The CSF-4 is intended to record, store, transfer, and display single-channel electrocardiogram (ECG) rhythms. The ECG signal is for quality checks of the data and for manual interpretation of heart rate. The CSF-4 also measures, records and displays pulse rate.

The CSF-4 is also indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2). The CSF-4 is for adult patients and health-conscious individuals in hospitals, clinics, long-term care facilities, and homes. The CSF-4 is a prescription device and should be used under the care of a physician. CSF-4 does not provide any alarms. It is not intended for pediatric use or use in critical care settings. The device is not intended to provide outputs during periods of motion.

Device Description

The CSF-4 is a non-invasive system comprised of software, hardware and mechanical components that enables the user to measure electrocardiography (ECG) and oxygen saturation of arterial hemoglobin (SpO2), as well as measuring pulse rate using photoplethysmography (PPG).

CSF-4 is a single-patient use, wearable monitoring device that collects intermittent data of physiological parameters, when little to no motion is detected.

The CSF-4 is comprised of 3 main components;

1. CS Watch 3 with CSF-4 Watch firmware ("Watch"): The CS Watch 3 is a wrist worn device embedded with non-invasive sensors. The watch includes firmware that activates the sensors, synchronizes the data sampled by the sensors, processes the data, stores the processed data in nonvolatile memory, and provides the data to the user. The processed data is transferred to the Mobile App via a secured BLE communication channel. In addition, the watch sends real-time raw data signals to the Mobile App.
1. CSF-4 Mobile Application ("Mobile App"): The Mobile App works on both Android OS and iOS. The mobile app communicates with the watch via BLE and to the Cloud App via HTTPS, thus acting as the watch gateway to the cloud application. The Mobile App caches the processed data from the watch and transfers it to the cloud application. It allows the user to conveniently view the measurement results and real time raw data. The Mobile App provides the user with the capability of creating an on-demand report and sharing it using 3rd party sharing applications.
1. CSF-4 Cloud Application ("Cloud App"): The Cloud App securely stores the user and processed data over designated databases. It provides the mechanism of creating and sending periodical reports which are sent to the user's email both automatically and on-demand.

AI/ML Overview

The provided text describes the acceptance criteria and study proving the device meets those criteria, specifically for the CardiacSense CSF-4 device. The information is extracted from the 510(k) Summary.

Here's a breakdown of the requested information:

1. Table of acceptance criteria and the reported device performance

Based on the "SUMMARY OF NON-CLINICAL TESTING" and "SUMMARY OF CLINICAL TESTING" sections:

Feature/Parameter	Acceptance Criteria (Implicit from testing methodology or standards)	Reported Device Performance
QRS Detection (ECG)	Sensitivity & PPV > 98% (MIT-BIH Arrhythmia & AHA) Sensitivity & PPV > 93% (MIT-BIH Noise Stress)	MIT-BIH Arrhythmia & AHA: Sensitivity > 98%, PPV > 98% MIT-BIH Noise Stress: Sensitivity > 93%, PPV > 93%
Heart Rate (HR) RMS Accuracy (ECG)	RMS Accuracy ~1-2% (MIT-BIH Arrhythmia & AHA) RMS Accuracy ~3% (MIT-BIH Noise Stress)	MIT-BIH Arrhythmia & AHA: RMS accuracy varies between 1-2% MIT-BIH Noise Stress: RMS accuracy slightly above 3%
Pulse Oximeter (SpO2) Accuracy	Accuracy as per ISO 80601-2-61:2017 standard (implied)	2.96% accuracy (SpO2 range 70% to 100%)
ECG Validation (overall performance)	(Not explicitly stated as numerical criteria, but performance validated)	Sensitivity of 99.59%, False Detection Rate of 0.54%
PPG Validation (overall performance)	(Not explicitly stated as numerical criteria, but performance validated)	Sensitivity of 99.78%, False Detection Rate of 0.03%

Note: For QRS detection and HR accuracy, the "acceptance criteria" are implied by the reported performance relative to the standards. For SpO2, it's explicitly linked to the ISO standard. For overall ECG and PPG validation, specific numerical criteria were not explicitly stated as "acceptance criteria" but rather as "performance."

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

QRS Algorithm (Bench Testing): Evaluated against three databases: MIT-BIH Arrhythmia, AHA, and MIT-BIH Noise Stress. The specific sample sizes (number of recordings/patients) for each database are not provided in this document, only that the evaluation was "per recording and per database."
Pulse Oximeter Testing:
- Sample Size: n=234 samples.
- Data Provenance: Conducted at the Hypoxia Research Laboratory, Department of Anesthesia Perioperative Care, University of California at San Francisco (UCSF). This is a prospective clinical study based on the context.
ECG and PPG Validation:
- Sample Size: Not explicitly stated, but the study was conducted at Fairview Research Center of the University of Minnesota. This was part of a previous submission (CSF-3) and was "reviewed and accepted by the Agency." This suggests it was likely a prospective clinical study.

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

The document does not explicitly state the number or qualifications of experts used to establish the ground truth for any of the tests.

For QRS algorithm testing, the ground truth for the MIT-BIH Arrhythmia and AHA databases is inherently part of those standardized, expert-annotated datasets.
For Pulse Oximeter Testing, the ISO 80601-2-61:2017 standard typically specifies requirements for a reference oximeter and a clinical study setup, implying a highly controlled environment with medical professionals overseeing the reference measurements, but specific expert involvement for ground truth adjudication is not detailed here.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The document does not specify any adjudication methods (like 2+1 or 3+1) used for establishing ground truth for the test sets.

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

The document mentions that the ECG signal is for "manual interpretation of heart rate." However, there is no mention of an MRMC comparative effectiveness study, nor any data on how human readers improve with AI vs. without AI assistance. The testing focuses on the device's standalone performance.

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

Yes, standalone performance was assessed for the following:

QRS Algorithm Performance: Evaluated against standardized databases (MIT-BIH Arrhythmia, AHA, MIT-BIH Noise Stress) - this is algorithm-only performance.
Pulse Oximeter Testing: The device's SpO2 accuracy was validated against reference measurements, indicating standalone performance.
ECG and PPG Validation: The reported sensitivity and false detection rates for ECG and PPG suggest standalone algorithmic performance.

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

QRS Algorithm: The ground truth for the MIT-BIH Arrhythmia and AHA databases is typically derived from expert-annotated ECG waveforms.
Pulse Oximeter Testing: The ground truth for SpO2 measurements typically comes from a reference oximeter or blood gas analyzer in a controlled clinical setting, as dictated by the ISO 80601-2-61:2017 standard.
ECG and PPG Validation: While not explicitly stated, clinical validation of ECG and PPG typically involves comparison to a gold standard, which for ECG could be a 12-lead ECG interpreted by cardiologists, and for PPG related to a reference heart rate/pulse measurement.

8. The sample size for the training set

The document does not provide any information regarding the training set size for the algorithms within the CSF-4 device. It focuses solely on the validation/test procedures and results.

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

Since information on the training set is not provided, details on how its ground truth was established are also not available in the provided text.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" stacked on top of each other.

May 2, 2024

CardiacSense % Oxana Pantchenko Sr. Consultant ROM+ 2251 San Diego Ave. Ste B-257 San Diego, California 92110

Re: K232445

Trade/Device Name: CSF-4 Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS, DQA, DXH Dated: April 1, 2024 Received: April 2, 2024

Dear Oxana Pantchenko:

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.

{1}------------------------------------------------

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" (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 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-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 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.

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-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).

{2}------------------------------------------------

Sincerely,

Jennifer W. Shih -S

Jennifer Shih 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

{3}------------------------------------------------

Indications for Use

510(k) Number (if known) K232445

Device Name CSF-4

Indications for Use (Describe)

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."

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image is a logo for CardiacSense. The logo features a green and blue design with the words "CardiacSense" in a combination of green and blue colors. The word "Cardiac" is in green, while "Sense" is in blue. Below the company name, there is a tagline that reads "Watching Over You." To the left of the text, there is a circular graphic composed of green circles with a blue heart in the center.

510(k) Summary

DATE PREPARED

May 1st, 2024

MANUFACTURER AND 510(k) OWNER

CardiacSense Leshem 6-8 North Industrial Park Caesarea, Israel Telephone: 330-285-7222 Official Contact: Benita Lanzer, Head of Clinical Affairs

REPRESENTATIVE/CONSULTANT

Oxana S. Pantchenko, Ph.D. Allison C. Komiyama, Ph.D., R.A.C. ROM+ 2790 Mosside Blvd Suite 800, Monroeville, PA 15146 Telephone: (412) 816-8253 Email: opantchenko@rgmplus.com, akomiyama@rgmplus.com

DEVICE INFORMATION

Name: CSF-4 Regulation Number: 870.2340 - Electrocardiograph Class: 2 Product Code: DPS, DOA, DXH Premarket Review: Cardiac Electrophysiology, Diagnostics, and Monitoring Devices (DHT2A) Review Panel: Cardiovascular

PREDICATE/REFERENCE DEVICE IDENTIFICATION

The CSF-4 is substantially equivalent to the following predicate and reference devices:

510(k) Number	Predicate Device Name / Manufacturer	Primary Predicate
K221260	CSF-3 / CardiacSense	✓
K181352	Loop System / Spry Health, Inc.

The predicate devices have not been subject to a design related recall.

DEVICE DESCRIPTION

CSF-4 is a single-patient use, wearable monitoring device that collects intermittent data of physiological parameters, when little to no motion is detected.

The CSF-4 is comprised of 3 main components;

1. CS Watch 3 with CSF-4 Watch firmware ("Watch"): The CS Watch 3 is a wrist worn device embedded with non-invasive sensors. The watch includes firmware that activates the sensors, synchronizes the data sampled by the sensors, processes the data, stores the processed data in nonvolatile memory, and provides the data to the user. The processed data is transferred to the Mobile

{5}------------------------------------------------

Image /page/5/Picture/1 description: The image is a logo for CardiacSense. The logo features a green and blue design with the word "CardiacSense" in a combination of green and blue colors. The word "Cardiac" is in green, while "Sense" is in blue. Below the company name is the text "Watching Over You" in a smaller font. To the left of the company name is a green circular design with a blue heart in the center.

App via a secured BLE communication channel. In addition, the watch sends real-time raw data signals to the Mobile App.

1. CSF-4 Mobile Application ("Mobile App"): The Mobile App works on both Android OS and iOS. The mobile app communicates with the watch via BLE and to the Cloud App via HTTPS, thus acting as the watch gateway to the cloud application. The Mobile App caches the processed data from the watch and transfers it to the cloud application. It allows the user to conveniently view the measurement results and real time raw data. The Mobile App provides the user with the capability of creating an on-demand report and sharing it using 3rd party sharing applications.
1. CSF-4 Cloud Application ("Cloud App"): The Cloud App securely stores the user and processed data over designated databases. It provides the mechanism of creating and sending periodical reports which are sent to the user's email both automatically and on-demand.

INDICATIONS FOR USE

The CSF-4 is also indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2). The CSF-4 is for adult patients and health-conscious individuals in hospitals, clinics, long-term care facilities, and homes. The CSF-4 is a prescription device and should be used under the care of a physician. CSF-4 does not provide any alarms. It is not intended for pediatic use or use in critical care settings. The device is not intended to provide outputs during periods of motion.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

The CSF-3 and the CSF-4 devices have the same indications for use in terms of measuring and displaying a number of physiological parameters. The CSF-4 proposed indications for use encompass those of the CSF-3 indications for use and add on an additional method for measuring heart rate/pulse rate using PPG. Currently, the CSF-3 device measures heart rate by ECG only. The CSF-4 is proposing to also measure heart rate by PPG. Additionally, CardiacSense proposes to use the Loop System by Spry Health, Inc. as a reference device to demonstrate substantial equivalence regarding additional method for measuring heart rate/pulse rate using PPG.

The CSF-3 and the CSF-4 use the same technology in recording, storing, and displaying ECG waveforms. Both devices are 1-lead ECGs and include three electrodes (2 contacting the skin and one reference electrode) and transmit the data wirelessly (via Bluetooth) to a dedicated mobile app. The CSF-3 and the CSF-4 use the same technology to measure, record, and display SpO2. Both devices measure SpO2 through a patient's finger. Lastly, the CSF-4 and the Loop System, both measure heart rate/pulse rate by using skin contacting sensors, utilizing PPG technology, worn around patient's wrist.

Based on the testing performed, including non-clinical data collected, it can be concluded that the CSF-4 device does not raise new issues of safety or effectiveness compared to the CSF-3 predicate device. The similar indications for use, technological characteristics, and performance characteristics for the proposed CSF-4 are assessed to be substantially equivalent to the CSF-3 predicate device. CardiacSense believes that the CSF-4 is substantially equivalent to the CSF-3 predicate device.

{6}------------------------------------------------

Image /page/6/Picture/1 description: The image is a logo for CardiacSense. The logo features a green and blue design with the word "CardiacSense" in a stylized font. The word "Cardiac" is in green, and the word "Sense" is in blue. Below the word "CardiacSense" is the phrase "Watching Over You" in a smaller font. To the left of the word "CardiacSense" is a green circular design with a blue heart in the center.

SUMMARY OF NON-CLINICAL TESTING

Biocompatibility Testing

Based on the device type and contact duration and FDA's Guidance for Industry and Food and Drug Administration Staff - Use of International ISO 10993-1, "Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process", the following biocompatibility tests were performed: in vitro cytotoxicity, irritation, and skin sensitization.

EMC, Wireless, Electrical, Mechanical and Thermal Testing

The CSF-3 System was evaluated for safety against the following standards;

ANSVAAMI IEC/EN 60601- 1:2005/(R)2012 + A1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-2-47:2012 Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic Systems
IEC 62133-2:2017 - Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary lithium cells, and for batteries made from them, for use in portable applications - Part 2: Lithium Systems
IEC 60601-1-2:2014 Ed. 4 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
IEC 60601-1-11:2015 Medical electrical equipment -- Part 1-11: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical Systems used in the home healthcare environment
IEC 62472:2006 Safety analysis performed based on IEC 62471 or other lamp optical safety standards applicable requirements have been met.

Bench Testing

The performance of the QRS algorithm was evaluated against three databases following the requirements stated in the IEC 60601-2-47 standard. The ORS statistic was calculated per recording and per database. The per-database statistic was calculated as both gross and average, as discussed above in detail.

The QRS detection performance is above 98% for both sensitivity and PPV parameters for the MIT-BIH Arrhythmia and AHA databases. In the more challenging MIT-BIH Noise Stress database, the sensitivity and PPV were above 93%.

The HR RMS accuracy varies between 1-2% for the MIT-BIH Arrhythmia and AHA databases but dropped to slightly above 3% for the more challenging MIT-BIH Noise Stress database.

The results of these tests indicate that the CSF-3 is substantially equivalent to the predicate device.

SUMMARY OF CLINICAL TESTING

The Pulse Oximeter Testing was conducted in the Hypoxia Research Laboratory, Department of Anesthesia Perioperative Care, University of California at San Francisco (UCSF) in compliance with the ISO 80601-2-61:2017 standard. The clinical study with n=234 samples, the SpO2 range was validated to be from 70% to 100% with accuracy of 2.96%.

The ECG and the PPG were tested in Fairview Research Center of the University of Minnesota. The study was reviewed and accepted by the Agency as part of the submission of CSF-3. The ECG was

{7}------------------------------------------------

Image /page/7/Picture/1 description: The image is a logo for CardiacSense. The logo features a green and blue color scheme. To the left of the company name is a green circular design with a blue heart in the center. Below the company name is the slogan "Watching Over You".

validated with the following performance, sensitivity of 99.59% and false detection rate of 0.54%. The PPG was validated with the following performance, sensitivity of 99.78% and false detection rate of 0.03% .

CONCLUSION

Based on the testing performed, it can be concluded that the CSF-4 does not raise new issues of safety or effectiveness compared to the predicate devices. The similar indications for use, technological characteristics, and performance characteristics for the proposed CSF-4 are assessed to be substantially equivalent to the predicate device.

Regulation Number and Section

§ 870.2340 Electrocardiograph.

(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).