Who is the manufacturer of Cala Trio?

Cala Health, Inc. filed the 510(k) submission for Cala Trio (K203288).

What is the FDA product code for Cala Trio?

QBC. It is classified under 21 CFR 882.5897 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for Cala Trio?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Cala Trio?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Cala Trio

K203288 · Cala Health, Inc. · QBC · Oct 5, 2021 · Neurology

Device Facts

Record ID	K203288
Device Name	Cala Trio
Applicant	Cala Health, Inc.
Product Code	QBC · Neurology
Decision Date	Oct 5, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.5897
Device Class	Class 2
Attributes	Therapeutic

Indications for Use

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

Device Story

Cala Trio is a wrist-worn neuromodulation system for essential tremor symptom relief. System components: rechargeable stimulator, wrist-worn electrode band, and charging base station. Device applies Transcutaneous Afferent Patterned Stimulation (TAPS) to median and radial nerves. Input: tremor motion measured by onboard triaxial accelerometer. Processing: embedded firmware controls stimulation delivery parameters, calibration, and amplitude adjustments based on user input via three housing buttons. Output: TAPS therapy delivered through integrated electrodes; device display provides instructions and status. Used in home setting by patient. Healthcare providers use device output to monitor therapy; device does not provide diagnostic data. Benefits: temporary reduction in hand tremor severity.

Clinical Evidence

Clinical evidence includes a prospective, multi-center, single-arm, 3-month home-use study (n=263 enrolled, 205 completed). Results showed 62% (TETRAS) and 68% (BF-ADL) of moderate/severe patients improved to mild/slight. Clinician-reported improvement (CGI-I) was 68%; patient-reported improvement (PGI-I) was 60%. Additional studies (Isaacson et al., 2020; Yu et al., 2020) support persistent tremor relief post-stimulation (median 60 minutes) and efficacy of TAPS therapy.

Technological Characteristics

Wrist-worn stimulator with triaxial accelerometer; TAPS delivered via three embedded electrodes in a biocompatible nylon/plastic band. Energy source: 3.8V Li-ion battery. Connectivity: Base station with LTE for cloud data transfer (monitoring only). Software: Embedded firmware for calibration and stimulation control. Standards: IEC 60601-1 (safety/EMC), ISO 10993-1:2018 (biocompatibility), IEC 62133 (battery). Output: Biphasic, rectangular waveform, 150Hz, 650µs pulse duration.

Indications for Use

Indicated for adults with essential tremor to aid in temporary relief of hand tremors in the treated hand via stimulation.

Regulatory Classification

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.

Special Controls

In combination with the general controls of the FD&C Act, the external upper limb tremor stimulator is subject to the following special controls:

*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.

Predicate Devices

Cala ONE (DEN170028, K182706)

Submission Summary (Full Text)

{0}------------------------------------------------ October 5, 2021 Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. Cala Health, Inc. Danielle Boyd Director, Regulatory Affairs 875 Mahler Road, Suite 168 Burlingame, California 94010 Re: K203288 Trade/Device Name: Cala Trio Regulation Number: 21 CFR 882.5897 Regulation Name: External upper limb tremor stimulator Regulatory Class: Class II Product Code: QBC Dated: November 6, 2020 Received: November 9, 2020 Dear Danielle Boyd: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part {1}------------------------------------------------ 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Patrick Antkowiak Acting Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K182706 Device Name Cala Trio Indications for Use (Describe) The Cala Trio device is indicated to aid in the temporary relief of hand tremors in the treated hand following stimulation in adults with essential tremor. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for Cala Health. The logo is blue and features the word "CALA" in a stylized font with a curved line above it. Below the word "CALA" is the word "HEALTH" in a smaller, sans-serif font. The logo is simple and modern, and the blue color gives it a sense of trustworthiness and reliability. ### 510(k) Summary 510(k): Device Modification [K203288] - I. Submitter Manufacturer: Cala Health, Inc. 875 Mahler Rd, Suite 168 Burlingame, CA 94010 Phone: (415) 890-3961 Fax: None Primary Contact: Danielle McDonnell Boyd Director, Regulatory Affairs, Cala Health danielle(@calahealth.com (415) 819-2935 Date Prepared: October 4, 2021 II. Subiect Device Cala Trio™ Trade Name: Classification Name: External upper limb tremor stimulator Device Classification: Class II Regulation: 21 CFR 882.5897 Product Code: QBC III. Predicate Device Predicate Device: Cala ONE DEN170028, K182706 Prior Submissions: Indications for Use: Cala ONE is indicated to aid in the transient relief of hand tremors in the treated hand following stimulation in adults with essential tremor. {4}------------------------------------------------ ### IV. Description of Device Cala Trio is a small, lightweight, wrist-worn stimulator device designed to aid in essential tremor symptom relief by applying Transcutaneous Afferent Patterned Stimulation (TAPS) to the median and radial nerves of a patient's wrist. The Cala Trio system includes three main components: (1) a rechargeable stimulator, (2) a wrist-worn electrode band, and (3) a base station that charges the device. The stimulator component contains the electronics for delivering TAPS to the patient's wrist. There are three buttons on the stimulator that are used for calibration and stimulation amplitude adjustments, among other functions. Text prompts, stimulation delivery parameters, timer, and other messages are provided on the stimulator's full color display to provide instructions and stimulation delivery information. To deliver therapy, the stimulator is attached to the wrist band, which includes integrated electrodes placed at appropriate intervals around the inner diameter of the band to properly target the median and radial nerves. To accommodate a broad distribution of wrist sizes, the band is available in three sizes (small, medium, and large). Each band size is also available in right or left-handed versions to target the appropriate nerves of the prescribed hand. #### V. Indications for Use Cala Trio is indicated to aid in the temporary relief of hand tremors in the treated hand following stimulation in adults with essential tremor. {5}------------------------------------------------ ### VI. Technological Characteristics The following table provides a summary comparison for technical characteristics between Cala ONE (predicate device) and Cala Trio (subject device). | | Cala ONE DEN170028 K182706 (Predicate Device) | Cala Trio K203288 (Subject Device) | Discussion of Differences | |--------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | Delivery of transcutaneous afferent patterned stimulation (TAPS) for hand tremors in essential tremor patients | Delivery of transcutaneous afferent patterned stimulation (TAPS) for hand tremors in essential tremor patients | Same | | Indications for Use | Cala ONE is indicated to aid in the transient relief of hand tremors in adults with essential tremor. | Cala Trio is indicated to aid in the temporary relief of hand tremors in adults with essential tremor. | Substantially Equivalent The indications for use is changed from "transient" to "temporary” but does not impact safety or effectiveness. Cala Trio is indicated for the same condition and patient population. Clinical evidence summarized in Section VII demonstrates that the indications for use change does not impact the safety or effectiveness of the device. | | | Cala ONE DEN170028 K182706 (Predicate Device) | Cala Trio K203288 (Subject Device) | Discussion of Differences | | Design | Stimulator with on- board motion sensors permanently mounted on wristband | Stimulator with on- board motion sensors that is detachable from wristband | Substantially Equivalent The difference in component attachment does not impact the safety or effectiveness of the device. The TAPS therapy parameters as controlled by Cala Trio are unchanged from Cala ONE. | | | Wrist-worn band with three 4x4 cm² electrodes manually attached by the user | Wrist-worn band with three 4.84 cm² electrodes embedded in the band | Substantially Equivalent The difference in electrode configuration does not impact the safety or effectiveness of the device. Clinical evidence summarized in Section VII demonstrates that the surface area change does not impact the safety or effectiveness of the device. The Cala Trio electrode surface area is equivalent and the electrode material are unchanged from Cala | | Cala ONE DEN170028 K182706 | Cala Trio K203288 | Discussion of Differences | | | (Predicate Device) | (Subject Device) | | | | AC-powered charger that connects to the stimulator via USB port | AC-powered base station for recharging the stimulator Base Station includes an LTE antenna that provides connection and data transfer to cloud system which supports device operations such as device assistance and maintenance | Substantially Equivalent The difference in the charging component does not impact the safety or effectiveness of the device. The Cala Trio energy source (battery) and stimulator circuitry is unchanged from Cala ONE. The cloud provides support and maintenance functions only. Transferred data is used for monitoring purposes only and is not used for diagnosis or other treatment-related recommendations or treatment adjustments. | | | Embedded firmware control of device calibration, stimulation delivery, and device function | Embedded firmware control of device calibration, stimulation delivery, and device function | Same | | | | Cala ONE DEN170028 K182706 (Predicate Device) | Cala Trio K203288 (Subject Device) | Discussion of Differences | | | Device sensors (gyroscope and triaxial accelerometer) measure tremor motion | Device sensors (triaxial accelerometer) measure tremor motion | Substantially Equivalent The difference in the motion sensors does not impact safety or effectiveness. Non-clinical performance testing demonstrated that the measurements obtained from the Cala Trio sensor are equivalent to those obtained from the Cala ONE sensors. | | Features | • Set-up calibration • Stimulation intensity control • Therapy available on demand | • Set-up calibration • Stimulation intensity control • Therapy available on demand | Same | | User Interface | Stimulator display guides device setup, operation, and usage information. Four buttons on the device housing allow user control of the stimulation amplitude and device calibration | Stimulator display guides device setup, operation, and usage information. Three buttons on the device housing allow user control of the stimulation amplitude and device calibration | Substantially Equivalent The difference in the user interface does not impact safety or effectiveness. The Cala Trio buttons serve the same combined functions as those controlled separately by the buttons in Cala ONE. The device setup, operation, and usage information are unchanged. | | Prescription or OTC | Prescription | Prescription | Same | | Sterility | Non-sterile | Non-sterile | Same | | Materials | Biocompatible wrist band | Biocompatible wrist band | Same | | | Cala ONE DEN170028 K182706 (Predicate Device) | Cala Trio K203288 (Subject Device) | Discussion of Differences | | Energy Source | Permanent 3.7V Lithium- Ion rechargeable battery | Permanent 3.8V Lithium- Ion rechargeable battery | Substantially Equivalent The difference in battery voltage does not impact safety or effectiveness. The Cala Trio and Cala ONE device batteries both comply with IEC 62133 standard. | | Frequency of Use | The device is used as needed by the patient | The device is used as needed by the patient | Same | | Band Use Life | Single Use (DEN170028) 30 Days (K182706) | 90 Days | Substantially Equivalent The difference in band use-life does not impact safety or effectiveness. Non-clinical performance testing demonstrated that the Cala Trio electrode maintains electrode integrity and delivers therapy as intended for the duration of the 90- day use-life. | | Principle of Operations | Biphasic Waveform, rectangular | Biphasic Waveform, rectangular | Same | | Output Modes | 1 channel with 2 alternating outputs | 2 alternating channels | Substantially Equivalent The difference in the number of output channels does not impact safety or effectiveness. The functionality of the output channel and the therapy parameters are unchanged. | | | Cala ONE DEN170028 K182706 (Predicate Device) | Cala Trio K203288 (Subject Device) | Discussion of Differences | | Output | Current Regulated | Current Regulated | Same | | Housing Materials | Plastic Velcro Straps (Nylon) | Plastic Velcro Straps (Nylon) | Same | | Weight | 56g | Stimulator: 28g Base Station: 209g Band: 13.4g - 15.9g | Substantially Equivalent The difference in device weight does not impact safety or effectiveness. The total weight of the patient-worn components of Cala Trio and Cala ONE (band and stimulator) have equivalent weights. | | Dimensions (mm) | 52 x 79 x 16 | Stimulator: 42 x 55 x 13 Base Station: 104 x 36 x 91 Band Length: 252.5 - 327.5 Band Width: 20.8 -54.1 | Substantially Equivalent The difference in device dimensions does not impact safety or effectiveness. The patient-worn components) of Cala Trio and Cala ONE (band and stimulator) have equivalent dimensions | | Output Specification Category | Cala ONE DEN170028 K182706 (Predicate Device) | Cala Trio K203288 (Subject Device) | Comparison Result | | Waveform | Biphasic | Biphasic | Same | | Shape | Rectangular | Rectangular | Same | | Maximum Output Voltage (volts) | 7.5 @ 500Ω | 7.5 @ 500Ω | Same | | | 120 @ 10kΩ | 80 @ 10kΩ | Substantially Equivalent The therapy pattern parameters are unchanged. Clinical evidence summarized in Section VII demonstrates that the reduction in maximum output voltage does not impact safety or effectiveness of the device | | Maximum Output Current (mA) | 15 @ 500Ω | 8 @ 500Ω | Substantially Equivalent The therapy pattern parameters are unchanged. | | | 12 @ 10kΩ | 8 @ 10kΩ | Clinical evidence summarized in Section VII demonstrates that the reduction in maximum output current does not impact safety or effectiveness of the device | | Output Specification Category | Cala ONE DEN170028 K182706 (Predicate Device) | Cala Trio K203288 (Subject Device) | Comparison Result | | Duration of primary (depolarizing) phase (µsec) | 300 | 300 | Same | | Pulse Duration (µsec) | 650 | 650 | Same | | Frequency (Hz) | 150 | 150 | Same | | Symmetrical phases? | Yes | Yes | Same | | Phase Duration (µS) | 300 each phase | 300 each phase | Same | | Net Charge (µC) | 0 @500Ω | 0 @500Ω | Same | | Maximum Phase Charge (µC) | 4.5 @ 500Ω | 2.4 @ 500Ω | Substantially Equivalent The therapy pattern parameters are unchanged. Clinical evidence summarized in Section VII demonstrates that the reduction in maximum phase charge does not impact safety or effectiveness of the device | | Output Specification Category | Cala ONE DEN170028 K182706 (Predicate Device) | Cala Trio K203288 (Subject Device) | Comparison Result | | Maximum Current Density (mA/cm², r.m.s.) | 2.41 @ 500Ω | 1.17 @ 500Ω | Substantially Equivalent The therapy pattern parameters are unchanged. Clinical evidence summarized in Section VII demonstrates that the reduction in maximum current density does not impact safety or effectiveness of the device | | Maximum Average Current (mA) (average absolute value) | 1.35 @ 500Ω | 0.72 @ 500Ω | Substantially Equivalent The therapy pattern parameters are unchanged. Clinical evidence summarized in Section VII demonstrates that the reduction in maximum average current does not impact safety or effectiveness of the device | | Output Specification Category | Cala ONE DEN170028 K182706 | Cala Trio K203288 | Comparison Result | | | (Predicate Device) | (Subject Device) | | | Maximum Average Power Density (mW/cm²) | 2.30 @ 500Ω | 1.12 @ 500Ω | Substantially Equivalent | | | | | The therapy pattern parameters are unchanged. | | | | | Clinical evidence summarized in Section VII demonstrates that the reduction in maximum average power density does not impact safety or effectiveness of the device | ## Technical Comparison of the Subject Device and Predicate Device {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ {9}------------------------------------------------ {10}------------------------------------------------ {11}------------------------------------------------ ### VII. Performance and Non-Clinical Testing The following tables provide a summary comparison for performance, and nonclinical testing of Cala ONE (predicate device) and Cala Trio (subject device). # Performance Comparison of the Modified Device and Predicate Device {12}------------------------------------------------ {13}------------------------------------------------ {14}------------------------------------------------ ## Nonclinical Testing Comparison of the Modified Device and Predicate Device | Output Specification Category | Cala ONE | Cala Trio | Comparison Result | |-------------------------------------|-----------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|-------------------| | | DEN170028 K182706 (Predicate Device) | K203288 (Subject Device) | | | Biocompatibility | Demonstrated Biocompatibility in accordance with ISO 10993-1:2009 | Demonstrated Biocompatibility in accordance with ISO 10993-1:2018 | Same | | EMC and Electrical Safety | Meets all requirements of IEC60601-1 and relevant collateral and particular standards | Meets all requirements of IEC60601-1 and relevant collateral and particular standards | Same | | Stimulation Waveform Testing | Stimulation waveform conforms to requirements of internal standard test method and acceptance criteria | Stimulation waveform conforms to requirements of internal standard test method and acceptance criteria | Same | {15}------------------------------------------------ | Output Specification Category | Cala ONE DEN170028 K182706 | Cala Trio K203288 | Comparison Result | |-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|-------------------| | | (Predicate Device) | (Subject Device) | | | Shelf Life<b…

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