ILUMIEN™ OPTIS™ System, OPTIS™ Integrated System, OPTIS™ Mobile System, with AptiVue™ Imaging Software version E.6

{0}------------------------------------------------ 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 the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. September 8, 2023 Abbott Medical Derek Pike Senior Regulatory Affairs Specialist 4 Robbins Road Westford, Massachusetts 01886 Re: K232386 Trade/Device Name: ILUMIEN™ OPTISTM System, OPTIS™ Integrated System, OPTIS™ Mobile System, with AptiVue™ Imaging Software version E.6 Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system. Regulatory Class: Class II Product Code: NQQ Dated: August 8. 2023 Received: August 9, 2023 Dear Derek Pike: 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. {1}------------------------------------------------ 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. 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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 S. Deoras -S Aneesh Deoras Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K232386 ## Device Name ILUMIEN™ OPTIS™ System, OPTIS™ Integrated System, OPTIS™ Mobile System, with AptiVue™ Imaging Software version E.6 ## Indications for Use (Describe) The AptiVue™ E series software is intended to be used only with compatible OPTIS™ 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 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) | | |---------------------------------------------------------------------------------------|--------------------------------------------------------------------------------| | <div> <span> <b> X</b> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | # CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ #### 510(K) SUMMARY 5.0 | 510(k) Summary<br>Per 21 CFR §807.92 | | | |-------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number | K232386 | | | Date Prepared | September 7, 2023 | | | Submitter Name<br>& Address | Abbott Medical<br>4 Robbins Road<br>Westford, MA, 01886 | | | Contact Person | Derek Pike<br>978-467-5880 | | | Alternative<br>Contact Person | Mingzi Deng<br>781-640-4474 | | | Proprietary /<br>Trade Name | ILUMIEN™ OPTIS™ System, OPTIS™ Integrated System, OPTIS™ Mobile<br>System, with AptiVue™ Imaging Software version E.6 | | | Common / Usual<br>Name | Ultrasonic Pulsed Echo Imaging System | | | Product<br>Classification | Product Code: NQQ | | | Product<br>Regulation<br>Number | 21 CFR 892.1560 | | | Predicate Device | ILUMIEN™ OPTIS™, OPTIS™ Integrated, OPTIS™ Mobile with AptiVue<br>Software version E.5 (K183320), cleared April 2, 2019 | | | Device<br>Description | OPTIS™ Systems with AptiVue™ Imaging Software (version E.6) perform<br>Optical Coherence Tomography (OCT), Fractional Flow Reserve (FFR), and<br>Resting Full-cycle Ratio (RFR) procedures and provides images of the coronary<br>arteries in patients who are candidates for transluminal interventional procedures.<br>Version E.6 adds cloud connectivity to enable remote installation of software<br>updates and transmission of system telemetry data. | | | Indications for<br>Use / Intended<br>Use | The AptiVue™ E series software is intended to be used only with compatible<br>OPTIS™ imaging systems.<br><br>The OPTIS imaging system with a compatible Dragonfly™ imaging catheter is<br>intended for the imaging of coronary arteries and is indicated in patients who are<br>candidates for transluminal interventional procedures. The compatible Dragonfly<br>imaging catheters are intended for use in vessels 2.0 to 3.5 mm in diameter. The<br>compatible Dragonfly imaging catheters are not intended for use in the left main<br>coronary artery or in a target vessel which has undergone a previous bypass<br>procedure.<br><br>The OPTIS imaging system is intended for use in the catheterization and related<br>cardiovascular specialty laboratories and will further compute and display | | | Feature | Predicate Device:<br>AptiVue Software version E.5 (K183320) | Proposed Device:<br>AptiVue Software version E.6 | | Intended<br>Use | The AptiVue™ E-series<br>software is intended for use<br>only with compatible<br>OPTIST™ imaging systems.<br>OPTIST™ imaging systems are<br>intended for use in the<br>catheterization and related<br>cardiovascular specialty<br>laboratories. | Same | | Indications<br>for Use<br><br>Comparison of<br>Subject to<br>Predicate Device | AptiVue™ E series software<br>is intended to be used only<br>with compatible OPTISTM<br>imaging systems.<br>The OPTIST™ imaging system<br>with a compatible<br>Dragonfly™ imaging catheter<br>is intended for the imaging of<br>coronary arteries and is<br>indicated in patients who are<br>candidates for transluminal<br>interventional procedures. The<br>compatible Dragonfly<br>imaging catheters are intended<br>for use in vessels 2.0 to 3.5<br>mm in diameter. The<br>compatible Dragonfly<br>imaging catheters are not<br>intended for use in the left<br>main coronary artery or in a<br>target vessel which has<br>undergone a previous bypass<br>procedure.<br>The OPTIS imaging system is<br>intended for use in the<br>catheterization and related | Same | | | | laboratories and will further<br>compute and display various<br>physiological parameters<br>based on the output from one<br>or more electrodes,<br>transducers, or measuring<br>devices. The physician may<br>use the acquired physiological<br>parameters, along with<br>knowledge of patient history,<br>medical expertise, and clinical<br>judgment to determine if | | | | therapeutic intervention is<br>indicated. | | Summary on<br>Non-Clinical<br>Testing | Software verification and validation tests were performed on OPTIS Systems<br>with AptiVue E.6 Software in compliance with internal design control<br>procedures. The results demonstrate that the AptiVue Software version E.6 meets<br>the user needs and product specifications and is appropriate for its intended use<br>and does not raise any new issues of safety and effectiveness. | | | Summary of<br>Clinical Testing | No clinical testing is provided in this pre-market notification. | | | Statement of<br>Equivalence | OPTIS Systems with AptiVue Imaging Software version E.6 is substantially<br>equivalent to the predicate OPTIS Systems with AptiVue Imaging Software<br>version E.5 (K183320) in terms of intended use, indications for use, operational<br>characteristics, fundamental design, and technological characteristics. | | {4}------------------------------------------------ {5}------------------------------------------------