(786 days)
The PhysioFlow System noninvasively measures cardiac output and other related cardiac parameters on adults. These parameters include: CI, Cardiac Index; CO, Cardiac Output; CTI, Contractility Index; EDV, End Diastolic Volume; EF, Ejection Fraction; HR, Heart Rate; LCWI, Left Cardiac Work Index; PEP, Pre Ejection Period; SV, Stroke Volume; SVR, Systemic Vascular Resistance; SVRI, Systemic Vascular Resistance Index; TFI, Thoracic Fluid Index; LVET, Left Ventricular Ejection Time. The PhysioFlow System is intended for use under the direct supervision of a licensed healthcare practitioner or personnel trained in its proper use within a hospital or facility providing healthcare.
The PhysioFlow System is a noninvasive hemodynamic monitor that uses thoracic electrical bioimpedance technology to measure cardiac output and related parameters. It has three main components: 1. An electronic device that generates a low magnitude, high frequency electrical current, sends it through the body of the patient via a patient cable and pre-gelled electrodes, and receives it after it has crossed the patient thorax. The impedance modulation (ΔΖ) is extracted from the received signal, providing a pulsatile waveform used by the software to compute stroke volume. The device also records one lead of a passive electrical signal that is similar to the ECG, in order to provide a time basis and trigger for the analysis of the impedance waveform, and to provide a measurement of heart rate. This ECG signal is not used for electrocardiography analysis. The device filters and digitizes both the impedance and the ECG signals, and transmits them to a computer via a serial communications link. The device has an analog output option, which makes the following signals available: ΔZ, ECG, Cardiac Output trend, and Stroke Volume trend. 2. A computer that runs a MS-Windows operating system, and performs the following tasks: Reception of digitized signal samples from the device via a serial port; Platform to operate the PhysioFlow software; Physical user interface (keyboard, mouse, display); Patient data storage capacity (on hard disk); (Optional) Reception of blood pressure values from an external blood pressure monitor device via a serial port (This device does not measure blood pressure); Management of a printer using the appropriate driver. 3. The PhysioFlow software, which performs following tasks: Signal processing and analysis; Computation of measured parameters; User interface and control of the measurement process (entering patient data, calibration procedure, monitoring phase, post processing of measurement results); Transmitting cardiac output and stroke volume values back to the device via a serial data link for analog output purposes; Management of event markers; Setup of measurement and screen configuration (averaging ratio, scales, screen appearance, printout options); Display of signal, trends, and graphics; Management of imported data (blood pressure values from external monitor); Management of patient data; Export of measurement data in text format (for import into programs such as Excel); Generating hard copy output.
Here's a breakdown of the acceptance criteria and study information for the PhysioFlow device, based on the provided text:
Acceptance Criteria and Device Performance
The provided 510(k) summary does not explicitly list quantitative acceptance criteria in a table format with specific thresholds. However, it states that the device was compared to a predicate device and a Swan-Ganz catheter, implying that its performance needed to be similar to or substantially equivalent to these established methods. The overall conclusion is that the PhysioFlow System is "substantially equivalent to the Philips ICG System" (the predicate) in its overall intended use, functioning, safety, and efficacy.
Table 1: PhysioFlow Performance & Equivalence
| Metric / Comparison Point | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Cardiac Output Measurement (Main Function) | Similar to predicate device (Philips ICG System) and Swan-Ganz catheter (thermodilution). | Clinically demonstrated to "record cardiac output similar to the predicate device and also to the Swan-Ganz catheter using thermodilution." |
| Other Cardiac Parameters | Similar to parameters measured by predicate device. | The parameters and signals are "essentially identical" except for Contractility Index (CTI) on PhysioFlow being similar to Acceleration Index (ACI) on Philips ICG. |
| Technological Characteristics | Similar to predicate device. | Utilizes "same basic technology" (thoracic electrical bioimpedance), "very similar" low current/high-frequency signals, and similar measurement procedures. |
| Safety and Efficacy | Comparable to predicate device. | Deemed "substantially equivalent" in safety and efficacy. |
Study Information
-
Sample Size Used for the Test Set and Data Provenance:
- Sample Size: "84 subjects"
- Data Provenance: The study was conducted at "two centers." The text does not specify the country of origin for the data or whether it was retrospective or prospective.
-
Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- The document does not provide information on the number of experts used or their qualifications for establishing ground truth. The ground truth was established by comparison to the "Swan-Ganz catheter using thermodilution," which is a reference measurement device rather than expert interpretation.
-
Adjudication Method for the Test Set:
- The document does not specify an adjudication method. The comparison was directly against objective measurements from the Swan-Ganz catheter and the predicate device.
-
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not conducted as this device does not involve human readers interpreting diagnostic images or data in a way that would require an MRMC study. It is a measurement device where the output is directly calculated by the algorithm.
-
Standalone Performance (Algorithm Only without Human-in-the-Loop Performance):
- Yes, the study effectively represents standalone performance. The PhysioFlow System is a noninvasive hemodynamic monitor that calculates parameters automatically based on collected bioimpedance and ECG signals. The study compared the device's output (its algorithm's performance) directly against established measurement methods (Swan-Ganz and predicate device).
-
Type of Ground Truth Used:
- The ground truth was established by direct measurement using a reference device: the "Swan-Ganz catheter using thermodilution." This is a gold-standard invasive method for measuring cardiac output. The predicate device (Philips ICG) also served as a comparative reference.
-
Sample Size for the Training Set:
- The document does not specify a separate training set sample size. It only mentions the 84 subjects for the clinical study which appears to be the primary dataset for performance evaluation.
-
How the Ground Truth for the Training Set was Established:
- Since no separate training set is mentioned, the method for establishing ground truth for any potential internal development or calibration would likely mirror the method used for the clinical study: comparison to established invasive cardiac output measurement techniques (like thermodilution). However, this is not explicitly stated for a training set.
{0}------------------------------------------------
510(k) Summary K060387
Submitter
Vasocom Inc. UnitG 2014 Ford Rd Bristol, Pa 19007
Fax (215) 826-8102 Phone: (215) 826-9998
| Contact Name: | Jim Gunnerson |
|---|---|
| Contact Title: | President |
Date this Summary was Prepared: April 4th 2008
Trade Name
PhysioFlow
Common Name
Noninvasive Hemodynamic Monitor
Classification Name
Impedance plethysmograph (per 21 CFR 870.2770)
Predicate Device
510(k) number K041434 Philips ICG (Formerly Analogic Corp.)
{1}------------------------------------------------
Device Description
Image /page/1/Picture/2 description: The image shows a PhysioFlow device connected to a laptop and a printer. A patient cable connects the device to a person. The person has several sensors attached to their chest and neck. The image shows the setup for a physiological measurement.
The PhysioFlow System is a noninvasive hemodynamic monitor that uses thoracic electrical bioimpedance technology to measure cardiac output and related parameters.
It has three main components :
-
- An electronic device that generates a low magnitude, high frequency electrical current (the "impedance current"), sends it through the body of the patient via a patient cable and pre-gelled electrodes (the sensors), and receives it after it has crossed the patient thorax. The impedance modulation (ΔΖ) is extracted from the received signal, providing a pulsatile waveform used by the software to compute stroke volume. The device also records one lead of a passive electrical signal that is similar to the ECG, in order to provide a time basis and trigger for the analysis of the impedance waveform, and to provide a measurement of heart rate. This ECG signal is not used for electrocardiography analysis. The device filters and digitizes both the impedance and the ECG signals, and transmits them to a computer via a serial communications link. The device has an analog output option, which makes the following signals available : ΔZ, ECG, Cardiac Output trend, and Stroke Volume trend.
-
- A computer that runs a MS-Windows operating system, and performs the following tasks :
- Reception of digitized signal samples from the device via a serial port .
- Platform to operate the PhysioFlow software .
- Physical user interface (keyboard, mouse, display) �
- Patient data storage capacity (on hard disk) ●
{2}------------------------------------------------
- (Optional) Reception of blood pressure values from an external blood pressure monitor . device via a serial port (This device does not measure blood pressure)
- Management of a printer using the appropriate driver .
-
- The PhysioFlow software, which performs following tasks :
- Signal processing and analysis .
- Computation of measured parameters .
- User interface and control of the measurement process (entering patient data, calibration . procedure, monitoring phase, post processing of measurement results)
- Transmitting cardiac output and stroke volume values back to the device via a serial data link . for analog output purposes
- Management of event markers .
- Setup of measurement and screen configuration (averaging ratio, scales, screen appearance, . printout options)
- Display of signal, trends, and graphics .
- Management of imported data (blood pressure values from external monitor) .
- Management of patient data ◆
- Export of measurement data in text format (for import into programs such as Excel) .
- Generating hard copy output .
The PhysioFlow System was designed and developed by Manatec Biomedical, a French company with headquarters in Petit-Ebersviller, France. The PhysioFlow System has been CE marked according to the European Medical Device Directive (93/42/CEE) as a class Ila device, and has been certified by the Japanese Ministry of Health Canada. The PhysioFlow System is manufactured in France according to the ISO 13485 and ISO 9001 standards.
{3}------------------------------------------------
Intended Use
The PhysioFlow System noninvasively measures cardiac output and other related cardiac parameters on adults. These parameters include:
| CI | Cardiac Index |
|---|---|
| CO | Cardiac Output |
| CTI | Contractility Index |
| EDV | End Diastolic Volume |
| EF | Ejection Fraction |
| HR | Heart Rate |
| LCWI | Left Cardiac Work Index |
| PEP | Pre Ejection Period |
| SV | Stroke Volume |
| SVR | Systemic Vascular Resistance |
| SVRI | Systemic Vascular Resistance Index |
| TFI | Thoracic Fluid Index |
| LVET | Left Ventricular Ejection Time |
The PhysioFlow System is intended for use under the direct supervision of a licensed healthcare practitioner or personnel trained in its proper use within a hospital or facility providing healthcare.
{4}------------------------------------------------
Technological Characteristics Compared to Predicate Device
The PhysioFlow System and the Philips ICG System both have the same general intended use. Both systems provide means for making noninvasive measurements of cardiac output and related cardiac parameters.
Both the PhysioFlow System and the Philips ICG System utilize the same basic technology, i.e., the measurement of thoracic electrical bioimpedance. The low current, high frequency electrical signals used in both systems to measure impedance are very similar.
The procedure for taking the measurements is similar for both systems. The connection from the measurement device to the patient in both systems includes a multi-lead patient cable that attaches to a number of disposable, pre-gelled, Ag/AgCl electrodes, which are applied to the patient's neck and thorax for a short period of time.
Both systems have similar features such as a keyboard or data entry interface for typing in relevant patient data (such as name, height), a display for showing the ECG and impedance signals in real time, the ability to display the computed cardiac parameters numerically and graphically, the ability to store records of a patient measurement session, and the ability to print hard copy reports.
Both systems handle noninvasive blood pressure (NIBP) readings by importing measurements from connected FDA-cleared devices. The PhysioFlow system also provides the ability for blood pressure values to be entered manually as an alternative. Both systems provide connections for analogue output of signals to other medical devices.
The differences between the PhysioFlow System and the Philips ICG System are minor. The PhysioFlow System software runs on Windows, whereas the Philips ICG software runs on its own operating system. The mechanical packaging differs in that the PhysioFlow System device connects to a suitable computer via an external serial cable connection, while the Philips ICG System device was built into a box that also enclosed the CPU.
The parameters and signals that are monitored, calculated and/or reported by the two units are compared in the tables below. They are essentially identical except for the Contractility Index which is similar to the Acceleration Index parameter reported on the PHILIPS ICG device.
| Signal | Description | PHILIPSICG | PhysioFlow |
|---|---|---|---|
| ECG | Electrocardiogram (for triggeringpurposes only) | X | X |
| Z | Impedance | X | X |
| dECG / dT | First derivative of electrocardiogram | X | |
| dZ / dT | First derivative of impedance | X | X |
| d2Z / dT² | Second derivative of impedance | X |
Table 1 – Signal Comparison
{5}------------------------------------------------
| Parameter | Description | Units | PHILIPSICG | PhysioFlow |
|---|---|---|---|---|
| ABP | Arterial Blood Pressure | mmHg | X | X |
| ACI | Acceleration index | 1/sec.sq | X | |
| BSA | Body Surface Area | m² | X | X |
| CI | Cardiac Index | l / min / m² | X | X |
| CO | Cardiac Output | l / min | X | X |
| CTI | Contractility Index | no unit | X | |
| CVP | Central Venous Pressure | mmHg | X | |
| DAP | Diastolic Arterial blood Pressure | mmHg | X | X |
| EDV | End Diastolic Volume | ml | X | |
| EF | Ejection Fraction | % | X | |
| Height | Height | cm | X | X |
| HR | Heart Rate | bpm | X | X |
| LCWI | Left Cardiac Work Index | kg.m / m² | X | X |
| LVET | Left Ventricular Ejection Time | millisec | X | X |
| MAP | Mean Arterial blood Pressure | mmHg | X | X |
| PEP | Pre Ejection Period | sec | X | X |
| SAP | Systolic Arterial blood Pressure | mmHg | X | X |
| STR | Systolic Time Ratio | No unit | X | |
| SV | Stroke Volume | ml | X | X |
| SV | Stroke Volume Index | ml/ m² | X | X |
| SVR | Systemic Vascular Resistance | dyn.s.cm-5 | X | X |
| SVRI | Systemic Vascular Resistance Index | dyn.s.cm-5.m² | X | X |
| TFI/TFC | Thoracic Fluid Index/Content | no unit | X | X |
| VI | Velocity Index | 1/sec/ cm² | X | |
| Weight | Weight | kg | X | X |
Table 2 – Parameter Comparison
{6}------------------------------------------------
Conclusions
Vasocom has provided bench and clinical data to verify that the subject device can indeed record cardiac output similar to the predicate device. The clinical study data includes 84 subjects at two centers, and compared the PhysioFlow Device to the predicate device and also to the Swan-Ganz catheter using thermodilution.
Based on technological comparisons and performance testing results, in its overall intended use, functioning, safety and efficacy, the PhysioFlow System is substantially equivalent to the Philips ICG System.
{7}------------------------------------------------
Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized graphic of four human figures, represented by simple, curved lines, arranged in a row.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 0 2008
VasoCOM, Inc. c/o Mr. John S. Samorajczyk Samorajczyk Regulatory Consultants, LLC 5414 Leilani Drive St. Pete Beach, FL 33706
Re: K060387
Trade/Device Name: PhysioFlow System, Model PF05 Regulation Number: 21 CFR 870.2770 Regulation Name: Impedance Plethysmograph Regulatory Class: Class II (Two) Product Code: DSB Dated: February 5, 2008 Received: February 5, 2008
Dear Mr. Samorajczyk:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
{8}------------------------------------------------
Page 2 - Mr. John S. Samorajczyk
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
B/hemmer for
Bram B. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{9}------------------------------------------------
Indications for Use
510(k) Number K060387
PhysioFlow System Device Name:
Indications for Use:
Indicated for use in adults only
The PhysioFlow System noninvasively measures cardiac output and other related cardiac parameters. These parameters include:
| CI | Cardiac Index |
|---|---|
| CO | Cardiac Output |
| CTI | Contractility Index |
| dZ/dTmax | Maximum value dZ / dT |
| EDV | End Diastolic Volume |
| EF | Ejection Fraction |
| HR | Heart Rate |
| LCWI | Left Cardiac Work Index |
| PEP | Pre Ejection Period |
| SV | Stroke Volume |
| SVR | Systemic Vascular Resistance |
| SVRI | Systemic Vascular Resistance Index |
| TFI | Thoracic Fluid Index |
| VET | Ventricular Ejection Time |
| Z0 | Base Impedance |
Page 1 of 2
the country of the county of the
:
:
{10}------------------------------------------------
The PhysioFlow System is intended for use under the direct supervision of a licensed healthcare practitioner or personnel trained in its proper use within a hospital or facility providing healthcare.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
B.Bumham
Vision Sian-Off Division of Cardlova 510(k) Num
Page 2 of 2
§ 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.