K Number
K243848
Device Name
Cala kIQ
Manufacturer
Date Cleared
2025-01-16

(31 days)

Product Code
Regulation Number
882.5897
Panel
NE
Reference & Predicate Devices
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Cala kIQ is indicated to aid in the temporary relief of hand tremors in the treated hand following stimulation in adults with essential tremor.

Cala kIQ is indicated to aid in the temporary relief of postural and kinetic hand tremor symptoms that impact some activities of daily living in the treated hand following stimulation in adults with Parkinson's disease.

Device Description

Cala kIQ is a small, lightweight, wrist-worn stimulator device designed to aid in the temporary relief of hand tremors for patients with essential tremor and to aid in the temporary relief of postural and kinetic hand tremor symptoms that impact some activities of daily living in the treated hand following stimulation in adults with Parkinson's disease. Cala kIQ is made up of three (3) components:

    1. Cala kIQ Stimulator
    1. Cala kIQ Band
    1. Cala kIO Base Station

Cala kIQ detects the frequency of a patient's tremor using on-board motion sensors and applies transcutaneous afferent patterned stimulation (TAPS), a constant current, charge-balanced waveform that alternates between the medial nerves of the wrist. The TAPS pattern is customized to the individual user through an automated device calibration, performed at device set-up.

Cala kIQ is only available via prescription. When Cala kIQ is prescribed for a patient, the ordering physician identifies a prescribed "tremor task," a tremor-inducing postural hold for the patient. The prescribed tremor task is performed by the patient during device callbration. Initial calibration is completed either in a patient's home or physician's office and is operated thereafter by the patient in a home-use setting. Calibration is completed only once for the initial set-up of the device. In addition, the tremor task is performed before and after sessions to measure changes in the patient's tremor amplitude. The patient is prompted on the device for these measurements for the first forty sessions and every seventh session thereafter.

AI/ML Overview

The Cala kIQ device is a wrist-worn stimulator intended to provide temporary relief for hand tremors in adults with essential tremor or Parkinson's Disease. The current submission (K243848) aims to demonstrate substantial equivalence to a previously cleared version of the Cala kIQ (K242259), despite a change in the electrode material formulation and a temporary reduction in the wristband shelf-life.

Here's a breakdown of the acceptance criteria and the study information:

1. Table of Acceptance Criteria and Reported Device Performance

CategoryAcceptance Criteria (Predicate Device K242259)Reported Device Performance (Subject Device K243848)
Intended UseDelivery of transcutaneous afferent patterned stimulation ("TAPS") for treatment of hand tremorsDelivery of transcutaneous afferent patterned stimulation ("TAPS") for treatment of hand tremors
Indications for UseAid in temporary relief of hand tremors in the treated hand following stimulation in adults with essential tremor.
Aid in temporary relief of postural and kinetic hand tremor symptoms that impact some activities of daily living in the treated hand following stimulation in adults with Parkinson's disease.Aid in temporary relief of hand tremors in the treated hand following stimulation in adults with essential tremor.
Aid in temporary relief of postural and kinetic hand tremor symptoms that impact some activities of daily living in the treated hand following stimulation in adults with Parkinson's disease.
Target PopulationAdults with essential tremor or Parkinson's DiseaseAdults with essential tremor or Parkinson's Disease
Anatomical siteMedian and radial nervesMedian and radial nerves
Intended UsersPatientPatient
Clinical SettingIn-home use after an initial calibration in the patient's home or in the physician's office.In-home use after an initial calibration in the patient's home or in the physician's office.
Rx or OTC usePrescription Use onlyPrescription Use only
TechnologyTranscutaneous afferent patterned stimulation (TAPS) delivered through electrodes embedded on wearable bandTranscutaneous afferent patterned stimulation (TAPS) delivered through electrodes embedded on wearable band
Energy used or deliveredElectrical stimulationElectrical stimulation
Human FactorsWrist-worn electrical stimulator with detachable wristband containing re-usable electrodes. Separate Base Station provides charging function and data transfer.Wrist-worn electrical stimulator with detachable wristband containing re-usable electrodes. Separate Base Station provides charging function and data transfer.
Patient Contacting MaterialsThe following components of the Cala kIQ Band have Surface, Intact Skin Long-Term contact (>30 days): Electrodes (silicone with carbon nanotube dispersion), Elastic (polyester with spandex), Band thread (cotton), Band silicone body, Band hook (sabic PC/ABS), Stimulator bottom (PC/ABS). All materials biocompatible per ISO-10993.The following components of the Cala kIQ Band have Surface, Intact Skin Long-Term contact (>30 days): Electrodes (silicone with carbon nanotube dispersion), Elastic (polyester with spandex), Band thread (cotton), Band silicone body, Band hook (sabic PC/ABS), Stimulator bottom (PC/ABS). All materials biocompatible per ISO-10993.
Operating PrincipleTranscutaneous Afferent Patterned Stimulation (TAPS) to the median and radial nerves of a patient's wristTranscutaneous Afferent Patterned Stimulation (TAPS) to the median and radial nerves of a patient's wrist
Electrodes6 individual electrodes, surface area 1.32 cm²6 individual electrodes, surface area 1.32 cm²
Battery and Base StationRechargeable Lithium-ion battery and AC-powered charger.Rechargeable Lithium-ion battery and AC-powered charger.
User Workflow1. Calibration (completed at device setup only)
  1. Set stimulation intensity
  2. Therapy available on demand | 1. Calibration (completed at device setup only)
  3. Set stimulation intensity
  4. Therapy available on demand |
    | Treatment Time | 40 minutes | 40 minutes |
    | Wristband life | 90 days | 90 days |
    | Shelf-life | Cala kIQ Band: 18 months | Cala kIQ Band: 3 months (reverting due to new electrode material, pending further testing) |
    | Waveform | Biphasic | Biphasic |
    | Shape | Rectangular | Rectangular |
    | Maximum Output Voltage | 4 @ 500Ω; 80 @ 10kΩ | 4 @ 500Ω; 80 @ 10kΩ |
    | Maximum Output Current | 8 @ 500Ω; 8 @ 10kΩ | 8 @ 500Ω; 8 @ 10kΩ |
    | Duration of primary (depolarizing) phase | 300 µsec | 300 µsec |
    | Pulse Duration | 650 µsec | 650 µsec |
    | Frequency | 150 Hz | 150 Hz |
    | Symmetrical phases? | Yes | Yes |
    | Phase Duration | 300 µS each phase | 300 µS each phase |
    | Net Charge | 0 @ 500Ω | 0 @ 500Ω |
    | Maximum Phase Charge | 2.4 @ 500Ω | 2.4 @ 500Ω |
    | Maximum Current Density | 1.29 @ 500Ω | 1.29 @ 500Ω |
    | Maximum Average Current | 0.72 @ 500Ω | 0.72 @ 500Ω |
    | Maximum Average Power Density | 2.18 @ 500Ω (0.0022 W/cm²) | 2.18 @ 500Ω (0.0022 W/cm²) |
    | Electrical safety | Conforms to IEC 60601 Electrical Safety | Conforms to IEC 60601 Electrical Safety |
    | Compatibility with intended environments | Conforms to EMC requirements | Conforms to EMC requirements |
    | Mechanical safety | Conforms to IEC 60601 Electrical Safety | Conforms to IEC 60601 Electrical Safety |
    | Chemical safety | Not applicable. | Not applicable. |
    | Thermal safety | Conforms to IEC 60601 Electrical Safety | Conforms to IEC 60601 Electrical Safety |
    | Radiation safety | Not applicable. | Not applicable. |

Study Proving Acceptance Criteria:

The current submission (K243848) for the Cala kIQ device primarily relies on demonstrating substantial equivalence to its predicate device (K242259). The core argument is that the only difference between the subject device and the predicate device is the formulation of the proprietary electrode material.

Therefore, the study focuses on validating the safety of this new electrode material and asserting that all other performance aspects remain identical to the predicate device, for which performance data was previously reviewed and accepted.

2. Sample size used for the test set and the data provenance:

  • Sample Size for Test Set: Not explicitly stated as a separate clinical test set for performance on tremor relief was conducted for this specific submission. The submission states, "No other non-clinical or clinical testing was performed in support of a substantial equivalence determination." The performance data reviewed for the predicate device (K242259) are considered applicable.
  • Data Provenance: Not applicable for new clinical performance data in this submission. The "acceptance criteria" table implies that the performance aspects derived from the predicate device are used as the benchmark.

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):

  • Not applicable, as no new clinical performance study was conducted requiring expert ground truth in this submission.

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

  • Not applicable, as no new clinical performance study was conducted requiring adjudication in this submission.

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 an external stimulator for tremor relief, not an AI-assisted diagnostic or interpretive tool that would involve multi-reader multi-case studies.

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

  • The device performs a standalone function (tremor detection and stimulation delivery). The "performance data reviewed in previous submissions, including the predicate submission, are still applicable to the subject device since they are similar in technology, and, hence, the previously reviewed data supports that the subject device meets special controls." This indicates that the standalone performance of the system (including its tremor detection and stimulation algorithm) was assessed in previous submissions.

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

  • For the predicate device's performance, the device's efficacy is to "aid in the temporary relief of hand tremors." This would typically be assessed through clinical outcomes data, likely involving tremor quantification (e.g., using accelerometers, clinical rating scales like the Fahn-Tolosa-Marin Tremor Rating Scale or the Unified Parkinson's Disease Rating Scale part III tremor scores), measured against baseline. The current submission does not provide new details on the ground truth used for the predicate's performance.

8. The sample size for the training set:

  • Not applicable for this submission, as no new machine learning model or algorithm training is mentioned as being performed for this particular 510(k). The device's TAPS pattern is customized to the individual user through an automated device calibration, not a general training set for an AI model.

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

  • Not applicable, as no new machine learning model training set is specifically discussed in this submission. The device uses individual patient "calibration" for customization, which is a process to adapt to the individual's tremor frequency, not a general training dataset for an AI model.

§ 882.5897 External upper limb tremor stimulator.

(a)
Identification. An external upper limb tremor stimulator is a prescription device which is placed externally on the upper limb and designed to aid in tremor symptom relief of the upper limb.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Non-clinical performance testing must assess the following:
(i) Characterization of the electrical stimulation, including the following, must be performed: Waveforms, output modes, maximum output voltage, maximum output current, pulse duration, frequency, net charge per pulse, maximum phase charge at 500 ohms, maximum current density, maximum average current, and maximum average power density.
(ii) Impedance testing, current distribution across the electrode surface area, adhesive integrity, and shelf life testing of the electrodes and gels must be conducted.
(iii) Simulated use testing of sensor performance and the associated algorithms that determine the stimulation output must be conducted.
(2) Patient-contacting components of the device must be demonstrated to be biocompatible.
(3) Performance testing must demonstrate electrical, thermal, and mechanical safety along with electromagnetic compatibility (EMC) of the device in the intended use environment.
(4) Software verification, validation, and hazard analysis must be performed.
(5) Physician and patient labeling must include:
(i) Summaries of electrical stimulation parameters;
(ii) Instructions on how to correctly use and maintain the device;
(iii) Instructions and explanations of all user-interface components;
(iv) Instructions on how to clean the device;
(v) A shelf life for the electrodes and gel; and
(vi) Reuse information.