(158 days)
The Axon Therapy is intended to stimulate peripheral nerves for relief of chronic intractable, post-traumatic and postsurgical pain for patients 18 and older.
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.
The provided text describes the 510(k) premarket notification for Axon Therapy by NeuraLace Medical, Inc. This document focuses on demonstrating substantial equivalence to a predicate device, as opposed to proving novel acceptance criteria in the traditional sense of a clinical trial for a new drug or high-risk device. Therefore, the "acceptance criteria" here largely refer to meeting the requirements for substantial equivalence to a legally marketed predicate device, primarily through non-clinical and clinical testing designed to show that the new device is as safe and effective as the predicate.
Given this context, I will interpret "acceptance criteria" as the performance and safety benchmarks established by the predicate device and the relevant FDA standards, which the Axon Therapy must meet or surpass. The "study that proves the device meets the acceptance criteria" refers to the set of tests and clinical data provided to demonstrate this substantial equivalence.
Here's a breakdown of the requested information based on the provided text:
Acceptance Criteria and Reported Device Performance
The "acceptance criteria" are implicitly defined by the characteristics of the predicate device (Shenzhen Roundwhale Technology Co., Ltd. R-C1 TENS and EMS Stimulator; K181688) and other reference devices, along with relevant industry standards (IEC, etc.). The reported device performance demonstrates how the Axon Therapy aligns with or improves upon these.
Table of (Implicit) Acceptance Criteria and Reported Device Performance:
| Feature/Criterion (Implicit) | Predicate Device/Standard Baseline (Implied Acceptance) | Reported Axon Therapy Performance | Statement of Equivalence/Met Criteria |
|---|---|---|---|
| Indications for Use | Symptomatic relief of chronic intractable pain, post-traumatic pain, and post-surgical pain (for patients 18+) | Stimulate peripheral nerves for relief of chronic intractable, post-traumatic and post-surgical pain for patients 18 and older. | Identical to the predicate device. |
| Magnetic Stimulation Type (vs. Electrical) | Electrical nerve stimulation (TENS/EMS) | Magnetic stimulator system providing brief and focused magnetic pulses. | This is a difference from the predicate but demonstrated to be substantially equivalent through testing. The document states: "Performance and clinical data demonstrate that there is no impact on safety and effectiveness when compared to the predicate device." "Axon Therapy does not result in burn marks, skin irritation, or analgesic tolerance, highlighting the safety benefit." |
| Safety - Electrical Safety | IEC 60601-1 (general), IEC 60601-1-11 (home use) | Tested compliance to IEC 60601-1:2005+AMD1:2012 CSV. | Substantially equivalent; no new questions of safety. |
| Safety - EMC | IEC 60601-1-2 | Tested compliance to IEC 60601-1-2 Edition 4.0 2014-02. | Substantially equivalent; no new questions of safety. |
| Safety - Software | IEC 62304 | Software development and testing in compliance to IEC 62304:2006. | Identical to predicate device; no new questions of safety. |
| Safety - Usability | IEC 62366 | Tested compliance to IEC 60601-1-6 Edition 3.1 2013-10 and IEC 62366:2007+AMD1:2014 CSV. | Substantially equivalent. |
| Safety - Biocompatibility | Implicitly met by predicate device materials and general standards. | Housing materials: Stimulator: AL sheet EN AW 5754 H111, Coil: ABS. Biocompatibility testing performed. | Substantially equivalent; no new questions of safety. |
| Safety - Adverse Events | Adverse events associated with predicate TENS devices (e.g., burn marks, skin irritation, analgesic tolerance) | Two non-serious adverse events related to device use: hypersensitivity (n=3) and muscle soreness (n=5). Does not result in burn marks, skin irritation, or analgesic tolerance. | AE profile is similar or better than predicate device. Demonstrates safety benefit. |
| Performance - Pain Relief Effectiveness | Effectiveness in relieving chronic pain (as per predicate's intended use). | Statistically significant decrease in pain scores (NRS/MVAS) after sessions. All subjects had a decreased MVAS score after 12 weeks. | Demonstrated clinical effectiveness; performance testing for substantial equivalence. |
| Performance - Clinical Use Case (Clinic/Home) | Predicate likely for home/clinic use (given TENS/EMS). | Intended for use in clinics (e.g., pain management, physical therapy clinics). | Consistent with expected use environment for such devices. |
| Performance - Stimulation Protocol Accuracy | Implicitly accurate for predicate. | Validated. | Performance testing for substantial equivalence. |
| Performance - Thermal Management | Implicitly managed by predicate or standard requirements. | Thermal shutdown feature activated at 45°C or >41°C for 9 mins during 20-min session. Temperature on surface at maximum output validated. | Addresses user safety and device longevity. |
| Technical - Waveform | Biphasic square (predicate); Biphasic wave (reference device K160280) | Biphasic wave. | Identical to reference device; no new safety/effectiveness questions compared to predicate. |
| Technical - Pulse Frequency | Unknown (predicate); 1-55 Hz (reference K973929); 0-22 Hz (reference K160280) | 0-2 Hz. | Similar to reference devices; no new safety/effectiveness questions. |
| Technical - Pulse Amplitude | Unknown (predicate); 0-100% (reference K973929, K160280) | 0 to 100% (max 80% recommended). | Identical to reference devices; no new safety/effectiveness questions. |
| Technical - Pulse Width | Unknown (predicate); Biphasic (280 µsec) (reference K160280) | Biphasic (290 µsec). | Identical to reference device; no new safety/effectiveness questions. |
| Technical - Maximum Repetition Rate | Unknown (predicate); 20 pps (reference K160280) | 2 pulses per second (pps). | Similar to reference device; no new safety/effectiveness questions. |
| Technical - Applied Part Area | 25 cm2 (predicate). | 16 cm2. | Substantially equivalent; no new safety/effectiveness questions. |
Study Details:
-
Sample Size Used for the Test Set and Data Provenance:
- Clinical Studies:
- Total subjects: n=105.
- Subgroup 1: 25 subjects.
- Subgroup 2: 80 subjects (105 - 25).
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It states "NeuraLace conducted multiple clinical studies," implying prospective studies conducted by the company.
- Clinical Studies:
-
Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- This information is not explicitly provided. For a pain relief device, "ground truth" is typically subjective patient-reported pain scores (NRS/MVAS) rather than readings established by experts.
-
Adjudication Method for the Test Set:
- Not applicable/Not mentioned, as the primary outcome (pain scores) is patient-reported.
-
If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC study was not done. The clinical studies focused on the effectiveness and safety of the device itself (with or without a human in the loop, but the device is user-applied in a clinical setting). It was not a comparative study of human readers assisted by AI vs. unassisted human readers.
-
If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This question is generally relevant for AI/software-based diagnostic devices. For a physical medical device like Axon Therapy, a "standalone algorithm" is not applicable in the same way. The device functions to stimulate nerves, and its performance is measured by its physical output (magnetic pulses) and clinical outcomes (pain relief), not by an algorithm making a diagnosis or interpretation. The software validation mentioned (IEC 62304) ensures the software controlling the device operates correctly, which is part of the integrated device performance.
-
The Type of Ground Truth Used:
- Clinical Efficacy: Patient-reported outcome measures (PROMs) using the Numeric Rating Scale (NRS) or Mechanical Visual Analog Scale (MVAS) for pain. This is a subjective patient outcome as ground truth for pain relief.
- Safety: Occurrence of adverse events, evaluated by clinicians and reported.
- Technical Performance: Quantitative measurements from performance testing (e.g., magnetic field characteristics, stimulation protocol accuracy, temperature). Compliance with electrical safety, EMC, and usability standards are also part of the "ground truth" for device safety and functionality.
-
The Sample Size for the Training Set:
- This document describes a premarket notification for a physical medical device, not an AI/ML algorithm that requires a "training set" in the context of machine learning. The term "training set" is not applicable here. The clinical studies described (n=105 total subjects) are the testing/validation set for the device's clinical performance and safety.
-
How the Ground Truth for the Training Set was Established:
- See point 7; "training set" in the AI/ML sense is not relevant. The device's "training" refers to its design, engineering, and manufacturing process, optimized through non-clinical and preclinical testing to ensure it meets its intended function prior to clinical evaluation.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the symbol of the Department of Health & Human Services on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out next to it.
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 (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 EMSStimulator; R-T1 TENS Stimulator / ShenzhenRoundwhale 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.
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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.Axon Therapy | Shenzhen Roundwhale TechnologyCo., Ltd.R-C1 TENS and EMS Stimulator; R-E1EMS Stimulator; R-T1 TENSStimulatorK181688 | Neotonus, Inc.MS-101 Magnetic Muscle StimulatorSystemK973929 | Tonica Elektronik A/SMagPro R20K160280 | ||
| Product Codes /Regulation Number | QPL / 21 CFR 882.5890IPF / 21 CFR 890.5850 | GZJ / 21 CFR 882.5890IPF / 21 CFR 890.5850 | IPF / 21 CFR 890.5850 | GWF / 21 CFR 882.1870 | The regulation is identicalto the predicate device.QPL is a new product codethat was generated due toproduct design differencesNo impact on safety andeffectiveness. |
| Technological Characteristics | |||||
| Power source | Power Supply: 110V to 240V ac,50/60HzPower consumption: 800VAmaximum, 115W idle | 4x AAA Batteries | Unknown | Power Supply via IsolationTransformerPower Supply: 120V~, 50/60Hz.Power consumption:Maximum 800VA | Substantially equivalent tothe predicate device. EStesting demonstrates thereis no impact on safety andeffectiveness. |
| User Interface | LED display | LCD display | Unknown | Intensity display (coiltemperature, intensity)Menu display and indicators | Substantially equivalent tothe predicate device. Noimpact on safety andeffectiveness. |
| Output channels | N/A | 2 alternating channels | Unknown | Unknown | This feature is notapplicable to the subjectdevice. Performance andclinical data demonstratethat there is no impact onsafety and effectiveness. |
| Number of treatmentprograms | N/A | 12 TENS, 9 EMS | Unknown | Unknown | This feature is notapplicable to the subjectdevice. Performance andclinical data demonstratethat there is no impact onsafety and effectiveness. |
| Waveform | Biphasic wave | Biphasic square | Unknown | Biphasic wave | Identical to the referencedevice. Performance andclinical data demonstratethat there is no impact onsafety and effectivenesswhen compared to thepredicate device. |
| Constant current orconstant voltage? | N/A | Constant current | Unknown | Unknown | This feature is notapplicable to the subjectdevice. ES and EMC testingdemonstrate that there isno impact on safety andeffectiveness. |
| Subject Device | Predicate Device | Reference Device | Reference Device | Statement of Equivalence | |
| NeuraLace Medical, Inc. | Shenzhen Roundwhale TechnologyCo., Ltd. | Neotonus, Inc. | Tonica Elektronik A/S | ||
| Axon Therapy | MS-101 Magnetic Muscle StimulatorSystem | MagPro R20 | |||
| R-C1 TENS and EMS Stimulator; R-E1 | |||||
| EMS Stimulator; R-T1 TENSStimulator | |||||
| K181688 | K973929 | K160280 | |||
| Software/Firmware/MicroprocessorControl? | Yes | Yes | Unknown | Unknown | Identical to the predicatedevice. No impact on safetyand effectiveness. |
| Indicationfunctions | On/off statusReady status | On/off statusLow batteryVoltage/current level | Unknown | Unknown | Substantially equivalent tothe predicate device. Noimpact on safety andeffectiveness. |
| Time range | 800 seconds (400 pulses at 0.5 Hertz) | Nonadjustable 28, 30 and 32minutes | Unknown | Unknown | Substantially equivalent tothe predicate device.Clinical and performancetesting demonstrate thatthere is no impact on safetyand effectiveness. |
| PatientLeakageCurrent | N/A | Normal condition: 11.4 μΑSingle fault condition: 9.6 μΑ | Unknown | Unknown | This feature is notapplicable to the subjectdevice. ES and EMC testingdemonstrate that there isno impact on safety andeffectiveness. |
| Subject Device | Predicate Device | Reference Device | Reference Device | Statement of Equivalence | |
| NeuraLace Medical, Inc. | Shenzhen Roundwhale TechnologyCo., Ltd. | Neotonus, Inc. | Tonica Elektronik A/S | ||
| Axon Therapy | R-C1 TENS and EMS Stimulator; R-E1EMS Stimulator; R-T1 TENSStimulator | MS-101 Magnetic Muscle StimulatorSystem | MagPro R20 | ||
| K181688 | K973929 | K160280 | |||
| Housing materialsconstruction | Stimulator: AL sheet EN AW 5754H111Coil: ABS | Plastic (ABS) enclosure | Unknown | Unknown | Substantially equivalent tothe predicate device.Biocompatibility, electricalsafety, and clinical testingdemonstrate that there areno new questions of safetyand 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 tothe predicate device.Performance and clinicaltesting demonstrate thatthere are no new questionsof safety and effectiveness. |
| Applied part area | 16 cm2 | 25 cm2 | Unknown | Circular coils: Ø110-126 mmButterfly coils: 2x75 mm, 2x96mmSpecial coils: Ø80x160 mm | Substantially equivalent tothe predicate device.Performance and clinicaltesting demonstrate thatthere are no new questionsof safety and effectiveness |
| Treatment area | Any area, such as Hand, Arm, Chest,Waist, Buttock, Thigh, Calf, Back andlow back etc. | Any area, such as Hand, Arm, Chest,Waist, Buttock, Thigh, Calf, Back andlow back etc. | Unknown | Unknown | Identical to the predicatedevice. No impact on safetyand effectiveness. |
| Weight | Stimulator: 17 kgCoil: 3.2 kgFull system (with cart): 54 kg | 0.243 lbs | Unknown | 44 lbs (20 kg) | Substantially equivalent tothe predicate device.Device weight will havelittle to no impact on safetyand 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 tothe predicate device. Unitdimensions will have littleto no impact on safety andeffectiveness. |
| Pulse frequency | 0-2 Hz | Unknown | 1-55 Hz | 0-22 Hz | Similar to the referencedevices. Performance andclinical testing demonstratethat there are no newquestions of safety andeffectiveness whencompared to the predicatedevice. |
| 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-E1EMS Stimulator; R-T1 TENSStimulatorK181688 | Neotonus, Inc.MS-101 Magnetic Muscle StimulatorSystemK973929 | Tonica Elektronik A/SMagPro R20K160280 | ||
| Pulse amplitude | 0 to 100%A maximum of 80% intensity isrecommended to reduce the risk ofcoil overheating | Unknown | 0-100% | 0-100% | Identical to the referencedevices. Performance andclinical testing demonstratethat there are no newquestions of safety andeffectiveness whencompared to the predicatedevice. |
| On-cycle duty period | 2-800 seconds | Unknown | 1-30 seconds | Unknown | Similar to the referencedevice. Performance andclinical testing demonstratethat there are no newquestions of safety andeffectiveness whencompared to the predicatedevice. |
| Off-duty rest period | N/A | Unknown | 0-60 seconds | Unknown | Similar to the referencedevice. Performance andclinical testing demonstratethat there are no newquestions of safety andeffectiveness whencompared to the predicatedevice. |
| Maximum repetitionrate | 2 pulses per second (pps) | Unknown | Unknown | 20 pulses per second (pps) | Similar to the referencedevice. Performance andclinical testing demonstratethat there are no newquestions of safety andeffectiveness whencompared to the predicatedevice. |
| Pulse mode | Standard | Unknown | Unknown | Standard | Identical to referencedevice. Performance andclinical testing demonstratethat there are no newquestions of safety andeffectiveness whencompared to the predicatedevice. |
| 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 TENSStimulatorK181688 | Neotonus, Inc.MS-101 Magnetic Muscle Stimulator SystemK973929 | Tonica Elektronik A/SMagPro R20K160280 | ||
| 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 pps75% at 10 pps40% at 15 pps35% 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 60601-1EMC testing per IEC 60601-1-2Software testing per IEC 62304Usability testing per IEC 62366-1 | TestingPerformance testing per IEC 60601-2-10Electrical safety per IEC 60601-1 and IEC 60601-1-11 (home use standard)EMC testing per IEC 60601-1-2Software testing per IEC 62304Usability testing per IEC 62366-1 | Unknown | Electrical safety per IEC 60601-1EMC 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.
§ 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).