(392 days)
The iRelieve Microcurrent Pain Relief System is intended to be used by physicians or licensed practitioners for symptomatic relief of chronic intractable pain.
The iRelieve Microcurrent Pain Relief System is a microcurrent TENS device that operates by sending electrical impulses through the skin to the nerves lying directly beneath the skin surface. These impulses help block the body's ability to send a pain message to the brain, thereby reducing the pain sensation. The iRelieve Microcurrent Pain Relief System is a single channel device that produces microampere currents with the selected envelopes, waveforms, frequencies, and polarity, with a maximum voltage of 3.0 volts. It is controlled by analogue electrical parts (voltage regulator, frequency oscillator, multiple resistors, etc.) and a digital microprocessor chip that contains embedded programmed software (firmware) that generates a sequence of current flows and frequencies during the course of a single treatment session. The iRelieve Microcurrent Pain Relief System performs this sequence of current flows without user manipulation or device controls other than switching the device on after application of the device to the electrodes.
The provided text is a 510(k) Summary for the iRelieve Microcurrent Pain Relief System. It describes the device, its intended use, and states that it has been determined to be substantially equivalent to a predicate device. However, it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria related to clinical performance or efficacy.
Instead, the performance testing for the iRelieve Microcurrent Pain Relief System focuses on:
- Output Performance: Micro Current Stimulator Measurements, Validation of Electrodes, Output sequence with Oscilloscope captures.
- Device Integrity/Safety: Shelf-life testing, Packaging testing (ASTM D4169-16), Battery use life testing, Biocompatibility testing (leveraged from predicate), Electromagnetic compatibility (EMC) and electrical safety (IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2 standards).
- Software Validation: Software verification and validation per FDA guidance for Class B level of concern (IEC 62304).
The document explicitly states that the determination of substantial equivalence is based on the device having the "same intended use and similar technical characteristics, performance and applications" as the predicate device (Model 7500 Microcurrent TENS Device, Version MCT-F50, K013167), and that it "does not pose any new question of safety or effectiveness."
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets clinical acceptance criteria because this information is not present in the provided document. The document details technical performance and safety testing to demonstrate substantial equivalence to a predicate device, not a new clinical efficacy study with acceptance criteria.
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September 14, 2022
Fast Track Technologies, Inc. % Michael Tomasovich Sr. Regulatory Affairs Manager Regulatory Affairs Associates, LLC. 4761 Tara Court West Bloomfield, Michigan 48323
Re: K212618
Trade/Device Name: iRelieve Microcurrent Pain Relief System Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: GZJ Dated: August 10, 2022 Received: August 11, 2022
Dear Michael Tomasovich:
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.
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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K212618
Device Name iRelieve Microcurrent Pain Relief System
Indications for Use (Describe)
The iRelieve Microcurrent Pain Relief System is intended to be used by physicians or licensed practitioners for symptomatic relief of chronic intractable pain.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
[as required by section 807.92(c)]
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92.
General Information
| Submitted by: | Fast Track Technologies, Inc.4400 MacArthur Boulevard, Ninth Floor PO Box 7849Newport Beach, CA 92658-7849 USA |
|---|---|
| Contact Person: | Michael Tomasovich, MS RAC Regulatory Affairs Associates, LLC4761 Tara CourtWest Bloomfield, MI 48323 |
| Phone: +1 (734) 788-3480Email: mtomasovich@regaffairs.net | |
| Date Prepared: | September 14, 2022 |
| Device Name | |
| Trade Name: | iRelieve Microcurrent Pain Relief System |
| Common Name(s): | Electrical nerve stimulator |
| Classification | |
| Regulation: | 21 CFR §882.5890 |
| Class: | Class II |
| Product Code: | GZJ |
| Classification Name: | Transcutaneous electrical nerve stimulator for pain relief |
| Review Panel: | Neurology |
Predicate Device
| Predicate - Model 7500 Microcurrent | K013167 | NewCare Products, LLC |
|---|---|---|
| TENS Device, Version MCT-F50 |
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Device Description
The iRelieve Microcurrent Pain Relief System is a microcurrent TENS device that operates by sending electrical impulses through the skin to the nerves lying directly beneath the skin surface. These impulses help block the body's ability to send a pain message to the brain, thereby reducing the pain sensation. The iRelieve Microcurrent Pain Relief System is a single channel device that produces microampere currents with the selected envelopes, waveforms, frequencies, and polarity, with a maximum voltage of 3.0 volts. It is controlled by analogue electrical parts (voltage regulator, frequency oscillator, multiple resistors, etc.) and a digital microprocessor chip that contains embedded programmed software (firmware) that generates a sequence of current flows and frequencies during the course of a single treatment session. The iRelieve Microcurrent Pain Relief System performs this sequence of current flows without user manipulation or device controls other than switching the device on after application of the device to the electrodes.
Electrodes
The device is snapped onto one of two electrode designs. One is a 1-piece electrode designed for use on the back along the spine. The other electrode is a 2-piece design that can be used on other areas of the body, including joints and extremities.
The electrodes are identical in materials to the electrodes cleared under K070807. Both electrodes are stamped out using a die stamp composed of the same material. Both are manufactured by Pepin Manufacturing, Inc. The only different between the electrodes cleared under K070807 and the electrodes in this submission are shape. Relevant testing including Electrode Dispersion and Impedance Testing, Adhesive Testing, Electrode Cord Pull Testing, Fluid Tolerance Testing, and Conformability Testing was conducted to account for this difference.
Indications
The iRelieve Microcurrent Pain Relief System is intended to be used by physicians or licensed practitioners for symptomatic relief of chronic intractable pain.
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Performance Testing
The following performance testing was conducted on the iRelieve Microcurrent Pain Relief System:
- Output Performance
- Micro Current Stimulator Measurements ●
- Validation of the iRelieve Microcurrent Stimulator Electrodes ●
- Shelf-life testing ●
- Packaging testing following ASTM D4169-16 ●
- . Output final sequence with Oscilloscope Screen Captures at 500, 2K and 10K Ohms
- Battery use life testing .
Biocompatibility testing
Biocompatibility testing was leveraged from electrodes cleared under K070807.
Electromagnetic compatibility (EMC) and electrical safety
Electrical safety and EMC testing were conducted on the iRelieve Microcurrent Pain Relief System. The system complies with the IEC 60601-1 and IEC 60601-2-10 standards for safety and the IEC 60601-1-2 standard for EMC.
Software Verification and Validation Testing
Software verification and validation testing was conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device is considered to be a Class B level of concern (nonserious injury is possible). IEC 62304 was followed.
Comparison to Predicate Devices
The iRelieve Microcurrent Pain Relief System is substantially equivalent to the Model 7500 Microcurrent TENS Device, Version MCT-F50(K013167).
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| Subject Device | Predicate Device | |
|---|---|---|
| Device Name | iRelieve MicrocurrentPain Relief System | Model 7500 MicrocurrentTENS Device, Version MCT-F50 |
| 510(k) Number | K212618 | K013167 |
| Manufacturer | Fast Track Technologies | NewCareProducts, LLC. |
| CFR Reference | 21 CFR 882.5890 | 21 CFR 882.5890 |
| Product Code | GZJ | GZJ |
| Rx/OTC | Rx only | Rx |
| Indications for Use | The iRelieve Microcurrent PainRelief System is intended to be usedby physicians or licensedpractitioners for symptomatic reliefof chronic intractable pain. | The subject device is intended to beused for the symptomatic relief ofchronic intractable pain. |
| Basic Unit Characteristics | Integrated (non-console), detachable,portable | Not publicly available |
| Components Console | Not applicable | Not publicly available |
| Power Source | 1 Coin Cell Battery (CR2032 / 3V) | Not publicly available |
| Patient Override ControlMethod | On/Off button or removing electrodesfrom skin | Not publicly available |
| Indicator DisplayFeatures | The iRelieve Microcurrent PainRelief System has a red LED light thatis inactive when OFF and blinks whenON | Not publicly available |
| User Controls | ON/OFF push button switch | Not publicly available |
| Software/Firmware Control | Yes | Not publicly available |
| Interface | Snap attachment to TENS electrodes | Not publicly available |
| Weight | Without battery: 0.84 oz. (23.7 g)With battery: 0.94 oz. (26.7 g) | Not publicly available |
| Dimensions | Length: 2.25 inchesWidth: 2.5 inchesHeight (thickness): 0.625 inches | Not publicly available |
| Performance Specifications:Components Console | Not applicable | Not publicly available |
| Method of line currentisolation | Not applicable | Not publicly available |
| Electrical Type | Not applicable | Not publicly available |
| Patient Leakage Current -Normal Condition (μΑ) | Not applicable | Not publicly available |
| Patient Leakage Current -Single Fault Condition (µA) | Not applicable | Not publicly available |
| Number of Output Modes | One | Not publicly available |
| Number of Output Channels | One (1) bipolar output channel | Not publicly available |
| Synchronous orAlternating | Not applicable | Not publicly available |
| Method of Channel Isolation | Not applicable | Not publicly available |
| Regulated Current ofRegulated Voltage (outputsignals only) | Not applicable | Not publicly available |
| Automatic Overload Trip | Not applicable | Not publicly available |
| Automatic No-Load Trip | Not applicable | Not publicly available |
| Automatic Shut Off | No | Not publicly available |
| Timer Range (minutes) | None | Not publicly available |
| Electrode area | 1-Piece electrode, total 109 cm22-Piece electrode half side 76.5 cm2, total 153 cm2 | Not publicly available |
| Housing material | Polycarbonate plastic | Not publicly available |
| OUTPUT SPECIFICATIONS | ||
| Four (4) | Not publicly available | |
| Output Modes | Under firmware control, a four-hourroutine applies the Modes (DC+, DC-,AC, Off) in a preprogrammed sequenceand the routine repeats itself every fourhours until removed from the skin orpowered off. | |
| Output Channels | One (1) bipolar output channel | Not publicly available |
| Output Regulation | Regulated current | Not publicly available |
| Output Control | Output control is regulated by means ofelectronic hardware componentscombined with an embeddedmicrocomputer under firmware control. | Not publicly available |
| No user adjustable output current controlis provided. Intensity varies between15uA / 20uA / 25uA / 30uA underfirmware control. | ||
| Waveform | DC+, DC-,AC (Square wave) | Not publicly available |
| Frequency | 3-909 Hz (specific preprogrammedfrequency sequence) | Not publicly available |
| Rated DC Output | 7.5mV - 15mV DC @15-30uA across 500Ω | Not publicly available |
| Maximum outputvoltage (±10%) | 15 mV @ 500Ω60 mV @ 2kΩ300 mV @ 10kΩ | Not publicly available |
| Maximum outputcurrent (±10%) | 30 uA @ 500Ω30 uA @ 2kΩ30 uA @ 10kΩ | Not publicly available |
| Pulse Width (us) | 167,000µs to 550µs | Not publicly available |
| Net Charge @ 500Ω(µC/pulse) | 0 µC @ 500Ω | Not publicly available |
| Maximum Phase Charge(µC) | 5.34 μC @ 500Ω | Not publicly available |
| Maximum CurrentDensity (µA/cm2) | 0.39 µA/cm² w smallest electrode | Not publicly available |
| Maximum PowerDensity (µW/cm2) | 0.0059 µW/cm² w smallest electrode | Not publicly available |
| Burst Mode (i.e., pulsetrains)a. Pulses per burstb. Bursts per secondc. Burst duration(seconds)d. Duty Cycle [Line (b) xLine (c)] | Not applicable | Not publicly available |
| On Time | On until removed or inactivated | Not publicly available |
| Off Time | Off until activated | Not publicly available |
| Treatment time (min) | On until removed or inactivated | Not publicly available |
| Output intensity levels | 15-30 uA | Not publicly available |
| Testing Standards | -IEC 60601 1: 2005 + CORR. 1:2006 +CORR. 2:2007 + AM1:2012(or IEC 60601-1: 2012reprint)-IEC 60601-1-6:2010(Third Edition) + A1:2013 | Not publicly available |
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Discussion of differences
While the subject device only contains one device model, the predicate device contains three separate models of the device with each model containing different output modes. The subject device is Substantially Equivalent in device output to one of these versions, the Model 7500 Microcurrent TENS Device, Version MCT-F50. The premarket notification provided a device description in sufficient detail to demonstrate substantial equivalence to the predicate device.
Conclusion
The iRelieve Microcurrent Pain Relief System and the predicate device have the same intended use and similar technical characteristics, performance and applications. The information supplied in the full 510(k) application illustrates that the device does not pose any new question of safety or effectiveness. The iRelieve Microcurrent Pain Relief System is substantially equivalent to the predicate device.
§ 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).