(105 days)
Not Found
No
The summary describes a system for imaging and calculating FFR based on pressure signals. There is no mention of AI or ML in the device description, intended use, or performance studies. The focus is on standard signal processing and imaging techniques.
No
The device is described as an imaging system used to determine physiological parameters and assist physicians in deciding if therapeutic intervention is needed, but it does not perform the therapeutic intervention itself.
Yes
The device is intended for the imaging of coronary arteries and calculates Fractional Flow Reserve (FFR), both of which are diagnostic parameters used by physicians to determine if therapeutic intervention is indicated.
No
The device description explicitly details hardware components such as a cart-mounted computer, Imaging Engine, Drive-motor and Optical Coupler, display monitors, keyboard, mouse, isolation transformer, and USB mounted FFR receivers. The performance studies also mention "engine hardware design verification".
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is for imaging coronary arteries and determining the physiological parameter Fractional Flow Reserve (FFR) using pressure measurements. This is a diagnostic procedure performed in vivo (within the living body).
- Device Description: The device is a cart-mounted system with imaging capabilities (OCT) and pressure measurement capabilities. It interacts directly with the patient's circulatory system via a catheter.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This device does not perform tests on samples in vitro.
The device is clearly designed for in vivo diagnostic and interventional guidance procedures within the coronary arteries.
N/A
Intended Use / Indications for Use
The ILUMIEN OPTIS with 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 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 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 (comma separated list FDA assigned to the subject device)
NQQ
Device Description
The ILUMIEN OPTIS is a cart-mounted computer and Imaging Engine (or optical engine) placed inside an ergonomically designed mobile cart with the cable underground. 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.
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
Physician, trans lumninal interventional procedures
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 ILUMIEN OPTIS has been tested and is in compliance with IEC 62304:2006 Medical device software -- Software life cycle processes, IEC 60601-1:2005+CORR. 1(2006) + CORR. 2(2007)-Part 1: General requirements for basic safety and essential performance, IEC 60825-1:2nd Ed. 2007 Part 1: Equipment classification and requirements, 21 CFR 1040.10 Performance Standards for Light Emitting Products, sections b5 and b15 and IEC 60601-1-2 Ed.3 Electromagnetic emissions and immunity requirements for medical electric equipment-Group 1 Equipment, Class A for non-life supporting equipment.
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 as a part of bench testing on the ILUMIEN OPTIS in compliance with internal design control procedures which included engine hardware design verification and OCT Imaging Parameter testing. The results of this testing concludes the ILUMIEN OPTIS is determined to be safe and effective and is substantially equivalent to the ILUMIEN OPTIS predicate device.
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
§ 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.
0
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, with a triple-line design above them.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 15, 2015
Lightlab Imaging, Inc. Erdie De Peralta Regulatory Affairs Director 4 Robbins Road Westford, Massachusetts 01886
Re: K150878
Trade/Device Name: ILUMIEN OPTIS Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic Pulsed Echo Imaging System Regulatory Class: Class II Product Code: NOO Dated: June 4, 2015 Received: June 9, 2015
Dear Erdie De Peralta:
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 (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.
Sincerelv vours.
Mitchell Stein
forBram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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4. INDICATIONS FOR USE
510(k) Number (if known):
Device Name: ILUMIEN OPTIS
The ILUMIEN OPTIS with 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 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 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)
AND/OR
Over-The-Counter Use (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)
3
ട. 510(K) SUMMARY
for the LightLab Imaging, Inc. ILUMIEN™ OPTISTM
(per 21CFR 807.92)
1. SUBMITTER/510(K) HOLDER
LightLab Imaging, Inc. 4 Robbins Road Westford, MA 01886
| Contact Person: | Erdie de Peralta |
|---|---|
| Telephone: | 978-577-3481 |
Date Prepared: 3/31/15
2. DEVICE NAME
| Proprietary Name: | ILUMIEN OPTIS |
|---|---|
| Common/Usual Name: | Ultrasonic pulsed echo imaging system |
| Classification Name: | Ultrasonic pulsed echo imaging system |
| Regulation number | 21 CFR 892.1560 |
| Product Code | NQQ |
3. PREDICATE DEVICE
- ILUMIEN OPTIS with Dragonfly OPTIS Imaging Catheter manufactured by . LightLab Imaging, Inc. K141453
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4. DEVICE DESCRIPTION
The ILUMIEN OPTIS is a cart-mounted computer and Imaging Engine (or optical engine) placed inside an ergonomically designed mobile cart with the cable underground. 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.
5. INTENDED USE
The ILUMIEN OPTIS with 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 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 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.
6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
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.
5
The ILUMIEN OPTIS represents an upgrade to the predicate device in terms of performance through a modified engine design and contains identical OCT imaging and hardware equipment specifications. The software has been upgraded to revision E.2 to accommodate FDML laser support.
7. PERFORMANCE TESTING
The ILUMIEN OPTIS has been tested and is in compliance with IEC 62304:2006 Medical device software -- Software life cycle processes, IEC 60601-1:2005+CORR. 1(2006) + CORR. 2(2007)-Part 1: General requirements for basic safety and essential performance, IEC 60825-1:2nd Ed. 2007 Part 1: Equipment classification and requirements, 21 CFR 1040.10 Performance Standards for Light Emitting Products, sections b5 and b15 and IEC 60601-1-2 Ed.3 Electromagnetic emissions and immunity requirements for medical electric equipment-Group 1 Equipment, Class A for non-life supporting equipment.
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 as a part of bench testing on the ILUMIEN OPTIS in compliance with internal design control procedures which included engine hardware design verification and OCT Imaging Parameter testing. The results of this testing concludes the ILUMIEN OPTIS is determined to be safe and effective and is substantially equivalent to the ILUMIEN OPTIS predicate device.