The CardioTag device is a tool that can be used to record, display and transfer vibrational waveforms produced by the heart contractions and transmitted to the chest as well as single-channel electrocardiogram (ECG) rhythms and heart rate. It also measures pulse waveform and pulse rate by photoplethysmograph (PPG). The CardioTag may be used as a tool to measure the timing of the aortic valve opening and closing in the cardiac cycle. The CardioTag is intended for spot-checking of adult patients in clinics or at home under the care of a physician. The data from the CardioTag is intended for use by healthcare professionals as an aid to diagnosis and treatment.

Device Description

The CardioTag device consists of a rechargeable wearable that is responsible for collecting raw cardiac signals from a single patient, and produces a spot-check report of a patient's electrocardiogram (ECG), photoplethysmogram (PPG), and seismocardiogram (SCG) signals and heart rate. To generate the report, the user places the wearable on the sternum and starts a 2 minute recording session for waveform output and heart rate /pulse rate calculation. The wearable contains electrodes to measure single-lead ECG, light sources and optical sensor arrays to measure PPG, and an accelerometer to measure vibrational waveforms from the heart's contractions transferred to the chest wall (SCG). Sensor data is then transferred for storage and processing to a cloud-based backend). The backend uses the recording to calculate heart rate and pulse rate and then visualizes the waveforms and heart rate in the format of a downloadable PDF report for the clinician. The SCG signal is intended to be used for manual interpretation by the clinician in conjunction with other information from the device. The device may be used as a tool to measure the timing of the aortic valve opening and closing in the cardiac cycle.

AI/ML Overview

The provided FDA 510(k) clearance letter and supporting documentation for the CardioTag device does not contain enough information to fully answer all aspects of the acceptance criteria and study design, specifically regarding the detailed performance metrics, sample sizes for test and training sets, expert adjudication details, and the specific ground truth establishment methods.

However, I can extract and infer information from the available text to address as many points as possible.

Here's a breakdown of the acceptance criteria and study details based on the provided document:

Acceptance Criteria and Device Performance

The document states that "The primary endpoints for the CardioTag study were all met. The study results demonstrated that the CardioTag performs at an acceptable level when compared to commercially available devices with high accuracy." While this confirms the device met its performance criteria, the specific metrics and numerical targets are not explicitly stated in the provided text.

Based on the device's functions, the implied acceptance criteria would relate to the accuracy of:

ECG waveform recording and display
Heart rate calculation (from ECG)
PPG waveform recording and display
Pulse rate calculation (from PPG)
SCG waveform recording and display
Measurement of aortic valve opening and closing timing (from SCG)

Since the document states "The primary endpoints for the CardioTag study were all met," we can infer that the reported device performance met or exceeded the (unspecified) acceptance thresholds for these functions, demonstrating high accuracy when compared to commercially available devices.

Table of Acceptance Criteria and Reported Device Performance (Inferred/General)

Acceptance Criteria (Inferred)	Reported Device Performance (General)
Accuracy of ECG waveform recording and display	Demonstrated high accuracy when compared to commercially available devices.
Accuracy of Heart Rate calculation (from ECG)	Demonstrated high accuracy when compared to commercially available devices.
Accuracy of PPG waveform recording and display	Demonstrated high accuracy when compared to commercially available devices.
Accuracy of Pulse Rate calculation (from PPG)	Demonstrated high accuracy when compared to commercially available devices.
Accuracy of SCG waveform recording and display	Demonstrated high accuracy when compared to commercially available devices.
Accuracy in measuring aortic valve timing (from SCG)	Demonstrated high accuracy when compared to commercially available devices.

Study Proving Device Meets Acceptance Criteria

The document describes a clinical study that was conducted to validate the CardioTag device.

Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: The exact numerical sample size for the clinical study is not specified in the provided document. It only states, "The CardioTag device has been clinically tested and validated in the US."
- Data Provenance: The data was collected from subjects recruited in the US. The study was prospective as it involved recruiting subjects for clinical testing. It also states, "subjects were recruited based on US demographics to present proper race and ethnicity to ensure diverse representation."
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- The document does not specify the number of experts or their qualifications used to establish ground truth for the clinical study. It only mentions that the data is "intended for use by healthcare professionals as an aid to diagnosis and treatment" and the SCG signal is for "manual interpretation by the clinician." This implies that expert interpretation would be crucial for ground truth, but the details are missing.
Adjudication Method for the Test Set:
- The document does not specify any adjudication method (e.g., 2+1, 3+1, none) used for the test set.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- The document does not mention a specific MRMC comparative effectiveness study. The study "compared [CardioTag] to commercially available devices" to demonstrate accuracy, which suggests a comparative element, but not necessarily an MRMC study assessing human reader performance with and without AI assistance.
- Therefore, no effect size for human reader improvement with AI vs. without AI assistance is reported in this document.
Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- The document does not explicitly describe a standalone algorithm-only performance study. The description of the device heavily emphasizes the output for "manual interpretation by the clinician" and "aid to diagnosis and treatment by healthcare professionals," suggesting a human-in-the-loop workflow.
- However, the validation of "ECG Validation," "PPG Validation," and "SCG Validation" in the performance testing section, which were "Bench-testing (non-clinical)," might imply a component of standalone algorithm evaluation of signal quality and derived parameters. The clinical study, by nature of validating against commercially available devices, would involve the device's outputs without necessarily detailing a separate "algorithm only" performance metric without human review.
Type of Ground Truth Used:
- The document implies that ground truth was established by comparison to "commercially available devices" which served as the reference standard. This suggests a clinical comparator ground truth rather than pathology or long-term outcomes data. For parameters like heart rate and pulse rate, the ground truth would likely come from validated measurements by the comparator devices. For waveform interpretation (ECG, SCG), expert consensus or comparison to gold-standard clinical systems would be the likely ground truth, though not explicitly stated.
Sample Size for the Training Set:
- The document does not specify the sample size used for the training set.
How the Ground Truth for the Training Set Was Established:
- The document does not specify how ground truth for the training set was established. Given the nature of a 510(k) submission, this information might be in a more detailed study report not included in this summary.

Summary

FDA 510(k) Clearance Letter - CardioTag Device

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.08.00

July 22, 2025

Cardiosense, Inc.
Arezou Azar
VP, Compliance
400 N Aberdeen St.
Suite 900
Chicago, Illinois 60642

Re: K243566
Trade/Device Name: CardioTag
Regulation Number: 21 CFR 870.2320
Regulation Name: Ballistocardiograph
Regulatory Class: Class II
Product Code: DXR, DRG, DPS, MWI
Dated: June 17, 2025
Received: June 17, 2025

Dear Arezou Azar:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

Page 2

K243566 - Arezou Azar Page 2

(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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).

Page 3

K243566 - Arezou Azar Page 3

Sincerely,

Jennifer W. Shih -S

Jennifer Kozen
Assistant Director
Division of Cardiac Electrophysiology,
Diagnostics, and Monitoring Devices
Office of Cardiovascular Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

Page 4

Food and Drug Administration
Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Submission Number (if known): K243566

Device Name: CardioTag™

Indications for Use (Describe)

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."

Page 5

CARDIOSENSE

K243566
Page 1 of 4

510(k) Summary

I. SUBMITTER

Cardiosense, Inc.
400 N Aberdeen St., Suite 900
Chicago, IL 60642

Contact Person: Arezou Azar, Ph.D.
VP Compliance (Regulatory, Quality, Clinical) and Program Management
email: arezou@cardiosense.com

Phone: (650) 804-0285

Date Prepared: November 15, 2024

II. DEVICE

Name of Device: CardioTag™
Common or Usual Name: Ballistocardiograph or seismocardiogram (SCG)
Classification Name: Ballistocardiograph (21 CFR 870.2320)
Regulatory Class: II
Product Code: DXR (primary); DRG, DPS, MWI

III. PREDICATE DEVICE

Primary: HeartForce Medical, dBG Digital Ballistocardiograph, K081603
Secondary: Meridian, McPulse Photoelectric Plethysmograph, K023238

IV. DEVICE DESCRIPTION

Page 6

CARDIOSENSE

K243566
Page 2 of 4

may be used as a tool to measure the timing of the aortic valve opening and closing in the cardiac cycle.

V. INDICATIONS FOR USE

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE

Both the subject device and predicates have the same intended use.

The subject device combines the outputs of the primary and secondary predicate devices as an all-in-one solution. The subject and primary predicate are aligned in that they are both reusable, battery powered devices placed on the chest via adhesives, perform spot checks (i.e. non-continuous measurements), and output ECG and vibrational waveforms in reports. The subject device and secondary predicate are similar in that they are battery powered, reusable devices that are used for spot-check measurements (i.e. non-continuous measurement), and both output PPG waveforms and use PPG as an input into heart rate calculations.

Minor technological differences have been addressed through risk management, bench-testing, clinical testing, and application of FDA-Recognized standards and, thus, do not raise new questions of safety and effectiveness.

VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility Testing

The biocompatibility evaluation for the CardioTag device was conducted in accordance with the FDA guidance document, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", September 2023, and International Standard ISO 10993-1 Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process, as recognized by FDA.

Patient-contacting parts of the device were subjected to the following tests:

Cytotoxicity
Sensitization
Irritation

Page 7

CARDIOSENSE

K243566
Page 3 of 4

The CardioTag has Limited (<24 hrs) contact duration with (surface) intact skin.

Electrical Safety and Electromagnetic Compatibility (EMC)

Electrical safety, EMC, and wireless coexistence testing were conducted on the CardioTag device. The device complies with the following standards:

Basic Safety and Performance

Basic safety and Essential Performance
Defibrillation - Proof Applied Parts (Differential Mode)
Proof Applied Parts (Common Mode)

Electromagnetic Compatibility

Electrical safety and EMC testing was performed to applicable standards, including EMC/RF disturbances and immunity.

Software Verification and Validation Testing

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, November 2021.

Performance Testing

Bench-testing (non-clinical) was conducted for ECG, PPG, SCG functions to confirm that the following functions met specifications:

ECG Validation
PPG Validation
SCG Validation

Animal Studies

No animal studies were undertaken to support substantial equivalence.

Clinical Studies

The CardioTag device has been clinically tested and validated in the US. Substantial equivalence was based in part on the clinical study. The subjects were recruited based on US demographics to present proper race and ethnicity to ensure diverse representation.

The primary endpoints for the CardioTag study were all met. The study results demonstrated that the CardioTag performs at an acceptable level when compared to commercially available devices with high accuracy.

Page 8

CARDIOSENSE

K243566
Page 4 of 4

VIII. CONCLUSIONS

The subject and predicate devices have the same Intended Use and similar technological characteristics. Bench-testing, biocompatibility, electrical safety and EMC, and clinical studies demonstrate that the differences in technological characteristics do not raise new questions of safety and effectiveness. As such, the CardioTag is substantially equivalent to the predicate devices.

Regulation Number and Section

§ 870.2320 Ballistocardiograph.

(a)
Identification. A ballistocardiograph is a device, including a supporting structure on which the patient is placed, that moves in response to blood ejection from the heart. The device often provides a visual display.(b)
Classification. Class II (performance standards).