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510(k) Data Aggregation
(210 days)
Jiajian® Electro-acupuncture Stimulator, Model WQ-10D1 and WQ-6F are electro-acupuncture stimulator devices, which are indicated for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.
Jiajian® Electro-acupuncture Stimulator, Model WQ-10D1, is a battery powered instrument with 3 channel outputs for acupuncture needle stimulation. The predicate device is ES-130, K081943. The output frequency and intensity for stimulation are adjustable. The stimulation time can be set. The 3 channels can output stimulation simultaneously. The device is powered by DC 9V battery, Type 6F22. When the battery has insufficient voltage (<8.5V), the light goes out. The user should replace battery. WQ-10D1 does not equip with acupuncture needles. The practitioners should select 510(k) cleared needles (with minimum diameter of 0.30mm and insertion depth of 15mm) for use. Jiajian® Electro-acupuncture Stimulator, Model WQ-6F, is an electro-acupuncture device, composed of a main unit and seven separate lead wires which represent 7 output channels. 4 output channels are grouped in Section A and 3 output channels are grouped in Section B. Section A and B have separate intensity and frequency adjusting knobs. The 4 channels in Section A can output waveforms simultaneously, and the 3 channels in Section B can output waveforms simultaneously but Section A and Section B can not output waveforms simultaneously. The main unit is powered by DC4.5V battery (three No 1 battery, Size "D"). When the battery has insufficient voltage (<4.1V), the light goes out. The user should replace battery. WQ-6F does not equip with acupuncture needles. The practitioners should select 510(k) cleared needles (with minimum diameter of 0.30mm and insertion depth of 15mm) for use. The predicate device of WQ-6F is ES-130, K081943.
The provided document describes the Wuxi Jiajian Medical Instrument Co., Ltd.'s Electro-acupuncture Stimulators (Model WQ-10D1 and WQ-6F) and its 510(k) summary for substantial equivalence to a predicate device. This submission focuses on comparing the new device's technical specifications and safety standards to those of the predicate device, not on clinical performance or specific acceptance criteria met through clinical studies with human subjects.
Therefore, many of the requested categories related to clinical study design (sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, training set) are not applicable to this type of regulatory submission, which primarily relies on engineering performance testing and comparison to a legally marketed predicate device.
However, the document does list product specifications and safety standard compliance, which could be considered criteria for acceptance in a technical and regulatory context.
Here's the information that can be extracted from the provided text according to your request categories:
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) submission for substantial equivalence based on technical characteristics and safety standards, the "acceptance criteria" are generally that the new device's parameters and safety performance are equivalent to or within the acceptable limits established by the predicate device and relevant standards. The "reported device performance" refers to the new device's measured specifications. The tables below synthesize this information for key parameters, highlighting where differences exist and how they are addressed in the substantial equivalence discussion.
Jiajian® Electro-acupuncture Stimulator, Model WQ-10D1 vs. Predicate Device ES-130 (K081943)
| Parameter | Acceptance Criteria (Predicate Device ES-130) | Reported Device Performance (Jiajian® WQ-10D1) | Substantial Equivalence Discussion / Justification |
|---|---|---|---|
| Intended Use | Practice of acupuncture by qualified practitioners | Practice of acupuncture by qualified practitioners | Similar. Same intended use. |
| Power Source | DC 9V battery, Type 6F22 | DC 9V battery, Type 6F22 | Similar. |
| Compliance with Voluntary Standards | IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2 | IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2 | Similar. Both comply with the same safety standards. |
| Compliance with 21 CFR 898 | Yes | Yes | Similar. |
| Waveform | Biphasic, Asymmetric biphasic square wave | Biphasic, Asymmetric biphasic square wave | Similar. |
| Net Charge (per pulse @500Ω) | 0μC | 0μC | Similar. Both devices have zero net charge, ensuring no DC current accumulation. |
| Max Output Voltage (Low Intensity @500Ω) | 18V ± 15% | 11V ± 15% | Difference. New device has lower max output voltage. Justified by physiological effectiveness depending primarily on delivered charge, and the new device's maximum phase charge is slightly higher while within safety limits. |
| Max Output Current (Low Intensity @500Ω) | 36.0mA ± 15% | 22mA ± 15% | Difference. New device has lower max output current. Justified by physiological effectiveness depending primarily on delivered charge, and the new device's maximum phase charge is slightly higher while within safety limits. |
| Pulse Duration (Positive) | 100μS | 480 ± 10% μS | Difference. New device has higher pulse width. Justified by physiological effectiveness depending primarily on delivered charge, and the new device's maximum phase charge is slightly higher while within safety limits. Duty cycle is similar. Does not raise new safety or effectiveness concerns. |
| Frequency (Hz) | 1~500Hz | 0~100Hz | Difference. New device has a lower frequency range. Justified by physiological effectiveness depending primarily on delivered charge, and the new device's maximum phase charge is slightly higher while within safety limits. Duty cycle is similar. Does not raise new safety or effectiveness concerns. |
| Maximum Phase Charge (μC) | 7.2μC | 17.2μC | Difference. New device has a higher maximum phase charge. Justified that this enables effectiveness and is within safety limits. Addressed as not raising new safety or effectiveness concerns. |
| Max Current Density (mA/cm², r.m.s.) | 25.5mA/cm² | 12.2mA/cm² | Difference. New device has lower current density. Justified as being within safety limits per IEC 60601-2-10 and FDA guidance. |
| Max Average Power Density (W/cm²) | 0.24W/cm² | 0.09W/cm² | Difference. New device has lower average power density. Justified as being within safety limits per IEC 60601-2-10 and FDA guidance. |
| Burst Mode | N/A (continuous train of impulses) | Present (various intermittent, rise-fall, sawtooth waves) | Difference. The new device has burst modes. Justified that the basic characteristics of burst mode are consistent with continuous wave, so this difference does not raise new types of safety or effectiveness questions. |
| CA-AM knob | Constant amplitude only | CA-AM knob (Constant Amplitude and Amplitude Modulated wave) | Difference. The new device offers amplitude modulation. Justified that physiological effectiveness can also be achieved through modulated amplitude, not just constant pulse trains, thus not raising new types of safety or effectiveness questions. |
| Battery Level Indicator | Check button | Auto shut off <8.5V | Difference. Different method of warning for low battery. No safety or effectiveness concerns raised. |
| Weight | 160g | 450g | Difference. Different physical characteristics, but not related to safety or effectiveness. |
| Dimensions | 96x63x27mm | 135x90x55mm | Difference. Different physical characteristics, but not related to safety or effectiveness. |
Jiajian® Electro-acupuncture Stimulator, Model WQ-6F vs. Predicate Device ES-130 (K081943)
| Parameter | Acceptance Criteria (Predicate Device ES-130) | Reported Device Performance (Jiajian® WQ-6F) | Substantial Equivalence Discussion / Justification |
|---|---|---|---|
| Intended Use | Practice of acupuncture by qualified practitioners | Practice of acupuncture by qualified practitioners | Similar. Same intended use. |
| Compliance with Voluntary Standards | IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2 | IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2 | Similar. Both comply with the same safety standards. |
| Compliance with 21 CFR 898 | Yes | Yes | Similar. |
| Waveform | Biphasic, Asymmetric biphasic square wave | Biphasic, Asymmetric biphasic square wave | Similar. |
| Net Charge (per pulse @500Ω) | 0μC | 0μC | Similar. Both devices have zero net charge, ensuring no DC current accumulation. |
| Power Source | DC 9V battery, Type 6F22 | DC 4.5V (Three No 1 batteries, Size "D") | Difference. Different power source. Addressed, but no safety concerns raised. |
| Max Output Voltage (Low Intensity @500Ω) | 18V ± 15% | 8V ± 15% | Difference. New device has lower max output voltage. Justified by physiological effectiveness depending primarily on delivered charge, and the new device's maximum phase charge is slightly higher while within safety limits. |
| Max Output Current (Low Intensity @500Ω) | 36.0mA ± 15% | 16mA ± 15% | Difference. New device has lower max output current. Justified by physiological effectiveness depending primarily on delivered charge, and the new device's maximum phase charge is slightly higher while within safety limits. |
| Pulse Duration (Positive) | 100μS | Section A: 700µs±10% (x1), 500µs±10% (x10) | Difference. New device has different pulse widths. Justified that both devices use "normal stimulation pulse width and frequency." Physiological effectiveness depends on delivered charge, and new device's max phase charge is slightly higher and within safety limits, so no new safety/effectiveness concerns. |
| Frequency (Hz) | 1~500Hz | Multiplier x 1: 0 | Difference. New device has different frequency ranges. Justified that both devices use "normal stimulation pulse width and frequency." Physiological effectiveness depends on delivered charge, and new device's max phase charge is slightly higher and within safety limits, so no new safety/effectiveness concerns. |
| Maximum Phase Charge (μC) | 7.2μC | 12.4μC | Difference. New device has a higher maximum phase charge. Justified that this enables effectiveness and is within safety limits. Addressed as not raising new safety or effectiveness concerns. |
| Max Current Density (mA/cm², r.m.s.) | 25.5mA/cm² | 17.6mA/cm² | Difference. New device has lower current density. Justified as being within safety limits per IEC 60601-2-10 and FDA guidance, even with 7 channels (considering only 4 active at once for patient safety). |
| Max Average Power Density (W/cm²) | 0.24W/cm² | 0.12W/cm² | Difference. New device has lower average power density. Justified as being within safety limits per IEC 60601-2-10 and FDA guidance. |
| Burst Mode | N/A (continuous train of impulses) | Present (various intermittent, rise-fall, sawtooth waves) | Difference. The new device has burst modes. Justified that the basic characteristics of burst mode are consistent with continuous wave, so this difference does not raise new types of safety or effectiveness questions. |
| CA-AM knob | Constant amplitude only | CA-AM knob (Constant Amplitude and Amplitude Modulated wave) | Difference. The new device offers amplitude modulation. Justified that physiological effectiveness can also be achieved through modulated amplitude, not just constant pulse trains, thus not raising new types of safety or effectiveness questions. |
| Battery Level Indicator | Check button | Auto shut off <4.1V | Difference. Different method of warning for low battery. No safety or effectiveness concerns raised. |
| Number of output channels | 3 | 7 (4 in Section A, 3 in Section B) | Difference. The new device has more channels, but only 4 can be active simultaneously for a single patient in Section A. This difference is accounted for in the safety analysis of maximum RMS current and power density, which are still within limits. |
| Weight | 160g | 1.03kg | Difference. Different physical characteristics, but not related to safety or effectiveness. |
| Dimensions | 96x63x27mm | 235x170x75mm | Difference. Different physical characteristics, but not related to safety or effectiveness. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The submission is based on engineering and performance testing against safety standards, not a clinical trial with a test set of patients or medical images. The device was manufactured in China.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided as there was no test set requiring expert ground truth in the context of a clinical study. The "ground truth" for this submission are the established safety standards (IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2) and the technical specifications of the predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided as there was no clinical test set requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
An MRMC comparative effectiveness study was not done. This device is an electro-acupuncture stimulator, not an AI-assisted diagnostic or treatment planning system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This is a physical medical device, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this submission consists of:
- Compliance with international safety standards: IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2.
- The technical specifications and established safety profile of the predicate device, ES-130 (K081943).
- Regulatory guidance from the FDA regarding safety limits.
8. The sample size for the training set
This information is not applicable as there was no training set in the context of machine learning or clinical trials.
9. How the ground truth for the training set was established
This information is not applicable as there was no training set.
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