The ILUMIEN 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 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 Dragonfly OPTIS Imaging Catheter with the OCT Imaging System is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The Dragonfly OPTIS Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The Dragonfly OPTIS Imaging Catheter is not intended for use in the left main coronary.

Device Description

The ILUMIEN is a cart-mounted computer and Imaging Engine (or optical engine) placed inside an ergonomically designed mobile cart with a mains power cable. It also includes the Drive-motor and Optical Controller (DOC), which provides the interconnection between the ILUMIEN 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 and includes two AO and PW USB Receivers which accept the distal intracoronary and proximal aortic pressure signals and status information from the AO Interface Unit and PressureWire® Aeris (K080813) respectively, and communicate the FFR data for display on the ILUMIEN system.

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.

AI/ML Overview

The provided text is a 510(k) summary for the Lightlab Imaging, Inc. ILUMIEN with Dragonfly OPTIS Imaging Catheter. It indicates that the device has been found substantially equivalent to a predicate device (Lightlab Imaging, Inc. ILUMIEN, K111200). However, the document does not contain specific acceptance criteria, reported performance metrics as a table, or details about patient studies for the new device's performance.

The document discusses performance testing in a general sense, noting that hardware/firmware are unchanged and that software verification/validation, as well as design verification/validation (bench testing), were conducted in compliance with FDA regulations. Crucially, it states: "The results of this testing conclude the software has met these requirements. Design verification and validation was also performed on the ILUMIEN and Dragonfly OPTIS Imaging Catheter in compliance with internal design control procedures which included bench testing. The results of this testing concludes the ILUMIEN and Dragonfly OPTIS Imaging Catheter is determined to be safe and effective and is substantially equivalent to the predicate ILUMIEN device."

This implies that the device meets safety and effectiveness requirements, demonstrating substantial equivalence to its predicate, but it does not provide a specific study with acceptance criteria and results. The 510(k) process is about demonstrating substantial equivalence to an already marketed device, not necessarily proving efficacy through new clinical trials with defined acceptance criteria for a novel device.

Therefore, many of the requested details are not available in the provided text.

Here is a summary of what can be extracted or inferred, and what is not available:

1. Table of acceptance criteria and the reported device performance

Not available in the provided text. The document states that testing was conducted and concluded the device is safe, effective, and substantially equivalent, but it does not specify quantitative acceptance criteria or detailed performance metrics. It refers to compliance with various electrical safety, EMI, laser safety, and DICOM standards, but these are compliance standards, not performance thresholds for clinical accuracy or diagnostic capabilities.

2. Sample size used for the test set and the data provenance

Not available in the provided text. The document mentions "bench testing" for design verification and validation but does not specify sample sizes or data provenance (e.g., country of origin, retrospective/prospective) for any test set that would evaluate clinical performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not available in the provided text. There is no mention of experts establishing ground truth for evaluating clinical performance. The testing described focuses on engineering compliance and bench tests.

4. Adjudication method for the test set

Not available in the provided text. As clinical performance testing with a ground truth established by experts is not described, an adjudication method is also not mentioned.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size

No, this was not done or at least not described in the document. The document does not mention any MRMC studies or human reader performance with or without AI assistance. The device is an imaging system and catheter, not an AI-based diagnostic tool that assists human readers in the way typically evaluated by MRMC studies.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not explicitly described as such. The device is an imaging system that produces OCT images and FFR parameters for a physician's use. It's not an algorithm producing a diagnostic output without human interpretation. Its performance is evaluated mechanically and through software validation, as outlined in the general "performance testing" section, but not in terms of standalone diagnostic accuracy in a clinical sense.

7. The type of ground truth used

Not explicitly stated in a clinical context. For the engineering and software validation, the "ground truth" would be established by the specifications and expected behavior based on internal design control procedures and established standards (e.g., UL, IEC, DICOM, FDA regulations). For the "imaging" aspect, the ground truth would be the physical properties of the tested objects in bench experiments. No pathology or outcomes data is mentioned as ground truth.

8. The sample size for the training set

Not applicable/Not available. The document describes modifications and upgrades to an existing imaging system and catheter. It does not refer to a machine learning or AI model that would require a "training set" in the conventional sense. The "software has been upgraded to revision D.2," indicating software development and testing, but not machine learning training.

9. How the ground truth for the training set was established

Not applicable/Not available. As there's no mention of a machine learning training set, there's no information on how its ground truth would be established.

In summary: The provided 510(k) summary focuses on demonstrating substantial equivalence through compliance with standards, verification, and validation of hardware and software modifications. It does not include specific clinical studies with defined acceptance criteria or expert-adjudicated performance data for the new device. The conclusion of substantial equivalence is based on the updated device having the same fundamental technological characteristics and indications for use as the predicate, with performance verified through bench testing and software validation against engineering standards and internal design controls.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, with a wavy line below them.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 5, 2015

Lightlab Imaging, Inc. Jeffrey Roberts Principal Regulatory Affairs Specialist 4 Robbins Road Westford, Massachusetts 01886

Re: K150237

Trade/Device Name: ILUMIEN with Dragonfly OPTIS Imaging Catheter Regulation Number: 21 CFR 892.1960 Regulation Name: Radiographic Intensifying Screen Regulatory Class: Class II Product Code: NOO. DOO Dated: March 3, 2015 Received: March 6, 2015

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

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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,

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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3. INDICATIONS FOR USE

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) Not yet assigned

Device Name

ILUMIEN with Dragonfly OPTIS Imaging Catheter

Indications for Use (Describe)

The ILUMIEN with C7 Dragonfly, Dragonfly OPTIS Imaging Catheter is intended for the 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 OPTS 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 II.UMIEN 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)	Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
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FORM FDA 3881 (8/14) Page 1 of 1

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Lightlab Imaging, Inc. ILUMIEN AND DragonflyTM Optis™ Imaging Catheter

510(k) Summary (per 21 CFR 807.92(c))

1. SPONSOR/MANUFACTURER

LightLab Imaging, Inc. 4 Robbins Road Westford, MA 01886

Contact Person:	Jeffrey Roberts
Telephone:	978-577-3451

1/29/15 Date Prepared:

2. DEVICE NAME

Proprietary Name:	ILUMIEN
Common/Usual Name:	Ultrasonic pulsed echo imaging system
Classification Name:	Ultrasonic pulsed echo imaging system
Proprietary Name:	The Dragonfly OPTIS Imaging Catheter
Common/Usual Name:	Diagnostic Intravascular Catheter
Classification Name:	Diagnostic Intravascular Catheter

3. PREDICATE DEVICE

Predicate Device:	Lightlab Imaging, Inc. ILUMIEN, K11120
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4. DEVICE DESCRIPTION

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equipped with two display monitors (one for the console operator, and the other for the physician), as well as a keyboard and mouse.

5. INDICATION FOR USE

ILUMIEN

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Dragonfly OPTIS Imaging Catheter

6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE ILUMIEN

The ILUMIEN 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 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 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 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 D.2 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 ●
Improved acquisition workflow display ●
Resting Pd / Pa

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 OCT Imaging System. Thev are both purged through the central catheter with 100% contrast media prior to use.

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In both the Dragonfly OPTIS Imaging Catheter and the predate device emitted and returned reflected light are combined and processed by the ILUMIEN 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
Improved break away joint
Improved purge tube ●
Dual lumen tip
High speed proximal end
155um fiber ●
RFID

7. PERFORMANCE TESTING

The ILUMIEN hardware and firmware is unchanged however previous testing including 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)

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 and Dragonfly OPTIS Imaging Catheter in compliance with internal design control procedures which included bench testing. The results of this testing concludes the ILUMIEN and Dragonfly OPTIS Imaging Catheter is determined to be safe and effective and is substantially equivalent to the predicate ILUMIEN device.

Regulation Number and Section

§ 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.