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The Falcon/Xpress is intended for use in the noninvasive evaluation of peripheral vascular pathology in patients. The Falcon/Xpress is not intended to replace other means of evaluating vital patient physiological processes, is not intended to be used in fetal applications, and is not intended to be used inside the sterile field. The Falcon/Xpress is to be used only by trained medical personnel in hospitals, clinics and physicians' offices by prescription or doctor's orders

The Falcon/Xpress is intended for use in the noninvasive evaluation of peripheral vascular pathology in patients . The Falcon/Xpress is a new model that is added to the cleared Falcon product family (K111416), which already includes the Falcon/Pro, Falcon/Quad and Falcon/ABI+ models. The Falcon/Xpress is similar to the other Falcon models in terms of technology, operation, software, intended use, applications, and accessories. The main differences are that the Falcon/Xpress supports 2 independent pressure channels (compared to 10 for the Pro and 4 for the Falcon/Quad and Falcon/ABI+), 2 PPG sensors (compared to 5 for the Pro and 4 for the Quad and ABI+), 2 Doppler ports (compared to 3 for the Pro and Quad and 0 for the ABI+), and no temperature sensor (compared to 1 for the Pro, Quad and ABI+). In addition, the Falcon/Xpress supports operation with an external battery and supports an 8-channel pressure selector (not available with the other Falcon models). The Falcon/Xpress supports an optional tablet, and can be mounted on a cart or within a dedicated bag. The Falcon/Xpress system is smaller in size, with dimensions of roughly 27x20x5.5 cm, compared to the Falcon legacy models with dimensions of 34x31x9.5 cm. In addition, the Falcon/Xpress system weighs roughly 2 kg, compared to roughly 4 kg for the Falcon legacy models. Similar to the other Falcon models, the Falcon/Xpress is based on pneumatic technology to measure systolic blood pressures and Pulse Volume Recording waveforms (PVR) at various peripheral limb sites. Similarly, the Falcon/Xpress includes the same Continuous Wave (CW) Doppler technology as the other Falcon models to allow measurements of blood flow velocities in peripheral blood vessels. The Falcon/Xpress also supports the same Photo-Plethysmography technology (PPG) as the other cleared Falcon models. The above-mentioned technologies allow the Falcon/Xpress to perform peripheral vascular diagnosis measurements in a similar manner to the cleared Falcon models (K111416), including the measurements of segmental systolic blood pressures, the Ankle-Brachial pressure index, PVR measurement, PPG measurements, and blood flow velocity measurements. The measurements support dedicated specialty test protocols such as measurements under various stress conditions, thoracic outlet syndrome, raynaud's syndrome, pulse wave velocity, penile function, venous reflux, venous capacitance and outflow, palmar arch test, arterio-venous fistula, and similar. All of the specialty tests simply use the measurements according to dedicated protocols and display for the evaluation of specific medical conditions. The pressure cuffs are connected to the air tubes via "Bayonet" connectors or Viasonix Vfit connectors. Both of these options are designed to avoid potential misconnections by being incompatible with standard Luer connectors or other connectors used for nonvascular applications.

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 Smartdop XT6 is intended for use in the non-invasive evaluation of peripheral vascular pathology in patients. It detects systolic pressures for ankle-brachial index (ABI), toe-brachial index (TBI), and arterial and venous blood flow in extremities. Measurements are provided utilizing cuffs, photoplethysmography (PPG) and/or Doppler probe. The optional foot temperature probe provides skin temperature readings on the foot. Collected data is captured and stored with Smart-XT-Link6 software that includes capabilities to print waveforms and export to into the facility's electronic health records. It is not intended to be used in fetal applications or used inside the sterile field. It is intended to be used by licensed healthcare practitioners on adults and pediatrics only.

The Smartdop XT6 with Smart-XT-Link6 is designed to provide both qualitative information. The qualitative information mainly includes visual display of waveform's shapes, including qualitative analysis of Pulse Volume Recordings (PVR), Photoplethysmography (PPG) and Doppler waveforms. The quantitative information is focused primarily on aiding the examiners in obtaining systolic segmental blood pressures, including the ABI (ankle-brachial index) and TBI (toe-brachial index). Additional quantitative measurements relate to the Doppler blood flow velocity waveforms. Foot skin temperature readings are done with optional temperature probe and can be displayed in either Fahrenheit or Celsius. All tests controlled and stored by computer with Smart-XT-Link6 software for Windows OS with capabilities to print waveform data and export to electronic health record management systems.

The Smartdop XT is intended for use in the non-invasive evaluation of peripheral vascular pathology in patients. It detects systolic pressures for ankle-brachial index (ABI), toe- brachial index (TBI), and arterial and venous blood flow in extremities. Measurements are provided utilizing cuffs and/or Doppler probe. The optional foot temperature provides skin temperature readings on the foot. Collected data is captured and stored with Smart-XT-Link software that includes capabilities to print waveforms and export to into the facility's electronic health records. It is not intended to be used in fetal applications or used inside the sterile field.

The Smartdop XT with Smart-XT-Link is designed to provide both qualitative and quantitative information. The qualitative information mainly includes visual display of waveform's shapes. including qualitative analysis of Pulse Volume Recordings (PVR), Photoplethysmography (PPG) and Doppler waveforms. The quantitative information is focused primarily on aiding the examiners in obtaining systolic segmental blood pressures, including the ABI (ankle-brachial index) and TBI (toe-brachial index). Additional quantitative measurements relate to the Doppler blood flow velocity waveforms. Foot skin temperature readings are done with optional temperature probe and can be displayed in either Fahrenheit or Celsius. All tests controlled and stored by computer with Smart-XT-Link software for Windows OS with capabilities to print waveform data and export to electronic health record management systems.

The VL40xx is a Non-Invasive diagnostic system designed to detect peripheral vascular pathology in adults. In all cases the intended use is for spot checking and attended use by trained medical professionals in a hospital or medical facility by the order of a medical doctor. The VL40xx is not intended to replace other means of evaluating vital patient physiological processes, is not intended to be used in fetal applications, and is not intended to be used inside the sterile field.

The VL40xx is a family of products designed for non-invasive peripheral vascular diagnostic systems. The VL40 indicates the family of products that are all made from the same parts with the only differences being that some parts are not installed or some features are not enabled. The "xx" will be used to indicate the family of products. Options of what Doppler or PPG probes are installed do not qualify for a specific model number because there is no physical change to the device to add them. Different air channels require a model number because the valves require a physical change to the device that can only be done at the factory. Specifically the following models are used. - . Model 4000: full system, twelve channel air - Model 4010: full system, two channel air portable . - Model 4030: ABI (Ankle Brachial Index), six channel air . The base unit has the same main printed circuit board (PCB), battery, speaker, software, and power supply. Adding the PPG option requires installing a PCB module to the main PCB and attaching the PPG sensors to the outside of the case. Adding the Doppler requires attaching the desired frequency probe (4 or 8 MHz) to the case. All Doppler frequency probes use the same PCB logic. This means that any probe frequency can be added without any changes to the main PCB or the connectors. The universal Doppler probe is possible because all the Doppler electronics are in the probe. The device PCB for the Doppler only has the logic to turn on the probe and read the data. The Doppler probe has all the electronics to control the IQ signal separation and power output of the probe. Adding the temperature reading requires purchasing a cleared FDA IR temperature probe from a 3rd party (example Exergen model TAT 5000, K011291). The IR device is a complete standalone product with its own FDA clearance. The VL40xx simply provides a method in software for the operator to record the temperature samples in a table for convenience of reporting. The temperature tests protocols do not care about the absolute temperature readings but do care about the differential readings. What is important is the temperature difference of before and after readings. For the above features there are no changes to the case and the changes can be made at any time. The following features require changes to the back panel of the case to support the number of air hoses. The number of air hoses installed is 2, 6, or 12. Internally only the required valves, pressure sensors, and pumps will be installed. Adding air hoses later would require a new case and the appropriate valves, pressure sensors, and pumps to be added. It is much easier to install all the valves and manage the air connectors by choosing what air hoses are attached externally. Unless weight / portability are an issue the easiest solution will always be to choose the 12 air hose system and manage the external air hoses. The external air hoses can be changed at any time to create a system that has 2-12 air hoses as needed. The VL4000 is the model with all air hoses enabled internally. The air hoses are color coded to help the user attach them to the correct blood pressure cuff. Each air hose has a Red for Right and Lemon for Left code in addition to another color (white, black. orange, yellow, blue, and green) to help identify the location of the software always displays the color of the side (Red or Lemon) and the color of the location that it intends to use. The system has no way to determine that the user connects the air hose to the correct cuff at the correct location. The software for all models is exactly the same. The software automatically detects what features are installed. All models have the following software features: patient history, comments, storage, printing, print preview, configuration, and online help. Optional software features include Modality Work List (MWL), exporting of data using DICOM Images / Structured Reporting, email, native PDF, long term data storage, data mirroring, and online support. The VL4030 ABI system will have all tests disabled in software except for the ABI specific tests. One of the main measurements of the system is segmental systolic blood pressures. In general, the measurement is conducted by applying an appropriately sized cuff to the measured segment, obtaining a reference PPG or a Doppler signal in a location distal to the cuff placement, and then inflating the cuff to such a pressure that will occlude the blood vessels and prevent blood flow distal to the cuff location, which will result in disappearance of the reference signal. Then, a slow cuff deflation begins, and the instantaneous cuff pressure at which the reference signal reappears is typically defined as the segmental systolic blood pressure. While the software automatically places a cursor at the time location which is suspected as being the systolic pressure, it is the total responsibility of the system operator and the medical staff to modify the cursor location according to their medical training, and define the correct segmental pressure. Based on the segmental pressures, the pressure indices are calculated, as the ratio between the systolic segmental pressure, and the higher of the 2 brachial systolic pressures that does not exceed a noncompressible limit (usually 240 mmHg). The ABI index is a commonly used index, which is a specific case of the above, calculated as the systolic right or left ankle pressure, divided by the hight or left brachial systolic pressure. The other main measurement of the system is recording a wave that represents the flow of blood for each heartbeat. The three main modalities for this are the Doppler, PPG, and PVR wave forms. All three of these modalities produce a wave form that has a systolic up stroke, a diastolic down stroke, a pause, and a repeat. Researchers have shown that the shape of these waveforms is a great indicator of disease and that the actual measurement of the wave is not as important. The system has a wireless remote control. Everything that the remote can do can also be done with the keyboard. The advantage of the remote is that it provides the most common functions needed to perform the measurement without requiring the operator to reach for the keyboard. If the IR remote is not available then the user will access the VL40xx using a directly wired keyboard, mouse, or touchscreen. The scientific principal of CW Doppler in very high level terms is as follows. A crystal is cut in half. One half of the crystal has a 4 or 8 MHz sine wave applied. When the acoustic output of the crystal is focused into human tissue it will bounce back and be absorbed by the remaining crystal. Any Doppler effect caused by moving blood can be detected in the phase shift when the transmitted signal is compared with the echoed signal. The phase shift for blood in humans is usually less than 6 kHz and therefore makes for a nice audio signal that can easily be heard. Most modern CW Doppler systems will use IQ modulation and FFT to detect the spectral of the audio signal returned. Tracing the envelope of the spectral will provide the familiar heart beat trace. The CW Doppler can measure the velocity of blood in a specific artery. The scientific principal of PPG in very high level terms is as follows. An Infra-Red pulse is provided by an LED and applied to the skin. The blood and tissue will absorb and reflect the IR signal. The amount of blood in the capillaries will determine how much IR signal is absorbed or reflected. An LED sensor is applied that measures the reflected IR signal. Displaying the LED sensor output will provide the familiar heart beat trace. The PPG can measure the change in blood flow in the skin. The scientific principal of VPR in very high level terms is as follows. A cuff is placed around an arm or leg and inflated to 60 mmHg. The higher the pressure without occluding the blood flow (below systolic blood pressure) will produce the best pressure change in the cuff for each heartbeat will cause a pressure change in the cuff ranging from 0.01 – 0.5 mmHg. Displaying the pressure sensor output will provide the familiar heart beat trace. The VPR can measure the change in blood flow for a network of arteries. The speaker is located on the front of the VL40xx and all other connectors (Doppler, PPG, VPR, USB, power supply, and status LEDs) are on the back.

The Falcon/Pro, Falcon/Quad, and Falcon/ABI+ are intended for use in the noninvasive evaluation of peripheral vascular pathology in patients. The devices are not intended to replace other means of evaluating vital patient physiological processes, are not intended to be used in fetal applications, and are not intended to be used inside the sterile field. They are to be used by trained medical personnel in hospitals, clinics and physicians offices by prescription or doctor's orders.

The Falcon/Pro, Falcon/Quad, and Falcon/ABI+ systems are part of the Falcon product family of non-invasive peripheral vascular diagnostic systems. The Falcon/Pro is a complete peripheral vascular system that supports 10 independent pressure channels, 5 PPG sensors, 3 Doppler frequencies, and a temperature sensor. The Falcon/Quad and the Falcon/ABI+ systems are merely sub-assemblies of the Falcon/Pro system. Both support only 4 pressure channels, 4 PPG sensors and a temperature sensor. The Falcon/Quad also includes support for the 3 Doppler frequencies, while the Falcon/ABI+ does not support any Doppler features. The Falcon/Pro and its' sub-assemblies Falcon/Quad and Falcon/ABI+ share the same hardware and software. While the main printed circuit board (PCB) is identical, the pneumatic components such as pumps, valves, sensors and check valves are assembled in the Falcon/Quad and Falcon/ABI+ to support only 4 pressure channels. In addition, one PPG sensor is omitted from the assembly of these systems. Furthermore, the Doppler board with its' PCB mount probe connectors is not assembled in the Falcon/ABI+ system. The same metal enclosure and connectors are used for the Falcon/Pro. Falcon/Quad, and Falcon/ABI+. The only difference lies in the front panel which is adapted according to the number of PPG sensors and Doppler probes. The software level of concern for the Falcon products is determined as Moderate. The software of the Falcon/Pro, Falcon/Quad, and Falcon/ABI+ systems is practically identical. The only software differences are as follows: the Falcon/Pro supports 10 pressure cuffs (tubing marked in red, blue, green, yellow, orange, and white with lines in red. blue, green, yellow, and orange), while the sub-assemblies support only 4 pressure cuffs (tubing marked in red, blue, green, yellow); the Falcon/Pro supports 5 color coded PPG sensors (red, blue, green, vellow and black) while the sub-assemblies support only 4 such sensors (red, blue, green, yellow); the default examination protocols are adapted according to the supported sensors and probes; the maximal protocol group allowed with the Falcon/Pro is 10. while the maximal allowed group for the sub-assemblies is 9: and the Falcon/ABI+ does not support any of the Doppler options and features. All other software features are identical for the Falcon/Pro and the 2 sub-assemblies Falcon/Quad and Falcon/ABI+. Some of the main features include patient details and patient database management; Dicom connectivity; printing configuration and printing options; writing examination reports; summary screen support; configuration and management of examination protocols: measurement site configuration: export in various formats: import of VSX files; backup features; restoring backup data: online help options: and review stations. All of the standard signal control options and signal display options. as well as measurement calculations, are identical for all 3 systems (excluding Doppler related options for the Falcon/ABI+ system). The quantitative measurements are the same for Falcon/Pro and the 2 sub-assemblies Falcon/Quad and Falcon/ABI+. The main measurement of the 3 systems is segmental systolic blood pressures. In general, the measurement is conducted by applying an appropriately sized cuff to the measured segment, obtaining a reference PPG or a Doppler signal in a location distal to the cuff placement, and then inflating the cuff to such a pressure that will occlude the blood vessels and prevent blood flow distal to the cuff location, which will result in disappearance of the reference signal. Then, a slow cuff deflation begins, and the instantaneous cuff pressure at which the reference signal reappears is typically defined as the segmental systolic blood pressure. While the software automatically places a cursor at the time location which is suspected as being the systolic pressure, it is the total responsibility of the system operator and the medical staff to modify the cursor location according to their medical training, and define the correct segmental pressure. Based on the segmental pressures, the pressure indices are calculated, as the ratio between the systolic segmental pressure, and the higher of the 2 brachial systolic pressures. The ABI index is a commonly used index, which is a specific case of the above, calculated as the systolic right or left ankle pressure, divided by the higher of the right or left brachial systolic pressure. The standard main Doppler parameters that are calculated (not for the Falcon/ABI+ system), include: Mean, representing the time-average value of the envelope (maximal velocity/frequency) over one cardiac cycle; Peak, representing the maximal systolic velocity/frequency during a cardiac cycle, in units of cm/sec or KHz; Diast, representing the minimal diastolic velocity/frequency during a cardiac cycle, in units of cm/sec or KHz; PI, representing the Gosling Pulsatility Index, calculated based on the peak envelope as (peak systolic velocity - minimal diastolic velocity) / mean velocity; RI. representing the Pourcelot Resistance Index. calculated based on the peak envelope as (peak systolic velocity - minimal diastolic velocity) / peak systolic velocity; S/D. representing the systolic to diastolic flow ratio, and is calculated based on the peak envelope as: (peak systolic velocity / minimal diastolic velocity); and HR, representing heart rate in beats (number of cardiac cycles) per minute. Additional parameters that are displayed are related to the specialty tests. During stress testing, a digital timer indicates the duration of the exposure to stress (for example the total time the patient exercised), and the recovery time for each measurement (the time that passed since the end of stress exercise and the current measurement). During venous reflux testing the system automatically places vertical cursors that denote the minimal PPG signal after sequential leg dorsiflexions and the point in time that the PPG signal returns to pre-dorsiflexion baseline. The time difference between these 2 cursors is calculated and referenced as the VRT (venous refill time). It is the responsibility of the examiner to determine the correct vertical cursor position, hence adjusting the VRT parameter. Likewise, the MVO/SVC ratio is based on the horizontal baseline and plateau signals, and the rate of signal drop immediately after rapid deflation of the thigh cuff. Again, it is the responsibility of the examiner to determine the correct cursor positions for the parameter calculation. The Falcon complies with Class B EMC requirements. Therefore, the Falcon is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Peripheral Vascular (CWD)

The Nicolet VersaLab is a DC rechargeable battery / DC powered device. The Nicolet VersaLab employs fixed [not adjustable] CW Doppler power levels that are pre-set at a limit below the maximum allowable of 720mw/cm²; therefore, the ALARA condition is always met. There are hardware levels controlling the power as well as redundant software controls.

This modification has no effect on intended use of the HP ultrasound systems.

The modification addressed in this submission is a change from analog to digital circuit technology for the front end of the HP ultrasound imaging systems listed above.

This modification expands the intended use statement for the HP SONOS 100CF Ultrasound Imaging System to include obstetrics and gynecology applications.

This 510(k) submission is to add an endovaginal transducer and a new EV(EndoVaginal)/Pelvic study type to the HP SONOS 100CF Ultrasound Imaging System.