(105 days)
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 provided text is an FDA 510(k) summary for the Falcon/Xpress device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study for assessing performance against specific acceptance criteria for AI integration.
Therefore, many of the requested details, particularly regarding acceptance criteria for AI performance, sample sizes for test sets, expert ground truth establishment, MRMC studies, standalone AI performance, and AI-specific training/ground truth, are not available in this document. The document explicitly states "No clinical study was conducted to support this application."
However, I can extract information related to the device's characteristics and the non-clinical testing performed to show its equivalence to the predicate device.
Here's an attempt to answer your questions based on the provided text, while acknowledging the limitations:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria in terms of AI model performance (e.g., AUC, sensitivity, specificity) because it's not a study of AI performance, but rather a submission for substantial equivalence based on device characteristics. Instead, the "acceptance criteria" are implied by the claim of substantial equivalence to the predicate device and compliance with relevant standards. The reported performance is an assertion of equivalency of the new model to the predicate device through non-clinical testing.
| Feature / "Acceptance Criteria" (Implied by Equivalence to Predicate) | Reported Device Performance (as stated in document) |
|---|---|
| Intended Use | Noninvasive evaluation of peripheral vascular pathology in patients. Not for fetal applications or inside sterile field. Used by trained medical personnel. |
| Technology, Operation, Software, Applications, Accessories | Based on pneumatic technology (systolic BP, PVR), Continuous Wave (CW) Doppler, Photo-Plethysmography (PPG). |
| Physical Characteristics (Size/Weight) | Roughly 27x20x5.5 cm, ~2 kg. |
| Pressure Channels | 2 independent (or 8 with external selector). |
| Simultaneous PVR Measurements | 2 simultaneous. |
| PPG Sensors | 2. |
| Doppler Probes | 4, 8 MHz CW. |
| Temperature Measurement | No integrated sensor. |
| Specialty Tests | Stress, TOS, Raynaud's, Pulse Wave Velocity, Penile function, Venous reflux, Venous capacitance and outflow, Palmar arch, Arterio-venous fistula, Popliteal entrapment. |
| Controls (Remote, Touch, Foot Switch, Mouse/Keyboard, Inflation/Deflation) | Yes (for all listed). |
| Acoustic Track, Doppler Spectral Analysis, Bidirectional Doppler, Doppler Volume/Envelope | FDA Tack 1, 256-point FFT, Yes (bidirectional, invert, volume), Upper/Lower/Both/None (envelope). |
| Calculated Parameters (BP, Doppler, Venous Reflux, MVO/SVC) | ABI, segmental pressure indices; Peak/mean/diastolic velocity, PI, RI, S/D, RT, HR; Venous refill time; MVO/SVC ratio. |
| Data Management (Backup, DICOM, Printer, Protocols, Reports, Patient Details, Search, Help) | DVD, USB, available, most commercial, available, available, full history, by name/ID/date/details, available. |
| Standards Compliance | IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 80369-1, ISO 10993-1, FDA Guidance (Diag Ultrasound). |
| Bio-compatibility, Electrical Safety, Mechanical Safety, Acoustic Output, EMC | Subjected to testing by certified laboratories. |
| Software Verification, Validation, Performance Testing | Internally subjected to full verification, validation, and performance testing. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable/not stated. The submission relies on non-clinical bench testing and substantial equivalence to a predicate device, not a clinical study with a specific test set of patient data for performance evaluation.
- Data Provenance: Not applicable, as there was no clinical data test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. No clinical test set with expert ground truth was used for this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical test set.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. The document explicitly states: "No clinical study was conducted to support this application." This device is not an AI-assisted diagnostic tool in the sense of image interpretation for which an MRMC study would typically be performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI algorithm submitting standalone performance data. The device itself is a diagnostic instrument, not solely an AI algorithm. Its performance is evaluated through its physical and software functionality as a whole unit, which is compared to its predicate.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the non-clinical testing, the "ground truth" would be established by validated test methods, reference standards, and specifications against which the device's components and integrated system are measured. For example:
- Pressure measurements: Calibration against known pressure standards.
- Doppler frequencies: Measurement against known frequency sources.
- Software functionality: Verification and validation against software requirements and design specifications.
- Safety/EMC: Compliance with international standards (IEC 60601 series).
8. The sample size for the training set
- Not applicable. This document does not describe the development or performance of an AI model that would require a "training set" in the machine learning sense. It's a medical device.
9. How the ground truth for the training set was established
- Not applicable, as there was no AI training set as described in the context of this submission.
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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.
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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
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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
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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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510(K) SUMMARY
1. ADMINISTRATIVE INFORMATION
| Date: | 1-Aug-2024 |
|---|---|
| Submitter: | Viasonix Ltd.10 Hamelacha StreetRaanana, ISRAEL 4366105Phone: 972-9-7441692 |
| Official Correspondent: | Dr. Dan Manor, CEO |
| Trade Name: | Falcon/Xpress |
| Classification Name:Classification Number: | Ultrasonic transducer21 CFR 870.2880 |
| Product Code:Device Class: | JOPClass 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.
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4.1 Summary Table of Comparison
| Feature | Falcon/Pro | Falcon/Quad | Falcon/ABI+ | Falcon/Xpress | Discussion of Differences |
|---|---|---|---|---|---|
| 510(k)number | K111416 | This application | |||
| RegulationNumber /Product Code | 21 CFR 870.2880 / JOP | 21 CFR 870.2880 / JOP | Identical | ||
| Indicationsfor use | The Falcon/Pro, Falcon/Quad, andFalcon/ABI+ are intended for use in thenoninvasive evaluation of peripheral vascularpathology in patients.The devices are not intended to replace othermeans of evaluating vital patientphysiological processes, are not intended tobe used in fetal applications, and are notintended to be used inside the sterile field.They are to be used by trained medicalpersonnel in hospitals, clinics and physicians'offices by prescription or doctor's orders. | The Falcon/Xpress isintended for use inthe noninvasiveevaluation ofperipheral vascularpathology in patients.The Falcon/Xpress isnot intended toreplace other meansof evaluating vitalpatient physiologicalprocesses, is notintended to be usedin fetal applications,and is not intended tobe used inside thesterile field.The Falcon/Xpress isto be used only bytrained medicalpersonnel inhospitals, clinics andphysicians' officesby prescription ordoctor's orders. | Identical, except theproduct model refers toXpress | ||
| Pressurechannels | 10 | 4 | 4 | 2 or 8 | EquivalentAll pressure channels arecompletely independentand perform exactly thesame without anydependency on the totalnumber of pressurechannels. Additionalpressure channels simplyhelp the operator whenpreparing the patient buthave no effect on theperformance or clinicaloutcome. In theFalcon/Xpress, there are 2default pressure channels,which can be extended toa total of 8 pressurechannels by connection toan external pressurechannels selector. Theperformance of eachchannel is identical to the |
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| Feature | Falcon/Pro | Falcon/Quad | Falcon/ABI+ | Falcon/Xpress | Discussion of Differences | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| SimultaneousPVRmeasurements | 10 | 4 | 4 | 2 | others. No impact on theindications for use.EquivalentAll pressure channels arecompletely independentand perform exactly thesame PVR measurementswithout any dependencyon the total number ofpressure channels.Additional pressurechannels just help theoperator when preparingthe patient for PVRmeasurements but have noeffect on the performanceor clinical outcome. In theFalcon/Xpress there aresimply fewer PVRpressure channels, whichrequire the operator toconnect the pressure tubesto other sites aftercompleting ameasurement, similar tothe Falcon/Quad orFalcon/ABI+ compared tothe Falcon/Pro. No impacton product performanceand effectiveness | ||||||
| PPG sensors | 5 | 4 | 4 | 2 | EquivalentThe PPG ports arecompletely independent,and the performance andmeasurements made byeach PPG sensor areidentical, regardless of thenumber of PPG portsavailable. TheFalcon/Xpress is capableof performing up to 2simultaneous PPGmeasurements, comparedto the Falcon/Quad orFalcon/ABI+, which canperform 4 simultaneousmeasurements or theFalcon/Pro with 5simultaneous PPGmeasurements. There isno clinical requirement toperform simultaneous PPGmeasurements, and it isprimarily to help theoperator. No impact onproduct performance andeffectiveness | ||||||
| Dopplerprobes | 4, 8 and 10 MHz CW | 4, 8 and 10 MHz CW | N/A | 4, 8 MHz CW | IdenticalThis is identical to theFalcon/Pro and | Falcon/Pro andFalcon/Quad. The 10 |
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| Feature | Falcon/Pro | Falcon/Quad | Falcon/ABI+ | Falcon/Xpress | Discussion of Differences |
|---|---|---|---|---|---|
| Temperaturemeasurement | yes | yes | yes | no | Temperature measurementis not a requirement forthe vascular applications.The Falcon/Xpress doesnot include thetemperature sensorbecause it can measureskin temperature usingother methods ifnecessary. The absence ofan integrated skintemperature sensor has noeffect on theFalcon/Xpress intendeduse or performance. |
| Specialtytests | Stress,TOS,raynaud's,penilefunction,venousreflux,venouscapacitanceandoutflow,palmar archtest, arterio-venousfistula,poplitealentrapment | Stress, TOS,raynaud's,penilefunction,venousreflux,venouscapacitanceand outflow,palmar archtest, arterio-venousfistula,poplitealentrapment | Stress, TOS,raynaud's,penilefunction,venousreflux,venouscapacitanceand outflow,palmar archtest, arterio-venousfistula,poplitealentrapment | Stress, TOS,raynaud's, pulsewave velocity, penilefunction, venousreflux, venouscapacitance andoutflow, palmar archtest, arterio-venousfistula, poplitealentrapment | EquivalentSame, except pulse wavevelocity, which is addedand is simply the distancebetween 2 pressure cuffsdivided by the timedifference between the endof diastole in the PVRwaveform for those cuffs.The addition of the pulsewave velocity test does notimpact the Falcon/Xpressindications for use. |
| Remotecontroloperation | yes | yes | yes | yes | Identical |
| Touch screencontrols | yes | yes | yes | yes | Identical |
| Foot switchcontrols | yes | yes | yes | yes | Identical |
| Mouse andkeyboardcontrols | yes | yes | yes | yes | Identical |
| Control oftargetinflationpressures | yes | yes | yes | yes | Identical |
| Control ofpressuresdeflation 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 |
| Dopplerspectralanalysis | yes, 256-point FFT | yes, 256-point FFT | N/A | yes, 256-point FFT | Identical to Falcon/Proand Falcon/Quad |
| BidirectionalDoppler,invertfunction | yes | yes | N/A | yes | Identical to Falcon/Proand Falcon/Quad |
| Dopplervolumecontrols | yes | yes | N/A | yes | Identical to Falcon/Proand Falcon/Quad |
| Dopplerenvelope | upper,lower, both,none | upper, lower,both, none | N/A | upper, lower, both,none | Identical to Falcon/Proand Falcon/Quad |
| Calculatedbloodpressureparameters | ABI,segmentalpressureindices | ABI,segmentalpressureindices | ABI,segmentalpressureindices | ABI, segmentalpressure indices | Identical |
| CalculatedDopplerparameters | Peakvelocity,meanvelocity,diastolicvelocity, PI,RI, S/D,RT, HR | Peakvelocity,meanvelocity,diastolicvelocity, PI,RI, S/D, RT,HR | N/A | Peak velocity, meanvelocity, diastolicvelocity, PI, RI, S/D,RT, HR | Identical to Falcon/Proand Falcon/Quad |
| Calculatedvenous refluxtestparameters | Venousrefill time | Venous refilltime | Venous refilltime | Venous refill time | Identical |
| CalculatedMVO/SVCtestparameters | MVO/SVCratio | MVO/SVCratio | MVO/SVCratio | MVO/SVC ratio | Identical |
| Backupoptions | DVD, USBstoragedevice | DVD, USBstoragedevice | DVD, USBstoragedevice | DVD, USB storagedevice | Identical |
| Dicomconnectivity | available | available | available | available | Identical |
| Printersupport | Mostcommercialprinters | Mostcommercialprinters | Mostcommercialprinters | Most commercialprinters | Identical |
| Customizedexaminationprotocols | available | available | available | available | Identical |
| Configurationof printedreports | availablemultipleoptions | availablemultipleoptions | availablemultipleoptions | available multipleoptions | Identical |
| Patient details | full, withpatienthistory | full, withpatienthistory | full, withpatienthistory | full, with patienthistory | Identical |
| Databasesearchoptions | By name,ID number,date, andotherexaminationdetails | By name, IDnumber, date,and otherexaminationdetails | By name, IDnumber, date,and otherexaminationdetails | By name, IDnumber, date, andother examinationdetails | Identical |
| Online help | available | available | available | available | Identical |
| StandardsCompliance | IEC 60601-1, IEC60601-1-2, | IEC 60601-1,IEC 60601-1-2, IEC | IEC 60601-1,IEC 60601-1-2, IEC | IEC 60601-1, IEC60601-1-2, IEC60601-2-37, IEC | IdenticalThe Falcon/Xpress meets |
| Feature | Falcon/Pro | Falcon/Quad | Falcon/ABI+ | Falcon/Xpress | Discussion of Differences |
| IEC 60601-2-37,ISO10993-1, ISO80369-1 | 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 FDAconsensuses standards | |
| AcousticTrack | FDA Tack1 | FDA Tack 1 | FDA Tack 1 | FDA Tack 1 | Identical |
| Externalbattery | No | No | No | Yes | The external battery inFalcon/Xpress allowsoperating the system withan external battery for atleast 2 hours while notconnected through theexternal power supply tothe mains. This has noimpact on the indicationsfor use. |
| Proposedaccessories | Cuffs, PPG,DopplerProbe,Wired andIR Remotecontrol,FootSwitch,Keyboardand Mouse | Cuffs, PPG,DopplerProbe, Wiredand IRRemotecontrol, FootSwitch,Keyboard andMouse | Cuffs, PPG,DopplerProbe, Wiredand IRRemotecontrol, FootSwitch,Keyboardand Mouse | Cuffs, PPG, DopplerProbe, Wired and IRRemote control, FootSwitch, Externalbattery, Pressureselector, Cart,Carrying bag, tablet,cart, Keyboard andMouse | EquivalentThe Falcon/Xpress sharesthe same accessories as thepredicate device. Inaddition, the proposedFalcon/Xpress includes anexternal battery, pressurechannels selector, carryingbag, and the use of anoptional tablet and cart,which do not impact theindication for use. |
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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
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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.
§ 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).