(58 days)
Not Found
No
The device description details standard electro-acupuncture stimulation controls and features, with no mention of AI/ML terms or functionalities. The performance studies focus on electrical safety and performance standards, not AI/ML validation.
Yes
The "Intended Use / Indications for Use" states it is "indicated for use in the practice of acupuncture" and the "Device Description" states it is "an electro-acupuncture device for acupuncture therapy".
No
Explanation: The "Intended Use / Indications for Use" section states that the device is an "electro-acupuncture stimulator device, which is indicated for use in the practice of acupuncture". This description clearly indicates a therapeutic or treatment function, not a diagnostic one.
No
The device description explicitly details hardware components such as a console, LCD, electrode cables, and battery power, indicating it is a physical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "electro-acupuncture stimulation" in the practice of acupuncture. This is a therapeutic procedure performed on a patient's body, not a diagnostic test performed on a sample taken from the body.
- Device Description: The device description details an electro-acupuncture stimulator with electrodes and controls for delivering electrical stimulation. It does not mention any components or functions related to analyzing biological samples (like blood, urine, tissue, etc.).
- Lack of IVD Characteristics: The description does not mention any reagents, assays, or procedures typically associated with in vitro diagnostic testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is to deliver electrical stimulation for therapeutic purposes.
N/A
Intended 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.
Product codes (comma separated list FDA assigned to the subject device)
BWK
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified practitioners of acupuncture
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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;
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
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
1
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
2
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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3
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 |
4
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 Medical | |||
| Appliance Co.,Ltd. | Wuxi Jiajian Medical | |||
| Instrument Co., Ltd | -- | |||
| Product Code | BWK | BWK | Same | |
| Intended use | Needle Stimulator 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 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. | Same | |||
| Type of use | Prescription use | Prescription use | Same | |
| Power Source(s) | DC 1.5Vx6 Type R14/UM2 | |||
| or AC 100-240V | DC 1.5Vx6 Type R14 or AC | |||
| 100-240V | Similar | |||
| Note 1 | ||||
| - Method of Line Current | ||||
| Isolation | Type BF | Type BF | Same | |
| - Patient Leakage Current | -- | -- | Same | |
| - Normal Condition (μΑ) | 2μΑ | 2μΑ | -- | |
| - Single Fault Condition (μΑ) | ≤50μΑ | ≤50μΑ | -- | |
| Average DC current through | ||||
| electrodes when device is on | ||||
| but 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 work | |||
| together on single patient) | 6 (3 channels at most work | |||
| together on single patient) | Same | |||
| - Synchronous or | ||||
| Alternating? | Synchronous | Synchronous | Same | |
| - Method of Channel | ||||
| Isolation | Transformer | Transformer | Same | |
| Regulated Current or Regulated | ||||
| Voltage? | Voltage Control | Voltage Control | Same | |
| Software/Firmware/Microproce | ||||
| ssor 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/Current | |||
| Level? | Yes | Yes | Same | |
| Timer Range (minutes) | 1-99min | 1-99min | Same | |
| Compliance with Voluntary | ||||
| Standards? | ANSI AAMI ES60601-1, | |||
| IEC 60601-2-10, IEC | ||||
| 60601-1-2 | IEC 60601-1, IEC | |||
| 60601-2-10, 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 square | |||
| wave | Asymmetric biphasie square | |||
| wave | Same | |||
| 27V±10% @500Ω | 27V±10% @500Ω | Same | ||
| Maximum | ||||
| Output | ||||
| (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 | ||
| Maximum | ||||
| Output | ||||
| (specify units) | Current | 30.2mA±10% @2kΩ | 30.2mA±10% @2kΩ | Same |
| 7.5mA±10% @10kΩ | 7.5mA±10% @10kΩ | Same | ||
| Pulse | ||||
| width | ||||
| (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) [or | ||||
| Rate (pps)] | 1~100Hz±10% | 1~100Hz±10% | Same | |
| Net Charge (µC per pulse) | 0μC@500Ω, + and - pulses | |||
| cancel | 0μC@500Ω, + and - pulses | |||
| cancel | 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 Power | ||||
| Density, (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 type | |||
| connectors | Lead wires, Alligator type | |||
| connectors | Same | |||
| Differences between New device and Predicate Device: |
5
6
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.