JAN 1 9 2005
`
`510(k) Summary
`
`K04ZS6I
`
`Common Name:
`Classification:
`Manufacturer:
`
`Contact Name:
`
`Fluorescent Angiographic System
`21 CFR 892.1600
`Novadaq Technologies Inc,
`2585 Skymark Avenue
`Suite 306
`Mississauga, Ontario
`Canada
`L4W 4L5
`905.629.3822
`Rick Mangat
`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 SPY™ Intra-operative Imaging System: SP2000 is indicated for use for intra
`operative visual assessment of the coronary vasculature and grafts during CABG
`surgery.
`
`The SPY™ 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.
`
`6
`
` VISIONSENSE - 1012
` VISIONSENSE v.
` NOVADAQ TECHNOLOGIESR
` Page 1 of 6
`
`
`
`510(k) Summary
`
`K04ZS6I
`
`Common Name:
`Classification:
`Manufacturer:
`
`Contact Name:
`
`Fluorescent Angiographic System
`21 CFR 892.1600
`Novadaq Technologies Inc,
`2585 Skymark Avenue
`Suite 306
`Mississauga, Ontario
`Canada
`L4W 4L5
`905.629.3822
`Rick Mangat
`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 SPY™ Intra-operative Imaging System: SP2000 is indicated for use for intra
`operative visual assessment of the coronary vasculature and grafts during CABG
`surgery.
`
`The SPY™ 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.
`
`6
`
` VISIONSENSE - 1012
` VISIONSENSE v.
` NOVADAQ TECHNOLOGIESR
` Page 1 of 6
`
`
`
`Testing:
`
`f. ('^
`
`Animal studies, human experience and in vitro testing were conducted to support
`the safe and effective use of the SPY™ system.
`
`In Vitro Testing:
`
`Testing of the SPY™ system was completed in conformance with the following
`standards. The SPY™ system successfully met all of the requirements for these
`standards.
`
`1. Electrical per IEC 60601-1 and UL260M
`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 SPY™ 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 SPY™ use.
`4. There were no acute or long-term cellular effects of using the SPY™
`system.
`5. There were no acute or long-term renal or hepatic effects of using the
`SPY™ system,
`6. The image quality of the SPY™ system was equivalent to radiographic
`angiography.
`7. The SPY™ 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 intra-
`operatively and is equivalent to the predicate devices.
`
`7
`
` VISIONSENSE - 1012
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` NOVADAQ TECHNOLOGIESR
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`
`
`
`DEPARTMENT OF HEALTH & HUMAN SERVICES
`
`Public Health Service
`
`£
`
`JAN 1 9 2005
`
`Pood and Drug Administration
`9200 Corporate Boulevard
`Rockville MD 20850
`
`Novadaq Technologies Inc.
`c/o Mr. Rick Mangat
`Vice President - Cardiac
`2585 Sky mark 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
`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 such 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.
`
` VISIONSENSE - 1012
` VISIONSENSE v.
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` Page 3 of 6
`
`
`
`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(lc)
`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 (240) 276-0120. Also, please note the regulation entitled,
`"Misbranding by reference to premarket notification" (21 CFR 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
`(800) 638-2041 or (301) 443-6597 or at its Internet address
`http ://www.fda, gov/cdrh/dsma/dsmamain.html
`
`Sincerely yours,
`
`Bram D. Zuckerman, M.D.
`Director
`Division of Cardiovascular Devices
`Office of Device Evaluation
`Center for Devices and
`Radiological Health
`
`Enclosure
`
` VISIONSENSE - 1012
` VISIONSENSE v.
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` Page 4 of 6
`
`
`
`Indications for Use
`
`510(k) Number (if known):, K04gff61
`
`Device Name: SPY™ intra^eratv^lgLMkg^temiSjP2Q.M
`
`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 $01 Subpart C)
`
`(PLEASE DO NOT WRITE BELOW THIS LINE-GONTINUE ON ANOTHER PAGE IF
`NEEDED)
`
`Concurrence of CDRH, Office of Device Evaluation (ODE)
`
`Division of Cardiovascular Devices
`5i0(kj NumberJjoj/jK/ [
`
`Page 1 of I
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` VISIONSENSE - 1012
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`
`
` VISIONSENSE - 1012
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`
`
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