(90 days)
The ILUMIEN OPTIS with Dragonfly™ Imaging Catheter is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The Dragonfly™ Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The Dragonfly™ 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.
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 Drivemotor and Optical Controller (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 provided text describes a 510(k) summary for the LightLab Imaging, Inc. ILUMIEN OPTIS system, stating its intended use, technological characteristics, and performance testing. However, it does not contain detailed acceptance criteria, specific performance metrics, or study results in the format requested.
The document primarily focuses on demonstrating substantial equivalence to a predicate device (C7 XR™ Imaging System) by highlighting upgrades in performance (engine A-scan rate, frame rate, pullback speeds, pullback length, pullback time, display option, automated lumen measurement) and compliance with various safety and regulatory standards (UL, IEC, EN, DICOM, CFR, FCC).
Therefore, I cannot fulfill all parts of your request with the information provided.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance:
- Cannot create: The document lists general performance upgrades (e.g., increased A-scan rate, frame rate), but it does not provide specific quantitative acceptance criteria or corresponding reported device performance values for these metrics. It states "Design verification and validation was also performed on the ILUMIEN OPTIS in compliance with internal design control procedures which included bench testing. This testing included physical, mechanical, and optical characteristics testing. The system hardware was evaluated for range, speed, and rotation accuracy and durability. Optical testing was conducted and included scan range and rate, resolution, and sensitivity." However, the actual criteria and results are not presented.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Cannot provide: The document mentions "bench testing" for design verification and validation but does not specify sample sizes for any test sets, data provenance, or whether the testing was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Cannot provide: The document refers to "software verification and validation" and "design verification and validation" (bench testing), but it does not mention the use of experts to establish ground truth for any test set, nor does it specify their number or qualifications. This type of expert assessment generally applies to clinical studies, which are not detailed here for performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Cannot provide: There is no mention of adjudication methods as no human expert review or clinical trial results establishing ground truth are detailed.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Cannot provide: The document does not describe any MRMC studies or any studies evaluating human reader improvement with AI assistance. The device is an imaging system (ILUMIEN OPTIS) and does not appear to involve AI assistance for human interpretation in the way your question implies.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Cannot provide: While software verification and validation were performed, the document does not detail specific algorithm-only performance studies or their results. It's an imaging device, and its "performance" largely relates to its hardware, software functionality, and physical/optical characteristics rather than a diagnostic algorithm's standalone accuracy against a ground truth.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Cannot provide: The document only mentions "bench testing" and "software verification and validation." The nature of the ground truth (e.g., physical specifications, simulated data) for these tests is not explicitly defined in terms of clinical or pathological outcomes.
8. The sample size for the training set:
- Cannot provide: There is no mention of a "training set" as the context is not about a machine learning algorithm being trained.
9. How the ground truth for the training set was established:
- Cannot provide: (See point 8).
In summary, the provided text is a regulatory submission summary focused on demonstrating substantial equivalence and compliance with general safety and performance standards for a medical device upgrade. It does not contain the detailed study information regarding specific acceptance criteria, performance metrics, and validation methodologies that your request asks for.
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510(K) SUMMARY 5.
for the LightLab Imaging, Inc. ILUMIEN OPTIS (per 21CFR 807.92)
JAN 3 0 2013
1. SUBMITTER/510(K) HOLDER
LightLab Imaging, Inc. 4 Robbins Road Westford, MA 01886
Jeffrey Roberts Contact Person: 978-577-3451 Telephone:
10/25/12 Date Prepared:
2. DEVICE NAME
| Proprietary Name: | ILUMIEN OPTIS |
|---|---|
| Common/Usual Name: | Ultrasonic pulsed echo imaging system |
| Classification Name: | Ultrasonic pulsed echo imaging system |
3. PREDICATE DEVICE
- C7 XR™ Imaging System with Fractional Flow Reserve (FFR) (ILUMIEN Guided . Therapy System) manufactured by LightLab Imaging, Inc., K111201.
4. 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 Drivemotor and Optical Controller (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
LightLab Imaging, Inc. Traditional 510(k) ILUMIEN OPTIS
10/25/12
. .
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K123369
pg 2 of 3
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 DragonflyTM Imaging Catheter is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The Dragonfly™ Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The Dragonfly™ 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 an upgrade to the previously cleared predicate device C7 XR™ Imaging System with Fractional Flow Reserve (FFR) (ILUMIEN Guided Therapy System) manufactured by LightLab Imaging, Inc. The ILUMIEN OPTIS is substantially equivalent to the C7 XR™ Imaging System with Fractional Flow Reserve (FFR) (ILUMIEN Guided Therapy System) based on intended use, indication for use, typical clinical use, operational characteristics, and fundamental technology characteristics.
The ILUMIEN OPTIS represents an upgrade to the predicate device in terms of performance through the same Drive-motor and Optical Controller (DOC) design and technological characteristics including an increase in engine A-scan rate, frame rate, pullback speeds, and pullback length. The pullback time, display option, and automated lumen measurement have also been upgraded.
7. 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
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K123369
pg 3 of 3
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 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 in compliance with internal design control procedures which included bench testing. This testing included physical, mechanical, and optical characteristics testing. The system hardware was evaluated for range, speed, and rotation accuracy and durability. Optical testing was conducted and included scan range and rate, resolution, and sensitivity. The results of this testing concludes the ILUMIEN OPTIS is determined to be safe and effective and is substantially equivalent to the predicate device C7 XR™ Imaging System with Fractional Flow Reserve (FFR) (ILUMIEN Guided Therapy System).
10/25/12
Document # 90111116 Rev A Page 5-3
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wavy lines extending from its body, representing the department's services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
JAN 3 0 2013 .
LightLab Imaging, Inc. C/O Mr. Jeffrey Roberts Principal Regulatory Affairs Specialist 4 Robbins Rd. Westford, MA 01886
Re: K123369
Trade/Device Name: Ilumien Optis Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic Pulsed Echo Imaging System Regulatory Class: Class II Product Code: NQQ Dated: October 25, 2012 Received: November 1, 2012
Dear Mr. 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 Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
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Page 2 - Mr. Jeffrey Roberts
device-related 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Owen P. Faris -S
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 4.
510(k) Number (if known): K123369
Device Name: ILUMIEN OPTIS
Indications for Use:
The ILUMIEN OPTIS with Dragonfly™ Imaging Catheter is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The Dragonfly™ Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The Dragonfly™ 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)
Owen P. Earis -S
LightLab Imaging, Inc. Traditional 510(k) ILUMIEN OPTIS
10/25/12
Document # 901111116 Rev A Page 4-1
§ 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.