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510(k) Data Aggregation

    K Number
    K133980
    Device Name
    PANTHEON ELECTROSTIMULATOR
    Manufacturer
    PANTHEON RESEARCH
    Date Cleared
    2014-11-07

    (315 days)

    Product Code
    BWK
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    K081943
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    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.

    Device Description

    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

    AI/ML Overview

    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 @ <30 mA. (Predicate: DC 9V. Different to predicate due to different power supply, but provided).
    Battery Life: Provided.18.8 hours (30mA max. @ a load of 620 ohms). (Not available for predicate, but provided).
    Environmental Operating & Storage Conditions: Comparable to predicate.Operating Temp: 10-40 degrees C. Storage Temp: 10-60 degrees C. (Identical to predicate). Humidity (Use): 30-85%. Humidity (Storage): 30-95%. (Identical to predicate). Barometric Pressure (Use & Storage): 700-1060 Pa. (Identical to predicate).
    Safety Features: At least equivalent to or improved over predicate.Device cannot turn ON unless all outputs knobs are first turned OFF. Prevents accidental shocking of patient. Multiple internal safety features to prevent electronic malfunction, such as current limiting resisters that are redundant. (Predicate: None listed. The subject device has enhanced safety features.)
    Test Functions: Provides functional checks.1) Clip lead tester, 2) Output tester, 3) Auto battery tester, 4) Manual battery test. (Predicate: None listed. The subject device has enhanced test functions).
    Electrical Safety and EMC: Compliance with international standards.Electrical Safety: IEC 60601-1: Ed.2, Amd 1, Amd 2, Corrigendum 1. IEC 60601-2-10: First Edition; Amendment 1. EMC: EN 60601-1-2:2007 / IEC 60601-1-2:2007 (Class B for Emissions, Immunity for Non Life-Supporting Equipment). (Compliance with these standards is explicitly stated).
    Biocompatibility: Compliance with international standards.Testing was performed in accordance with ISO 10993-1. (Compliance with this standard is explicitly stated).

    2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

    The document describes non-clinical testing for electrical safety, EMC, and biocompatibility. These types of tests typically use a sample of the manufactured device itself and do not involve patient data or study subjects in the way a clinical trial would. Therefore, there is no mention of a "test set" in the context of patient data, nor its provenance, as this submission is for an electro-acupuncture stimulator supported by technical and safety standards rather than a disease-detection or diagnostic device.

    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 section is not applicable as the submission relies on technical and safety standard compliance, and a comparison of technical characteristics to a predicate device, rather than a clinical study with a "test set" requiring expert-established ground truth.

    4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

    This section is not applicable for the same reasons as #3.

    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

    A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an electro-acupuncture stimulator, not an AI-powered diagnostic or assistive device for "human readers."

    6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

    This section is not applicable. The device is an electro-acupuncture stimulator, and it does not contain an "algorithm" in the sense of a decision-making or diagnostic AI algorithm. Its performance is evaluated based on its electrical output characteristics and safety compliance, not a standalone algorithm's accuracy.

    7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

    The "ground truth" for this device's performance relies on compliance with established international electrical safety and electromagnetic compatibility (EMC) standards, and biocompatibility standards (ISO 10993-1). Additionally, the technical specifications (voltage, current, frequency, pulse width, etc.) are compared to those of a legally marketed predicate device to demonstrate substantial equivalence. No patient-specific outcomes data, pathology, or expert consensus on clinical findings are mentioned as ground truth for this type of device submission.

    8. The sample size for the training set

    This section is not applicable as this device does not involve machine learning or AI that would require a "training set."

    9. How the ground truth for the training set was established

    This section is not applicable for the same reasons as #8.

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