(88 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description is purely hardware-based with no mention of software or algorithms that would suggest AI/ML.
Yes
The device is described as an "electro-acupuncture stimulator device" and an "electro-acupuncture device for acupuncture therapy" which directly implies its use for therapeutic purposes.
No
The device is an electro-acupuncture stimulator indicated for therapy, not for diagnosing conditions.
No
The device description explicitly states it is composed of a console and electrode cables, powered by batteries or AC, indicating it is a hardware device with physical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The Needle Stimulator is described as an electro-acupuncture stimulator device used in the practice of acupuncture. It applies electrical stimulation externally to the body through acupuncture needles.
- Lack of Specimen Analysis: There is no mention of the device analyzing any biological specimens from the patient. Its function is to deliver electrical stimulation.
Therefore, the Needle Stimulator falls under the category of a therapeutic or physical medicine device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
BWK
Device Description
Needle Stimulator 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 console and 6 channels of electrode cables with alligator type connectors. The console has the operating controls including function knobs or buttons. Needle Stimulator does not equip with acupuncture needles. The practitioners should select legally marketed needles.
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 / Not Found
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)
The new devices have passed testings according to the following standards:
- ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021]Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) [Including Amendment 2 (2021)];
- IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION Medical electrical equipment - Part
1-2: General requirements for basic safety and essential performance - Collateral Standard:
Electromagnetic disturbances - Requirements and tests; - IEC TS 60601-4-2 Edition 1.0 2024-03 Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 28, 2025
Wuxi Jiajian Medical Instrument Co., Ltd. % Doris Dong Official Correspondent Shanghai CV Technology Co., Ltd. Room 805, No.19 Dongbao Road, Songjiang Area Shanghai, Shanghai 201613 China
Re: K244030
Trade/Device Name: Needle Stimulator (CMNS6-1 PLUS, CMNS6-3) Regulatory Class: Unclassified Product Code: BWK Dated: December 2, 2024 Received: December 30, 2024
Dear Doris Dong:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
2
Sincerely,
Amber T. Ballard -S
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
3
Indications for Use
510(k) Number (if known) K244030
Device Name Needle Stimulator (CMNS6-1 PLUS, CMNS6-3)
Indications for Use (Describe)
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.
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)
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4
510(k) Summary [As required by 21 CFR 807.92]
1. Submission Information:
| 510(k) Number: | K244030 |
|---|---|
| Date: | March 24, 2025 |
| Type of 510(k) Submission: | Traditional |
| Basis for 510(k) Submission: | New device |
| Submitter/Manufacturer: | Wuxi Jiajian Medical Instrument Co., Ltd |
| No. 35 Baiqiao Rd., Ehu Town, Xishan District, Wuxi, | |
| Jiangsu, China 214116 | |
| Contact: | Doris Dong |
| [Consultant, from Shanghai CV Technology Co., Ltd.] | |
| Add: Room 805, No. 19 Dongbao Road, Songjiang Area, Shanghai, 201613 | |
| China | |
| E-mail: doris.d@ceve.org.cn | |
| Tel: 86 21-31261348 / Fax: 86 21-57712250 |
2. Device Description:
| Proprietary Name: | Needle Stimulator |
|---|---|
| Model: | CMNS6-1 PLUS, CMNS6-3 |
| Common Name: | Electro-Acupuncture |
| Classification Name: | Stimulator, Electro-Acupuncture |
| Product Code: | BWK |
| Device Class: | Unclassified |
| Review Panel: | Neurology |
| Device Description: | Needle Stimulator 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 console and 6 channels of electrode cables with alligator type connectors. The console has the operating controls including function knobs or buttons. Needle Stimulator does not equip with acupuncture needles. The practitioners should select legally marketed needles. |
| Indications for 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. |
3. Predicate Device Identification
| Predicate 510(k) Number: | K202861 |
|---|---|
| Marketing Clearance Date: | 08/27/2021 |
| Product Name: | Needle Stimulator |
| Manufacturer: | Wuxi Jiajian Medical Instrument Co., Ltd. |
4. Substantial Equivalence to Predicate device:
Detailed comparison data is included in "Substantial Equivalence Discussion - CMNS6-1 PLUS" of this 510(k) submission.
5
Table 1-
| Parameters | Subject Device | Predicate Device | Remark | ||
|---|---|---|---|---|---|
| 1 | 510(k) Number: | K244030 | K202861 | -- | |
| 2 | Marketing clearance date: | -- | 08/27/2021 | -- | |
| 3 | Device Name | Needle Stimulator | Needle Stimulator | -- | |
| 4 | Model | CMNS6-1 PLUS | CMNS6-1 | -- | |
| 5 | Manufacturer | Wuxi Jiajian Medical Instrument Co.,Ltd | Wuxi Jiajian Medical Instrument Co.,Ltd | Same | |
| 6 | Indications for 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 | |
| 7 | Type of use | Prescription use | Prescription use | Same | |
| 8 | Power Source(s) | DC 1.5Vx6 Type R14 or AC 100-240V | DC 1.5Vx6 Type R14 or AC 100-240V | Same | |
| 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 | |||
| 9 | Average DC current through electrodes when device is on but no pulses are being applied (µA) | N/A | N/A | Same | |
| 10 | 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 | ||
| 11 | Synchronous or Alternating? | Synchronous | Synchronous | Same | |
| Method of Channel Isolation | Transformer | Transformer | Same | ||
| 12 | Regulated Current or Regulated Voltage? | Voltage Control | Voltage Control | Same | |
| 13 | Software/Firmware/Microprocessor | Yes | Yes | Same | |
| 14 | Automatic Overload | ||||
| Trip? | No | No | Same | ||
| 15 | Automatic No-Load | ||||
| Trip? | Yes | No | Similar | ||
| Note 1 | |||||
| 16 | Automatic Shut Off? | Yes | Yes | Same | |
| 17 | User | ||||
| Override | |||||
| Control? | Yes | Yes | Same | ||
| Indicator | |||||
| Display: | On/Off | ||||
| Status? | Yes | Yes | Same | ||
| 18 | Low | ||||
| Battery? | No | Yes | Similar | ||
| Note 1 | |||||
| Voltage/ | |||||
| Current | |||||
| Level? | No | Yes | |||
| 19 | Timer | ||||
| (minutes) | Range | 1-60min | 0-60min | Similar | |
| Note 3 | |||||
| 20 | Compliance with | ||||
| Voluntary Standards? | IEC 60601-1,IEC 60601-1-2 | IEC 60601-1, IEC 60601-2-10, | |||
| IEC 60601-1-2 | Similar | ||||
| Note 2 | |||||
| 21 | Compliance with 21 | ||||
| CFR 898? | Yes | Yes | Same | ||
| 22 | Weight (grams) | 740g | 740g | Same | |
| 23 | Dimensions [W x H | ||||
| x D] | 23416076mm | 23015555mm | Similar | ||
| Note 3 | |||||
| 24 | Housing Materials & | ||||
| Construction | ABS;Injection molded | ABS; Injection molded | Same | ||
| 25 | Waveform | Biphasic | Biphasic | Same | |
| 26 | Shape | Asymmetric biphasic square | |||
| wave | Asymmetric biphasic square | ||||
| wave | Same | ||||
| Maximum | |||||
| Output | |||||
| Voltage (volts) | 35V±20%@500Ω | 27V±10% @500Ω | Similar | ||
| 27 | 60.4V±20%@2kΩ | 60.4V±10% @2kΩ | Note 4 | ||
| 75V±20%@10kΩ | 75V±10%@10kΩ | ||||
| Maximum | |||||
| Output | |||||
| Current | |||||
| (specify | |||||
| units) | 70mA±20%@500Ω | 54mA±10% @500Ω | |||
| 28 | 30.2mA±20%@2kΩ | 30.2mA±10% @2kΩ | |||
| 7.5mA±20%@10kΩ | 7.5mA±10% @10kΩ | ||||
| Pulse | Positive | 175 $\mu$ s±20% | 200 $\mu$ s±10% | ||
| 29 | width | ||||
| ( $\mu$ sec) | Negative | 1051 $\mu$ s (6 x (+Phase) ) | 1030 $\mu$ s (5.15 x (+Phase) ) | ||
| 30 | Pulse | ||||
| (msec) | Period | 10~1000ms | 10~1000ms | Same | |
| 31 | Max. | ||||
| frequency | pulse | ||||
| (Hz) | 1~100Hz±20% | 1~100Hz±10% | Similar | ||
| Note 4 | |||||
| Rate (pps)] | |||||
| 32 | Net Charge (µC per pulse) | 0µC@500Ω, + and – pulses cancel | 0µC@500Ω, + and – pulses cancel | Same | |
| 33 | Maximum Phase Charge, (µC) | 8.6µC @500Ω | 9.4µC @500Ω | Similar Note 5 | |
| 34 | Maximum Average Current, (mA) | 1.17mA @500Ω | 1.08mA @500Ω | ||
| 35 | Maximum Current Density, (mA/cm², r.m.s.) | 8.6mA/cm² @500Ω | 9.4mA/cm² @500Ω | ||
| 36 | Maximum Average Power Density, (W/cm²) | 0.135W/cm²@500Ω | 0.141W/cm²@500Ω | ||
| 37 | Biocompatibility | ISO10993-5, ISO 10993-10 | ISO10993-5, ISO 10993-10 | Same | |
| 38 | Accessories | Lead wires, Alligator type connectors | Lead wires, Alligator type connectors | Same | |
| Parameters | Modified Device | Predicate Device | Remark | ||
| 1 | 510(k) Number: | K244030 | K202861 | -- | |
| 2 | Marketing clearance date: | -- | 08/27/2021 | -- | |
| 3 | Device Name | Needle Stimulator | Needle Stimulator | -- | |
| 4 | Model | CMNS6-3 | CMNS6-2 | -- | |
| 5 | Manufacturer | Wuxi Jiajian Medical | |||
| Instrument Co.,Ltd | Wuxi Jiajian Medical | ||||
| Instrument Co.,Ltd | Same | ||||
| 6 | Indications for 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 | ||||
| 7 | Type of use | Prescription use | Prescription use | Same | |
| Power Source(s) | DC 1.5Vx6 Type R14 or AC | ||||
| 100-240V | DC 1.5Vx6 Type R14 or AC | ||||
| 100-240V | Same | ||||
| 8 | 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 | |||
| 9 | Average DC current | ||||
| through electrodes | |||||
| when device is on | |||||
| but no pulses are | |||||
| being applied (µA) | N/A | N/A | Same | ||
| 10 | 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 | ||||
| 11 | Synchronous | ||||
| or Alternating? | Synchronous | Synchronous | Same | ||
| Method of | |||||
| Channel Isolation | Transformer | Transformer | Same | ||
| Regulated Current or | |||||
| Regulated Voltage? | Voltage Control | Voltage Control | Same | ||
| 13 | Software/Firmware/ | ||||
| Microprocessor | |||||
| Control? | Yes | Yes | Same | ||
| 14 | Automatic Overload | ||||
| Trip? | No | No | Same | ||
| 15 | Automatic No-Load | ||||
| Trip? | Yes | No | Similar | ||
| Note 1 | |||||
| 16 | Automatic Shut Off? | Yes | Yes | Same | |
| 17 | User | ||||
| Override | |||||
| Control? | Yes | Yes | Same | ||
| 18 | Indicator | ||||
| Display: | On/Off | ||||
| Status? | Yes | Yes | Same | ||
| Low | |||||
| Battery? | No | Yes | Similar | ||
| Note 1 | |||||
| Voltage/ | |||||
| Current | |||||
| Level? | Yes | Yes | Same | ||
| 19 | Timer | ||||
| (minutes) | Range | 1-100min | 1-99min | Similar | |
| Note 3 | |||||
| 20 | Compliance | ||||
| with | |||||
| Voluntary Standards? | IEC 60601-1, IEC 60601-1-2 | IEC 60601-1, IEC 60601-2-10, | |||
| IEC 60601-1-2 | Similar | ||||
| Note 2 | |||||
| 21 | Compliance with 21 | ||||
| CFR 898? | Yes | Yes | Same | ||
| 22 | Weight (grams) | 740g | approx. 657g | Similar | |
| 23 | Dimensions [W x H | ||||
| x D] | 23416076mm | 23818475mm | Note 3 | ||
| 24 | Housing Materials & | ||||
| Construction | ABS; Injection molded | ABS; Injection molded | Same | ||
| 25 | Waveform | Biphasic | Biphasic | Same | |
| 26 | Shape | Asymmetric, square wave | Asymmetric, square wave | Same | |
| 27 | Maximum | ||||
| Output | |||||
| Voltage (volts) | 35V±20%@500Ω | 27V±10% @500Ω | Similar | ||
| Note 4 | |||||
| 60.4V±20%@2kΩ | 60.4V±10% @2kΩ | ||||
| 75V±20%@10kΩ | 75V±10%@10kΩ | ||||
| Maximum | |||||
| Current | Output | ||||
| (specify | 70mA±20%@500Ω | 54mA±10% @500Ω | |||
| 28 | 30.2mA±20%@2kΩ | 30.2mA±10% @2kΩ | |||
| units) | 7.5mA±20%@10kΩ | 7.5mA±10% @10kΩ | |||
| Pulse | Positive | 175µs±20% | 175µs±10% | ||
| 29 | width | ||||
| (µsec) | Negative | 1051µs (6 x (+Phase) ) | 1051µs (6 x (+Phase) ) | ||
| 30 | Pulse | ||||
| Period | |||||
| (msec) | |||||
| 30 | Pulse | ||||
| Period | |||||
| (msec) | 10~1000ms | 10~1000ms | Same | ||
| 31 | Max. | ||||
| pulse | |||||
| frequency (Hz) [or | |||||
| Rate (pps)] | 1~100Hz±20% | 1~100Hz±10% | Similar | ||
| Note 4 | |||||
| 32 | Net Charge (µC per | ||||
| pulse) | 0μC@500Ω, + and – pulses | ||||
| cancel | 0μC@500Ω, + and – pulses | ||||
| cancel | Same | ||||
| 33 | Maximum Phase | ||||
| Charge, (µC) | 8.6μC @500Ω | 8.225μC @500Ω | Similar | ||
| Note 5 | |||||
| 34 | Maximum Average | ||||
| Current, (mA) | 1.17mA @500Ω | 0.945mA @500Ω | |||
| 35 | Maximum Current | ||||
| Density, (mA/cm², | |||||
| r.m.s.) | 8.6mA/cm² @500Ω | 8.225mA/cm² @500Ω | |||
| 36 | Maximum Average | ||||
| Power Density, | |||||
| (W/cm²) | 0.135W/cm²@500Ω | 0.1234W/cm²@500Ω | |||
| 37 | Biocompatibility | ISO10993-5, ISO 10993-10 | ISO10993-5, ISO 10993-10 | Same | |
| 38 | Accessories | Lead wires, Alligator type | |||
| connectors | Lead wires, Alligator type | ||||
| connectors | Same |
6
7
Note 1:
The proposed device's average DC current at overload, low battery and voltage/current level are different from those of the primary predicate device. As the proposed device and the predicate device adopt the same fundamental output technology and similar treatment effect, therefore, the proposed device is considered to be substantially equivalent. Also, the proposed device had passed AAMI / ANSI ES60601-1 and IEC 60601-1-2 tests, so these differences will not raise any new safety and effectiveness issues.
Note 2:
The IEC 60601-2-10 for testing of predicate device is specific to neuromuscular stimulation, and the BWK product code does not appear in the FDA's testing standards, so we do not believe that this test is required for the proposed device.
Note 3:
The dimensions and appearance of the proposed device are a little different from those of the predicate device, depending on the design and sales requirements of the product. But these differences are insignificant in terms of safety or effectiveness.
Note 4:
There are some differences in the maximum output voltage, maximum output current, pulse width, pulse period and frequency between the proposed device and the predicate device. Based on the calculation of maximum current density, maximum average power density, these parameters don't exceed the safety limit. Also, the worst cases have been considered in risk analysis report. Therefore, these differences do not raise new questions of safety and effectiveness.
Note 5:
The net charge, maximum phase charge, maximum average current, maximum current density, maximum average power density have some differences between the proposed device and the predicate device. The differences are minor and do not raise new questions of safety and effectiveness.
8
Detailed comparison data is included in "Substantial Equivalence Discussion - CMNS6-3" of this 510(k) submission.
Table 2-
9
10
Note 1:
The proposed device's average DC current at no load and voltage/current level are different from those of the primary predicate device. As the proposed device and the predicate device adopt the same fundamental output technology and similar treatment effect, therefore, the proposed device is considered to be substantially equivalent. Also, the proposed device had passed AAMI / ANSI ES60601-1 and IEC 60601-1-2 tests, so these differences will not raise any new safety and effectiveness issues.
Note 2:
The IEC 60601-2-10 for testing of predicate device is specific to neuromuscular stimulation, and the BWK product code does not appear in the FDA's testing standards, so we do not believe that this test is required for the proposed device.
Note 3:
The time range, weight, dimensions and appearance of the proposed device are a little different from those of the predicate device, depending on the design and sales requirements of the product. But thesed ifferences are insignificant in terms of safety or effectiveness.
11
Note 4:
There are some differences in the maximum output voltage, maximum output current, pulse width, pulse period, and frequency between the proposed device and the predicate device. Based on the calculation of maximum current density, maximum average power density, these parameters don't exceed the safety limit. Also, the worst cases have been considered in risk analysis report. Therefore, these differences do not raise new questions of safety and effectiveness.
Note 5:
The net charge, maximum phase charge, maximum average current, maximum current density, maximum average power density have some differences between the proposed device and the predicate device. The differences are minor and do not raise new questions of safety and effectiveness.
5. Test summary:
Needle Stimulator is safe and effective as the predicate device cited above. The new devices have passed testings according to the following standards:
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ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021]Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) [Including Amendment 2 (2021)];
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IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION Medical electrical equipment - Part
1-2: General requirements for basic safety and essential performance - Collateral Standard:
Electromagnetic disturbances - Requirements and tests;
- IEC TS 60601-4-2 Edition 1.0 2024-03 Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems
6. Clinical Test
Clinical data were not included in this submission.
7. Conclusion
The conclusion drawn from the non-clinical tests demonstrates that the device performs as intended and is as safe, and effective as the legally marketed device identified in the submission. Thus, the subject device is substantially equivalent to the predicate device.