Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description mentions automated calibration and detection of tremor frequency using motion sensors, but it does not explicitly mention or describe the use of AI or ML algorithms for these functions or any other aspect of the device's operation. The "Mentions AI, DNN, or ML" section is also marked as "Not Found".

Therapeutic

Yes.
The device is indicated for the temporary relief of hand tremors in adults with essential tremor and Parkinson's disease, which directly addresses a medical condition and aims to improve patient health.

Diagnostic

No

The device is described as a stimulator that aids in the temporary relief of hand tremors, not for diagnosing a medical condition. While it detects tremor frequency and measures tremor amplitude changes, these functions are for customizing the stimulation and monitoring treatment progress, not for diagnosing the presence or nature of a disease.

SaMD (Software as a Medical Device)

No

The device description explicitly lists three hardware components: the Stimulator, Band, and Base Station. It also describes the device as a "wrist-worn stimulator device" that uses "on-board motion sensors" and applies "transcutaneous afferent patterned stimulation (TAPS)". This indicates a significant hardware component beyond just software.

IVD (In Vitro Diagnostic)

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

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Cala kIQ Function: The Cala kIQ device is a wearable stimulator that detects tremor frequency and applies electrical stimulation to nerves in the wrist. It interacts directly with the patient's body and does not analyze samples taken from the body.
Intended Use: The intended use is to provide temporary relief of hand tremors through stimulation, not to diagnose or detect a condition based on biological samples.

Therefore, the Cala kIQ falls under the category of a therapeutic or neuromodulation device, not an in vitro diagnostic device.

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 kinetic hand 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 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.

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)

The only design difference between the subject device and the predicate device is the formulation of the proprietary electrode material. 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.

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

Not Found

Predicate Device(s)

K242259

Reference Device(s)

Not Found

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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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"

1

(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.

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.

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 94404
Phone: (415) 890-3961
Fax: None |
|--------------------|--------------------------------------------------------------------------------------------------------------|
| Primary Contact: | Alexander Kent
Sr. Director, Research, Cala Health, Inc.
alex.kent@calahealth.com
(267) 973-4180 |
| Secondary Contact: | Amanda Johnston
Regulatory 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 in
the 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.

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.

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.

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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	Yes
Subject Device is identical to
Predicate 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. | Yes
Subject Device is identical to
Predicate Device |
| Target Population | Adults with essential tremor or Parkinson's Disease | Adults with essential tremor or Parkinson's Disease | Yes
Subject Device is identical to
Predicate Device |
| Anatomical site | Median and radial nerves | Median and radial nerves | Yes
Subject Device is identical to
Predicate Device |
| Category | Predicate Device | Subject Device | Substantially Equivalent? |
| Intended Users | Patient | Patient | Yes
Subject Device is identical to
Predicate Device |
| 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 | Transcutaneous afferent patterned
stimulation (TAPS) delivered
through electrodes embedded on
wearable band | 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 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 | Yes
Subject Device is identical to
Predicate Device |
| Category | Predicate Device | Subject Device | Substantially Equivalent? |
| 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) | 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) | Yes
All patient-contacting
materials are 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 | Yes
Subject Device is identical to
Predicate Device |
| Electrodes | 6

Individual Electrode Surface area
22mm x 6mm = 1.32 cm² | 6

8

9

10

11

12

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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 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.

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.