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    K Number
    K231440

    Validate with FDA (Live)

    Device Name
    Combo Electrotherapy Device
    Manufacturer
    Shenzhen Roundwhale Technology Co., Ltd.
    Date Cleared
    2023-11-03

    (169 days)

    Product Code
    IPF,GZJ,LIH
    Regulation Number
    890.5850
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    K171978
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Model:R-C101W:

    • For TENS/IF/MIC mode
      1. Symptomatic relief of chronic intractable pain
      1. Post traumatic pain
      1. Post surgical pain
    • For EMS/RUSS mode
      1. Relaxation of muscle spasm.
      1. Increase of local blood flow circulation
      1. Prevention or retardation of disuse atrophy
      1. Muscle re-education
      1. Maintaining or increasing range of motion.
      1. Immediate post-surgical stimulation of muscles to prevent venous thrombosis

    Model:R-C101A

    • For TENS/IF mode
      1. Symptomatic relief of chronic intractable pain.
      1. Post traumatic pain.
      1. Post surgical pain.
    • For EMS/RUSS mode
      1. Relaxation of muscle spasm.
      1. Increase of blood flow circulation.
      1. Prevention or retardation of disuse atrophy.
      1. Muscle re-education.
      1. Maintaining or increasing range of motion.
      1. Immediate post-surgical stimulation of muscles to prevent venous thrombosis

    Model:R-C101B
    For TENS/IF mode

      1. Symptomatic relief of chronic intractable pain
      1. Post traumatic pain
      1. Post surgical pain
    • For EMS/RUSS mode
      1. Relaxation of muscle spasm.
      1. Increase of local blood flow circulation
      1. Prevention or retardation of disuse atrophy
      1. Muscle re-education
      1. Maintaining or increasing range of motion.
      1. Immediate post-surgical stimulation of muscles to prevent venous thrombosis

    Model:R-C101E
    For IF mode

      1. Symptomatic relief of chronic intractable pain
      1. Post traumatic pain
      1. Post surgical pain
        For RUSS mode
      1. Relaxation of muscle spasm.
      1. Increase of local blood flow circulation
      1. Prevention or retardation of disuse atrophy
      1. Muscle re-education
      1. Maintaining or increasing range of motion.
      1. Immediate post-surgical stimulation of muscles to prevent venous thrombosis

    Model:R-C101H
    For TENS and IF mode

      1. Symptomatic relief of chronic intractable pain.
      1. Post traumatic pain.
      1. Post surgical pain.

    Model:R-C101D
    For TENS mode

      1. Symptomatic relief of chronic intractable pain
      1. Post traumatic pain
      1. Post surgical pain

    Model:R-C101G
    For TENS mode

      1. Symptomatic relief of chronic intractable pain.
      1. Post traumatic pain.
      1. Post surgical pain.
        For EMS mode
      1. Relaxation of muscle spasm.
      1. Increase of local blood flow circulation
      1. Prevention or retardation of disuse atrophy
      1. Muscle re-education
      1. Maintaining or increasing range of motion.
    1. Immediate post-surgical stimulation of muscles to prevent venous thrombosis
    Device Description

    The Combo Electrotherapy Device (Models: R-C101W, R-C101B, R-C101E, R-C101H, R-C101D, and R-C101G) is a Transcutaneous Electrical Nerve Stimulator. The device features two independent output channels and four selfadhesive electrode gel pads. The stimulator sends a gentle electrical current to the underlying nerves and muscle groups via electrodes applied on the skin. Users can choose from pre-set programs or specify their own to suit their individual needs. All controls and indicators are controlled by software which also controls waveform characteristics. The 7 models have similar housing with a viewable LCD display and an accessible keypad. The LCD is located on the upper half of the rectangular face of the device above the keypad. It is used to display system information to the user. The device is battery-powered but can be connected to an external power supply its internal battery which is a non-user serviceable or accessible 3.7V D.C., Li-ion battery. There are only two external connections on the device - power input and electrode connector - with no connection to any other devices. The Battery Charger is not included in the package; however, users can choose adapters that meet IEC 60601-1 medical stardards.

    AI/ML Overview

    The provided document is a 510(k) Premarket Notification for a "Combo Electrotherapy Device." It establishes substantial equivalence to a predicate device, K171978. The document primarily focuses on non-clinical performance and safety data, as no clinical data was performed.

    Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based solely on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    The acceptance criteria for this device are largely based on demonstrating equivalence to the predicate device (K171978) in technical characteristics and compliance with relevant safety standards. The reported device performance is presented as a comparison to the predicate device.

    Acceptance Criteria CategorySpecific Criteria (Implicitly based on Predicate Device)Reported Device Performance (New Device K231440)Discussion
    Indications for UseSame indications as predicate: Symptomatic relief of chronic intractable pain, post-traumatic pain, post-surgical pain (TENS/IF/MIC); Relaxation of muscle spasm, increased local blood flow, prevention/retardation of disuse atrophy, muscle re-education, maintaining/increasing range of motion, immediate post-surgical stimulation to prevent venous thrombosis (EMS/RUSS).Primarily the same across all models (R-C101W, R-C101A, R-C101B, R-C101E, R-C101H, R-C101D, R-C101G), with some models having subsets of the modes. For example, R-C101E only has IF and RUSS modes for the specified indications.Same. The document states, "The proposed device has the same intended use... as the predicate device." While some models have fewer modes, the indications for the available modes are identical.
    Power Source3.7V Li-ion Battery Charger output: 5.0V DC, 300mA3.7 V Li-ion battery Charger Output: 5V DC, 300mASame.
    Patient Leakage CurrentNormal condition: 5 uA; Single fault condition: 5 uANormal condition: 5 uA; Single fault condition: 5 uASame.
    Number of Output Channels22Same.
    Channel IsolationBy enclosureBy enclosureSame.
    Current/Voltage ControlConstant Current: Yes; Constant Voltage: NoConstant Current: Yes; Constant Voltage: NoSame.
    Software/Firmware ControlYesYesSame.
    Safety FeaturesAutomatic Overload Trip: Yes; Automatic Over Current Trip: Yes; Automatic No-Load Trip: Yes; Automatic Shut-off: Yes; Patient Override Control: NoAll "Yes" for trip/shut-off features, "No" for patient override control.Same.
    Indicator DisplayOn/Off Status: Yes; Voltage/Current Level: Yes; Low Battery: YesAll "Yes".Same.
    Waveform TypeBiphasic for TENS, EMS, Interferential, Russian; Monophasic for Microcurrent. Shapes are all Square.Bi-phase for all except MIC (Mono-phase). All shapes are Square.Same.
    Max Output Voltage (V) ±20% (Various Loads)Ranges provided for Predicate (e.g., TENS 500Ω: 50V, 2kΩ: 102V)Ranges provided for New Device (e.g., TENS 500Ω: 45V, 2kΩ: 96V).Different, but the discussion notes these parameters passed IEC 60601-2-10 tests and do not exceed safety limits (calculated max current density and average power density). No new safety/effectiveness issues.
    Max Output Current (mA) ±20% (Various Loads)Ranges provided for Predicate (e.g., TENS 500Ω: 100mA, 2kΩ: 51mA)Ranges provided for New Device (e.g., TENS 500Ω: 90mA, 2kΩ: 48mA).Different, but the discussion notes these parameters passed IEC 60601-2-10 tests and do not exceed safety limits (calculated max current density and average power density). No new safety/effectiveness issues.
    Pulse Width RangeRanges provided for Predicate (e.g., TENS: 50-400uS; EMS: 200~400uS)Ranges provided for New Device (e.g., TENS/EMS: 50 to 450 μs; IF: 50µs/100µs; MIC: 2ms - 500ms; RUSS: 200μs).Different, but noted as minor and compliant with 60601-2-10, thus not raising safety/effectiveness issues.
    Frequency RangeRanges provided for Predicate (e.g., TENS: 1150Hz; EMS: 1100Hz)Ranges provided for New Device (e.g., TENS/EMS: 2 to 150 Hz; IF Carrier F 5KHz/10KHz Beat F1Hz -200Hz; MIC: 0.1Hz - 150Hz; RUSS Carrier F 2.5KHz Burst F10Hz -70Hz).Different, but noted as minor and compliant with 60601-2-10, thus not raising safety/effectiveness issues.
    Beat Frequency (IF)1-200Hz1-200HzSame.
    Maximum Phase Charge (uC, 500Ω)TENS: 2.40; EMS: 2.40; IF: 0.79; MIC: 0.48; RUSS: 3.5TENS: 2.73; EMS: 2.73; IF: 0.75; MIC: 0.42; RUSS: 9Different, but stated to have passed IEC 60601-2-10 tests and safety limits (current density < 2 mA/cm², power density < 0.25 W/cm²). No new safety/effectiveness issues.
    Maximum Current Density (mA/cm², 500Ω, r.m.s)TENS: 0.24; EMS: 0.24; IF: 0.63; MIC: 0.01; RUSS: 0.7TENS: 0.24; EMS: 0.24; IF: 0.6; MIC: 0.01; RUSS: 1.8Mostly similar or within acceptable limits. The RUSS mode is higher but within the stated IEC limit of <2 mA/cm².
    Maximum Average Current (mA)TENS: 6; EMS: 6; IF: 15.75; MIC: 0.24; RUSS: 17.5TENS: 6.075; EMS: 6.075; IF: 15; MIC: 0.21; RUSS: 45Different, explained by calculations showing compliance with safety limits. RUSS is significantly higher but justified by remaining within safety limits (Note 3).
    Maximum Power Density (mW/cm², 500Ω, r.m.s)TENS: 0.72; EMS: 0.72; IF: 4.96; MIC: 0.01; RUSS: 6.13TENS: 0.74; EMS: 0.74; IF: 4.5; MIC: 0.01; RUSS: 40.5Different, explained by calculations showing compliance with safety limits. RUSS is significantly higher but justified by remaining within safety limits (<0.25 W/cm² Guidance Document).
    ON/OFF TimeNot publicly available for predicate.TENS: N/A; EMS: 1-90 S; IF: N/A; MIC: N/A; RUSS: 1-90 S.Different from predicate (likely), but compliant with FDA Guidance Document and not impacting safety/effectiveness.
    Electrode Area (cm²)2525Same.
    Timer Range (minutes)5-90 minutes5-90 minutesSame.
    Compliance with Voluntary StandardsIEC60601-1, IEC60601-1-2, IEC60601-2-10IEC60601-1, IEC60601-1-2, IEC60601-2-10Same.
    Compliance with 21 CFR 898YesYesSame.
    Weight (lbs.)0.28About 140 grams (0.31lbs)Different, but noted as not raising different questions of safety & effectiveness.
    Dimensions H x W x L4.6x2.36x0.9 inch120.5 mm (L) x 69.5 mm (W) x 27mm (H)Different, but noted as not raising different questions of safety & effectiveness.
    Housing Materials & ConstructionEnclosure: ABSEnclosure: ABSSame.
    Burst Mode CharacteristicsNot publicly available for predicate.TENS: Pulses per burst: 7; Bursts per second: 0.5, 1, 2, 3, 4, 5; Burst duration: 70mS; Duty Cycle: 3.5% - 35%. Other modes N/A for these parameters.Different from predicate (likely), but noted as not adversely impacting safety and effectiveness.
    AccessoriesAll listed accessories (electrode, conductive medium, lead wires, batteries) are the same as predicate. Battery charger not included.All listed accessories (self-adhesive electrode (50mm x 50mm), conductive media (gel), electrode lead wires, 3.7V D.C., Li-ion batteries) are the same as predicate. Battery charger not provided.Same. The electrodes are explicitly stated to have been previously cleared (K22252, same manufacturer).
    BiocompatibilityAcceptable for skin contact.The same Self-Adhesive Electrode (K22252) used for the device was evaluated based on ISO10993 for intact skin contact (max 10-15 uses) and submitted to FDA.Met. Reference to existing cleared accessories and ISO10993 compliance.
    Electrical Safety and EMCCompliance with IEC 60601-1:2012 and IEC 60601-1-2:2014.The system complies with IEC 60601-1: 2012 and IEC 60601-1-2: 2014 standards.Met. Testing conducted and compliance confirmed.
    Bench TestingCompliance with IEC 60601-1-11:2015 and IEC 60601-2-10:2016.The system complies with IEC 60601-1-11: 2015 and IEC 60601-2-10: 2016 standards.Met. Testing conducted and compliance confirmed.
    Software Verification and ValidationCompliance with FDA "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" for "Moderate" level of concern.Software verification and validation testing conducted, documentation provided as recommended by FDA guidance. Software considered "Moderate" level of concern.Met. V&V conducted and documented per FDA guidance.

    Study Proving Acceptance Criteria:

    The studies proving the device meets the acceptance criteria are non-clinical tests, as indicated in Section 7 of the 510(k) summary: "No clinical testing was performed."

    2. Sample Size Used for the Test Set and Data Provenance

    • Test Set Sample Size: The document does not specify a quantitative sample size for the "test set" in terms of number of devices or data points beyond stating that "Non-clinical tests were conducted to verify that the proposed device met all design specifications." The testing appears to be primarily laboratory-based bench testing on the device itself.
    • Data Provenance: The data provenance is from bench testing and laboratory evaluations conducted by the manufacturer, Shenzhen Roundwhale Technology Co., Ltd. (China), or their contracted testing facilities. It is not retrospective or prospective clinical data in the traditional sense, as no clinical studies were performed.

    3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

    This information is not applicable in the context of this 510(k) submission. The ground truth for electrical muscle stimulators in a 510(k) premarket notification is established through:
    * Comparison to a legally marketed predicate device.
    * Adherence to recognized safety and performance standards (e.g., IEC 60601 series).
    * Bench testing to demonstrate the device performs according to its specifications and within acceptable safety limits.

    There are no "experts" establishing a "ground truth" on patient data for this type of submission because no clinical data was submitted.

    4. Adjudication Method for the Test Set

    Not applicable. Since no clinical data or expert evaluations of patient outcomes were performed, there is no need for an adjudication method. The compliance is demonstrated via engineering and safety tests.

    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

    Not applicable. This device is a powered muscle stimulator/TENS unit, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers or AI assistance is irrelevant to this submission.

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

    Not applicable in the context of AI/algorithms affecting diagnostic performance. While the device does contain software/firmware (item 9 in the comparison table indicates "Software/Firmware/Microprocessor Control? Yes"), the performance testing detailed (Section 7) is related to the device's electrical safety, EMC, and bench performance according to standards, not the diagnostic accuracy of an algorithm. The software verification and validation are for the operational integrity and safety of the device's control system, not for an independent diagnostic capability.

    7. The Type of Ground Truth Used

    The ground truth for this submission is established by:
    * Predicate Device Equivalence: The primary ground truth is the performance and safety profile of the legally marketed predicate device (K171978). The new device aims to be substantially equivalent in design and performance.
    * Consensus Standards: Adherence to recognized national and international consensus standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-10). These standards define acceptable performance and safety limits for such devices.
    * Bench Test Results: Direct measurements and calculations from bench testing that demonstrate the device's electrical characteristics (output voltage, current, pulse width, frequency, current density, power density, etc.) remain within acceptable limits defined by the standards and are comparable to the predicate.

    8. The Sample Size for the Training Set

    Not applicable. This device is not an AI/machine learning model that requires a training set of data. The "training" of this device refers to its engineering design and manufacturing to meet specified parameters.

    9. How the Ground Truth for the Training Set Was Established

    Not applicable. As stated above, there is no "training set" for this type of medical device submission.

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