The SPY Fluorescent Imaging System is intended to provide fluorescent images for the visual assessment of blood flow in vessels and related tissue perfusion during cardiovascular surgical procedures.

Device Description

The Novadaq® Technologies SPY® Fluorescent Imaging System consists of 2 components:

the SP2000 Imaging Device; and
the SPY Paq®

The SPY Pag constitutes a 6 procedure kit. Each SPY Pag contains The Sir I aq constitution a o procours ... " procedures ... " leG and diluent to carry out 6 cardiovascular imaging procedures. Novadaq provides the ICG as it is sold by the manufacturer and does not adulterate the integrity of the original packaging or labeling. IC-Green™ (Akorn, Inc.) is packaged in an IC-Green kit that contains 6 x 25 mg vials of ICG along with 6 x 10 ml ampules of Aqueous Solvent.

The SP2000 Imaging Device consists of an imaging head containing a charge coupled device (CCD) camera, a laser light source, motion sensor and distance sensor attached via an articulating arm to a mobile cart. The mobile cart contains a flat panel display, computer, electronics enclosure and printer.

The SPY System provides the surgeon with the capability to view record and replay fluorescent images of blood flow in vessels and bypass grafts of the heart. A laser light source is used to illuminate the area of interest. ICG is injected intravenously through the central venous line, bypass pump, cardioplegia line and coronary graft and while it is passing through the vessels, the absorption of laser light causes excitation of the dye followed by emission of infrared energy. The result is a fluorescent image of blood flow and related tissue perfusion in the vessels. A CCD camera captures the image. These images are used to evaluate the integrity of the coronary vasculature and blood flow in the heart and bypass grafts.

AI/ML Overview

The provided text describes the Novadaq SPY Fluorescent Imaging System (SPY System), model SP2000, and its expanded indications for use. It outlines testing conducted to support the device's safety and effectiveness.

Here’s a breakdown of the information requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the traditional sense of specific, quantifiable metrics that the device must achieve (e.g., sensitivity, specificity, accuracy against a gold standard). Instead, it describes general safety and performance assessments. The reported device performance is qualitative and based on the ability to produce high-quality images and a lack of adverse effects.

Acceptance Criteria Category (Implied)	Reported Device Performance
Safety - Electrical	Successfully met all requirements per IEC 60601-1 and UL2601-1.
Safety - Electromagnetic Compatibility	Successfully met all requirements per IEC 60601-1-2.
Safety - Laser Products	Successfully met requirements per 21 CFR 1040 and ANSI Z136.3, ANSI Z136.1.
Safety - Thermal Effects	No increase in myocardial tissue temperature (pig studies). Exposure (35 mW/cm²) is far below maximum permissible exposure (327 mW/cm²) by ANSI. Does not cause thermal damage, even after repeated imaging.
Safety - Physiological Effects	No detrimental effects on heart function, coronary flow, or peripheral pressure (pig studies). No changes in electrocardiograms or arterial pressures during and/or following SPY use.
Safety - Cellular/Organ Effects	No adverse acute or long-term cellular, renal, or hepatic effects reported in human use (over 4000 CABG procedures). No acute or long-term cellular, renal, or hepatic effects (pig studies).
Effectiveness - Image Quality	Able to acquire high-quality images in a simple and reproducible manner (pig studies). Capable of visualizing all coronary beds with high-quality images (pig studies). Able to acquire high-quality images of the entire vascular bed on each area of interest. Produces high-quality and resolution images of the entire vascular bed of the point of interest (human experience).
Effectiveness - Clinical Utility	Non-invasively, quickly, and safely identified 17 conduits requiring revision in 311 patients, visualizing lack of patency clearly (human literature). Capable of imaging through the skin to provide visual assessment of dermal and subdermal blood flow.

2. Sample Size Used for the Test Set and Data Provenance

Human Data:
- Sample Size: Over 4000 CABG procedures (for general market availability and safety data) and 311 patients (for specific outcome data mentioned in peer-reviewed literature for identifying conduits requiring revision).
- Data Provenance: "Commercially available in the United States of America, Japan, Europe and Canada." This suggests retrospective (post-market surveillance) data collected from various countries.
Animal Data:
- Sample Size: Six pig studies.
- Data Provenance: Not explicitly stated, but likely conducted in a controlled lab or animal facility. This would be prospective data for the original 510(k).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not specify the number of experts or their qualifications for establishing ground truth for the human or animal test sets.

For the human data, the "literature reports" refer to surgeons (implied experts) identifying an issue and performing revisions, suggesting the clinical judgment of the operating surgeon as a form of ground truth for that specific outcome.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method. For the human data, the "literature reports that the SPY System was able to... identify 17 conduits... that required revision," implying that the need for revision was determined by the operating surgeon(s) based on intraoperative findings and the SPY system's input, but no formal adjudication process is detailed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a MRMC comparative effectiveness study was not explicitly mentioned or described. The document focuses on the standalone performance and safety of the device, and qualitative improvements due to intraoperative visualization. It doesn't report on an effect size of human readers improving with AI vs. without AI assistance, as this is not an AI-assisted device in the sense of predictive or diagnostic algorithms.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The SPY System is an imaging device meant for human-in-the-loop performance. It provides visual information to the surgeon. Therefore, a purely "standalone" (algorithm-only) performance evaluation, separate from human interpretation, is not applicable or described for this type of device. The system's "performance" is its ability to acquire high-quality images of blood flow for human assessment.

7. The Type of Ground Truth Used

Human Data:
- For safety: Absence of reported adverse acute or long-term cellular, renal, or hepatic effects; absence of reported major complications in over 4000 CABG procedures.
- For effectiveness: Surgeon judgment/intraoperative findings (the need for graft revision identified by the SPY system and confirmed by the surgeon), and the ability to visualize various vascular beds and perfusion.
Animal Data:
- Direct physiological measurements (e.g., heart function, coronary flow, peripheral pressure, myocardial tissue temperature, electrocardiograms, arterial pressures, cellular, renal, hepatic effects).
- Visual assessment by researchers/veterinarians of image quality and visualization capabilities.

8. The Sample Size for the Training Set

This report does not mention a training set in the context of an AI/machine learning algorithm. The SPY System is an imaging device, not a diagnostic algorithm that requires a "training set" in the typical sense. Its development would involve engineering and optical design validations, not data-driven model training.

9. How the Ground Truth for the Training Set Was Established

As there is no mention of a training set for an AI/machine learning algorithm, this question is not applicable based on the provided text.

Summary

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510(k) Summary

Trade Name:	SPY® Fluorescent Imaging System
Model Number:	SP2000
Common Name:	Fluorescent Angiographic System
Classification:	21 CFR 892.1600
Product Code:	90 IZI	NOV 0 9 2007
Classification:	Class II
Manufacturer:	Novadaq Technologies Inc.2585 Skymark AvenueSuite 306Mississauga, OntarioCanadaL4W 4L5905.629.3822 ext. 240
Contact Name:	Allison MannersVice President - Regulatory and Clinical Affairs

Date 510(k) Summary Prepared: October 31, 2007

Legally Marketed Predicate Devices:

The Novadaq® SPY Fluorescent Imaging System (SPY System) had received FDA 510(k) clearance for market in January 2005 (K#042961), subsequent 510(k) clearances for a labeling change in May 2006 (K#060867) and use of an alternative brand of fluorescent dye in May 2007, pending drug approval (K#071037).

The Leica FL800 had received FDA 510(k) clearance for market in September 2006 (K#061871). The Leica FL800 is intended for use to allow neurosurgeons to view blood flow.

Device Description:

The SPY Imaging System: SP2000 is currently cleared for intraoperative visual assessment of the coronary vasculature and grafts during coronary artery bypass graft (CABG) surgery.

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The Novadaq® Technologies SPY® Fluorescent Imaging System consists of 2 components:

· the SP2000 Imaging Device; and
= the SPY Paq®

The SP2000 Imaging Device

There have been no significant changes or modifications made to the SP2000 Imaging device since the original 510(k) clearance in January 2005, premarket notification 510(k) K#042961, or for the 510(k) submitted for a label change for this device, K#060867.

This 510(k) submission describes a proposed change in intended use that does not alter the devices fundamental scientific technology or characteristics in anyway.

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Proposed Intended Use of the SPY System:

This premarket notification 510(k) application is being made to revise the indications for use.

In addition to the already cleared indication for use of the SPY® System, the System is also intended to provide fluorescent images for the visual assessment of blood flow in vessels and related tissue perfusion during cardiovascular surgical procedures.

Testing:

Animal studies, human experience and in vitro testing were conducted to support the safe and effective use of the SPY System in its original premarket notification 510(k) application (K#042961).

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

In Vivo Testing:

The SPY System is commercially available in the United States of America, Japan, Europe and Canada. To date, the SPY System has been used in over 4000 CABG procedures in humans and there have been no reports of adverse acute or long-term cellular, renal or hepatic effects. Along with the data from intra-operative imaging in CABG surgery, the use of the SPY System in plastic, micro- or reconstructive and other vasular surgery demonstrates the clinical utility of the device in producing bigh quality and resolution images of the entire vascular bed of the point of interest.

The SPY® System was originally cleared by the FDA for use in intraoperative visual assessment of the coronary vasculature and bypass grafts during CABG surgery. During the period that the SPY System has been placed in surgical units, several cardiovascular surgeons have made use of the SPY System for purposes other than the original indication. The present application seeks clearance for this broader range of cardiovascular indications, including but not limited to that already cleared for CABG surgery. Specifically, the SPY System has been used to:

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Assess the coronary vasculature and related myocardial perfusion .
- To assess delivery of cardioplegia o
- To assess the impact of procedures involving the aortic valve o and/or ascending aorta on coronary artery function
- o Following heart transplant
Confirm blood flow through vessels branching off the aorta . following surgical procedures on the descending aorta
Confirm blood flow through vessels following vascular procedures .
- Carotid endarterectomy o
- Peripheral vascular procedures o
Assess perfusion of extremities without skin incision .

Examples and the rationale for each of these indications are described in more detail in Section 19 of this traditional 510(k) premarket notification.

Results from the use of the SPY System has been the subject of 12 peer reviewed journal articles, 10 related to its use in cardiac surgery and 2 related to its use in transplantation surgeries, namely kidney and liver Please refer to the bibliography in Section 19 - Clinical for a listing of all relevant journal articles.

The literature reports that the SPY System was able to non-invasively, quickly and safely identify 17 conduits in 311 patients that reguired revision during the surgical procedures. In all cases the lack of patency was visualized clearly by the SPY System using doses of ICG wel below that approved for human use, allowing the surgeon to revise the graft thus decreasing subsequent myocardial infarctions and the morbidity and mortality associated with poor graft patency. Cardiac, renal and he atic function were monitored during use of the SPY System and there were no reported adverse effects.

To support the original premarket notification 510(k) application, the system was used in six pig studies. These studies demonstrated that:

1. it was possible to acquire high quality images in a simple and reproducible manner using small doses of ICG well below the concentrations approved for human use;
1. it was possible to perform multiple imaging sequences with no detrimental effects on heart function, coronary flow or peripheral pressure; and
1. it was possible to acquire images with no increase in myocardial tissue temperature; and
1. it was possible to visualize all of the coronary beds with high quality images even when the heart was in a vertical position for visualizing posterior arteries.

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Therefore, the in vivo evidence shows that:

The exposure for the SPY® System is 35 mW/cm² which is far 1. below the maximum permissible exposure of 327 mW/cm2 established by ANSI for exposure to the skin.
Use of the SPY System does not cause any thermal damage to 2. the area of interest, even after repeated imaging sequences.
1. For the heart, there were no changes in electrocardiograms or arterial pressures during and/or following SPY use.
1. There were no acute or long-term cellular effects of using the SPY System.
1. There were no acute or long-term renal or hepatic effects of using the SPY System.
1. The SPY System was able to acquire high quality images of the entire vascular bed on each area of interest.
1. The SPY System is capable of imaging through the skin to provide a visual assessment of dermal and subdermal blood flow.

Conclusions:

The above testing demonstrates that the SPY Fluorescent Imaging System is safe and effective in imaging blood flow indicative of tissue perfusion, and related tissue-transfer circulation in cardiovascular surgical procedures and is equivalent to the predicate devices.

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Image /page/5/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of three birds in flight, arranged in a row.

Food and Druq Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 0 9 2007

Novadaq Technologies, Inc. c/o Ms. Allison Manners Vice President, Regulatory and Clinical Affairs 2585 Skymark Avenue Suite 306 Mississauga, Ontario Canada L4W 4L5

Re: K071619

Trade/Device Name: SPY® Intraoperative Imaging System Regulation Number: 21 CFR 892.1600 Regulation Name: Fluorescent angiography system Regulatory Class: Class II (two) Product Code: IZI Dated: October 31, 2007 Received: November 1, 2007

Dear Ms. Manners:

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.

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Page 2 – Ms. Allison Manners

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours.

B.Zimmerman 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):

Device Name: SPY® Imaging System: SP2000

Indications for Use:

The SPY Fluorescent Imaging System is intended to provide fluorescent images for the visual assessment of blood flow in vessels and related tissue perfusion during cardiovascular surgical procedures.

Prescription Use Prescription Use _____________________________________________________________________________________________________________________________________________________________

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Bhimman

IDivision Sign-Off Division of Cardlovascular Devices 510(k) Number

Page I of I

Regulation Number and Section

§ 892.1600 Angiographic x-ray system.

(a)
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.(b)
Classification. Class II.