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

Device Description

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

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

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

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

AI/ML Overview

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

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

1. Table of Acceptance Criteria and Reported Device Performance

Category	Acceptance Criteria (Predicate Device K242259)	Reported Device Performance (Subject Device K243848)
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
Indications for Use	Aid in temporary relief of hand tremors in the treated hand following stimulation in adults with essential tremor. Aid in temporary relief of postural and kinetic hand tremor symptoms that impact some activities of daily living in the treated hand following stimulation in adults with Parkinson's disease.	Aid in temporary relief of hand tremors in the treated hand following stimulation in adults with essential tremor. Aid in temporary relief of postural and kinetic hand tremor symptoms that impact some activities of daily living in the treated hand following stimulation in adults with Parkinson's disease.
Target Population	Adults with essential tremor or Parkinson's Disease	Adults with essential tremor or Parkinson's Disease
Anatomical site	Median and radial nerves	Median and radial nerves
Intended Users	Patient	Patient
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.
Rx or OTC use	Prescription Use only	Prescription Use only
Technology	Transcutaneous afferent patterned stimulation (TAPS) delivered through electrodes embedded on wearable band	Transcutaneous afferent patterned stimulation (TAPS) delivered through electrodes embedded on wearable band
Energy used or delivered	Electrical stimulation	Electrical stimulation
Human Factors	Wrist-worn electrical stimulator with detachable wristband containing re-usable electrodes. Separate Base Station provides charging function and data transfer.	Wrist-worn electrical stimulator with detachable wristband containing re-usable electrodes. Separate Base Station provides charging function and data transfer.
Patient Contacting Materials	The following components of the Cala kIQ Band have Surface, Intact Skin Long-Term contact (>30 days): Electrodes (silicone with carbon nanotube dispersion), Elastic (polyester with spandex), Band thread (cotton), Band silicone body, Band hook (sabic PC/ABS), Stimulator bottom (PC/ABS). All materials biocompatible per ISO-10993.	The following components of the Cala kIQ Band have Surface, Intact Skin Long-Term contact (>30 days): Electrodes (silicone with carbon nanotube dispersion), Elastic (polyester with spandex), Band thread (cotton), Band silicone body, Band hook (sabic PC/ABS), Stimulator bottom (PC/ABS). All materials biocompatible per ISO-10993.
Operating 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
Electrodes	6 individual electrodes, surface area 1.32 cm²	6 individual electrodes, surface area 1.32 cm²
Battery and Base Station	Rechargeable Lithium-ion battery and AC-powered charger.	Rechargeable Lithium-ion battery and AC-powered charger.
User Workflow	1. Calibration (completed at device setup only) 2. Set stimulation intensity 3. Therapy available on demand	1. Calibration (completed at device setup only) 2. Set stimulation intensity 3. Therapy available on demand
Treatment Time	40 minutes	40 minutes
Wristband life	90 days	90 days
Shelf-life	Cala kIQ Band: 18 months	Cala kIQ Band: 3 months (reverting due to new electrode material, pending further testing)
Waveform	Biphasic	Biphasic
Shape	Rectangular	Rectangular
Maximum Output Voltage	4 @ 500Ω; 80 @ 10kΩ	4 @ 500Ω; 80 @ 10kΩ
Maximum Output Current	8 @ 500Ω; 8 @ 10kΩ	8 @ 500Ω; 8 @ 10kΩ
Duration of primary (depolarizing) phase	300 µsec	300 µsec
Pulse Duration	650 µsec	650 µsec
Frequency	150 Hz	150 Hz
Symmetrical phases?	Yes	Yes
Phase Duration	300 µS each phase	300 µS each phase
Net Charge	0 @ 500Ω	0 @ 500Ω
Maximum Phase Charge	2.4 @ 500Ω	2.4 @ 500Ω
Maximum Current Density	1.29 @ 500Ω	1.29 @ 500Ω
Maximum Average Current	0.72 @ 500Ω	0.72 @ 500Ω
Maximum Average Power Density	2.18 @ 500Ω (0.0022 W/cm²)	2.18 @ 500Ω (0.0022 W/cm²)
Electrical safety	Conforms to IEC 60601 Electrical Safety	Conforms to IEC 60601 Electrical Safety
Compatibility with intended environments	Conforms to EMC requirements	Conforms to EMC requirements
Mechanical safety	Conforms to IEC 60601 Electrical Safety	Conforms to IEC 60601 Electrical Safety
Chemical safety	Not applicable.	Not applicable.
Thermal safety	Conforms to IEC 60601 Electrical Safety	Conforms to IEC 60601 Electrical Safety
Radiation safety	Not applicable.	Not applicable.

Study Proving Acceptance Criteria:

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

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

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

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

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

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

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

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

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

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

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

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

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

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

8. The sample size for the training set:

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

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

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

Summary

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January 16, 2025

Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and 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.

Cala Health, Inc. % Amanda Johnston Regulatory Counsel for Cala Health, Inc. Gardner Law PLLC 432 Main Street Stillwater, Minnesota 55082

Re: K243848

Trade/Device Name: Cala kIQ Regulation Number: 21 CFR 882.5897 Regulation Name: External upper limb tremor stimulator Regulatory Class: Class II Product Code: QBC Dated: December 6, 2024 Received: December 16, 2024

Dear Amanda Johnston:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).

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Sincerely,

Jitendra V. Virani -S

CDR Jitendra Virani, MS, MBA 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

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Indications for Use

Submission Number (if known)

K243848

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.

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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cala®

510(k) Summary

K243848

I. SUBMITTER

Manufacturer:	Cala Health, Inc.1800 Gateway Drive, Suite 120 San Mateo, CA 94404Phone: (415) 890-3961Fax: None
Primary Contact:	Alexander KentSr. Director, Research, Cala Health, Inc.alex.kent@calahealth.com(267) 973-4180
Secondary Contact:	Amanda JohnstonRegulatory Counsel for Cala Health, Inc.ajohnston@gardner.law(763) 639-6951
Date Prepared:	December 13, 2024
	SUBJECT DEVICE
II.
Trade Name:	Cala kIQ™
Regulation Name:	External upper limb tremor stimulator
Regulatory Class:	Class II
Regulation Number:	21 CFR 882.5897
Product Code:	QBC

III. PREDICATE DEVICE

Predicate Device:	Cala kIQ™
Prior Submissions:	K242259
Indications for Use:	Cala kIQ is indicated to aid in the temporary relief of hand tremors inthe treated hand following stimulation in adults with essential tremor.Cala kIQ is indicated to aid in the temporary relief of postural and

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

DEVICE DESCRIPTION IV.

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

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.

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COMPARISON WITH THE PREDICATE DEVICE VI.

The subject device has the same intended use as the predicate device. The subject device has the same indications for use, control mechanisms, principles of operation, and energy type as the legally marketed predicate device, Cala kIQ (K242259).

The design difference between the subject device and the predicate device is the formulation of the proprietary electrode material. In addition, the shelf-life of the Band is different between the subject device and the predicate device. With the exception of the electrode material and shelflife, the subject device has identical technological characteristics as the predicate device.

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Table 1. Cala kIQ Substantial Equivalence

Category	Predicate Device	Subject Device	Substantially Equivalent?
510(k) Number	K242259	This submission
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	YesSubject Device is identical toPredicate Device
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.	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.	YesSubject Device is identical toPredicate Device
Target Population	Adults with essential tremor or Parkinson's Disease	Adults with essential tremor or Parkinson's Disease	YesSubject Device is identical toPredicate Device
Anatomical site	Median and radial nerves	Median and radial nerves	YesSubject Device is identical toPredicate Device
Category	Predicate Device	Subject Device	Substantially Equivalent?
Intended Users	Patient	Patient	YesSubject Device is identical toPredicate Device
Clinical Setting	In-home use after an initialcalibration in the patient's home orin the physician's office.	In-home use after an initialcalibration in the patient's home orin the physician's office.	YesSubject Device is identical toPredicate Device
Rx or OTC use	Prescription Use only	Prescription Use only	YesSubject Device is identical toPredicate Device
Design
Technology	Transcutaneous afferent patternedstimulation (TAPS) deliveredthrough electrodes embedded onwearable band	Transcutaneous afferent patternedstimulation (TAPS) deliveredthrough electrodes embedded onwearable band	YesSubject Device is identical toPredicate Device
Energy used ordelivered	Electrical stimulation	Electrical stimulation	YesSubject Device is identical toPredicate Device
Human Factors	Wrist-worn electrical stimulatorwith detachable wristbandcontaining re-usable electrodes.Separate Base Station providescharging function and data transfer	Wrist-worn electrical stimulator withdetachable wristband containing re-usable electrodes.Separate Base Station providescharging function and data transfer	YesSubject Device is identical toPredicate Device
Category	Predicate Device	Subject Device	Substantially Equivalent?
Patient ContactingMaterials	The following components of theCala kIQ Band have Surface, IntactSkin Long-Term contact (>30 days):• Electrodes (silicone with carbonnanotube dispersion)• Elastic (polyester with spandex)• Band thread (cotton)• Band silicone body• Band hook (sabic PC/ABS)• Stimulator bottom (PC/ABS)	The following components of theCala kIQ Band have Surface, IntactSkin Long-Term contact (>30 days):• Electrodes (silicone with carbonnanotube dispersion)• Elastic (polyester with spandex)• Band thread (cotton)• Band silicone body• Band hook (sabic PC/ABS)• Stimulator bottom (PC/ABS)	YesAll patient-contactingmaterials are biocompatibleper ISO-10993.
Operating Principle	Transcutaneous Afferent PatternedStimulation (TAPS) to the medianand radial nerves of a patient's wrist	Transcutaneous Afferent PatternedStimulation (TAPS) to the medianand radial nerves of a patient's wrist	YesSubject Device is identical toPredicate Device
Electrodes	6Individual Electrode Surface area22mm x 6mm = 1.32 cm²	6Individual Electrode Surface area22mm x 6mm = 1.32 cm²	YesSubject Device is identical toPredicate Device
Battery and BaseStation	Rechargeable Lithium-ionbattery and AC-powered charger.	Rechargeable Lithium-ionbattery and AC-powered charger.	YesSubject Device is identical toPredicate Device
Performance
User Workflow	1. Calibration (completed at devicesetup only)2. Set stimulation intensity3. Therapy available on demand	1. Calibration (completed at devicesetup only)2. Set stimulation intensity3. Therapy available on demand	YesSubject Device is identical toPredicate Device
Treatment Time	40 minutes	40 minutes	YesSubject Device is identical toPredicate Device
Category	Predicate Device	Subject Device	Substantially Equivalent?
Wristband life	90 days	90 days	YesSubject Device is identical toPredicate Device.
Shelf-life	Cala kIQ Band: 18 months	Cala kIQ Band: 3 months	YesIn K242259, Cala receivedFDA clearance to extend theshelf life of its current bands to18 months. However, with theintroduction of the newelectrode material, we proposereverting to a 3-month shelflife until we complete thenecessary testing to support theincrease in shelf life.
Output Specifications
Waveform (e.g.,pulsed monophasic,biphasic)	Biphasic	Biphasic	YesSubject Device is identical toPredicate Device
Shape (e.g.,rectangular, spike,rectified sinusoidal)	Rectangular	Rectangular	YesSubject Device is identical toPredicate Device
Maximum OutputVoltage (volts)	4 @ 500Ω	4 @ 500Ω	YesSubject Device is identical toPredicate Device
	80 @ 10kΩ	80 @ 10kΩ
Maximum OutputCurrent (mA)	8 @ 500Ω	8 @ 500Ω	Yes
Category	Predicate Device	Subject Device	Substantially Equivalent?
	8 @ 10kΩ	8 @ 10kΩ	Subject Device is identical toPredicate Device
Duration of primary(depolarizing) phase(usec)	300	300	YesSubject Device is identical toPredicate Device
Pulse Duration(usec)	650	650	YesSubject Device is identical toPredicate Device
Frequency (Hz)	150	150	YesSubject Device is identical toPredicate Device
Symmetricalphases?	Yes	Yes	YesSubject Device is identical toPredicate Device
Phase Duration (µS)	300 each phase	300 each phase	YesSubject Device is identical toPredicate Device
Net Charge (µC)	0 @500Ω	0 @500Ω	YesSubject Device is identical toPredicate Device
Maximum PhaseCharge (µC)	2.4 @ 500Ω	2.4 @ 500Ω	YesSubject Device is identical toPredicate Device
Maximum CurrentDensity (mA/cm²,r.m.s.)	1.29 @ 500Ω	1.29 @ 500Ω	YesSubject Device is identical toPredicate Device
Category	Predicate Device	Subject Device	Substantially Equivalent?
Maximum AverageCurrent (mA)(average absolutevalue)	0.72 @ 500Ω	0.72 @ 500Ω	YesSubject Device is identical toPredicate Device
Maximum AveragePower Density(mW/cm²)	2.18 @ 500Ω(0.0022 W/cm²)	2.18 @ 500Ω(0.0022 W/cm²)	Yes;Subject Device is identical toPredicate Device
Safety
Electrical safety	Conforms to IEC 60601 ElectricalSafety	Conforms to IEC 60601 ElectricalSafety	YesSubject Device is identical toPredicate Device
Compatibility withintendedenvironments	Conforms to EMC requirements	Conforms to EMC requirements	YesSubject Device is identical toPredicate Device
Mechanical safety	Conforms to IEC 60601 ElectricalSafety	Conforms to IEC 60601 ElectricalSafety	YesSubject Device is identical toPredicate Device
Chemical safety	Not applicable.	Not applicable.	YesSubject Device is identical toPredicate Device
Thermal safety	Conforms to IEC 60601 ElectricalSafety	Conforms to IEC 60601 ElectricalSafety	YesSubject Device is identical toPredicate Device
Radiation safety	Not applicable.	Not applicable.	YesSubject Device is identical toPredicate Device

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VII. PERFORMANCE DATA

The only design difference between the subject device and the predicate device is the formulation of the proprietary electrode material. With the exception of the electrode material, the subject device has identical technological characteristics as the predicate device. All patient-contacting materials were demonstrated to be biocompatible per ISO-10993. No other non-clinical or clinical testing was performed in support of a substantial equivalence determination.

VIII. CONCLUSION

The subject device, Cala kIQ with the new formulation of the electrode material, has the same intended use and indications for use as the predicate device, Cala kIQ (K242259). The subject device has the same control mechanisms, principles of operation, and energy type as the legally marketed predicate device.

The new formulation of the electrode material and all other patient-contacting materials were tested and demonstrated to be biocompatible per ISO-10993. No other non-clinical or clinical testing was performed in support of a substantial equivalence determination.

The performance data reviewed in previous submissions, including the predicate submission, are still applicable to the subject device since they are similar in technology, and, hence, the previously reviewed data supports that the subject device meets special controls. Therefore, the subject device is substantially equivalent to the predicate device.

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.