(30 days)
Not Found
No
The document describes image processing and physiological parameter computation but does not mention AI, ML, or related terms. There is no description of training or test sets, which are typically associated with ML development.
No
The device is described as an imaging system that helps physicians determine if therapeutic intervention is indicated, rather than providing therapy itself.
Yes
The "Intended Use / Indications for Use" section states: "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." and "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." This indicates the device provides information for diagnosis and treatment planning.
No
The device description explicitly states "OPTIS™ Systems with AptiVue™ Imaging Software (version E.6) perform Optical Coherence Tomography (OCT), Fractional Flow Reserve (FFR), and Resting Full-cycle Ratio (RFR) procedures and provides images of the coronary arteries". This indicates the device includes hardware components (the OPTIS™ Systems) in addition to the software. The software is described as being used with compatible OPTIS™ imaging systems and Dragonfly™ imaging catheters, which are hardware.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use and device description clearly state that this system is used for imaging coronary arteries in patients using an imaging catheter. This is an in vivo (within the living body) procedure, not an in vitro (in glass/outside the body) examination of a specimen.
- The device performs imaging and physiological measurements directly within the patient's body. It uses Optical Coherence Tomography (OCT) and measures physiological parameters like Fractional Flow Reserve (FFR) and Resting Full-cycle Ratio (RFR) based on inputs from electrodes, transducers, or measuring devices placed within the patient.
Therefore, this device falls under the category of medical imaging and physiological monitoring devices used for diagnostic and interventional guidance in vivo, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
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.
Product codes
NQQ
Device Description
OPTIS™ Systems with AptiVue™ Imaging Software (version E.6) perform Optical Coherence Tomography (OCT), Fractional Flow Reserve (FFR), and Resting Full-cycle Ratio (RFR) procedures and provides images of the coronary arteries in patients who are candidates for transluminal interventional procedures. Version E.6 adds cloud connectivity to enable remote installation of software updates and transmission of system telemetry data.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Optical Coherence Tomography (OCT)
Anatomical Site
coronary arteries
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Software verification and validation tests were performed on OPTIS Systems with AptiVue E.6 Software in compliance with internal design control procedures. The results demonstrate that the AptiVue Software version E.6 meets the user needs and product specifications and is appropriate for its intended use and does not raise any new issues of safety and effectiveness.
No clinical testing is provided in this pre-market notification.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
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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.
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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 801 and Part 809); 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 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
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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) | |
|---|---|
| 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 5.0
| 510(k) Summary
| Per 21 CFR §807.92 | ||
|---|---|---|
| 510(k) Number | K232386 | |
| Date Prepared | September 7, 2023 | |
| Submitter Name | ||
| & Address | Abbott Medical | |
| 4 Robbins Road | ||
| Westford, MA, 01886 | ||
| Contact Person | Derek Pike | |
| 978-467-5880 | ||
| Alternative | ||
| Contact Person | Mingzi Deng | |
| 781-640-4474 | ||
| Proprietary / | ||
| Trade Name | ILUMIEN™ OPTIS™ System, OPTIS™ Integrated System, OPTIS™ Mobile | |
| System, with AptiVue™ Imaging Software version E.6 | ||
| Common / Usual | ||
| Name | Ultrasonic Pulsed Echo Imaging System | |
| Product | ||
| Classification | Product Code: NQQ | |
| Product | ||
| Regulation | ||
| Number | 21 CFR 892.1560 | |
| Predicate Device | ILUMIEN™ OPTIS™, OPTIS™ Integrated, OPTIS™ Mobile with AptiVue | |
| Software version E.5 (K183320), cleared April 2, 2019 | ||
| Device | ||
| Description | OPTIS™ Systems with AptiVue™ Imaging Software (version E.6) perform | |
| Optical Coherence Tomography (OCT), Fractional Flow Reserve (FFR), and | ||
| Resting Full-cycle Ratio (RFR) procedures and provides images of the coronary | ||
| arteries in patients who are candidates for transluminal interventional procedures. | ||
| Version E.6 adds cloud connectivity to enable remote installation of software | ||
| updates and transmission of system telemetry data. | ||
| Indications for | ||
| Use / Intended | ||
| Use | 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 | |
| Feature | Predicate Device:
AptiVue Software version E.5 (K183320) | Proposed Device:
AptiVue Software version E.6 |
| Intended
Use | The AptiVue™ E-series
software is intended for use
only with compatible
OPTIST™ imaging systems.
OPTIST™ imaging systems are
intended for use in the
catheterization and related
cardiovascular specialty
laboratories. | Same |
| Indications
for Use
Comparison of
Subject to
Predicate Device | AptiVue™ E series software
is intended to be used only
with compatible OPTISTM
imaging systems.
The OPTIST™ 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 | Same |
| | | 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. |
| Summary on
Non-Clinical
Testing | Software verification and validation tests were performed on OPTIS Systems
with AptiVue E.6 Software in compliance with internal design control
procedures. The results demonstrate that the AptiVue Software version E.6 meets
the user needs and product specifications and is appropriate for its intended use
and does not raise any new issues of safety and effectiveness. | |
| Summary of
Clinical Testing | No clinical testing is provided in this pre-market notification. | |
| Statement of
Equivalence | OPTIS Systems with AptiVue Imaging Software version E.6 is substantially
equivalent to the predicate OPTIS Systems with AptiVue Imaging Software
version E.5 (K183320) in terms of intended use, indications for use, operational
characteristics, fundamental design, and technological characteristics. | |
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