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.

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.

AI/ML Overview

The Cala Health, Inc. Cala ONE device is an external upper limb tremor stimulator indicated for the transient relief of hand tremors in adults with essential tremor. This 510(k) submission (K182706) for the Cala ONE focuses on a modification to the electrodes: changing from single-use to multi-use (30-day durability) electrodes.

Here's a breakdown of the acceptance criteria and study information provided:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria with reported device performance in the format requested. However, it indicates that the "change does not significantly affect the safety or effectiveness of the device" concerning the electrode material and that "the present Premarket Notification documents the substantial equivalence including electrical safety, energy transfer, biocompatibility, and shelf-life." This implies that the device maintained its performance for these parameters, which would have been established in the predicate device (DEN170028).

The key performance aspect reported for the modification is the multi-use durability of the electrodes to 30 days.

Based on the information provided, we can infer the following:

Acceptance Criteria	Reported Device Performance
Electrical Safety	Maintained (Substantially Equivalent)
Energy Transfer	Maintained (Substantially Equivalent)
Biocompatibility	Maintained (Substantially Equivalent)
Shelf-Life	Maintained (Substantially Equivalent)
Electrode Durability	Multi-use for 30 days
Safety and Effectiveness	Not significantly affected by the change as demonstrated by the predicate device performance.

2. Sample size used for the test set and the data provenance

The document does not specify the sample size used for the test set or the data provenance for the studies conducted for this particular 510(k) submission (K182706). This submission focuses on a modification to an already cleared device (predicate DEN170028). The studies referenced (electrical safety, energy transfer, biocompatibility, shelf-life) were likely comparative and focused on demonstrating that the new multi-use electrode maintains the performance of the single-use electrode. The original studies for the predicate device (DEN170028) would contain the clinical efficacy data, which is not detailed here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. As this is a 510(k) for a device modification (electrode change), the primary evidence provided focuses on engineering and bench testing rather than clinical expert evaluation of diagnostic accuracy.

4. Adjudication method for the test set

This information is not provided in the document.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

An MRMC study is not applicable to this device. The Cala ONE is a therapeutic device (tremor stimulator), not a diagnostic device involving human readers or AI assistance in interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

A standalone performance evaluation in the context of an algorithm is not applicable here as this is a physical medical device (tremor stimulator) and not an AI/algorithm-based diagnostic tool. The device itself operates autonomously to deliver stimulation.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

For this modification submission, the "ground truth" would be the established performance characteristics of the original single-use electrode (e.g., electrical properties, biocompatibility) from the predicate device (DEN170028). The studies for this modification aimed to demonstrate that the new multi-use electrodes perform equivalently to the predicate device's electrodes in terms of safety and functional characteristics (electrical safety, energy transfer, biocompatibility, shelf-life). Clinical efficacy (outcomes data regarding tremor relief) likely relies on the studies conducted for the predicate device, which are not detailed in this specific document.

8. The sample size for the training set

This information is not applicable/not provided. As this is a physical medical device (tremor stimulator) and not an AI/machine learning algorithm, there is no "training set" in the conventional sense.

9. How the ground truth for the training set was established

This information is not applicable/not provided as there is no "training set" for this device.

Summary

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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

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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

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:

1. 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.
1. 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.

Regulation Number and Section

§ 882.5897 External upper limb tremor stimulator.

(a)
Identification. An external upper limb tremor stimulator is a prescription device which is placed externally on the upper limb and designed to aid in tremor symptom relief of the upper limb.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Non-clinical performance testing must assess the following:
(i) Characterization of the electrical stimulation, including the following, must be performed: Waveforms, output modes, maximum output voltage, maximum output current, pulse duration, frequency, net charge per pulse, maximum phase charge at 500 ohms, maximum current density, maximum average current, and maximum average power density.
(ii) Impedance testing, current distribution across the electrode surface area, adhesive integrity, and shelf life testing of the electrodes and gels must be conducted.
(iii) Simulated use testing of sensor performance and the associated algorithms that determine the stimulation output must be conducted.
(2) Patient-contacting components of the device must be demonstrated to be biocompatible.
(3) Performance testing must demonstrate electrical, thermal, and mechanical safety along with electromagnetic compatibility (EMC) of the device in the intended use environment.
(4) Software verification, validation, and hazard analysis must be performed.
(5) Physician and patient labeling must include:
(i) Summaries of electrical stimulation parameters;
(ii) Instructions on how to correctly use and maintain the device;
(iii) Instructions and explanations of all user-interface components;
(iv) Instructions on how to clean the device;
(v) A shelf life for the electrodes and gel; and
(vi) Reuse information.