(28 days)
No
The document describes signal processing and parameter computation based on thoracic electrical bioimpedance, but there is no mention of AI or ML techniques being used for these processes or any other function of the device.
No.
The device is indicated for measuring cardiac parameters, providing diagnostic information, rather than directly treating a condition.
Yes
Explanation: The device "noninvasively measures cardiac output and other related cardiac parameters," which are used by healthcare practitioners to assess a patient's physiological state. Though it doesn't explicitly state "diagnosis," measuring these parameters for medical assessment falls under the umbrella of diagnostic activities.
No
The device description explicitly states it consists of a portable electronic unit that attaches to the patient via a cable and electrodes, indicating hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The PhysioFlow Enduro PF07 measures cardiac parameters noninvasively by utilizing thoracic electrical bioimpedance. It does not involve the collection or analysis of specimens taken from the human body.
- Intended Use: The intended use describes measuring cardiac output and related parameters directly from the patient's body, not from a sample.
Therefore, the device falls under the category of a noninvasive medical device used for physiological monitoring, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The PhysioFlow Enduro PF07 and PhysioFlow System Model PF05 have the same intended use/indications for use. Both devices are intended for use in adults only to noninvasively measures cardiac output and other related cardiac parameters, including the following: cardiac output, cardiac index, contractility index, maximum value dZ/dt, end diastolic volume, ejection fraction, heart rate, left cardiac work index, pre-ejection period, stroke volume, systemic vascular resistance, systemic vascular resistance index, thoracic fluid index, ventricular ejection time, and base impedance. Both devices are intended for use under the direct supervision of a licensed practitioner or personnel trained in its proper use within a hospital or facility providing healthcare.
Indications for Use:
Indicated for use in adults only.
The PhysioFlow Enduro PF07 noninvasively measures cardiac output and other related cardiac parameters. These parameters include:
CI - Cardiac Index
CO - Cardiac Output
CTI - Contractility Index
dZ / dt max - 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
ZO - Base Impedance
The Enduro System Model PF-07 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.
Product codes
DBS, DSB
Device Description
The PhysioFlow Enduro Model PF07 is a noninvasive, hemodynamic monitor that utilizes thoracic electrical bioimpedance technology to measure cardiac output and related cardiac parameters. It consists of a small, portable, lightweight (less than 250 gm with batteries) electronic unit that attaches to the patient via a six lead, patient cable using commerciallyavailable silver/silver chloride skin electrodes. The electronic unit incorporates recorder capabilities, enabling it to capture and store up to 24 hours of monitor data for later transmission to a host computer running the PhysioFlow PF107 software. Communication options include Bluetooth wireless and USB wired technology. The PhysioFlow PF107 software performs multiple tasks including signal processing and analysis, measured parameter computation, user interface display and control, measurement process control, event marker management, and output display/report generation. Available accessories include the patient cable, a Bluetooth antenna. USB cable, and electronic unit carrying case.
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 only
Intended User / Care Setting
Under the direct supervision of a licensed practitioner or personnel trained in its proper use within a hospital or facility providing healthcare.
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)
Design verification tests were performed on representative samples of the PhysioFlow Enduro Model PF07 and PhysioFlow PF107 software as a result of a comprehensive product development and risk management plan. All tests were verified to meet the pre-specified acceptance criteria. Product validation tests were performed in a simulated use setting and compared subject and predicate device performance. The results demonstrate a difference between the subject and predicate devices of less than 4% across the measured parameters, which is below the acceptable clinical variability of 5%. As such, the PhysioFlow Enduro Model PF07 is considered substantially equivalent to the PhysioFlow System Model PF05.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
Vasocom, Inc.
K103283
CONFIDENTIAL
510(k) SUMMARY
This 510(k) summary is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.87
Establishment Registration Number:
3005467960
DEC - 3 2010
Address of Manufacturer:
2014 Ford Road, Unit G Bristol, PA 19007
Contact Person:
James Gunnerson
President
Date Prepared:
Oct. 26, 2010
PhysioFlow Enduro Model PF07
Common or Usual Name:
Trade or Proprietary Name:
Classification Name:
Noninvasive hemodynamic monitor
Impedance plethysmograph (21 CFR 870.2770)
Product code: DBS (plethysmograph, impedance)
Class II
Predicate Device Identification:
PhysioFlow System Model PF05 (K060387)
Device Description:
The PhysioFlow Enduro Model PF07 is a noninvasive, hemodynamic monitor that utilizes thoracic electrical bioimpedance technology to measure cardiac output and related cardiac parameters. It consists of a small, portable, lightweight (less than 250 gm with batteries)
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CONFIDENTIAL
Vasocom, Inc.
electronic unit that attaches to the patient via a six lead, patient cable using commerciallyavailable silver/silver chloride skin electrodes. The electronic unit incorporates recorder capabilities, enabling it to capture and store up to 24 hours of monitor data for later transmission to a host computer running the PhysioFlow PF107 software. Communication options include Bluetooth wireless and USB wired technology. The PhysioFlow PF107 software performs multiple tasks including signal processing and analysis, measured parameter computation, user interface display and control, measurement process control, event marker management, and output display/report generation. Available accessories include the patient cable, a Bluetooth antenna. USB cable, and electronic unit carrying case.
Intended use and comparison to predicate devices:
The PhysioFlow Enduro PF07 and PhysioFlow System Model PF05 have the same intended use/indications for use. Both devices are intended for use in adults only to noninvasively measures cardiac output and other related cardiac parameters, including the following: cardiac output, cardiac index, contractility index, maximum value dZ/dt, end diastolic volume, ejection fraction, heart rate, left cardiac work index, pre-ejection period, stroke volume, systemic vascular resistance, systemic vascular resistance index, thoracic fluid index, ventricular ejection time, and base impedance. Both devices are intended for use under the direct supervision of a licensed practitioner or personnel trained in its proper use within a hospital or facility providing healthcare.
Technological characteristics and comparison to predicate devices:
The PhysioFlow Enduro Model PF07 is a modification of the PhysioFlow System Model PF05. It utilizes the same thoracic electrical bioimpedance technology to measure the same cardiac output and related cardiac parameters, but its size has been reduced to make it portable and lightweight (less than 250 gm with batteries). Compared with the Model PF05, technological changes also now enable the use of battery power and communication using Bluetooth wireless and USB wired technology with a MS Windows based host computer running an upgraded version of the PF05 software (i.e., PhysioFlow PF107). In addition, software and hardware changes now enable a standalone recorder capability, enabling of up to 24 hours capture of monitor data for later transmission to the host PC. Use of the same silver/silver chloride skin electrodes (Skintact FS-50 Pre-gelled Electrodes) is recommended.
The differences in technological characteristics between the subject and predicate devices do not raise new types of safety or effectiveness questions. Accepted scientific methods, such as performance (bench) testing, do exist for assessing the effect of the differences in characteristics.
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CONFIDENTIAL
Vasocom, Inc.
Summary of performance data:
Design verification tests were performed on representative samples of the PhysioFlow Enduro Model PF07 and PhysioFlow PF107 software as a result of a comprehensive product development and risk management plan. All tests were verified to meet the pre-specified acceptance criteria. Product validation tests were performed in a simulated use setting and compared subject and predicate device performance. The results demonstrate a difference between the subject and predicate devices of less than 4% across the measured parameters, which is below the acceptable clinical variability of 5%. As such, the PhysioFlow Enduro Model PF07 is considered substantially equivalent to the PhysioFlow System Model PF05.
James A. Gunnerson
Special 510(k) - PhysioFlow Enduro PF07 October 26, 2010
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
VasoCOM, Inc. c/o Mr. James Gunnerson President, 2014 Ford Road, Unit G Bristol, PA 19007
DEC - 3 2010
Re: K103283
Trade/Device Name: PhysioFlow® Enduro Model PF07 Regulatory Number: 21 CFR 870.2770 Regulation Name: Impedance Plethysmograph Regulatory Class: II (two) Product Code: 74 DSB Dated: October 27, 2010 Received: November 5, 2010
Dear Mr. Gunnerson:
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 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
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Page 2 - Mr. James Gunnerson
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 device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
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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CONFIDENTIAL
Vasocom, Inc.
| Indications for Use | |
|---|---|
| K103283 |
510(k) Number (if known):
Device Name: PhysioFlow Enduro Model PF-07 DEC - 3 2010
Indications for Use:
Indicated for use in adults only.
The PhysioFlow Enduro PF07 noninvasively measures cardiac output and other related cardiac parameters. These parameters include:
| CI | Cardiac Index |
|---|---|
| CO | Cardiac Output |
| CTI | Contractility Index |
| dZ / dt max | 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 |
| ZO | Base Impedance |
The Enduro System Model PF-07 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.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use: ____________________________________________________________________________________________________________________________________________________________ X (21 CFR 801 Subpart D) AND/OR
Over-the-Counter Use:
(21 CFR 807 Subpart e)
W
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Special 510(k) - PhysioFlow Enduro PF07 October 26, 2010
slon Slan-Off) of Cardiovascular Dev
10(k) Number