(105 days)
No
The document describes a device based on pneumatic, Doppler, and PPG technologies for measuring physiological parameters. There is no mention of AI or ML in the device description, intended use, or performance studies. The focus is on hardware and established measurement techniques.
No
The intended use states the device is for "noninvasive evaluation of peripheral vascular pathology," indicating a diagnostic rather than therapeutic purpose.
Yes
The device's intended use and description explicitly state its purpose is for "noninvasive evaluation of peripheral vascular pathology" and to "perform peripheral vascular diagnosis measurements." It describes various diagnostic measurements and specialty test protocols for the "evaluation of specific medical conditions."
No
The device description explicitly details hardware components such as pressure channels, PPG sensors, Doppler ports, pressure cuffs, air tubes, and mentions pneumatic, CW Doppler, and PPG technologies. It also describes physical characteristics like size and weight. The performance studies section mentions electrical and mechanical safety testing, further indicating a hardware component.
Based on the provided information, the Falcon/Xpress device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "noninvasive evaluation of peripheral vascular pathology in patients." This indicates the device is used directly on the patient's body to gather physiological data.
- Device Description: The description details the use of technologies like pneumatic pressure, Continuous Wave (CW) Doppler, and Photo-Plethysmography (PPG) to measure physiological parameters like blood pressure, blood flow velocity, and PVR waveforms. These are all in-vivo measurements.
- Lack of In Vitro Activities: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body. IVD devices are specifically designed for testing such specimens.
Therefore, the Falcon/Xpress is a non-invasive medical device used for physiological measurements on patients, not an in vitro diagnostic device.
N/A
Intended Use / 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
Product codes
JOP
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained medical personnel in hospitals, clinics and physicians' offices
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
No clinical study was conducted to support this application.
Key Metrics
Not Found
Predicate Device(s)
Falcon - K111416
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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)
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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:
-
- IEC 60601-1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance
-
- 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
-
- IEC 60601-2-37 Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
-
- ISO 80369-1 Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements
-
- ISO 10993-1 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
-
- 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.