SPY INTRA-OPERATIVE IMAGING SYSTEM: SP2000

K042961 · Novadaq Technologies, Inc. · IZI · Jan 19, 2005 · Radiology

Device Facts

• Record ID: K042961
• Device Name: SPY INTRA-OPERATIVE IMAGING SYSTEM: SP2000
• Applicant: Novadaq Technologies, Inc.
• Product Code: IZI · Radiology
• Decision Date: Jan 19, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1600
• Device Class: Class 2

Intended Use

For use in intra-operative visual assessment of the coronary vasculature and bypass grafts during coronary artery bypass (CABG) surgery.

Device Story

SPY Intra-operative Imaging System (SP2000) provides real-time visualization of coronary vasculature and bypass grafts during CABG surgery. System uses laser light source to illuminate heart surface; Indocyanine Green (ICG) dye injected intravenously (central venous line, bypass pump, or cardioplegia line). Laser light causes ICG fluorescence; infrared energy emitted by dye captured by CCD camera. System produces fluorescent images of blood vessels and grafts; surgeon views, records, and replays images intraoperatively. Output assists surgeon in evaluating integrity of coronary vasculature and bypass grafts. Used in OR by surgeons to confirm graft patency and vascular integrity, potentially improving surgical outcomes.

Clinical Evidence

Clinical evidence includes human experience in 950 CABG procedures. Study results: no thermal damage to heart tissue; no changes to ECG or arterial pressures; no acute or long-term cellular, renal, or hepatic effects. Image quality reported as equivalent to radiographic angiography with ability to acquire images of entire vascular bed on each aspect of heart. Exposure levels (35 mW/cm2) confirmed well below ANSI MPE limits (327 mW/cm2).

Technological Characteristics

System utilizes laser-induced fluorescence imaging. Components include laser light source, CCD camera, and ICG contrast agent. Electrical safety per IEC 60601-1/UL2601-1; EMC per IEC 60601-1-2; laser safety per 21 CFR 1040, ANSI Z136.1, and ANSI Z136.3. Operates as intra-operative imaging system for real-time visualization.

Indications for Use

Indicated for intra-operative visual assessment of coronary vasculature and bypass grafts in patients undergoing coronary artery bypass (CABG) surgery.

Regulatory Classification

Identification

An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• Philips Integra Series 2 Systems (K984545)
• Heidelberg Retinal Angiographic System (K944261)

Submission Summary (Full Text)

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JAN 1 9 2005

K042961
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# 510(k) Summary

| Common Name: | Fluorescent Angiographic System |
|-----------------|----------------------------------------------------------------------------------------------------------------------------|
| Classification: | 21 CFR 892.1600 |
| Manufacturer: | Novadaq Technologies Inc.<br>2585 Skymark Avenue<br>Suite 306<br>Mississauga, Ontario<br>Canada<br>L4W 4L5<br>905.629.3822 |
| Contact Name: | Rick Mangat<br>Vice President - Cardiac |

#### Legally Marketed Predicate Devices:

The Novadaq SPY™ Intra-operative Imaging System: SP2000 is equivalent to two predicate devices.

The Philips Integra Series 2 Systems (K984545) is an Angiographic X-Ray System intended for use in acquiring diagnostic quality images during cardiac, angiographic, vascular, neurovascular, and interventional applications.

The Heidelberg Retinal Angiographic System (K944261) is also equivalent to the SPY™ system. The indication for use is to acquire images of the posterior segment of the eye and to analyze these images quantitatively for diagnostic purposes.

#### Device Description:

The SPYTM Intra-operative Imaging System: SP2000 is indicated for use for intraoperative visual assessment of the coronary vasculature and grafts during CABG surgery.

The SPYTM system provides the surgeon with the capability to view, record and replay fluorescent images of blood vessels and bypass grafts of the heart. A laser light source is used to illuminate the heart surface. Indocyanine Green (ICG) is injected intravenously through the central venous line, bypass pump or cardioplegia line and, while coursing through the coronary arteries and grafts, the absorption of laser light causes excitation of the dye followed by emission of infrared energy. The result is a fluorescent image of the coronary vasculature. A CCD camera captures the image. These images are used to evaluate the integrity of the coronary vasculature and bypass grafts.

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# Testing:

Animal studies, human experience and in vitro testing were conducted to support the safe and effective use of the SPYTM system.

# In Vitro Testing:

Testing of the SPYTM system was completed in conformance with the following standards. The SPYTM system successfully met all of the requirements for these standards.

- 1. Electrical per IEC 60601-1 and UL2601-1
- 2. Electromagnetic Compatibility per IEC 60601-1-2
- 3. Light Emitting Laser Products per 21 CFR 1040
- 4. Safe Use of Lasers in Health Care Facilities per ANSI Z136.3
- 5. American National Standard for Safe Use of Lasers per ANSI Z136.1

# In Vivo Testing:

Animal studies and human experience in 950 CABG procedures were completed to demonstrate safety and effectiveness.

- 1. The exposure for the SPY™ system is 35 mW/cm2 which is far below the MPE of 327 mW/cm2 established by ANSI for exposure to the skin.
- 2. Use of the SPYTM system does not cause any thermal damage to the heart tissue.
- 3. There were no changes to the electrocardiograms or arterial pressures during and following SPYTM use.
- 4. There were no acute or long-term cellular effects of using the SPYTM system.
- 5. There were no acute or long-term renal or hepatic effects of using the SPYTM system.
- 6. The image quality of the SPYTM system was equivalent to radiographic angiography.
- 7. The SPYTM system was able to acquire excellent images of the entire vascular bed on each aspect of the heart.

# Conclusions:

The above testing demonstrates that the SPY™ Intra-operative Imaging System is safe and effective in imaging the coronary vasculature and bypass grafts intraoperatively and is equivalent to the predicate devices.

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Public Health Service

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JAN 1 9 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Novadaq Technologies Inc. c/o Mr. Rick Mangat Vice President - Cardiac 2585 Skymark Avenue, Suite 306 Mississauga, Ontario Canada L4W 4L5

Re: K042961

Trade Name: SPY™ Intra-operative Imaging System: SP2000 Regulation Number: 21 CFR 892.1600 Regulation Name: Angiographic X-Ray System Regulatory Class: II (two) Product Code: IZI Dated: November 23, 2004 Received: November 24, 2004

Dear Mr. Mangat:

We have reviewed your Section 510(k) premarket notification of intent to market the device to we nave reviewed your bection 910(t) processor is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule for regars mannetted to the Medical Device American be to commerce proc to May 20, 1776, the enasting with the provisions of the Federal Food. Drug.
devices that have been reclassified in accordance with the provisions of the UNAA devices that have been recalismed in acceranted will of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval ap You may, therefore, market the device, subject to the general controls provisions of the Act. The You may, therefore, market the devrees, becaments for annual registration, listing of general controls provisions of the rest 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 il your device is classified (see above) ins. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major and chick on ED may be subject to such additional controller Little 21, Parts 800 to 898. In addition, FDA may be found in the Oods of Pouchs concerning your device in the Federal Register.

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## Page 2 – Mr. Rick Mangat

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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/cdrh/dsma/dsmamain.html

Sincerely yours,

Brimimer 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

510(k) Number (if known): _K042961

Device Name: SPY™ Intra-operative Imaging System: SP2000

Indications For Use:

For use in intra-operative visual assessment of the coronary vasculature and bypass grafts during coronary artery bypass (CABG) surgery.

Prescription Use X (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

B. Blummer Jr.

(División Sign-Off) Division of Cardiovascular Devices 510(K) Number K04096

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