(217 days)
The VasoGuard devices are intended for use in the non-invasive evaluation of peripheral vascular pathology in patients. The devices are not intended to replace other means of evaluating vital patient physiological testing, are not intended to be used in neonatal applications, and are not intended to be used inside the sterile field. The intended use is attended use by trained medical professionals in hospitals, clinics, and physician offices by prescription or on the order of a medical doctor.
The VasoGuard is a family of products designed for non-invasive peripheral vascular diagnostic testing. It uses Doppler probes and photoplethysmography (PPG) sensors positioned on the body to measure physiologic signals and report data to the interpreting clinician. The system consists of up to 10 independent pneumatic pressure channels, up to five PPG ports, up to three Doppler ports that support 4MHz and 8MHz continuous wave (CW) Doppler probes, and a touchless temperature sensor. The V series indicates the products are all made from the same parts with the only differences being that certain parts are not installed when assembled during manufacturing or some features are not enabled.
The VasoGuard family consists of five different configurations of the same device, each varying in the number of pressure channels and sensor ports accessible through one of two available enclosures. The Full-Size enclosure supports Models V6, V8 and V10, and the Mini enclosure supports Models V2 and V4.
All VasoGuard models contain the same main printed circuit board (PCB), manifold PCB(s), built-in power supply, built-in USB hub, and connect to a dedicated Windows-based medical grade PC via USB. Internally the models all utilize the same manifold assemblies and only differ in the quantity installed. The models include physical connections for control of 10 BP cuffs simultaneously, up to five PPG sensors simultaneously, one of up to three Doppler probes (4 MHz or 8 MHz), one USB camera, one IR remote control, and one touch-free infrared skin thermometer.
The VasoGuard software is pre-installed on the Windows PC. It controls all the models and automatically recognizes which model is connected thereby exposing only software capabilities only available on that model.
Each model includes certain components and accessories in addition to the VasoGuard device, including:
- Medical Grade Touchscreen PC
- Windows® 10 Enterprise LTSC
- Washable Keyboard with Trackpad
- Mobile Cart with Height-adjustable Rolling Cart
- Set of Pneumatic Hoses with Articulating Support Arm
- Set of Blood Pressure Cuffs (Shenzhen Vistar Medical Supplies Co., Ltd. K152468)
- Set of PPG Sensors
- Doppler Probes (4 MHz and/or 8 MHz)
- USB Camera
- Infrared Remote Control and Receiver
- Touch-free Infrared Skin Thermometer (Tecnimed SRL - 510(k) K122412)
The VasoGuard software features include patient database management; patient and exam search; importing and exporting of exams; facility management; importing of settings; exam protocol management, custom segment and vessel naming; customizable testing screens, reports, and graphs; backup and restore database; and keyboard shortcuts.
The quantitative measurements are the same for all VasoGuard models. One of the primary measurements is the Ankle Brachial Index (ABI). The ABI uses the Doppler probe to determine the ratio of the highest systolic pressure at the arm to the systolic pressure at the ankle. Another primary measurement of the VasoGuard is segmental blood pressures. Another main measurement of the VasoGuard is recording a waveform representing blood flow for each heartbeat. The system is capable of recording Doppler, PPG (photoplethysmography) and PVR (Pulse Volume Recording) waveforms.
The provided document, an FDA 510(k) summary for the VasoGuard device, does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a study proving the device meets those criteria. The document focuses on demonstrating substantial equivalence to a predicate device through technological characteristics and non-clinical testing, rather than presenting a performance study with defined acceptance criteria.
However, based on the information available, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria for clinical performance nor does it provide reported device performance in a format that would directly fulfill this request from a clinical study standpoint.
Instead, the document focuses on bench testing for comparability to the predicate device. The "acceptance criteria" here are implicitly that the VasoGuard device performs "comparably" to the predicate in terms of waveform quality, sensitivity, and accuracy of reported values.
| Acceptance Criteria (Implied from Bench Testing) | Reported Device Performance (Bench Testing) |
|---|---|
| Comparable waveform quality to predicate | Found to be substantially equivalent in waveform quality |
| Comparable sensitivity to predicate | Found to be substantially equivalent in sensitivity |
| Comparable accuracy of reported values to predicate | Found to be substantially equivalent in accuracy of reported values |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily refers to "bench testing with the predicate device using simulators and live signals" and "unit, design verification, performance, accelerated aging, and validation testing." This indicates the tests were largely non-clinical and involved simulators and controlled signals, not patient data. Therefore, there isn't a "test set" in the sense of clinical patient data, nor is there information on data provenance (country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Given that the testing described is non-clinical bench testing with simulators and live signals, there wouldn't be "experts" establishing ground truth in the clinical interpretation sense. Ground truth in this context would likely be derived from the known parameters of the simulators or the specifications of the "live signals" themselves, as per engineering and quality control standards. No specific number or qualifications of experts are mentioned for this type of ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
No adjudication method is mentioned, as the testing described is non-clinical bench testing, not a clinical study involving human interpretation.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No such study (MRMC or AI assistance) is mentioned or implied. The VasoGuard device is described as a diagnostic system for non-invasive peripheral vascular testing (Doppler, PPG, PVR), not an AI-powered diagnostic tool aiding human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is described as producing quantitative measurements such as Ankle Brachial Index (ABI), segmental blood pressures, and waveforms (Doppler, PPG, PVR). While the device performs calculations and generates data, it explicitly states: "The software automatically places a cursor at the time location which is suspected as being the systolic pressure, yet it is the responsibility of the medical staff to modify the cursor location to define the correct segmental pressure." This indicates a human-in-the-loop design where medical staff are responsible for final interpretation and adjustment, rather than a purely standalone AI algorithm. It's a measurement device, not an AI for diagnosis.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical bench testing, the "ground truth" would be the known, controlled inputs from the simulators and "live signals" used during the testing. This is a technical ground truth based on engineering specifications rather than clinical ground truth (expert consensus, pathology, outcomes data).
8. The sample size for the training set
The document does not mention any training set. This suggests that the VasoGuard device is a measurement instrument, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
Since no training set is mentioned, this question is not applicable.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
July 19, 2024
CorVascular Diagnostics, LLC % Paul Dryden President ProMedic Consulting, LLC 131 Bay Point Dr. NE St. Petersburg, Florida 33704
Re: K233976
Trade/Device Name: VasoGuard (V10, V8, V6, V4, V2) Regulation Number: 21 CFR 870.2880 Regulation Name: Ultrasonic transducer Regulatory Class: Class II Product Code: JOP Dated: June 19, 2024 Received: June 20, 2024
Dear Paul Dryden:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
{1}------------------------------------------------
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely, for Hetal B. Odobasic -S
LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
{2}------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K233976
Device Name VasoGuard (V10, V8, V6, V4, V2)
Indications for Use (Describe)
The VasoGuard devices are intended for use in the non-invasive evaluation of peripheral vascular pathology in patients. The devices are not intended to replace other means of evaluating vital testing, are not intended to be used in neonatal applications, and are not intended to be used inside the sterile field. The intended use by qualified and trained medical professionals in hospitals, clinics, and physician offices by prescription or on the order of a medical doctor.
Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
510(k) Summary
Submission Type
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with 21CFR Part 807.92.
Device Name
VasoGuard® V10, V8, V6, V4, V2
Owner/Submitter
807
| 7.92(a)(1) | |
|---|---|
| Company Name: | CorVascular Diagnostics, LLC |
| 600 Twelve Oaks Center Drive, Suite 102 | |
| Wayzata, MN 55391 | |
| Telephone: | (763) 333-1540 |
| Contact Person: | Spencer Lien |
| Contact Title: | Managing Director |
| Preparation Date: | December 8, 2023 |
Device Name
| 807.92(a)(2) | |
|---|---|
| Device Trade Name: | VasoGuard V10, V8, V6, V4, V2 |
| Common Name: | CW Doppler, PPG, VPR / PVR |
| Classification Name: | Transducer, Ultrasonic |
| Regulation Number: | 21 CFR 870.2880 |
| Product Code: | JOP |
| Class: | Class II |
| Review Panel: | Cardiovascular |
Substantial Equivalence
807.92(a)(3)
| 510(k): | K111416 |
|---|---|
| Trade Name: | Falcon/Pro, Falcon/Quad, Falcon/ABI+ |
| Company Name: | Viasonix Ltd |
{4}------------------------------------------------
Device Description
807.92(a)(4)
The VasoGuard is a family of products designed for non-invasive peripheral vascular diagnostic testing. It uses Doppler probes and photoplethysmography (PPG) sensors positioned on the body to measure physiologic signals and report data to the interpreting clinician. The system consists of up to 10 independent pneumatic pressure channels, up to five PPG ports, up to three Doppler ports that support 4MHz and 8MHz continuous wave (CW) Doppler probes, and a touchless temperature sensor. The V series indicates the products are all made from the same parts with the only differences being that certain parts are not installed when assembled during manufacturing or some features are not enabled.
The VasoGuard family consists of five different configurations of the same device, each varying in the number of pressure channels and sensor ports accessible through one of two available enclosures. The Full-Size enclosure supports Models V6, V8 and V10, and the Mini enclosure supports Models V2 and V4:
| Model V10: | 10 Pressure Channels / 5 PPG / 3 Doppler |
|---|---|
| Model V8: | 8 Pressure Channels / 4 PPG / 2 Doppler |
| Model V6: | 6 Pressure Channels / 4 PPG / 1 Doppler |
| Model V4: | 4 Pressure Channels / 4 PPG / 1 Doppler |
| Model V2: | 2 Pressure Channels / 2 PPG / 0 Doppler |
All VasoGuard models contain the same main printed circuit board (PCB), manifold PCB(s), built-in power supply, built-in USB hub, and connect to a dedicated Windows-based medical grade PC via USB. Internally the models all utilize the same manifold assemblies and only differ in the quantity installed. The models include physical connections for control of 10 BP cuffs simultaneously, up to five PPG sensors simultaneously, one of up to three Doppler probes (4 MHz or 8 MHz), one USB camera, one IR remote control, and one touch-free infrared skin thermometer.
The two enclosures are made of the same aluminum material and share a common design. The Mini enclosure is approximately 20% smaller footprint. The Mini enclosure differs from the Full-Size enclosure only by the pressure channel connections on the front of the device instead of the back. Each model differs only in the number of pressure, Doppler and PPG ports on front and back panels of the device.
The VasoGuard software is pre-installed on the Windows PC. It controls all the models and automatically recognizes which model is connected thereby exposing only software capabilities only available on that model.
Each model includes certain components and accessories in addition to the VasoGuard device, including:
- Medical Grade Touchscreen PC
- . Windows® 10 Enterprise LTSC
- . Washable Keyboard with Trackpad
- . Mobile Cart with Height-adjustable Rolling Cart
- . Set of Pneumatic Hoses with Articulating Support Arm
{5}------------------------------------------------
- . Set of Blood Pressure Cuffs (Shenzhen Vistar Medical Supplies Co., Ltd. K152468)
- . Set of PPG Sensors
- . Doppler Probes (4 MHz and/or 8 MHz)
- . USB Camera
- . Infrared Remote Control and Receiver
- Touch-free Infrared Skin Thermometer (Tecnimed SRL - 510(k) K122412)
VasoGuard V10 System
Image /page/5/Picture/9 description: The image shows a medical diagnostic machine on a mobile cart. The machine has a large monitor at the top, a keyboard and other controls on the middle shelf, and a diagnostic unit with wires and connectors on the bottom shelf. The cart is white and gray and has wheels for easy movement.
Pneumatic Hose and Articulating Support Arm
Image /page/5/Figure/11 description: The image shows two different views of a pneumatic tube system. The left side of the image shows a technical drawing of the system, with labels pointing to the pneumatic tube, locking levers, retaining clips, junction box, and mounting bolt. The right side of the image shows the system installed on a wall, with the pneumatic tube connected to a junction box and a monitor.
VasoGuard V10 Device – Front
VasoGuard V10 Device – Back
VasoGuard V4 Device - Back
g
Image /page/5/Picture/14 description: The image shows the front and back of a device labeled as "VasoGuard V10 Device". The front of the device has several ports labeled "Doppler" and "PPG", each with multiple connection points. The back of the device features multiple USB ports, a power input, and other connection interfaces.
VasoGuard Device V10, V8, V6 Dimensions: 4″H x 16″W x 13″D
Image /page/5/Picture/16 description: The image shows the front of a VasoGuard V4 device. The device has several ports labeled "Doppler", "PPG", and "Pneumatic". Each port has multiple inputs with different colored rings around them. There are also small icons of a person near some of the ports.
VasoGuard Device V4, V2 Dimensions: 4"H x 11"W x 12"D
Image /page/5/Picture/18 description: The image shows the text "CorVascular | VasoGuard 510k Submission". The text is arranged horizontally, with "CorVascular" on the left, followed by a vertical line, and then "VasoGuard 510k Submission" on the right. The text is in a simple, sans-serif font and is presented against a plain white background.
{6}------------------------------------------------
VasoGuard Accessories
Image /page/6/Picture/3 description: The image shows a white tray filled with medical equipment. There is a white handheld device with a screen, a silver remote control, two black cylindrical objects, two black cables with blue and black connectors, and four black cables with silver clips. The equipment is arranged neatly in the tray, which has a black foam lining.
8 MHz Doppler 4 MHz Doppler PPG (Red, Green, Yellow, Blue, Gray) Remote Control Temperature Meter
Image /page/6/Picture/5 description: The image shows a blue water reservoir bag with a tube coming out of it. The tube is connected to a series of colorful resistance bands. The bands are arranged in a curved pattern, with the ends of the bands facing the viewer.
Blood Pressure Cuffs and Tubing
The VasoGuard software features include patient database management; patient and exam search; importing and exporting of exams; facility management; importing of settings; exam protocol management, custom segment and vessel naming; customizable testing screens, reports, and graphs; backup and restore database; and keyboard shortcuts.
The quantitative measurements are the same for all VasoGuard models. One of the primary measurements is the Ankle Brachial Index (ABI). The ABI uses the Doppler probe to determine the ratio of the highest systolic pressure at the arm to the systolic pressure at the ankle. Systolic pressures are taken at both arms, and at the posterior tibial and dorsalis pedis arteries on each leg by inflating pressure cuffs past the point where Doppler sounds cease, then slowly deflating the cuffs until Doppler sounds return. The ABI is calculated by dividing the ankle pressure by the highest arm pressure.
Another primary measurement of the VasoGuard is segmental blood pressures. Segmental pressure studies are performed using the same method as an ABI but incorporate additional pressure cuffs wrapped at various positions on the leg. The software automatically places a cursor at the time location which is suspected as being the systolic pressure, yet it is the responsibility of the medical staff to modify the cursor location to define the correct segmental pressure.
Another main measurement of the VasoGuard is recording a waveform representing blood flow for each heartbeat. The system is capable of recording Doppler, PPG (photoplethysmography) and PVR (Pulse Volume Recording) waveforms. Each corresponds to the phases of the cardiac cycle, with a brisk upstroke and sharp peak that occur during systole, followed by a gradual downslope that occurs in diastole. A reflective wave, or dicrotic notch, represents reflected blood flow.
A high-level overview of continuous-wave (CW) Doppler is as follows. A CW Doppler transducer contains two piezoelectric elements: one to transmit the sound waves of constant frequency continuously and one to receive the echoes continuously. A single-element transducer cannot send
{7}------------------------------------------------
and receive at the same time. The sampling volume is restricted by the transmitted ultrasonic field (dependent on the frequency and focal properties of the sound beam) and the geometric arrangement of the elements. For the detection of a moving reflector located along the path of the transmitted beam, the resulting echo must strike the receiving crystal. The sensitive volume, or zone of sensitivity, is defined by the intersection of the transmitted ultrasound field and the reception zone. In essence then, each two-element transducer is focused to a particular depth. The two elements are tilted slightly to allow overlap between their respective fields of view (transmission and reception). The Doppler signal is amplified, filtered to remove unwanted low-frequency components caused by slow-moving structures such as vessel walls, and then routed to the speaker. The pitch of the audio output corresponds to the frequency shift between the transmitted and received sound waves and indicates the flow velocity within the vessel. As flow velocity becomes greater, a higher pitch is heard. A typical audio Doppler display for an artery exhibits a rhythmic rise and fall in the audible frequency due to the acceleration and deceleration of blood with systole and diastole.
A high-level overview of photoplethysmography (PPG) is as follows. PPG makes uses of low-intensity infrared (IR) light. When light travels through biological tissues it is absorbed by bones, skin pigments and both venous and arterial blood. Since light is more strongly absorbed by blood than the surrounding tissues, the changes in blood flow can be detected by PPG sensors as changes in the intensity of light. The voltage signal from PPG is proportional to the quantity of blood flowing through the blood vessels. The PPG waveform comprises a pulsatile ('AC') physiological waveform attributed to cardiac synchronous changes in the blood volume with each heartbeat, and is superimposed on a slowly varying ('DC') baseline with various lower frequency components attributed to respiration, sympathetic nervous system activity and thermoregulation.
A high-level overview of pulse volume recording (PVR) is as follows. A PVR is a graph of the pulsatile change in limb volume from blood flow using constant standard pressure. Users acquire these tracings using the same pressure cuffs used for segmental limb pressure measurement. Normal PVRs consist of a rapid upstroke with a sharp peak, a dicrotic notch, and a concave-up late diastolic component. A reduced amplitude from trough to peak has been used as a criterion for diagnosing vascular claudication. Abrupt changes in amplitude and contour can indicate occlusion between the two levels.
Indications for Use
807.92(a)(5)
The VasoGuard devices are intended for use in the non-invasive evaluation of peripheral vascular pathology in patients. The devices are not intended to replace other means of evaluating vital patient physiological testing, are not intended to be used in neonatal applications, and are not intended to be used inside the sterile field. The intended use by qualified and trained medical professionals in hospitals, clinics, and physician offices by prescription or on the order of a medical doctor.
{8}------------------------------------------------
Summary of Technological Characteristics Compared to Predicate
807.92(a)(6)
| Feature | Falcon/Pro, Falcon/Quad, Falcon/ABI+ | VasoGuardV2, V4, V6, V8, V10 | Diff |
|---|---|---|---|
| 510(k) Number | K111416 | This application | |
| Classification | JOP | JOP | |
| Date | July 15, 2011 | Pending | |
| Manufacturer | Viasonix Ltd | CorVascular Diagnostics, LLC | |
| Indications for use | The Falcon/Pro, Falcon/Quad,Falcon/ABI+ are intended for use inthe noninvasive evaluation ofperipheral vascular pathology inpatients.The devices are not intended toreplace other means of evaluating vitalpatient physiological processes, arenot intended to be used in fetalapplications, and are not intended tobe used inside the sterile field.They are to be used by trained medicalpersonnel in hospitals, clinics andphysicians offices by prescription ordoctor's orders. | The VasoGuard devices are intended foruse in the non-invasive evaluation ofperipheral vascular pathology inpatients.The devices are not intended to replaceother means of evaluating vital patientphysiological testing, are not intended tobe used in neonatal applications, and arenot intended to be used inside the sterilefield.The intended use is attended use bytrained medical professionals inhospitals, clinics, and physician offices byprescription or on the order of a medicaldoctor. | |
| Auto cuff inflation | Yes | Yes | |
| Pressure channels | 4, 4, 10 | 2, 4, 6, 8, 10 | (1) |
| Simultaneous PVRmeasurements | 4, 4, 10 | 2, 4, 6, 8, 10 | (2) |
| PPG sensors | 4, 4, 5 | 2, 4, 4, 4, 5 | |
| Doppler probes | 4, 8 and 10 MHz CW | 4 and 8 MHz CW | (3) |
| Doppler ports | 0, 3, 3 | 0, 1, 1, 2, 3 | |
| Skin temperaturemeasurement | Yes, wired (auto) | Yes, touchless (manual) | (4) |
| Remote control operation | Yes, wired | Yes, (infrared) | (5) |
| Touchscreen controls | Yes | Yes | |
| Foot switch controls | Yes | No | (6) |
| Mouse and keyboardcontrols | Yes | Yes | |
| Control of target inflationpressures | Yes | Yes | |
| Control of pressuresdeflation rate | Yes | Yes | |
| Acoustic testing | Track 1 | Track 1 | |
| Max Ispta.α 4 MHz | 691 mW/cm² | 366 mW/cm² | (7) |
| Max Ispta.α 8 MHz | 662 mW/cm² | 306 mW/cm² | (7) |
| Doppler spectral analysis | 256 FFT | 256 FFT | |
| Bidirectional Dopplerinvert function | Yes | Yes | |
| Doppler volume controls | Yes | Yes | |
| Doppler envelope | Upper, lower, both, none | Upper, lower, both, none | (8) |
| Doppler, PVR, segmentalpressure, exercise, venousreflux, Raynauds, TOStesting | Yes | Yes | |
| Complete System Testedto IEC 60601 | No | Yes | (9) |
{9}------------------------------------------------
The technical characteristics differences listed in the "Diff" column in the table above were compared to determine if any different issues of safety and/or efficacy exist. Upon review it was determined no safety or efficacy issues exist and no different questions of safety and effectiveness were raised. The differences listed do not constitute a new intended use.
Non-Clinical Testing
807.92(b)(1)
The VasoGuard (V10, V8, V6, V4, V2) range of non-invasive peripheral vascular diagnostic systems have been subjected to Biocompatibility, Acoustic Output, EMC Emissions and Immunity, Environmental Exposure, RFID Immunity, Electrical Safety, Performance, and Mechanical Safety testing by certified laboratories to ensure the devices comply with applicable industry and safety standards. Internally the VasoGuard has been subjected to unit, design verification, performance, accelerated aging, and validation testing to ensure the devices meet all their functional requirements and specifications.
Bench testing with the predicate device using simulators and live signals was conducted to ensure comparable waveform quality, sensitivity, and accuracy of reported values. The VasoGuard was found to be substantially equivalent to the predicate in all functions and parameters evaluated.
Conclusions
807.92(b)(3)
The conclusion drawn from these tests is that the VasoGuard V10, V8, V6, V2 range of non-invasive peripheral vascular diagnostic systems are equivalent in safety and efficacy to the predicate devices listed in the comparison table above.
§ 870.2880 Ultrasonic transducer.
(a)
Identification. An ultrasonic transducer is a device applied to the skin to transmit and receive ultrasonic energy that is used in conjunction with an echocardiograph to provide imaging of cardiovascular structures. This device includes phased arrays and two-dimensional scanning transducers.(b)
Classification. Class II (performance standards).