(58 days)
Needle Stimulator (Model: RJNS6-1) is an electro-acupuncture stimulator device, which is indicated for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.
Needle Stimulator (Model: RJNS6-1) is an electro-acupuncture device for acupuncture therapy, powered by 6 pieces of 1.5V batteries or AC 100-240V. It is composed of a LCD, a console and 6 channels of electrode cables with alligator type connectors. Only 3 channels at most could work together on single patient. The console has the operating elements of Channel selecting button, Setting button, Operation suspending switch button, Wave-selecting button, On/off switch, Mute button, Therapy time adjusting button, Output frequency adjusting button, Intensity adjust knobs, and Output indicator light. Needle Stimulator (Model: RJNS6-1) does not equip with acupuncture needles. The practitioners should select 510(k) cleared needles (with minimum diameter of 0.40mm and insertion depth of 16mm) for use.
The provided text describes the 510(k) submission for the "Needle Stimulator (Model: RJNS6-1)" and its substantial equivalence to a predicate device. However, the document does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/human-in-the-loop diagnostic system.
The device in question is an electro-acupuncture stimulator, and the FDA's review focuses on its electrical safety, performance parameters, and substantial equivalence to a legally marketed predicate device (K202861). The testing mentioned is related to electrical safety and electromagnetic compatibility (e.g., IEC 60601 standards), not diagnostic performance or AI assistance.
Therefore, I cannot provide a table of acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC study details, standalone performance, or ground truth establishment as these concepts are not applicable or mentioned in the context of this specific device's 510(k) submission as provided.
The document confirms the following:
- Device Name: Needle Stimulator (Model: RJNS6-1)
- Intended Use: An electro-acupuncture stimulator indicated for use in the practice of acupuncture by qualified practitioners.
- Regulatory Pathway: 510(k) Premarket Notification.
- Predicate Device: Needle Stimulator (Model: CMNS6-2), K202861.
- Performance Evaluation: Substantial equivalence based on non-clinical tests (electrical safety, EMC, etc.) according to recognized standards (ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-10).
In summary, the provided text does not contain the specific information requested about acceptance criteria and a study proving an AI-powered device meets them. The evaluation described is for a non-AI medical device and focuses on electrical and functional equivalence.
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March 18, 2022
Bozhou Rongjian Medical Appliance Co., Ltd. Wu Zhifang General Manager Jianghuai Supply Base, Zhongkai Group, Mengcheng County Bozhou. Anhui 233500 China
Re: K220153
Trade/Device Name: Needle Stimulator (Model: RJNS6-1) Regulatory Class: Unclassified Product Code: BWK Dated: December 31, 2021 Received: January 19, 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.
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
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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 medical devices and radiation-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) K220153
Device Name Needle Stimulator (Model: RJNS6-1)
Indications for Use (Describe)
Needle Stimulator (Model: RJNS6-1) is an electro-acupuncture stimulator device, which is indicated for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.
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 21 CFR 807.92]
| 1. Submission Information | |
|---|---|
| 510(k) Number: | K220153 |
| Date: | March 17, 2022 |
| Type of 510(k) Submission: | Traditional 510(k) |
| Basis for 510(k) Submission: | New device |
| Submitter/Manufacturer: | Bozhou Rongjian Medical Appliance Co.,Ltd. |
| Jianghuai Supply Base, Zhongkai Group, Mengcheng County, Bozhou City, | |
| 233500 Anhui, China | |
| Contact: | Wu Zhifang |
| E-mail: rongjianzl@rjmed.com.cn | |
| Tel: +86-558-7662968 | |
| 2. Device Description | |
| Proprietary Name: | Needle Stimulator (Model: RJNS6-1) |
| Common Name: | Electro-Acupuncture |
| Product Code: | BWK |
| Device Class: | Unclassified |
| Review Panel: | Neurology |
| Device Description: | Needle Stimulator (Model: RJNS6-1) is an electro-acupuncture device for |
| acupuncture therapy, powered by 6 pieces of 1.5V batteries or AC | |
| 100-240V. | |
| It is composed of a LCD, a console and 6 channels of electrode cables with | |
| alligator type connectors. Only 3 channels at most could work together on | |
| single patient. The console has the operating elements of Channel selecting | |
| button, Setting button, Operation suspending switch button, Wave-selecting | |
| button, On/off switch, Mute button, Therapy time adjusting button, Output | |
| frequency adjusting button, Intensity adjust knobs, and Output indicator | |
| light. | |
| Needle Stimulator (Model: RJNS6-1) does not equip with acupuncture | |
| needles. The practitioners should select 510(k) cleared needles (with | |
| minimum diameter of 0.40mm and insertion depth of 16mm) for use. | |
| Indications for use: | Needle Stimulator (Model: RJNS6-1) is an electro-acupuncture stimulator |
| device, which is indicated for use in the practice of acupuncture by qualified | |
| practitioners of acupuncture as determined by the states. | |
3. Predicate Device Identification
| Predicate 510(k) Number: | K202861 |
|---|---|
| Marketing clearance date: | August 27, 2021 |
| Product name: | Needle Stimulator (Model: CMNS6-2) |
| Manufacturer: | Wuxi Jiajian Medical Instrument Co., Ltd |
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4. Substantial Equivalence to Predicate device
Table 1-
| Parameters | New Device | Predicate Device | Remark | |
|---|---|---|---|---|
| 510(k) Number | K220153 | K202861 | -- | |
| Marketing clearance date | No | August 27, 2021 | -- | |
| Device Name | Needle Stimulator (Model:RJNS6-1) | Needle Stimulator (Model:CMNS6-2) | -- | |
| Manufacturer | Bozhou Rongjian MedicalAppliance Co.,Ltd. | Wuxi Jiajian MedicalInstrument Co., Ltd | -- | |
| Product Code | BWK | BWK | Same | |
| Intended use | Needle Stimulator is anelectro-acupuncturestimulator device, which isindicated for use in thepractice of acupuncture byqualified practitioners ofacupuncture as determinedby the states. | Needle Stimulator is anelectro-acupuncturestimulator device, which isindicated for use in thepractice of acupuncture byqualified practitioners ofacupuncture as determinedby the states. | Same | |
| Type of use | Prescription use | Prescription use | Same | |
| Power Source(s) | DC 1.5Vx6 Type R14/UM2or AC 100-240V | DC 1.5Vx6 Type R14 or AC100-240V | SimilarNote 1 | |
| - Method of Line CurrentIsolation | Type BF | Type BF | Same | |
| - Patient Leakage Current | -- | -- | Same | |
| - Normal Condition (μΑ) | 2μΑ | 2μΑ | -- | |
| - Single Fault Condition (μΑ) | ≤50μΑ | ≤50μΑ | -- | |
| Average DC current throughelectrodes when device is onbut no pulses are being applied(μΑ) | N/A | N/A | Same | |
| Number of Output Modes | 3 (continuous wave/interrupted wave/Dense-disperse wave) | 3 (continuous wave/interrupted wave/Dense-disperse wave) | Same | |
| Number of Output channels: | 6 (3 channels at most worktogether on single patient) | 6 (3 channels at most worktogether on single patient) | Same | |
| - Synchronous orAlternating? | Synchronous | Synchronous | Same | |
| - Method of ChannelIsolation | Transformer | Transformer | Same | |
| Regulated Current or RegulatedVoltage? | Voltage Control | Voltage Control | Same | |
| Software/Firmware/Microprocessor Control? | Yes | Yes | Same | |
| Automatic Overload Trip? | No | No | Same | |
| Automatic No-Load Trip? | No | No | Same | |
| Automatic Shut Off? | Yes | Yes | Same | |
| User Override Control? | Yes | Yes | Same | |
| Indicator | On/Off Status? | Yes | Yes | Same |
| Low Battery? | Yes | Yes | Same | |
| Display: | Voltage/CurrentLevel? | Yes | Yes | Same |
| Timer Range (minutes) | 1-99min | 1-99min | Same | |
| Compliance with VoluntaryStandards? | ANSI AAMI ES60601-1,IEC 60601-2-10, IEC60601-1-2 | IEC 60601-1, IEC60601-2-10, IEC 60601-1-2 | Same | |
| Compliance with 21 CFR 898? | Yes | Yes | Same | |
| Weight (grams) | approx. 657g | approx. 657g | Same | |
| Dimensions [W x H x D] | 23818475mm | 23818475mm | Same | |
| Housing Materials &Construction | ABS; Injection molded | ABS; Injection molded | Same | |
| Waveform | Biphasic | Biphasic | Same | |
| Shape | Asymmetric biphasie squarewave | Asymmetric biphasie squarewave | Same | |
| 27V±10% @500Ω | 27V±10% @500Ω | Same | ||
| MaximumOutput(volts) | Voltage | 60.4V±10% @2kΩ | 60.4V±10% @2kΩ | Same |
| 75V±10% @10kΩ | 75V±10% @10kΩ | Same | ||
| 54mA±10% @500Ω | 54mA±10% @500Ω | Same | ||
| MaximumOutput(specify units) | Current | 30.2mA±10% @2kΩ | 30.2mA±10% @2kΩ | Same |
| 7.5mA±10% @10kΩ | 7.5mA±10% @10kΩ | Same | ||
| Pulsewidth(µsec) | Positive | 175μs±10% | 175μs±10% | Same |
| Negative | 1051µs (6 x (+Phase) ) | 1051µs (6 x (+Phase) ) | Same | |
| Pulse | Period (msec) | 10~1000ms | 10~1000ms | Same |
| Max. pulse frequency (Hz) [orRate (pps)] | 1~100Hz±10% | 1~100Hz±10% | Same | |
| Net Charge (µC per pulse) | 0μC@500Ω, + and - pulsescancel | 0μC@500Ω, + and - pulsescancel | Same | |
| Maximum Phase Charge, (µC) | 8.225μC @500Ω | 8.225μC @500Ω | Same | |
| Maximum Average Current,(mA) | 0.945mA @500Ω | 0.945mA @500Ω | Same | |
| Maximum Current Density,(mA/cm², r.m.s.) | 8.225mA/cm² @500Ω | 8.225mA/cm² @500Ω | Same | |
| Maximum Average PowerDensity, (W/cm²) | 0.1234W/cm²@500Ω | 0.1234W/cm²@500Ω | Same | |
| Biocompatibility | ISO10993-5, ISO 10993-10 | ISO10993-5, ISO 10993-10 | ||
| Accessories | Lead wires, Alligator typeconnectors | Lead wires, Alligator typeconnectors | Same | |
| Differences between New device and Predicate Device: |
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Note 1:
The proposed device can use more battery types than the predicate device, but the battery used by the proposed device is commonly used in the market. Therefore, this difference will not raise any safety or effectiveness issue.
5. Test summary
Needle Stimulator (Model: RJNS6-1) is as safe and effective as the predicate device cited above. The new device has passed testing according to the following standards:
-
ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD);
-
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 60601-2-10 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;
6. Conclusion
Based on 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 K202861.
N/A