patient care and not a placebo effect. In addition to pain relief, both the QoL-DN and PGIC scales show that this pain relief manifests into better quality of life outcomes at a statistically significant level.

### CONCLUSION

The Axon Therapy is considered substantially equivalent to the predicate device based on the testing performed, the similar indications for use, and identical technological characteristics. Based on the testing performed it can be concluded that the subject device does not raise new issues of safety or effectiveness compared to the predicate devices.