Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description mentions "onboard sensors measure the tremor frequency which is then used to customize the TAPS output pattern". This describes a calibration process based on sensor data, not necessarily AI/ML. There is no mention of AI, ML, or related terms in the document.

Therapeutic

Yes

The device is indicated to aid in the temporary relief of hand tremors and postural/tremor symptoms in adults with essential tremor and Parkinson's disease, respectively, which classifies it as a therapeutic device.

Diagnostic

No

The device is described as a stimulator that applies Transcutaneous Afferent Patterned Stimulation (TAPS) to provide temporary relief of hand tremors. While it measures tremor frequency for calibration, its primary function is therapeutic, not diagnostic.

SaMD (Software as a Medical Device)

No

The device description explicitly lists hardware components: Stimulator (containing sensors, electronics, and firmware), Band (containing electrodes), and Base Station (for charging). This indicates it is a hardware device with embedded software/firmware, not a software-only medical device.

IVD (In Vitro Diagnostic)

Based on the provided information, the Cala kIQ device is not an In Vitro Diagnostic (IVD).

Here's why:

IVDs analyze samples from the human body. IVDs are designed to examine specimens like blood, urine, tissue, etc., to provide information about a person's health status.
Cala kIQ is a therapeutic device. The description clearly states that Cala kIQ is a "wrist-worn stimulator device designed to aid in the relief of hand tremors by applying a calibrated Transcutaneous Afferent Patterned Stimulation (TAPS)". It directly interacts with the patient's body to provide therapy, rather than analyzing a sample.
The intended use is therapeutic. The indications for use are to "aid in the temporary relief of hand tremors" and "aid in the temporary relief of postural and tremor symptoms". These are therapeutic goals, not diagnostic ones.
The device description focuses on stimulation. The description details how the device measures tremor frequency and delivers electrical stimulation to nerves. This is a therapeutic mechanism.

In summary, Cala kIQ is a therapeutic device that provides electrical stimulation to alleviate symptoms, not a diagnostic device that analyzes biological samples.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

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

Product codes

QBC

Device Description

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.

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).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Median and radial nerves

Indicated Patient Age Range

Adults

Intended User / Care Setting

Patient, In-home use after an initial calibration in the patient's home or in the physician's office.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

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. 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. 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.

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K203288

Reference Device(s)

DEN170028, K182706

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.

Summary

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Build Correspondence

Image /page/0/Picture/2 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

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

1

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 (1-800-638-2041 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

2

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)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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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.
1800 Gateway Drive, Suite 300 San Mateo, CA 94404
Phone: (415) 890-3961
Fax: None |

---------------	--------------------------------------------------------------------------------------------------------------

Primary Contact: Danielle McDonnell Boyd Senior Director, Regulatory Affairs & Quality Assurance Cala Health danielle@calahealth.com (415) 819-2935
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
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
Equivalent? |
|----------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Cala Trio | Cala kIQ | |
| | K203288 | K222237 | |
| 510(k) Number | K203288 | K222237 | |
| Manufacturer | Cala Health | Cala Health | |
| Intended Use | Delivery of transcutaneous afferent patterned
stimulation ("TAPS") for treatment of hand
tremors | Delivery of transcutaneous afferent patterned
stimulation ("TAPS") for treatment of hand
tremors | Yes
Subject Device is identica
to Predicate Device |
| 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 | 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. | Yes
Substantial equivalence
demonstrated through
clinical evidence |
| Target Population | Adults with essential tremor | Adults with essential tremor or Parkinson's
Disease | Yes
Substantial equivalence
demonstrated through
clinical evidence |
| Anatomical site | Median and radial nerves | Median and radial nerves | Yes
Subject Device is identica
to Predicate Device |
| Intended Users | Patient | Patient | Yes
Subject Device is identica
to Predicate Device |
| | Predicate Device
Cala Trio
K203288 | Subject Device
Cala kIQ
K222237 | Substantially
Equivalent? |
| Clinical Setting | In-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. | Yes
Subject Device is identical
to Predicate Device |
| Rx or OTC use | Prescription Use only | Prescription Use only | Yes
Subject Device is identical
to Predicate Device |
| | | Design | |
| Technology | Calibrated Transcutaneous Afferent Patterned
Stimulation (TAPS) delivered through
electrodes embedded on wearable band | Calibrated Transcutaneous Afferent Patterned
Stimulation (TAPS) delivered through
electrodes embedded on wearable band | Yes
Subject Device is identical
to Predicate Device |
| Energy used or
delivered | Electrical stimulation | Electrical stimulation | Yes
Subject Device is identical
to Predicate Device |
| Human Factors | Wrist-worn electrical stimulator with
detachable band containing multi-use
electrodes. Base station provides charging
function and contains indicator lights for
operating status | Wrist-worn electrical stimulator with
detachable band containing multi-use
electrodes. Base station provides charging
function and contains indicator lights for
operating status | Yes
Subject Device is identical
to Predicate Device |
| Patient Contacting
Materials | The following components of the Cala Trio
Band have Surface, Intact Skin Long-Term
contact (>30 days):
• Elastic
• Electrodes
• Microfiber
• Elastic
• Band thread | The following components of the Cala kIQ
Band have Surface, Intact Skin Long-Term
contact (>30 days):
• Elastic
• Electrodes
• Microfiber
• Elastic
• Band thread | Yes
Subject Device is identical
to Predicate Device |
| | Predicate Device
Cala Trio
K203288 | Subject Device
Cala kIQ
K222237 | Substantially
Equivalent? |
| Operating Principle | Transcutaneous Afferent Patterned
Stimulation (TAPS) to the median and
radial nerves of a patient's wrist | Transcutaneous Afferent Patterned
Stimulation (TAPS) to the median and radial
nerves of a patient's wrist | Yes
Subject Device is identical
to Predicate Device |
| Electrodes | 1 common, 2 active electrodes

Individual Electrode Surface area
$22mm x 22mm = 4.84 cm^2$ | 2 common electrodes paired with 2 active
electrodes

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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
Rate	N	Pre	Post	Change	Responder
Rate
		Mean ± SD	Mean ± SD	Mean ± SD	(%)		Mean ± SD	Mean ± SD	Mean ± SD	(%)
					MDS-UPDRS
Average
across 6
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
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
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-
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
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
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
Mean ± SD	Post
Mean ± SD	Change
Mean ± SD	Responder
Rate (%)	N	Pre
Mean ± SD	Post
Mean ± SD	Change
Mean ± SD	Responder
Rate (%)
BF-ADLs
Average
ADL Rating
(8 Tasks,
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
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
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
from a bottle
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
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
change in a
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
electric plug
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
front door
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
Rate	N	Pre	Post	Change	Responder
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
Global
Impression –
Improvement
(CGI-I)	40	N/A			78%
(31/40)	36	N/A			83%
(30/36)
Patient
Global
Impression –
Improvement
(PGI-I)	40	N/A			75%
(30/40)	36	N/A			81%
(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
Mean ± SD	Responder Rate (%)	N	Change
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
Mean ± SD	Responder Rate (%)	N	Change
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

17

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

18

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.