(219 days)
No
The description focuses on calculating physiological ratios (FFR, dPR) based on pressure measurements, which are standard calculations, not AI/ML algorithms. There is no mention of AI, ML, or related terms in the summary.
No
The device is indicated for obtaining intravascular pressure measurements for diagnosis, not for treating the condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "indicated for obtaining intravascular pressurements for use in the diagnosis and treatment of coronary and peripheral artery disease." Furthermore, the "Device Description" section details how it measures FFR and dPR for "physiological assessment of ischemic stenotic lesions," which are diagnostic activities.
No
The device description explicitly states the system includes a "RXi System console containing embedded software" and is used with a "Navvus catheter which contains a pressure sensor". This indicates the device is a system with both hardware (console, catheter with sensor) and software components, not a software-only device.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states the system is for "obtaining intravascular pressurements for use in the diagnosis and treatment of coronary and peripheral artery disease." This directly aligns with the definition of an IVD, which is used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition.
- Measurement of Physiological Parameters: The device measures intravascular pressure (both hyperemic FFR and non-hyperemic dPR and PdPa). These are physiological parameters derived from the patient's body.
- Diagnostic Information: The measurements obtained are used to "compute and display fractional flow reserve (FFR) using hyperemic agents and/or nonhyperemic indices of diastolic pressure ratio (dPR) and PdPa for physiological assessment of ischemic stenotic lesions." This assessment provides diagnostic information about the severity of blockages in arteries.
- Use in a Clinical Setting: The device is intended for use in "catheterization and related cardiovascular specialty laboratories," which are clinical settings where diagnostic procedures are performed.
While the device involves invasive procedures (using a catheter), the core function described is the in vitro analysis of pressure signals obtained from within the body to provide diagnostic information. The pressure measurements themselves are the "specimen" being analyzed by the system's software to generate the diagnostic indices (FFR, dPR, PdPa).
Therefore, the ACIST RXi System, as described, fits the criteria of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ACIST RXi System is indicated for obtaining intravascular pressure measurements for use in the diagnosis and treatment of coronary and peripheral artery disease. The ACIST Navvus II MicroCatheter is intended for use with the ACIST RXi System.
Product codes (comma separated list FDA assigned to the subject device)
DXO
Device Description
The current RXi system obtains intravascular pressure measurements for use in the diagnosis and treatment of coronary and peripheral artery disease. The RXi measures intravascular pressure in a hyperemic state following administration of adenosine as fractional flow reserve (FFR). The proposed software update for the RXi system adds a diastolic pressure ratio (dPR), which measures intravascular pressure in a non-hyperemic (resting) state. Both current and proposed ACIST RXi Systems are used in conjunction with the Navvus Catheter.
The proposed RXi System console containing embedded software that provides the main user interface. The system is used with the Navvus catheter which contains a pressure sensor for acquisition of pressure distal (Pd) to a lesion. The proximal aortic pressure (Pa) is acquired via an interface to a third-party hemodynamic system. The system is intended for use in catheterization and related cardiovascular specialty laboratories to compute and display fractional flow reserve (FFR) using hyperemic agents and/or nonhyperemic indices of diastolic pressure ratio (dPR) and PdPa for physiological assessment of ischemic stenotic lesions.
Measurement of FFR requires simultaneously monitoring the blood pressures proximal and distal to a lesion while inducing hyperemia. dPR is a measure of the diastolic portion of the hemodynamic waveform and can be used by the physician to perform a physiologic assessment without inducing hyperemia in the patient.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Coronary artery, peripheral artery
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Catheterization and related cardiovascular specialty laboratories; Angiographic Catheterization Lab; Interventional Radiology Lab; Operating Room (OR)
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
The diagnostic performance evaluation used a non-clinical bench top hemodynamic test fixture to reproduce resting and hyperemic clinical waveform recordings from the prospective CONTRAST clinical study. Resting and hyperemic pressure readings from each recorded waveform were measured using the ACIST RXi System and Navvus Catheter, and in parallel, the Philips Verrata PLUS wire and Philips (Volcano) CORE Mobile system.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A statistical analysis of the collected datasets demonstrated all three pre-determined primary endpoints (diagnostic accuracy, sensitivity, and specificity) were met.
Compared to FFR measurements (cutpoint 0.80), the accuracy of dPR (cutpoint 0.89) was 76.39%, and the accuracy of iFR (cutpoint 0.89) was 78.46%, resulting in a diagnostic accuracy difference of -2.08%. The sensitivity for dPR vs iFR was 99.68% and was higher than the pre-determined performance goal of 90%. The specificity for dPR vs iFR was 88.92% and was higher than the pre-determined performance goal of 84%. The diagnostic accuracy of dPR compared to iFR was 93.89%, confirming the agreement of diagnostic accuracy between dPR and iFR compared to FFR and supporting a conclusion of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy of dPR: 76.39%
Accuracy of iFR: 78.46%
Diagnostic accuracy difference (dPR vs iFR): -2.08%
Sensitivity for dPR vs iFR: 99.68%
Specificity for dPR vs iFR: 88.92%
Diagnostic accuracy of dPR compared to iFR: 93.89%
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2870 Catheter tip pressure transducer.
(a)
Identification. A catheter tip pressure transducer is a device incorporated into the distal end of a catheter. When placed in the bloodstream, its mechanical or electrical properties change in relation to changes in blood pressure. These changes are transmitted to accessory equipment for processing.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 17, 2024
ACIST Medical Systems, Inc Bobbie Daughters Senior Regulatory Affairs Specialist 7905 Fuller Rd Eden Prairie, Minnesota 55344
Re: K233904
Trade/Device Name: ACIST RXi System; ACIST Navvus II Catheter Regulation Number: 21 CFR 870.2870 Regulation Name: Catheter Tip Pressure Transducer Regulatory Class: Class II Product Code: DXO Dated: December 11, 2023 Received: December 11, 2023
Dear Bobbie Daughters:
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.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Robert T. Kazmierski -S
for
LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices
2
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) K233904
Device Name ACIST RXi System and Navvus II MicroCatheter
Indications for Use (Describe)
The ACIST RXi System is indicated for obtaining intravascular pressurements for use in the diagnosis and treatment of coronary and peripheral artery disease. The ACIST Navvus II MicroCatheter is intended for use with the ACIST RXi System.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) |
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K233904 - 510(k) Summary [21 CFR 807.92]
SUBMITTER
ACIST Medical Systems, Inc. 7905 Fuller Road Eden Prairie, MN 55344
Phone: 952.995.9300 Fax: 952.941.4648
Contact Person: Bobbie Daughters, Senior Regulatory Affairs Specialist E-mail: Bobbie.Daughters(@bracco.com Alternative Contact: Katie Molland, Director, Regulatory Affairs E-mail: Katie.Molland(@bracco.com
Date Prepared: 11 December 2023
DEVICE
Name of Device: RXi® System and Navvus® [] MicroCatheter Common or Usual Name: Catheter tip pressure transducer Classification Name: Transducer, pressure, catheter tip (870.2870) Regulatory Class: II Product Code: DXO
PREDICATE DEVICE
ACIST RXi® System and Navvus® MicroCatheter (K190473)
REFERENCE DEVICE
The dPR index calculation algorithm software upgrade subject to this substantially equivalent to the reference device, Volcano iFR Modality in the s5"%55/CORE/CORE™ Mobile Precision Guided Therapy System cleared under K173860 on 04/11/2018 for similar intended use.
DEVICE DESCRIPTION
The current RXi system obtains intravascular pressure measurements for use in the diagnosis and treatment of coronary and peripheral artery disease. The RXi measures intravascular pressure in a hyperemic state following administration of adenosine as fractional flow reserve (FFR). The proposed software update for the RXi system adds a diastolic pressure ratio (dPR), which measures intravascular pressure in a non-hyperemic (resting) state. Both current and proposed ACIST RXi Systems are used in conjunction with the Navvus Catheter.
The proposed RXi System console containing embedded software that provides the main user interface. The system is used with the Navvus catheter which contains a pressure sensor for acquisition of
5
pressure distal (Pd) to a lesion. The proximal aortic pressure (Pa) is acquired via an interface to a third-party hemodynamic system. The system is intended for use in catheterization and related cardiovascular specialty laboratories to compute and display fractional flow reserve (FFR) using hyperemic agents and/or nonhyperemic indices of diastolic pressure ratio (dPR) and PdPa for physiological assessment of ischemic stenotic lesions.
Measurement of FFR requires simultaneously monitoring the blood pressures proximal and distal to a lesion while inducing hyperemia. dPR is a measure of the diastolic portion of the hemodynamic waveform and can be used by the physician to perform a physiologic assessment without inducing hyperemia in the patient.
INDICATIONS FOR USE
The ACIST RXi® System is indicated for obtaining intravascular pressure measurements for use in the diagnosis and treatment of coronary and peripheral artery disease. The ACIST Navvus® Catheter is intended for use with the ACIST RXi System.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The proposed RXi System with dPR software update is substantially equivalent to the predicate RXi System (K190473). The fundamental technology and principle of operation of the RXi System are unchanged from the predicate device. The only change to the RXi System is a software updated labeling to describe the additional software features. The software update to the RXi console will allow the user to select between the existing hyperemic-induced FFR measurement and a new modality of non-hyperemic dPR measurement.
The following technological difference exists between the subject and predicate device:
Software update to allow the current system to compute and display a non-hyperemic diastolic ● pressure ratio (dPR) index for physiological assessment.
The subject device (RXi® System with dPR modality) has the same intended use, design, materials, and energy source as the legally marketed predicate device (RXi® System) cleared by FDA under premarket notification K190473. While the subject device introduces an additional technological characteristic (the dPR modality), verification and validation testing demonstrate that this technological difference does not raise of safety and effectiveness.
The identified questions of safety and efficacy apply to both the new device and the predicate. Performance testing confirmed the software update for dPR does not raise any different questions of safety and efficacy and therefore the RXi System with dPR meets substantial equivalence requirements with regards to the legally marketed predicate RXi System (K190473).
PERFORMANCE DATA
The risk management process has been used to evaluate the dPR software update to the RXi System in accordance with the guidelines set forth in ISO 14971:2007, Medical Devices - Application of Risk Management to Medical Devices. The risk analysis for the RXi System with dPR has taken into consideration the medical device vigilance data and product experience of the predicate RXi System. All residual risks that relate to the software update to include dPR have been taken into consideration. All RXi System and software residual risks are outweighed by potential benefits and are therefore acceptable.
6
Verification and Validation testing was completed to establish the RXi system console software with dPR functionality meets specifications and performs as intended.
Software verification included unit testing, software integration, and GUI-level verification.
ACIST validated the diagnostic performance of the RXi software update to introduce the dPR modality by demonstrating the agreement between the non-hyperemic RXi dPR index and the non-hyperemic instantaneous wave-free ratio (iFR) modality of the FDA-cleared reference device, Volcano s5/s5i CORE Mobile (K173860) as compared to FFR using a dataset collected in a prospective clinical study.
The diagnostic performance evaluation used a non-clinical bench top hemodynamic test fixture to reproduce resting and hyperemic clinical waveform recordings from the prospective CONTRAST clinical study. Resting and hyperemic pressure readings from each recorded waveform were measured using the ACIST RXi System and Navvus Catheter, and in parallel, the Philips Verrata PLUS wire and Philips (Volcano) CORE Mobile system. A statistical analysis of the collected datasets demonstrated all three pre-determined primary endpoints (diagnostic accuracy, sensitivity, and specificity) were met.
Compared to FFR measurements (cutpoint 0.80), the accuracy of dPR (cutpoint 0.89) was 76.39%, and the accuracy of iFR (cutpoint 0.89) was 78.46%, resulting in a diagnostic accuracy difference of -2.08%. The sensitivity for dPR vs iFR was 99.68% and was higher than the pre-determined performance goal of 90%. The specificity for dPR vs iFR was 88.92% and was higher than the pre-determined performance goal of 84%. The diagnostic accuracy of dPR compared to iFR was 93.89%, confirming the agreement of diagnostic accuracy between dPR and iFR compared to FFR and supporting a conclusion of substantial equivalence.
CONCLUSIONS
The results from the tests mentioned above demonstrate that the technological and performance characteristics of the proposed RXi System are comparable to the predicate device. The results of testing and outputs of the risk management process support the safety and effectiveness of the dPR software upgrade and ensure the subject device can perform in a manner equivalent to the predicate device with the same intended use. The results of the verification/validation tests and the risk analysis have demonstrated that the software upgrade to allow calculation of dPR does not add any new questions of safety and is therefore substantially equivalent to the predicate RXi System (K190473) and reference device, Volcano iFR Modality (K173860).
SUBSTANTIAL EQUIVALENCE
The new proposed device is the RXi System including a new dPR modality. The predicate device is the currently marketed RXi System without a dPR modality (K190473). The Navvus Catheter and accessories included in K190743 are not affected by this submission. The only change to the RXi System is to add a nonhyperemic diastolic pressure ratio (dPR) calculation for added functionality in the software capabilities and updated labeling to describe the additional software features. The reference device is the marketed Volcano s5 system (K173860), specifically the iFR modality. The purpose of the reference device iFR modality is to demonstrate safety and effectiveness of the dPR modality.
Equivalence of Intended Use:
1 Johnson NP, Jeremias A, Zimmermann FM, et al. Continuum of vasodilator stress from rest to contrast medium to adenosine hyperemia for fractional flow reserve assessment. JACC: Cardiovascular Interventions. 2016;9(8):757-767
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Indications for the device remain unchanged from the predicate device. The reference device contains similar indications for the pressure measurement modality.
Equivalence of Technological Characteristics:
The only difference between the subject and predicate devices is the addition of the dPR modality embedded into the software of the RXi System. Otherwise, the subject and predicate device share identical technological characteristics. Performance testing has confirmed the equivalent diagnostic performance of the subject device dPR modality relative to the iFR modality of the reference device.
No new questions of safety and effectiveness were identified during review of Risk Management documentation or execution of Verification and Validation activities.
Safety and Effectiveness:
The identified questions of safety and efficacy apply to both the new device and the predicate; therefore, the new device does not raise different questions of safety and efficacy. Specifically, a resting index calculation poses less risk to the patient as there is no need to use a hyperemic agent. The proposed device does not raise any different questions of safety and efficacy.
Conclusion:
The proposed device, RXi System with dPR software upgrade, was shown to be substantially equivalent to the legally marketed predicate RXi System (K190473), except for a software change introducing the dPR modality.
The safety and effectiveness of the RXi System dPR modality has been shown to be substantially equivalent to the iFR modality of marketed device K173860.
| Feature | Proposed Device –
RXi System | Predicate Device –
RXi System | Reference Device –
Volcano iFR | |
|-----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory Information | Name | RXi System | RXi System | Volcano
s5/s5i/CORE/CORE
Mobile Precision Guided
Therapy System |
| | 510(k)# | Not yet assigned | K190473 | K173860 |
| | Predicates | K190473 | K132474 | K133323
K170133 |
| | Classification Name | Catheter, pressure
monitoring, cardiac | Catheter, pressure
monitoring, cardiac | Ultrasonic Pulsed Echo
Imaging System |
| | Product Code &
Regulation Number | DXO, OBI
21 CFR 870.2870,
21 CFR 870.1200 | OBI, DXO
21 CFR 870.1200,
21 CFR 870.2870 | IYO
21 CFR 892.1560 |
| | FDA Classification | II | II | II |
| | Classification Panel | Cardiovascular | Cardiovascular | Radiology |
| Feature | Proposed Device –
RXi System | Predicate Device –
RXi System | Reference Device –
Volcano iFR | |
| | Indications for Use/
Intended Use | The ACIST RXi System is
indicated for obtaining
intravascular pressure
measurements for use in the
diagnosis and treatment of
coronary and peripheral
artery disease. The ACIST
Navvus Catheter is intended
for use with the ACIST RXi
System. | The ACIST RXi System is
indicated for obtaining
intravascular pressure
measurements for use in
the diagnosis and treatment
of coronary and peripheral
artery disease. The ACIST
Navvus Catheter is
intended for use with the
ACIST RXi System. | |
| Contraindications | The ACIST Navvus
Catheter is contraindicated
for use in the cerebral
vasculature. | The ACIST Navvus
Catheter is contraindicated
for use in the cerebral
vasculature. | Use of the Volcano
system is contraindicated
wherever tissue or organ
damage is a reasonable
probability.
The catheter is not for
fetal use. | |
| Feature | | Proposed Device –
RXi System | Predicate Device –
RXi System | Reference Device –
Volcano iFR |
| Technological Characteristics | Fundamental
Scientific
Technology | A device with an integrated
pressure sensor used in the
real-time calculation of FFR
or dPR based on patient
blood pressure | A device with an integrated
pressure sensor used in the
real-time calculation of
FFR based on patient blood
pressure | A device with an
integrated pressure sensor
used in the real-time
calculation of FFR or dPR
based on patient blood
pressure |
| | Prescription Use | Rx Only | Rx Only | Rx Only |
| | System
Components and
accessories | Console with embedded
software, Navvus Catheter
connection port, FISO
signal conditioner,
touchscreen, and graphical
user interface (GUI), and
accessories (mount, cart,
hemodynamic cables, power
supply and cord, AO
interface box) | Console with embedded
software, Navvus Catheter
connection port, FISO
signal conditioner,
touchscreen, and graphical
user interface (GUI), and
accessories (mount, cart,
hemodynamic cables,
power supply and cord, AO
interface box) | This reference device is a
larger system with
additional capabilities not
related to this submission. |
| | Pressure Sensing
and Signal
Transmission
Technology | EEPROM in the Navvus
Catheter connector
communicates with the
FISO board in the RXi
Console | EEPROM in the Navvus
Catheter connector
communicates with the
FISO board in the RXi
Console | Pressure measurement is
captured through the use
of pressure wires. |
| | Connected
Device(s) | Navvus/Navvus II Catheter | Navvus/Navvus II Catheter | SmartWire II, PrimeWire
Prestige,
Prime Wire
Prestige Plus, Verrata,
Verrata Plus |
| | Auto-Zeroing | Yes | Yes | Yes |
| | Diastolic Resting
Indices | dPR, Pd/Pa | Pd/Pa | iFR |
| | User Interface
Displays | • Audible and visual
alarm
• LED Status
Indicators
• Console
touchscreen | • Audible and visual
alarm
• LED Status
Indicators
• Console
touchscreen | • Bedside:
Touchpad or joystick
• Control room:
Console |
| | Intended Operating
Environment | • Angiographic
Catheterization Lab
• Interventional
Radiology Lab
• Operating Room
(OR) | • Angiographic
Catheterization Lab
• Interventional
Radiology Lab
• Operating Room
(OR) | • Angiographic
Catheterization Lab
• Interventional
Radiology Lab
• Operating Room
(OR) |
| | Electrical Isolation
(UL Classification) | Class II (double isolation) | Class II (double isolation) | Class I (functional
ground) |
| | Operating Pressure | -30 to +300 mmHg | -30 to +300 mmHg | -30 to 300 mmHg |
| Feature | Proposed Device -
RXi System | Predicate Device -
RXi System | Reference Device -
Volcano iFR | |
| Zero Drift |