(158 days)
No
The summary does not mention AI, ML, or related concepts like training/test sets, image processing, or specific performance metrics typically associated with AI/ML devices. The device description focuses on the physical components and a thermal shutdown feature.
Yes.
The device's intended use is to stimulate peripheral nerves for the relief of chronic intractable, post-traumatic and postsurgical pain, which is explicitly a therapeutic purpose.
No
The device is intended to stimulate peripheral nerves for pain relief, which is a therapeutic function, not a diagnostic one. It is used to treat chronic pain, not to identify or assess a medical condition.
No
The device description explicitly lists hardware components: Magnetic Stimulation Coil, Liquid Cool Unit, and a Cart. This indicates it is a hardware device, not software-only.
Based on the provided information, the Axon Therapy device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "stimulate peripheral nerves for relief of chronic intractable, post-traumatic and postsurgical pain". This is a therapeutic use, not a diagnostic one.
- Device Description: The device is described as a "magnetic stimulator system" that provides "magnetic pulses" to "stimulate peripheral nerves". This aligns with a therapeutic device, not one used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze biological samples (blood, urine, tissue, etc.) or to provide information about a person's health status based on such analysis.
IVD devices are specifically designed to perform tests on specimens taken from the human body to provide information for diagnosis, monitoring, or screening. The Axon Therapy device's function is to directly interact with the body through magnetic stimulation for pain relief.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
QPL, IPF
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Any area, such as Hand, Arm, Chest, Waist, Buttock, Thigh, Calf, Back and low back etc.
Indicated Patient Age Range
patients 18 and older.
Intended User / Care Setting
in clinics such as pain management clinics and physical therapy clinics.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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: akomiyama@acknowledge-rs.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 |
| 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 | |
| Stimulator; R-T1 TENS Stimulator / Shenzhen | ||
| Roundwhale Technology Co., Ltd. | ✓ | |
| K973929 | MS-101 Magnetic Muscle Stimulator System / | |
| 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.
4
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. | |||||
| Axon Therapy | Shenzhen Roundwhale Technology | ||||
| Co., Ltd. | |||||
| R-C1 TENS and EMS Stimulator; R-E1 | |||||
| EMS Stimulator; R-T1 TENS | |||||
| Stimulator | |||||
| K181688 | Neotonus, Inc. | ||||
| MS-101 Magnetic Muscle Stimulator | |||||
| System | |||||
| K973929 | Tonica Elektronik A/S | ||||
| MagPro R20 | |||||
| K160280 | |||||
| Product Codes / | |||||
| Regulation Number | QPL / 21 CFR 882.5890 | ||||
| IPF / 21 CFR 890.5850 | GZJ / 21 CFR 882.5890 | ||||
| IPF / 21 CFR 890.5850 | IPF / 21 CFR 890.5850 | GWF / 21 CFR 882.1870 | The regulation is identical | ||
| to the predicate device. | |||||
| QPL is a new product code | |||||
| that was generated due to | |||||
| product design differences | |||||
| No impact on safety and | |||||
| effectiveness. | |||||
| Technological Characteristics | |||||
| Power source | Power Supply: 110V to 240V ac, | ||||
| 50/60Hz |
Power consumption: 800VA
maximum, 115W idle | 4x AAA Batteries | Unknown | Power Supply via Isolation
Transformer
Power Supply: 120V~, 50/60
Hz.
Power consumption:
Maximum 800VA | Substantially equivalent to
the predicate device. ES
testing demonstrates there
is no impact on safety and
effectiveness. |
| User Interface | LED display | LCD display | Unknown | Intensity display (coil
temperature, intensity)
Menu display and indicators | Substantially equivalent to
the predicate device. No
impact on safety and
effectiveness. |
| Output channels | N/A | 2 alternating channels | Unknown | Unknown | This feature is not
applicable to the subject
device. Performance and
clinical data demonstrate
that there is no impact on
safety and effectiveness. |
| Number of treatment
programs | N/A | 12 TENS, 9 EMS | Unknown | Unknown | This feature is not
applicable to the subject
device. Performance and
clinical data demonstrate
that there is no impact on
safety and effectiveness. |
| Waveform | Biphasic wave | Biphasic square | Unknown | Biphasic wave | Identical to the reference
device. Performance and
clinical data demonstrate
that there is no impact on
safety and effectiveness
when compared to the
predicate device. |
| Constant current or
constant voltage? | N/A | Constant current | Unknown | Unknown | This feature is not
applicable to the subject
device. ES and EMC testing
demonstrate that there is
no impact on safety and
effectiveness. |
| | Subject Device | Predicate Device | Reference Device | Reference Device | Statement of Equivalence |
| | NeuraLace Medical, Inc. | Shenzhen Roundwhale Technology
Co., Ltd. | Neotonus, Inc. | Tonica Elektronik A/S | |
| | Axon Therapy | | MS-101 Magnetic Muscle Stimulator
System | MagPro R20 | |
| | | R-C1 TENS and EMS Stimulator; R-E1 | | | |
| | | EMS Stimulator; R-T1 TENS
Stimulator | | | |
| | | K181688 | K973929 | K160280 | |
| Software/Firmware/
Microprocessor
Control? | Yes | Yes | Unknown | Unknown | Identical to the predicate
device. No impact on safety
and effectiveness. |
| Indication
functions | On/off status
Ready status | On/off status
Low battery
Voltage/current level | Unknown | Unknown | Substantially equivalent to
the predicate device. No
impact on safety and
effectiveness. |
| Time range | 800 seconds (400 pulses at 0.5 Hertz) | Nonadjustable 28, 30 and 32
minutes | Unknown | Unknown | Substantially equivalent to
the predicate device.
Clinical and performance
testing demonstrate that
there is no impact on safety
and effectiveness. |
| Patient
Leakage
Current | N/A | Normal condition: 11.4 μΑ
Single fault condition: 9.6 μΑ | Unknown | Unknown | This feature is not
applicable to the subject
device. ES and EMC testing
demonstrate that there is
no impact on safety and
effectiveness. |
| | Subject Device | Predicate Device | Reference Device | Reference Device | Statement of Equivalence |
| | NeuraLace Medical, Inc. | Shenzhen Roundwhale Technology
Co., Ltd. | Neotonus, Inc. | Tonica Elektronik A/S | |
| | Axon Therapy | R-C1 TENS and EMS Stimulator; R-E1
EMS Stimulator; R-T1 TENS
Stimulator | MS-101 Magnetic Muscle Stimulator
System | MagPro R20 | |
| | | K181688 | K973929 | K160280 | |
| Housing materials
construction | Stimulator: AL sheet EN AW 5754
H111
Coil: ABS | Plastic (ABS) enclosure | Unknown | Unknown | Substantially equivalent to
the predicate device.
Biocompatibility, electrical
safety, and clinical testing
demonstrate that there are
no new questions of safety
and effectiveness. |
| Applied part(s) | Coil 60BF-NL | Electrode pad | C-shaped magnetic coil | Compatible coils:
Static cooled coils (MCF-B65,
MCF-125, MCF-B70)
Non-cooled coils (C-100, C-
B60, MMC-140-II, RT-120-II) | Substantially equivalent to
the predicate device.
Performance and clinical
testing demonstrate that
there are no new questions
of safety and effectiveness. |
| Applied part area | 16 cm2 | 25 cm2 | Unknown | Circular coils: Ø110-126 mm
Butterfly coils: 2x75 mm, 2x96
mm
Special coils: Ø80x160 mm | Substantially equivalent to
the predicate device.
Performance and clinical
testing demonstrate that
there are no new questions
of 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. | Unknown | Unknown | Identical to the predicate
device. No impact on safety
and effectiveness. |
| Weight | Stimulator: 17 kg
Coil: 3.2 kg
Full system (with cart): 54 kg | 0.243 lbs | Unknown | 44 lbs (20 kg) | Substantially equivalent to
the predicate device.
Device weight will have
little to no impact on safety
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
the predicate device. Unit
dimensions will have little
to no impact on safety and
effectiveness. |
| Pulse frequency | 0-2 Hz | Unknown | 1-55 Hz | 0-22 Hz | Similar to the reference
devices. Performance and
clinical testing demonstrate
that there are no new
questions of safety and
effectiveness when
compared to the predicate
device. |
| | Subject Device | Predicate Device | Reference Device | Reference Device | Statement of Equivalence |
| | NeuraLace Medical, Inc.
Axon Therapy | Shenzhen Roundwhale Technology Co., Ltd.
R-C1 TENS and EMS Stimulator; R-E1
EMS Stimulator; R-T1 TENS
Stimulator
K181688 | Neotonus, Inc.
MS-101 Magnetic Muscle Stimulator
System
K973929 | Tonica Elektronik A/S
MagPro R20
K160280 | |
| Pulse amplitude | 0 to 100%
A maximum of 80% intensity is
recommended to reduce the risk of
coil overheating | Unknown | 0-100% | 0-100% | Identical to the reference
devices. Performance and
clinical testing demonstrate
that there are no new
questions of safety and
effectiveness when
compared to the predicate
device. |
| On-cycle duty period | 2-800 seconds | Unknown | 1-30 seconds | Unknown | 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. |
| Off-duty rest period | N/A | Unknown | 0-60 seconds | Unknown | 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. |
| Maximum repetition
rate | 2 pulses per second (pps) | Unknown | Unknown | 20 pulses per second (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. |
| Pulse mode | Standard | Unknown | Unknown | Standard | 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. |
| | Subject Device | Predicate Device | Reference Device | Reference Device | Statement of Equivalence |
| | NeuraLace Medical, Inc.
Axon Therapy | Shenzhen Roundwhale Technology Co., Ltd.
R-C1 TENS and EMS Stimulator; R-E1 EMS Stimulator; R-T1 TENS
Stimulator
K181688 | Neotonus, Inc.
MS-101 Magnetic Muscle Stimulator System
K973929 | Tonica Elektronik A/S
MagPro R20
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
75% at 10 pps
40% at 15 pps
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
EMC testing per IEC 60601-1-2
Software testing per IEC 62304
Usability testing per IEC 62366-1 | Testing
Performance testing per IEC 60601-2-10
Electrical safety per IEC 60601-1 and IEC 60601-1-11 (home use standard)
EMC testing per IEC 60601-1-2
Software testing per IEC 62304
Usability testing per IEC 62366-1 | Unknown | Electrical safety per IEC 60601-1
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.