K103283 · Vasocom, Inc. · DSB · Dec 3, 2010 · Cardiovascular
Device Facts
Record ID
K103283
Device Name
PHYSIOFLOW ENDURO
Applicant
Vasocom, Inc.
Product Code
DSB · Cardiovascular
Decision Date
Dec 3, 2010
Decision
SESE
Submission Type
Special
Regulation
21 CFR 870.2770
Device Class
Class 2
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.
Device Story
PhysioFlow Enduro PF07 is a portable, battery-powered, noninvasive hemodynamic monitor; utilizes thoracic electrical bioimpedance technology to measure cardiac output and related parameters. Device attaches to patient via six-lead cable and silver/silver chloride skin electrodes. Electronic unit captures/stores up to 24 hours of data; transmits via Bluetooth or USB to host computer running PhysioFlow PF107 software. Software performs signal processing, parameter computation, and report generation. Used in hospitals or healthcare facilities under supervision of licensed practitioners or trained personnel. Output allows clinicians to monitor cardiac function and hemodynamic status, aiding in clinical decision-making.
Clinical Evidence
Bench testing and simulated use validation performed. Design verification confirmed all pre-specified acceptance criteria met. Product validation in simulated use setting compared subject device to predicate; results demonstrated <4% difference across measured parameters, below 5% clinical variability threshold.
Technological Characteristics
Thoracic electrical bioimpedance technology; silver/silver chloride skin electrodes (Skintact FS-50). Portable electronic unit (<250g with batteries). Connectivity: Bluetooth wireless, USB wired. Software: PhysioFlow PF107 (MS Windows-based host). Standalone recorder capability (24-hour storage).
Indications for Use
Indicated for use in adults only to noninvasively measure cardiac output and related hemodynamic parameters (CI, CO, CTI, dZ/dt max, EDV, EF, HR, LCWI, PEP, SV, SVR, SVRI, TFI, VET, Z0). Intended for use under direct supervision of licensed healthcare practitioner or trained personnel in hospital or healthcare facility settings.
Regulatory Classification
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.
Special Controls
*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)
{1}------------------------------------------------
### 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.
{2}------------------------------------------------
#### 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
{3}------------------------------------------------
# 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
{4}------------------------------------------------
# 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
{5}------------------------------------------------
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
25
Special 510(k) - PhysioFlow Enduro PF07 October 26, 2010
slon Slan-Off) of Cardiovascular Dev
10(k) Number
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
