(83 days)
Not Found
No
The summary describes standard signal processing and image generation from optical and pressure data, with no mention of AI or ML algorithms for analysis, interpretation, or decision support.
No
The device is strictly for imaging and diagnostic purposes (OCT and FFR) to help physicians determine if therapeutic intervention is needed, but it does not perform any therapeutic intervention itself.
Yes
Explanation: The device is explicitly intended for "imaging of coronary arteries" and for determining the "physiological parameter, Fractional Flow Reserve (FFR)". These functions are used by a physician to gather information about a patient's condition and help "determine if therapeutic intervention is indicated," which are characteristic activities of a diagnostic device.
No
The device description explicitly lists multiple hardware components including a laser, engine, DOC, monitor, keyboard, video mouse, system cabinet, remoting cable, DOC holster, and tableside controller. It also mentions hardware design verification and system-level design verification.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The description clearly states the device is used for "imaging of coronary arteries" and acquires "radio frequency signal outputs from both a distal intracoronary pressure transducer and a proximal aortic pressure transducer." This involves direct interaction with the patient's body, not the analysis of a specimen taken from the body.
- The device performs imaging and physiological measurements within the body. Optical Coherence Topography (OCT) and Fractional Flow Reserve (FFR) are procedures performed in vivo (within a living organism).
- The intended use is for guiding transluminal interventional procedures. This is a clinical procedure performed on the patient, not a laboratory test on a sample.
Therefore, the OPTIS Integrated System with Dragonfly DUO or Dragonfly OPTIS Imaging Catheter is a medical device used for in vivo imaging and physiological measurement, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The OPTIS Integrated System 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 Integrated 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.
Product codes
NQQ
Device Description
The OPTIS Integrated System performs optical coherence topography (OCT) and fractional flow reserve (FFR) procedures and provides images of the coronary arteries in patients who are candidates for transluminal interventional procedures. The device utilizes fiber-optic technology to emit near infrared light and receive light reflected from coronary tissue in order to produce high resolution, real time images. The imaging engine generates wavelength scanning light, which is guided to the DOC and the catheter. The reflection is collected and sent back to the engine. The engine processes the optical signal and converts it to electrical signal, which is then fed into the Host PC. The software application processes the signal and generates OCT images. The device is compatible with Dragonfly OPTIS, Dragonfly Duo and PressureWire Aeris.
The OPTIS Integrated System configuration has the following components integrated into a single catheterization lab.
| Component | Location |
|---|---|
| Laser and Engine | Contained within the system cabinet (M5a) |
| PC Embedded Software | Contained within the system cabinet |
| DOC | Located on the table side, connected directly to the DOC Holster |
| Monitor Keyboard Video Mouse | Located in the control room |
| System Cabinet | Located within the control room or technical closet |
| Remoting Cable | The cable connects the DOC Holster to the system cabinet |
| DOC Holster | Located table side |
| Tableside Controller | Located table side |
The OPTIS Integrated System Mobile Workstation (MWS) is an accessory for the OPTIS Integrated System. The MWS is a mobile terminal that mirrors the functionality of the control room monitor, keyboard and mouse that is part of the OPTIS Integrated System. The Control room monitor, keyboard and mouse of OPTIS Integrated System is a desktop setup located in the control room for operating system controls.
The MWS consists of two major subassemblies:
- MWS console is comprised of a cart, keyboard, mouse, monitor, wireless . Keyboard/Video/Mouse (KVM) receiver, cabling, branding labels and compliance label.
- MWS transmitter is comprised of a wireless KVM transmitter, video splitter, power supplies and cabling. All items are shipped together in a single carton.
Mentions image processing
The engine processes the optical signal and converts it to electrical signal, which is then fed into the Host PC. The software application processes the signal and generates OCT images.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
optical coherence topography (OCT)
Anatomical Site
coronary arteries
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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 Integrated System Mobile Workstation has been tested and is in compliance with IEC 60601-1:2005 + A1: 2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance, IEC 60601-1-6:2010 + A1: 2013 Medical electrical equipment - Part 1-6: General requirements for safety - Collateral Standard: Usability, IEC 60601-2-18:2009 Medical equipment - Part 2: Particular requirements for the basic safety and essential performance of endoscopic equipment, and IEC 60601-1-2 Ed. 3, Electromagnetic emissions and immunity requirements for medical electrical equipment - Group 1 Equipment. Class A for non-life supporting equipment.
In addition to the Electrical Safety Testing performed, Hardware Design Verification, System Level Design Verification and Transport & Storage Conditions Verification was conducted to FDA regulations, standards, guidance document requirements and internal design control procedures. The results of this testing conclude the OPTIS Integrated System and Mobile Workstation have met these requirements. The Design Verification activities demonstrate that OPTIS Integrated System and the Mobile Workstation comply with the defined design and performance specifications. The addition of Mobile Workstation does not affect the safety, efficacy and performance of OPTIS Integrated System. The results of this testing concludes the OPTIS Integrated System with Mobile Workstation is determined to be safe and effective and is substantially equivalent to the OPTIS Integrated System predicate 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
§ 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
DEPARTMENT OF HEALTH & HUMAN SERVICES - USA
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 5, 2015
Lightlab Imaging, Inc. % Erdie De Peralta Regulatory Director Lightlab Imaging,inc. 4 Robbins Road Westford, Massachusetts 01866
Re: K151286
Trade/Device Name: OPTIS Integrated System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic Pulsed Echo Imaging System Regulatory Class: Class II Product Code: NOO Dated: May 12, 2015 Received: May 14, 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
1
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 (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 yours,
Bram D. Zuckerman -S
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): K151286
Device Name: OPTIS Integrated System
Indications for Use:
The OPTIS Integrated System 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 Integrated 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.
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
510(K) SUMMARY ട്.
For the LightLab Imaging, Inc. OPTIS Integrated System (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: | 5th August 2015 |
2. DEVICE NAME
| Proprietary Name: | OPTIS Integrated System |
|---|---|
| Common/Usual Name: | OPTIS Integrated System |
| Classification Name: | Ultrasonic pulsed echo imaging system |
| Product Code: | NQQ |
| Classification Regulation: | 21 CFR 892.1560 |
3. PREDICATE DEVICE
- OPTIS Integrated System, Dragonfly OPTIS Imaging Catheter manufactured by ● LightLab Imaging, Inc.K141769
4. DEVICE DESCRIPTION
The OPTIS Integrated System performs optical coherence topography (OCT) and fractional flow reserve (FFR) procedures and provides images of the coronary arteries in patients who are candidates for transluminal interventional procedures. The device utilizes fiber-optic technology to emit near infrared light and receive light reflected from coronary tissue in order to produce high resolution, real time images. The imaging engine generates wavelength scanning light, which is guided to the DOC and the catheter. The reflection is collected and sent back to the engine. The engine processes the optical signal and converts it to electrical signal, which is then fed into the Host PC. The software application processes the signal and generates OCT images. The device is compatible with Dragonfly OPTIS, Dragonfly Duo and
4
PressureWire Aeris.
The OPTIS Integrated System configuration has the following components integrated into a single catheterization lab.
| Component | Location |
|---|---|
| Laser and | |
| Engine | Contained within the system cabinet (M5a) |
| PC Embedded | |
| Software | Contained within the system cabinet |
| DOC | Located on the table side, |
| connected directly to the DOC Holster | |
| Monitor | |
| Keyboard | |
| Video Mouse | Located in the control room |
| System | |
| Cabinet | Located within the control room or technical closet |
| Remoting | |
| Cable | The cable connects the DOC Holster to the system cabinet |
| DOC Holster | Located table side |
| Tableside | |
| Controller | Located table side |
The OPTIS Integrated System Mobile Workstation (MWS) is an accessory for the OPTIS Integrated System. The MWS is a mobile terminal that mirrors the functionality of the control room monitor, keyboard and mouse that is part of the OPTIS Integrated System. The Control room monitor, keyboard and mouse of OPTIS Integrated System is a desktop setup located in the control room for operating system controls.
The MWS consists of two major subassemblies:
- MWS console is comprised of a cart, keyboard, mouse, monitor, wireless . Keyboard/Video/Mouse (KVM) receiver, cabling, branding labels and compliance label.
- MWS transmitter is comprised of a wireless KVM transmitter, video splitter, power supplies and cabling. All items are shipped together in a single carton.
5. INTENDED USE
The OPTIS Integrated System 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
5
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 Integrated 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.
6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
OPTIS Integrated System Mobile Workstation
The OPTIS Integrated System with Mobile Workstation accessory is equivalent to the OPTIS Integrated System predicate device in that both devices perform optical coherence tomography (OCT) and fractional flow reserve (FFR) procedures and provide images of the coronary arteries in patients who are candidates for transluminal interventional procedures. Both devices utilizes fiber-optic technology to emit near infrared light and receive light reflected from coronary tissue in order to produce high resolution, real time images. The imaging engine in both devices generates wavelength scanning light, which is guided to the Digital Optical Coupler (DOC) and the catheter. The reflection is collected and sent back to the engine. The engine processes the optical signal and converts it to electrical signal, which is then fed into the Host PC. The software application processes the signal and generates OCT images. Both devices are compatible with Dragonfly Duo and Dragonfly OPTIS imaging catheters, in addition to the PressureWire Aeris.
The Mobile Workstation accessory has been added to the OPTIS Integrated System predicate device as an option to the OPTIS Integrated System providing an additional control point to input patient demographics and to control the OCT procedure, when needed, from anywhere in the procedure room outside the sterile field. The Mobile Workstation will communicate with the OPTIS Integrated System via a wireless communication interface capable of supporting video signal transmission and a USB keyboard and mouse interface. The Mobile Workstation functionality can be broken into two major functional blocks. The transmitter connects to the System Cabinet, and the Mobile Station itself which will be powered via AC mains and will otherwise be free of physical connections to the OPTIS Integrated System.
7. PERFORMANCE TESTING
The OPTIS Integrated System Mobile Workstation has been tested and is in compliance with IEC 60601-1:2005 + A1: 2012 Medical electrical equipment - Part 1: General requirements
6
for basic safety and essential performance, IEC 60601-1-6:2010 + A1: 2013 Medical electrical equipment - Part 1-6: General requirements for safety - Collateral Standard: Usability, IEC 60601-2-18:2009 Medical equipment - Part 2: Particular requirements for the basic safety and essential performance of endoscopic equipment, and IEC 60601-1-2 Ed. 3, Electromagnetic emissions and immunity requirements for medical electrical equipment - Group 1 Equipment. Class A for non-life supporting equipment.
In addition to the Electrical Safety Testing performed, Hardware Design Verification, System Level Design Verification and Transport & Storage Conditions Verification was conducted to FDA regulations, standards, guidance document requirements and internal design control procedures. The results of this testing conclude the OPTIS Integrated System and Mobile Workstation have met these requirements. The Design Verification activities demonstrate that OPTIS Integrated System and the Mobile Workstation comply with the defined design and performance specifications. The addition of Mobile Workstation does not affect the safety, efficacy and performance of OPTIS Integrated System. The results of this testing concludes the OPTIS Integrated System with Mobile Workstation is determined to be safe and effective and is substantially equivalent to the OPTIS Integrated System predicate device.