Cala kIQ

K222237 · Cala Health, Inc. · QBC · Nov 22, 2022 · Neurology

Device Facts

• Record ID: K222237
• Device Name: Cala kIQ
• Applicant: Cala Health, Inc.
• Product Code: QBC · Neurology
• Decision Date: Nov 22, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5897
• Device Class: Class 2
• Attributes: Therapeutic

Indications for 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 Story

Cala kIQ is a wrist-worn stimulator for hand tremor relief via Transcutaneous Afferent Patterned Stimulation (TAPS) to median and radial nerves. Device includes stimulator, conductive electrode band, and charging base station. During setup, patient performs postural hold; onboard sensors measure tremor frequency to calibrate patient-specific stimulation pattern. Patient uses buttons to initiate therapy, adjust amplitude, and complete calibration. Used in-home by patients after initial calibration in clinic or home. Output is biphasic, rectangular electrical stimulation. Therapy sessions last 40 minutes. Device provides temporary tremor relief, potentially improving performance of daily living activities (e.g., writing, pouring, using utensils).

Clinical Evidence

Two clinical studies provided. Study 1 (n=40, Parkinson's): Single-arm, non-significant risk study. TAPS therapy showed improvement in MDS-UPDRS tremor tasks and Bain and Findley ADL tasks. Responder rates (≥0.5-point improvement) ranged from 28-70% across tasks. Study 2 (n=19, crossover): Prospective, two-arm study comparing Cala kIQ to Cala Trio. Results showed equivalent safety and effectiveness between devices. No device-related serious adverse events reported in either study.

Technological Characteristics

Wrist-worn electrical stimulator; TAPS therapy; biphasic rectangular waveform; 150 Hz frequency; 650 µs pulse duration; 300 µs phase duration. Materials: elastic, microfiber, conductive electrodes. Connectivity: standalone with base station charging. Complies with IEC 60601 (electrical/mechanical/thermal safety) and ISO 10993-1:2018 (biocompatibility).

Indications for Use

Indicated for adults with essential tremor or Parkinson's disease experiencing hand tremors or postural/kinetic tremor symptoms impacting activities of daily living.

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 Trio (K203288)

Submission Summary (Full Text)

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Build Correspondence

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11/22/2022

Cala Health, Inc. Danielle McDonnell Boyd Senior Director, Regulatory Affairs 1800 Gateway Dr. Suite 300 San Mateo, California 94404

Re: K222237

Trade/Device Name: Cala kIQTM Regulation Number: 21 CFR 882.5897 Regulation Name: External upper limb tremor stimulator Regulatory Class: Class II Product Code: QBC Dated: October 21, 2022 Received: October 21, 2022

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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 (OS) 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 [phone] or 301-796-7100).

Sincerely,

Date: 2022.11.22 Xiaorui Tang 13:34:34 -05'00'

For:

CDR Jitendra Virani Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known) K22237

Device Name Cala kIQ

Indications for Use (Describe)

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 tremor symptoms that impact some activities of daily living in the treated hand following stimulation in adults with Parkinson's disease.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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Image /page/3/Picture/0 description: The image shows the logo for Cala Health. The logo consists of the word "CALA" in a stylized, sans-serif font, with a curved line extending from the bottom of the "C" to the top of the second "A". Below the word "CALA" is the word "HEALTH" in a smaller, sans-serif font. The logo is a light blue color.

## 510(k) Summary

#### I. SUBMITTER

| Manufacturer: | Cala Health, Inc.<br>1800 Gateway Drive, Suite 300 San Mateo, CA 94404<br>Phone: [phone]<br>Fax: None |
|---------------|--------------------------------------------------------------------------------------------------------------|
|---------------|--------------------------------------------------------------------------------------------------------------|

- Primary Contact: Danielle McDonnell Boyd Senior Director, Regulatory Affairs & Quality Assurance Cala Health [e-mail] [phone]
July 22, 2022 Date Prepared:

#### II. SUBJECT DEVICE

| Trade Name: | Cala kIQTM |
|------------------------|---------------------------------------|
| 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 Trio™ |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Prior Submissions: | DEN170028, K182706, K203288 |
| Indications for Use: | Cala Trio is indicated to aid in the temporary relief of hand tremors in<br>the treated hand following stimulation in adults with essential tremor. |

#### DEVICE DESCRIPTION IV.

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

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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 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 Cala kIQ Stimulator
- . Base Station: Provides charging function and contains an indicator light to alert the user to operating conditions.

The Cala kIQ Stimulator contains the electronics, sensors, and firmware for calibrating and delivering TAPS therapy. The patient uses the Cala kIQ Stimulator buttons to complete device calibration, adjust the stimulation amplitude, and initiate therapy sessions. The Cala kIQ Stimulator is attached to the Cala kIQ band, which includes embedded electrodes placed at appropriate intervals 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).

#### V. INDICATIONS FOR 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.

#### VI. SUBSTANTIAL EQUIVALENCE

Table 1 below provides a summary comparison between the Subject Device, Cala kIQ and the Predicate Device, Cala Trio, with respect to intended use, technological characteristics, and principles of operation, providing detailed information regarding the basis for the determination of substantial equivalence.

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## Table 1. Cala kIQ Substantial Equivalence

| | Predicate Device | Subject Device | Substantially<br>Equivalent? |
|----------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Cala Trio | Cala kIQ | |
| | K203288 | K222237 | |
| 510(k) Number | K203288 | K222237 | |
| Manufacturer | Cala Health | Cala Health | |
| Intended Use | Delivery of transcutaneous afferent patterned<br>stimulation ("TAPS") for treatment of hand<br>tremors | Delivery of transcutaneous afferent patterned<br>stimulation ("TAPS") for treatment of hand<br>tremors | Yes<br>Subject Device is identica<br>to Predicate Device |
| Indications for Use | Cala Trio is indicated to aid in the temporary<br>relief of hand tremors in the treated hand<br>following stimulation in adults with essential<br>tremor | Cala kIQ is indicated to aid in the temporary<br>relief of hand tremors in the treated hand<br>following stimulation in adults with essential<br>tremor.<br>Cala kIQ is indicated to aid in the temporary<br>relief of postural and kinetic hand tremor<br>symptoms that impact some activities of daily<br>living in the treated hand following<br>stimulation in adults with Parkinson's<br>disease. | Yes<br>Substantial equivalence<br>demonstrated through<br>clinical evidence |
| Target Population | Adults with essential tremor | Adults with essential tremor or Parkinson's<br>Disease | Yes<br>Substantial equivalence<br>demonstrated through<br>clinical evidence |
| Anatomical site | Median and radial nerves | Median and radial nerves | Yes<br>Subject Device is identica<br>to Predicate Device |
| Intended Users | Patient | Patient | Yes<br>Subject Device is identica<br>to Predicate Device |
| | Predicate Device<br>Cala Trio<br>K203288 | Subject Device<br>Cala kIQ<br>K222237 | Substantially<br>Equivalent? |
| Clinical Setting | In-home use after an initial calibration in the<br>patient's home or in the physician's office. | In-home use after an initial calibration in the<br>patient's home or in the physician's office. | Yes<br>Subject Device is identical<br>to Predicate Device |
| Rx or OTC use | Prescription Use only | Prescription Use only | Yes<br>Subject Device is identical<br>to Predicate Device |
| | | Design | |
| Technology | Calibrated Transcutaneous Afferent Patterned<br>Stimulation (TAPS) delivered through<br>electrodes embedded on wearable band | Calibrated Transcutaneous Afferent Patterned<br>Stimulation (TAPS) delivered through<br>electrodes embedded on wearable band | Yes<br>Subject Device is identical<br>to Predicate Device |
| Energy used or<br>delivered | Electrical stimulation | Electrical stimulation | Yes<br>Subject Device is identical<br>to Predicate Device |
| Human Factors | Wrist-worn electrical stimulator with<br>detachable band containing multi-use<br>electrodes. Base station provides charging<br>function and contains indicator lights for<br>operating status | Wrist-worn electrical stimulator with<br>detachable band containing multi-use<br>electrodes. Base station provides charging<br>function and contains indicator lights for<br>operating status | Yes<br>Subject Device is identical<br>to Predicate Device |
| Patient Contacting<br>Materials | The following components of the Cala Trio<br>Band have Surface, Intact Skin Long-Term<br>contact (>30 days):<br>• Elastic<br>• Electrodes<br>• Microfiber<br>• Elastic<br>• Band thread | The following components of the Cala kIQ<br>Band have Surface, Intact Skin Long-Term<br>contact (>30 days):<br>• Elastic<br>• Electrodes<br>• Microfiber<br>• Elastic<br>• Band thread | Yes<br>Subject Device is identical<br>to Predicate Device |
| | Predicate Device<br>Cala Trio<br>K203288 | Subject Device<br>Cala kIQ<br>K222237 | Substantially<br>Equivalent? |
| Operating Principle | Transcutaneous Afferent Patterned<br>Stimulation (TAPS) to the median and<br>radial nerves of a patient's wrist | Transcutaneous Afferent Patterned<br>Stimulation (TAPS) to the median and radial<br>nerves of a patient's wrist | Yes<br>Subject Device is identical<br>to Predicate Device |
| Electrodes | 1 common, 2 active electrodes<br><br>Individual Electrode Surface area<br>$22mm x 22mm = 4.84 cm^2$ | 2 common electrodes paired with 2 active<br>electrodes<br><br>Individual Electrode Surface area<br>$22mm x 6mm = 1.32 cm^2$ | Yes<br>Substantial equivalence<br>demonstrated through<br>non- clinical performance<br>testing and clinical<br>evidence |
| Battery and Base<br>Station | Rechargeable Lithium-ion battery and AC-<br>powered charger. | Rechargeable Lithium-ion battery and AC-<br>powered charger. | Yes<br>Subject Device is identical<br>to Predicate Device |
| | Performance | | |
| User Workflow | 1. Calibration<br>2. Set stimulation intensity<br>3. Therapy available on demand | 1. Calibration<br>2. Set stimulation intensity<br>3. Therapy available on demand | Yes<br>Subject Device is identical<br>to Predicate Device |
| Treatment Time | 40 minutes | 40 minutes | Yes<br>Subject Device is identical<br>to Predicate Device |
| Wristband life | 90 days | 90 days | Yes<br>Subject Device is identical<br>to Predicate Device. |
| | Predicate Device<br>Cala Trio<br>K203288 | Subject Device<br>Cala kIQ<br>K222237 | Substantially<br>Equivalent? |
| Shelf-life | Cala Trio Band: 24 months | Cala kIQ Band: 3 months | Yes<br>Shelf-life testing confirms<br>Cala kIQ Band meets<br>product specification at<br>labeled shelf-life.<br>Shelf-life difference from<br>predicate due to<br>availability of test data,<br>not performance<br>characteristics |
| Output Specifications | | | |
| Waveform (e.g.,<br>pulsed monophasic,<br>biphasic) | Biphasic | Biphasic | Yes<br>Subject Device is identical<br>to Predicate Device |
| Shape (e.g.,<br>rectangular, spike,<br>rectified sinusoidal) | Rectangular | Rectangular | Yes<br>Subject Device is identical<br>to Predicate Device |
| Maximum Output<br>Voltage<br>(volts) | 4 @ 500Ω | 4 @ 500Ω | Yes<br>Subject Device is identical<br>to Predicate Device |
| | 80 @ 10kΩ | 80 @ 10kΩ | |
| Maximum Output<br>Current<br>(mA) | 8 @ 500Ω | 8 @ 500Ω | Yes<br>Subject Device is identical<br>to Predicate Device |
| | 8 @ 10kΩ | 8 @ 10kΩ | |
| Duration of primary<br>(depolarizing) phase<br>(μsec) | 300 | 300 | Yes<br>Subject Device is identical<br>to Predicate Device |
| | Predicate Device<br>Cala Trio<br>K203288 | Subject Device<br>Cala kIQ<br>K222237 | Substantially Equivalent? |
| Pulse Duration<br>(μsec) | 650 | 650 | Yes<br>Subject Device is identical<br>to Predicate Device |
| Frequency<br>(Hz) | 150 | 150 | Yes<br>Subject Device is identical<br>to Predicate Device |
| Symmetrical phases? | Yes | Yes | Yes<br>Subject Device is identical<br>to Predicate Device |
| Phase Duration<br>(μS) | 300 each phase | 300 each phase | Yes<br>Subject Device is identical<br>to Predicate Device |
| Net Charge<br>(μC) | 0 @500Ω | 0 @500Ω | Yes<br>Subject Device is identical<br>to Predicate Device |
| Maximum Phase<br>Charge<br>(μC) | 2.4 @ 500Ω | 2.4 @ 500Ω | Yes<br>Subject Device is identical<br>to Predicate Device |
| Maximum Current<br>Density<br>(mA/cm², r.m.s.) | 0.50 @ 500Ω | 1.29 @ 500Ω | Yes<br>Substantial equivalence<br>demonstrated through non-<br>clinical performance testing<br>and clinical evidence |
| Maximum Average<br>Current<br>(mA) (average<br>absolute value) | 0.72 @ 500Ω | 0.72 @ 500Ω | Yes<br>Subject Device is identical<br>to Predicate Device |
| | Predicate Device<br>Cala Trio<br>K203288 | Subject Device<br>Cala kIQ<br>K222237 | Substantially<br>Equivalent? |
| Maximum Average<br>Power Density<br>(mW/cm²) | 0.59 @ 500Ω<br>(.0006 W/cm²) | 2.18 @ 500Ω<br>(0.0022 W/cm²) | Yes<br>Substantial equivalence<br>demonstrated through non-<br>clinical performance testing<br>and clinical evidence |
| Safety | | | |
| Electrical safety | Conforms to IEC 60601 Electrical Safety | Conforms to IEC 60601 Electrical Safety | Yes<br>Subject Device is identical<br>to Predicate Device |
| Compatibility<br>with intended<br>environments | Conforms to EMC requirements | Conforms to EMC requirements | Yes<br>Subject Device is identical<br>to Predicate Device |
| Mechanical safety | Conforms to IEC 60601 Electrical Safety | Conforms to IEC 60601 Electrical Safety | Yes<br>Subject Device is identical<br>to Predicate Device |
| Chemical safety | Not applicable | Not applicable | Yes<br>Subject Device is identical<br>to Predicate Device |
| Thermal safety | Conforms to IEC 60601 Electrical Safety | Conforms to IEC 60601 Electrical Safety | Yes<br>Subject Device is identical<br>to Predicate Device |
| Radiation safety | Not applicable | Not applicable | Yes<br>Subject Device is identical<br>to Predicate Device |

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#### VII. PERFORMANCE DATA

Non-clinical performance testing confirmed that Cala kIQ complies with performance standards and functions as intended.

Performance testing included bench testing to confirm electrode function, physical characteristics, mechanical function, shelf life, and system performance. Testing confirmed that the Cala kIQ meets the product requirements.

EMC and Electrical Safety testing demonstrated that Cala kIO is compliant with the applicable IEC 60601 clauses. Biocompatibility evaluations and assessments per FDA Guidance documents demonstrate that Cala kIQ meets the ISO 129993-1:2018 standard and is acceptable for use.

### VIII. CLINICAL DATA

Clinical data to support substantial equivalence for the differences in indicated patient populations and technological characteristics includes evidence from two clinical studies.

The first clinical study was a single-arm. non-significant risk study that evaluated calibrated TAPS therapy in patients with Parkinson's Disease who also had postural hand tremor.

A total of forty patients were enrolled in the study. There were no reports of device-related serious adverse events, and all device-related adverse events were resolved with minimal intervention.

Across visits, TAPS therapy improved 0.5±0.5 points on an unvalidated subset of MDS-UPDRS dominant hand tasks listed below:

- Rest Tremor Amplitude ●
- Postural Tremor ●
- Kinetic Tremor ●
- Pronation-Supination ●
- Finger Tapping ●
- Hand Movements ●

Also, across visits, TAPS therapy improved the ability to perform some activities of daily living by 0.4±0.5 points based on an unvalidated subset of BF-ADL tasks listed below:

- Use a spoon to drink soup .
- Hold a cup of tea ●
- Pour milk from a bottle or carton ●
- Dial a telephone
- Pick up your change in a shop
- Insert an electric plug into a socket ●
- . Unlock your front door with a key
- Write a letter ●

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These results were descriptive in nature, different patients showed improvement in different tasks tested. None of the patients showed improvement in all of the tasks tested and some of the patients showed no improvement in any of the tasks tested.

Pre-stimulation to post-stimulation change was evaluated for each of the MDS-UPDRS Part III dominant hand tasks and the Bain and Findley ADL tasks at both Visits 2 and 3. The MDS-UPDRS and BF-ADL scales are assessed at 1-point increments and improvement was calculated for the average scores as well as for each individual task. The responder rate, defined as the percent of subjects that had a ≥ 0.5-point average per-task improvement, was calculated for the average scores as well as for each individual task. The study design included two visits with study clinicians and a 2-week home use period of during which subjects were instructed to complete TAPS therapy sessions twice daily. Assessment performed during study visits were completed while subjects were off medication, home-use sessions completed with subjects on medication per their standard of care.

Table 2 below provides study data for all enrolled subjects and includes responder rates for assessment averages and individual tasks. Of note, the CGI-I were used as secondary endpoints in the study:

Table 3 below provides the responder rates for study subjects with a score of > 2 for a specific task at the applicable visit. The data in Table 3 are a subset of the results summarized in Table 2.

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| | Visit 2 | | | | Visit 3 | | | | | |
|--------------------------------------------------------------|---------|------------------|-------------------|---------------------|-----------------------|---------|------------------|-------------------|---------------------|-----------------------|
| | N | Pre | Post | Change | Responder<br>Rate | N | Pre | Post | Change | Responder<br>Rate |
| | | Mean ± SD | Mean ± SD | Mean ± SD | (%) | | Mean ± SD | Mean ± SD | Mean ± SD | (%) |
| | | | | | MDS-UPDRS | | | | | |
| Average<br>across 6<br>tasks* | 40 | 1.63 ± 0.55 | 1.20 ± 0.69 | -0.44 ± 0.44 | 40% | 36 | 1.51 ± 0.50 | 1.11 ± 0.57 | -0.40 ± 0.37 | 44% |
| Rest Tremor | 40 | 1.85 ± 1.10 | 1.33 ± 1.07 | -0.53 ± 0.82 | 45% | 36 | 1.94 ± 0.95 | 1.44 ± 1.05 | -0.50 ± 0.94 | 39% |
| Postural<br>Tremor | 40 | 2.30 ± 0.88 | 1.35 ± 1.08 | -0.95 ± 0.88 | 70% | 36 | 2.14 ± 0.96 | 1.31 ± 1.06 | -0.83 ± 0.88 | 61% |
| Kinetic<br>Tremor | 40 | 1.08 ± 0.92 | 0.75 ± 0.81 | -0.33 ± 0.53 | 35% | 36 | 1.06 ± 0.92 | 0.83 ± 0.74 | -0.22 ± 0.42 | 22% |
| Pronation-<br>Supination | 40 | 1.50 ± 0.91 | 1.23 ± 0.95 | -0.28 ± 0.72 | 33% | 36 | 1.31 ± 0.95 | 1.17 ± 1.00 | -0.14 ± 0.76 | 28% |
| Finger<br>Tapping | 40 | 1.75 ± 0.87 | 1.45 ± 0.96 | -0.30 ± 0.76 | 28% | 36 | 1.47 ± 0.84 | 1.03 ± 0.77 | -0.44 ± 0.56 | 42% |
| Hand<br>Movements | 40 | 1.30 ± 0.82 | 1.10 ± 0.87 | -0.20 ± 0.79 | 35% | 36 | 1.14 ± 0.80 | 0.89 ± 0.67 | -0.25 ± 0.69 | 28% |
| | Visit 2 | | | | Visit 3 | | | | | |
| | N | Pre<br>Mean ± SD | Post<br>Mean ± SD | Change<br>Mean ± SD | Responder<br>Rate (%) | N | Pre<br>Mean ± SD | Post<br>Mean ± SD | Change<br>Mean ± SD | Responder<br>Rate (%) |
| BF-ADLs | | | | | | | | | | |
| Average<br>ADL Rating<br>(8 Tasks,<br>8-32)* | 40 | 1.93 ± 0.50 | 1.48 ± 0.43 | -0.44 ± 0.43 | 43% | 36 | 1.76 ± 0.48 | 1.44 ± 0.37 | -0.32 ± 0.39 | 25% |
| Use a spoon<br>to drink soup | 40 | 2.23 ± 0.97 | 1.60 ± 0.74 | -0.63 ± 0.74 | 55% | 36 | 2.19 ± 0.92 | 1.78 ± 0.76 | -0.42 ± 0.77 | 33% |
| Hold a cup of<br>tea | 40 | 2.13 ± 0.94 | 1.75 ± 0.84 | -0.38 ± 0.84 | 40% | 36 | 2.03 ± 1.00 | 1.69 ± 0.79 | -0.33 ± 0.68 | 25% |
| Pour milk<br>from a bottle<br>or carton | 40 | 2.00 ± 0.72 | 1.48 ± 0.68 | -0.53 ± 0.78 | 45% | 36 | 1.89 ± 0.67 | 1.56 ± 0.73 | -0.33 ± 0.68 | 42% |
| Dial a<br>telephone | 40 | 1.75 ± 0.74 | 1.23 ± 0.58 | -0.53 ± 0.72 | 45% | 36 | 1.53 ± 0.61 | 1.17 ± 0.38 | -0.36 ± 0.54 | 33% |
| Pick up your<br>change in a<br>shop | 40 | 1.60 ± 0.71 | 1.33 ± 0.53 | -0.28 ± 0.64 | 23% | 36 | 1.42 ± 0.60 | 1.31 ± 0.52 | -0.11 ± 0.52 | 19% |
| Insert an<br>electric plug<br>into a socket | 40 | 1.65 ± 0.70 | 1.30 ± 0.52 | -0.35 ± 0.70 | 38% | 36 | 1.42 ± 0.65 | 1.14 ± 0.42 | -0.28 ± 0.61 | 25% |
| Unlock your<br>front door<br>with a key | 40 | 1.59 ± 0.72 | 1.33 ± 0.53 | -0.26 ± 0.59 | 23% | 36 | 1.44 ± 0.61 | 1.17 ± 0.38 | -0.28 ± 0.51 | 25% |
| | Visit 2 | | | | | Visit 3 | | | | |
| | N | Pre | Post | Change | Responder<br>Rate | N | Pre | Post | Change | Responder<br>Rate |
| | | Mean ± SD | Mean ± SD | Mean ± SD | (%) | | Mean ± SD | Mean ± SD | Mean ± SD | (%) |
| Write a letter | 40 | 2.48 ± 0.78 | 1.85 ± 0.74 | -0.63 ± 0.70 | 53% | 36 | 2.19 ± 0.86 | 1.72 ± 0.81 | -0.47 ± 0.61 | 42% |
| Global Impression - Improvement | | | | | | | | | | |
| Clinical<br>Global<br>Impression –<br>Improvement<br>(CGI-I) | 40 | N/A | | | 78%<br>(31/40) | 36 | N/A | | | 83%<br>(30/36) |
| Patient<br>Global<br>Impression –<br>Improvement<br>(PGI-I) | 40 | N/A | | | 75%<br>(30/40) | 36 | N/A | | | 81%<br>(29/36) |

# Table 2. PD-02 Responder Rates for All Enrolled Subjects

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*For averaged scores, a Responder was defined as subjects that had a ≥ 0.5-point average per-task improvement

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| Visit 2 | | | Visit 3 | | | |
|---------------------------------------|---------------------|---------------------|--------------------|---------------------|---------------------|--------------------|
| N | Change<br>Mean ± SD | Responder Rate (%) | N | Change<br>Mean ± SD | Responder Rate (%) | |
| MDS-UPDRS | | | | | | |
| Action Tremor (Postural and Kinetic)* | 18 | -0.61 ± 0.58 | 67% | 16 | -0.59 ± 0.61 | 63% |
| Rest Tremor Amplitude | 28 | -0.79 ± 0.79 | 61% | 28 | -0.57 ± 1.00 | 39% |
| Postural Tremor | 33 | -1.00 ± 0.94 | 70% | 28 | -0.93 ± 0.94 | 64% |
| Kinetic Tremor | 13 | -0.54 ± 0.52 | 54% | 12 | -0.58 ± 0.51 | 58% |
| Pronation-Supination | 17 | -0.59 ± 0.80 | 53% | 13 | -0.23 ± 1.01 | 38% |
| Finger Tapping | 21 | -0.57 ± 0.81 | 38% | 17 | -0.65 ± 0.61 | 59% |
| Hand Movements | 15 | -0.47 ± 0.64 | 40% | 10 | -0.90 ± 0.74 | 70% |
| BF-ADLs | | | | | | |
| Use a spoon to drink soup | 30 | -0.87 ± 0.68 | 73% | 27 | -0.56 ± 0.85 | 44% |
| Hold a cup of tea | 29 | -0.59 ± 0.87 | 55% | 23 | -0.52 ± 0.79 | 39% |
| Pour milk from a bottle or carton | 30 | -0.73 ± 0.78 | 60% | 26 | -0.46 ± 0.76 | 58% |
| Dial a telephone | 23 | -0.91 ± 0.73 | 78% | 17 | -0.76 ± 0.56 | 71% |
| Visit 2 | | | Visit 3 | | | |
| | N | Change<br>Mean ± SD | Responder Rate (%) | N | Change<br>Mean ± SD | Responder Rate (%) |
| Pick up your change in a shop | 19 | $-0.63 \pm 0.76$ | 47% | 13 | $-0.54 \pm 0.52$ | 54% |
| Insert an electric plug into a socket | 21 | $-0.81 \pm 0.60$ | 71% | 12 | $-0.83 \pm 0.83$ | 75% |
| Unlock your front door with a key | 18 | $-0.61 \pm 0.70$ | 50% | 14 | $-0.71 \pm 0.61$ | 64% |
| Write a letter | 36 | $-0.69 \pm 0.71$ | 58% | 27 | $-0.63 \pm 0.63$ | 56% |

# Table 3. PD-02 Responder Rates for Subjects with Score ≥ 2 per Task

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*For averaged scores, a Responder was defined as subjects that had a ≥ 0.5-point average per-task improvement

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Considering existing data for versions of this device, reviewed and cleared under previous submissions for patients with similar symptoms, this study provides sufficient information to demonstrate that Cala kIQ may be effective 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.

The second study was a prospective, single-center, two-arm, non-significant risk, crossover study demonstrating that Cala kIO provides TAPS therapy with equivalent safety and effectiveness as compared to Cala Trio.

A total of 19 subjects completed the study, 6 of which had Parkinson's Disease. There were no reports of device-related serious adverse events, and all were resolved with minimal intervention. Clinician-rated tremor assessments (TETRAS and MDS-UPDRS), and subject-rated assessments (BF- ADLs) results were similar for Cala kIQ and Cala Trio.

#### SUBSTANTIAL EQUIVALENCE IX.

Substantial equivalence of the Subject Device, Cala kIQ, to the Predicate Device, Cala Trio, is demonstrated based on the comparison of labeling, technical characteristics, performance, and both clinical and non-clinical testing.

The intended use is unchanged and the difference in the indications for use has been supported by clinical data as described above.

Performance testing demonstrated that Cala kIQ complies with the same special controls and the same consensus and performance standards as Cala Trio.

#### CONCLUSION X.

The Subject Device, Cala kIQ, has the same intended use as the Predicate Device, Cala Trio. The differences between the subject and predicate device indications for use do not alter the intended use of the device. Clinical data support the temporary relief of postural and kinetic hand tremor symptoms of some activities of daily living in Parkinson's Disease and demonstrate that Cala kIQ delivers TAPS therapy with equivalent safety and effectiveness as Cala Trio.

The subject and predicate device have similar technological characteristics and the differences do not raise new questions of safety or effectiveness. Performance testing demonstrates that Cala kIQ is as safe, as effective, and performs as well as Cala Trio.

Cala kIQ and Cala Trio are substantially equivalent. Cala Health has provided evidence as described above to demonstrate that any differences in the indications for use and technological characteristics do not impact safety or effectiveness.