(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 (
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 |
N/A