(86 days)
The Transcutaenous Electrical Nerve Stimulator (Model RJTENS-1) is an electrical nerve stimulator indicated for use for pain relief by applying an electrical current to electrodes on a patient's skin to treat pain. In particular, this device is indicated for use for symptomatic relief of chronic intractable pain and adjunctive treatment of post surgical and post traumatic pain.
Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1) sends gentle electrical current to underlying nerves and muscle group via electrodes applied on the skin to relieve pain. The device has 16 programs (12 standard programs and 4 editable programs). It is a battery-powered portable device, comprising electronic stimulatory module and accessories of lead wires, electrodes and 4x1.5V AAA alkaline batteries. Two outlet sockets are used to connect skin electrodes by lead wires. The accessories of electrodes is 510(k) cleared device (K213879), Size 50*50mm.
The provided text describes the 510(k) summary for the Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1). Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are implicitly derived from its substantial equivalence to the predicate device (K202893). The "Comparison" column in the table indicates "Same" or "Similar" for most parameters, meaning the new device's performance aligns with the established performance of the predicate. Note 1 explicitly addresses the difference in deviation from amplitude, frequency, and pulse width.
| Parameter | Acceptance Criteria (Predicate Device K202893) | Reported Device Performance (Model RJTENS-1) |
|---|---|---|
| Indications for Use | Same as predicate | Same as predicate |
| Type of Use | Prescription use | Prescription use |
| Power Source(s) | 1.5Vx4 AAA alkaline battery | 1.5Vx4 AAA alkaline battery |
| Method of Line Current Isolation | N/A | N/A |
| Patient Leakage Current - Normal Condition | 2μΑ | 2μΑ |
| Patient Leakage Current - Single Fault Condition | NA | NA |
| Average DC current through electrodes | <0.01μA | <0.01μA |
| Number of programs | 16 | 16 |
| Number of Output channels | 2 | 2 |
| Synchronous or Alternating? | Synchronous | Synchronous |
| Method of Channel Isolation | By Transformer | By Transformer |
| Regulated Current or Regulated Voltage? | Current control | Current control |
| Software/Firmware/Microprocessor Control? | Yes | Yes |
| Automatic Overload Trip? | No | No |
| Automatic No-Load Trip? | No | No |
| Automatic Shut Off? | Yes | Yes |
| User Override Control? | Yes | Yes |
| Indicator Display - On/Off Status? | Yes | Yes |
| Indicator Display - Low Battery? | Yes | Yes |
| Indicator Display - Voltage/Current Level? | Yes | Yes |
| Timer Range (minutes) | 10~90 min | 10~90 min |
| Compliance with Voluntary Standards? | ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-10 | ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-10 |
| Compliance with 21 CFR 898? | Yes | Yes |
| Weight (grams) | Approx. 96g without battery | Approx. 96g without battery |
| Dimensions (mm) | 1406428 mm | 1406428 mm |
| Housing Materials & Construction | ABS | ABS |
| Waveform | Monophasic | Monophasic |
| Shape | Rectangular pulse | Rectangular pulse |
| Maximum Output Voltage (volts) | $30V±20% @500Ω$ | $30V±10% @500Ω$ |
| Maximum Output Current (mA) | $60mA±20% @500Ω$ | $60mA±10% @500Ω$ |
| Pulse width (μsec) | $75-300μs±20%$ | $75-300μs±10%$ |
| Pulse Period (msec) | 8.33-1000ms | 8.33-1000ms |
| Max. pulse frequency (Hz) | $1-120Hz±20%$ | $1-120Hz±10%$ |
| Net Charge (µC per pulse) | $0.65μC @500Ω$ | $0.65μC @500Ω$ |
| Maximum Phase Charge (μC) | $18μC @500Ω$ | $18μC @500Ω$ |
| Maximum Average Current (mA) | $2.16mA @500Ω$ | $2.16mA @500Ω$ |
| Maximum Average Power Density (mW/cm²) | 2.59mW/cm² @500Ω | 2.59mW/cm² @500Ω |
| Accessories | Electrodes, cables, battery | Electrodes, cables, battery |
Study to Prove Acceptance Criteria:
The study proving the device meets the acceptance criteria is a non-clinical bench test study.
2. Sample Size for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated as "sample size" in the traditional sense for an AI/diagnostic study. For bench tests, it typically refers to the number of devices tested. This information is not provided in the document.
- Data Provenance: Not applicable in the context of clinical data for this type of submission, as no clinical data was included. For bench tests, the data would have originated from laboratory testing of the manufactured devices. The manufacturer is Bozhou Rongjian Medical Appliance Co., Ltd. in China.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- This information is not applicable/not provided. The assessment of these types of electrical stimulators primarily relies on objective physical and electrical measurements against established standards, not necessarily on expert interpretation of ambiguous data points.
4. Adjudication Method for the Test Set:
- This information is not applicable/not provided. Adjudication methods like 2+1 or 3+1 are used for expert consensus in interpretive tasks (e.g., radiology reads), which is not the nature of the bench tests reported here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
- No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical data was not including in this submission."
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done:
- Not applicable. This device is a Transcutaneous Electrical Nerve Stimulator, not an AI algorithm. Its performance is evaluated through its physical and electrical characteristics according to safety and performance standards.
7. The Type of Ground Truth Used:
- The ground truth for this device's performance evaluation is established through compliance with recognized voluntary standards and objective physical and electrical measurements as defined by those standards.
- ANSI AAMI ES60601-1: 2005/(R) 2012 And A1: 2012, C1: 2009/(R) 2012 And A2: 2010/(R) 2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (IEC 60601-1: 2005, MOD)
- IEC 60601-2-10 Edition 2.1 2016-04, Medical Electrical Equipment - Part 2-10: Particular Requirements For The Basic Safety And Essential Performance Of Nerve And Muscle Stimulators
- 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
8. The Sample Size for the Training Set:
- Not applicable. The device is an electrical stimulator, not an AI/machine learning algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no training set for this device.
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May 25, 2022
Bozhou Rongjian Medical Appliance Co., Ltd. Wu Zhifang General Manager Jianghuai Supply Base, Zhongkai Group, Mengcheng County Bozhou, Anhui 233500 China
Re: K220578
Trade/Device Name: Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1) Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: GZJ Dated: February 18, 2022 Received: February 28, 2022
Dear Wu Zhifang:
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 Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K220578
Device Name
Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1)
Indications for Use (Describe)
The Transcutaenous Electrical Nerve Stimulator (Model RJTENS-1) is an electrical nerve stimulator indicated for use for pain relief by applying an electrical current to electrodes on a patient's skin to treat pain. In particular, this device is indicated for use for symptomatic relief of chronic intractable pain and adjunctive treatment of post surgical and post traumatic pain.
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) |
|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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 21 CFR 807.92]
| 1. Submission Information | |
|---|---|
| 510(k) Number: | K220578 |
| Date: | April 25, 2022 |
| Type of 510(k) Submission: | Traditional 510(k) |
| Submitter/Manufacturer: | Bozhou Rongjian Medical Appliance Co.,Ltd. |
| Jianghuai Supply Base, Zhongkai Group, Mengcheng County, BozhouCity, 233500 Anhui, China | |
| Contactor: | Wu ZhifangE-mail: doris.d@ceve.org.cnTel: +86-558-7662968 |
| 2. Device Description | |
| Proprietary Name: | Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1) |
| Common Name: | TENS (Transcutaneous Electrical Nerve Stimulator) |
| Classification Name: | Transcutaneous electrical nerve stimulator for pain relief |
| Product Code: | GZJ |
| Device Class: | 2 |
| Regulation Number: | 21 CFR 882.5890 |
| Review Panel: | Neurology |
| Indications for use: | Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1) isan electrical nerve stimulator indicated for use for pain relief byapplying an electrical current to electrodes on a patient's skin to treatpain. In particular, this device is indicated for use for symptomatic reliefof chronic intractable pain and adjunctive treatment in the management ofpost surgical and post traumatic pain. |
| Device Description: | Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1) sendsgentle electrical current to underlying nerves and muscle group viaelectrodes applied on the skin to relieve pain.The device has 16 programs (12 standard programs and 4 editableprograms). It is a battery-powered portable device, comprising electronicstimulatory module and accessories of lead wires, electrodes and 4×1.5VAAA alkaline batteries.Two outlet sockets are used to connect skin electrodes by lead wires. Theaccessories of electrodes is 510(k) cleared device (K213879), Size50*50mm. |
3. Predicate Device Identification
| Predicate 510(k) Number: | K202893 |
|---|---|
| Marketing clearance date: | June 18, 2021 |
| Product name: | Transcutaneous Electrical Nerve Stimulator |
| Manufacturer: | Wuxi Jiajian Medical Instrument Co., Ltd |
4. Substantially Equivalent Comparison Conclusion
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| Parameters | New Device | Predicate Device | Comparison |
|---|---|---|---|
| 510(k) Number | K220578 | K202893 | -- |
| Device Name | Transcutaneous ElectricalNerve Stimulator (ModelRJTENS-1) | Transcutaneous ElectricalNerve Stimulator | -- |
| Manufacturer | Bozhou Rongjian MedicalAppliance Co.,Ltd. | Wuxi Jiajian MedicalInstrument Co., Ltd | -- |
| Indication for Use | Transcutaneous Electrical NerveStimulator ((Model RJTENS-1) isan electrical nerve stimulatorindicated for use for pain reliefby applying an electricalcurrent to electrodes on apatient's skin to treat pain. Inparticular, this device is indicatedfor use for symptomatic relief ofchronic intractable pain andadjunctive treatment in themanagement of post surgical andpost traumatic pain. | Transcutaneous ElectricalNerve Stimulator is an electricalnerve stimulator indicated foruse for pain relief by applyingan electrical current toelectrodes on a patient's skin totreat pain. In particular, thisdevice is indicated for use forsymptomatic relief of chronicintractable pain and adjunctivetreatment in the management ofpost surgical and post traumaticpain. | Same |
| Type of use | Prescription use | Prescription use | Same |
| Power Source(s) | 1.5Vx4 AAA alkaline battery | 1.5Vx4 AAA alkaline battery | Same |
| - Method of LineCurrent Isolation | N/A | N/A | Same |
| - Patient LeakageCurrent | -- | -- | Same |
| - NormalCondition (μΑ) | 2μΑ | 2μΑ | Same |
| - Single FaultCondition (μΑ) | NA | NA | Same |
| Average DC currentthrough electrodeswhen device is on butno pulses are beingapplied (μΑ) | <0.01μA | <0.01μA | Same |
| Number of program | 16 | 16 | Same |
| Number of Outputchannels: | 2 | 2 | Same |
| - Synchronousor Alternating? | Synchronous | Synchronous | Same |
| - Method ofChannel Isolation | By Transformer | By Transformer | Same |
| Regulated Current orRegulated Voltage? | Current control | Current control | Same |
| Software/Firmware/ | Yes | Yes | Same |
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| MicroprocessorControl? | |||||
|---|---|---|---|---|---|
| Automatic OverloadTrip? | No | No | Same | ||
| Automatic No-LoadTrip? | No | No | Same | ||
| Automatic Shut Off? | Yes | Yes | Same | ||
| User OverrideControl? | Yes | Yes | Same | ||
| On/OffStatus? | Yes | Yes | Same | ||
| IndicatorDisplay | LowBattery? | Yes | Yes | Same | |
| Voltage/CurrentLevel? | Yes | Yes | Same | ||
| Timer Range(minutes) | 10~90 min | 10~90 min | Same | ||
| Compliance withVoluntary Standards? | ANSI AAMI ES60601-1, IEC60601-1-2, IEC 60601-2-10 | ANSI AAMI ES60601-1, IEC60601-1-2, IEC 60601-2-10 | Same | ||
| Compliance with 21CFR 898? | Yes | Yes | Same | ||
| Weight (grams) | Approx.96g without battery | Approx.96g without battery | Same | ||
| Dimensions (mm) [Wx H x D] | 1406428 mm | 1406428 mm | Same | ||
| Housing Materials &Construction | ABS | ABS | Same | ||
| Waveform | Monophasic | Monophasic | Same | ||
| Shape | Rectangular pulse | Rectangular pulse | Same | ||
| Maximum OutputVoltage (volts) | $30V±10% @500Ω$ | $30V±20% @500Ω$ | |||
| Maximum OutputCurrent (specifyunits) | $60mA±10% @500Ω$ | $60mA±20% @500Ω$ | SimilarNote 1 | ||
| Pulse width (μsec) | $75-300μs±10%$ | $75-300μs±20%$ | |||
| Pulse Period (msec) | 8.33-1000ms | 8.33-1000ms | |||
| Max. pulse frequency(Hz) [or Rate (pps)] | $1-120Hz±10%$ | $1-120Hz±20%$ | |||
| Net Charge (µC perpulse) | $0.65μC @500Ω$ | $0.65μC @500Ω$ | |||
| Maximum PhaseCharge, (μC) | $18μC @500Ω$ | $18μC @500Ω$ | Same | ||
| Maximum AverageCurrent, (mA) | $2.16mA @500Ω$ | $2.16mA @500Ω$ |
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| Density, (mA/cm², r.m.s.) | |||
|---|---|---|---|
| Maximum AveragePower Density,(mW/cm²) | 2.59mW/cm² @500Ω | 2.59mW/cm² @500Ω | |
| Accessories | Electrodes, cables, battery | Electrodes, cables, battery | Same |
Comparison in details:
Note 1:
The deviation from the amplitude, frequency and pulse width of the proposed device are different from those of the predicate device. The proposed device has less deviation than the predicate device, which means that its output is more stable. And both the proposed device and predicate device passed ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-10 standards tests. Therefore, this difference will not raise any safety or effectiveness issue.
5. Non-Clinical Test Conclusion
Bench tests were conducted on Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1) to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The following tests were performed on the proposed device:
• ANSI AAMI ES60601-1: 2005/(R) 2012 And A1: 2012, C1: 2009/(R) 2012 And A2: 2010/(R) 2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (IEC 60601-1: 2005, MOD);
· IEC 60601-2-10 Edition 2.1 2016-04, Medical Electrical Equipment - Part 2-10: Particular Requirements For The Basic Safety And Essential Performance Of Nerve And Muscle Stimulators;
· 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;
6. Clinical Test
Clinical data was not including in this submission.
7. Conclusions
The conclusions drawn from the non-clinical tests demonstrate that the device is as safe, as effective, and performs as well as the legally marketed device identified in the subject device 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).