(315 days)
The Pantheon Research Electrostimulator 4c.Pro, 8c.Pro, 12c.Pro, & 9c3i are for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.
The Pantheon Research Pro Series electro-acupuncture stimulators are electrical stimulators that introduce calibrated and controlled electrical impulses into acupuncture needles inserted into patients for therapeutic purposes. These devices are built in 5 models: the 4c.Pro. 6c.Pro. 12c.Pro. and 9c3i models. The Pantheon electro-acupuncture stimulator series does not come equipped with acupuncture needles. The practitioners should select 510(k) cleared needles
This document is a 510(k) Pre-market Notification for the Pantheon Electrostimulator Models 4c.Pro, 6c.Pro, 8c.Pro, 12c.Pro, and 9c3i. It aims to demonstrate substantial equivalence to a predicate device.
Here's the breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" for performance metrics in a numerical or target-based format. Instead, it demonstrates performance by comparing technical characteristics to the predicate device and by complying with relevant safety and EMC standards. The implicit acceptance criteria are that the device's technical characteristics are comparable or safer than the predicate, and that it passes the specified electrical safety, EMC, and biocompatibility tests.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Indications for Use: Equivalent to legally marketed predicate. | The Pantheon Research Electrostimulator 4c.Pro, 6c.Pro, 8c.Pro, 12c.Pro, & 9c3i are for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states. This is identical to the predicate device's intended use. |
| Device Type: Equivalent to predicate. | Stimulator, Electro-Acupuncture (Identical to predicate). |
| Product Code: Equivalent to predicate. | BWK (Identical to predicate). |
| Authorized Use: Equivalent to predicate. | Prescription Use (Identical to predicate). |
| Accessory Attachment Methods: Comparable to predicate. | Leads: alligator clips on wires (Identical to predicate). |
| Voltage: Within acceptable range for electro-acupuncture. | 2.95 Vrms @ 300 ohm; 14.5 Vrms @ 2500 ohm; 24.9 Vrms @ 10000 ohm. (Predicate: 20 V @ 500 ohms, 30 V @ 10,000 ohms. The subject device has lower voltage output at comparable impedances, suggesting a safer profile.) |
| Current: Within acceptable range for electro-acupuncture, preferably lower/safer than predicate. | 5.76 mA rms @ 300 ohms; 0 to 600 microamperes. (Predicate: Low: 0-20 mA, High: 0-40 mA. The subject device has significantly lower current, notably in microamperes, which is safer.) |
| Max. Power Density: Provided and considered acceptable. | .248 W/cm² @300 ohms, 500hz. (Not available for predicate, but provided as a characteristic). |
| Max Current Density: Provided and considered acceptable. | 9.78 MA rms @300 ohms, 500 hz. (Not available for predicate, but provided as a characteristic). |
| Frequency: Comparable or within functional range of predicate. | 0.5 to 200 Hertz (for 4c.Pro, 6c.Pro, 8c.Pro, 12c.Pro). 0.5 to 500 Hertz (for 9c3i only). (Predicate: L: 1 ~ 20 Hz, M: 20 ~ 150 Hz, H: 150 ~ 500 Hz. The ranges are largely comparable, with the 9c3i model matching the highest predicate frequency). |
| Pulse Width: Comparable to predicate. | 400 microseconds. (Predicate: 250 microseconds. The subject device has a longer pulse width, still within acceptable electro-acupuncture parameters). |
| Pulse Shape (Design & Measurement): Equivalent to predicate. | Asymmetric Biphasic Square wave (Identical to predicate). |
| Power Supply: Safe and functional. | 4, 6, 8, 12c.Pro: 2 9v batteries. 9c3i: 4 9v batteries. (Predicate: One 9 V Battery. Different battery configuration, but still battery-powered). |
| Rated Power Consumption: Provided and considered acceptable. | DC 18 V @ |
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