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 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.

AI/ML Overview

The provided document is a 510(k) summary for the Axon Therapy device, which is a magnetic stimulator system intended for pain relief. The submission seeks to establish substantial equivalence to a previously cleared device (K210021, also Axon Therapy by NeuraLace). This document does not contain information about acceptance criteria and a study proving the device meets those criteria in the typical format of an AI/ML medical device submission.

Instead, it focuses on demonstrating substantial equivalence by highlighting that the subject device has identical design, dimensions, materials, intended use, and technological characteristics to the predicate device. The primary change is an expansion of the Indications for Use to include "chronic painful diabetic peripheral neuropathy in the lower extremities."

Therefore, the information regarding acceptance criteria, test set details, expert ground truth establishment, MRMC studies, and standalone performance for an AI/ML device is not present in this document. The document describes a clinical study done to support the expanded indication, which is different from a performance study for an AI/ML algorithm.

Here's a breakdown of what can be extracted and what is missing/not applicable based on the provided text, assuming the request is looking for AI/ML device study details:

Information Present or Inferable:

1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria (Inferable for Clinical Study): The primary efficacy objective for the clinical study was to compare the proportion of "responders" (>=50% 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) between the Axon Therapy plus CMM group and the Sham plus CMM group. While not a formal "acceptance criteria" table for AI/ML, this is the clinical endpoint criteria.
- Reported Device Performance:
  - Axon Therapy group: -57.6% reduction in VAS pain scores.
  - Sham group: -12.5% reduction in VAS pain scores.
  - p-value: <0.00001 (indicating statistical significance)
  - Difference: -45.1% VAS pain reduction from Sham.
  - Additionally, QoL-DN and PGIC scales showed statistically significant improvements in quality of life outcomes.
2. Sample size used for the test set and the data provenance:
- Sample Size (for Clinical Study): Not explicitly stated, but it's a clinical trial comparing two groups (Axon Therapy + CMM vs. Sham + CMM).
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, clinical trials are typically prospective.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Ground Truth (for Clinical Study): This is based on patient-reported outcomes (Visual Analog Scale for pain, QoL-DN, and PGIC scales), which can be considered "outcomes data" indicating symptomatic relief.
8. The sample size for the training set:
- Training Set (for AI/ML): Not applicable or not provided. This device is not described as an AI/ML device requiring a training set in the traditional sense. The "training" referred to in the document is likely the development and testing of the device hardware/software, not an AI model.
9. How the ground truth for the training set was established:
- Ground Truth for Training Set (for AI/ML): Not applicable or not provided, as this is not an AI/ML device.

Information Missing or Not Applicable (for AI/ML Context):

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The ground truth for the clinical study is patient-reported outcomes, not expert labeling of images or data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This applies to expert labeling, not patient-reported outcomes in a clinical trial.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI-assisted diagnostic or interpretative device; it's a therapeutic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device for treatment, not an algorithm for diagnosis or image analysis.

In summary: The provided document is a 510(k) summary for a neuromodulation device, not an AI/ML-driven device. Therefore, many of the requested criteria related to AI/ML device performance validation are not applicable or not present in this type of submission. The clinical study described focuses on validating the therapeutic effectiveness of the device for an expanded indication.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY K233364

DATE PREPARED

January 10, 2024

MANUFACTURER AND 510(k) OWNER

NeuraLace Medical, Inc. 16990 Goldentop Road, San Diego, CA 92127 Telephone: +1 (858) 229-9218 Official Contact: Joe Milkovits, CTO Email: joe@neuralacemedical.com

REPRESENTATIVE/CONSULTANT

Allison C. Komiyama, Ph.D., RAC, VP, MedTech Innovation Charles Neitzel, Principal Consultant RQM+ Telephone: +1 (412) 816-8253 Email: akomiyama@rqmplus.com

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:	QPLIPF
Review Panel:	NeurologyPhysical 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

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/ Device Name	NeuraLace Medical Inc.Axon Therapy	NeuraLace Medical Inc.Axon Therapy	N/A
Indications for Use	The Axon Therapy is intendedto stimulate peripheralnerves for relief of chronicintractable pain, post-traumatic pain, post-surgicalpain and/or for relief ofchronic painful diabeticperipheral neuropathy in thelower extremities. The AxonTherapy is for use on patients18 and older.	The Axon Therapy is intendedto stimulate peripheral nervesfor relief of chronicintractable, post-traumaticand post-surgical pain forpatients 18 and older.	Substantially equivalentto the predicate device.Clinical testingdemonstrates that thereis no impact on safety andeffectiveness forexpanded indication.
Product Codes / RegulationNumbers	QPL / 21 CFR 882.5890IPF / 21 CFR 890.5850	QPL / 21 CFR 882.5890IPF / 21 CFR 890.5850	Identical to predicatedevice with no impact onsafety and effectiveness.
Technological Characteristics
Power Source	Power Supply: 110V to 240Vac, 50/60HzPower consumption: 800VAmaximum, 115W idle	Power Supply: 110V to 240Vac, 50/60HzPower consumption: 800VAmaximum, 115W idle	Identical to predicatedevice with no impact onsafety and effectiveness.
Comparison Topic	Subject Device	Predicate Device	Statement of Equivalence
Company Name/ Device Name	NeuraLace Medical Inc.Axon Therapy	NeuraLace Medical Inc.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 /Microprocessor Control?	Yes	Yes	Identical to predicate device with no impact on safety and effectiveness.
Indication Functions	On/off statusReady status	On/off statusReady 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 H111Coil: ABS	Stimulator: AL sheet EN AW 5754 H111Coil: 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 kgCoil: 3.2 kgFull system (with cart): 54 kg	Stimulator: 17 kgCoil: 3.2 kgFull 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%A maximum of 80% intensity is recommended to reduce the risk of coil overheating	0 to 100%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/ Device Name	NeuraLace Medical Inc.Axon Therapy	NeuraLace Medical Inc.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 60601-1EMC testing per IEC 60601-1-2Software testing per IEC 62304Usability testing per IEC 62366-1	Electrical safety per IEC 60601-1EMC testing per IEC 60601-1-2Software testing per IEC 62304Usability 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.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.

Regulation Number and Section

§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.

(a)
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.(b)
Classification. Class II (performance standards).