(28 days)
No
The summary describes a device that delivers electrical stimulation based on a pre-defined pattern (TAPS) and does not mention any adaptive or learning capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is indicated to aid in the transient relief of hand tremors in adults with essential tremor, which describes a therapeutic purpose.
No
The device description states its purpose is to provide "transient relief of hand tremors" and "symptom relief by applying transcutaneous afferent patterned stimulation (TAPS)". This indicates a therapeutic or symptomatic relief function, not a diagnostic one.
No
The device description explicitly states the system consists of a charger, stimulator, and electrodes, which are hardware components.
Based on the provided information, the Cala ONE device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Cala ONE Function: The description clearly states that the Cala ONE is a "wrist-worn stimulator" that applies "transcutaneous afferent patterned stimulation (TAPS) to the median and radial nerves of a patient's wrist." This is a therapeutic device that delivers electrical stimulation to the body, not a test performed on a sample outside the body.
The device's purpose is to provide transient relief of hand tremors, which is a therapeutic intervention, not a diagnostic test.
N/A
Intended Use / Indications for Use
The Cala ONE device is indicated to aid in the transient relief of hand tremors in the treated hand following stimulation in adults with essential tremor.
Product codes
QBC
Device Description
As described in DEN170028, the Cala ONE is a small, lightweight, wrist-worn stimulator designed to aid in transient essential tremor symptom relief by applying transcutaneous afferent patterned stimulation (TAPS) to the median and radial nerves of a patient's wrist. The Cala ONE device system consists of a charger, the stimulator, and a set of removable electrodes (gels) that work together to transcutaneously deliver electrical stimulation to the nerves.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand, wrist
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)
The design control activities associated with development of the multi-use (30 day) electrode included consideration of the relevant special controls established in FDA's letter of April 26, 2018 regarding DEN170028, in particular the assessment of electrical stimulation transfer, biocompatibility, shelf life, and labeling.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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October 25, 2018
Cala Health, Inc. Scott Wilson Vice President, Regulatory Affairs and Quality Assurance 875 Mahler Road, Suite 168 Burlingame, California 94010
Re: K182706
Trade/Device Name: External upper limb tremor stimulator Regulation Number: 21 CFR 882.5897 Regulation Name: External upper limb tremor stimulator Regulatory Class: Class II Product Code: QBC Dated: September 25, 2018 Received: September 27, 2018
Dear Scott Wilson:
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name Cala ONE
Indications for Use (Describe)
The Cala ONE device is indicated to aid in the transient 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) |
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510(k) Summary:
Special 510(k) for Device Modification
I. Submitter
Cala Health, Inc. 875 Mahler Rd, Suite 168 Burlingame, CA 94010
Official Correspondent:
| Scott A. Wilson, Ph.D.
| Vice President, Regulatory Affairs and Quality Assurance | |
|---|---|
| Cala Health, Inc. | |
| Phone Number: | 925.876.5480 |
| Fax Number: | none |
| Email: | scott.wilson@calahealth.com |
II. Device
| Name: | Cala ONE |
|---|---|
| Classification: | Class II with Special Controls |
| Regulation name: | External upper limb tremor stimulator |
| Regulation: | 21 CFR 882.5897 |
| Product Code: | QBC |
III. Predicate Device
| Name: | Cala ONE |
|---|---|
| Prior submission: | DEN170028 |
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IV. Description of Device and Modification
As described in DEN170028, the Cala ONE is a small, lightweight, wrist-worn stimulator designed to aid in transient essential tremor symptom relief by applying transcutaneous afferent patterned stimulation (TAPS) to the median and radial nerves of a patient's wrist. The Cala ONE device system consists of a charger, the stimulator, and a set of removable electrodes (gels) that work together to transcutaneously deliver electrical stimulation to the nerves.
In configuration cleared under DEN170028, the Cala ONE device includes a set of three single-use hydrogel electrodes. For the convenience of the patient. Cala Health is changing these three single-use electrodes (intended for daily replacement) to three multiuse electrodes (intended for replacement after 30 days). This change is both to the electrode material and to the device labeling. This Premarket Notification has been prepared to address the relevant considerations of FDA guidance "Deciding When to Submit a 510(k) for a Change to an Existing Device," which are:
-
- Regarding the electrode material, per guidance Section C "Material Changes" this change does not significantly affect the safety or effectiveness of the device. The present Premarket Notification documents the substantial equivalence including electrical safety, energy transfer, biocompatibility, and shelf-life. Specifically, the change does not affect the performance specification, with the exception of the electrode have multi-use durability to 30 days.
-
- Regarding the labeling, per guidance Section A "Labeling" the change from a device labeled for single use to a device labeled as reusable could affect the safety or effectiveness and would likely require submission of a new 510(k). As noted above, the electrode change does not significantly affect safety or effectiveness of the device and that the minor change in labeling (specifically, to the use instructions in the Patient Guide) is appropriately supported.
Indications for Use V.
The Cala ONE is indicated to aid in the transient relief of hand tremors in the treated hand following stimulation in adults with essential tremor.
VI. Summary of Risk Assessment and Design Control Activities
The design control activities associated with development of the multi-use (30 day) electrode included consideration of the relevant special controls established in FDA 's letter of April 26, 2018 regarding DEN170028, in particular the assessment of electrical stimulation transfer, biocompatibility, shelf life, and labeling.
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The risk assessment activities included analysis of relevant risks identified in FDA's letter of April 26, 2018 regarding DEN170028.
VII. Conclusions
The change being made does not: (1) affect the intended use or (2) alter the fundamental scientific technology of the Cala ONE device.