(330 days)
Not Found
No
The summary describes a stimulator device delivering patterned electrical stimulation. There is no mention of AI/ML in the device description, intended use, or performance studies. The device appears to be based on pre-programmed stimulation patterns, not adaptive algorithms.
Yes
The device is indicated to aid in the temporary relief of hand tremors in adults with essential tremor, which directly addresses a medical condition.
No
The device description states that the Cala Trio is a "stimulator device designed to aid in essential tremor symptom relief by applying Transcutaneous Afferent Patterned Stimulation (TAPS)". Its intended use is to "aid in the temporary relief of hand tremors", which describes a therapeutic function, not a diagnostic one.
No
The device description explicitly details hardware components including a stimulator, wrist-worn electrode band, and base station, which are integral to the device's function.
Based on the provided information, the Cala Trio device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. They are used outside of the body to analyze biological samples.
- Cala Trio Function: The Cala Trio device is a stimulator that applies electrical stimulation to the patient's wrist to provide temporary relief of hand tremors. It does not analyze any biological samples taken from the body.
- Intended Use: The intended use clearly states it's for "temporary relief of hand tremors... following stimulation." This is a therapeutic function, not a diagnostic one.
- Device Description: The description details a stimulator, electrode band, and base station, all designed for applying external stimulation. There is no mention of collecting or analyzing biological specimens.
Therefore, the Cala Trio device falls under the category of a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Cala Trio device is indicated to aid in the temporary relief of hand tremors in the treated hand following stimulation in adults with essential tremor.
Product codes (comma separated list FDA assigned to the subject device)
QBC
Device Description
Cala Trio is a small, lightweight, wrist-worn stimulator device designed to aid in essential tremor symptom relief by applying Transcutaneous Afferent Patterned Stimulation (TAPS) to the median and radial nerves of a patient's wrist. The Cala Trio system includes three main components: (1) a rechargeable stimulator, (2) a wrist-worn electrode band, and (3) a base station that charges the device.
The stimulator component contains the electronics for delivering TAPS to the patient's wrist. There are three buttons on the stimulator that are used for calibration and stimulation amplitude adjustments, among other functions. Text prompts, stimulation delivery parameters, timer, and other messages are provided on the stimulator's full color display to provide instructions and stimulation delivery information.
To deliver therapy, the stimulator is attached to the wrist band, which includes integrated electrodes placed at appropriate intervals around the inner diameter of the band 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). Each band size is also available in right or left-handed versions to target the appropriate nerves of the prescribed hand.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hand/Wrist (upper limb)
Indicated Patient Age Range
Adults
Intended User / Care Setting
Prescription Use
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)
Clinical Evidence
- Study 1 (Isaacson, S. H. et al. (2020)): End-of-study survey following three months of repeated home use.
- Sample Size: 205 patients (of 263 enrolled subjects) completed the study.
- Key Results: 64% of patients self-reported persistent tremor relief after 40 minutes of stimulation, lasting on average 94 minutes (standard deviation = 138; median = 60). Results from this prospective, multi-center, single-arm three months study demonstrated that 62% (TETRAS) and 68% (BF-ADL) of 'severe' or 'moderate' patients improved to 'mild' or 'slight'. Clinicians (CGI-I) reported improvement in 68% of patients, 60% (PGI-I) of patients reported improvement, and QUEST improved.
- Study 2 (Yu. J. et al. (2020)): In-office, single session study.
- Sample Size: 15 participants with ET.
- Key Results: Demonstrated tremor relief after stimulation for 60 minutes for 70-80% of TAPS users.
Non-Clinical Testing
- Biocompatibility: Demonstrated in accordance with ISO 10993-1:2018.
- EMC and Electrical Safety: Meets all requirements of IEC60601-1 and relevant collateral and particular standards.
- Stimulation Waveform Testing: Conforms to requirements of internal standard test method and acceptance criteria.
- Shelf Life Testing: Electrode performance conforms to requirements of internal standard test method and acceptance criteria at T=24 months.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Isaacson, S. H. et al. (2020):
- 64% of 205 patients self-reported persistent tremor relief.
- Tremor relief lasted on average 94 minutes (standard deviation = 138; median = 60).
- 62% (TETRAS) of 'severe' or 'moderate' patients improved to 'mild' or 'slight'.
- 68% (BF-ADL) of 'severe' or 'moderate' patients improved to 'slight' or 'mild'.
- Clinicians (CGI-I) reported improvement in 68% of patients.
- 60% (PGI-I) of patients reported improvement.
- Yu. J. et al. (2020): Tremor relief for 60 minutes for 70-80% of TAPS users.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
October 5, 2021
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Cala Health, Inc. Danielle Boyd Director, Regulatory Affairs 875 Mahler Road, Suite 168 Burlingame, California 94010
Re: K203288
Trade/Device Name: Cala Trio Regulation Number: 21 CFR 882.5897 Regulation Name: External upper limb tremor stimulator Regulatory Class: Class II Product Code: QBC Dated: November 6, 2020 Received: November 9, 2020
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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 (QS) 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,
Patrick Antkowiak Acting 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
2
Indications for Use
510(k) Number (if known) K182706
Device Name Cala Trio
Indications for Use (Describe)
The Cala Trio device is indicated to aid in the temporary relief of hand tremors in the treated hand following stimulation in adults with essential tremor.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X 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 is blue and features the word "CALA" in a stylized font with a curved line above it. Below the word "CALA" is the word "HEALTH" in a smaller, sans-serif font. The logo is simple and modern, and the blue color gives it a sense of trustworthiness and reliability.
510(k) Summary 510(k): Device Modification [K203288]
- I. Submitter Manufacturer: Cala Health, Inc. 875 Mahler Rd, Suite 168 Burlingame, CA 94010 Phone: (415) 890-3961 Fax: None Primary Contact: Danielle McDonnell Boyd Director, Regulatory Affairs, Cala Health danielle(@calahealth.com (415) 819-2935 Date Prepared: October 4, 2021 II. Subiect Device Cala Trio™ Trade Name: 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 ONE DEN170028, K182706 Prior Submissions: Indications for Use: Cala ONE is indicated to aid in the transient relief of hand tremors in the treated hand following stimulation in
adults with essential tremor.
4
IV. Description of Device
Cala Trio is a small, lightweight, wrist-worn stimulator device designed to aid in essential tremor symptom relief by applying Transcutaneous Afferent Patterned Stimulation (TAPS) to the median and radial nerves of a patient's wrist. The Cala Trio system includes three main components: (1) a rechargeable stimulator, (2) a wrist-worn electrode band, and (3) a base station that charges the device.
The stimulator component contains the electronics for delivering TAPS to the patient's wrist. There are three buttons on the stimulator that are used for calibration and stimulation amplitude adjustments, among other functions. Text prompts, stimulation delivery parameters, timer, and other messages are provided on the stimulator's full color display to provide instructions and stimulation delivery information.
To deliver therapy, the stimulator is attached to the wrist band, which includes integrated electrodes placed at appropriate intervals around the inner diameter of the band 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). Each band size is also available in right or left-handed versions to target the appropriate nerves of the prescribed hand.
V. Indications for Use
Cala Trio is indicated to aid in the temporary relief of hand tremors in the treated hand following stimulation in adults with essential tremor.
5
VI. Technological Characteristics
The following table provides a summary comparison for technical characteristics between Cala ONE (predicate device) and Cala Trio (subject device).
| | Cala ONE
DEN170028
K182706
(Predicate Device) | Cala Trio
K203288
(Subject Device) | Discussion of
Differences |
|--------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Delivery of transcutaneous
afferent patterned
stimulation (TAPS) for
hand tremors in essential
tremor patients | Delivery of transcutaneous
afferent patterned
stimulation (TAPS) for
hand tremors in essential
tremor patients | Same |
| Indications
for Use | Cala ONE is indicated to
aid in the transient relief of
hand tremors in adults with
essential tremor. | Cala Trio is indicated to
aid in the temporary relief
of hand tremors in adults
with essential tremor. | Substantially Equivalent
The indications for use
is changed from
"transient" to
"temporary” but does
not impact safety or
effectiveness. Cala Trio
is indicated for the same
condition and patient
population.
Clinical evidence
summarized in Section
VII demonstrates that
the indications for use
change does not impact
the safety or
effectiveness of the
device. |
| | Cala ONE
DEN170028
K182706
(Predicate Device) | Cala Trio
K203288
(Subject Device) | Discussion of
Differences |
| Design | Stimulator with on- board
motion sensors
permanently mounted on
wristband | Stimulator with on- board
motion sensors that is
detachable from wristband | Substantially Equivalent
The difference in
component attachment
does not impact the
safety or effectiveness of
the device.
The TAPS therapy
parameters as
controlled by Cala Trio
are unchanged from
Cala ONE. |
| | Wrist-worn band with three
4x4 cm² electrodes
manually attached by the
user | Wrist-worn band with three
4.84 cm² electrodes
embedded in the band | Substantially Equivalent
The difference in
electrode configuration
does not impact the
safety or effectiveness of
the device.
Clinical evidence
summarized in Section
VII demonstrates that
the surface area change
does not impact the
safety or effectiveness of
the device.
The Cala Trio electrode
surface area is
equivalent and the
electrode material are
unchanged from Cala |
| Cala ONE
DEN170028
K182706 | Cala Trio
K203288 | Discussion of
Differences | |
| (Predicate Device) | (Subject Device) | | |
| AC-powered charger that
connects to the stimulator
via USB port | AC-powered base station
for recharging the
stimulator
Base Station includes an
LTE antenna that provides
connection and data
transfer to cloud system
which supports device
operations such as device
assistance and maintenance | Substantially Equivalent
The difference in the
charging component
does not impact the
safety or effectiveness of
the device.
The Cala Trio energy
source (battery) and
stimulator circuitry is
unchanged from Cala
ONE.
The cloud provides
support and maintenance
functions only.
Transferred data is used
for monitoring
purposes only and is not
used for diagnosis or
other treatment-related
recommendations or
treatment adjustments. | |
| Embedded firmware
control of device
calibration, stimulation
delivery, and device
function | Embedded firmware
control of device
calibration, stimulation
delivery, and device
function | Same | |
| | Cala ONE
DEN170028
K182706
(Predicate Device) | Cala Trio
K203288
(Subject Device) | Discussion of
Differences |
| | Device sensors (gyroscope
and triaxial accelerometer)
measure tremor motion | Device sensors (triaxial
accelerometer) measure
tremor motion | Substantially Equivalent
The difference in the
motion sensors does not
impact safety or
effectiveness.
Non-clinical
performance testing
demonstrated that the
measurements obtained
from the Cala Trio
sensor are equivalent to
those obtained from the
Cala ONE sensors. |
| Features | • Set-up calibration
• Stimulation intensity
control
• Therapy available on
demand | • Set-up calibration
• Stimulation intensity
control
• Therapy available on
demand | Same |
| User
Interface | Stimulator display
guides device setup,
operation, and usage
information.
Four buttons on the device
housing allow
user control of the
stimulation amplitude and
device calibration | Stimulator display
guides device setup,
operation, and usage
information.
Three buttons on the
device housing allow
user control of the
stimulation amplitude and
device calibration | Substantially Equivalent
The difference in the
user interface does not
impact safety or
effectiveness.
The Cala Trio buttons
serve the same combined
functions as those
controlled separately by
the buttons in Cala
ONE. The device setup,
operation, and usage
information are
unchanged. |
| Prescription
or OTC | Prescription | Prescription | Same |
| Sterility | Non-sterile | Non-sterile | Same |
| Materials | Biocompatible wrist band | Biocompatible wrist band | Same |
| | Cala ONE
DEN170028
K182706
(Predicate Device) | Cala Trio
K203288
(Subject Device) | Discussion of
Differences |
| Energy Source | Permanent 3.7V Lithium-
Ion rechargeable
battery | Permanent 3.8V Lithium-
Ion rechargeable
battery | Substantially Equivalent
The difference in battery
voltage does not impact
safety or effectiveness.
The Cala Trio and Cala
ONE device batteries
both comply with IEC
62133 standard. |
| Frequency
of Use | The device is used as
needed by the patient | The device is used as
needed by the patient | Same |
| Band Use Life | Single Use (DEN170028)
30 Days (K182706) | 90 Days | Substantially Equivalent
The difference in band
use-life does not impact
safety or effectiveness.
Non-clinical
performance testing
demonstrated that the
Cala Trio electrode
maintains electrode
integrity and delivers
therapy as intended for
the duration of the 90-
day use-life. |
| Principle of
Operations | Biphasic Waveform,
rectangular | Biphasic Waveform,
rectangular | Same |
| Output Modes | 1 channel with 2
alternating outputs | 2 alternating channels | Substantially Equivalent
The difference in the
number of output
channels does not
impact safety or
effectiveness.
The functionality of the
output channel and the
therapy parameters are
unchanged. |
| | Cala ONE
DEN170028
K182706
(Predicate Device) | Cala Trio
K203288
(Subject Device) | Discussion of
Differences |
| Output | Current Regulated | Current Regulated | Same |
| Housing
Materials | Plastic
Velcro Straps (Nylon) | Plastic
Velcro Straps (Nylon) | Same |
| Weight | 56g | Stimulator: 28g
Base Station: 209g
Band: 13.4g - 15.9g | Substantially Equivalent
The difference in device
weight does not impact
safety or effectiveness.
The total weight of the
patient-worn
components of Cala
Trio and Cala ONE
(band and stimulator)
have equivalent weights. |
| Dimensions
(mm) | 52 x 79 x 16 | Stimulator: 42 x 55 x 13
Base Station: 104 x 36 x 91
Band Length: 252.5 - 327.5
Band Width: 20.8 -54.1 | Substantially Equivalent
The difference in device
dimensions does not
impact safety or
effectiveness.
The patient-worn
components) of Cala
Trio and Cala ONE
(band and stimulator)
have equivalent
dimensions |
| Output
Specification
Category | Cala ONE
DEN170028
K182706
(Predicate Device) | Cala Trio
K203288
(Subject Device) | Comparison Result |
| Waveform | Biphasic | Biphasic | Same |
| Shape | Rectangular | Rectangular | Same |
| Maximum
Output Voltage
(volts) | 7.5 @ 500Ω | 7.5 @ 500Ω | Same |
| | 120 @ 10kΩ | 80 @ 10kΩ | Substantially
Equivalent
The therapy pattern
parameters are
unchanged.
Clinical evidence
summarized in Section
VII demonstrates that
the reduction in
maximum output
voltage does not
impact safety or
effectiveness of the
device |
| Maximum Output
Current (mA) | 15 @ 500Ω | 8 @ 500Ω | Substantially
Equivalent
The therapy pattern
parameters are
unchanged. |
| | 12 @ 10kΩ | 8 @ 10kΩ | Clinical evidence
summarized in Section
VII demonstrates that
the reduction in
maximum output
current does not
impact safety or
effectiveness of the
device |
| Output
Specification
Category | Cala ONE
DEN170028
K182706
(Predicate Device) | Cala Trio
K203288
(Subject Device) | Comparison Result |
| Duration of
primary
(depolarizing)
phase
(µsec) | 300 | 300 | Same |
| Pulse Duration
(µsec) | 650 | 650 | Same |
| Frequency (Hz) | 150 | 150 | Same |
| Symmetrical
phases? | Yes | Yes | Same |
| Phase Duration
(µS) | 300
each phase | 300
each phase | Same |
| Net Charge
(µC) | 0 @500Ω | 0 @500Ω | Same |
| Maximum
Phase Charge
(µC) | 4.5 @ 500Ω | 2.4 @ 500Ω | Substantially
Equivalent
The therapy pattern
parameters are
unchanged.
Clinical evidence
summarized in
Section VII
demonstrates that
the reduction in
maximum phase
charge does not
impact safety or
effectiveness of the
device |
| Output
Specification
Category | Cala ONE
DEN170028
K182706
(Predicate Device) | Cala Trio
K203288
(Subject Device) | Comparison Result |
| Maximum
Current Density
(mA/cm², r.m.s.) | 2.41 @ 500Ω | 1.17 @ 500Ω | Substantially
Equivalent
The therapy pattern
parameters are
unchanged.
Clinical evidence
summarized in Section
VII demonstrates that
the reduction in
maximum current
density does not
impact safety or
effectiveness of the
device |
| Maximum
Average Current
(mA) (average
absolute value) | 1.35 @ 500Ω | 0.72 @ 500Ω | Substantially
Equivalent
The therapy pattern
parameters are
unchanged.
Clinical evidence
summarized in Section
VII demonstrates that
the reduction in
maximum average
current does not
impact safety or
effectiveness of the
device |
| Output
Specification
Category | Cala ONE
DEN170028
K182706 | Cala Trio
K203288 | Comparison Result |
| | (Predicate Device) | (Subject Device) | |
| Maximum
Average Power
Density
(mW/cm²) | 2.30 @ 500Ω | 1.12 @ 500Ω | Substantially
Equivalent |
| | | | The therapy pattern
parameters are
unchanged. |
| | | | Clinical evidence
summarized in Section
VII demonstrates that
the reduction in
maximum average
power density does not
impact safety or
effectiveness of the
device |
Technical Comparison of the Subject Device and Predicate Device
6
7
8
9
10
11
VII. Performance and Non-Clinical Testing
The following tables provide a summary comparison for performance, and nonclinical testing of Cala ONE (predicate device) and Cala Trio (subject device).
Performance Comparison of the Modified Device and Predicate Device
12
13
14
Nonclinical Testing Comparison of the Modified Device and Predicate Device
| Output
Specification
| Category | Cala ONE | Cala Trio | Comparison Result |
|---|---|---|---|
| DEN170028 | |||
| K182706 | |||
| (Predicate Device) | K203288 | ||
| (Subject Device) | |||
| Biocompatibility | Demonstrated | ||
| Biocompatibility | |||
| in accordance with | |||
| ISO 10993-1:2009 | Demonstrated | ||
| Biocompatibility in | |||
| accordance with | |||
| ISO 10993-1:2018 | Same | ||
| EMC and | |||
| Electrical | |||
| Safety | Meets all requirements | ||
| of IEC60601-1 and | |||
| relevant collateral and | |||
| particular standards | Meets all requirements | ||
| of IEC60601-1 and | |||
| relevant collateral and | |||
| particular standards | Same | ||
| Stimulation | |||
| Waveform | |||
| Testing | Stimulation waveform | ||
| conforms to | |||
| requirements of | |||
| internal standard test | |||
| method and acceptance | |||
| criteria | Stimulation waveform | ||
| conforms to | |||
| requirements of internal | |||
| standard test method and | |||
| acceptance criteria | Same |
15
| Output
Specification
Category | Cala ONE
DEN170028
K182706 | Cala Trio
K203288 | Comparison Result |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|-------------------|
| | (Predicate Device) | (Subject Device) | |
| Shelf Life
Testing | Electrode performance
conforms to
requirements of
internal standard test
method and acceptance
criteria at T=24 months | Electrode performance
conforms to
requirements of internal
standard test method and
acceptance criteria at
T=24 months | Same |
Clinical VIII.
The following clinical evidence was used to support the change in the indications for use:
- . In an end-of-study survey following three months of repeated home use in Essential Tremor (ET) patients, 64% of the 205 patients who completed the study self-reported persistent tremor relief after the 40 minutes of stimulation lasting on average 94 minutes (standard deviation = 138; median = 60). (Isaacson, S. H. et al. (2020) "Prospective home-use study on noninvasive neuromodulation therapy for Essential Tremor," Tremor Other Hyperkinet. Mov., 10(1): 29. pp.-6 | doi: 10.5334/tohm.59).
- . A study on 15 participants with ET who completed an in-office, single session study that measured tremor relief during stimulation, immediately after stimulation, and up to an hour after the end of stimulation demonstrated tremor relief after stimulation for 60 minutes for 70-80% of TAPS users (Yu. J. et al. (2020). "Transcutaneous afferent patterned stimulation therapy reduces hand tremor for one hour in essential tremor patients," Front. Neurosci., Vol. 14, pp. 1- 9 | doi: 10.3389/fnins.2020.530300)
The following clinical evidence was used to support the change in electrode surface area and reduction in output stimulation intensity:
- . A prospective, multi-center, single-arm three months study of repeated home use of the Cala TRIO device (263 enrolled subjects with 205 subjects completing the study) in ET patients demonstrated results consistent with the original clinical study supporting the granting of DEN170028 for the Cala ONE. Results demonstrated that 62% (TETRAS) and 68% (BF-ADL) of 'severe' or 'moderate' patients improved to 'mild' or 'slight'. Clinicians (CGI-I) reported improvement in 68% of patients, 60% (PGI-I) of patients reported improvement, and QUEST improved. (Isaacson, S. H. et al. (2020) "Prospective home-use study on noninvasive neuromodulation therapy for Essential Tremor." Tremor Other Hyperkinet. Mov., 10(1): 29, pp.-6 | doi: 10.5334/tohm.59).
16
IX. Substantial Equivalence
Substantial equivalence of Cala Trio to Cala ONE is demonstrated based on the comparison of technical characteristics, performance, and clinical and nonclinical testing. In summary:
- . The intended use is unchanged but the indications for use has changed and has been supported by clinical data as described above.,
- . Cala has provided the following evidence to demonstrate that any differences in labeling, technological characteristics, or materials do not impact safety or effectiveness (see Sections VII and VII above for additional detail):
- The Cala Trio labeling contains all content per the Special Controls identified for external limb tremor stimulators per 21 CFR 882.5897
- Clinical performance testing as described in Section VIII above -
- Non-clinical performance testing confirmed the following: -
- Electrical stimulation characterization .
- . Electrode impedance testing and shelf-life
- . Sensor performance and associated algorithms
- Biocompatibility testing demonstrates that both Cala ONE and Cala Trio meet the ISO 10993-1 standard and are therefore substantially equivalent with respect to biocompatibility.
- EMC and Electrical Safety testing demonstrates that Cala ONE and Cala Trio are ● compliant with the same applicable IEC 60601 clauses and are substantially equivalent with respect to Electrical Safety and EMC considerations.
- Stimulation waveform testing demonstrates that Cala ONE and Cala Trio produce a stimulation output that meets the same internal testing and acceptance criteria and are substantially equivalent with respect to stimulation output.
- . Real time aging and performance testing of Electrodes demonstrate that both Cala ONE and Cala Trio bands meet the same performance requirements at 24 months and are substantially equivalent with respect to shelf life.
X. Conclusion
In summary, Cala ONE and Cala Trio are substantially equivalent. Cala 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.