(112 days)
Not Found
No
The document describes an imaging system and software for OCT and physiological parameter measurement (RFR, FFR, Pd/Pa). It mentions computing and displaying parameters but does not mention any AI or ML techniques used in the image processing, parameter calculation, or interpretation. The performance studies focus on verification, validation, human factors, and clinical analysis of published literature for RFR, not on the performance of an AI/ML algorithm.
No
The device is described as an "Imaging System" used for imaging coronary arteries and measuring physiological parameters to help physicians determine if therapeutic intervention is indicated, rather than performing therapeutic intervention itself.
Yes
The OPTIS Next Imaging System is explicitly stated to "compute and display various physiological parameters based on the output from one or more electrodes, transducers, or measuring devices," including Resting Full-cycle Ratio (RFR), Fractional Flow Reserve (FFR), and Pd/Pa at rest physiological waveforms to "assess the severity of a coronary lesion." The physician then uses these acquired physiological parameters, along with other clinical information, to "determine if therapeutic intervention is indicated," which is a diagnostic purpose.
No
The device description explicitly states that the system is comprised of hardware components, including a cart-mounted personal computer, imaging engine, power supply, keyboard, display monitors, mouse, tableside controller, and a Drive-motor and Optical Controller (DOC). While the submission is for the Ultreon™ 1.0 Software, it is intended to be used with these hardware components, making the overall system a hardware and software combination, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Ultreon™ 1.0 Software, used with the OPTIS™ Next Imaging Systems and compatible catheters, performs imaging of coronary arteries using Optical Coherence Tomography (OCT). It also measures physiological parameters like RFR, FFR, and Pd/Pa based on output from electrodes, transducers, or measuring devices.
- Intended Use: The intended use is for imaging and measuring physiological parameters within the coronary arteries in vivo (inside the body) during transluminal interventional procedures. The physician uses this information, along with other clinical factors, to guide treatment decisions.
- Lack of Sample Analysis: The device does not analyze samples taken from the body. It directly interacts with and measures within the body.
Therefore, because the device operates in vivo and does not perform tests on samples taken from the body, it does not fit the definition of an In Vitro Diagnostic. It is an imaging and physiological measurement device used during medical procedures.
N/A
Intended Use / Indications for Use
The UltreonTM 1.0 Software is intended to be used only with compatible OPTISTM Next Imaging Systems. The OPTIS Next Imaging System with a compatible DragonflyTM OPTISTM Imaging Catheter or Dragonfly OpStarTM Imaging Catheter is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The Dragonfly OPTIS Imaging Catheter or Dragonfly OpStar Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The Dragonfly OPTIS Imaging Catheter or Dragonfly OpStar Imaging Catheter is not intended for use in the left main coronary artery or in a target vessel which has undergone a previous bypass procedure.
The OPTIS Next Imaging System is intended for use in the catheterization and related cardiovascular specialty laboratories and will further compute and display various physiological parameters based on the output from one or more electrodes, transducers, or measuring devices. The physician may use the acquired physiological parameters, along with knowledge of patient history, medical expertise, and clinical judgment to determine if thervention is indicated.
The OPTISTM Mobile Next and OPTISTM Integrated Next with a compatible DragonflyTM OPTISTM or DragonflyTM OpStarTM Imaging Catheter is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The Dragonfly OPTIS or Dragonfly OpStar Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The Dragonfly OPTIS or Dragonfly OpStar Imaging Catheter is not intended for use in the left main coronary artery or in a target vessel which has undergone a previous bypass procedure. The OPTIS Mobile Next and OPTISTM Integrated Next is intended for use in the catheterization and related cardiovascular specialty laboratories and will further compute and display various physiological parameters based on the output from one or more electrodes, transducers, or measuring devices. The physician may use the acquired physiological parameters, along with knowledge of patient history, medical expertise, and clinical judgment to determine if therapeutic intervention is indicated.
Product codes
NQQ, DQK, DSK
Device Description
The OPTISTM Next Imaging System is comprised of two devices providing the same set of features:
• The OPTISTM Mobile Next Imaging System is comprised of a cart-mounted personal computer, imaging engine, and power supply that are placed inside an ergonomically designed mobile cart. This system includes a keyboard, display monitors, mouse, tableside controller, and a Drive-motor and Optical Controller (DOC).
• The OPTISTM Integrated Next is comprised of a PC, imaging engine, and power supply that are housed in stationary cabinet which is located in the clinic/hospital equipment closet of a catheter lab. The tableside controller, DOC and DOC Holster are located in the procedure room, and the keyboard, display monitor, and mouse are located in the control room.
With the UltreonTM 1.0 software application, these systems perform Optical Coherence Tomography (OCT) imaging of coronary arteries using compatible Dragonfly imaging catheters. Resting Full-cycle Ratio (RFR), Fractional Flow Reserve (FFR), and Pd/Pa at rest physiological waveforms are also measured by the system to assess the severity of a coronary lesion by measuring the pressure drop across the lesion (distal vs proximal pressure). The physician may use the RFR or FFR parameter, along with knowledge of patient history, medical expertise, and clinical judgment to determine if therapeutic intervention is indicated.
Mentions image processing
The UltreonTM 1.0 software application, these systems perform Optical Coherence Tomography (OCT) imaging of coronary arteries using compatible Dragonfly imaging catheters.
Modifications to the Ultreon 1.0 software have been made to include automated morphology assessment of External Elastic Lamina (EEL) and calcium, display of live angiography imagery on the OPTIS Next Imaging System display monitors, and user interface guided workflows for image data acquisition and review.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Optical Coherence Tomography (OCT), angiography
Anatomical Site
coronary arteries
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Catheterization and related cardiovascular specialty laboratories. The physician may use the acquired physiological parameters, along with knowledge of patient history, medical expertise, and clinical judgment to determine if thervention is indicated.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
No new clinical testing was completed, nor relied upon, in support of this Traditional 510(k). However, clinical analysis of published literature was used to support a labeling change to reflect the resting full cycle ratio (RFR) cut-off of 0.89. RFR has been validated for clinical accuracy and outcomes in over 2,500 patients 1-6. Multiple peer-reviewed publications demonstrate the equivalence of RFR to other non-hyperemic pressure ratios (NHPR). IRIS-FFR and 3V FFR-FRIENDS studies compared all NHPRs and concluded that all have the same class effect and are broadly equivalent in terms of diagnostic and prognostic performance 3-5. Therefore, RFR-guided treatment at a cut-off of 0.89 is equivalent to other NHPR-guided treatment. The above RFR dichotomous cut-off of 0.89 represents a threshold for lesions indicative of hemodynamically significant. An RFR of 0.89 is, therefore, equivalent to an FFR of 0.80 as a threshold for ischemia detection.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
Image /page/0/Picture/0 description: The image shows 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 the FDA logo, which 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.
June 8, 2021
Abbott Medical Steve Vitale Regulatory Affairs Project Manager 4 Robbins Road Westford, Massachusetts 01886
Re: K210458
Trade/Device Name: OPTISTM Mobile Next Imaging System, OPTIS™ Integrated Next Imaging System with Ultreon™ Software 1.0 Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic Pulsed Echo Imaging System Regulatory Class: Class II Product Code: NQQ, DQK, DSK Dated: May 6, 2021 Received: May 7, 2021
Dear Steve Vitale:
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 (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 located 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.
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
1
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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 medical devices and radiation-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,
Aneesh Deoras Acting Assistant Director DHT2A: Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K210458
Device Name
OPTIS™ Mobile Next Imaging System, OPTIS™ Integrated Next Imaging System with Ultreon™ Software 1.0.
Indications for Use (Describe)
The Ultreon™ 1.0 Software is intended to be used only with compatible OPTIS™ Next Imaging Systems. The OPTIS Next Imaging System with a compatible Dragonfly™ OPTIS™ Imaging Catheter or Dragonfly OpStar™ Imaging Catheter is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The Dragonfly OPTIS Imaging Catheter or Dragonfly OpStar Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The Dragonfly OPTIS Imaging Catheter or Dragonfly OpStar Imaging Catheter is not intended for use in the left main coronary artery or in a target vessel which has undergone a previous bypass procedure.
The OPTIS Next Imaging System is intended for use in the catheterization and related cardiovascular specialty laboratories and will further compute and display various physiological parameters based on the output from one or more electrodes, transducers, or measuring devices. The physician may use the acquired physiological parameters, along with knowledge of patient history, medical expertise, and clinical judgment to determine if thervention is indicated.
The OPTIS™ Mobile Next and OPTIS™ Integrated Next with a compatible Dragonfly™ OPTIS™ or Dragonfly™ OpStar™ Imaging Catheter is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The Dragonfly OPTIS or Dragonfly OpStar Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The Dragonfly OPTIS or Dragonfly OpStar Imaging Catheter is not intended for use in the left main coronary artery or in a target vessel which has undergone a previous bypass procedure. The OPTIS Mobile Next and OPTIS™ Integrated Next is intended for use in the catheterization and related cardiovascular specialty laboratories and will further compute and display various physiological parameters based on the output from one or more electrodes, transducers, or measuring devices. The physician may use the acquired physiological parameters, along with knowledge of patient history, medical expertise, and clinical judgment to determine if therapeutic intervention is indicated.
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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3
510(K) SUMMARY
| 510(k) Summary | |
|---|---|
| Per 21 CFR §807.92 | |
| 510(k) Number | K210458 |
| Date Prepared | May 6, 2021 |
| Submitter | |
| Name & | |
| Address | Abbott Medical |
| 4 Robbins Road | |
| Westford, MA, 01886 | |
| Contact Person | Steven Vitale |
| (m) 612-214-9102 | |
| steve.vitale@abbott.com | |
| Alternative | |
| Contact Person | Jose Marquez |
| (m) 978-846-2640 | |
| jose.marquez1@abbott.com | |
| Proprietary / | |
| Trade Name | OPTIST™ Mobile Next Imaging System, OPTIST™ Integrated Next Imaging System |
| with Ultreon™ Software 1.0 | |
| Common / | |
| Usual Name | OPTIS Next |
| Product | |
| Classification | Product Code: NQQ |
| Product | |
| Regulation | |
| Number | 21 CFR 892.1560 |
| 21 CFR 870.1425 | |
| 21 CFR 870.1110 | |
| Device Class | II |
| Predicate | |
| Device | K192019: Dragonfly Opstar™ Imaging Catheter, AptiVue™ Software version E.5.1, |
| cleared November 8, 2019 | |
| Device | |
| Description | The OPTIST™ Next Imaging System is comprised of two devices providing the same set |
| of features: | |
| • The OPTIST™ Mobile Next Imaging System is comprised of a cart-mounted | |
| personal computer, imaging engine, and power supply that are placed inside an | |
| ergonomically designed mobile cart. This system includes a keyboard, display | |
| monitors, mouse, tableside controller, and a Drive-motor and Optical Controller | |
| (DOC). |
• The OPTIST™ Integrated Next is comprised of a PC, imaging engine, and power
supply that are housed in stationary cabinet which is located in the clinic/hospital
equipment closet of a catheter lab. The tableside controller, DOC and DOC Holster
are located in the procedure room, and the keyboard, display monitor, and mouse
are located in the control room. |
| | With the Ultreon™ 1.0 software application, these systems perform Optical Coherence
Tomography (OCT) imaging of coronary arteries using compatible Dragonfly imaging
catheters. Resting Full-cycle Ratio (RFR), Fractional Flow Reserve (FFR), and Pd/Pa
at rest physiological waveforms are also measured by the system to assess the severity
of a coronary lesion by measuring the pressure drop across the lesion (distal vs
proximal pressure). The physician may use the RFR or FFR parameter, along with
knowledge of patient history, medical expertise, and clinical judgment to determine if
therapeutic intervention is indicated. |
| Indications for
Use / Intended
Use | Indications for Use (Software)
The Ultreon™ 1.0 Software is intended to be used only with compatible OPTIS™ Next
Imaging Systems.
The OPTIS Next Imaging System with a compatible Dragonfly™ OPTIS™ Imaging
Catheter or Dragonfly OpStar™ Imaging Catheter is intended for the imaging of
coronary arteries and is indicated in patients who are candidates for transluminal
interventional procedures. The Dragonfly OPTIS Imaging Catheter or Dragonfly
OpStar Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The
Dragonfly OPTIS Imaging Catheter or Dragonfly OpStar Imaging Catheter is not
intended for use in the left main coronary artery or in a target vessel which has
undergone a previous bypass procedure.
The OPTIS Next Imaging System is intended for use in the catheterization and related
cardiovascular specialty laboratories and will further compute and display various
physiological parameters based on the output from one or more electrodes, transducers,
or measuring devices. The physician may use the acquired physiological parameters,
along with knowledge of patient history, medical expertise, and clinical judgment to
determine if therapeutic intervention is indicated.
Indications for Use (capital equipment hardware)
The OPTIS™ Mobile Next [and OPTIS™ Integrated Next] with a compatible
Dragonfly™ OPTIS™ or Dragonfly™ OpStar™ Imaging Catheter is intended for the
imaging of coronary arteries and is indicated in patients who are candidates for
transluminal interventional procedures. The Dragonfly OPTIS or Dragonfly OpStar
Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The
Dragonfly OPTIS or Dragonfly OpStar Imaging Catheter is not intended for use in the
left main coronary artery or in a target vessel which has undergone a previous bypass
procedure.
The OPTIS Mobile Next [and OPTIS™ Integrated Next] is intended for use in the
catheterization and related cardiovascular specialty laboratories and will further
compute and display various physiological parameters based on the output from one or
more electrodes, transducers, or measuring devices. The physician may use the |
4
5
| acquired physiological parameters, along with knowledge of patient history, medical
| expertise, and clinical judgment to determine if therapeutic intervention is indicated. | |||
|---|---|---|---|
| The OPTIS™ Next Imaging System with Ultreon™ Software version 1.0 is equivalent | |||
| to the predicate OPTISTM Imaging System with AptiVue™ Software version E.5.1 | |||
| (K192019) in terms of intended use, indications for use, operational characteristics, | |||
| fundamental design, and technological characteristics. Changes to technological | |||
| characteristics of the device do not raise new questions of safety or effectiveness. | |||
| Feature | Predicate Device: | ||
| OPTIS System with | |||
| AptiVue™ Software Version | |||
| E.5.1 (K192019) | Proposed Device: | ||
| OPTIS Next Imaging System | |||
| with Ultreon Software version | |||
| 1.0 | |||
| Comparison of | |||
| Subject to | |||
| Predicate Device | Intended Use | The AptiVue™ E-series | |
| software is intended for use only | |||
| with compatible OPTISTM | |||
| imaging systems. OPTISTM | |||
| imaging systems are intended | |||
| for use in the catheterization and | |||
| related cardiovascular specialty | |||
| laboratories. | The Ultreon™ 1.0 Software is | ||
| intended to be used only with | |||
| compatible OPTIS™ Next | |||
| Imaging Systems. | |||
| Indications for | |||
| Use | The AptiVue™ E series | ||
| software is intended to be used | |||
| only with compatible OPTISTM | |||
| imaging systems. | |||
| The OPTIS imaging system | |||
| with a compatible Dragonfly™ | |||
| imaging catheter is intended for | |||
| the imaging of coronary arteries | |||
| and is indicated in patients who | |||
| are candidates for transluminal | |||
| interventional procedures. The | |||
| compatible Dragonfly™ | |||
| imaging catheters are intended | |||
| for use in vessels 2.0 to 3.5 mm | |||
| in diameter. The compatible | |||
| Dragonfly™ imaging catheters | |||
| are not intended for use in the | |||
| left main coronary artery or in a | |||
| target vessel which has | |||
| undergone a previous bypass | |||
| procedure. | |||
| The OPTIS imaging system is | |||
| intended for use in the | |||
| catheterization and related | |||
| cardiovascular specialty | |||
| laboratories and will further | |||
| compute and display various | |||
| physiological parameters based | |||
| on the output from one or more | The OPTIS Next Imaging System | ||
| with a compatible Dragonfly™ | |||
| OPTIS™ Imaging Catheter or | |||
| Dragonfly OpStar™ Imaging | |||
| Catheter is intended for the | |||
| imaging of coronary arteries and | |||
| is indicated in patients who are | |||
| candidates for transluminal | |||
| interventional procedures. The | |||
| Dragonfly OPTIS Imaging | |||
| Catheter or Dragonfly OpStar | |||
| Imaging Catheter is intended for | |||
| use in vessels 2.0 to 3.5 mm in | |||
| diameter. The Dragonfly OPTIS | |||
| Imaging Catheter or Dragonfly | |||
| OpStar Imaging Catheter is not | |||
| intended for use in the left main | |||
| coronary artery or in a target | |||
| vessel which has undergone a | |||
| previous bypass procedure. | |||
| The OPTIS Next Imaging System | |||
| is intended for use in the | |||
| catheterization and related | |||
| cardiovascular specialty | |||
| laboratories and will further | |||
| electrodes, transducers, or | |||
| measuring devices. The | |||
| physician may use the acquired | |||
| physiological parameters, along | |||
| with knowledge of patient | |||
| history, medical expertise and | |||
| clinical judgment to determine | |||
| if therapeutic intervention is | |||
| indicated. | compute and display various | ||
| physiological parameters based | |||
| on the output from one or more | |||
| electrodes, transducers, or | |||
| measuring devices. The physician | |||
| may use the acquired | |||
| physiological parameters, along | |||
| with knowledge of patient | |||
| history, medical expertise, and | |||
| clinical judgment to determine if | |||
| therapeutic intervention is | |||
| indicated. | |||
| Measurement | |||
| & Display | |||
| Features | OCT recordings, FFR, Pd/Pa at | ||
| rest, and RFR physiological | |||
| waveforms | OCT recordings, FFR, Pd/Pa at | ||
| rest, and RFR physiological | |||
| waveforms | |||
| Design | |||
| Modifications | N/A | Modifications to the Ultreon 1.0 | |
| software have been made to | |||
| include automated morphology | |||
| assessment of External Elastic | |||
| Lamina (EEL) and calcium, | |||
| display of live angiography | |||
| imagery on the OPTIS Next | |||
| Imaging System display | |||
| monitors, and user interface | |||
| guided workflows for image data | |||
| acquisition and review. Software | |||
| updates were made to the | |||
| following existing features: | |||
| ● OCT image color map | |||
| ● OCT pullback auto-trigger | |||
| ● Angio co-registration | |||
| ● Vessel sizing | |||
| ● Stent analysis | |||
| ● Stent expansion | |||
| ● Cybersecurity | |||
| Software design verification and | |||
| validation testing have been | |||
| performed which concludes these | |||
| modifications demonstrate claims | |||
| of substantial equivalence to the | |||
| AptiVue E.5.1 software. | |||
| Feature | OPTIS Mobile, OPTIS | ||
| Integrated Hardware | |||
| (Predicate) | OPTIS Mobile Next, OPTIS | ||
| Integrated Next Hardware | |||
| (Proposed) | |||
| Indications for Use | The OPTIST™ mobile system [and OPTIST™ integrated system] with a compatible Dragonfly™ imaging catheter is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The Dragonfly imaging catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The Dragonfly imaging catheter is not intended for use in the left main coronary artery or in a target vessel which has undergone a previous bypass procedure. The OPTIS mobile system [and OPTIS integrated system] is intended for use in the catheterization and related cardiovascular specialty laboratories and will further compute and display various physiological parameters based on the output from one or more electrodes, transducers, or measuring devices. The physician may use the acquired physiological parameters, along with knowledge of patient history, medical expertise, and clinical judgment to determine if therapeutic intervention is indicated. | The OPTIST™ Mobile Next [and OPTIST™ Integrated Next] with a compatible Dragonfly™ OPTIS™ or Dragonfly™ OpStar™ Imaging Catheter is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The Dragonfly OPTIS or Dragonfly OpStar Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The Dragonfly OPTIS or Dragonfly OpStar Imaging Catheter is not intended for use in the left main coronary artery or in a target vessel which has undergone a previous bypass procedure. The OPTIS Mobile Next [and OPTIS Integrated Next] is intended for use in the catheterization and related cardiovascular specialty laboratories and will further compute and display various physiological parameters based on the output from one or more electrodes, transducers, or measuring devices. The physician may use the acquired physiological parameters, along with knowledge of patient history, medical expertise, and clinical judgment to determine if therapeutic intervention is indicated. | |
| Design Modifications | N/A | Modifications to the OPTIS Mobile Next, OPTIS Integrated Next Hardware have been made to support of the computational speed, display, electrical compliance, and cybersecurity requirements of the system. Graphics processing unit Memory Power supply Main motherboard and CPU |
6
7
8
| Summary on
Non-Clinical
Testing | Trusted Platform Module
(TPM) chip supporting
cybersecurity Ferrites added to the USB-
over-Ethernet Extender Cable Design verification and validation
testing has been performed which
concludes these modifications
demonstrate claims of substantial
equivalence to the OPTIS
Mobile, OPTIS Integrated
Hardware. | |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|
| | Verification and Validation testing were completed to demonstrate safety and effectiveness and ensure that the subject device performs as intended. Design verification and validation included the following: Software Verification and Validation – performed to ensure that the subject device meets requirements and functions as intended Human Factors -Summative Usability Study – performed to demonstrate that the updated user interface, 1) does not trigger any serious harm based on use error or use problems, for the intended uses, and under the expected use conditions; and, 2) shows no pattern of use errors or problems that could result in serious harm and that could be eliminated or reduced through further modification of the user interface, device labeling, or user training. Hardware/System/packaging Verification – performed to demonstrate that the OPTIS Next Imaging System products and packaging meet specifications, are appropriate for their intended use, and do not raise new questions of safety or effectiveness. | |
| | No new clinical testing was completed, nor relied upon, in support of this Traditional 510(k). However, clinical analysis of published literature was used to support a labeling change to reflect the resting full cycle ratio (RFR) cut-off of 0.89 | |
| | RFR Interpretation | |
| | RFR Value | Interpretation1,2 |
| | RFR ≤ 0.89 | Indicates that a lesion is hemodynamically significant. |
| | RFR > 0.89 | Indicates that a lesion is not hemodynamically significant. |
| Summary of
Clinical Testing | RFR has been validated for clinical accuracy and outcomes in over 2,500 patients 1-6. Multiple peer-reviewed publications demonstrate the equivalence of RFR to other non-hyperemic pressure ratios (NHPR). IRIS-FFR and 3V FFR-FRIENDS studies compared all NHPRs and concluded that all have the same class effect and are broadly equivalent in terms of diagnostic and prognostic performance 3-5. Therefore, RFR-guided treatment at a cut-off of 0.89 is equivalent to other NHPR-guided treatment. The above RFR dichotomous cut-off of 0.89 represents a threshold for lesions indicative of hemodynamically significant. An RFR of 0.89 is, therefore, equivalent to an FFR of 0.80 as a threshold for ischemia detection.
References:
- Svanerud et. al. Validation of a novel non-hyperaemic index of coronary artery stenosis severity: the Resting Full-cycle Ratio (VALIDATE RFR) study. Eurolntervention 2018;
14(7): 806-814. | |
| | severity-Resting full-cycle ratio-RE-VALIDATE. Catheter Cardiovasc Interv. 2020;
96(1): E53-E58. - Lee et. al. Physiologic and Clinical Assessment of Resting Physiologic Indices. Circulation
2019; 139:889-900. - Ahn J et al. Fractional Flow Reserve and Cardiac Events in Coronary Artery Disease.
Circulation. 2017 Jun 6; 135(23): 2241-2251. - Lee et al. Clinical Outcome of Lesions with Discordant Results Among Different Invasive
Physiologic Indices. Circulation J 2019; 83: 2210-2221. - Jeremias et al. RFR: A Novel Physiologic Index Compared to FFR. | |
| Statement of
Equivalence | As demonstrated by risk management activities, software verification, and HFE
usability study testing the proposed OPTIS Next Imaging System does not raise new
questions of safety or effectiveness, as compared to the predicate device, meets
requirements, supports claims of substantial equivalence, and is acceptable for use.
Modifications to the software of the device do no raise new questions of safety or
effectiveness.
As demonstrated by risk management activities, hardware/system verification, and
electrical compliance testing the proposed OPTIS Next Imaging System does not raise
new questions of safety or effectiveness, as compared to the predicate device, meets
requirements, supports claims of substantial equivalence, and is acceptable for use.
Modifications to the hardware of the device do no raise new questions of safety or
effectiveness. | |
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