C7 XR IMAGING SYSTEM WITH C7 DRAGONFLY IMAGING CATHETER AND DISPOSABLE ACCESSORIES

K093857 · Lightlab Imaging, Inc. · NQQ · Apr 30, 2010 · Radiology

Device Facts

• Record ID: K093857
• Device Name: C7 XR IMAGING SYSTEM WITH C7 DRAGONFLY IMAGING CATHETER AND DISPOSABLE ACCESSORIES
• Applicant: Lightlab Imaging, Inc.
• Product Code: NQQ · Radiology
• Decision Date: Apr 30, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2

Intended Use

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 DragonflyTM 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.

Device Story

C7 XR Imaging System uses near-infrared light via fiber-optic Dragonfly catheter to produce high-resolution, real-time coronary artery images. System includes cart-mounted computer, optical engine, and Device Optical Coupler (DOC) controlling catheter rotation/axial motion. Catheter is sterile, single-use, with fiber-optic core and stainless steel torque wire. Used in catheterization labs by clinicians to visualize coronary anatomy. Off-line workstation allows review/analysis of stored images. Provides cross-sectional lumen area and diameter measurements; assists clinicians in assessing vessel morphology during interventional procedures. Benefits include high-resolution visualization of coronary tissue to guide interventions.

Clinical Evidence

Prospective, multi-center study (n=59) evaluated safety and effectiveness. Primary endpoint: Clear Image Length (median 44.0 mm, exceeding 24 mm hypothesis). Intra/inter-observer reliability for lumen area and image length showed concordance correlation >0.95. Safety: 0% predefined safety events during procedure; 5.1% (3/59) post-procedure (non-Q-wave myocardial infarctions, not device-related). One serious adverse event (sinus bradycardia) reported, not device-related. No deaths.

Technological Characteristics

Near-infrared light imaging system; fiber-optic catheter with stainless steel torque wire; rapid exchange mini-rail tip. System includes cart-mounted computer, optical engine, and DOC. Software-based image processing and display. Complies with ISO 10993 (biocompatibility), EN 60601-1 (electrical), and IEC 60825 (laser safety).

Indications for Use

Indicated for patients who are candidates for transluminal interventional procedures requiring coronary artery imaging. Catheter intended for vessels 2.0-3.5 mm diameter. Contraindicated for use in left main coronary artery or target vessels with previous bypass procedures.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Boston Scientific Galaxy Intravascular Ultrasound System
• Atlantis™ SR Pro Coronary Imaging Catheter (K010707)

Submission Summary (Full Text)

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K093857

# SUMMARY OF SAFETY AND EFFECTIVENESS

### GENERAL INFORMATION 1

### Submitter and Owner of the 510(k) 1.1

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

APR 3 0 2010

### Official Correspondent 1.2

Christine L. Brauer, PhD Regulatory Affairs Consultant 7 Trail House Court Rockville, MD 20850

Telephone: [phone] Fax: [phone] E-mail: [e-mail]

#### Date of Preparation 1.3

April 30, 2010

#### 1.4 510(k) Application

K093857

### NAME OF THE DEVICE 2

#### Trade/Proprietary Name 2.1

C7 XR™ Imaging System C7 Dragonfly™ Imaging Catheter and Disposable Accessories

### Common/Usual Name 2.2

Imaging system Intravascular imaging catheter

### Classification Information 2.3

Ultrasonic Pulsed Echo Imaging System Classification Name: Diagnostic Intravascular Catheter

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### Classification Regulation:21 CFR § 892.1560 21 CFR & 870.1200

II Class: II NOO Product Code: ORD Radiology Panel:

Cardiovascular

### PREDICATE DEVICES ಗ

The predicate devices are the Boston Scientific Galaxy Intravascular Ultrasound System The predicted do need are and the Atlantis™ SR Pro Coronary Imaging Catheter cleared under premarket notification K010707. Together the predicate devices form an imaging system.

### DESCRIPTION OF THE DEVICE ব

The C7 XR™ Imaging System (C7 System) and C7 Dragonfly™ Imaging Catheter (Dragonfly Catheter) provide images of the coronary arteries in patients who are candidates (Dragonif) Sunleter) procedures. The system utilizes fiber-optic technology to for transfallmar interventional provisht reflected from coronary tissue in order to produce high resolution, real-time images.

The system consists of the following components:

- 1. C7 XR™ Imaging System: This cart-mounted computer and optical engine control the entire device and function as user interface and data storage. It includes the the entre as not und tall Coupler (DOC). The DOC is an optical-electro-mechanical device that provides the optical interconnection between the C7 System and device that provides and controls the rotational and axial motion of the fiber-optic core within the catheter.
- 2. C7 Dragonfly™ Imaging Catheter and Disposable Accessories: The Dragonfly Catheter is a sterile, single-use catheter that consists of a fiber optic imaging core and Catherer is a scethe, bingle are external sheath serves two primary functions: 1) to facilitate an external shoulin - The into the coronary artery, and 2) to cover and protect the inner placement of the device one. The optical fiber imaging core rotates inside the imaging sheath and is driven by a stainless steel torque wire. The optical fiber imaging sheath und is arrow of a light to the tissue and receives reflected light. The catheter attaches to the DOC, which is covered with a sterile, single-use plastic I he calleter anaenes to the DOO, triggered by a sterile, single-use pressure transducer.
- 3. Off-line Review Workstation: The Off-line Review Station consists of a personal On-mile Review 17 of ware to allow a healthcare professional to import,

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maintain and review images collected by the C7 System and Dragonfly Catheter. The software is a Microsoft Windows XP application running on a host personal computer. It allows healthcare professionals the convenience to review, analyze and maintain OCT images on a personal computer rather than on the C7 System itself, which is located in the catheterization laboratory.

## 5 INDICATIONS FOR USE AND INTENDED USE

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 DragonflyTM 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.

### TECHNOLOGICAL CHARACTERISTICS COMPARED TO THE PREDICATE 6 DEVICES

The C7 System and Dragonfly Catheter (the LightLab system) and the predicate devices (predicate system) have some different technological characteristics, but also share many technological characteristics. The primary design difference between the LightLab system and the predicate system is use of a near infrared light versus sound waves for imaging.

The LightLab system and the predicate system share many common design and technological f the Digittedo bystems incorporate a disposable, sterile intravascular imaging catheter. Both icatures. Both by Stems morporation vice function, user interface and data storage. Both systems require disposable accessories, including probe covers, for use. A comparison of the similarities of the systems and their components follows.

The LightLab and the predicate systems rely upon an intravascular imaging catheter with a I he Lightebao and are protheans by functions. Both catheters share similar design features, such as a rapid exchange, mini-rail tip design and similar dimensions. Both catheters sucilitate the placement of the device into coronary artery. Both catheters deliver energy to the tissues and collect reflections. The energy source differs between the systems with the the usbes and concert rear infrared light and the predicate system using sound waves. In ErghtDao systems, the energy source (sound waves or near infrared light) has different absorption bout systems, the chergy boards (sources and structures, and these differences are used to create an image.

Both the LightLab and predicate systems rely upon a reusable, electronic, software-based Doth the EightDao and process electrical signals to produce images, to provide a unn to control device ranenon, to procent manage data. These systems are also responsible user interface und display, and to boverfaces with intravascular imaging catheters. In both for the clectio mechanical ophromotesses patterns and signals received from the intravascular systems, the company these signals into an image that is displayed.

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Both the LightLab and predicate system incorporate a user interface. Both systems provide a Both the Lightedd and and These features include the ability to annotate images and computer aided measurements. Both systems store the collected image data with proper patient identification information and procedural details. Both systems store images in digital format and allow for the review of images after collection.

## 7 PERFORMANCE TESTING

The 510(k) submission provided performance data to establish the substantial equivalence of the C7 System and Dragonfly Catheter (LightLab system) compared to the predicate devices (predicate system). These performance data.included: biocompatibility data, software (predication and validation testing, electrical safety, electromagnetic compatibility and laser safety testing, laboratory testing, animal testing and clinical testing.

Biocompatibility: LightLab conducted a series of biocompatibility studies to demonstrate that the catheter device materials are safe, suitable and appropriate for their intended use, and in compliance with two international standards (ISO 10993:1 and ISO 10993:4). The device successfully passed the biocompatibility testing.

Software Testing: LightLab performed system level software verification and validation testing to demonstrate the system performs as intended. The software passed all requirements.

International and Performance Standards: The LightLab system was tested to international safety standards, including electrical and electromagnetic safety testing (EN 60601-1, 60601surely sumards, merating cres system was tested and evaluated for its compliance with 21 CFR Part 1040 and internal safety standards for laser products and optical fiber communication systems (IEC 60825). The system met all standards.

Bench (Performance) Testing: LightLab performed a series of bench tests, including Dench (i erformance) resting. I ests, to demonstrate its system meets its performance specifications. The LightLab system passed the test requirements. LightLab also conducted specifications: "The Erginated the measurement accuracy of its system compared to the predicate system. In this study, LightLab used a simulated model of the coronary vasculature produce system. In this basily of different sizes. Both the LightLab system and the predicate system were used separately to visualize and measure the arterial phantoms. The presults demonstrate that the measurement accuracy of the LightLab system compared favorably to the predicate system. The LightLab system measurements had an error of 3.7% for diameter and 8.6% for area; the corresponding predicate system measurements had an for thanker and 0.070 tor area, 17.0% for area. These values represent the upper 95" percentile limits of the error distribution for each modality.

Animal Testing: LightLab conducted an animal study to evaluate the safety and Ammar Testing: "EightEast connated to the predicate system. The LightLab system encerveness of its of the official compisition were similar between the two performent groups (LightLab system versus predicate system).

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Clinical Study: LightLab Imaging, Inc. conducted a prospective, multi-center study under a Significant risk IDE application to confirm the safety and effectiveness of the LightLab" C7 Significally Instern and C7 Dragonfly Imaging Catheter, and to demonstrate its ability to obtain images suitable for the measurement of lumen diameter and cross-sectional area within a stent and artery. The study's primary efficacy endpoint was Clear Image Length, whiled as the cumulative length of the OCT pullback containing clear cross-sectional image frames. The study's primary hypothesis was that the true, population median Clear Image Length exceeded 24 mm. Additionally, intra- and inter-observer reliability (variability) of cross-sectional lumen area measurements and Clear Image Length measurements were evaluated. Safety was evaluated based on the incidence of the following events: angina and/or ST segment changes that persist despite treatment, spasm that persists despite treatment, ventricular tachycardia and ventricular fibrillation, angiographic dissection, peritreatinent, ventronal infarction, perforation, angiographic no-reflow phenomenon, thrombus formation, distal embolization, emergency coronary artery bypass surgery, and death.

The results demonstrated that the LightLab system was safe and effective for the visualization of coronary arteries. The median Clear Image Length in imaged subjects was 44.0 mm which was statistically significant and close to the maximum (system-limited) 44.0 mill which of 50 mm. Substudy variability analyses were conducted which assessed the pundated for of of to milled of Clear Image Length and cross-sectional lumen area measurements both within one reader and between the two readers. These analyses concluded that both oom within one reader agreements were very good or excellent. Lin Concordance Correlation milla-und meer all 0.95 or greater. None (0/59, 0.0%) of the predefined safety events Occurred during the procedure and 3 (3/59, 5.1%) occurred during the post-procedure period. occarred to be events were peri-procedural, non Q-wave myocardial infarctions and none of them were adjudicated to have been device-related. Regarding adverse events, one (1/59, them were adjudited to serious adverse event which was judged by the DSMB to be related to 11:70) subject had a berroad as . No subjects died during the clinical study. One (1/59, 1.7%) the procedure bat not als adverse event which was sinus bradycardia although this event was not determined to be serious.

## 8 CONCLUSIONS

This 510(k) submission demonstrates that the C7 System and Dragonfly Catheter are substantially equivalent to the predicate devices.

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread, facing to the right.

### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

LightLab Imaging Inc. C/O Christine Brauer, Ph.D. Brauer Device Consultants, LLC 7 Trail House Court Rockville, MD 20850

APR 3 0 2010

Re: K093857

Trade Name: C7 XR Imaging System with C7 Dragonfly Imaging Catheter and Disposable Accessories Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic Pulsed Echo Imaging System Regulatory Class: Class II Product Code: NQQ, ORD Dated: April 26, 2010 Received: April 27, 2010

Dear Dr. Brauer:

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

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Page 2 - Christine L. Brauer, PhD

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/ucm11.5809.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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,
W. Med

r 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 (K093857):

C7 XR™ Imaging System Device Name:

C7 Dragonfly™ Imaging Catheter and Disposable Accessories

Indications for Use:

The C7 XR™ Imaging System with C7 Dragonfly™ Imaging Catheter is intended for the The OF XF - Thiaging Offective and is indicated in patients who are candidates for imaging of coronary attence and is interest in the C7 Dragonfly™ Imaging Catheter is intended translanimal interventional procedures . The C7 Dragonfly™ Imaging Catheter is not ior use in vessels 2.0 to 0.0 min in alamoter. The or or in a target vessel which has undergone a previous bypass procedure.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)


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