OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System

K210458 · ABBOTT MEDICAL · NQQ · Jun 8, 2021 · Radiology

Device Facts

• Record ID: K210458
• Device Name: OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System
• Applicant: ABBOTT MEDICAL
• Product Code: NQQ · Radiology
• Decision Date: Jun 8, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2

Intended Use

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. 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 Story

System performs Optical Coherence Tomography (OCT) of coronary arteries using Dragonfly imaging catheters; measures physiological parameters (RFR, FFR, Pd/Pa) to assess coronary lesion severity. Input: OCT image data and pressure transducer signals. Processing: Ultreon 1.0 software performs automated morphology assessment (EEL, calcium), vessel sizing, stent analysis, and co-registration with live angiography. Output: Displayed OCT images, physiological waveforms, and quantitative measurements on system monitors. Used in catheterization labs by physicians to guide therapeutic intervention decisions. Benefits: Provides real-time anatomical and physiological data to assist clinical judgment regarding lesion significance and stent placement.

Clinical Evidence

No new clinical testing performed. Relied on published literature for RFR cut-off validation (0.89). Literature (n > 2,500 patients) supports RFR equivalence to other non-hyperemic pressure ratios (NHPR) and FFR for ischemia detection.

Technological Characteristics

System includes cart-mounted (Mobile) or cabinet-housed (Integrated) PC, imaging engine, power supply, and Drive-motor/Optical Controller (DOC). Connectivity: Networked/standalone. Cybersecurity: TPM chip. Software: Ultreon 1.0 with automated morphology and measurement algorithms.

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 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.

Special Controls

*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.

Predicate Devices

• Dragonfly Opstar™ Imaging Catheter, AptiVue™ Software version E.5.1 (K192019)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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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# 510(K) SUMMARY

| 510(k) Summary | |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Per 21 CFR §807.92 | |
| 510(k) Number | K210458 |
| Date Prepared | May 6, 2021 |
| Submitter<br>Name &<br>Address | Abbott Medical<br>4 Robbins Road<br>Westford, MA, 01886 |
| Contact Person | Steven Vitale<br>(m) 612-214-9102<br>[e-mail] |
| Alternative<br>Contact Person | Jose Marquez<br>(m) 978-846-2640<br>[e-mail] |
| Proprietary /<br>Trade Name | OPTIST™ Mobile Next Imaging System, OPTIST™ Integrated Next Imaging System<br>with Ultreon™ Software 1.0 |
| Common /<br>Usual Name | OPTIS Next |
| Product<br>Classification | Product Code: NQQ |
| Product<br>Regulation<br>Number | 21 CFR 892.1560<br>21 CFR 870.1425<br>21 CFR 870.1110 |
| Device Class | II |
| Predicate<br>Device | K192019: Dragonfly Opstar™ Imaging Catheter, AptiVue™ Software version E.5.1,<br>cleared November 8, 2019 |
| Device<br>Description | The OPTIST™ Next Imaging System is comprised of two devices providing the same set<br>of features:<br>• The OPTIST™ Mobile Next Imaging System is comprised of a cart-mounted<br>personal computer, imaging engine, and power supply that are placed inside an<br>ergonomically designed mobile cart. This system includes a keyboard, display<br>monitors, mouse, tableside controller, and a Drive-motor and Optical Controller<br>(DOC).<br><br>• The OPTIST™ Integrated Next is comprised of a PC, imaging engine, and power<br>supply that are housed in stationary cabinet which is located in the clinic/hospital<br>equipment closet of a catheter lab. The tableside controller, DOC and DOC Holster<br>are located in the procedure room, and the keyboard, display monitor, and mouse<br>are located in the control room. |
| | With the Ultreon™ 1.0 software application, these systems perform Optical Coherence<br>Tomography (OCT) imaging of coronary arteries using compatible Dragonfly imaging<br>catheters. Resting Full-cycle Ratio (RFR), Fractional Flow Reserve (FFR), and Pd/Pa<br>at rest physiological waveforms are also measured by the system to assess the severity<br>of a coronary lesion by measuring the pressure drop across the lesion (distal vs<br>proximal pressure). The physician may use the RFR or FFR parameter, along with<br>knowledge of patient history, medical expertise, and clinical judgment to determine if<br>therapeutic intervention is indicated. |
| Indications for<br>Use / Intended<br>Use | Indications for Use (Software)<br>The Ultreon™ 1.0 Software is intended to be used only with compatible OPTIS™ Next<br>Imaging Systems.<br><br>The OPTIS Next Imaging System with a compatible Dragonfly™ OPTIS™ Imaging<br>Catheter or Dragonfly OpStar™ Imaging Catheter is intended for the imaging of<br>coronary arteries and is indicated in patients who are candidates for transluminal<br>interventional procedures. The Dragonfly OPTIS Imaging Catheter or Dragonfly<br>OpStar Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The<br>Dragonfly OPTIS Imaging Catheter or Dragonfly OpStar Imaging Catheter is not<br>intended for use in the left main coronary artery or in a target vessel which has<br>undergone a previous bypass procedure.<br><br>The OPTIS Next Imaging System is intended for use in the catheterization and related<br>cardiovascular specialty laboratories and will further compute and display various<br>physiological parameters based on the output from one or more electrodes, transducers,<br>or measuring devices. The physician may use the acquired physiological parameters,<br>along with knowledge of patient history, medical expertise, and clinical judgment to<br>determine if therapeutic intervention is indicated.<br><br>Indications for Use (capital equipment hardware)<br>The OPTIS™ Mobile Next [and OPTIS™ Integrated Next] with a compatible<br>Dragonfly™ OPTIS™ or Dragonfly™ OpStar™ Imaging Catheter is intended for the<br>imaging of coronary arteries and is indicated in patients who are candidates for<br>transluminal interventional procedures. The Dragonfly OPTIS or Dragonfly OpStar<br>Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The<br>Dragonfly OPTIS or Dragonfly OpStar Imaging Catheter is not intended for use in the<br>left main coronary artery or in a target vessel which has undergone a previous bypass<br>procedure.<br><br>The OPTIS Mobile Next [and OPTIS™ Integrated Next] is intended for use in the<br>catheterization and related cardiovascular specialty laboratories and will further<br>compute and display various physiological parameters based on the output from one or<br>more electrodes, transducers, or measuring devices. The physician may use the |

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| acquired physiological parameters, along with knowledge of patient history, medical<br>expertise, and clinical judgment to determine if therapeutic intervention is indicated. | | | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| The OPTIS™ Next Imaging System with Ultreon™ Software version 1.0 is equivalent<br>to the predicate OPTISTM Imaging System with AptiVue™ Software version E.5.1 | | | |
| (K192019) in terms of intended use, indications for use, operational characteristics,<br>fundamental design, and technological characteristics. Changes to technological<br>characteristics of the device do not raise new questions of safety or effectiveness. | | | |
| | Feature | Predicate Device:<br>OPTIS System with<br>AptiVue™ Software Version<br>E.5.1 (K192019) | Proposed Device:<br>OPTIS Next Imaging System<br>with Ultreon Software version<br>1.0 |
| Comparison of<br>Subject to<br>Predicate Device | Intended Use | The AptiVue™ E-series<br>software is intended for use only<br>with compatible OPTISTM<br>imaging systems. OPTISTM<br>imaging systems are intended<br>for use in the catheterization and<br>related cardiovascular specialty<br>laboratories. | The Ultreon™ 1.0 Software is<br>intended to be used only with<br>compatible OPTIS™ Next<br>Imaging Systems. |
| | Indications for<br>Use | The AptiVue™ E series<br>software is intended to be used<br>only with compatible OPTISTM<br>imaging systems.<br>The OPTIS imaging system<br>with a compatible Dragonfly™<br>imaging catheter is intended for<br>the imaging of coronary arteries<br>and is indicated in patients who<br>are 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 mm<br>in diameter. The compatible<br>Dragonfly™ imaging catheters<br>are not intended for use in the<br>left 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<br>cardiovascular specialty<br>laboratories and will further<br>compute and display various<br>physiological parameters based<br>on the output from one or more | The OPTIS Next Imaging System<br>with a compatible Dragonfly™<br>OPTIS™ Imaging Catheter or<br>Dragonfly OpStar™ Imaging<br>Catheter is intended for the<br>imaging of coronary arteries and<br>is indicated in patients who are<br>candidates for transluminal<br>interventional procedures. The<br>Dragonfly OPTIS Imaging<br>Catheter or Dragonfly OpStar<br>Imaging Catheter is intended for<br>use in vessels 2.0 to 3.5 mm in<br>diameter. The Dragonfly OPTIS<br>Imaging Catheter or Dragonfly<br>OpStar Imaging Catheter is not<br>intended for use in the left main<br>coronary artery or in a target<br>vessel which has undergone a<br>previous bypass procedure.<br>The OPTIS Next Imaging System<br>is intended for use in the<br>catheterization and related<br>cardiovascular specialty<br>laboratories and will further |
| | electrodes, transducers, or<br>measuring devices. The<br>physician may use the acquired<br>physiological parameters, along<br>with knowledge of patient<br>history, medical expertise and<br>clinical judgment to determine<br>if therapeutic intervention is<br>indicated. | compute and display various<br>physiological parameters based<br>on the output from one or more<br>electrodes, transducers, or<br>measuring devices. The physician<br>may use the acquired<br>physiological parameters, along<br>with knowledge of patient<br>history, medical expertise, and<br>clinical judgment to determine if<br>therapeutic intervention is<br>indicated. | |
| Measurement<br>& Display<br>Features | OCT recordings, FFR, Pd/Pa at<br>rest, and RFR physiological<br>waveforms | OCT recordings, FFR, Pd/Pa at<br>rest, and RFR physiological<br>waveforms | |
| Design<br>Modifications | N/A | Modifications to the Ultreon 1.0<br>software have been made to<br>include automated morphology<br>assessment of External Elastic<br>Lamina (EEL) and calcium,<br>display of live angiography<br>imagery on the OPTIS Next<br>Imaging System display<br>monitors, and user interface<br>guided workflows for image data<br>acquisition and review. Software<br>updates were made to the<br>following existing features:<br>● OCT image color map<br>● OCT pullback auto-trigger<br>● Angio co-registration<br>● Vessel sizing<br>● Stent analysis<br>● Stent expansion<br>● Cybersecurity<br>Software design verification and<br>validation testing have been<br>performed which concludes these<br>modifications demonstrate claims<br>of substantial equivalence to the<br>AptiVue E.5.1 software. | |
| Feature | OPTIS Mobile, OPTIS<br>Integrated Hardware<br>(Predicate)…