(258 days)
No
The summary describes standard signal processing and comparison to existing methods, with no mention of AI/ML terms or training/test data sets.
No
The device is identified as a tool to measure the timing of part of the cardiac cycle, not to treat or alleviate a condition. The predicate device is also a diagnostic tool.
No
The device records waveforms and measures the timing of part of the cardiac cycle. It is compared to an echocardiogram for accuracy in timing events, but its intended use statement does not mention diagnosing disease or conditions. It is presented as a "tool to measure," not to diagnose.
No
The device description explicitly states it uses "3 standard ECG electrodes for the ECG signal and with a suitable miniature electronic accelerometer for the mechanical motions," indicating the presence of hardware components beyond just software.
Based on the provided information, the CorSens Device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The description of the CorSens Device clearly states it records vibrational waveforms transmitted to the chest wall and senses mechanical movement of the heart using ECG electrodes and an accelerometer. This is a non-invasive method that does not involve analyzing biological samples (like blood, urine, tissue, etc.).
- The intended use describes measuring the timing of part of the cardiac cycle. This is a physiological measurement taken directly from the patient, not an analysis of a sample taken from the patient.
The device appears to be a physiological monitoring device that measures mechanical and electrical activity of the heart.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
DXR
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
chest wall
Indicated Patient Age Range
adult population.
Intended User / Care Setting
Not Found
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 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.
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 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.
CorSens Medical Ltd. believes that animal and clinical studies are not required to determine the safety and efficacy of the device due to comprehensive clinical studies, scientific research and published literature of Ballistocardiograph devices using the same technology and with its predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
dBG 300 Digital Ballistocardiograph (K081603)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Visi Mobile Monitoring System (K142827), BPCard device diagnostic (K073630)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other, creating a sense of depth and unity.
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
1
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
2
Indications for Use
510(k) Number (if known) K160656
Device Name CorSens Device
Indications for Use (Describe)
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.
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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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 Medical
3 Azrieli Center Triangular Tower
132 Menachem Begin Rd.
Tel Aviv, Israel
Tel: +972- 3-607-0306 |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Yoram Levy, Qsite
31 Haavoda Street
Binyamina, Israel 30500
Tel (972)4-638-8837; Fax (972)4-638-0510
Yoram@qsitemed.com |
| Trade Name: | CorSens Device |
| Summary
Preparation Date: | 04 February, 2015 |
| Classification: | Name: Ballistocardiograph
Product Code: DXR
Regulation No: 21 CFR 870.2320
Class: II
Classification Panel: Cardiology |
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.
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