(102 days)
No
The summary describes image processing and physiological parameter computation but does not mention AI or ML.
No
The device is described as an "imaging catheter" and an "imaging system" used for "imaging of coronary arteries" and displaying "physiological parameters." It is clearly stated that 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," implying it is for diagnosis and assessment, not treatment.
Yes
The device is described as an "imaging system ... intended for the imaging of coronary arteries" and also measures "physiological parameters (FFR, Pd/Pa at rest, and RFR physiological waveforms) ... to assess the severity of a coronary lesion." These functions are for the purpose of diagnosis.
No
The device description clearly details a physical imaging catheter (Dragonfly OpStar™ Imaging Catheter) with hardware components (fiber optic imaging core, torque wire, external sheath) that is integral to the device's function of acquiring OCT images. While the AptiVue™ software processes the data and controls the system, it is part of a larger hardware-software system, not a standalone software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The Dragonfly OpStar imaging catheter and OPTIS system are used in vivo (inside the body) to image coronary arteries and measure physiological parameters like FFR and RFR. They do not analyze specimens taken from the body.
- Intended Use: The intended use is for imaging coronary arteries and providing physiological measurements during transluminal interventional procedures. This is a direct assessment within the body, not an analysis of a sample outside the body.
Therefore, while this is a medical device used for diagnostic purposes (imaging and physiological measurement), it falls under the category of in vivo diagnostic devices, not in vitro diagnostic devices.
N/A
Intended Use / Indications for Use
The Dragonfly OpStar™ imaging catheter with OCT imaging system is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The Dragonfly OpStar Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The 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 AptiVue™ E-series software is intended for use 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
DQO, NQQ
Device Description
The Dragonfly OpStar™ Imaging Catheter is a sterile, single-use intravascular catheter consisting of a catheter body external sheath and an internal rotating fiber optic imaging core. The external sheath serves two primary functions: 1) to facilitate placement of the device into the coronary artery and 2) to cover and protect the internal rotating fiber optic imaging core. The inner rotating fiber optic imaging core emits near infrared light to tissues and receives reflected light. It is driven by a stainless-steel torque wire visible under fluoroscopy and pulled back through the window tube of the external sheath by the Drive-motor and Optical Controller (DOC). The emitted and returned reflected light are combined and processed by the OPTIS System software to construct an OCT image. The patient is never exposed to moving parts as the external sheath completely covers the rotating imaging core.
The AptiVue™ Software version E.5.1 controls the Optical Coherence Tomography (OCT) imaging engine to collect and store pressure wave form data for computing, Fractional Flow Reserve (FFR), and Resting Full-cycle Ratio (RFR) during procedures and to 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).
Mentions image processing
Yes
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 physician / catheterization and related cardiovascular specialty laboratories
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)
Design verification and validation was performed on the Dragonfly OPSTAR Imaging Catheter as compared to the predicate Dragonfly OPTIS Imaging catheter in compliance with internal design control procedures, which included bench testing and pre-clinical animal testing. The testing involved head-to-head comparison between the proposed and predicate devices for modifications to technological characteristics. The results of this testing conclude the Dragonfly OPSTAR Imaging Catheter is substantially equivalent to the Dragonfly OPTIS Imaging Catheter.
Verification and Validation testing was completed for the AptiVue software version E.5.1 to demonstrate safety and effectiveness and ensure that the subject device performs as intended. Software design verification concludes these modifications do not raise different questions of safety or 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)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1200 Diagnostic intravascular catheter.
(a)
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.(b)
Classification. Class II (performance standards).
0
November 8, 2019
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with an abstract design. To the right of the seal, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG" are written in blue, with the word "ADMINISTRATION" written in a smaller font size below.
Abbott Medical Richard Demello Senior Regulatory Affairs Specialist 4 Robbins Road Westford, Massachusetts 01886
Re: K192019
Trade/Device Name: Dragonfly OpStar™ Imaging Catheter, AptiVue™ Software version E.5.1 Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: DQO, NQQ Dated: October 4, 2019 Received: October 7, 2019
Dear Richard Demello:
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 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,
Nicole Gillette Assistant Director (Acting) 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) K192019
Device Name
Dragonfly OpStar™ Imaging Catheter, AptiVue™ Software version E.5.1
Indications for Use (Describe)
The Dragonfly OpStar™ imaging catheter with OCT imaging system is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The Dragonfly OpStar Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The 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 AptiVue™ E-series software is intended for use 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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(K) SUMMARY 5.0
| 510(k) Summary
| Per 21 CFR §807.92 | |
|---|---|
| 510(k) Number | K192019 |
| Date Prepared | October 4, 2019 |
| Submitter Name | |
| & Address | Abbott Medical |
| 4 Robbins Road | |
| Westford, MA, 01886 | |
| Contact Person | Richard DeMello |
| 978-577-3504 | |
| Alternative | |
| Contact Person | Jose Marquez |
| 978-577-3578 | |
| Proprietary / | |
| Trade Name | Dragonfly OpStar™ Imaging Catheter, AptiVue™ Software version E.5.1 |
| Common / Usual | |
| Name | Diagnostic Imaging Catheter |
| Product | |
| Classification | Product Code: DQO, NQQ |
| Product | |
| Regulation | |
| Number | 21 CFR 870.1200 |
| Predicate Device | OPTIS Integrated System, Dragonfly OPTIS™ Imaging Catheter (K141769), cleared |
| 18 August 2014 | |
| Reference Device | ILUMIEN OPTIS, OPTIS Integrated, OPTIS Mobile with AptiVue™ Software version |
| E.5 (K183320), cleared April 2, 2019 | |
| Device | |
| Description | The Dragonfly OpStar™ Imaging Catheter is a sterile, single-use intravascular catheter |
| consisting of a catheter body external sheath and an internal rotating fiber optic | |
| imaging core. The external sheath serves two primary functions: 1) to facilitate | |
| placement of the device into the coronary artery and 2) to cover and protect the internal | |
| rotating fiber optic imaging core. The inner rotating fiber optic imaging core emits | |
| near infrared light to tissues and receives reflected light. It is driven by a stainless-steel | |
| torque wire visible under fluoroscopy and pulled back through the window tube of the | |
| external sheath by the Drive-motor and Optical Controller (DOC). The emitted and | |
| returned reflected light are combined and processed by the OPTIS System software to | |
| construct an OCT image. The patient is never exposed to moving parts as the external | |
| sheath completely covers the rotating imaging core. | |
| The AptiVue™ Software version E.5.1 controls the Optical Coherence Tomography | |
| (OCT) imaging engine to collect and store pressure wave form data for computing, | |
| Fractional Flow Reserve (FFR), and Resting Full-cycle Ratio (RFR) during procedures | |
| and to 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). |
4
| Indications for
Use / Intended
Use | The Dragonfly OpStar™ Imaging Catheter with OCT imaging system is intended for
the imaging of coronary arteries and is indicated in patients who are candidates for
transluminal interventional procedures. The Dragonfly OpStar Imaging Catheter is
intended for use in vessels 2.0 to 3.5 mm in diameter. The 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.
AptiVue™ E-series software:
The AptiVue™ E-series software is intended for use 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. | | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison of
Subject to
Predicate and
Reference
Devices | The Dragonfly OpStar Imaging Catheter is equivalent to the predicate Dragonfly
OPTIS Imaging Catheter (K141769) in terms of intended use, indications for use,
operational characteristics, fundamental design, and technological characteristics.
Changes to technological characteristics of the device do not raise new questions of
safety or effectiveness. | | |
| | Feature | Predicate Device:
Dragonfly OPTIS™ Imaging
Catheter (K141769) | Proposed Device:
Dragonfly OpStar™ Imaging
Catheter |
| | Intended Use | The Dragonfly OPTIS™
Imaging Catheter with OCT
Imaging System is intended for
the Visualization and Imaging
of Coronary Arteries during an | The Dragonfly OpStar™ Imaging
Catheter with OCT Imaging
System is intended for the
Visualization and Imaging of
Coronary Arteries during an |
| | | | |
| Indications for Use | Intended for the imaging of
coronary arteries and is
indicated in patients who are
candidates for transluminal
interventional procedures. The
Dragonfly OPTIS Imaging
Catheter is intended for use in
vessels 2.0 to 3.5 mm in
diameter. The 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. | Intended for the imaging of
coronary arteries and is indicated
in patients who are candidates for
transluminal interventional
procedures. The Dragonfly
OpStar Imaging Catheter is
intended for use in vessels 2.0 to
3.5 mm in
diameter. The 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. | |
| Design
Modifications | N/A | Modifications are made for
improved shaft support,
deliverability, and reliability.
These changes have been
thoroughly assessed through
head-to-head bench and animal
testing, which conclude these
modifications do not change the
safety or effectiveness of the
Dragonfly OpStar Imaging
Catheter. | |
| AptiVue™ Version E.5.1 software is equivalent to the reference AptiVue™ Version
E.5 Software (K183320) for intended use, operational characteristics, and fundamental
design of the device. Changes to technological characteristics of the device do not raise
different questions of safety or effectiveness. | | | |
| Feature | AptiVue™ Version E.5
Software (Reference) | AptiVue™ Version E.5.1
Software (Proposed) | |
| 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™ 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. | |
| Indications for
Use | The AptiVue™ E series
software is intended to be used
only with compatible OPTISTM
imaging systems.
The OPTIS imaging system
with a compatible Dragonfly™
imaging catheter is intended for
the imaging of coronary arteries | 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 | |
| | are candidates for transluminal interventional procedures. The compatible DragonflyTM imaging catheters are intended for use in vessels 2.0 to 3.5 mm in diameter. The compatible DragonflyTM 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. | are candidates for transluminal interventional procedures. The compatible DragonflyTM imaging catheters are intended for use in vessels 2.0 to 3.5 mm in diameter. The compatible DragonflyTM 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. | |
| Measurement &
Display
Features | OCT recordings, FFR, Pd/Pa at rest, and RFR physiological waveforms | OCT recordings, FFR, Pd/Pa at rest, and RFR physiological waveforms | |
| Design
Modifications | N/A | Modifications to the AptiVue software version E.5.1 have been made to include recognition of the Dragonfly OpStar catheter, improvements to the Angio Co-registration feature, minor configuration changes and upgrade support. Software design verification and validation testing has been performed which concludes these modifications do | |
5
6
7
| Summary on
Non-Clinical
Testing | Design verification and validation was performed on the Dragonfly OPSTAR Imaging
Catheter as compared to the predicate Dragonfly OPTIS Imaging catheter in
compliance with internal design control procedures, which included bench testing and
pre-clinical animal testing. The testing involved head-to-head comparison between the
proposed and predicate devices for modifications to technological characteristics. The
results of this testing conclude the Dragonfly OPSTAR Imaging Catheter is
substantially equivalent to the Dragonfly OPTIS Imaging Catheter.
Verification and Validation testing was completed for the AptiVue software version
E.5.1 to demonstrate safety and effectiveness and ensure that the subject device
performs as intended. Software design verification concludes these modifications do
not raise different questions of safety or effectiveness. |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Summary of
Clinical Testing | No clinical testing is provided in this pre-market notification. |
| Statement of
Equivalence | The Dragonfly OpStar Imaging Catheter is equivalent to the predicate Dragonfly
OPTIS Imaging Catheter (K141769) in terms of operational and technological features,
hardware components, operational use and target population. Changes to technological
characteristics of the device do not raise new questions of safety or effectiveness. |