Cala kIQ

K242259 · Cala Health, Inc. · QBC · Nov 22, 2024 · Neurology

Device Facts

• Record ID: K242259
• Device Name: Cala kIQ
• Applicant: Cala Health, Inc.
• Product Code: QBC · Neurology
• Decision Date: Nov 22, 2024
• 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 Gen 2 is a wrist-worn stimulator for temporary relief of hand tremors. Device uses onboard sensors to measure patient-specific tremor frequency during a postural hold; transforms input into calibrated Transcutaneous Afferent Patterned Stimulation (TAPS) delivered to median and radial nerves. System includes stimulator, conductive electrode band, and charging base station. Used in-home or clinic; operated by patient. Patient initiates sessions and adjusts stimulation amplitude via device buttons. Output provides non-invasive nerve stimulation to modulate tremor symptoms, potentially improving performance of daily activities.

Clinical Evidence

No clinical testing conducted for this submission; substantial equivalence supported by previous performance data and identical technological characteristics.

Technological Characteristics

Wrist-worn electrical stimulator; TAPS delivered via 6 electrodes (silicone with carbon nanotube dispersion) on a wearable band. Biphasic, rectangular waveform; 150 Hz frequency; 300 µsec phase duration. Rechargeable Li-ion battery. Materials include PC/ABS, polyester, spandex, cotton. Conforms to IEC 60601 electrical/mechanical/thermal safety and EMC requirements.

Indications for Use

Indicated for adults with essential tremor or Parkinson's disease experiencing postural and kinetic hand tremors 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 kIQ Gen 1 (K222237)

Submission Summary (Full Text)

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November 22, 2024

Cala Health, Inc. % Amanda Johnston Regulatory Counsel for Cala Health, Inc. Gardner Law. PLLC 423 Main Street Stillwater, Minnesota 55082

Re: K242259

Trade/Device Name: Cala kIQ Regulation Number: 21 CFR 882.5897 Regulation Name: External upper limb tremor stimulator Regulatory Class: Class II Product Code: OBC Dated: July 31, 2024 Received: July 31, 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 ([e-mail]) or phone [phone] 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)

K242259

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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Image /page/4/Picture/0 description: The image shows the logo for Cala Health. The logo is in blue and features the word "CALA" in a stylized font with a swoosh above it. Below the word "CALA" is the word "HEALTH" in a smaller, sans-serif font.

## 510(k) Summary

#### I. SUBMITTER

| Manufacturer: | Cala Health, Inc. |
|--------------------|---------------------------------------------------|
| | 1800 Gateway Drive, Suite 120 San Mateo, CA 94404 |
| | Phone: [phone] |
| | Fax: None |
| Primary Contact: | Alexander Kent |
| | Sr. Director, Research, Cala Health, Inc. |
| | [e-mail] |
| | [phone] |
| Secondary Contact: | Amanda Johnston |
| | Regulatory Counsel for Cala Health, Inc. |

Regulatory Counsel for Cala Health, Inc. [e-mail] [phone]

Date Prepared: October 28, 2024

#### SUBJECT DEVICE II.

| Trade Name: | Cala kIQTM |
|--------------------|---------------------------------------|
| 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: | K222237 |
| 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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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.

#### IV. DEVICE DESCRIPTION

Cala kIQ Gen 2 is a small, lightweight, wrist-worn stimulator device designed to aid in the temporary 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 Gen 2 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 the Cala kIQ Gen 2 Stimulator
- Base Station: Provides charging function and contains an indicator light to alert the user to operating conditions.

The Cala kIQ Gen 2 Stimulator contains the electronics, and firmware for calibrating and delivering TAPS therapy. The patient uses the Cala kIQ Gen 2 Stimulator buttons to complete device calibration, adjust the stimulation amplitude, and initiate therapy sessions. The Cala kIQ Gen 2 Stimulator is attached to the Cala kIQ Gen 2 Band, which includes embedded electrodes placed at appropriate intervals to properly target the medial 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.

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#### VI. SUBSTANTIAL EQUIVALENCE

The Subject Device of this premarket notification is Cala kIQ Gen 2 with labeling updates, utilizing Cala kIQ Gen 1 as the predicate device. Cala kIQ Gen 1 (K222237) is legally marketed as a Class II device, subject to Special Controls as per 21 CFR 882.5897. Cala kIQ Gen 2 was released under note-to-file. Both Cala kIQ Gen 1 and Gen 2 are manufactured by Cala Health, Inc.

Cala kIQ Gen 1 and Gen 2 share:

- . The same intended use
- The same control mechanisms, operating principles and energy type .
- The same calibration algorithm and stimulation waveform .
- . The same architecture of Stimulator attached to Wristband with charging Base Station

The scope of this submission is only labeling changes to the currently-released Cala kIQ (Gen 2), including the following updates to the Patient and Healthcare Professional (HCP) Guides:

- Clarifying the contraindications language .
- . Updating warnings and cautions
- . Adding troubleshooting steps for patient convenience in resolving band connection errors
- Simplifying patient instructions for accessing the Patient Portal ●

Table 1 below provides a summary comparison between the Subject Device, Cala kIQ Gen 2 with proposed labeling updates, and the Predicate Device, Cala kIQ Gen 1, 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

| | | | Substantially |
|----------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Predicate Device<br>Cala kIQ Gen 1 | Subject Device<br>Cala kIQ Gen 2 with proposed<br>labeling updates | Equivalent? |
| 510(k) Number | K222237 | This submission | |
| Manufacturer | Cala Health | Cala Health | |
| Intended Use | | | |
| 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 identical<br>to Predicate Device |
| Indications for Use | 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. | 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. | Yes<br>Subject Device is identical<br>to Predicate Device |
| | 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. | 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. | |
| Target Population | Adults with essential tremor or Parkinson's<br>Disease | Adults with essential tremor or Parkinson's<br>Disease | Yes<br>Subject Device is identical<br>to Predicate Device |
| Anatomical site | Median and radial nerves | Median and radial nerves | Yes<br>Subject Device is identical<br>to Predicate Device |
| Intended Users | Patient | Patient | Yes<br>Subject Device is identical<br>to Predicate Device |
| | Predicate Device<br>Cala kIQ Gen 1<br>K222237 | Subject Device<br>Cala kIQ Gen 2 with proposed<br>labeling updates | 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 | Transcutaneous Afferent Patterned<br>Stimulation (TAPS) delivered through<br>electrodes embedded on wearable band | 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 kIQ<br>Band have Surface, Intact Skin Long-Term<br>contact (>30 days):<br>Elastic (polyester)Electrodes (silicone with carbon<br>nanotube dispersion)Microfiber (polyurethane and nylon)Elastic (nylon with spandex)Band thread (polyester) | The following components of the Cala kIQ Band<br>have Surface, Intact Skin Long-Term contact<br>(>30 days):<br>Electrodes (silicone with carbon<br>nanotube dispersionElastic (polyester with spandex)Band thread (cotton)Band silicone bodyBand hook (sabic PC/ABS)Stimulator bottom (PC/ABS) | Yes<br>All patient-contacting<br>materials are<br>biocompatible per ISO-<br>10993. The electrode<br>material is unchanged<br>from the predicate device. |
| | Predicate Device<br>Cala kIQ Gen 1<br>K222237 | Subject Device<br>Cala kIQ Gen 2 with proposed<br>labeling updates | 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 | 6<br>Individual Electrode Surface area<br>22mm x 6mm = 1.32 cm² | 6<br>Individual Electrode Surface area<br>22mm x 6mm = 1.32 cm² | Yes<br>Subject Device is identical<br>to Predicate Device |
| 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 kIQ Gen 1<br>K222237 | Subject Device<br>Cala kIQ Gen 2 with proposed<br>labeling updates | Substantially<br>Equivalent? |
| Shelf-life | Cala kIQ Band: 3 months | Cala kIQ Band: 18 months | Yes<br>Increased shelf-life is due<br>to availability of test data,<br>not from changes in<br>performance or safety<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<br><br>80 @ 10kΩ | 4 @ 500Ω<br><br>80 @ 10kΩ | Yes<br>Subject Device is identical<br>to Predicate Device |
| Maximum Output<br>Current<br>(mA) | 8 @ 500Ω<br><br>8 @ 10kΩ | 8 @ 500Ω<br><br>8 @ 10kΩ | Yes<br>Subject Device is identical<br>to Predicate Device |
| Duration of primary<br>(depolarizing) phase<br>(μsec) | 300 | 300 | Yes<br>Subject Device is identical<br>to Predicate Device |
| | Predicate Device<br>Cala kIQ Gen 1<br>K222237 | Subject Device<br>Cala kIQ Gen 2 with proposed<br>labeling updates | 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.) | 1.29 @ 500Ω | 1.29 @ 500Ω | Yes<br>Subject Device is identical<br>to Predicate Device |
| 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 kIQ Gen 1<br>K222237 | Subject Device<br>Cala kIQ Gen 2 with proposed<br>labeling updates | Substantially<br>Equivalent? |
| Maximum Average<br>Power Density<br>(mW/cm²) | 2.18 @ 500Ω<br>(0.0022 W/cm²) | 2.18 @ 500Ω<br>(0.0022 W/cm²) | Yes<br>Subject Device is identical<br>to Predicate Device |
| 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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#### PERFORMANCE DATA VII.

There was no performance testing conducted in support of Cala kIQ Gen 2 premarket application.

## VIII. CLINICAL DATA

There was no clinical testing conducted in support of Cala kIQ Gen 2 premarket application.

#### IX. SUBSTANTIAL EQUIVALENCE

Substantial equivalence of the Subject Device, Cala kIQ Gen 2 with proposed labeling updates, to the Predicate Device, Cala kIQ Gen 1, is demonstrated based on the comparison of labeling, technical characteristics, performance, and testing.

The intended use and indications for use are unchanged.

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.

#### X. CONCLUSION

The Subject Device, Cala kIQ Gen 2 with labeling updates, has the same intended use and indications for use as the Predicate Device, Cala kIQ Gen 1. The subject and predicate device have similar technological characteristics and the differences do not raise new questions of safety or effectiveness.

Cala kIQ Gen 2 and Cala kIQ Gen 1 are substantially equivalent. Cala Health has provided evidence as described above to demonstrate that any differences in the technological characteristics do not impact safety or effectiveness.