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. The Novadaq Technologies SPY Intra-operative Imaging System consists of 2 components: the SPY Imaging Device; and the SPY Paq®

AI/ML Overview

This 510(k) pertains to a medical imaging system rather than an AI/ML device. Therefore, the typical acceptance criteria and study designs for AI/ML devices involving performance metrics like sensitivity, specificity, AUC, and multi-reader studies are not applicable in this context.

The document describes the SPY® Intra-operative Imaging System (Model SP2000), which is a fluorescent angiographic system used for intraoperative visual assessment of coronary vasculature and grafts during coronary artery bypass graft (CABG) surgery.

The FDA's decision is based on a determination of substantial equivalence to legally marketed predicate devices, not on specific performance acceptance criteria as would be typical for an AI/ML diagnostic or prognostic device.

Here's an analysis of what can be extracted from the provided text, recognizing the limitations due to the nature of the device (imaging system, not AI/ML):

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: Not explicitly stated as quantifiable performance metrics (e.g., sensitivity, specificity thresholds) in this 510(k) summary. The primary "acceptance criterion" for clearance in this context is demonstrating substantial equivalence to a predicate device.
Reported Device Performance: The document does not contain specific quantifiable performance results (e.g., accuracy rates, image quality scores, comparison against a gold standard in a statistical sense). Instead, it describes:
- Intended Use: "For use in intraoperative visual assessment of the coronary vasculature and bypass grafts during coronary artery bypass (CABG) surgery."
- Functional 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." This indicates its functional capability rather than statistical performance.
- Substantial Equivalence: The FDA determined the device is "substantially equivalent" to legally marketed predicate devices (K042961, K060867). This is the core "performance" assessment for this type of device submission.

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

Not applicable / Not provided: The document does not describe a "test set" in the context of an AI/ML algorithm's evaluation with specific patient data. The substantial equivalence determination likely relied on technical specifications, design comparisons, and potentially non-clinical testing (e.g., bench testing, animal studies, or limited human clinical data typical for device safety and efficacy demonstration for systems of this type) that are not detailed here. Data provenance (country of origin, retrospective/prospective) is therefore not mentioned.

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

Not applicable / Not provided: Since there's no defined "test set" for performance evaluation in the AI/ML sense, expert-established ground truth information is not present. The assessment relates to the system's ability to produce images suitable for a human clinician's visual assessment, rather than an AI's interpretation.

4. Adjudication Method for the Test Set:

Not applicable / Not provided: No test set or corresponding adjudication method is described.

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

No: This type of study is typically conducted for AI/ML diagnostic devices to assess how AI assistance impacts human reader performance. This device is an imaging system, not an AI diagnostic tool, so an MRMC study is not relevant here.

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

No: This concept is not applicable as the SPY system itself is an imaging tool designed for human interpretation, not an automated algorithm for standalone diagnosis.

7. The Type of Ground Truth Used:

Not applicable / Not provided: For a medical device like an imaging system, the "ground truth" often relates to its ability to accurately visualize anatomical structures or physiological processes as confirmed by established clinical methods, but the 510(k) summary does not detail the specific studies or ground truth methodologies. The assessment focuses on the system's ability to aid a clinician in "visual assessment."

8. The Sample Size for the Training Set:

Not applicable / Not provided: There is no "training set" in the context of AI/ML algorithm development for this device.

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

Not applicable / Not provided: As above, no training set or associated ground truth establishment is relevant to this device submission.

In summary: The provided document is a 510(k) summary for an imaging system, not an AI/ML device. Therefore, the requested information points related to AI/ML device evaluation (like test/training sets, ground truth, expert adjudication, MRMC studies, standalone performance, and quantified acceptance criteria) are not present or applicable. The FDA clearance is based on the device's substantial equivalence to previously cleared predicate devices for its intended use as an intraoperative imaging tool.

Summary

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8071037

510(k) Summary

Trade Name:	SPY® Intra-operative Imaging System
Model Number:	SP2000	MAY 10 200
Common Name:	Fluorescent Angiographic System
Classification:	21 CFR 892.1600
Product Code:	90 IZI
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: April 9, 2007

Legally Marketed Predicate Devices:

The Novadaq SPY Imaging System had received FDA 510(k) clearance for market in January 2005 (K042961) and subsequently received 510(k) clearance for a labeling change in May 2006 (K060867).

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.

The Novadaq Technologies SPY Intra-operative Imaging System consists of 2 components:

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

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 0 2007

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

Re: K071037

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: April 11, 2007 Received: April 12, 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). You may not market this device, however, until such time as the new drug application for the drug indocyanine green manufactured by PULSION® Medical Systems is approved for human use by The Center for Drug Evaluation and Research, FDA. When the device is marketed, it will be subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (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.

However, you are responsible to determine that the medical devices you use as components in the SPY® Intraoperative Imaging System have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the Act), or were on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments.

Image /page/1/Picture/10 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name encircling a symbol composed of four stylized human profiles facing right. The profiles are stacked vertically, with the top profile being the largest and each subsequent profile decreasing in size. The overall design is simple and conveys a sense of unity and service.

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Page 2 – Ms. Allison Manners

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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 510(k) premarket notification subject to approval of the indocyanine green manufactured by PULSION® Medical Systems. 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (240) 276-3150,

or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Blommer for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known):

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

Indications for Use:

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

Prescription 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)

Blammima

Division of Cardio 510ik) Nu

Page l of J

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.