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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.

Cala kIQ Gen 2 is a small, lightweight, wrist-worn stimulator device designed to aid in the temporary relief of hand tremors by applying a calibrated Transcutaneous Afferent Patterned Stimulation (TAPS) to the median and radial nerves of a patient's wrist.

The TAPS output pattern is calibrated to the individual patient's tremor frequency. During device setup, the patient performs a postural hold, during which the onboard sensors measure the tremor frequency, which is then used to customize the TAPS output pattern to deliver therapy to the median and radial nerves at the appropriate, patient-specific, optimal stimulation frequency.

Cala kIQ Gen 2 is comprised of the following components:

• . Stimulator: Contains sensors, electronics, and firmware for delivering TAPS therapy and provides user interface
• . Band: Contains multi-use, conductive electrodes spaced at intervals to align with targeted nerves and attachment points for the Cala kIQ Gen 2 Stimulator
• Base Station: Provides charging function and contains an indicator light to alert the user to operating conditions.

The Cala kIQ Gen 2 Stimulator contains the electronics, and firmware for calibrating and delivering TAPS therapy. The patient uses the Cala kIQ Gen 2 Stimulator buttons to complete device calibration, adjust the stimulation amplitude, and initiate therapy sessions. The Cala kIQ Gen 2 Stimulator is attached to the Cala kIQ Gen 2 Band, which includes embedded electrodes placed at appropriate intervals to properly target the medial nerves. To accommodate a broad distribution of wrist sizes, the band is available in three sizes (small, medium, and large).

The provided document is a 510(k) premarket notification for the Cala kIQ device. While it establishes substantial equivalence to a predicate device, it explicitly states that no new performance or clinical data was collected or submitted for this specific 510(k) application (K242259).

The document indicates that the submission is primarily for "labeling updates" to an existing device (Cala kIQ Gen 2), which itself was released under a "note-to-file" and compared to a prior predicate device (Cala kIQ Gen 1, K222237). Therefore, the information you're requesting regarding acceptance criteria and study details would pertain to the original K222237 submission or earlier development phases, which are not detailed in this document.

Based on the provided text, I cannot describe the acceptance criteria and the study that proves the device meets the acceptance criteria as requested because the document explicitly states:

• "There was no performance testing conducted in support of Cala kIQ Gen 2 premarket application." (Page 13, Section VII. PERFORMANCE DATA)
• "There was no clinical testing conducted in support of Cala kIQ Gen 2 premarket application." (Page 13, Section VIII. CLINICAL DATA)

The concluding statement on page 13, Section IX. SUBSTANTIAL EQUIVALENCE, clarifies: "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."

To answer your request, information from the K222237 submission or the original developmental studies for Cala kIQ Gen 1 would be required, which are not part of this document.

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