Upon intravenous administration of SPY AGENT™ GREEN (Indocyanine green for injection, USP) the SPY-PHI System is used with SPY AGENT™ GREEN in capturing and viewing fluorescence images for the visual assessment of blood flow as an adjunctive method for the evaluation of tissue perfusion, and related tissue-transfer circulation in tissue and free flaps used in plastic, micro- and reconstructive surgical procedures.

The SPY-PHI System is used with SPY AGENT™ GREEN to provide fluorescence images for the visual assessment of blood flow in vessels and related tissue perfusion before, during and after gastrointestinal surgical procedures.

Device Description

The SPY-PHI System is an imaging system used in capturing and viewing fluorescent images for the visual assessment of blood flow, as an adjunctive method for the evaluation of tissue perfusion, and related tissuetransfer circulation in tissue and free flaps used during plastic, micro-, reconstructive, and gastrointestinal surgical procedures.

The SPY-PHI System consists of the following main components: Imaging Head/ Imager (HH9030) with an integrated light guide cable and the Video Processor/Illuminator (VPI) (PC9001).

Indocyanine green (ICG) is injected intravenously into the patient. The Imaging Head may be either handheld or attached to a mechanical arm and provides illumination of the regions of a patient's body to be observed with near infrared laser light to excite ICG fluorescence. Alternatively, the Imaging Head provides white light illumination of the reqions of a patient's body to be observed for color imaging.

A CMOS camera in the Imaging Head captures the fluorescent image under laser illumination or a color image under white light illumination. The VPI receives the video signal from the Imaging Head and processes and outputs the video image to a medical grade video monitor and/or video recorder. Adjustments to the operation of the SPY-PHI System are possible through switches at either the Imaging Head or the VPI.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study proving the device meets them, formatted as requested:

Acceptance Criteria and Device Performance Study for SPY Portable Handheld Imaging (SPY-PHI) System (K190729)

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state specific numerical acceptance criteria for clinical performance metrics (e.g., sensitivity, specificity, accuracy) for the SPY-PHI System. Instead, it focuses on demonstrating substantial equivalence to a predicate device by comparing technological characteristics, intended use, and confirming adherence to various safety and performance standards.

Therefore, the "acceptance criteria" primarily relate to compliance with regulatory standards and the "reported device performance" is its demonstrated conformance to these standards and its substantial equivalence to the predicate.

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Safety & Essential Performance	Conformance with IEC 60601-1:2006 (General requirements for basic safety and essential performance)	SPY-PHI was tested and determined to be in conformance with IEC 60601-1:2006.
Electromagnetic Compatibility (EMC)	Conformance with IEC 60601-1-2 (4th edition)	SPY-PHI was tested and determined to be in conformance with IEC 60601-1-2 (4th edition).
Laser Safety	Conformance with IEC 60825:2007 (Safety of laser products -- Part 1: Equipment classification and requirements)	SPY-PHI was tested and determined to be in conformance with IEC 60825:2007.
Software Life-Cycle Processes	Conformance with IEC 62304:2006 (Medical device software - Software life-cycle processes)	An assessment of the SPY-PHI system software was conducted, demonstrating that all processes and activities necessary for the safe design and maintenance of SPY-PHI software are performed in accordance with IEC 62304:2006.
Drug Compatibility	Compatibility with Stryker ICG - SPY AGENT™ GREEN (Indocyanine green for injection, USP)	Bench testing was performed to demonstrate compatibility of the SPY-PHI System with Stryker ICG - SPY AGENT™ GREEN.
Substantial Equivalence	Demonstrated substantial equivalence to the predicate device (SPY PHI Open Field Handheld Fluorescence Imaging System, K162885) based on fundamental scientific technological characteristics, principle of operation, intended use, environment of use, and indications for use.	Based on the information presented, and on the fundamental scientific technological characteristics, principle of operation, intended use, environment of use, and indications for use, the SPY-PHI System has been determined to be substantially equivalent to the predicate device (K162885). Minor technological/design differences and the change in drug labeling do not raise safety or effectiveness concerns.

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

The provided text does not include information about a distinct "test set" with a specific sample size, nor does it detail data provenance (e.g., country of origin, retrospective/prospective) for clinical performance evaluation. The submission primarily relies on bench testing, software assessment, and a comparison of technological characteristics to a predicate device to establish substantial equivalence.

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

Given the lack of a distinct clinical "test set" with performance metrics, the document does not mention the number of experts used or their qualifications to establish ground truth. The study is primarily focused on engineering and regulatory compliance rather than clinical accuracy adjudicated by experts.

4. Adjudication Method for the Test Set

As there is no described clinical "test set" with performance data requiring expert review, no adjudication method is mentioned.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size

The provided text does not mention a Multi Reader Multi Case (MRMC) comparative effectiveness study. The submission focuses on demonstrating substantial equivalence through technical and regulatory compliance, not on comparing human reader performance with and without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

The SPY-PHI System is an imaging system designed for visual assessment by a human user ("capturing and viewing fluorescence images for the visual assessment of blood flow"). It is not described as an AI-powered diagnostic algorithm that would operate in a standalone mode without human interpretation. Therefore, a standalone (algorithm-only) study is not applicable or mentioned in this context.

7. The Type of Ground Truth Used

For the safety and performance studies mentioned, the "ground truth" was established by regulatory standards and industry requirements, such as:

Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60825:2007 for physical device performance.
Compliance with IEC 62304:2006 for software processes.
Demonstrating physical compatibility through bench testing for the drug-device combination.
The overall "ground truth" for the 510(k) submission is the demonstration of substantial equivalence to a previously cleared predicate device.

8. The Sample Size for the Training Set

Since the SPY-PHI System is described as an imaging system and not an AI/machine learning algorithm requiring a "training set" for model development, no training set sample size is mentioned.

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

As no training set is applicable or mentioned, no information on how its ground truth was established is provided.

Summary

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Section 5 - 510(k) Summary K190729

This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR § 807.92.

Trade Name:	SPY Portable Handheld Imaging (SPY-PHI) System
Device Model Number:	HH9000
Common Name:	Fluorescence Angiographic System
Regulation:	21 CFR § 892.1600
Classification Name:	Angiographic X-Ray System
FDA 510(k) Review Panel:	General and Plastic Surgery
Product Code:	OWN
Classification:	Class II
Manufacturer:	Novadaq Technologies ULC. (now a part of Stryker)8329 Eastlake Drive, Unit 101Burnaby, British ColumbiaCanada, V5A 4W2
Contact Name:	Agatha SzeligaRegulatory Affairs ManagerTel: 604-422-7516Fax: 604-232-9841
Date 510(k) Summary Prepared:	March 5, 2019

Predicate Device:

Device Trade Name:	SPY PHI Open Field Handheld Fluorescence Imaging System
510(k) Reference:	K162885
Submitter Name:	Novadaq Technologies Inc.
Device Common Name:	Fluorescence Angiographic System
Product Code/Regulation:	OWN/ 21 CFR § 892.1600
Classification:	Class II

Device Description:

The SPY-PHI System consists of the following main components: Imaging Head/ Imager (HH9030) with an integrated light guide cable and the Video Processor/Illuminator (VPI) (PC9001).

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Indications for Use for the SPY-PHI System:

Feature	Subject Device	Predicate Device
	SPY-PHI System	SPY PHI Open Field HandheldFluorescence Imaging System
510(k) Holder/Manufacturer	Novadaq Technologies ULC. (now a part of Stryker)	Novadaq Technologies Inc.
SubmissionReference	Current Submission	K162885
CombinationProduct	Yes	Yes
Product Code	OWN	OWN
Regulation	21 CFR 876.1500	21 CFR 876.1500
Intended Use	Near infrared fluorescence imaging for visualization of blood flow and tissue perfusion during surgical procedures	Near infrared fluorescence imaging for visualization of blood flow and tissue perfusion during surgical procedures
Indications for Use	Upon intravenous administration of SPY AGENTTM GREEN (Indocyanine green for injection, USP) the SPY-PHI System is used with SPY AGENTTM GREEN in capturing and viewing fluorescence images for the visual assessment of blood flow as an adjunctive method for the evaluation of	The SPY Phi Open Field Handheld Fluorescence Imaging System is an imaging system used in capturing and viewing fluorescence images for the visual assessment of blood flow as an adjunctive method for the evaluation of tissue perfusion, and related tissue-transfer circulation in tissue and free

Comparison of Technological Characteristics with the Predicate Device:

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Feature	Subject Device	Predicate Device
	SPY-PHI System	SPY PHI Open Field HandheldFluorescence Imaging System
	tissue perfusion, and related tissue-transfer circulation in tissue and freeflaps used in plastic, micro- andreconstructive surgical procedures.The SPY-PHI System is used withSPY AGENTTM GREEN to providefluorescence images for the visualassessment of blood flow in vesselsand related tissue perfusion before,during and after gastrointestinal	flaps used in plastic, micro-, andreconstructive surgical procedures.The SPY Phi Open Field HandheldFluorescence Imaging System isintended to provide fluorescenceimages for the visual assessment ofblood flow in vessels and related tissueperfusion during gastrointestinalsurgical procedures.
Operating Principle	surgical procedures.Full color visible light and NIRfluorescence video imaging. TheCMOS camera in the Imaging Headcaptures the fluorescent image underlaser illumination or a color imageunder white light illumination. The VPI	Full color visible light and NIRfluorescence video imaging. TheCMOS camera in the Imaging Headcaptures the fluorescent image underlaser illumination or a color image underwhite light illumination. The VPI
	receives the video signal from theImaging Head and processes andoutputs the video image to a medicalgrade video monitor and/or videorecorder.	receives the video signal from theImaging Head and processes andoutputs the video image to a medicalgrade video monitor and/or videorecorder.
Major components	SPY-PHI imager (with integrated lightguide cable) and VPI (VideoProcessor/ Illuminator)	SPY-PHI imager, light guide cable, VPI(Video Processor/ Illuminator)
Illumination/imagingmodes	White light and NIR fluorescence	White light and NIR fluorescence
Image sensor type	Color CMOS	Color CMOS
Fluorescenceexcitation source	NIR laser	NIR laser
Contrast imagingagent	SPY AGENTTM GREEN (Indocyaninegreen for injection, USP)	Indocyanine green (ICG)

Performance Testing of the SPY-PHI System:

The SPY-PHI System was designed and developed by Novadaq Technologies Inc. in accordance with the applicable requirements and standards to establish performance and safety of the device's safety and performance were verified by tests conducted by Novadaq and accredited third-party laboratories.

SPY-PHI was tested and determined to be in conformance with IEC 60601-1:2006 Medical Electrical Equipment – Part 1: General requirements for basic safety and essential performance, IEC 60601-1-2 (4th edition) and IEC 60825:2007 Safety of laser products -- Part 1: Equipment classification and requirements.

An assessment of the SPY-PHI system software was conducted to demonstrate conformance with the applicable requirements of IEC 62304:2006 Medical device software - Software life-cycle processes. It

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has been demonstrated that all processes and activities necessary for the safe design and maintenance of SPY-PHI software are performed in accordance with the standard.

Additionally, bench testing was performed to demonstrate compatibility of the SPY-PHI System with Stryker ICG - SPY AGENT™ GREEN (Indocyanine green for injection, USP).

Conclusion & Summary of Substantial Equivalence

Based on the information presented in this Special 510(k) premarket notification, and based on the fundamental scientific technological characteristics, principle of operation, intended use, environment of use, and indications for use, the SPY-PHI System has been determined to be substantially equivalent to the predicate device, the SPY PHI Open Field Handheld Fluorescence Imaging System (FDA 510(k)-cleared in K162885).

Any minor technological or design differences between the SPY-PHI System and its predicate do not raise any questions related to safety or effectiveness. The proposed change to the labeling, proposing use of the SPY-PHI System with Stryker's brand of ICG - SPY AGENT™ GREEN (Indocyanine green for injection, USP), does not raise any issues related to safety or effectiveness for this device-drug combination product.

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Indications for Use

510(k) Number (if known) K190729

Device Name

SPY Portable Handheld Imaging (SPY-PHI) System

Indications for Use (Describe)

Upon intravenous administration of SPY AGENT™ GREEN (Indocyanine green for injection, USP) the SPY-PHI System is used with SPY AGENT™ GREEN in capturing and viewing fluorescence images for the visual assessment of blood flow as an adjunctive method for the evaluation of tissue transfer circulation in tissue and free flaps used in plastic, micro- and reconstructive surgical procedures.

Type of Use (Select one or both, as applicable)

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

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Image /page/5/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Novadaq Technologies ULC. (now a part of Stryker) Agatha Szeliga Regulatory Affairs Manager 8329 Eastlake Drive, Unit 101 Burnaby, V5A 4W2 Ca

April 19, 2019

Re: K190729

Trade/Device Name: SPY Portable Handheld Imaging (SPY-PHI) System Regulation Number: 21 CFR 892.1600 Regulation Name: Angiographic X-Ray System Regulatory Class: Class II Product Code: OWN Dated: March 20, 2019 Received: March 21, 2019

Dear Agatha Szeliga:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, fi applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Binita S. Ashar, M.D., M.B.A., F.A.C.S. For Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.