(118 days)
Not Found
No
The document does not mention AI, ML, or any related terms, and the description of the device's functionality focuses on established physiological measurements and imaging techniques.
No
The device is intended for imaging and measuring physiological parameters to help physicians determine if therapeutic intervention is indicated, but it does not perform the therapeutic intervention itself.
Yes
Explanation: The device is intended for imaging coronary arteries and computes and displays physiological parameters (FFR, Pd/Pa at rest, RFR) to assess the severity of a coronary lesion. This information aids the physician in determining if therapeutic intervention is indicated, which is a diagnostic purpose.
No
The device description explicitly states that the system performs OCT, FFR, and RFR procedures and provides images, which requires hardware components like the compatible Dragonfly imaging catheter and likely other system hardware to acquire the data and perform the procedures. The software is part of a larger system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The ILUMIEN system with the Dragonfly imaging catheter is used for imaging coronary arteries and measuring physiological parameters (FFR, RFR, Pd/Pa) directly within the patient's body. It involves inserting a catheter into the coronary arteries.
- No Sample Analysis: The device does not analyze samples taken from the body. It interacts directly with the body.
Therefore, while it is a medical device used for diagnosis and assessment, it falls under the category of in vivo (within the living body) diagnostic and measurement devices, not in vitro diagnostics.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
NQQ
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Optical Coherence Tomography (OCT)
Anatomical Site
coronary arteries, vessels 2.0 to 3.5 mm in diameter. Not intended for use in the left main coronary artery or in a target vessel which has undergone a previous bypass procedure.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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)
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:
- 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
No new clinical testing was completed, nor relied upon, in support of this Special 510(k).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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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
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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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) |
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| 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. |
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| 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. | |
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