Axon Therapy

K210021 · Neuralace Medical, Inc. · QPL · Jun 11, 2021 · Neurology

Device Facts

• Record ID: K210021
• Device Name: Axon Therapy
• Applicant: Neuralace Medical, Inc.
• Product Code: QPL · Neurology
• Decision Date: Jun 11, 2021
• 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, post-traumatic and postsurgical pain for 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 or physical therapy clinics by clinicians. System comprises a magnetic stimulation coil, liquid cooling unit, and cart. Device delivers brief, focused magnetic pulses to target nerves. Thermal shutdown feature monitors coil temperature (activates at 45°C or >41°C for 9 minutes in a 20-minute session). Clinicians operate the device to deliver stimulation; output is used to manage patient pain levels. Benefits include non-invasive pain relief without common TENS-related issues like skin irritation or burn marks.

Clinical Evidence

Clinical evaluation included 105 subjects with post-traumatic or post-surgical neuropathic pain. Subjects assessed via Numeric Rating Scale (NRS) or Mechanical Visual Analog Scale (MVAS). 25 subjects received three sessions in one week; others followed a 12-week, nine-session protocol. All subjects showed statistically significant decreases in pain scores. Reported adverse events were non-serious (hypersensitivity n=3, muscle soreness n=5), consistent with predicate TENS devices.

Technological Characteristics

Magnetic stimulator; stimulator housing: AL sheet EN AW 5754 H111; coil: ABS. Biphasic waveform (290 µsec pulse width). Power: 110-240V AC, 50/60Hz. Thermal shutdown safety feature. 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, post-traumatic, or post-surgical pain requiring peripheral nerve stimulation.

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

• R-C1 TENS and EMS Stimulator; R-E1 EMS Stimulator; R-T1 TENS Stimulator (K181688)

Reference Devices

• MS-101 Magnetic Muscle Stimulator System (K973929)
• MagPro R20 (K160280)

Submission Summary (Full Text)

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June 11, 2021

NeuraLace Medical, Inc. % Allison Komiyama Principal Consultant AcKnowledge Regulatory Strategies LLC 2251 San Diego Ave, Suite B-257 San Diego, California 92121

Re: K210021

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: May 10, 2021 Received: May 11, 2021

Dear Allison 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 (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Jitendra Virani Acting Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine 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) K210021

Device Name Axon Therapy

Indications for Use (Describe)

The Axon Therapy is intended to stimulate peripheral nerves for relief of chronic intractable, post-traumatic and postsurgical pain for patients 18 and older.

| 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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Image /page/3/Picture/0 description: The image features the logo for NeuraLace Medical. The logo consists of the company name, "NeuraLace MEDICAL," in a sans-serif font, with "NeuraLace" in a larger size than "MEDICAL." To the right of the text is an abstract representation of a brain, formed by interconnected lines and dots, giving it a geometric and modern appearance. The background is a solid light green color, providing a clean and professional look.

DATE PREPARED

June 11, 2021

### MANUFACTURER AND 510(k) OWNER

NeuraLace Medical, Inc. 3770 Tansy St #101, San Diego, CA 92121 Telephone: Official Contact: Joe Milkovits, CTO

### REPRESENTATIVE/CONSULTANT

Allison C. Komiyama, Ph.D., R.A.C. Michelle Rubin-Onur, Ph.D. AcKnowledge Regulatory Strategies, LLC Telephone: 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 |
| Primary Product Code: | QPL |
| Secondary Product Code: | IPF |
| Premarket Review: | Neurological and Physical Medicine Devices (OHT5) |
| | Neuromodulation and Physical Medicine Devices (DHT5B) |
| Review Panel: | Neurology |
| | Physical Medicine |

### PREDICATE DEVICE IDENTIFICATION

The Axon Therapy is substantially equivalent to the following predicate:

| 510(k) Number | Predicate Device Name / Manufacturer | Primary Predicate |
|---------------|--------------------------------------------------------------------------------------------------------------------------|--------------------|
| K181688 | R-C1 TENS and EMS Stimulator; R-E1 EMS<br>Stimulator; R-T1 TENS Stimulator / Shenzhen<br>Roundwhale Technology Co., Ltd. | ✓ |
| K973929 | MS-101 Magnetic Muscle Stimulator System /<br>Neotonus, Inc. | (Reference Device) |
| K160280 | MagPro R20 / Tonica Elektronik A/S | (Reference Device) |

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, post-traumatic and post-surgical pain for 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 a similar design and dimensions and uses similar or identical materials as the device cleared in K181688. The subject device has the same intended use and similar technological characteristics (i.e., nerve stimulation for relief of chronic intractable pain) to the devices cleared in K181688, K973929, and K160280. These technological characteristics have undergone testing to ensure the device is as safe and effective as the predicate.

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Image /page/5/Picture/1 description: This image is a table that compares the indications for use of several medical devices. The table has five columns: Subject Device, Predicate Device, Reference Device, Reference Device, and Statement of Equivalence. The Subject Device is the NeuraLace Medical, Inc. Axon Therapy, which is intended to stimulate peripheral nerves for relief of chronic intractable, post-traumatic and post-surgical pain for patients 18 and older. The Predicate Device is the Shenzhen Roundwhale Technology Co., Ltd. R-C1 TENS and EMS Stimulator; R-E1 EMS Stimulator; R-T1 TENS Stimulator, which has several indications for use, including symptomatic relief of chronic intractable pain, post traumatic pain, and post surgical pain.

NeuraLace MEDICAL

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Image /page/6/Picture/0 description: The image shows the logo for NeuraLace Medical. The logo is in a light green color and features the company name in a sans-serif font. To the right of the name is a stylized image of a brain made up of interconnected dots and lines.

| | Subject Device | Predicate Device | Reference Device | Reference Device | Statement of Equivalence |
|--------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | NeuraLace Medical, Inc.<br>Axon Therapy | Shenzhen Roundwhale Technology<br>Co., Ltd.<br>R-C1 TENS and EMS Stimulator; R-E1<br>EMS Stimulator; R-T1 TENS<br>Stimulator<br>K181688 | Neotonus, Inc.<br>MS-101 Magnetic Muscle Stimulator<br>System<br>K973929 | Tonica Elektronik A/S<br>MagPro R20<br>K160280 | |
| Product Codes /<br>Regulation Number | QPL / 21 CFR 882.5890<br>IPF / 21 CFR 890.5850 | GZJ / 21 CFR 882.5890<br>IPF / 21 CFR 890.5850 | IPF / 21 CFR 890.5850 | GWF / 21 CFR 882.1870 | The regulation is identical<br>to the predicate device.<br>QPL is a new product code<br>that was generated due to<br>product design differences<br>No impact on safety and<br>effectiveness. |
| Technological Characteristics | | | | | |
| Power source | Power Supply: 110V to 240V ac,<br>50/60Hz<br><br>Power consumption: 800VA<br>maximum, 115W idle | 4x AAA Batteries | Unknown | Power Supply via Isolation<br>Transformer<br>Power Supply: 120V~, 50/60<br>Hz.<br>Power consumption:<br>Maximum 800VA | Substantially equivalent to<br>the predicate device. ES<br>testing demonstrates there<br>is no impact on safety and<br>effectiveness. |
| User Interface | LED display | LCD display | Unknown | Intensity display (coil<br>temperature, intensity)<br>Menu display and indicators | Substantially equivalent to<br>the predicate device. No<br>impact on safety and<br>effectiveness. |
| Output channels | N/A | 2 alternating channels | Unknown | Unknown | This feature is not<br>applicable to the subject<br>device. Performance and<br>clinical data demonstrate<br>that there is no impact on<br>safety and effectiveness. |
| Number of treatment<br>programs | N/A | 12 TENS, 9 EMS | Unknown | Unknown | This feature is not<br>applicable to the subject<br>device. Performance and<br>clinical data demonstrate<br>that there is no impact on<br>safety and effectiveness. |
| Waveform | Biphasic wave | Biphasic square | Unknown | Biphasic wave | Identical to the reference<br>device. Performance and<br>clinical data demonstrate<br>that there is no impact on<br>safety and effectiveness<br>when compared to the<br>predicate device. |
| Constant current or<br>constant voltage? | N/A | Constant current | Unknown | Unknown | This feature is not<br>applicable to the subject<br>device. ES and EMC testing<br>demonstrate that there is<br>no impact on safety and<br>effectiveness. |
| | Subject Device | Predicate Device | Reference Device | Reference Device | Statement of Equivalence |
| | NeuraLace Medical, Inc. | Shenzhen Roundwhale Technology<br>Co., Ltd. | Neotonus, Inc. | Tonica Elektronik A/S | |
| | Axon Therapy | | MS-101 Magnetic Muscle Stimulator<br>System | MagPro R20 | |
| | | R-C1 TENS and EMS Stimulator; R-E1 | | | |
| | | EMS Stimulator; R-T1 TENS<br>Stimulator | | | |
| | | K181688 | K973929 | K160280 | |
| Software/Firmware/<br>Microprocessor<br>Control? | Yes | Yes | Unknown | Unknown | Identical to the predicate<br>device. No impact on safety<br>and effectiveness. |
| Indication<br>functions | On/off status<br>Ready status | On/off status<br>Low battery<br>Voltage/current level | Unknown | Unknown | Substantially equivalent to<br>the predicate device. No<br>impact on safety and<br>effectiveness. |
| Time range | 800 seconds (400 pulses at 0.5 Hertz) | Nonadjustable 28, 30 and 32<br>minutes | Unknown | Unknown | Substantially equivalent to<br>the predicate device.<br>Clinical and performance<br>testing demonstrate that<br>there is no impact on safety<br>and effectiveness. |
| Patient<br>Leakage<br>Current | N/A | Normal condition: 11.4 μΑ<br>Single fault condition: 9.6 μΑ | Unknown | Unknown | This feature is not<br>applicable to the subject<br>device. ES and EMC testing<br>demonstrate that there is<br>no impact on safety and<br>effectiveness. |
| | Subject Device | Predicate Device | Reference Device | Reference Device | Statement of Equivalence |
| | NeuraLace Medical, Inc. | Shenzhen Roundwhale Technology<br>Co., Ltd. | Neotonus, Inc. | Tonica Elektronik A/S | |
| | Axon Therapy | R-C1 TENS and EMS Stimulator; R-E1<br>EMS Stimulator; R-T1 TENS<br>Stimulator | MS-101 Magnetic Muscle Stimulator<br>System | MagPro R20 | |
| | | K181688 | K973929 | K160280 | |
| Housing materials<br>construction | Stimulator: AL sheet EN AW 5754<br>H111<br>Coil: ABS | Plastic (ABS) enclosure | Unknown | Unknown | Substantially equivalent to<br>the predicate device.<br>Biocompatibility, electrical<br>safety, and clinical testing<br>demonstrate that there are<br>no new questions of safety<br>and effectiveness. |
| Applied part(s) | Coil 60BF-NL | Electrode pad | C-shaped magnetic coil | Compatible coils:<br>Static cooled coils (MCF-B65,<br>MCF-125, MCF-B70)<br>Non-cooled coils (C-100, C-<br>B60, MMC-140-II, RT-120-II) | Substantially equivalent to<br>the predicate device.<br>Performance and clinical<br>testing demonstrate that<br>there are no new questions<br>of safety and effectiveness. |
| Applied part area | 16 cm2 | 25 cm2 | Unknown | Circular coils: Ø110-126 mm<br>Butterfly coils: 2x75 mm, 2x96<br>mm<br>Special coils: Ø80x160 mm | Substantially equivalent to<br>the predicate device.<br>Performance and clinical<br>testing demonstrate that<br>there are no new questions<br>of safety and effectiveness |
| Treatment area | Any area, such as Hand, Arm, Chest,<br>Waist, Buttock, Thigh, Calf, Back and<br>low back etc. | Any area, such as Hand, Arm, Chest,<br>Waist, Buttock, Thigh, Calf, Back and<br>low back etc. | Unknown | Unknown | Identical to the predicate<br>device. No impact on safety<br>and effectiveness. |
| Weight | Stimulator: 17 kg<br>Coil: 3.2 kg<br>Full system (with cart): 54 kg | 0.243 lbs | Unknown | 44 lbs (20 kg) | Substantially equivalent to<br>the predicate device.<br>Device weight will have<br>little to no impact on safety<br>and effectiveness. |
| Unit Dimensions | 485 x 380 x 165 mm | 2.78x 4.82x 1.08 in (HxWxD) | Unknown | 5.9x15.3x17.3 in (HxWxD) | Substantially equivalent to<br>the predicate device. Unit<br>dimensions will have little<br>to no impact on safety and<br>effectiveness. |
| Pulse frequency | 0-2 Hz | Unknown | 1-55 Hz | 0-22 Hz | Similar to the reference<br>devices. Performance and<br>clinical testing demonstrate<br>that there are no new<br>questions of safety and<br>effectiveness when<br>compared to the predicate<br>device. |
| | Subject Device | Predicate Device | Reference Device | Reference Device | Statement of Equivalence |
| | NeuraLace Medical, Inc.<br>Axon Therapy | Shenzhen Roundwhale Technology Co., Ltd.<br>R-C1 TENS and EMS Stimulator; R-E1<br>EMS Stimulator; R-T1 TENS<br>Stimulator<br>K181688 | Neotonus, Inc.<br>MS-101 Magnetic Muscle Stimulator<br>System<br>K973929 | Tonica Elektronik A/S<br>MagPro R20<br>K160280 | |
| Pulse amplitude | 0 to 100%<br>A maximum of 80% intensity is<br>recommended to reduce the risk of<br>coil overheating | Unknown | 0-100% | 0-100% | Identical to the reference<br>devices. Performance and<br>clinical testing demonstrate<br>that there are no new<br>questions of safety and<br>effectiveness when<br>compared to the predicate<br>device. |
| On-cycle duty period | 2-800 seconds | Unknown | 1-30 seconds | Unknown | Similar to the reference<br>device. Performance and<br>clinical testing demonstrate<br>that there are no new<br>questions of safety and<br>effectiveness when<br>compared to the predicate<br>device. |
| Off-duty rest period | N/A | Unknown | 0-60 seconds | Unknown | Similar to the reference<br>device. Performance and<br>clinical testing demonstrate<br>that there are no new<br>questions of safety and<br>effectiveness when<br>compared to the predicate<br>device. |
| Maximum repetition<br>rate | 2 pulses per second (pps) | Unknown | Unknown | 20 pulses per second (pps) | Similar to the reference<br>device. Performance and<br>clinical testing demonstrate<br>that there are no new<br>questions of safety and<br>effectiveness when<br>compared to the predicate<br>device. |
| Pulse mode | Standard | Unknown | Unknown | Standard | Identical to reference<br>device. Performance and<br>clinical testing demonstrate<br>that there are no new<br>questions of safety and<br>effectiveness when<br>compared to the predicate<br>device. |
| | Subject Device | Predicate Device | Reference Device | Reference Device | Statement of Equivalence |
| | NeuraLace Medical, Inc.<br>Axon Therapy | Shenzhen Roundwhale Technology Co., Ltd.<br>R-C1 TENS and EMS Stimulator; R-E1 EMS Stimulator; R-T1 TENS<br>Stimulator<br>K181688 | Neotonus, Inc.<br>MS-101 Magnetic Muscle Stimulator System<br>K973929 | Tonica Elektronik A/S<br>MagPro R20<br>K160280 | |
| Pulse width | Biphasic (290 µsec) | Unknown | Unknown | Biphasic (280 µsec) | Identical to reference device. Performance and clinical testing demonstrate that there are no new questions of safety and effectiveness when compared to the predicate device. |
| Maximum output power | 100% at 2 pps | Unknown | Unknown | 100% at 5 pps<br>75% at 10 pps<br>40% at 15 pps<br>35% at 20 pps | Similar to the reference device. Performance and clinical testing demonstrate that there are no new questions of safety and effectiveness when compared to the predicate device. |
| 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 | Testing<br>Performance testing per IEC 60601-2-10<br>Electrical safety per IEC 60601-1 and IEC 60601-1-11 (home use standard)<br>EMC testing per IEC 60601-1-2<br>Software testing per IEC 62304<br>Usability testing per IEC 62366-1 | Unknown | Electrical safety per IEC 60601-1<br>EMC testing per IEC 60601-1-2 | Substantially equivalent to the predicate device. Performance and clinical testing demonstrate that there are no new questions of safety and effectiveness |
| Clinical Testing | Three studies that evaluated the effectiveness and safety of the subject device. | None | Comparative study of the physiological effect of the MS-101 and the predicate on the knee extensor muscles of 9 healthy volunteers | None | 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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Image /page/7/Picture/0 description: The image features the logo for NeuraLace Medical. The text "NeuraLace" is prominently displayed in a sans-serif font, with the word "MEDICAL" appearing in smaller letters beneath it. To the right of the text is an abstract representation of a brain, composed of interconnected dots and lines, giving it a networked or technological appearance.

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Image /page/8/Picture/0 description: The image shows the logo for NeuraLace Medical. The text "NeuraLace" is in a large, sans-serif font, and the word "MEDICAL" is in a smaller font below it. To the right of the text is an image of a brain made up of connected dots. The background is a solid green color.

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Image /page/9/Picture/0 description: The image shows the logo for NeuraLace Medical. The text "NeuraLace" is in a sans-serif font, and the word "MEDICAL" is in a smaller font below it. To the right of the text is an image of a brain made up of interconnected lines and dots. The background is a solid green color.

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Image /page/10/Picture/0 description: The image features the logo for NeuraLace Medical. The text "NeuraLace" is prominently displayed above the word "MEDICAL". To the right of the text is a graphic of a brain made up of interconnected dots and lines, creating a network-like appearance.

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Image /page/11/Picture/1 description: The image features the logo for NeuraLace Medical. The logo consists of the text "NeuraLace" in a sans-serif font, with the word "MEDICAL" in smaller letters underneath. To the right of the text is an image of a brain made up of interconnected dots, resembling a neural network. The background is a solid green color.

### SUMMARY OF NON-CLINICAL TESTING

The following tests were performed to demonstrate safety based on current industry standards:

Software Verification: The software development and testing were executed in compliance to IEC 62304:2006 Medical device software - Software life cycle processes

Electromagnetic Compatibility and Electrical Safety: The subject device was tested in compliance to:

- IEC 60601-1:2005+AMD1:2012 CSV Consolidated version, Medical electrical equipment -। Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2 Edition 4.0 2014-02 Medical Electrical Equipment Part 1-2: General -Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements And Tests
- -IEC 60601-1-8 Edition 2.1 2012-11 Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

Usability: The subject device was tested in compliance to:

- -IEC 60601-1-6 Edition 3.1 2013-10 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- -IEC 62366:2007+AMD1:2014 CSV Medical devices - Application of usability engineering to medical device

Performance Testing: The subject device underwent the following performance testing:

- -Cleaning validation
- Packaging validation l
- Magnetic field characteristic measurements and stimulation model -
- -Stimulation protocol accuracy validation
- Temperature on surface at maximum output validation -
- -Magnetic field model and measurement comparison

## SUMMARY OF CLINICAL TESTING

NeuraLace conducted multiple clinical studies to assess the safety and effectives of the Axon Therapy in subjects with post-traumatic or post-surgical neuropathic pain. All subjects (n=105) were evaluated for pain prior to and after device use using the numeric rating scale (NRS) or the Mechanical Visual Analog Scale (MVAS). Twenty-five of 105 subjects underwent three consecutive sessions within one week and were asked to rate their pain after the session, one week, and one month later. All subjects had a statistically significant decrease in their pain

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Image /page/12/Picture/0 description: The image shows the logo for NeuraLace Medical. The logo consists of the company name "NeuraLace" in a sans-serif font, with the word "MEDICAL" in smaller letters below it. To the right of the text is an image of a brain made up of interconnected dots and lines, giving it a futuristic or technological appearance. The background color is a light green.

score. The remaining subjects followed a 12-week schedule (a total of nine sessions). Pain levels were assessed multiple times throughout the study commencement, after the first three sessions, after session 6, after session 9 using the MVAS. After 12 weeks, all subjects had a decreased MVAS score, highlighting the effectiveness of the subject device. During the studies, two non-serious adverse events related to device use occurred: hypersensitivity (n=3) and muscle soreness (n=5). These adverse events are the same or similar to the adverse events associated with the predicate TENS device. Furthermore, unlike the predicate device, Axon Therapy does not result in burn marks, skin irritation, or analgesic tolerance, highlighting the safety benefit of the subject device.

## CONCLUSION

Based on the testing performed, including clinical testing, software validation, electrical safety testing, and performance testing, it can be concluded that the subject device does not raise new issues of safety and effectiveness compared to the predicate device. The similar indications for use, technological characteristics, and performance characteristics for the proposed Axon Therapy are assessed to be substantially equivalent to the predicate device supported by the performance data discussed above.