The C7 XR™ Imaging System with C7 Dragonfly™ 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™ Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The C7 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 C7 XR™ Imaging 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.

Device Description

The C7 XR™ Imaging System K093857 (C7 XR) and Dragonfly™ Imaging Catheter (Dragonfly Catheter or DF) provide images of the coronary arteries in patients who are candidates for transluminal interventional procedures. The system 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 C7 XR will include two USB receivers to accept radiofrequency signals from a distal intracoronary pressure transducer and a proximal aortic pressure transducer and display the acquired pressure waveforms and calculated Fractional Flow Reserve on the C7 XR system monitor.

The C7 with FFR system consists of the following components:

C7 XR Imaging System (K093857): A cart-mounted computer and optical engine control the device and function as user interface, display and data storage. It includes the Drive-motor and Optical Coupler (DOC). The DOC is an optical-electro-mechanical device that provides the optical interconnection between the C7 XR and Dragonfly Catheter, and controls the rotational and axial motion of the fiber-optic core within the catheter and will include two USB receivers to accept radiofrequency signals from the distal intracoronary pressure transducer and a proximal aortic pressure transducer.

AI/ML Overview

The provided text describes a 510(k) submission for the C7 XR™ Imaging System with Fractional Flow Reserve (FFR) and primarily focuses on its substantial equivalence to predicate devices and adherence to various standards. While it mentions "Clinical performance evaluation (Usability Testing)" for equivalence, it does not provide detailed information about specific acceptance criteria for system performance regarding FFR calculations or a study proving those criteria are met.

Therefore, the following information cannot be extracted from the provided text:

A table of acceptance criteria and the reported device performance.
Sample sizes used for the test set and data provenance.
Number of experts used to establish ground truth.
Qualifications of those experts.
Adjudication method.
Multi-reader multi-case (MRMC) comparative effectiveness study details.
Standalone (algorithm only) performance study details.
Type of ground truth used.
Sample size for the training set.
How the ground truth for the training set was established.

The text is a regulatory submission for a device modification, focusing on safety, effectiveness, and substantial equivalence, not a detailed clinical performance study report.

Information Extracted from the Text (as relevant to the request, even if it highlights missing information):

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

Acceptance Criteria: Not explicitly stated in terms of performance metrics for FFR accuracy or any other quantitative measure. The submission relies on "Usability Testing" and compliance with standards for substantial equivalence.
Reported Device Performance: No specific performance metrics (e.g., accuracy, sensitivity, specificity, or numerical concordance for FFR values) are reported in this summary.

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

Sample Size: Not specified. The clinical performance evaluation is referred to as "Usability Testing," which typically focuses on user interaction rather than extensive FFR accuracy testing against a gold standard.
Data Provenance: Not specified.

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

Not specified.

4. Adjudication method for the test set

Not specified.

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 MRMC study is mentioned. The device provides "Fractional Flow Reserve (FFR)" which is a physiological parameter calculated from pressure transducers, not an AI interpretation of images requiring human reader comparative effectiveness. The text indicates that "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," implying FFR (the output of the device) is an input to human clinical judgment, rather than the device assisting human readers in interpreting complex images directly.

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

The device calculates FFR based on pressure transducer signals and displays it. It is inherently a "standalone" calculation, as it's an automated measurement. However, there are no reported performance metrics for this calculation within this document. The FFR calculation itself is well-established in cardiology. The submission focuses on the incorporation of this functionality into the C7 XR system and its equivalence to predicate FFR devices (RadiAnalyzer® Xpress and Pressure Wire®).

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

Not specified. For FFR, the ground truth would typically be the measurement itself using an established reference method, but no such comparison data is presented. The "Usability Testing" mentioned would not typically establish this kind of ground truth.

8. The sample size for the training set

Not applicable, as this is a device incorporating a known physiological measurement technique (FFR) and not a machine learning algorithm requiring a training set in the conventional sense. The "algorithm" for FFR calculation is based on principles of fluid dynamics.

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

Not applicable (see point 8).

Summary

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K///201

AUG 1 0 2011

510(k) SUMMARY as required per 807.92(c)

LightLab Imaging, Inc. Submitter's Name and Address: One Technology Park Drive Westford, MA 01886

Name, Title, and Telephone Number of Contact:

Bryan Cowell, M.Sc., RAC Principal Regulatory Affairs Specialist Tel: (978) 399-1073 Fax: (978) 692-1409 bcowell@sjm.com

Date submission was prepared: April 28, 2011

Device Name:

C7 XRTM Imaging System with Fractional Flow Reserve (FFR) (ILUMIEN Guided Therapy System)

Common Name:

Imaging system

Product Code:	NQQ
Class:	II
Classification Name and Rule:	Ultrasonic Pulsed Echo Imaging System

Classification Panel:

21 CFR § 892.1560

Establishment Registration:

Establishment:

LightLab Imaging, Inc. One Technology Park Drive Westford, MA 01886

Registration Number: 3004672267

Owner/Operator:

LightLab Imaging, Inc. One Technology Park Drive Westford, MA 01886 Owner /Operator Number: 9101521

Legally Marketed Device Identification:

Optical Coherence Tomography Imaging System

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Proposed Device Description:

The C7 with FFR system consists of the following components:

Proposed Intended Use:

C7 XR System (K093857) modification for Fractional Flow Reserve

The C7 XR™ Imaging System with C7 Dragonfly™ Imaging Catheter is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The C7 DragonflyTM Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The C7 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.

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Predicate Devices:

K093857 510(k) No .: . C7 XRTM Imaging System with C7 DragonflyTM Imaging Catheter Trade Name: SE Date: 04/30/2010 Manufacturer: LightLab Imaging, Inc.
. 510(k) No .: K092105 Trade Name: RadiAnalyzer® Xpress SE Date: 10/09/2009 Manufacturer: Radi Medical Systems AB, Inc.
510(k) No.: K080813 . Trade Name: Pressure Wire® SE Date: 7/01/2008 Manufacturer: Radi Medical Systems AB, Inc.

Substantial Equivalence:

Assessment of non-clinical performance data for equivalence: The C7 XRTM Imaging System with FFR was tested in accordance with applicable standards and internal design control procedures and was determined to be as safe and effective for its intended use as the predicate device(s).

Assessment of clinical performance data for equivalence:

Clinical performance evaluation (Usability Testing) indicates that the C7 XR™ Imaging System with FFR is substantially equivalent to the predicate devices C7 XR™ Imaging System (K093857) and RadiAnalyzer® Xpress (K092105):

Sterilization:

Not applicable. The C7 XR™ Imaging System with FFR is composed of the C7 XR System which is not supplied sterile. There are no modifications to the Dragonfly catheter in this submission.

Biocompatibility:

Not applicable. The C7 XR™ Imaging System with FFR does not directly contact the patient. If patient contact is made by C7 XR™ Imaging System with FFR it is transient and should be with intact unbroken skin. There are no modifications to the Dragonfly catheter in this submission.

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K111201

Standards and Guidance Documentation for reference:

DocumentNumber/Standard	Description
ISO 13485	Medical devices -- Quality management systems --Requirements for regulatory purposes
ISO 14971	Medical devices -- Application of risk management to medicaldevices
ISO 15223	Medical devices -- Symbols to be used with medical devicelabels, labeling and information to be supplied
ISO 11607-1	Packaging for terminally sterilized medical devices -- Part 1:Requirements for materials, sterile barrier systems andpackaging systems
ISO 11607-2	Packaging for terminally sterilized medical devices -- Part 2:Validation requirements for forming, sealing and assemblyprocesses
ISO 10993	Biological evaluation of medical devices
EN980	Symbols for use in Labeling of Medical Devices
IEC 60601-1	Medical electrical equipment - General requirements for basicsafety and essential performance
IEC 60601-1-1	Medical electrical equipment - Part 1-1: General requirementsfor safety - Collateral standard: Safety requirements for medicalelectrical systems
IEC 60601-1-2	Medical electrical equipment - Part 1-2: General requirementsfor basic safety and essential performance - Collateral standard:Electromagnetic compatibility - Requirements and tests
IEC 60825-1	IEC 60825-1 - Part 1: Equipment classification, requirementsand user's guide
IEC 62304	Medical device software - Software lifecycle processes
EN 62366	Medical devices. Application of usability engineering tomedical devices
EN 60825-1	Safety of laser products - Part 1: Equipment classification andrequirements
404P08	Software Development Process
405P02	Software Validation Procedure
IEC 60601-1-4	Medical electrical equipment - Part 1: General Requirementsfor Safety - Collateral Standard: Programmable electricalmedical systems
IEC 60601-1-6	Medical electrical equipment - Part 1-6: General requirementsfor basic safety and essential performance - Collateral standard:Usability

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract emblem featuring three stylized horizontal lines that resemble an eagle or bird in flight.

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

LightLab Imaging, Inc. c/o Mr. Bryan Cowell Principal Regulatory Affairs Specialist One Technology Park Drive Westford, MA 01886

AUG 1 0 2011

Re: K111201

Trade/Device Name: C7 XR Imaging System with Fractional Flow Reserve (FFR) Regulatory Number: 21 CFR 892.1560 Regulation Name: Ultrasonic Pulsed Echo Imaging System Regulatory Class: II (two) Product Code: NOO Dated: July 13, 2011 Received: July 15, 2011

Dear Mr. Cowell:

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.

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

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Page 2 - Mr. Bryan Cowell

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 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/ReportalProblem/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 vours.

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): TBD

Device Name: C7 XRTM Imaging System with FFR (Fractional Flow Reserve)

Intended Use:

Prescription Use(Part 21 CFR 801 Subpart D)	✓	AND/OR	Over-The-Counter Use(21 CFR 801 Subpart C)
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Cardiovascular Devices

510(k) Number	K111201
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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.