(263 days)
StimOn™ Pain Relief System (GM2439) is used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical or post-traumatic pain.
StimOn™ Pain Relief System (GM2439) is a hand-held stimulator designed to pass electrical signals via surface electrodes through the skin to the underlying nerves. It may be used as a TENS device to aid the blocking of pain signals traveling to the brain.
The document describes the StimOn™ Pain Relief System (GM2439) and its substantial equivalence to predicate devices, but it does not contain specific acceptance criteria for performance metrics (like sensitivity, specificity, accuracy) for an AI/algorithm-based device, nor does it detail a study proving the device meets such criteria in terms of AI performance.
Instead, the document focuses on the regulatory clearance of a Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief, primarily through comparison with existing predicate devices and compliance with relevant electrical safety and performance standards. The "performance testing" mentioned refers to these safety and electrical performance standards, not to clinical efficacy measured by AI performance metrics.
Therefore, many of the requested items regarding acceptance criteria and study details for an AI-based device's performance cannot be extracted from this document.
Here's the information that can be extracted, and where the document does not provide the requested information:
1. A table of acceptance criteria and the reported device performance:
The document does not specify quantified acceptance criteria for AI performance (e.g., sensitivity > X%, specificity > Y%). Instead, it discusses the device's technical characteristics and how they compare to predicate devices. The "performance testing" section refers to compliance with electrical safety and performance standards, not AI accuracy.
| Characteristic | Acceptance Criteria (Not explicitly stated for AI performance) | Reported Device Performance (from "Table 1. Comparison table" and subsequent descriptions) |
|---|---|---|
| Intended Use | Same as predicate devices | Symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical or post-traumatic pain. |
| Product Code | GZJ | GZJ |
| Power Supply | Not explicitly stated as acceptance criteria, but compared to predicates | One 3.7V, 125mAh rechargeable Lithium polymer battery |
| Treatment Timer Maximum | Not explicitly stated as acceptance criteria, but compared to predicates | 15 minutes |
| Number of Output Modes | Not explicitly stated as acceptance criteria | 1 (RF Mode) |
| Number of Waveforms | Not explicitly stated as acceptance criteria | 1 |
| Waveform | Not explicitly stated as acceptance criteria | Biphasic (Sine Wave) |
| RF Stimulation Mode | Not explicitly stated as acceptance criteria | Transcutaneous Pulsed Radio-frequency (PRF) mode |
| RF Frequency | Not explicitly stated as acceptance criteria | 500 kHz fixed |
| Burst Time | Not explicitly stated as acceptance criteria | 25ms |
| Burst Frequency | Not explicitly stated as acceptance criteria | 2Hz |
| Electrode Contact | Not explicitly stated as acceptance criteria | Hydrogel pad |
| Load Impedance | Not explicitly stated as acceptance criteria, but stated as a shutdown threshold | 1 k Ohm, Over this load, the system will automatically shut off. |
| Maximum Output Voltage | Not explicitly stated as acceptance criteria | 7.4 V+/-10% (6.6 V +/- 20% @@500Ω with Electrode Pad) |
| Maximum Output Current | Not explicitly stated as acceptance criteria | 14.8 mA (Peak)@500Ω (13.2 mA (Peak)@500Ω with Electrode Pad) |
| Maximum Average Current (Over primary phase) | Not explicitly stated as acceptance criteria | 9.43 mA (Peak)@500Ω (8.41mA(Peak)@500Ω with Electrode Pad) |
| Maximum Average Power Density (Smallest electrode area) “P” | Must be within value range of predicates | 112.81 µW/mm² @500Ohm with Electrode |
| Maximum Current (RMS) Density (mA/mm²) | Not explicitly stated as acceptance criteria | 0.0242 mA /mm² @500Ω with Electrode |
| Net Charge | Not explicitly stated as acceptance criteria | The theoretical value is 0. |
| Maximum average phase charge | Not explicitly stated as acceptance criteria | 0.00942μC |
| Electrical Safety & Performance | Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-10, ANSI/AAMI NS4 | Device underwent testing and demonstrated compliance (implied by substantial equivalence). |
| Biocompatibility | Meet standards for electrodes leveraged from K180865 | Leveraged from cleared electrodes (K180865). |
| Usability | Compliance with IEC 62366: Medical devices Part 1: Application of usability engineering to medical devices | Device complies with IEC 62366 and is similar to K180943 (BioWaveGO) cleared for OTC use. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Not provided. The document states "No Human Clinical Performance Testing have been required" for this application. The performance testing refers to electrical and safety standards, not clinical performance data from a test set of patients/cases.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable / Not provided. No clinical test set requiring expert ground truth was used for assessing the device's efficacy, as per the submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. No clinical test set requiring adjudication was used.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable / Not provided. This device is a Transcutaneous Electrical Nerve Stimulator, not an AI-assisted diagnostic or interpretative device that augments human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable / Not provided. This device is hardware for pain relief, not an algorithm/AI system in the sense of a diagnostic or predictive tool.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable / Not provided. No clinical ground truth was established for "performance" as it relates to AI or clinical efficacy. The "performance testing" was for electrical safety, electromagnetic compatibility, and biocompatibility, which rely on technical standards and laboratory measurements.
8. The sample size for the training set
- Not applicable / Not provided. Not an AI/algorithm-based device requiring a training set.
9. How the ground truth for the training set was established
- Not applicable / Not provided. Not an AI/algorithm-based device requiring a training set.
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol is a stylized representation of a human figure, while the FDA name is written in blue and includes the words "U.S. Food & Drug Administration".
August 26, 2022
Gimer Medical Co., Ltd. % Anita Chen RA ZhengCheng Limited Company 238 No.19. 335 Lane, Fu-Xi Road, Shulin District New Taipei City, Taiwan 238 Taiwan
Re: K213802
Trade/Device Name: StimOn™ Pain Relief System (GM2439) Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: GZJ Dated: July 5, 2022 Received: July 25, 2022
Dear Anita Chen:
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.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 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 (QS) 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.
for Amber Ballard, PhD 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) K213802
Device Name StimOn™ Pain Relief System (GM2439)
Indications for Use (Describe)
StimOn™ Pain Relief System (GM2439) is used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical or post-traumatic pain.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
This 510(k) summary of safety and effectiveness information is submitted as part of the Premarket Notification in compliance with requirements of CFR Part 807, Subpart E and Section 807.92.
The assigned 510(k) Number: K213802
| 1. | Manufacturer | Gimer Medical Co., Ltd. |
|---|---|---|
| Mail Address | Address: 9F.-5, No. 97, Sec. 1, Xintai 5th Road,Xizhi District, New Taipei City, TaiwanTel. +886-2-2697-2680Fax. +886-2-2697-2670Website: http://www.gimermed.com/ | |
| Manufacturer address | Address: 9F.-7 and 9F.-8, No. 97, Sec. 1, Xintai 5thRoad, Xizhi District, New Taipei City, Taiwan | |
| Contact Person | Mrs. Anita Chen/ Regulatory Advisor of GimerMedical Co., Ltd. | |
| Phone: | +886(0) 939-855-759 | |
| E-mail: | Anita9104303@gmail.com | |
| Date Prepared | 8/26/22 | |
| 2 | Device Name | |
| Trade Name: | StimOn™ Pain Relief System (GM2439) | |
| Common or usual name | Nerve stimulator | |
| Product Code | GZJ | |
| Regulation Name | Transcutaneous electrical nerve stimulator for painrelief | |
| CFR Classification | CFR Part 882.5890 | |
| Device Class | II | |
| Classification Panel | Neurology | |
| 3 | Primary Predicate Device | |
| 510(k) number: | K081835 | |
| Trade or proprietary or | Bioinduction Acticare HFT/HFI |
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model name:
4
| Manufacturer: | Bioinduction Limited(178-180 Hotwell Road, BRISTOL, BS8 4RP,United Kingdom, Telephone number: +44 117 375275, Fax number: +44 117 377 5405) |
|---|---|
| Secondary Predicate Device | |
| 510(k) number: | K161091 |
| Trade or proprietary ormodel name: | STIMPOD NMS460 Nerve Stimulator |
| Manufacturer: | XAVANT TECHNOLOGY (PTY) LTDStreet Address: Unit 102 The Tannery IndustrialPark309 Derdepoort RoadSilvertonCity: PretoriaState/Province: GautengCountry: South Africa |
| Reference Device ofElectrode Pad (Accessary) | |
| 510(k) number: | K180865 |
| Trade or proprietary or modelname: | ZMI Self-Adhesive Electrodes |
| Manufacturer: | ZMI Electronics, Ltd.6F-1,286-4,Shin Ya RoadKaohsiung, TW 806 |
| Reference Device for OTCusability | |
| 510(k) number: | K180943 |
| Trade or proprietary or modelname: | BioWaveGO |
| Manufacturer: | Biowave Corporation8 Knight Street, Suite 201Norwalk, CT 06851 |
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| 5 | Device Description: | StimOn™ Pain Relief System (GM2439) is a hand-held stimulator designed to pass electrical signals via surface electrodes through the skin to the underlying nerves. It may be used as a TENS device to aid the blocking of pain signals traveling to the brain. |
|---|---|---|
| --- | --------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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-
- Indications for Use: StimOn™ Pain Relief System (GM2439) is used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical or post-traumatic pain. 7. Technological A comparison of the device features, intended use, and
- Characteristics and Substantial Equivalence Comparison with Predicates:
other information demonstrates that the Product name is substantially equivalent to the predicate device as summarized in Table 1. The differences raise no new question of safety and effectiveness.
Table 1. Comparison table
| Description | Subject Device | Predicate Device | Predicate Device |
|---|---|---|---|
| 510(k) Number | K213802 | K081835 | K161091 |
| Manufacture | Gimer MedicalCo., Ltd | Bioinduction Limited | XAVANTTECHNOLOGY(PTY) LTD |
| Product code | GZJ | GZJ, IPF | GZJ |
| Device Name | StimOn™Pain Relief System(GM2439) | BioinductionActicareHFT/HFI | STIMPODNMS460NerveStimulator |
| Indications for use | StimOn™ PainRelief System(GM2439) is usedfor the symptomaticrelief andmanagement ofchronic intractablepain and/or as anadjunctive treatmentin the managementof post-surgical or | As a TranscutaneousElectronic NerveStimulation (TENS)device for: thesymptomatic relief ofchronic intractablepain, and as anadjunctive treatment | The STIMPODNMS460 NerveStimulator is aTranscutaneousElectrical NerveStimulation(TENS)device used forsymptomatic relief |
| post-traumatic pain | in the management of | and management of | |
| post-surgical or | chronic intractable | ||
| post-traumatic pain. | pain and/or as an | ||
| As a Neuromuscular | adjunctive | ||
| Electrostimulation | treatment in the | ||
| (NMS) device for: | management of | ||
| the relaxation of | post-surgical pain, | ||
| muscle | post traumatic acute | ||
| spasms, prevention or | pain problems, as | ||
| retardation of disuse | well as an adjunct | ||
| atrophy, increasinglocal blood | for pain control dueto rehabilitation. | ||
| circulation, muscle | |||
| re-education, | |||
| immediate post- | |||
| surgical stimulation | |||
| of the calf muscles to | |||
| prevent venous | |||
| thrombosis and to | |||
| maintain or increase | |||
| the range of motion. | |||
| Prescription/over-the counter use | Over-the-counteruse | Prescription | Prescription |
| Power Supply | One 3.7V, 125mAhrechargeableLithium polymerbattery | Not publiclyavailable | 4 x AAA alkalinebatteries |
| Treatment TimerMaximum | 15 minutes | Not publiclyavailable | 99 minutes |
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| Number of OutputModes | 1 (RF Mode) | Not publicly available | 1 |
|---|---|---|---|
| Number ofWaveforms | 1 | Not publicly available | 2 (Monophasic,Biphasic with offset) |
| Waveform | Biphasic(SineWave) | Not publicly available | Monophasic squarewave/Hybrid RFwave |
| RFStimulationMode | TranscutaneousPulsed Radio-frequency(PRF)mode | Not publicly available | Hybrid RFwaveform whichconsists of aMonophasic SquareWave with asuperimposed RadioFrequency waveform |
| RF Frequency | 500 kHz fixed | Not publicly available | 160kHz fixed |
| Burst Time | 25ms | Not publicly available | 100μs, 200μs |
| Burst Frequency | 2Hz | Not publicly available | 1,2,5,10 Hz |
| Electrode Contact | Hydrogel pad | Not publicly available | Probe electrode |
| Load Impedance | 1 k Ohm, Over thisload, the systemwill automaticallyshut off. | Not publicly available | 7 K Ohm |
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| Maximum OutputVoltage | 7.4 V+/-10%6.6 V +/- 20% @@500Ω withElectrode Pad | Not publiclyavailable | 220 V |
|---|---|---|---|
| Maximum OutputCurrent | 14.8 mA(Peak)@500Ω13.2 mA(Peak)@500Ω withElectrode Pad | Not publiclyavailable | 43.7mA @500Ohm |
| MaximumAverage Current(Over primaryphase) | 9.43 mA (Peak)@500Ω8.41mA(Peak)@500Ω withElectrode | Not publiclyavailable | 29.85mA@500Ohm |
| MaximumAverage PowerDensity (Smallestelectrode area) “P” | 112.81 µW/mm²@500Ohm withElectrode | Notpubliclyavailable | 71.5µW/mm²@500Ohm |
| MaximumCurrent (RMS)Density(mA/mm²) | 0.0242 mA /mm²@500Ωwith Electrode | Not publiclyavailable | 93.28µA/mm²@500Ohm |
| Net Charge | The theoretical valueis 0. | Not publiclyavailable | 6.06μC |
| Maximumaveragephasecharge [µC] | 0.00942μC | Notpubliclyavailable | 6.06µC |
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Summary of the technological characteristics of subject and predicate devices:
The StimOn™ Pain Relief System (GM2439) and Bioinduction Acticare are the same in use for body contact with the hydrogel pad. The other predicate STMPOD NMS460 is using the probe electrode instead. The subject and predicate devices have available RF stimulation modes. The slight differences between these three devices are the burst time. burst frequency, and RF frequency and the differences between the three devices are treatment timer maximum, power source, load impedance and maximum output.
The StimOn™ Pain Relief System (G2439) only has a single stimulation treatment mode at 500KHz, and impedance ranges from 100 to 1000 ohms to simplify the operation of device. Comparison of RF Stimulating Options (RF mode) of StimOn™ Pain Relief System (GM2439), and two predicates of Bioinduction Acticare and STMPOD NMS460 in waveform, RF Frequency, Burst time, Burst Frequency in Table1.
It indicated that from a safety perspective, the StimOn™ Pain Relief System (GM2439) its maximum average power density is within the value range of the two predicates (above STIMPOD and below Acticare). Thus, in the RF mode of energy output mechanism, it could infer that the treatment efficacy of StimOn™ Pain Relief System (GM2439) is sufficient to compare with the two predicate device and the differences between the subject and predicate(s) do not impact safety and effectiveness.
8. Performance Testing
Performance testing has been carried out to demonstrate that this device meets the performance specifications for its intended use. The following tests were performed on the device.
- IEC 60601-1. Medical Electrical Equipment Part 1: General Requirements for Safety,
- •IEC 60601-1-2: Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
- •IEC 60601-1-11: Medical Electrical Equipment Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
- · IEC 60601-2-10: Medical electrical equipment Part 2: Particular requirements for the
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basic safety and essential performance of nerve and muscle stimulators
· ASI/AAMI NS4: Medical Electrical Equipment Transcutaneous electrical nerve stimulators
Biocompatibility and Performance of electrodes:
The subject device utilizes electrodes cleared under K180865. Performance data (e.g. impedance, current dispersion, adhesion and electrode stability) and biocompatibility testing for the electrodes was leveraged from K180865.
Animal testing
No animal studies have been required for these devices.
Clinical testing
No Human Clinical Performance Testing have been required for StimOn™ Pain Relief System (GM2439) device for this application.
Usabilitv
The StimOn™ Pain Relief System (GM2439) is similar in intended use and technical specifications to the BioWaveGO (K180943), which was cleared for over-the-counter (OTC) use. The subject device also complies with IEC 62366: Medical devices Part 1: Application of usability engineering to medical devices.
9. Conclusion
StimOn™ Pain Relief System (GM2439) has the same intended use as the predicate device. Although there is a slightly different technological design, as compared to the predicate, the conclusions drawn from the test data demonstrate that the device is as safe and as effective as the legally marketed device identified in the submission. Therefore, the subject device is "Substantially Equivalent" to the predicate devices.
§ 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).