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.

AI/ML Overview

The provided text describes the SPY™ Intra-operative Imaging System: SP2000, its intended use, and the testing performed to demonstrate its safety and effectiveness. However, it does not specify discrete acceptance criteria in a quantitative format (e.g., minimum sensitivity or specificity targets) with corresponding reported device performance metrics in a table. It instead outlines the types of testing and general conclusions on safety and effectiveness, and equivalence to predicate devices, without detailed performance data against specific, quantifiable criteria.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes for test sets, expert involvement, and ground truth establishment cannot be fully extracted from the provided document. The document focuses more on regulatory compliance, safety, and equivalence rather than a detailed performance study with explicit acceptance criteria.

Below is an attempt to address the prompts based on the available information:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly define quantitative acceptance criteria for device performance (e.g., specific sensitivity, specificity, accuracy thresholds). Instead, the "Testing" section outlines general requirements and conclusions from in vitro and in vivo studies. The performance is primarily reported as meeting safety standards and achieving image quality equivalent to radiographic angiography.

Acceptance Criteria (Inferred/General)	Reported Device Performance
In Vitro Safety & Compliance
- 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 (ANSI Z136.3, ANSI Z136.1)	- Successfully met all requirements.
In Vivo Safety
- Laser exposure below Maximum Permissible Exposure (MPE)	- Exposure: 35 mW/cm². MPE (ANSI for skin): 327 mW/cm². Exposure is far below MPE.
- No thermal damage to heart tissue	- Use of the SPY™ system does not cause any thermal damage to the heart tissue.
- No changes to ECGs or arterial pressures	- There were no changes to the electrocardiograms or arterial pressures during and following SPY™ use.
- No acute or long-term cellular, renal, or hepatic effects	- There were no acute or long-term cellular effects of using the SPY™ system. No acute or long-term renal or hepatic effects.
In Vivo Effectiveness/Performance
- Image quality equivalent to radiographic angiography	- The image quality of the SPY™ system was equivalent to radiographic angiography.
- Ability to acquire excellent images of entire vascular bed	- The SPY™ system was able to acquire excellent images of the entire vascular bed on each aspect of the heart.
- (Implied) Equivalence to predicate devices for intended use	- The testing demonstrates 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 (Philips Integra Series 2 Systems (K984545) and Heidelberg Retinal Angiographic System (K944261), although the predicate devices are listed as angiographic X-ray and retinal imaging systems, respectively, which is somewhat incongruous with a direct comparison for cardiac imaging).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: The document states "human experience in 950 CABG procedures were completed to demonstrate safety and effectiveness." This indicates a substantial sample size from clinical use.
Data Provenance: The document does not specify the country of origin of the data. It also does not explicitly state whether the human experience was collected retrospectively or prospectively, but "human experience" in conjunction with demonstrating safety and effectiveness could encompass a variety of observational or trial-like data collection methods. Given the context of a 510(k) summary, it's likely a combination of clinical observations and possibly some form of prospective data collection, but this is not explicitly stated.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. The text refers to "human experience" and the "image quality... was equivalent to radiographic angiography," implying expert assessment of images. However, it does not detail how many experts were involved, their qualifications, or their role in establishing ground truth for the 950 CABG procedures.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

MRMC Study: An MRMC comparative effectiveness study is not mentioned. The document describes "intra-operative visual assessment" and "image quality... was equivalent to radiographic angiography," but it does not detail any study designed to compare human reader performance with and without the device, or against an AI, as the device itself is an imaging system, not an AI-assisted diagnostic tool.
Effect Size of AI assistance: Not applicable as the device is an imaging system and not designed with AI assistance, nor is an AI component mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device is an imaging system (hardware and associated software for image acquisition and display), not an algorithm for standalone diagnosis. Therefore, a "standalone algorithm only" performance study is not applicable in this context. The SPY™ system is designed for "intra-operative visual assessment," implying human-in-the-loop use.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The document primarily relies on the following for demonstrating effectiveness:

Equivalence to Radiographic Angiography: This suggests a comparison against an established imaging modality, likely interpreted by experts.
Clinical Observation/Experience: "Human experience in 950 CABG procedures" implies direct clinical observation and assessment by surgeons regarding the system's ability to visualize vasculature and grafts.
Absence of Adverse Events/Safety Measures: Lack of thermal damage, ECG/pressure changes, or cellular/organ effects were key safety "ground truths."

While expert assessment is strongly implied for "image quality" and "visual assessment," explicit details on how ground truth for vessel patency or graft integrity was formally established (e.g., through a gold standard like pathology or long-term clinical outcomes) are not detailed. It appears to be based on the established clinical utility and visual confirmation during procedures.

8. The sample size for the training set

This information is not provided. The SPY™ system is an imaging device, not an AI model that typically has a distinct training set. The "human experience" of 950 CABG procedures served as part of the validation/testing to demonstrate safety and effectiveness.

9. How the ground truth for the training set was established

Not applicable, as the device is not an AI model trained on a dataset with established ground truth in the conventional sense. The "training" for such a system would involve engineering and physical testing, not data labeling for an algorithm.

Summary

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JAN 1 9 2005

K042961
p. 1/2

510(k) Summary

Common Name:	Fluorescent Angiographic System
Classification:	21 CFR 892.1600
Manufacturer:	Novadaq Technologies Inc.2585 Skymark AvenueSuite 306Mississauga, OntarioCanadaL4W 4L5905.629.3822
Contact Name:	Rick MangatVice 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.

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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
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:

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.
1. Use of the SPYTM 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 SPYTM use.
1. There were no acute or long-term cellular effects of using the SPYTM system.
1. There were no acute or long-term renal or hepatic effects of using the SPYTM system.
1. The image quality of the SPYTM system was equivalent to radiographic angiography.
1. 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

Image /page/2/Picture/2 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 a stylized symbol that resembles three abstract shapes, possibly representing human figures or waves.

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 (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 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,

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

Page 1 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.