(109 days)
Not Found
No
The summary describes image processing for OCT image construction and FFR calculation, but there is no mention of AI or ML technologies being used for these or any other functions.
No.
The device is intended for imaging coronary arteries and determining physiological parameters (FFR) to aid the physician in deciding if therapeutic intervention is indicated, rather than providing therapy itself.
Yes
The device is explicitly stated to acquire radio frequency signal outputs to determine the physiological parameter, Fractional Flow Reserve (FFR), which a physician can use "to determine if therapeutic intervention is indicated." This indicates its role in providing diagnostic information for medical decisions. Additionally, it constructs OCT images of coronary arteries, which are used for imaging and assessment.
No
The device description clearly outlines significant hardware components including a cart-mounted computer, Imaging Engine, Drive-motor and Optical Coupler (DOC), display monitors, keyboard, mouse, isolation transformer, and USB mounted FFR receivers. While software is mentioned for image processing and FFR calculation, it is integral to a larger hardware system.
Based on the provided text, this device is likely an IVD (In Vitro Diagnostic).
Here's why:
- It measures a physiological parameter (FFR) using signals acquired from pressure transducers. While the primary function described is imaging, the device also acquires and processes signals from pressure transducers to determine Fractional Flow Reserve (FFR). FFR is a physiological measurement used to assess the severity of coronary artery stenosis.
- The FFR parameter is used by the physician to determine if therapeutic intervention is indicated. This directly relates to providing information for diagnosis and treatment decisions, which is a core function of IVDs.
- The pressure transducers are described as "distal intracoronary pressure transducer" and "proximal aortic pressure transducer". These are devices that measure pressure within the body, and the signals they produce are then processed by the ILUMIEN OPTIS system.
While the device also performs imaging (OCT), the inclusion of the FFR measurement and its intended use in guiding treatment decisions strongly suggests it falls under the definition of an In Vitro Diagnostic device, as it provides diagnostic information derived from physiological measurements.
N/A
Intended Use / Indications for Use
The ILUMIEN OPTIS with C7 Dragonfly, 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, Dragonfly DUO, or Dragonfly OPTIS Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The C7 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 ILUMIEN OPTIS 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.
Product codes
DOO, NOO
Device Description
The ILUMIEN OPTIS is a cart-mounted computer and Imaging Engine (or optical engine) placed inside an ergonomically designed mobile cart. It also includes the Drive-motor and Optical Coupler (DOC), which provides the interconnection between the ILUMIEN OPTIS System and the Dragonfly Catheter. The cart is equipped with two display monitors (one for the console operator, and the other for the physician), as well as a keyboard and mouse. The cart also contains an isolation transformer for electrical safety. The cart includes two USB mounted FFR receivers which provide wireless reception of distal intracoronary and aortic pressure signals originating at the PressureWire® Aeris and the aortic pressure transducer (AIU). These signals are used to calculate and display the patient's Fractional Flow Reserve (FFR) on the system monitor.
The Dragonfly OPTIS 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 inner rotating fiber optic imaging core.
The inner rotating fiber optic imaging core emits near infrared light to the tissue 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 DOC. The emitted and returned reflected light are combined and processed by the Ilumien Optis System software to construct an an OCT image. The patient is never exposed to moving parts as the external sheath completely covers the rotating imaging core.
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
Physician / Not Found
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)
The ILLUMIEN OPTIS has been tested and is in compliance with UL Standard No 60601-1, Medical Electrical Equipment Part I: General Requirements for Safety, IEC 60601-1-2 Ed. 2.1, Electromagnetic emissions and immunity requirements for medical electrical equipment - Group 1 Equipment, Class B for non-life supporting equipment, EN 60601-1-2:2007, Electromagnetic emissions and immunity requirements for medical electrical equipment -Group 1 Equipment, Class B for non-life supporting equipment, IEC 60825-1, 2nd, Ed., 2007, SAFETY OF LASER PRODUCTS - Part 1: Equipment classification and requirements, DICOM Standard (PS 3.2-2008), 21 CFR 1040.10, Performance Standards for Light-Emitting Products, Laser Products, and CFR 47 FCC Part 15 Subpart B Class B emissions requirements (USA)
In addition to the electrical safety testing performed, software verification and validation was conducted to FDA regulations, standards and guidance document requirements. The results of this testing conclude the software has met these requirements. Design verification and validation was also performed on the ILUMIEN OPTIS and Dragonfly OPTIS Imaging Catheter in compliance with internal design control procedures which included bench testing and pre-clinical animal testing. The results of this testing concludes the ILUMIEN OPTIS and Dragonfly OPTIS Imaging Catheter is determined to be safe and effective and is substantially equivalent to the predicate ILUMIEN OPTIS device.
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
§ 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
Image /page/0/Picture/1 description: The image is a logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the largest and the bottom profile being the smallest.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 19, 2014
Lightlab Imaging, Inc. Jeffrey Roberts Principal Regulatory Affairs Specialist 4 Robbins Road Westford, Massachusetts 01886
Re: K141453
Trade/Device Name: Ilumien Optis, Dragonfly Optis Imaging Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: DOO. NOO Dated: August 7, 2014 Received: August 8, 2014
Dear Jeffrey Roberts.
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. 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
1
Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely
Image /page/1/Picture/8 description: The image shows a signature that appears to be "KSL" in cursive. Below the signature, the text "Ken Skodacek for" is printed in a smaller, sans-serif font. The signature is bold and slightly stylized, with each letter distinct but connected. The background is plain, allowing the signature and text to stand out.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
4. INDICATIONS FOR USE
510(k) Number (if known):
Device Name: ILUMIEN OPTIS
Indications for Use:
The ILUMIEN OPTIS with C7 Dragonfly, 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, Dragonfly DUO, or Dragonfly OPTIS Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The C7 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 ILUMIEN OPTIS 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.
Prescription Use × (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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5. 510(K) SUMMARY
for the LightLab Imaging, Inc. ILUMIEN OPTIS and Dragonfly OPTIS Imaging Catheter (per 21CFR 807.92)
1. SUBMITTER/510(K) HOLDER
LightLab Imaging, Inc. 4 Robbins Road Westford, MA 01886
| Contact Person: | Jeffrey Roberts |
|---|---|
| Telephone: | 978-577-3451 |
Date Prepared: 5/30/14
2. DEVICE NAME
| Proprietary Name: | ILUMIEN OPTIS |
|---|---|
| Common/Usual Name: | Ultrasonic pulsed echo imaging system |
| Classification Name: | Ultrasonic pulsed echo imaging system |
| The Call Call Call Call Call Call Call Call Call Call Call Call Call Call Call Call Call Call Call Call Call Call Call Call Call Call Call Call Call Call Call Call Call Call | mi a mana mara ya mana mana mana mana mana mana mana mana mana mana mana mana mana mana mana mana mana mana mana mana mana mana mana mana mana mana mana mana mara mara marka |
| Proprietary Name: | The Dragonfly OPTIS Imaging Catheter |
|---|---|
| Common/Usual Name: | Diagnostic Intravascular Catheter |
| Classification Name: | Diagnostic Intravascular Catheter |
3. DEVICE CLASSIFICATION
| The ILUMIEN OPTIS medical device comprises the following: | |
|---|---|
| Classification Name | Ultrasonic Pulsed Echo Imaging System |
| Classification Regulation | 21 CFR 892.1560 |
| Product Code | NQQ |
The Dragonfly OPTIS Imaging Catheter device comprises the following: Classification Name: Diagnostic Intravascular Catheter Classification Regulation: 21 CFR 870.1200 Product Code: DQO
4
4. PREDICATE DEVICE
- ILUMIEN OPTIS with Dragonfly I Catheter manufactured by LightLab Imaging, Inc. ● K123369
5. DEVICE DESCRIPTION
The ILUMIEN OPTIS is a cart-mounted computer and Imaging Engine (or optical engine) placed inside an ergonomically designed mobile cart. It also includes the Drive-motor and Optical Coupler (DOC), which provides the interconnection between the ILUMIEN OPTIS System and the Dragonfly Catheter. The cart is equipped with two display monitors (one for the console operator, and the other for the physician), as well as a keyboard and mouse. The cart also contains an isolation transformer for electrical safety. The cart includes two USB mounted FFR receivers which provide wireless reception of distal intracoronary and aortic pressure signals originating at the PressureWire® Aeris and the aortic pressure transducer (AIU). These signals are used to calculate and display the patient's Fractional Flow Reserve (FFR) on the system monitor.
The Dragonfly OPTIS 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 inner rotating fiber optic imaging core.
The inner rotating fiber optic imaging core emits near infrared light to the tissue 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 DOC. The emitted and returned reflected light are combined and processed by the Ilumien 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.
5
6. INTENDED USE
The ILUMIEN OPTIS with C7 Dragonfly, 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, Dragonfly DUO, or Dragonfly OPTIS Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The C7 Dragonfly, 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 ILUMIEN OPTIS 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.
7. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
ILUMIEN OPTIS
The ILUMIEN OPTIS is equivalent to the predicate device in terms of hardware and firmware components. They both contain a DOC which provides the interconnection between the ILUMIEN OPTIS and the optical imaging catheters that emit near-infrared light to produce high-resolution real-time images. This process is accomplished for both the ILUMIEN OPTIS and the predicate device through a graphical user interface (GUI) and software control to obtain Optical Coherence Tomography (OCT) imaging modality and fractional flow reserve (FFR) measurements.
The ILUMIEN OPTIS represents an upgrade to the predicate device in terms of performance through the same hardware and firmware design and technological characteristics. The software has been upgraded to revision E.1 for the following features:
- A curtain GUI interface.
- Dragonfly OPTIS Imaging Catheter Support
- Continuous calibration for TiO2 doped catheter window
- DICOM modality integration
- Manual pull back triggering ●
- Catheter user connection interface ●
- Improved acquisition workflow display ●
6
Dragonfly OPTIS Imaging Catheter
The Dragonfly OPTIS Imaging Catheter is equivalent to the predicate device in terms of hardware components and operational use. They both are comprised of a catheter body external sheath and internal rotating fiber optic imaging core which emits near infrared light to the tissue and receives reflected light. They both are driven by a stainless steel torque wire by the DOC which is connected to the ILUMIEN OPTIS OCT Imaging System. They are both purged through the central catheter with 100% contrast media prior to use. In both the Dragonfly OPTIS Imaging Catheter and the predate device emitted and returned reflected light are combined and processed by the ILUMIEN OPTIS software to construct an OCT image.
The Dragonfly OPTIS Imaging Catheter represents an upgrade to the predicate device in terms of performance through the same operational characteristics, and fundamental technological characteristics to include the following:
- TiO2 Doped window
- Flexible proximal end ●
- o Improved break away joint
- Improved purge tube
- Dual lumen tip
- High speed proximal end ●
- 155um fiber
- o RFID.
8. PERFORMANCE TESTING
The ILLUMIEN OPTIS has been tested and is in compliance with UL Standard No 60601-1, Medical Electrical Equipment Part I: General Requirements for Safety, IEC 60601-1-2 Ed. 2.1, Electromagnetic emissions and immunity requirements for medical electrical equipment - Group 1 Equipment, Class B for non-life supporting equipment, EN 60601-1-2:2007, Electromagnetic emissions and immunity requirements for medical electrical equipment -Group 1 Equipment, Class B for non-life supporting equipment, IEC 60825-1, 2nd, Ed., 2007, SAFETY OF LASER PRODUCTS - Part 1: Equipment classification and requirements, DICOM Standard (PS 3.2-2008), 21 CFR 1040.10, Performance Standards for Light-Emitting Products, Laser Products, and CFR 47 FCC Part 15 Subpart B Class B emissions requirements (USA)
In addition to the electrical safety testing performed, software verification and validation was conducted to FDA regulations, standards and guidance document requirements. The results of this testing conclude the software has met these requirements. Design verification and
7
validation was also performed on the ILUMIEN OPTIS and Dragonfly OPTIS Imaging Catheter in compliance with internal design control procedures which included bench testing and pre-clinical animal testing. The results of this testing concludes the ILUMIEN OPTIS and Dragonfly OPTIS Imaging Catheter is determined to be safe and effective and is substantially equivalent to the predicate ILUMIEN OPTIS device.