Who is the manufacturer of ILUMIEN System with AptiVue Software version D.3?

ABBOTT MEDICAL filed the 510(k) submission for ILUMIEN System with AptiVue Software version D.3 (K192267).

What is the FDA product code for ILUMIEN System with AptiVue Software version D.3?

DQO. It is classified under 21 CFR 870.1200 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for ILUMIEN System with AptiVue Software version D.3?

510(k) clearance (submission type: Special).

What are the predicate devices for ILUMIEN System with AptiVue Software version D.3?

ILUMIEN™ System (K150237); ILUMIEN™ OPTIS™, OPTIS™ Integrated, OPTIS™ Mobile (K183320).

Who can help prepare an FDA 510(k) submission like ILUMIEN System with AptiVue Software version D.3?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

ILUMIEN System with AptiVue Software version D.3

K192267 · ABBOTT MEDICAL · DQO · Dec 17, 2019 · Cardiovascular

Device Facts

Record ID	K192267
Device Name	ILUMIEN System with AptiVue Software version D.3
Applicant	ABBOTT MEDICAL
Product Code	DQO · Cardiovascular
Decision Date	Dec 17, 2019
Decision	SESE
Submission Type	Special
Regulation	21 CFR 870.1200
Device Class	Class 2

Intended Use

The ILUMIEN™ 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 ILUMIEN 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.

Device Story

ILUMIEN System with AptiVue Software D.3 performs Optical Coherence Tomography (OCT), Fractional Flow Reserve (FFR), and Resting Full-cycle Ratio (RFR) procedures. System inputs include radio frequency signals from distal intracoronary and proximal aortic pressure transducers; OCT imaging data from Dragonfly catheters. System computes physiological parameters (FFR, RFR, Pd/Pa) to assess coronary lesion severity via pressure drop measurement. Used in catheterization/cardiovascular labs by physicians. Output displayed on system monitor; assists clinical decision-making regarding therapeutic intervention. Benefits include improved visualization and physiological assessment of coronary arteries to guide interventional procedures.

Clinical Evidence

No clinical testing was performed or relied upon for this submission. Evidence consists of bench testing, including software verification and validation, and a usability study to evaluate the graphical user interface and potential use errors.

Technological Characteristics

System performs OCT imaging and physiological pressure monitoring. Software-based computation of FFR and RFR. Connectivity via catheter-based transducers. Operates in catheterization laboratory environments. Software version D.3.

Indications for Use

Indicated for patients who are candidates for transluminal interventional procedures requiring coronary artery imaging. Compatible with vessels 2.0 to 3.5 mm in diameter. Contraindicated for use in the left main coronary artery or target vessels with previous bypass procedures.

Regulatory Classification

Identification

An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.

Predicate Devices

ILUMIEN™ System (K150237)
ILUMIEN™ OPTIS™, OPTIS™ Integrated, OPTIS™ Mobile (K183320)

Related Devices

K183320 — Ilumien Optis, Optis Integrated, Optis Mobile · St. Jude Medical (Now Abbott Medical) · Apr 2, 2019
K141769 — OPTIS INTEGRATED SYSTEM, DRAGONFLY OPTIS IMAGING CATHETER · Lightlab Imaging, Inc. · Aug 18, 2014
K150878 — ILUMIEN OPTIS · Lightlab Imaging, Inc. · Jul 15, 2015
K123369 — ILUMIEN OPTIS · Lightlab Imaging, Inc. · Jan 30, 2013
K210458 — OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System · ABBOTT MEDICAL · Jun 8, 2021

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & 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. December 17, 2019 Abbott Medical Anita Xavier RA Project Manager 4 Robbins Road Westford, Massachusetts 01886 Re: K192267 Trade/Device Name: ILUMIEN System with AptiVue Software version D.3 Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic Pulsed Echo Imaging System Regulatory Class: Class II Product Code: NQQ Dated: November 18, 2019 Received: November 21, 2019 Dear Anita Xavier: 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 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 {1}------------------------------------------------ 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 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, Nicole Gillette Acting 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) K192267 ## Device Name ILUMIEN System with AptiVue Software version D.3 Indications for Use (Describe) The ILUMIEN™ 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 ILUMIEN 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) | | |-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. 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) Number | K192267 | |---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Date Prepared | 20 November 2019 | | Submitter Name & Address | Abbott Medical 4 Robbins Road Westford, MA 01886 | | Contact Person | Anita Xavier Regulatory Affairs Project Manager Phone: (408) 674 8367 Email: anita.xavier@abbott.com | | Alternative Contact Person | Jose Marquez Associate Director, Regulatory Affairs Phone: (978) 577-3578 Email: jose.marquez1@abbott.com | | Proprietary/Trade Name | ILUMIEN System with AptiVue Software version D.3 | | Common/Usual Name | ILUMIEN Systems | | Product Classification Code | Product Code: NQQ | | Product Regulation Number and Name | 21 CFR 892.1560 | | Device Class | II | | Predicate Device | Primary: ILUMIEN™ System (K150237), cleared 05 May 2015 Secondary: ILUMIEN™ OPTIS™, OPTIS™ Integrated, OPTIS™ Mobile (K183320), cleared 02 April 2019 | | Device Description | ILUMIEN™ with AptiVue™ Software (version D.3) perform Optical Coherence Tomography (OCT), Fractional Flow Reserve (FFR), and Resting Full-cycle Ratio (RFR) procedures and provide images of the coronary arteries in patients who are candidates for transluminal interventional procedures. FFR, Pd/Pa at rest, and RFR physiological waveforms measured by the system are used to assess the severity of a coronary lesion by measuring the pressure drop across the lesion (distal vs proximal pressure). | | Indications for Use/ Intended Use | The ILUMIEN™ 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 ILUMIEN 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. | {4}------------------------------------------------ | ILUMIENT™ with AptiѴиет™ Version D.3 software is equivalent to the predicate ILUMIENT™ system (K150237) for intended use, operational characteristics, and fundamental design of the device. Changes to technological characteristics of the device do no raise different questions of safety or effectiveness. ILUMIENT™ with AptiѴиет™ Version D.3 software is equivalent to the OPTISTM Systems with AptiVue™ Version E.5 Software (K183320). The tables below provide a comparison of the subject device to the primary and secondary predicate devices. | | | | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Comparison of Subject to Predicate Device | Feature | ILUMIEN Systems with version D.2 Software (Primary Predicate) | ILUMIENT™ Systems with AptiVue Software Version D.3 (Proposed) | | | Indications for Use | The ILUMIEN imaging system with C7 Dragonfly™ DUO or Dragonfly™ OPTIS Imaging Catheter is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The C7 Dragonfly™ DUO or Dragonfly™ OPTIS Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The Dragonfly™ DUO or Dragonfly™ OPTIS 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 ILUMIENT™ 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 ILUMIEN imaging system will further acquire radio frequency signal outputs from both a distal intracoronary pressure transducer and a proximal aortic pressure transducer to determine the physiological parameter, Fractional Flow Reserve (FFR). The physician may use the FFR parameter, along with knowledge of patient history, medical expertise and clinical judgment to determine if therapeutic intervention is indicated. | The ILUMIEN 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. | | | Intended Use | Same as Indications for Use | The AptiVue™ D-series software is intended for use | | Measurement & Display Features | OCT recordings, Pd/Pa recordings and FFR physiological waveforms | only with compatible ILUMIENT™ imaging systems. The ILUMIEN 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. | | | Design Modifications | NA | OCT recordings, Pd/Pa at rest, FFR, and RFR physiological waveforms. Modifications to the software included the addition of a new physiological index named RFR and support for the Dragonfly OpStar catheter | | | Feature | OPTIS Systems with AptiVue Software Version E.5 (Secondary Predicate) | ILUMIENT™ Systems with AptiVue Software Version D.3 (Proposed) | | | Indications for Use | 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 | The ILUMIENT™ 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 ILUMIENT™ 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 | | | | | | | | | 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 AptiVue™ D-series software is intended for use only with compatible ILUMIEN™ imaging systems. The ILUMIEN 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. | | | Measurement & Display Features | OCT recordings, Pd/Pa recordings, RFR and FFR physiological waveforms | OCT recordings, Pd/Pa recordings, RFR and FFR physiological waveforms | | | The modifications in the proposed D.3 software version do not affect the intended use of the ILUMIEN System with AptiVue D.3 software nor do they alter the fundamental scientific technology of the system. There was no increase in existing risks with the addition of the RFR feature. The same RFR feature that was cleared under K183320 for AptiVue software version E.5 on the OPTIS systems has been implemented in the proposed AptiVue software version D.3. The device user interface, overall functionality, the RFR feature and the risks associated with the overall implementation of the RFR algorithm in the proposed D.3 software remain identical to the cleared AptiVue software version E.5. | | | | | 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: | | | | Summary on Non- Clinical Testing | ● | Software Verification and Validation - performed to ensure that the subject device meets requirements and functions as intended ● Usability Study - performed to evaluate the usability and possible use errors that may lead to patient safety issues with the introduction of the new features on the graphical user interface | | | Summary of Clinical Testing | | No new clinical testing was completed, nor relied upon, in support of this Special 510(k). | | | Statement of Equivalence | ILUMIEN™ with AptiVue™ Version D.3 software is equivalent to the predicate ILUMIEN™ system (K150237) for intended use, operational characteristics, and fundamental design of the device. Changes to technological characteristics of the device do no raise different questions of safety or effectiveness | | | | | | ILUMIEN™ with AptiVue™ Version D.3 software is equivalent to the OPTIS™ systems with AptiVue™ Version E.5 software (K183320) for the Resting Full-Cycle Ratio physiological index. | | {5}------------------------------------------------ {6}------------------------------------------------