The SPY Intraoperative 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 A laser light source is used to illuminate the heart surface. heart. 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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
In Vitro
Electrical safety (IEC 60601-1, UL2601-1)	Successfully met all requirements.
Electromagnetic Compatibility (IEC 60601-1-2)	Successfully met all requirements.
Light Emitting Laser Products (21 CFR 1040)	Successfully met all requirements.
Safe Use of Lasers in Health Care Facilities (ANSI Z136.3)	Successfully met all requirements.
American National Standard for Safe Use of Lasers (ANSI Z136.1)	Successfully met all requirements.
In Vivo (Safety)
Exposure below ANSI MPE for skin	Exposure of 35 mW/cm² is far below MPE of 327 mW/cm².
No thermal damage to heart tissue	No thermal damage observed.
No changes to electrocardiograms	No changes to electrocardiograms during and following use.
No changes to arterial pressures	No changes to arterial pressures during and following use.
No acute or long-term cellular effects	No acute or long-term cellular effects observed.
No acute or long-term renal or hepatic effects	No acute or long-term renal or hepatic effects observed.
In Vivo (Effectiveness)
Ability to acquire excellent images of entire vascular bed	Able to acquire excellent images of the entire vascular bed on each aspect of the heart.

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

Sample Size: The device's safety and effectiveness were supported by "human experience in 1485 CABG procedures." This likely refers to the number of procedures involving the device itself.
Data Provenance: The text does not explicitly state the country of origin. It mentions the manufacturer as "Novadaq Technologies Inc." located in Mississauga, Ontario, Canada. It also states the studies were "human experience," which implies prospective observation during actual surgeries. Further details about the study design (e.g., retrospective vs. prospective) are not explicitly provided beyond 'human experience'.

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

The provided text does not specify the number of experts used to establish ground truth or their qualifications. The evaluation of image quality and clinical observations during the 1485 CABG procedures would have inherently involved surgeons and potentially other medical personnel, but details about an independent expert panel for ground truth establishment are not given.

4. Adjudication Method for the Test Set

The provided text does not specify an adjudication method (such as 2+1, 3+1, or none) for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study, and Effect Size

The provided text does not mention a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance. The study focuses on the device's standalone performance and safety.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone study was done. The "In Vivo Testing" describes the device's performance in acquiring images and its safety parameters (e.g., exposure levels, lack of tissue damage, no impact on ECG/arterial pressures). The device itself (SPY System) performs the imaging and provides the visual assessment, and the study demonstrates its ability to do so effectively and safely.

7. Type of Ground Truth Used

The ground truth used appears to be a combination of:

Clinical Observation/Surgical Assessment: The ability to "acquire excellent images of the entire vascular bed" and the observations regarding thermal damage, ECG changes, and arterial pressures during and following SPY use, and cellular/renal/hepatic effects, all rely on direct clinical observation and possibly standard diagnostic assessments within the context of the CABG procedures.
Established Safety Standards: In vitro testing confirmed compliance with electrical, electromagnetic, and laser safety standards (IEC, UL, ANSI, 21 CFR).

8. Sample Size for the Training Set

The provided text does not specify a training set sample size. The device is not described as an AI/ML algorithm that requires a separate training set. Its function is to acquire and display fluorescent images, with the evaluation being done by the surgeon. The "human experience in 1485 CABG procedures" serves as the clinical data demonstrating the device's performance, but not specifically a "training set" in the AI sense.

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

Since the device is not described as an AI/ML algorithm requiring a training set, the concept of establishing ground truth for a training set in this context is not applicable from the provided information.

Summary

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510(k) Summary

CONFIDENTIAL

3 2006 MAY

Common Name: Fluorescent Angiographic System

Classification: 21 CFR 892.1600

Manufacturer: Novadaq Technologies Inc. 2585 Skymark Avenue Suite 306 Mississauga, Ontario Canada L4W 4L5 905.629.3822 ext. 240

Contact Name: Allison Manners Vice President - Regulatory and Clinical Affairs

Legally Marketed Predicate Devices:

The Novadaq SPY® Intraoperative Imaging System had received FDA 510(k) clearance in January 2005 (#K042961).

Device Description:

The SPY Intraoperative Imaging System: SP2000 is indicated for use for intra-operative visual assessment of the coronary vasculature and grafts during CABG surgery.

No changes or modifications have been made to the device since the 510(k) clearance of this device, #K042961. This 510(k) submission entails a labeling revision that does not alter the device's intended use or alter the devices fundamental scientific technology.

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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 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 Testina:

Animal studies and human experience in 1485 CABG procedures, as of February 2006, were completed to demonstrate safety and effectiveness.

1. The exposure for the SPY System is 35 mWcm2 which is far below the MPE of 327 mW/cm2 established by ANSI for exposure to the skin.
1. Use of the SPY System does not cause any thermal damage to the heart tissue.
1. There were no changes to the electrocardiograms or arterial pressures during and 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 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.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

3 2006 MAY

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

Re: K060867

Trade Name: SPY® Intraoperative Imaging System Regulation Number: 21 CFR 892.1600 Regulation Name: Angiographic X-Ray System Regulatory Class: Class II (two) Product Code: IZI Dated: March 29, 2006 Received: March 30, 2005

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 Office of Compliance at (240) 276-0120. 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 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/industry/support/index.html.

Sincerely yours,

Afummar 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):

K_060867

Device Name:

SPY® Intra-operative Imaging System: SP2000

Indications for Use:

ﻪ « « « « « « «

For use in intraoperative 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 OF NEEDED)

Concurrence of CDRH. Office of Device Evaluation (ODE)

Blumuma

n Sign-C

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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.