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.

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.

AI/ML Overview

The provided document is a 510(k) summary for the OPTIS™ Mobile Next Imaging System, OPTIS™ Integrated Next Imaging System with Ultreon™ Software 1.0. It primarily focuses on demonstrating substantial equivalence to a predicate device (K192019: Dragonfly Opstar™ Imaging Catheter, AptiVue™ Software version E.5.1) rather than detailing specific acceptance criteria for AI performance and a study proving those criteria are met for the Ultreon™ Software 1.0's automated morphology assessment features.

The document states that modifications to the Ultreon 1.0 software include:

Automated morphology assessment of External Elastic Lamina (EEL) and calcium.
Display of live angiography imagery.
User interface guided workflows.
Updates to existing features: OCT image color map, OCT pullback auto-trigger, Angio co-registration, Vessel sizing, Stent analysis, Stent expansion, Cybersecurity.

However, the "Summary on Non-Clinical Testing" section does not provide details for the acceptance criteria and the study that proves the device meets the acceptance criteria specifically for the automated morphology assessment of EEL and calcium. It only generally states: "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." No specific quantitative metrics (like sensitivity, specificity, accuracy, dice score etc.) or study methodologies for the automated morphology assessment are described.

The document does mention "Human Factors - Summative Usability Study" and "Hardware/System/packaging Verification," but these are general safety and performance tests, not specific to the performance of the AI-driven automated morphology assessment.

The section "Summary of Clinical Testing" discusses the Resting Full-cycle Ratio (RFR) and its interpretation, referencing clinical studies used to support a labeling change for the RFR cut-off. This RFR functionality appears to be a physiological parameter measurement and interpretation, which is distinct from the "automated morphology assessment" mentioned earlier. The RFR discussion relies on published literature for its validation, not a de novo study conducted for this 510(k) submission to evaluate the Ultreon software's performance in automatically assessing EEL and calcium.

Therefore, based solely on the provided text, the specific information requested about the acceptance criteria and the study proving the device meets those criteria for the "automated morphology assessment of External Elastic Lamina (EEL) and calcium" is NOT detailed.

If we were to infer based on the provided text, and assuming the question is about the overall device and not just the AI component (which is not explicitly elaborated upon in sufficient detail for the AI-specific performance), here's what can be extracted, acknowledging the limitations for AI-specific performance:

Based on the provided document, detailed acceptance criteria and a study proving the device meets these criteria for the automated morphology assessment features of the Ultreon™ Software 1.0 are not explicitly stated. The document primarily focuses on demonstrating substantial equivalence to a predicate device through general software and hardware verification and validation, and literature-based validation for RFR.

The document indicates that the Ultreon™ 1.0 Software includes "automated morphology assessment of External Elastic Lamina (EEL) and calcium," but the specifics of how this particular AI component's performance was evaluated against quantitative acceptance criteria are not present.

However, if we are to interpret the request as broadly as possible within the confines of the provided text, particularly focusing on the stated "design verification and validation testing" for software modifications and the comparison to the predicate device, here is a breakdown. Please note that the AI-specific performance metrics and study details for the automated morphology assessment are absent in this document.

Inferred Study Overview and Acceptance Criteria (with significant caveats as explicit details for AI performance are missing):

The submission relies on a demonstration of substantial equivalence to a predicate device (K192019). The "acceptance criteria" appear to be broadly defined by ensuring the modified device (including the Ultreon 1.0 software with its new features like automated morphology assessment) performs as intended, does not raise new questions of safety or effectiveness, and maintains the same indications for use and operational characteristics as the predicate.

The "study" encompasses general Software Verification and Validation and Hardware/System/packaging Verification. The qualitative outcome of these tests is that they "conclude these modifications demonstrate claims of substantial equivalence."

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Inferred from Substantial Equivalence and V&V)	Reported Device Performance (General Outcome)
Software Functionality & Safety:
- Meets requirements and functions as intended.	- Design verification and validation (including for automated morphology assessment) performed.
- Does not trigger serious harm based on use error/problems.	- Summative Usability Study performed, showing no serious harm from use error or problems, and no patterns requiring further modification of UI, labeling, or training.
- Does not raise new questions of safety or effectiveness.	- Software V&V concludes modifications (including automated morphology assessment) demonstrate substantial equivalence, implying no new safety/effectiveness concerns.
Hardware/System Performance & Safety:
- Meets specifications.	- Hardware/System/packaging Verification performed, concluding products and packaging meet specifications.
- Appropriate for intended use.	- Hardware/System/packaging Verification performed.
- Does not raise new questions of safety or effectiveness.	- Hardware/System V&V (including for computational speed, display, electrical compliance, cybersecurity, TPM chip, ferrites) concludes modifications demonstrate substantial equivalence, implying no new safety/effectiveness concerns.
Physiological Parameter Accuracy (RFR):
- RFR interpretation matches established clinical cut-offs.	- RFR validated for clinical accuracy and outcomes in >2,500 patients through published literature.
- RFR equivalence to other NHPRs.	- Multiple peer-reviewed publications demonstrate equivalence of RFR to other NHPRs; studies like IRIS-FFR and 3V FFR-FRIENDS concluded broad equivalence in diagnostic and prognostic performance, supporting RFR-guided treatment at 0.89 cut-off being equivalent to FFR 0.80. This supports the clinical utility of the RFR measurement displayed by the device.

Missing specific quantifiable acceptance criteria related to the accuracy or performance of the "automated morphology assessment of External Elastic Lamina (EEL) and calcium" (e.g., sensitivity, specificity, Dice score, etc.). The document does not elaborate on the specific "design verification and validation" tests for these AI features.

2. Sample Size for the Test Set and Data Provenance:

For "automated morphology assessment" or AI features: Not specified. The document mentions "Software design verification and validation testing," but provides no details on the size or characteristics of the dataset used for these tests, nor its provenance (country of origin, retrospective/prospective).
For RFR validation: The document refers to "over 2,500 patients" across multiple peer-reviewed publications (e.g., VALIDATE RFR, IRIS-FFR, 3V FFR-FRIENDS studies). This data provenance would be from various clinical studies, likely international and retrospective/prospective depending on the specific study design cited.

3. Number of Experts and Qualifications for Ground Truth:

For "automated morphology assessment" or AI features: Not specified. The document does not describe how ground truth was established for the "automated morphology assessment of External Elastic Lamina (EEL) and calcium."
For RFR validation: Ground truth for RFR (and FFR) studies is typically established by consensus of interventional cardiologists based on invasive physiological measurements and clinical outcomes, though the specific number and qualifications of experts for the studies cited are not detailed in this 510(k) summary.

4. Adjudication Method for the Test Set:

For "automated morphology assessment" or AI features: Not specified.
For RFR validation: Not described for the referenced clinical studies in this document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC study is explicitly mentioned or detailed for the Ultreon™ Software 1.0, specifically regarding how human readers improve with or without AI assistance for the "automated morphology assessment" features. The focus is on substantial equivalence and verification/validation, not a clinical effectiveness trial for the AI component's impact on human performance.

6. Standalone (Algorithm Only) Performance:

Not explicitly detailed for the "automated morphology assessment" features. While "Software design verification and validation testing" implies evaluation of the algorithm, specific standalone performance metrics (e.g., sensitivity, specificity, accuracy of EEL/calcium detection/segmentation) and the methodology for assessing these are not provided in this summary. The RFR discussion refers to the validated performance of the RFR parameter itself, not the software's ability to automatically interpret it.

7. Type of Ground Truth Used:

For "automated morphology assessment": Not specified. Presumable an "expert consensus" or "pathology" (histology/ex-vivo) ground truth would be ideal for morphological assessments, but it is not mentioned.
For RFR validation: The ground truth for RFR (and FFR) would be based on invasive physiological measurements (e.g., pressure wire readings) and clinical outcomes data from the referenced studies.

8. Sample Size for the Training Set:

Not specified. The document does not provide any information regarding the training dataset used for the development of the Ultreon™ software's "automated morphology assessment" features.

9. How Ground Truth for Training Set was Established:

Not specified. As the training set size is not mentioned, neither is the method for establishing its ground truth.

Summary

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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

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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

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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)

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

510(k) Summary
Per 21 CFR §807.92
510(k) Number	K210458
Date Prepared	May 6, 2021
SubmitterName &Address	Abbott Medical4 Robbins RoadWestford, MA, 01886
Contact Person	Steven Vitale(m) 612-214-9102steve.vitale@abbott.com
AlternativeContact Person	Jose Marquez(m) 978-846-2640jose.marquez1@abbott.com
Proprietary /Trade Name	OPTIST™ Mobile Next Imaging System, OPTIST™ Integrated Next Imaging Systemwith Ultreon™ Software 1.0
Common /Usual Name	OPTIS Next
ProductClassification	Product Code: NQQ
ProductRegulationNumber	21 CFR 892.156021 CFR 870.142521 CFR 870.1110
Device Class	II
PredicateDevice	K192019: Dragonfly Opstar™ Imaging Catheter, AptiVue™ Software version E.5.1,cleared November 8, 2019
DeviceDescription	The OPTIST™ Next Imaging System is comprised of two devices providing the same setof features:• The OPTIST™ Mobile Next Imaging System is comprised of a cart-mountedpersonal computer, imaging engine, and power supply that are placed inside anergonomically designed mobile cart. This system includes a keyboard, displaymonitors, mouse, tableside controller, and a Drive-motor and Optical Controller(DOC).• The OPTIST™ Integrated Next is comprised of a PC, imaging engine, and powersupply that are housed in stationary cabinet which is located in the clinic/hospitalequipment closet of a catheter lab. The tableside controller, DOC and DOC Holsterare located in the procedure room, and the keyboard, display monitor, and mouseare located in the control room.
	With the Ultreon™ 1.0 software application, these systems perform Optical CoherenceTomography (OCT) imaging of coronary arteries using compatible Dragonfly imagingcatheters. Resting Full-cycle Ratio (RFR), Fractional Flow Reserve (FFR), and Pd/Paat rest physiological waveforms are also measured by the system to assess the severityof a coronary lesion by measuring the pressure drop across the lesion (distal vsproximal pressure). The physician may use the RFR or FFR parameter, along withknowledge of patient history, medical expertise, and clinical judgment to determine iftherapeutic intervention is indicated.
Indications forUse / IntendedUse	Indications for Use (Software)The Ultreon™ 1.0 Software is intended to be used only with compatible OPTIS™ NextImaging Systems.The OPTIS Next Imaging System with a compatible Dragonfly™ OPTIS™ ImagingCatheter or Dragonfly OpStar™ Imaging Catheter is intended for the imaging ofcoronary arteries and is indicated in patients who are candidates for transluminalinterventional procedures. The Dragonfly OPTIS Imaging Catheter or DragonflyOpStar Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. TheDragonfly OPTIS Imaging Catheter or Dragonfly OpStar Imaging Catheter is notintended for use in the left main coronary artery or in a target vessel which hasundergone a previous bypass procedure.The OPTIS Next Imaging System is intended for use in the catheterization and relatedcardiovascular specialty laboratories and will further compute and display variousphysiological 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 todetermine if therapeutic intervention is indicated.Indications for Use (capital equipment hardware)The OPTIS™ Mobile Next [and OPTIS™ Integrated Next] with a compatibleDragonfly™ OPTIS™ or Dragonfly™ OpStar™ Imaging Catheter is intended for theimaging of coronary arteries and is indicated in patients who are candidates fortransluminal interventional procedures. The Dragonfly OPTIS or Dragonfly OpStarImaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. TheDragonfly OPTIS or Dragonfly OpStar Imaging Catheter is not intended for use in theleft main coronary artery or in a target vessel which has undergone a previous bypassprocedure.The OPTIS Mobile Next [and OPTIS™ Integrated Next] is intended for use in thecatheterization and related cardiovascular specialty laboratories and will furthercompute and display various physiological parameters based on the output from one ormore electrodes, transducers, or measuring devices. The physician may use the

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acquired physiological parameters, along with knowledge of patient history, medicalexpertise, and clinical judgment to determine if therapeutic intervention is indicated.
The OPTIS™ Next Imaging System with Ultreon™ Software version 1.0 is equivalentto 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 technologicalcharacteristics of the device do not raise new questions of safety or effectiveness.
	Feature	Predicate Device:OPTIS System withAptiVue™ Software VersionE.5.1 (K192019)	Proposed Device:OPTIS Next Imaging Systemwith Ultreon Software version1.0
Comparison ofSubject toPredicate Device	Intended Use	The AptiVue™ E-seriessoftware is intended for use onlywith compatible OPTISTMimaging systems. OPTISTMimaging systems are intendedfor use in the catheterization andrelated cardiovascular specialtylaboratories.	The Ultreon™ 1.0 Software isintended to be used only withcompatible OPTIS™ NextImaging Systems.
	Indications forUse	The AptiVue™ E seriessoftware is intended to be usedonly with compatible OPTISTMimaging systems.The OPTIS imaging systemwith a compatible Dragonfly™imaging catheter is intended forthe imaging of coronary arteriesand is indicated in patients whoare candidates for transluminalinterventional procedures. Thecompatible Dragonfly™imaging catheters are intendedfor use in vessels 2.0 to 3.5 mmin diameter. The compatibleDragonfly™ imaging cathetersare not intended for use in theleft main coronary artery or in atarget vessel which hasundergone a previous bypassprocedure.The OPTIS imaging system isintended for use in thecatheterization and relatedcardiovascular specialtylaboratories and will furthercompute and display variousphysiological parameters basedon the output from one or more	The OPTIS Next Imaging Systemwith a compatible Dragonfly™OPTIS™ Imaging Catheter orDragonfly OpStar™ ImagingCatheter is intended for theimaging of coronary arteries andis indicated in patients who arecandidates for transluminalinterventional procedures. TheDragonfly OPTIS ImagingCatheter or Dragonfly OpStarImaging Catheter is intended foruse in vessels 2.0 to 3.5 mm indiameter. The Dragonfly OPTISImaging Catheter or DragonflyOpStar Imaging Catheter is notintended for use in the left maincoronary artery or in a targetvessel which has undergone aprevious bypass procedure.The OPTIS Next Imaging Systemis intended for use in thecatheterization and relatedcardiovascular specialtylaboratories and will further
	electrodes, transducers, ormeasuring devices. Thephysician may use the acquiredphysiological parameters, alongwith knowledge of patienthistory, medical expertise andclinical judgment to determineif therapeutic intervention isindicated.	compute and display variousphysiological parameters basedon the output from one or moreelectrodes, transducers, ormeasuring devices. The physicianmay use the acquiredphysiological parameters, alongwith knowledge of patienthistory, medical expertise, andclinical judgment to determine iftherapeutic intervention isindicated.
Measurement& DisplayFeatures	OCT recordings, FFR, Pd/Pa atrest, and RFR physiologicalwaveforms	OCT recordings, FFR, Pd/Pa atrest, and RFR physiologicalwaveforms
DesignModifications	N/A	Modifications to the Ultreon 1.0software have been made toinclude automated morphologyassessment of External ElasticLamina (EEL) and calcium,display of live angiographyimagery on the OPTIS NextImaging System displaymonitors, and user interfaceguided workflows for image dataacquisition and review. Softwareupdates were made to thefollowing existing features:● OCT image color map● OCT pullback auto-trigger● Angio co-registration● Vessel sizing● Stent analysis● Stent expansion● CybersecuritySoftware design verification andvalidation testing have beenperformed which concludes thesemodifications demonstrate claimsof substantial equivalence to theAptiVue E.5.1 software.
Feature	OPTIS Mobile, OPTISIntegrated Hardware(Predicate)	OPTIS Mobile Next, OPTISIntegrated 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

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Summary onNon-ClinicalTesting	Trusted Platform Module(TPM) chip supportingcybersecurity Ferrites added to the USB-over-Ethernet Extender Cable Design verification and validationtesting has been performed whichconcludes these modificationsdemonstrate claims of substantialequivalence to the OPTISMobile, OPTIS IntegratedHardware.
	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 ofClinical 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:1. 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-E58.3. Lee et. al. Physiologic and Clinical Assessment of Resting Physiologic Indices. Circulation2019; 139:889-900.4. Ahn J et al. Fractional Flow Reserve and Cardiac Events in Coronary Artery Disease.Circulation. 2017 Jun 6; 135(23): 2241-2251.5. Lee et al. Clinical Outcome of Lesions with Discordant Results Among Different InvasivePhysiologic Indices. Circulation J 2019; 83: 2210-2221.6. Jeremias et al. RFR: A Novel Physiologic Index Compared to FFR.
Statement ofEquivalence	As demonstrated by risk management activities, software verification, and HFEusability study testing the proposed OPTIS Next Imaging System does not raise newquestions of safety or effectiveness, as compared to the predicate device, meetsrequirements, supports claims of substantial equivalence, and is acceptable for use.Modifications to the software of the device do no raise new questions of safety oreffectiveness.As demonstrated by risk management activities, hardware/system verification, andelectrical compliance testing the proposed OPTIS Next Imaging System does not raisenew questions of safety or effectiveness, as compared to the predicate device, meetsrequirements, supports claims of substantial equivalence, and is acceptable for use.Modifications to the hardware of the device do no raise new questions of safety oreffectiveness.

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Regulation Number and Section

§ 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.