(91 days)
No
The document describes image processing and automated detection features, but does not explicitly mention the use of AI or ML algorithms. The performance studies focus on software verification and validation against requirements and substantial equivalence to a predicate device, not on the performance metrics typically associated with AI/ML models.
No.
The device is intended for imaging and measurement to help physicians determine if therapeutic intervention is indicated, but it does not perform therapeutic intervention itself.
Yes
The device is intended for the imaging of coronary arteries and determines the physiological parameter Fractional Flow Reserve (FFR), which physicians use for diagnosis and to determine if therapeutic intervention is indicated. This function directly supports making a medical diagnosis, classifying it as a diagnostic device.
No
The device is described as OCT system software that controls an OCT imaging engine and collects data from pressure transducers. It is also compatible with imaging catheters. While the submission focuses on the software update, the device's functionality is intrinsically linked to and controls hardware components (OCT imaging engine, pressure transducers, catheters) to acquire data and perform its intended use. Therefore, it is not a software-only medical 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 OPTIS™ Software with Dragonfly™ DUO or Dragonfly™ OPTIS™ Imaging Catheter is used for imaging coronary arteries and determining a physiological parameter (FFR) in vivo (within the living body). It directly interacts with the patient's circulatory system.
- Lack of Specimen Analysis: The device does not analyze specimens taken from the body. It acquires data directly from within the coronary arteries.
Therefore, while it is a medical device used for diagnostic purposes (imaging and FFR measurement), it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The OPTIS™ Software 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 OPTIS™ Software 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)
NOO
Device Description
The Metallic Stent Optimization SW E.4 is an OCT system software that allows update of the current software version of ILUMIEN OPTIS (K150878), OPTIS Mobile System (K152120) and OPTIS Integrated OCT Systems (K151286) on the field for the Stent Optimization Tool features. The Metallic Stent Optimization SW E.4 is also compatible with flush catheters compatible with the above mentioned OCT systems (Dragonfly OPTIS and Dragonfly DUO catheters).
The OCT system software is used to control the OCT imaging engine in order to acquire OCT images, it is used to make measurements based on acquired OCT images, it is used to maintain a database of OCT images and data, and it is used to review previously acquired OCT images and data.
The OCT System software is also used to control the Aortic (AO) and PressureWire (PW) USB receivers to collect and store pressure waveform data for computing Fractional Flow Reserve (FFR). Similar to the OCT images, the FFR waveforms are stored in the database and are available for later review.
The OPTIS™ Metallic Stent Optimization E.4 SW software runs on 64-bit Microsoft Windows 7 Embedded Operating System only. The software also contains Intel JPEG Library, Microsoft MPEG-4 Video Codec, Microsoft Video 1 codec, AMD FirePro V4900 Display Adapter Driver, Intel 82579LM/82583V Gigabit Ethernet Controller Driver, Microsoft Foundation Class Library, Active Template Library, Microsoft Standard C++ Library, LEADTOOLS Medical Imaging Suite SDK, Microsoft SQL Server Express 2008 Service Pack 2 (SP2), Open Inventor Library, Haru PDF Library, IDEA Video Driver, iWRAP Bluetooth Stack and Intel Integrated Performance Primitives commercial off the shelf (COTS) software.
The E.4 software introduces the following new features:
- . 3D Flythrough, 3D Bifurcation (Bifurcation Visualization)- Enhance assessment of ostium geometry with optimized 3D views
- Cross Frame Angio (Stent Roadmap) Display stent roadmap with . OCT/angiography coregistrations
- Stent Display (Quantification of Stent Strut Apposition, Metallic Stent . Visualization) and 3D Display Options (Guide Wire Detection, Side Branch Detection) - Provide intra-procedural guidance by automatic detection and 3D visualization of BMS struts, side branches, and guidewires
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Optical Coherence Tomography (OCT), Angiography
Anatomical Site
coronary arteries, vessels 2.0 to 3.5 mm in diameter
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 OPTIS™ Metallic Stent Optimization E.4 SW has been developed and tested in compliance with IEC 62304: 2006 and DICOM Standard: 2015b. 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 in compliance with internal design control procedures. The results of this testing conclude the OPTIS™ Metallic Stent Optimization E.4 SW is determined to be safe and effective and is substantially equivalent to the predicate OPTIS Mobile System software.
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.
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. The logo is simple, clean, and easily recognizable.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 29, 2016
Lightlab Imaging, Inc. Padmini Suravaram Regulatory Affairs Specialist 4 Robbins Road Westford, MA 01866
Re: K160878
Trade/Device Name: Optis™ Metallic Stent Optimization E.4 SW Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic Pulsed Echo Imaging System Regulatory Class: Class II Product Code: NOO Dated: April 18, 2016 Received: April 20, 2016
Dear Padmini Suravaram:
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 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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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 vours
Mitchell Stein
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K160878
Device Name OPTIS Metallic Stent Optimization E.4 SW
Indications for Use (Describe)
The OPTIS™ Software 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 OPTIS™ Software 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.
| 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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K160878
Lightlab Imaging, Inc. OPTIS METALLIC STENT OPTIMIZATION E.4 SW 510(k) Summary (Per 21 CFR 807.92(c))
1. SPONSOR/MANUFACTURER
LightLab Imaging, Inc. 4 Robbins Road Westford, MA 01886
| Contact Person: | Padmini Suravaram |
|---|---|
| Telephone: | 978-577-3483 |
Date Prepared: 03/28/16
2. DEVICE NAME
| Proprietary Name: | OPTIS™ Metallic Stent Optimization E.4 SW |
|---|---|
| Common/Usual Name: | Ultrasonic pulsed echo imaging system |
| Classification Name: | Ultrasonic pulsed echo imaging system |
3. PREDICATE DEVICE
Predicate Device: Lightlab Imaging, Inc. OPTIS™ Mobile System, K152120
4. DEVICE DESCRIPTION
The Metallic Stent Optimization SW E.4 is an OCT system software that allows update of the current software version of ILUMIEN OPTIS (K150878), OPTIS Mobile System (K152120) and OPTIS Integrated OCT Systems (K151286) on the field for the Stent Optimization Tool features. The Metallic Stent Optimization SW E.4 is also compatible with flush catheters compatible with the above mentioned OCT systems (Dragonfly OPTIS and Dragonfly DUO catheters).
The OCT system software is used to control the OCT imaging engine in order to acquire OCT images, it is used to make measurements based on acquired OCT images, it is used to maintain a database of OCT images and data, and it is used to review previously acquired OCT images and data.
4
K160878
The OCT System software is also used to control the Aortic (AO) and PressureWire (PW) USB receivers to collect and store pressure waveform data for computing Fractional Flow Reserve (FFR). Similar to the OCT images, the FFR waveforms are stored in the database and are available for later review.
The OPTIS™ Metallic Stent Optimization E.4 SW software runs on 64-bit Microsoft Windows 7 Embedded Operating System only. The software also contains Intel JPEG Library, Microsoft MPEG-4 Video Codec, Microsoft Video 1 codec, AMD FirePro V4900 Display Adapter Driver, Intel 82579LM/82583V Gigabit Ethernet Controller Driver, Microsoft Foundation Class Library, Active Template Library, Microsoft Standard C++ Library, LEADTOOLS Medical Imaging Suite SDK, Microsoft SQL Server Express 2008 Service Pack 2 (SP2), Open Inventor Library, Haru PDF Library, IDEA Video Driver, iWRAP Bluetooth Stack and Intel Integrated Performance Primitives commercial off the shelf (COTS) software.
The E.4 software introduces the following new features:
- . 3D Flythrough, 3D Bifurcation (Bifurcation Visualization)- Enhance assessment of ostium geometry with optimized 3D views
- Cross Frame Angio (Stent Roadmap) Display stent roadmap with . OCT/angiography coregistrations
- Stent Display (Quantification of Stent Strut Apposition, Metallic Stent . Visualization) and 3D Display Options (Guide Wire Detection, Side Branch Detection) - Provide intra-procedural guidance by automatic detection and 3D visualization of BMS struts, side branches, and guidewires
INDICATIONS FOR USE
The OPTIS™ Software 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 DragonflyTM DUO or DragonflyTM 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 OPTIS™ Software 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
5
and clinical judgment to determine if therapeutic intervention is indicated.
5. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
The OPTIS™ Metallic Stent Optimization E.4 SW is substantially equivalent in terms of product design, materials of construction, operational and technological features, clinical use, and target population.
Both the proposed OPTIS™ Metallic Stent Optimization E.4 SW and the predicate device OCT System Software perform OCT Image acquisition and FFR. This application is preformed through the System OCT Software. The OPTIS application software and firmware is responsible for controlling the OCT system hardware for the purposes of acquiring raw OCT image data in polar format and scan converting it to raster format for display on the screen using a bilinear interpolation algorithm. This data is stored in a proprietary variant of the TIFF format. The software is also responsible for controlling the FFR hardware for the purposes of acquiring raw aortic and distal pressure waveforms, computing the mean pressure values over a user-defined number of heart cycles, and computing the resulting Fractional Flow Reserve and/or Resting Pd/Pa parameters from the mean pressure waveforms. For both modalities, the software provides storage and retrieval functionality including database storage of the corresponding patient demographic information using the commercial off the shelf SQL Server Express database. The software also enables storage of the OCT and FFR data in a variety of file formats on external DICOM servers.
In addition to providing the basic OCT and FFR modalities, the software contains a number of proprietary OCT image processing algorithms for automatically calibrating the images and segmenting the vessel lumen, side branches, guide wires and metallic stent struts, using a commercial off the shelf volume rendering library (Open Inventor) to provide an interactive 3D display of the image data and segmented objects in a variety of formats. The software also contains a number of proprietary angio image processing algorithms to track the Dragonfly Duo and OPTIS lens marker to provide a complete two dimensional Co-Registration between each OCT frame and each angio frame from simultaneously acquired image sequences.
The OPTIS™ Metallic Stent Optimization E.4 SW represents an upgrade to the predicate device OCT System software in terms of offering the following features:
- . Metallic Stent optimization and Stent Apposition Mapping
- . Stent Roadmap on Angio Co-registration
- Enhanced 3D Views ●
6
- Lumen Profile default is on ●
- Side-branch display o
- . Guide wire display
- . OCT/Angio export
- . Rotational stabilization improvement
- . Intravascular OCT (IVOCT) DICOM file format
- . Improved Coregistration Workflow
- . Improved OCT Frame Indicator on Angio
- . Bookmarks Displayed on Angio
- . New Home Screen
- Improved DICOM Export Workflow .
- XA added to DICOM Modality Worklist Query .
- On-Screen Display of Lumen Dimensions o
- Scrolling of Full Screen 3D Display
6. PERFORMANCE TESTING
The OPTIS™ Metallic Stent Optimization E.4 SW has been developed and tested in compliance with IEC 62304: 2006 and DICOM Standard: 2015b. 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 in compliance with internal design control procedures.
The results of this testing conclude the OPTIS™ Metallic Stent Optimization E.4 SW is determined to be safe and effective and is substantially equivalent to the predicate OPTIS Mobile System software.