(119 days)
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.
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).
Here's a summary of the acceptance criteria and the study proving the device meets them, based on the provided text:
Device: Cala kIQTM
Predicate Device: Cala Trio™
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly define clear quantitative acceptance criteria for the Cala kIQ device across all metrics in the format you requested, especially for the Parkinson's Disease indication. Instead, it relies on demonstrating comparable effectiveness to the predicate device for Essential Tremor and provides descriptive results for Parkinson's Disease.
However, based on the provided clinical data, we can infer performance and the study's findings directly:
| Acceptance Criterion (Inferred from Study Goals) | Reported Device Performance (Cala kIQ for Parkinson's Disease) |
|---|---|
| Aid in temporary relief of hand tremors in the treated hand (Essential Tremor) | Demonstrated as equivalent to Cala Trio™: "Clinician-rated tremor assessments (TETRAS and MDS-UPDRS), and subject-rated assessments (BF- ADLs) results were similar for Cala kIQ and Cala Trio." (Study 2) |
| Aid in temporary relief of postural and tremor symptoms involving some Activities of Daily Living (ADLs) in the treated hand (Parkinson's Disease) | MDS-UPDRS Dominant Hand Tasks (average across 6 tasks): - Week 2: -0.44 ± 0.44 change (Improvement); 40% responder rate (≥0.5-point average improvement). - Week 3: -0.40 ± 0.37 change; 44% responder rate.BF-ADL Tasks (average across 8 tasks): - Week 2: -0.44 ± 0.43 change (Improvement); 43% responder rate (≥0.5-point average improvement). - Week 3: -0.32 ± 0.39 change; 25% responder rate.CGI-I (Clinical Global Impression – Improvement): - Week 2: 78% (31/40 subjects). - Week 3: 83% (30/36 subjects).PGI-I (Patient Global Impression – Improvement): - Week 2: 75% (30/40 subjects). - Week 3: 81% (29/36 subjects). |
| Safety Profile | Low incidence of Adverse Events: No device-related serious adverse events reported in either study. All device-related adverse events were resolved with minimal intervention. |
| Compliance with Performance Standards | Confirmed to meet physical, mechanical, shelf life, system performance, EMC, Electrical Safety (IEC 60601), and Biocompatibility (ISO 129993-1:2018) standards. |
2. Sample Size Used for the Test Set and Data Provenance
Study 1 (Parkinson's Disease - standalone performance):
- Sample Size: 40 patients were enrolled.
- Data Provenance: Not explicitly stated, but the submission is for a US FDA clearance, implying results relevant to a US or general population. The study was described as a "single-arm, non-significant risk study," suggesting it was prospective.
Study 2 (Comparative Effectiveness - Cala kIQ vs. Cala Trio):
- Sample Size: 19 subjects completed the study, 6 of whom had Parkinson's Disease.
- Data Provenance: Prospective, single-center study. Country of origin not explicitly stated, but again, implied to be relevant to a US FDA clearance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The ground truth was established through clinician-rated and subject-rated assessments:
- Clinician-rated assessments: MDS-UPDRS (Movement Disorder Society-Unified Parkinson's Disease Rating Scale) and TETRAS (Tremor Essential Tremor Rating Assessment Scale) were used. The document does not specify the number or qualifications of the clinicians who performed these assessments. However, these are standardized scales typically administered by neurologists or movement disorder specialists.
- Subject-rated assessments: BF-ADLs (Bain and Findley Activities of Daily Living) were used, representing patient self-reported outcomes.
- Global Impression: CGI-I (Clinical Global Impression – Improvement) and PGI-I (Patient Global Impression – Improvement) were also used, which involve clinician judgment and patient self-perception, respectively.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method for reconciling disagreements between experts. The assessments are presumably taken as direct measurements by the administering clinicians or self-reported by patients. This indicates that assessments were likely unadjudicated for the purposes described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done in the traditional sense of evaluating multiple readers' interpretations of diagnostic images or data. The studies involved:
- Study 1: A single-arm physiological intervention study assessing the device's direct effect on tremor and ADLs.
- Study 2: A crossover study comparing the Cala kIQ directly against the Cala Trio device in the same subjects, with assessments made by clinicians and subjects. This is a head-to-head device comparison, not an MRMC study related to interpretation.
Therefore, there is no discussion of the "effect size of how much human readers improve with AI vs. without AI assistance."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, Study 1 indirectly represents a standalone performance assessment of the Cala kIQ device (though not an "algorithm-only" assessment in the context of interpretation, rather a direct clinical effect). In this study, the device was used to deliver therapy, and its effect on patients' tremors and ADLs was measured. The device itself (Cala kIQ) functions autonomously in delivering calibrated TAPS therapy based on the patient's tremor frequency measured by onboard sensors. The reported results are the direct outcome of the device's therapy application.
7. The Type of Ground Truth Used
The ground truth for evaluating the device's effectiveness was a combination of:
- Expert Clinical Assessment: Clinician-administered standardized scales (MDS-UPDRS, TETRAS, CGI-I) which reflect expert observation and rating of tremor severity and overall improvement.
- Patient-Reported Outcomes (PROs): Subject-rated scales (BF-ADLs, PGI-I) which reflect the patient's direct experience of symptom relief and functional improvement.
There was no pathology or specific outcomes data (like long-term mortality or disease progression) used as ground truth for this temporary relief indication.
8. The Sample Size for the Training Set
The document does not explicitly state the sample size of a "training set" for the Cala kIQ device or its underlying algorithm. The device's TAPS output pattern is "calibrated to the individual patient's tremor frequency" during device setup using "onboard sensors." This suggests a patient-specific calibration rather than a broad, pre-trained algorithm in the AI/ML sense that would require a large training dataset. The studies described are for clinical validation, not algorithm training. Previous predicate devices (DEN170028, K182706, K203288 for Cala Trio) likely contributed to the iterative development and refinement of the TAPS technology, but specific training set information is not provided.
9. How the Ground Truth for the Training Set Was Established
As noted above, a distinct "training set" with ground truth in the traditional AI/ML sense is not described. The device calibrates to each individual patient's tremor frequency. The underlying science and engineering of Transcutaneous Afferent Patterned Stimulation (TAPS) and the ability to measure tremor frequency would have been developed and validated through initial research and development phases, but the details of this are not provided in this 510(k) summary. The clinical studies (Study 1 and Study 2) served as validation, not training.
{0}------------------------------------------------
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW!
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
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 94404Phone: (415) 890-3961Fax: 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 inthe 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.
{4}------------------------------------------------
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.
{5}------------------------------------------------
Table 1. Cala kIQ Substantial Equivalence
| Predicate Device | Subject Device | SubstantiallyEquivalent? | |
|---|---|---|---|
| Cala Trio | Cala kIQ | ||
| K203288 | K222237 | ||
| 510(k) Number | K203288 | K222237 | |
| Manufacturer | Cala Health | Cala Health | |
| Intended Use | Delivery of transcutaneous afferent patternedstimulation ("TAPS") for treatment of handtremors | Delivery of transcutaneous afferent patternedstimulation ("TAPS") for treatment of handtremors | YesSubject Device is identicato Predicate Device |
| Indications for Use | Cala Trio is indicated to aid in the temporaryrelief of hand tremors in the treated handfollowing stimulation in adults with essentialtremor | Cala kIQ is indicated to aid in the temporaryrelief of hand tremors in the treated handfollowing stimulation in adults with essentialtremor.Cala kIQ is indicated to aid in the temporaryrelief of postural and kinetic hand tremorsymptoms that impact some activities of dailyliving in the treated hand followingstimulation in adults with Parkinson'sdisease. | YesSubstantial equivalencedemonstrated throughclinical evidence |
| Target Population | Adults with essential tremor | Adults with essential tremor or Parkinson'sDisease | YesSubstantial equivalencedemonstrated throughclinical evidence |
| Anatomical site | Median and radial nerves | Median and radial nerves | YesSubject Device is identicato Predicate Device |
| Intended Users | Patient | Patient | YesSubject Device is identicato Predicate Device |
| Predicate DeviceCala TrioK203288 | Subject DeviceCala kIQK222237 | SubstantiallyEquivalent? | |
| Clinical Setting | In-home use after an initial calibration in thepatient's home or in the physician's office. | In-home use after an initial calibration in thepatient's home or in the physician's office. | YesSubject Device is identicalto Predicate Device |
| Rx or OTC use | Prescription Use only | Prescription Use only | YesSubject Device is identicalto Predicate Device |
| Design | |||
| Technology | Calibrated Transcutaneous Afferent PatternedStimulation (TAPS) delivered throughelectrodes embedded on wearable band | Calibrated Transcutaneous Afferent PatternedStimulation (TAPS) delivered throughelectrodes embedded on wearable band | YesSubject Device is identicalto Predicate Device |
| Energy used ordelivered | Electrical stimulation | Electrical stimulation | YesSubject Device is identicalto Predicate Device |
| Human Factors | Wrist-worn electrical stimulator withdetachable band containing multi-useelectrodes. Base station provides chargingfunction and contains indicator lights foroperating status | Wrist-worn electrical stimulator withdetachable band containing multi-useelectrodes. Base station provides chargingfunction and contains indicator lights foroperating status | YesSubject Device is identicalto Predicate Device |
| Patient ContactingMaterials | The following components of the Cala TrioBand have Surface, Intact Skin Long-Termcontact (>30 days):• Elastic• Electrodes• Microfiber• Elastic• Band thread | The following components of the Cala kIQBand have Surface, Intact Skin Long-Termcontact (>30 days):• Elastic• Electrodes• Microfiber• Elastic• Band thread | YesSubject Device is identicalto Predicate Device |
| Predicate DeviceCala TrioK203288 | Subject DeviceCala kIQK222237 | SubstantiallyEquivalent? | |
| Operating Principle | Transcutaneous Afferent PatternedStimulation (TAPS) to the median andradial nerves of a patient's wrist | Transcutaneous Afferent PatternedStimulation (TAPS) to the median and radialnerves of a patient's wrist | YesSubject Device is identicalto Predicate Device |
| Electrodes | 1 common, 2 active electrodesIndividual Electrode Surface area$22mm x 22mm = 4.84 cm^2$ | 2 common electrodes paired with 2 activeelectrodesIndividual Electrode Surface area$22mm x 6mm = 1.32 cm^2$ | YesSubstantial equivalencedemonstrated throughnon- clinical performancetesting and clinicalevidence |
| Battery and BaseStation | Rechargeable Lithium-ion battery and AC-powered charger. | Rechargeable Lithium-ion battery and AC-powered charger. | YesSubject Device is identicalto Predicate Device |
| Performance | |||
| User Workflow | 1. Calibration2. Set stimulation intensity3. Therapy available on demand | 1. Calibration2. Set stimulation intensity3. Therapy available on demand | YesSubject Device is identicalto Predicate Device |
| Treatment Time | 40 minutes | 40 minutes | YesSubject Device is identicalto Predicate Device |
| Wristband life | 90 days | 90 days | YesSubject Device is identicalto Predicate Device. |
| Predicate DeviceCala TrioK203288 | Subject DeviceCala kIQK222237 | SubstantiallyEquivalent? | |
| Shelf-life | Cala Trio Band: 24 months | Cala kIQ Band: 3 months | YesShelf-life testing confirmsCala kIQ Band meetsproduct specification atlabeled shelf-life.Shelf-life difference frompredicate due toavailability of test data,not performancecharacteristics |
| Output Specifications | |||
| Waveform (e.g.,pulsed monophasic,biphasic) | Biphasic | Biphasic | YesSubject Device is identicalto Predicate Device |
| Shape (e.g.,rectangular, spike,rectified sinusoidal) | Rectangular | Rectangular | YesSubject Device is identicalto Predicate Device |
| Maximum OutputVoltage(volts) | 4 @ 500Ω | 4 @ 500Ω | YesSubject Device is identicalto Predicate Device |
| 80 @ 10kΩ | 80 @ 10kΩ | ||
| Maximum OutputCurrent(mA) | 8 @ 500Ω | 8 @ 500Ω | YesSubject Device is identicalto Predicate Device |
| 8 @ 10kΩ | 8 @ 10kΩ | ||
| Duration of primary(depolarizing) phase(μsec) | 300 | 300 | YesSubject Device is identicalto Predicate Device |
| Predicate DeviceCala TrioK203288 | Subject DeviceCala kIQK222237 | Substantially Equivalent? | |
| Pulse Duration(μsec) | 650 | 650 | YesSubject Device is identicalto Predicate Device |
| Frequency(Hz) | 150 | 150 | YesSubject Device is identicalto Predicate Device |
| Symmetrical phases? | Yes | Yes | YesSubject Device is identicalto Predicate Device |
| Phase Duration(μS) | 300 each phase | 300 each phase | YesSubject Device is identicalto Predicate Device |
| Net Charge(μC) | 0 @500Ω | 0 @500Ω | YesSubject Device is identicalto Predicate Device |
| Maximum PhaseCharge(μC) | 2.4 @ 500Ω | 2.4 @ 500Ω | YesSubject Device is identicalto Predicate Device |
| Maximum CurrentDensity(mA/cm², r.m.s.) | 0.50 @ 500Ω | 1.29 @ 500Ω | YesSubstantial equivalencedemonstrated through non-clinical performance testingand clinical evidence |
| Maximum AverageCurrent(mA) (averageabsolute value) | 0.72 @ 500Ω | 0.72 @ 500Ω | YesSubject Device is identicalto Predicate Device |
| Predicate DeviceCala TrioK203288 | Subject DeviceCala kIQK222237 | SubstantiallyEquivalent? | |
| Maximum AveragePower Density(mW/cm²) | 0.59 @ 500Ω(.0006 W/cm²) | 2.18 @ 500Ω(0.0022 W/cm²) | YesSubstantial equivalencedemonstrated through non-clinical performance testingand clinical evidence |
| Safety | |||
| Electrical safety | Conforms to IEC 60601 Electrical Safety | Conforms to IEC 60601 Electrical Safety | YesSubject Device is identicalto Predicate Device |
| Compatibilitywith intendedenvironments | Conforms to EMC requirements | Conforms to EMC requirements | YesSubject Device is identicalto Predicate Device |
| Mechanical safety | Conforms to IEC 60601 Electrical Safety | Conforms to IEC 60601 Electrical Safety | YesSubject Device is identicalto Predicate Device |
| Chemical safety | Not applicable | Not applicable | YesSubject Device is identicalto Predicate Device |
| Thermal safety | Conforms to IEC 60601 Electrical Safety | Conforms to IEC 60601 Electrical Safety | YesSubject Device is identicalto Predicate Device |
| Radiation safety | Not applicable | Not applicable | YesSubject Device is identicalto Predicate Device |
{6}------------------------------------------------
{7}------------------------------------------------
{8}------------------------------------------------
{9}------------------------------------------------
{10}------------------------------------------------
{11}------------------------------------------------
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 ●
{12}------------------------------------------------
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.
{13}------------------------------------------------
| Visit 2 | Visit 3 | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| N | Pre | Post | Change | ResponderRate | N | Pre | Post | Change | ResponderRate | |
| Mean ± SD | Mean ± SD | Mean ± SD | (%) | Mean ± SD | Mean ± SD | Mean ± SD | (%) | |||
| MDS-UPDRS | ||||||||||
| Averageacross 6tasks* | 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% |
| PosturalTremor | 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% |
| KineticTremor | 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% |
| FingerTapping | 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% |
| HandMovements | 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 | PreMean ± SD | PostMean ± SD | ChangeMean ± SD | ResponderRate (%) | N | PreMean ± SD | PostMean ± SD | ChangeMean ± SD | ResponderRate (%) | |
| BF-ADLs | ||||||||||
| AverageADL 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 spoonto 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 oftea | 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 milkfrom a bottleor 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 atelephone | 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 yourchange in ashop | 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 anelectric pluginto 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 yourfront doorwith 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 | ResponderRate | N | Pre | Post | Change | ResponderRate | |
| 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 | ||||||||||
| ClinicalGlobalImpression –Improvement(CGI-I) | 40 | N/A | 78%(31/40) | 36 | N/A | 83%(30/36) | ||||
| PatientGlobalImpression –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
{14}------------------------------------------------
{15}------------------------------------------------
*For averaged scores, a Responder was defined as subjects that had a ≥ 0.5-point average per-task improvement
{16}------------------------------------------------
| Visit 2 | Visit 3 | |||||
|---|---|---|---|---|---|---|
| N | ChangeMean ± SD | Responder Rate (%) | N | ChangeMean ± 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 | ChangeMean ± SD | Responder Rate (%) | N | ChangeMean ± 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.
§ 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.