(28 days)
Indicated for use in adults only.
The PhysioFlow Q-Link 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 PhysioFlow Q-Link 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 Q-Link 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 electronic unit that attaches to the patient via a six lead, patient cable using commercially available silver/silver chloride skin electrodes. Monitor data is transmitted to a host computer running the PhysioFlow PF107 software. Communication to the host computer is via 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 and USB cables.
Here's an analysis of the provided text regarding the acceptance criteria and study for the PhysioFlow Q-Link device:
The provided document (a 510(k) summary) is very limited in its description of specific acceptance criteria and detailed study data. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a standalone validation study report for the new device.
Here's what can be extracted and what is explicitly not available from the text:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, specific numerical acceptance criteria (e.g., accuracy +/- X%) and corresponding reported performance metrics are NOT available.
The document states:
"Design verification tests were performed on representative samples of the PhysioFlow Q-Link as a result of a comprehensive product development and risk management plan. All tests were verified to meet the pre-specified acceptance criteria."
This confirms that acceptance criteria exist internally, and the device met them, but the criteria themselves and the detailed performance results are not reported in this summary. The summary implies the acceptance criteria were met by comparison to the predicate device's performance, as the core argument for substantial equivalence.
2. Sample Size for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated. The document refers to "representative samples" for design verification tests, but the number of devices or subjects is not quantified.
- Data Provenance: Not explicitly stated. The nature of the tests ("design verification tests") suggests these were likely bench tests or in-house engineering evaluations rather than clinical studies with human subjects. The comparison is made to the previous device's performance, but no information is given about the original predicate device's data provenance either in this document.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable/Not stated. This type of information (experts, their qualifications) is typically associated with studies involving human interpretation (e.g., radiologists reviewing images) or clinical trials requiring expert assessment. The "design verification tests" described here do not involve such expert review for ground truth establishment in the way typically seen in diagnostic AI/medical imaging devices. For a hemodynamic monitor, "ground truth" often refers to a reference standard (e.g., invasive cardiac catheterization) which is not mentioned here.
4. Adjudication Method for the Test Set
Not applicable/Not stated. As no expert review process for ground truth establishment is described, no adjudication method would be relevant.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done.
This type of study is relevant for devices where human readers interpret data (e.g., images) and the AI aims to assist or replace that interpretation. The PhysioFlow Q-Link is a non-invasive hemodynamic monitor that provides objective physiological parameters. There is no human "reading" of the data in the sense that an MRMC study would apply. Therefore, no effect size for human readers improving with AI assistance is applicable or reported.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, in essence, a standalone performance assessment was done, but the details are minimal.
The "design verification tests" assess the device's ability to measure physiological parameters. Since it's a direct measurement device, its "standalone" performance is its fundamental operation. The summary does not describe a human-in-the-loop component in the measurement or calculation process that would necessitate a distinction between standalone and assisted performance. However, specific performance metrics for this standalone operation are not detailed in the summary.
7. Type of Ground Truth Used
Not explicitly stated, but inferred to be a reference standard or validated measurement method.
For a device measuring cardiac output and related parameters, the "ground truth" in a comprehensive validation study would typically be established using an invasive, gold-standard method (e.g., thermodilution via pulmonary artery catheter) or another well-validated non-invasive method. The summary does not specify how the "pre-specified acceptance criteria" were derived or validated, nor what reference method was used to establish the true values of the parameters being measured during the verification tests. Given the context of a 510(k) for a modification (Q-Link compared to Enduro PF-07), the implicit "ground truth" for the Q-Link's performance would be its agreement with the predicate device's measurements.
8. Sample Size for the Training Set
Not applicable/Not stated.
This device is not an AI/Machine Learning algorithm that undergoes a distinct "training" phase. It uses established thoracic electrical bioimpedance technology. Therefore, there is no "training set" in the context of an AI model. Its operational algorithms are based on physiological principles, not on learning from a dataset.
9. How the Ground Truth for the Training Set Was Established
Not applicable/Not stated.
As there is no training set for an AI/ML model, the concept of establishing ground truth for a training set does not apply. The device's underlying physical models and algorithms would have been developed using established physiological principles and prior research in bioimpedance.
Summary of what's provided for acceptance criteria and studies:
The provided 510(k) summary for the PhysioFlow Q-Link is brief and focuses on demonstrating substantial equivalence to its predicate device (PhysioFlow Enduro Model PF07) due to being a modification rather than a fundamentally new device. It asserts that "Design verification tests were performed on representative samples... All tests were verified to meet the pre-specified acceptance criteria." However, it does not provide the following crucial details:
- The specific numerical values for the "pre-specified acceptance criteria."
- Detailed quantitative performance data for the PhysioFlow Q-Link against those criteria.
- The sample size of items or subjects used in the verification tests.
- The method or reference standard used to establish "ground truth" for these tests, beyond implied comparison to the predicate.
- Any information regarding expert review, adjudication methods, or MRMC studies, as the device type does not involve human interpretation in that manner.
- Information about training sets or how ground truth was established for a training set, as it is not an AI/ML device relying on trained models.
Essentially, the document states that tests were done and criteria were met, but it does not reveal what those criteria or results were in this public summary. This level of detail is typically found in the full 510(k) submission or an internal design verification report, not usually in the summary provided.
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510(k) SUMMARY
FEB 1 2 2014
This 510(k) summary is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.87
| Establishment Registration Number: | 3005467960 |
|---|---|
| Address of Manufacturer: | 2014 Ford Road, Unit G |
| Bristol, PA 19007 | |
| Contact Person: | James Gunnerson |
| President | |
| Date Prepared: | December 20, 2013 |
| Trade or Proprietary Name: | PhysioFlow Q-Link |
| Common or Usual Name: | Noninvasive hemodynamic monitor |
| Classification Name: | Impedance plethysmograph (21 CFR 870.2770) |
| Product code: DBS (plethysmograph, impedance) | |
| Class II | |
| Predicate Device Identification: | PhysioFlow Enduro Model PF07 (K103283) |
Device Description:
The PhysioFlow Q-Link 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 electronic unit that attaches to the patient via a six lead, patient cable using commercially available silver/silver chloride skin electrodes. Monitor data is transmitted to a host computer running the PhysioFlow PF107 software. Communication to the
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host computer is via 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 and USB cables.
Indications for Use:
Indicated for use in adults only.
The PhysioFlow Q-Link 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 PhysioFlow O-Link 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.
Intended use and comparison to predicate devices:
The PhysioFlow O-Link and PhysioFlow Enduro Model PF-07 have the same intended for use/indications for use. Both devices are intended for use in adults only to noninvasively measure 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
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practitioner or personnel trained in its proper use within a hospital or facility providing healthcare.
Technological characteristics and comparison to predicate devices:
The PhysioFlow Q-Link is a modification of the PhysioFlow Enduro Model PF-07. It utilizes the same thoracic electrical bioimpedance technology to measure the same cardiac output and related cardiac parameters. It remains similar to the predicate device in size, but excludes the battery power source, on-board data storage, and wireless Bluetooth technology features of the predicate device. The PhysioFlow Q-Link will fill a position amongst the PhysioFlow family of devices for users who find the battery life or wireless communication features of the PhysioFlow Enduro Model PF-07 to be inconvenient or cumbersome, but still desire a small, portable unit. Like the PhysioFlow Enduro Model PF-07, the PhysioFlow Q-Link continues to interface with a MS Windows based host computer running the previously-cleared PhysioFlow PF107 software (K103283). No changes to the PhysioFlow PF107 software were required to enable its use with the PhysioFlow Q-Link.
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.
Summary of performance data:
1
Design verification tests were performed on representative samples of the PhysioFlow O-Link as a result of a comprehensive product development and risk management plan. All tests were verified to meet the pre-specified acceptance criteria. As such, the PhysioFlow Q-Link is considered substantially equivalent to the PhysioFlow Enduro Model PF-07.
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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features an eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Public Health Service
February 12, 2014
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Vasocom, Inc. Mr. James Gunnerson President 2014 Ford Rd., Unit G Bristol, PA 19007 US
Re: K140102
Trade/Device Name: Physioflow Q-link Regulation Number: 21 CFR 870.2770 Regulation Name: Noninvasive Hemodynamic Monitor Regulatory Class: Class II (two) Product Code: DSB Dated: January 14, 2014 Received: January 15, 2014
Dear Mr. James 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. 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
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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 (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/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.htmfor 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Owen-PFaris -S
for
Bram D. Zuckerman. M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
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Vasocom, Inc.
K140102 Page 1 of 1
Indications for Use
510(k) Number (if known):
PhysioFlow Q-Link Device Name:
Indications for Use:
Indicated for use in adults only.
The PhysioFlow Q-Link 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 PhysioFlow Q-Link 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: ____________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart D)
AND/OR
Over-the-Counter Use: _ (21 CFR 807 Subpart C)
Digitally signed by
Owen P. Faris -S
Date: 2014.02.11
16:04:51-05'00'
l
Special 510(k) - PhysioFlow Q-Link December 31, 2013
§ 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.