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.

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.

AI/ML Overview

The provided text is a 510(k) summary for the ILUMIEN OPTIS device, which is an ultrasonic pulsed echo imaging system. The primary goal of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to set and meet specific acceptance criteria in the same way a de novo or PMA submission might.

Therefore, the document focuses on demonstrating that the new device shares similar technological characteristics and performance to its predicate. It does not contain specific "acceptance criteria" presented as quantitative clinical performance metrics, nor does it describe a detailed "study that proves the device meets the acceptance criteria" in the way one might expect for a new clinical claim. Instead, the performance testing described is primarily focused on safety, fundamental functionality, and compliance with general medical device standards.

Here's an attempt to answer your request based on the available information, noting the limitations of a 510(k) summary for this type of request:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria for clinical performance (e.g., sensitivity, specificity for a specific diagnostic task) or quantitative clinical performance metrics alongside reported device performance. It primarily focuses on compliance with general standards and demonstrating equivalence to the predicate device.

Acceptance Criterion (Compliance)	Reported Performance
IEC 62304:2006 (Software)	In compliance; software verification and validation conducted to FDA regulations, standards, and guidance document requirements. Results conclude software met requirements.
IEC 60601-1:2005+CORR.1(2006)+CORR.2(2007) (Basic Safety/Essential Performance)	In compliance.
IEC 60825-1:2nd Ed. 2007 (Laser Safety)	In compliance.
21 CFR 1040.10 (Light Emitting Products)	In compliance (sections b5 and b15).
IEC 60601-1-2 Ed.3 (EMC)	In compliance (Electromagnetic emissions and immunity requirements for medical electric equipment-Group 1 Equipment, Class A for non-life supporting equipment).
Hardware and OCT Imaging Parameter Performance	Bench testing and design verification/validation performed in compliance with internal design control procedures, including engine hardware design verification and OCT Imaging Parameter testing. Results conclude the ILUMIEN OPTIS is safe and effective and substantially equivalent to the predicate device.
FFR Measurement Accuracy	Not explicitly defined as a separate acceptance criterion with a specific threshold. The device acquires RF signals from pressure transducers to "determine" FFR, and the physician uses this parameter. The document implies its functionality is equivalent to the predicate by virtue of being an "upgrade" to the engine.

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

The document does not mention a "test set" in the context of clinical data for performance evaluation (e.g., in vivo patient data). The testing described is primarily bench testing, software verification/validation, and compliance with electrical/safety standards. Therefore, information regarding sample size and data provenance (country of origin, retrospective/prospective) for a clinical test set is not provided.

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

This information is not applicable and not provided. The testing described does not involve human experts establishing ground truth for a clinical test set.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not applicable and not provided. There is no mention of a test set requiring adjudication in the context of clinical performance.

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

No such study is described in the document. The device, ILUMIEN OPTIS, is an imaging system and FFR measurement device, not an AI-assisted diagnostic tool that aids human readers in interpreting images in the context of this 510(k). The document states it is an upgrade to an existing imaging system with improved performance through a modified engine design and updated software to accommodate FDML laser support. Its purpose is to acquire and display OCT images and FFR parameters. The physician uses these outputs.

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

This concept is not relevant to the described device as an imaging and FFR measurement system. The device produces images and FFR parameters for physician interpretation and use. No standalone algorithmic diagnostic performance is mentioned.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the performance testing mentioned, the "ground truth" would be related to the specifications and expected outputs of the system (e.g., accurate optical coherence tomography images, correct calculation of FFR based on input pressure signals, compliance with safety and electrical standards, accurate software functionality). This is not a clinical ground truth like pathology or expert consensus on a diagnosis.

8. The sample size for the training set

This information is not applicable and not provided. The device is not described as using machine learning or AI that requires a "training set" in the conventional sense for clinical performance. The software upgrade is to "accommodate FDML laser support," which implies hardware and data processing adjustments, not AI model training.

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

This information is not applicable and not provided, as no training set for an AI/ML model is mentioned.

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, 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

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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

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)

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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

5. INTENDED USE

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.

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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.

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.