(215 days)
Not Found
No
The description focuses on traditional signal processing and calculation methods (strain gauge, impedance plethysmography, calculation based on height and PTT). There is no mention of AI or ML in the device description, intended use, or performance studies.
No.
The device is intended to obtain measurements (PWV, PR, BW, and BMI) for diagnostic purposes, not to treat or cure a disease or condition.
Yes
The device obtains physiological measurements (PWV, PR, BW) and calculates BMI, and its intended use is to obtain these measurements, which are typically used to assess a patient's health status. While it doesn't explicitly state "diagnosis," devices that measure physiological parameters to assess or monitor health are generally considered diagnostic. Furthermore, the "Intended Use / Indications for Use" section describes obtaining specific health-related parameters.
No
The device description explicitly lists multiple hardware components including a Scale Platform, Console, USB Cable, Isolated Power Supply and Power Cord, Height Rod, Visual Guide Accessory, and Console Wall Mount. It also mentions using strain gauge sensors and impedance plethysmography sensing.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Cardiovascular Analyzer performs non-invasive physiological measurements (PWV, PR, BW, BMI) directly on the patient's body using physical sensors (strain gauge and impedance electrodes). It does not analyze samples taken from the body.
The device is a medical device that performs physiological measurements, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Cardiovascular Analyzer is intended to obtain Pulse Wave Velocity (PWV) and Pulse Rate (PR) through a combination of impedance plethysmography and weight measurements in adults 18 years of age and older. The Cardiovascular Analyzer also measures Body Weight and calculates BMI.
Product codes (comma separated list FDA assigned to the subject device)
DSB, DSK, DXN
Device Description
The Cardiovascular Analyzer is designed to perform non-invasive physiologic measurements for PWV, PR, and BW, and to calculate BMI. The Cardiovascular Analyzer uses strain gauge sensors to measure BW and the ballistocardiogram (BCG). The BCG provides an indication of the arterial pulsation in the aortic arch. The Cardiovascular Analyzer also uses impedance plethysmography (IPG) sensing to estimate the PR and arterial pulsation in the legs. PWV is then calculated using the subject's sternal height (measured with a height rod) and the Pulse Transit Time (PTT) derived from the BCG and IPG signals.
The Cardiovascular Analyzer is comprised of the following key components and accessories: Scale Platform, Console, USB Cable, Isolated Power Supply and Power Cord, Height Rod, Visual Guide Accessory and Console Wall Mount.
The device uses two sensing modalities (load cells and impedance electrodes) to perform the following three measurements: PWV, PR and BW. BMI is calculated using BW and the operator-entered subject's overall height measurement.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adults 18 years of age and older
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing was conducted to evaluate and characterize the performance of the Cardiovascular Analyzer. The following performance testing was conducted in accordance with the applicable FDA consensus standards to support a determination of substantial equivalence to the predicate device.
- System Verification
- Device Repeatability and Reproducibility
- Use Life
- Operational Environment
- Packaging and Transportation
- Usability
- Software Verification and Validation
- Safety/EMC Testing
- Biocompatibility
- Clinical Performance Testing
System Verification and Validation testing was completed to demonstrate that the device satisfactorily met the predefined Product System Requirements. Testing included safety testing in accordance with recognized standards and equivalence testing between common measurements of the new device and the predicate as well as common measurements of the new device and a gold standard FDA-cleared ECG monitor and Class I patient scale.
Additionally, side-by-side equivalence testing was performed for the BW, BMI, PR and PWV functions of the CA device against the comparison devices. The comparison tests demonstrated very high correlation of all measured and calculated parameters between the new device and the comparison devices and satisfactorily passed the acceptance criteria. The performance data demonstrates that the Cardiovascular Analyzer is substantially equivalent to the predicate device.
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.
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.
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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
§ 870.2770 Impedance plethysmograph.
(a)
Identification. An impedance plethysmograph is a device used to estimate peripheral blood flow by measuring electrical impedance changes in a region of the body such as the arms and legs.(b)
Classification. Class II (special controls). The device, when it is a body composition analyzer which is not intended to diagnose or treat any medical condition, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
March 14, 2018
PhysioWave, Inc. % Diana DeGregorio Regulatory Affairs Consultant Lince Consulting, LLC 111 Deerwood Road, Suite 200 San Ramon, California 94583
Re: K172431
Trade/Device Name: Cardiovascular Analyzer Regulation Number: 21 CFR 870.2770 Regulation Name: Impedance Plethysmograph Regulatory Class: Class II Product Code: DSB, DSK, DXN Dated: March 13, 2018 Received: March 14, 2018
Dear Diana DeGregorio:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
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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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-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,
M.A. Hillebrand
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K172431
Device Name Cardiovascular Analyzer
Indications for Use (Describe)
The Cardiovascular Analyzer is intended to obtain Pulse Wave Velocity (PWV) and Pulse Rate (PR) through a combination of impedance plethysmography and weight measurements in adults 18 years of age and older. The Cardiovascular Analyzer also measures Body Weight and calculates BMI.
| 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) |
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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510(k) Summary
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
l. SUBMITTER
Laurent Giovangrandi, PhD Chief Technical Officer PhysioWave, Inc. 1700 Wyatt Drive, Suite 2 Santa Clara, CA 95054 Phone: (408) 638-0008 Fax: (408) 610-2373 Establishment Reqistration No.: TBD
Contact Person: Diana DeGregorio Lincé Consulting, LLC Regulatory Affairs Consultant (925) 980-8047 ddegregorio@linceconsulting.com
Alternate Contact: Nancy Lincé Clinical & Regulatory Affairs Consultant Lincé Consulting, LLC Phone: (650) 759-6186 nlince@linceconsulting.com
Date Prepared: December 4, 2017
II. DEVICE
Trade Name: Cardiovascular Analyzer Impedance Plethysmograph Common Name: Classification Name: Impedance Plethysmograph Classification: 21 CFR§ 870.2770 Product Code: DSB Device Class: Class II
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lll. PREDICATE
Primary:
The PhysioWave Cardiovascular Analyzer's Pulse Wave Velocity (PWV) and Pulse Rate (PR) measurements are substantially equivalent to the primary predicate, AtCor Medical SphygmoCor® XCEL (K122129).
Secondary:
The Cardiovascular Analyzer also provides Body Weight (BW) and calculates Body Mass Index (BMI) similar to several 510(k)-exempt body weight medical scales and body composition analyzers, including the Detecto Solo® scale (Class 1 21 CFR 880.2700 Stand-on patient scale product code FRI), manufactured by Cardinal Health. The company used the Detecto Solo scale as the secondary predicate device to compare the measured BW and BMI calculation.
Reference devices are noted to demonstrate that the technological differences, namely use of ballistocardiogram and impedance plethysmography, are already wellestablished when used to obtain hemodynamic parameters and used in other devices with the same intended use for which there are known scientific methods of testing.
DEVICE DESCRIPTION IV.
The Cardiovascular Analyzer is designed to perform non-invasive physiologic measurements for PWV, PR, and BW, and to calculate BMI. The Cardiovascular Analyzer uses strain gauge sensors to measure BW and the ballistocardiogram (BCG). The BCG provides an indication of the arterial pulsation in the aortic arch. The Cardiovascular Analyzer also uses impedance plethysmography (IPG) sensing to estimate the PR and arterial pulsation in the legs. PWV is then calculated using the subject's sternal height (measured with a height rod) and the Pulse Transit Time (PTT) derived from the BCG and IPG signals.
The Cardiovascular Analyzer is comprised of the following key components and accessories: Scale Platform, Console, USB Cable, Isolated Power Supply and Power Cord, Height Rod, Visual Guide Accessory and Console Wall Mount.
The device uses two sensing modalities (load cells and impedance electrodes) to perform the following three measurements: PWV, PR and BW. BMI is calculated using BW and the operator-entered subject's overall height measurement.
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V. INDICATIONS FOR USE
The Cardiovascular Analyzer is intended to obtain Pulse Wave Velocity (PWV) and Pulse Rate (PR) through a combination of impedance plethysmography and weight measurements in adults 18 years of age and older. The Cardiovascular Analyzer also measures Body Weight and calculates BMI.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The subject and predicate devices have the same intended use. Specifically, both the subject and predicate devices are intended to monitor physiologic parameters noninvasively within hospitals and other healthcare facilities providing patient care. The XCEL device can be used in two modes, Pulse Wave Analysis Measurement (PWA) and Pulse Wave Velocity Measurement (PWV). It is the PWV mode to which substantial equivalence is being claimed. Both subject and predicate devices are designed to calculate PWV and PR non-invasively, providing lower-risk alternatives to the invasive arterial line catheterization PWV approach. Both subject and predicate devices measure the PTT, which is the time a blood pressure pulse travels along an artery, using a pair of sensors to measure proximal and distal pulsations. PWV is then calculated by dividing the respective estimated proximal-distal distances by the measured PTT. A linear calibration factor is applied to the Cardiovascular Analyzer results to correct for any differences in PTT due to sensor location and posture.
Both devices are constructed of an electronics hardware module and sensors. The basic operation for both devices involves a patient's physiological signals being gathered by the electronics hardware module via the patient-contacting sensors. In the case of the CA, these signals are then analyzed on-board and results transferred to a USB-connected, Android-based Console for display. BMI is calculated by the Console. For the XCEL, the data is first transferred to a USB-connected, Windowsbased PC and then analyzed by a custom application. In both cases, the software applications also provide a GUI-based interface to allow the operator to initiate measurements and to display the measured parameters to the operator.
The primary differences between the predicate and new devices are the sensors and locations used to measure the PTT. The XCEL measures PWV using a pressure sensor (tonometer) applied to the carotid artery, and a blood pressure cuff on the thigh, to record the PTT along the carotid-aortic-femoral arterial branches. The Cardiovascular Analyzer calculates PWV by measuring small weight fluctuations from the load cell signals (BCG), fluctuations that indicate the pressure pulse timing in the aortic arch, and measuring distal pressure pulses by impedance plethysmography
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using foot electrodes to detect the pulse arrivals in the upper and lower leg, near the foot. The subject and predicate devices both have automated algorithms to determine PTT based on the proximal and distal pulse measurements, to compute PWV, and also compute PR based upon the periodicity of the distal pulse.
The Cardiovascular Analyzer also provides BW and calculates BMI similar to several 510(k)-exempt body weight medical scales and body composition analyzers, including the Detecto Solo scale (Class 1 21 CFR 880.2700 Stand-on patient scale product code FRI), manufactured by Cardinal Health.
Additionally, reference devices are noted to demonstrate that the technological differences, namely use of BCG and IPG, are already well-established when used to obtain hemodynamic parameters and used in other devices with the same intended use for which there are known scientific methods of testing.
The information presented in the 510(k) application demonstrates that any differences in technological characteristics do not raise new or different questions of safety and effectiveness when compared to the XCEL primary predicate device. The Cardiovascular Analyzer was designed to increase convenience of use of PWV and PR functionality, without altering the intended use or risk profile, relative to the XCEL (K122129). In addition, BW is measured and BMI calculated concomitantly, and since these are typically measured on patient intake, this will allow PWV and PR to also be measured without significant change nor disruption to clinical workflow.
VII. PERFORMANCE DATA
Performance testing was conducted to evaluate and characterize the performance of the Cardiovascular Analyzer. The following performance testing was conducted in accordance with the applicable FDA consensus standards to support a determination of substantial equivalence to the predicate device.
- System Verification
- Device Repeatability and Reproducibility ●
- Use Life ●
- . Operational Environment
- Packaging and Transportation
- Usability ●
- . Software Verification and Validation
- Safety/EMC Testing ●
- Biocompatibility
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- Clinical Performance Testing ●
VIII. CONCLUSIONS
The Cardiovascular Analyzer has been carefully compared to the legally marketed primary predicate device with respect to intended use/indications for use, technological characteristics, performance, safety characteristics, and labeling.
The information presented in the 510(k) application demonstrates that any differences in technological characteristics do not raise new or different questions of safety and effectiveness when compared to the XCEL predicate device.
The Cardiovascular Analyzer was extensively and systematically evaluated to demonstrate substantial equivalence to the predicate device in performing noninvasive physiologic measurements. Specifically, the performance testing demonstrates the safe use of the system to facilitate non-invasive PWV, PR, and BW measurements and to calculate BMI. The performance testing of the Cardiovascular Analyzer included testing against documented design specifications relating to physical characteristics, functionality, performance, and safety, and evaluated performance in accordance with the labeling and applicable standards to ensure that design inputs met design outputs. Specifications were developed based on clinical input, examination of the predicate, human factors considerations, relevant external standards, and outputs from the company's internal risk management process (Hazard Analysis and FMEAs).
System Verification and Validation testing was completed to demonstrate that the device satisfactorily met the predefined Product System Requirements. Testing included safety testing in accordance with recognized standards and equivalence testing between common measurements of the new device and the predicate as well as common measurements of the new device and a gold standard FDA-cleared ECG monitor and Class I patient scale.
The software was designed and developed in accordance with robust software development processes and controls and underwent comprehensive verifications and validations. FDA guidance documents, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (Issued May 11, 2005) and "Draft Guidance for the Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" (Issued June 14, 2013) and the standard IEC 62304 Medical Device Software - Software Life Cycle Processes were considered and applied in preparation of this section of the traditional Premarket Notification. The
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software verification and validation testing results indicate that the new device complies with its predetermined specification.
Additionally, side-by-side equivalence testing was performed for the BW, BMI, PR and PWV functions of the CA device against the comparison devices. The comparison tests demonstrated very high correlation of all measured and calculated parameters between the new device and the comparison devices and satisfactorily passed the acceptance criteria. The performance data demonstrates that the Cardiovascular Analyzer is substantially equivalent to the predicate device.