The SPY Analysis Toolkit is a separate companion software application to the SPY Intra-operative Imaging System and is intended as a display, analysis, and comparison tool for the interpretation of SPY images by trained healthcare professionals including cardiovascular, plastic & reconstructive, and organ transplant surgeons.

Note: The clinician retains the ultimate responsibility for making the pertinent diagnosis based on their standard practices and visual comparison of the separate images. The SPY Analysis Toolkit is a complement to the SPY procedures.

Device Description

The SPY® Analysis Toolkit is a separate companion application to the SPY Intraoperative Imaging System's (SPY System) software, which is currently cleared for use in cardiovascular, plastic and reconstruction, and organ transplant surgeries. The Analysis Toolkit is capable of working cooperatively, as an accessory plug-in feature, with the SPY software or standalone on a physician's desktop computer. The Analysis Toolkit is not real-time.

Novadaq's SPY System allows surgeons (including cardiovascular, plastic and reconstructive, and transplant) to produce real-time images of blood vessels, surrounding tissue and related perfusion of those tissues/organs during various types of surgeries. The Analysis Toolkit provides a set of clinical image analysis tools and makes them available to clinicians for either intra-operative post image acquisition or retrospective analysis. The ultimate goal of analysis will be to provide surgeons with another parameter, in addition to standard of care information, including data from other imaging modalities, for use in pre-operative decision-making and post-operative evaluation of results as an input to post-operative care.

The SPY Analysis Toolkit is a plug-in module to the SPY Imaging Device and does not have any control over the device or the previously cleared software. The SPY Analysis Toolkit is an accessory software feature designed and developed to work with images acquired on the SPY System, models SP2000 and SP2001. The SPY Analysis Toolkit has no capability to modify in any way the underlying images previously acquired intraoperatively by the SPY System. The resolution and the quality of the images captured by the SPY System and analyzed by the SPY Analysis Toolkit remain the same.

The SPY Analysis Toolkit application is for viewing, manipulation, measurement and comparison of medical image sequences produced at single or multiple time-points by the SPY System. Entire image time-sequences are processed for viewing using a variety of analytical algorithms that provide visual or numerical results.

The Analysis Toolkit can also accept DICOM and AVI images independent of the SPY device for post-operative analysis.

AI/ML Overview

The provided text describes the SPY Analysis Toolkit, its intended use, and its equivalence to predicate devices, but it does not contain information about specific acceptance criteria, a scientific study with a test set, or detailed performance metrics. The document is a 510(k) summary for regulatory clearance, focusing on demonstrating substantial equivalence rather than reporting on a clinical or performance study with acceptance criteria.

The "Testing" section mentions that the device was "designed and developed with the input from experienced SPY System users," and "scanned image datasets from the various disciplines were used as input for testing of the software functionalities in accordance with the Software Development Plan." It also states that "A full description of the software functionality, device hazard analysis, software requirements, and verification and validation protocols and testing can be found in Section 16 - Software, of this submission." However, these details are not provided in the excerpt.

Therefore, I cannot populate the table or answer most of the questions as the required information is not present in the provided text.

Here's a breakdown of what can be extracted or inferred from the given text:

1. Table of Acceptance Criteria and Reported Device Performance:

Cannot be created. The document does not define specific acceptance criteria (e.g., sensitivity, specificity, accuracy targets) nor does it report specific performance metrics against such criteria. The document focuses on "substantial equivalence" to predicate devices based on intended use and technological characteristics rather than quantitative performance.

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: Not explicitly stated. The text mentions "Scanned image datasets from the various disciplines were used for testing," but no specific number or size of these datasets is provided.
Data Provenance: Not explicitly stated. It mentions "datasets from the various disciplines," implying a medical context, but no country of origin is given. It is likely retrospective as it refers to "scanned image datasets."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Number of Experts: Not specified.
Qualifications of Experts: The device was "designed and developed with the input from experienced SPY System users," which included "all disciplines currently cleared to use the SPY System, in cardiovascular, plastic and reconstructive, organ transplant surgeries." This implies the "experts" were practicing surgeons in these fields. However, their specific role in establishing "ground truth" for a test set is not detailed.

4. Adjudication method for the test set:

Not explicitly stated. The document does not describe any specific adjudication method for a test set.

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

No such study is described or referenced. The document indicates the SPY Analysis Toolkit is "a complement to the SPY procedures" and that "The clinician retains the ultimate responsibility for making the pertinent diagnosis based on their standard practices and visual comparison of the separate images." This suggests the tool is an aid, but no MRMC study or AI assistance effect size is mentioned.

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

The document implies the software is not intended for standalone, unsupervised diagnosis. It explicitly states: "The clinician retains the ultimate responsibility for making the pertinent diagnosis based on their standard practices and visual comparison of the separate images." and "Device output and analysis is not real-time and is only used to indicate the appropriateness of a referral or surgical decision."

7. The type of ground truth used:

Not explicitly stated. Given the context of a medical imaging analysis tool, ground truth would typically come from clinical diagnosis, pathology reports, or expert consensus, but the document does not specify.

8. The sample size for the training set:

Not mentioned. The document refers to "scanned image datasets... used for testing," but does not distinguish between training and testing sets, nor does it provide sample sizes for either.

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

Not mentioned.

Summary

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CONFIDENTIAL

510(k) Summary

SEP 1 7 2008

K 081792

Date SummaryPrepared:	June 19, 2008
Trade Name:	SPY® Analysis Toolkit
Common Name:	Medical Image Processing Software
Classification:	Class II device
Classification Name:	System, Image Processing, Radiological
CFR Classification:	21CFR892.2050
Product Code :	LLZ
Manufacturer:	Novadaq Technologies Inc.2585 Skymark Avenue,Suite 306,Mississauga, Ontario,Canada,L4W 4L5905.629.3822 ext. 240
Contact Name:	Allison MannersVice President - Regulatory and Clinical Affairs

Legally Marketed Predicate Devices:

The Novadaq SPY Analysis Toolkit utilizes the same technological characteristics, has the same intended use and is substantially equivalent to at least three predicate devices previously cleared for commercial distribution. The enclosed information for three of these demonstrates substantial equivalence. These commercial products include:

1. American Radiologist Network xViewNet cleared for market via K080290 Trade Name: xViewNet Product Code: LLZ
1. Siemens syngo TrueD, Model VC10A cleared for market via K061671 Trade Name: Siements syngo TrueD, Model VC10A Product Code: LLZ
1. Biotronics3D 3Dnet Suite cleared for market via K063107 Trade Name: Biotronics3D 3Dnet Suite Product Code: LLZ

tn each of these software devices, including the SPY Analysis Toolkit, the analysis software is used to receive images from various sources which can then be stored, communicated, manipulated, annotated, measured, compared, displayed and reported within the intended systems or at individual work stations with the appropriate configurations.

Detailed information regarding each of these predicates, including 510(k) Summaries and Indications for Use can be found in Section 21- Predicates, of this Traditional 510(k) Pre-market Notification submission.

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Device Description:

The Analysis Toolkit can also accept DICOM and AVI images independent of the SPY device for post-operative analysis.

Proposed Intended Use / Indications for Use:

The SPY Analysis Toolkit is a separate companion software application to the SPY Intraoperative Imaging System and is intended as a display, analysis, and comparison tool for the interpretation of SPY images by trained healthcare professionals including cardiovascular, plastic & reconstructive, and organ transplant surgeons.

Testing:

The SPY Analysis Toolkit was designed and developed with the input from experienced SPY System users. The feedback and input was from all disciplines currently cleared to use the SPY System, in cardiovascular, plastic and reconstructive, organ transplant surgeries. The input was captured in a written and approved Software Requirement Specifications Document. The SPY Analysis Toolkit has been developed in a manner

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NOVADAQ Technologies Inc. 510(k) Summary

consistent with accepted standards for software development, including both unit and system integration testing protocols.

Scanned image datasets from the various disciplines were used as input for testing of the software functionalities in accordance with the Software Development Plan. A full description of the software functionality, device hazard analysis, software requirements, and verification and validation protocols and testing can be found in Section 16 -Software, of this submission.

The device has no patient contacting materials and is utilized only by trained professionals. The output of the device is evaluated by trained professionals allowing sufficient review for identification and intervention in the event of a malfunction. Device output and analysis is not real-time and is only used to indicate the appropriateness of a referral or surgical decision. Additional clinically relevant parameters / tests, including data from alternative imaging modalities, must be used in the any surgical intervention. The device does not impact the quality or status of the original acquired data.

Conclusions:

The SPY Analysis Toolkit has the same intended use and similar technological characteristics as the previously noted predicate software devices. As demonstrated within this Traditional 510(k) pre-market notification, there are no substantial differences between the SPY Analysis Toolkit and the stated predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it, representing medicine and health. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

SEP 1 7 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K081792

Trade/Device Name: SPY Analysis Toolkit Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: June 23, 2008 Roccived: June 25, 2008

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.

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.

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Page 2 - Ms. Allison Manners

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 markcted 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) 276-0115. 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/cdrh/industry/support/index.html.

Sincerely yours.

Mark N. Mulleen

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

SPY Analysis Toolkit Device Name:

Indications for Use:

Prescription Use(Part 21 CFR 801 Subpart D)	X
	AND/OR
Over-The-Counter Use(21 CFR 801 Subpart C)

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

	(Division Sign-Off)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of General, Restorative, and Neurological Devices	Page ___ of ___
510(k) Number	K011792

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).