← Product Code [JOP](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/JOP) · K242662 # Falcon/Xpress (Falcon/Xpress) (K242662) _Viasonix , Ltd. · JOP · Dec 18, 2024 · Cardiovascular · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/JOP/K242662 ## Device Facts - **Applicant:** Viasonix , Ltd. - **Product Code:** [JOP](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/JOP.md) - **Decision Date:** Dec 18, 2024 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 870.2880 - **Device Class:** Class 2 - **Review Panel:** Cardiovascular ## Indications for Use 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 ## Device Story Falcon/Xpress is a noninvasive peripheral vascular diagnostic system. It utilizes pneumatic technology for systolic blood pressure and Pulse Volume Recording (PVR) waveforms, Continuous Wave (CW) Doppler for blood flow velocity, and Photo-Plethysmography (PPG) sensors. Inputs include pneumatic pressure from limb cuffs, Doppler ultrasound signals, and PPG optical signals. The system processes these inputs to calculate parameters like Ankle-Brachial Index (ABI), segmental pressure indices, blood flow velocities, and venous refill times. It supports specialty protocols including stress testing, thoracic outlet syndrome, Raynaud's syndrome, pulse wave velocity, penile function, and venous/arterial assessments. Operated by trained medical personnel in clinical settings, the device displays results on a screen or tablet, aiding clinicians in diagnosing peripheral vascular conditions. It features an optional external battery, pressure channel selector, and connectivity for DICOM reporting. The device provides objective physiological data to support clinical decision-making regarding vascular health. ## Clinical Evidence No clinical data. Substantial equivalence is based on bench testing, including biocompatibility, electrical safety, mechanical safety, acoustic output, EMC emissions/immunity, and comprehensive software verification and validation. ## Technological Characteristics Pneumatic pressure sensing, CW Doppler (4, 8, 10 MHz), and PPG sensors. Dimensions: 27x20x5.5 cm; weight: ~2 kg. Connectivity: DICOM, USB, DVD. Power: Mains or external battery. Software: 256-point FFT for Doppler spectral analysis. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-1, ISO 80369-1. ## Regulatory 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. ## Predicate Devices - Falcon ([K111416](/device/K111416.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. December 18, 2024 Viasonix Ltd. Dan Manor CEO 10 Hamelacha Street Ra'anana, 4366105 Israel Re: K242662 Trade/Device Name: Falcon/Xpress (Falcon/Xpress) Regulation Number: 21 CFR 870.2880 Regulation Name: Ultrasonic Transducer Regulatory Class: Class II Product Code: JOP Dated: August 25, 2024 Received: September 4, 2024 Dear Dan Manor: 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. {1}------------------------------------------------ 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" (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 QS 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. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system. 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-regulatory {2}------------------------------------------------ assistance/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, Robert T. Kazmierski -S for 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 Enclosure {3}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K242662 Device Name Falcon/Xpress Indications for Use (Describe) 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 | 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." {4}------------------------------------------------ ## 510(K) SUMMARY ### 1. ADMINISTRATIVE INFORMATION | Date: | 1-Aug-2024 | |------------------------------------------------|-----------------------------------------------------------------------------------------| | Submitter: | Viasonix Ltd.
10 Hamelacha Street
Raanana, ISRAEL 4366105
Phone: 972-9-7441692 | | Official Correspondent: | Dr. Dan Manor, CEO | | Trade Name: | Falcon/Xpress | | Classification Name:
Classification Number: | Ultrasonic transducer
21 CFR 870.2880 | | Product Code:
Device Class: | JOP
Class II | | Predicate Devices: | Falcon - K111416 | ### 2. DEVICE DESCRIPTION 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 {5}------------------------------------------------ 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. ### 3. Intended Use and Indications for Use 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 ### 4. Summary of Technical Characteristics The Falcon/Xpress is similar to the predicate device cited above in technology, function, software platform, intended use, applications, and accessories. The technological characteristics, e.g., overall design, materials, mechanism of action, mode of operation, performance characteristics, the intended use, use environment and target patient population of the Falcon/Xpress, are substantially equivalent to the predicate device cited above. {6}------------------------------------------------ # 4.1 Summary Table of Comparison | Feature | Falcon/Pro | Falcon/Quad | Falcon/ABI+ | Falcon/Xpress | Discussion of Differences | |----------------------------------------|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k)
number | K111416 | | | This application | | | Regulation
Number /
Product Code | 21 CFR 870.2880 / JOP | | | 21 CFR 870.2880 / JOP | Identical | | Indications
for use | | 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/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. | Identical, except the
product model refers to
Xpress | | Pressure
channels | 10 | 4 | 4 | 2 or 8 | Equivalent
All pressure channels are
completely independent
and perform exactly the
same without any
dependency on the total
number of pressure
channels. Additional
pressure channels simply
help the operator when
preparing the patient but
have no effect on the
performance or clinical
outcome. In the
Falcon/Xpress, there are 2
default pressure channels,
which can be extended to
a total of 8 pressure
channels by connection to
an external pressure
channels selector. The
performance of each
channel is identical to the | {7}------------------------------------------------ | Feature | Falcon/Pro | Falcon/Quad | Falcon/ABI+ | Falcon/Xpress | Discussion of Differences | | | | | | | |-------------------------------------|------------|--------------------|-------------|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|--|-------------|--|---------------------------------------------------------|---------------------------------------| | Simultaneous
PVR
measurements | 10 | 4 | 4 | 2 | others. No impact on the
indications for use.
Equivalent
All pressure channels are
completely independent
and perform exactly the
same PVR measurements
without any dependency
on the total number of
pressure channels.
Additional pressure
channels just help the
operator when preparing
the patient for PVR
measurements but have no
effect on the performance
or clinical outcome. In the
Falcon/Xpress there are
simply fewer PVR
pressure channels, which
require the operator to
connect the pressure tubes
to other sites after
completing a
measurement, similar to
the Falcon/Quad or
Falcon/ABI+ compared to
the Falcon/Pro. No impact
on product performance
and effectiveness | | | | | | | | PPG sensors | 5 | 4 | 4 | 2 | Equivalent
The PPG ports are
completely independent,
and the performance and
measurements made by
each PPG sensor are
identical, regardless of the
number of PPG ports
available. The
Falcon/Xpress is capable
of performing up to 2
simultaneous PPG
measurements, compared
to the Falcon/Quad or
Falcon/ABI+, which can
perform 4 simultaneous
measurements or the
Falcon/Pro with 5
simultaneous PPG
measurements. There is
no clinical requirement to
perform simultaneous PPG
measurements, and it is
primarily to help the
operator. No impact on
product performance and
effectiveness | | | | | | | | Doppler
probes | | 4, 8 and 10 MHz CW | | 4, 8 and 10 MHz CW | | N/A | | 4, 8 MHz CW | | Identical
This is identical to the
Falcon/Pro and | Falcon/Pro and
Falcon/Quad. The 10 | {8}------------------------------------------------ | Feature | Falcon/Pro | Falcon/Quad | Falcon/ABI+ | Falcon/Xpress | Discussion of Differences | |---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Temperature
measurement | yes | yes | yes | no | Temperature measurement
is not a requirement for
the vascular applications.
The Falcon/Xpress does
not include the
temperature sensor
because it can measure
skin temperature using
other methods if
necessary. The absence of
an integrated skin
temperature sensor has no
effect on the
Falcon/Xpress intended
use or performance. | | Specialty
tests | Stress,
TOS,
raynaud's,
penile
function,
venous
reflux,
venous
capacitance
and
outflow,
palmar arch
test, arterio-
venous
fistula,
popliteal
entrapment | Stress, TOS,
raynaud's,
penile
function,
venous
reflux,
venous
capacitance
and outflow,
palmar arch
test, arterio-
venous
fistula,
popliteal
entrapment | Stress, TOS,
raynaud's,
penile
function,
venous
reflux,
venous
capacitance
and outflow,
palmar arch
test, arterio-
venous
fistula,
popliteal
entrapment | Stress, TOS,
raynaud's, pulse
wave velocity, penile
function, venous
reflux, venous
capacitance and
outflow, palmar arch
test, arterio-venous
fistula, popliteal
entrapment | Equivalent
Same, except pulse wave
velocity, which is added
and is simply the distance
between 2 pressure cuffs
divided by the time
difference between the end
of diastole in the PVR
waveform for those cuffs.
The addition of the pulse
wave velocity test does not
impact the Falcon/Xpress
indications for use. | | Remote
control
operation | yes | yes | yes | yes | Identical | | Touch screen
controls | yes | yes | yes | yes | Identical | | Foot switch
controls | yes | yes | yes | yes | Identical | | Mouse and
keyboard
controls | yes | yes | yes | yes | Identical | | Control of
target
inflation
pressures | yes | yes | yes | yes | Identical | | Control of
pressures
deflation rate | yes | yes | yes | yes | Identical | | Acoustic | track 1 | track 1 | N/A | track 1 | Identical to Falcon/Pro | | Feature | Falcon/Pro | Falcon/Quad | Falcon/ABI+ | Falcon/Xpress | Discussion of Differences | | Doppler
spectral
analysis | yes, 256-
point FFT | yes, 256-
point FFT | N/A | yes, 256-point FFT | Identical to Falcon/Pro
and Falcon/Quad | | Bidirectional
Doppler,
invert
function | yes | yes | N/A | yes | Identical to Falcon/Pro
and Falcon/Quad | | Doppler
volume
controls | yes | yes | N/A | yes | Identical to Falcon/Pro
and Falcon/Quad | | Doppler
envelope | upper,
lower, both,
none | upper, lower,
both, none | N/A | upper, lower, both,
none | Identical to Falcon/Pro
and Falcon/Quad | | Calculated
blood
pressure
parameters | ABI,
segmental
pressure
indices | ABI,
segmental
pressure
indices | ABI,
segmental
pressure
indices | ABI, segmental
pressure indices | Identical | | Calculated
Doppler
parameters | Peak
velocity,
mean
velocity,
diastolic
velocity, PI,
RI, S/D,
RT, HR | Peak
velocity,
mean
velocity,
diastolic
velocity, PI,
RI, S/D, RT,
HR | N/A | Peak velocity, mean
velocity, diastolic
velocity, PI, RI, S/D,
RT, HR | Identical to Falcon/Pro
and Falcon/Quad | | Calculated
venous reflux
test
parameters | Venous
refill time | Venous refill
time | Venous refill
time | Venous refill time | Identical | | Calculated
MVO/SVC
test
parameters | MVO/SVC
ratio | MVO/SVC
ratio | MVO/SVC
ratio | MVO/SVC ratio | Identical | | Backup
options | DVD, USB
storage
device | DVD, USB
storage
device | DVD, USB
storage
device | DVD, USB storage
device | Identical | | Dicom
connectivity | available | available | available | available | Identical | | Printer
support | Most
commercial
printers | Most
commercial
printers | Most
commercial
printers | Most commercial
printers | Identical | | Customized
examination
protocols | available | available | available | available | Identical | | Configuration
of printed
reports | available
multiple
options | available
multiple
options | available
multiple
options | available multiple
options | Identical | | Patient details | full, with
patient
history | full, with
patient
history | full, with
patient
history | full, with patient
history | Identical | | Database
search
options | By name,
ID number,
date, and
other
examination
details | By name, ID
number, date,
and other
examination
details | By name, ID
number, date,
and other
examination
details | By name, ID
number, date, and
other examination
details | Identical | | Online help | available | available | available | available | Identical | | Standards
Compliance | IEC 60601-
1, IEC
60601-1-2, | IEC 60601-1,
IEC 60601-1-
2, IEC | IEC 60601-1,
IEC 60601-
1-2, IEC | IEC 60601-1, IEC
60601-1-2, IEC
60601-2-37, IEC | Identical
The Falcon/Xpress meets | | Feature | Falcon/Pro | Falcon/Quad | Falcon/ABI+ | Falcon/Xpress | Discussion of Differences | | | IEC 60601-
2-37,
ISO10993-
1, ISO
80369-1 | 60601-2-37,
ISO10993-1,
ISO 80369-1 | 60601-2-37,
ISO10993-1,
ISO 80369-1 | 62133-2, ISO 10993-
1, ISO 80369-1 | the recent FDA
consensuses standards | | Acoustic
Track | FDA Tack
1 | FDA Tack 1 | FDA Tack 1 | FDA Tack 1 | Identical | | External
battery | No | No | No | Yes | The external battery in
Falcon/Xpress allows
operating the system with
an external battery for at
least 2 hours while not
connected through the
external power supply to
the mains. This has no
impact on the indications
for use. | | Proposed
accessories | Cuffs, PPG,
Doppler
Probe,
Wired and
IR Remote
control,
Foot
Switch,
Keyboard
and Mouse | Cuffs, PPG,
Doppler
Probe, Wired
and IR
Remote
control, Foot
Switch,
Keyboard and
Mouse | Cuffs, PPG,
Doppler
Probe, Wired
and IR
Remote
control, Foot
Switch,
Keyboard
and Mouse | Cuffs, PPG, Doppler
Probe, Wired and IR
Remote control, Foot
Switch, External
battery, Pressure
selector, Cart,
Carrying bag, tablet,
cart, Keyboard and
Mouse | Equivalent
The Falcon/Xpress shares
the same accessories as the
predicate device. In
addition, the proposed
Falcon/Xpress includes an
external battery, pressure
channels selector, carrying
bag, and the use of an
optional tablet and cart,
which do not impact the
indication for use. | {9}------------------------------------------------ {10}------------------------------------------------ #### 5.1 Utilization of Standards and Guidances: The Falcon/Xpress meets the following standards and guidances: - 1. IEC 60601-1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance - 2. IEC 60601-1-2 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests - 3. IEC 60601-2-37 Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment - 4. ISO 80369-1 Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements - 5. ISO 10993-1 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process - 6. Guidance for Industry and FDA Staff Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers: February 2023 {11}------------------------------------------------ #### Summary of Non-Clinical Performance Testing 5.2 Summary of Non-Clinical Tests: The Falcon/Xpress device has been subjected to bio-compatibility, electrical safety, mechanical safety, acoustic output, EMC emissions and immunity, by certified laboratories. Internally, the Falcon/Xpress device was subjected to full software verification, validation, and performance testing to ensure that the device met all of its functional specifications. #### 5.3 Summary of Clinical Performance Data No clinical study was conducted to support this application. #### 5.4 Conclusions Based on its underlying technology and bench tests performed, the Falcon/Xpress is substantially equivalent to the predicate device. --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/JOP/K242662](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/JOP/K242662) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com