CorSens Device records vibrational waveforms produced by the heart contractions and transmitted to the chest wall. CorSens Device may be used as a tool to measure the timing of part of the cardiac cycle for adult population.

Device Description

CorSens Device senses and analyzes the mechanical movement of the heart. This is accomplished by 3 standard ECG electrodes for the ECG signal and with a suitable miniature electronic accelerometer for the mechanical motions.

AI/ML Overview

The CorSens Device, a Ballistocardiograph, records vibrational waveforms produced by heart contractions to measure the timing of part of the cardiac cycle in adults.

Here's an analysis of its acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in a table format. However, it indicates a high-level performance expectation and makes a direct comparison to an established clinical method.

Acceptance Criterion (Inferred from text)	Reported Device Performance
Ability to provide accurate timing of part of the cardiac cycle events.	"CorSens Device can provide accurate timing of part of the event of the cardiac cycle, at least as accurate as the echocardiogram."
Safety and efficacy comparable to predicate devices.	"Results of tests and validations, performed with the proposed CorSens Device demonstrates that it is as safe and effective as its primary predicate device, without raising any new safety and/or effectiveness concerns."

2. Sample Size and Data Provenance for Test Set

The provided document does not explicitly detail a specific 'test set' with a defined sample size for a clinical study comparing the CorSens Device to an echocardiogram. It refers to a "comparison test" with echocardiogram, stating: "In addition to the verification and validation testing, a comparison test with the current common clinical practice to measure the timing of the events in the cardiac cycle, an Echocardiogram, was conducted."

Without further information, the specific sample size, country of origin, or whether the data was retrospective or prospective cannot be determined from this document.

3. Number and Qualifications of Experts for Ground Truth

The document does not specify the number or qualifications of experts used to establish ground truth for any test set. The ground truth (echocardiogram measurements) would typically be established by trained sonographers and/or cardiologists.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method for the comparison test with echocardiogram.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. Therefore, information on the effect size of human readers improving with or without AI assistance is not applicable or provided.

6. Standalone (Algorithm Only) Performance Study

The document indicates that "the proposed CorSens Device safety and the efficacy of the system were established by performance lab tests and Software V&V." While this suggests evaluation of the device's technical performance in isolation, it does not specifically describe a 'standalone (algorithm only without human-in-the-loop performance)' study in the way it might be discussed for an AI-driven diagnostic algorithm. The device is a measurement tool, and its 'performance' inherently involves its ability to capture and process data to produce timing measurements.

7. Type of Ground Truth Used

For the comparison test, the ground truth used was echocardiogram. The text explicitly states: "a comparison test with the current common clinical practice to measure the timing of the events in the cardiac cycle, an Echocardiogram, was conducted."

8. Sample Size for the Training Set

The document does not mention any specific training set or its sample size. This implies that the device's core functionality does not rely on a machine learning model that requires a discrete training phase with labeled data in the way many contemporary AI devices do. The device's operation is based on established biophysical principles of measuring vibrational waveforms.

9. How Ground Truth for the Training Set Was Established

Since no training set is mentioned as part of the device's development or validation process in this document, the method for establishing its ground truth is not applicable or provided. The device likely operates on fixed algorithms rather than a trained machine learning model.

Summary

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Public Health Service

November 21, 2016

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

CorSens Medical Ltd. % Yoram Levy Qsite General Manager Qsite 31 Haavoda St Binyamina, 30500 IL

Re: K160656

Trade/Device Name: CorSens Device Regulation Number: 21 CFR 870.2320 Regulation Name: Ballistocardiograph Regulatory Class: Class II Product Code: DXR Dated: September 12, 2016 Received: September 14, 2016

Dear Yoram Levy:

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. 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 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Mule Jellman
for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K160656

Device Name CorSens Device

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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K160656

Image /page/3/Picture/1 description: The image shows the logo for Corsens medical. The logo consists of a red heart shape with a small circle at the bottom, followed by the text "Corsens medical" in a simple, sans-serif font. The heart shape is stylized and appears to be hand-drawn.

510(K) SUMMARY

CorSens device

510(k) Number K160656

Applicant's Name:	CorSens Medical3 Azrieli Center Triangular Tower132 Menachem Begin Rd.Tel Aviv, IsraelTel: +972- 3-607-0306
Contact Person:	Yoram Levy, Qsite31 Haavoda StreetBinyamina, Israel 30500Tel (972)4-638-8837; Fax (972)4-638-0510Yoram@qsitemed.com
Trade Name:	CorSens Device
SummaryPreparation Date:	04 February, 2015
Classification:	Name: BallistocardiographProduct Code: DXRRegulation No: 21 CFR 870.2320Class: IIClassification Panel: Cardiology

Device Description:

Intended Use Statement:

CorSens device records vibrational waveforms produced by the heart contractions and transmitted to the chest wall. CorSens device may be

Page 1 of 4 CorSens Device– 510k Submission

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Image /page/4/Picture/1 description: The image shows the logo for Corsens medical. The logo consists of a red heart shape with a small circle at the bottom left, followed by the text "Corsens medical" in a simple, sans-serif font. The heart shape is stylized and appears to be drawn with a single line.

used as a tool to measure the timing of part of the events in the cardiac cycle for adult population.

Predicate Devices:

The CorSens device is substantially equivalent to the following marketcleared device:

dBG 300 Digital Ballistocardiograph (K081603) in respect to intended use, clinical indication and technological characteristics.
Reference Devices:
. Visi Mobile Monitoring System (K142827)- in respect the use of 3 ECG leads to capture ECG signals.
BPCard device diagnostic (K073630)- in respect to the ● use of a microphone to sense the heart sounds.

Substantial Equivalence to Predicate Devices

CorSens Device has similar intended use and indications for use as its predicate, dBG 300 Digital Ballistocardiograph (K081603).

CorSens Device utilizes the same technology as the cleared dBG 300 Digital Ballistocardiograph (K081603).

CorSens Device has a similar User interface as the cleared dBG 300 Digital Ballistocardiograph (K081603).

Any minor differences in the design do not raise any new questions of safety and effectiveness issues, as verified by performance testing.

Results of tests and validations, performed with the proposed CorSens Device demonstrates that it is as safe and effective as its primary predicate device, without raising any new safety and/or effectiveness concerns.

Therefore, the CorSens Device is substantially equivalent to its predicate device.

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Image /page/5/Picture/1 description: The image shows the logo for Corsens medical. The logo consists of a red heart shape with a small circle at the bottom, followed by the text "Corsens medical" in a simple, sans-serif font. The heart shape is stylized and appears to be hand-drawn.

Performance Standards:

CorSens device complies with:

· IEC 60601-1 Medical Electrical Equipment-Part 1: General Requirements for Safety. Collateral Standard: Safety Requirements for Medical Electrical Systems.
IEC 60601-1-2 Medical Electrical Equipment Part 1-2: Collateral Standard: Electromagnetic Compatibility - Requirements and Tests.
· IEC 60601-1-4 Medical Electrical Equipment-Part 1-4: General requirements for safety- collateral standards: Programmable electrical medical system
· ISO 62304 Medical device software- Software life cycle processes
· ISO 14971 Medical Devices- Application of risk management to medical devices
ISO 15223-1 Medical Devices- Symbols to be used with medical device labels, labeling and information to be supplied- Part 1.

Performance Bench Tests

The proposed CorSens Device safety and the efficacy of the system were established by performance lab tests and Software V&V. The proposed CorSens Device performs according to its specificiation.

The design of CorSens Device was done in accordance with CorSens Medical quality management system and design controls per 21CFR 820 and ISO 13485. Engineering testing and standards compliance testing were successfully conducted and did not raise any new safety questions or identify any new risks.

In addition to the verification and validation testing, a comparison test with the current common clinical practice to measure the timing of the events in the cardiac cycle, an Echocardiogram, was conducted. As CorSens Device

Page 3 of 4 CorSens Device– 510k Submission

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orsens medical

performance test demonstrates, CorSens Device can provide accurate timing of part of the event of the cardiac cycle, at least as accurate as the echocardiogram.

Summary of Pre-Clinical and clinical study

CorSens Device is a Ballistocardiograph. The safety and efficacy of the CorSens Device has been well established in scientific research. Due to the comprehensive clinical studies, scientific research and published literature of Ballistocardiograph devices using the same technology and with its predicate devices, CorSens Medical Ltd. believes that animal and clinical studies are not required to determine the safety and efficacy of the device.

Conclusions

The CorSens Device was proven to meet the safety and effectiveness endpoints

Substantial equivalence conclusion

The performance tests and the clinical study that were conducted shows that the CorSens Device is as safe and effective as the listed predicate device without raising any new questions of safety and efficacy

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).