SPY-PHI System with SPY-PHI Fluorescence Assessment Software

K202244 · Novadaq Technologies Ulc. (Now A Part of Stryker) · OWN · Nov 5, 2020 · Gastroenterology, Urology

Device Facts

• Record ID: K202244
• Device Name: SPY-PHI System with SPY-PHI Fluorescence Assessment Software
• Applicant: Novadaq Technologies Ulc. (Now A Part of Stryker)
• Product Code: OWN · Gastroenterology, Urology
• Decision Date: Nov 5, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Upon intravenous administration of SPY AGENT™ GREEN (indocyanine green for injection, USP) the SPY-PHI System is used with SPY AGENT™ GREEN to perform intraoperative fluorescence angiography. The SPY-PHI System is indicated for use in adult and pediatric patients one month of age and older. The SPY-PHI System is indicated for fluorescence imaging of blood flow and tissue perfusion before, during, and after: vascular, gastrointestinal, organ transplant, and plastic, micro- and reconstructive surgical procedures. Upon interstitial administration of SPY AGENT™ GREEN, the SPY-PHI System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.

Device Story

SPY-PHI is a handheld imaging system for intraoperative fluorescence angiography and lymphatic visualization. It captures real-time white-light and NIR fluorescence images using an imaging head and Video Processor/Illuminator (VPI). NIR laser light excites SPY AGENT™ GREEN (ICG) in the patient; the camera captures resulting fluorescence. The VPI processes signals for display on medical-grade monitors. The new SPY-PHI Fluorescence Assessment Software adds real-time relative fluorescence quantification and visualization tools (raw/relative color maps) to assist surgeons in assessing tissue perfusion. Used in operating rooms by trained healthcare professionals. The system provides visual feedback to surgeons, aiding intraoperative decision-making regarding tissue viability and blood flow, potentially improving surgical outcomes.

Clinical Evidence

Bench testing only. Verification included electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and laser safety (IEC 60825-1). Software verification conducted per IEC 62304. Design validation study performed to assess the suitability of the SPY-PHI Fluorescence Assessment Software against user needs.

Technological Characteristics

Handheld imager with integrated light guide cable and VPI. NIR laser excitation source. Imaging modes: White Light, SPY Overlay, Color Segmented Fluorescence (CSF), and color maps (raw/relative). Connectivity: Video output to medical-grade monitors. Software: Firmware module on VPI. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60825-1, IEC 62304.

Indications for Use

Indicated for adult and pediatric patients (1 month+) undergoing vascular, gastrointestinal, organ transplant, or plastic/micro/reconstructive surgery. Used for intraoperative fluorescence angiography (IV administration) or lymphatic system visualization (interstitial administration) using SPY AGENT™ GREEN.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• SPY Portable Handheld Imaging (SPY-PHI) System (K200737)
• SPY Elite Intraoperative Perfusion Assessment System (K182907)

Submission Summary (Full Text)

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Image /page/0/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, British Columbia V5A 4W2 Canada

November 5, 2020

### Re: K202244

Trade/Device Name: SPY-PHI System with SPY-PHI Fluorescence Assessment Software Regulation Number: 21 CFR 892.1600 Regulation Name: Angiographic X-Ray System Regulatory Class: Class II Product Code: IZI Dated: August 7, 2020 Received: August 10, 2020

### 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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, if 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Neil R.P. Ogden Assistant Director, Cancer Diagnosis & Treatment Team DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known)

#### K202244

Device Name

SPY Portable Handheld Imaging (SPY-PHI) System with SPY-PHI Fluorescence Assessment Software

#### 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 to perform intraoperative fluorescence angiography. The SPY-PHI System is indicated for use in adult and pediatric patients one month of age and older.

The SPY-PHI System is indicated for fluorescence imaging of blood flow and tissue perfusion before, and after: vascular, gastrointestinal, organ transplant, and plastic, micro- and reconstructive surgical procedures.

Upon interstitial administration of SPY AGENT™ GREEN, the SPY-PHI System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| <span style="font-family: Arial, sans-serif; font-size: 10pt;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> | |
| <span style="font-family: Arial, sans-serif; font-size: 10pt;"> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> | |

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## Section 5 - 510(k) Summary

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

| Subject Device Trade Name: | SPY-PHI System with SPY-PHI Fluorescence Assessment<br>Software |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| 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: | IZI |
| Classification: | Class II |
| Manufacturer: | Novadaq Technologies ULC. (now a part of Stryker)<br>8329 Eastlake Drive, Unit 101<br>Burnaby, British Columbia<br>Canada, V5A 4W2 |
| Contact Name: | Agatha Szeliga<br>Regulatory Affairs Manager<br>Tel: [phone]<br>Fax: [phone] |

Date 510(k) Summary Prepared: August 5, 2020

#### Predicate Device(s) Information:

| Predicate Device Trade Name | SPY Portable Handheld<br>Imaging (SPY-PHI) System<br>(primary predicate) | SPY Elite Intraoperative<br>Perfusion Assessment System<br><br>(secondary predicate to<br>support technological<br>differences/ software feature) |
|-------------------------------------------------------------------------------|--------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K200737 | K182907 |
| Submitter/510(k) Holder Name | Novadaq Technologies ULC.<br>(now a part of Stryker) | Novadaq Technologies ULC.<br>(now a part of Stryker) |
| Classification Name | Confocal Optical Imaging | Angiographic X-ray<br>System |
| Product Code and Regulation | OWN; 21 CFR § 876.1500 | IZI; 21 CFR § 892.1600 |
| Classification | Class II | Class II |
| Note: The predicate devices have not been subject to a design-related recall. | | |

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#### 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 for use in imaging during various surgical procedures.

The SPY-PHI System provides real-time, white-light and fluorescence imaging during surgical procedures. The system consists of a SPY-PHI imager/imaging head with an integrated light quide cable and a Video Processor/Illuminator (VPI).

Fluorescence imaging with the SPY-PHI System is achieved with the use of a fluorescence imaging agent, namely SPY AGENT™ GREEN (indocyanine green for injection, USP), which is supplied in single-use convenience kits for use in conjunction with the SPY-PHI System during surgical procedures.

During surgical procedures, SPY AGENT™ GREEN is administered to the patient. The SPY-PHI imaging head/imager provides illumination of the regions of a patient's body to be observed with near infrared (NIR) laser light to excite ICG fluorescence. Alternatively, the SPY-PHI imager provides white light illumination of the regions of a patient's body to be observed for color imaging.

The 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. The SPY-PHI System is intended for use by trained healthcare professionals in the operating room.

This Traditional 510(k) premarket notification proposes a modification to the currently 510(k) cleared SPY-PHI System with the addition of a new software feature. The new software feature, referred to as the SPY-PHI Fluorescence Assessment Software, will offer real-time relative fluorescence quantification (i.e. relative fluorescence values) and visualization tools (i.e. color maps) on the SPY-PHI device. Addition of this new software feature has no impact on the current intended use of the SPY-PHI System. The SPY-PHI Fluorescence Assessment Software is a firmware module installed on the VPI component of the SPY-PHI System for use during open field surgery where fluorescence imaging is used.

The SPY-PHI Fluorescence Assessment Software enables quantification of fluorescence which may be used as an additional intraoperative tool to assist trained healthcare practitioners in the assessment of fluorescence response in tissue during various surgical procedures. The healthcare practitioner retains the ultimate responsibility for making the pertinent diagnosis based on their clinical judgment and standard practices.

#### Indications for Use of the SPY-PHI System:

Upon intravenous administration of SPY AGENT™ GREEN (indocyanine green for injection, USP) the SPY-PHI System is used with SPY AGENT™ GREEN to perform intraoperative fluorescence angiography. The SPY-PHI System is indicated for use in adult and pediatric patients one month of age and older.

The SPY-PHI System is indicated for fluorescence imaging of blood flow and tissue perfusion before, during, and after: vascular, gastrointestinal, organ transplant, and plastic, micro- and reconstructive surgical procedures.

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Upon interstitial administration of SPY AGENT™ GREEN, the SPY-PHI System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.

| | Comparison of Device Characteristics of the Subject Device and the Predicate Devices: | | | |
|--|---------------------------------------------------------------------------------------|--|--|--|
| | | | | |

| | SUBJECT DEVICE | PREDICATE DEVICE<br>(primary predicate) | PREDICATE DEVICE<br>(secondary predicate to<br>support technological<br>differences/ new software<br>feature) | |
|---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| Name | SPY Portable Handheld<br>Imaging (SPY-PHI) System<br>with SPY-PHI<br>Fluorescence Assessment<br>Software | SPY Portable Handheld<br>Imaging (SPY-PHI) System | SPY Elite Intraoperative<br>Perfusion Assessment<br>System | |
| Company/ 510(k) Holder | Novadaq Technologies<br>ULC. (now a part of<br>Stryker) | Novadaq Technologies<br>ULC. (now a part of<br>Stryker) | Novadaq Technologies<br>ULC. (now a part of<br>Stryker) | |
| Model | HH9000 | HH9000 | LC3000 | |
| 510(k) Reference | TBD (current submission) | K200737 | K182907 | |
| Product Code | IZI | OWN | IZI | |
| Regulation Number | 21 CFR 892.1600 | 21 CFR 876.1500 | 21 CFR 892.1600 | |
| Classification | Class II | Class II | Class II | |
| Combination Product | Yes | Yes | Yes | |
| Device Classification<br>Name | Angiographic X-ray System | Confocal Optical Imaging | Angiographic X-ray System | |
| Intended Use | Near infrared fluorescence<br>imaging for visualization of<br>blood flow and tissue<br>perfusion before, during and<br>after surgical procedures,<br>and intraoperative<br>fluorescence imaging and<br>visualization of the lymphatic<br>system, including lymphatic<br>vessels and lymph nodes. | Near infrared fluorescence<br>imaging for visualization of<br>blood flow and tissue<br>perfusion before, during and<br>after surgical procedures,<br>and intraoperative<br>fluorescence imaging and<br>visualization of the lymphatic<br>system, including lymphatic<br>vessels and lymph nodes. | Near infrared fluorescence<br>imaging for visualization of<br>blood flow and tissue<br>perfusion before, during<br>and after surgical<br>procedures. | |
| Indications for Use | Upon intravenous<br>administration of SPY<br>AGENTTM GREEN<br>(indocyanine green for<br>injection, USP) the SPY-PHI<br>System is used with SPY<br>AGENTTM GREEN to<br>perform intraoperative<br>fluorescence<br>angiography. The SPY-PHI | Upon intravenous<br>administration of SPY<br>AGENTTM GREEN<br>(indocyanine green for<br>injection, USP) the SPY-PHI<br>System is used with SPY<br>AGENTTM GREEN to<br>perform intraoperative<br>fluorescence<br>angiography. The SPY-PHI | Upon intravenous<br>administration of SPY<br>AGENTTM GREEN<br>(indocyanine green for<br>injection, USP) the SPY<br>Elite System is used with<br>SPY AGENTTM GREEN to<br>perform intraoperative<br>fluorescence<br>angiography. The SPY | |
| | SUBJECT DEVICE | PREDICATE DEVICE<br>(primary predicate) | PREDICATE DEVICE<br>(secondary predicate to<br>support technological<br>differences/ new software<br>feature) | |
| Name | SPY Portable Handheld<br>Imaging (SPY-PHI) System<br>with SPY-PHI<br>Fluorescence Assessment<br>Software | SPY Portable Handheld<br>Imaging (SPY-PHI) System | SPY Elite Intraoperative<br>Perfusion Assessment<br>System | |
| Company/ 510(k) Holder | Novadaq Technologies<br>ULC. (now a part of<br>Stryker) | Novadaq Technologies<br>ULC. (now a part of<br>Stryker) | Novadaq Technologies<br>ULC. (now a part of<br>Stryker) | |
| | System used is indicated for<br>use in adult and pediatric<br>patients one month of age<br>and older.<br>The SPY-PHI System is<br>indicated for fluorescence<br>imaging of blood flow and<br>tissue perfusion before,<br>during, and after: vascular,<br>gastrointestinal, organ<br>transplant, and plastic,<br>micro- and reconstructive<br>surgical procedures.<br>Upon interstitial<br>administration of SPY<br>AGENT™ GREEN, the<br>SPY-PHI System is used to<br>perform intraoperative<br>fluorescence imaging and<br>visualization of the lymphatic<br>system, including lymphatic<br>vessels and lymph nodes. | System is indicated for use<br>in adult and pediatric<br>patients one month of age<br>and older.<br>The SPY-PHI System is<br>indicated for fluorescence<br>imaging of blood flow and<br>tissue perfusion before,<br>during, and after: vascular,<br>gastrointestinal, organ<br>transplant, and plastic,<br>micro- and reconstructive<br>surgical procedures.<br>Upon interstitial<br>administration of SPY<br>AGENT™ GREEN, the<br>SPY-PHI System is used to<br>perform intraoperative<br>fluorescence imaging and<br>visualization of the lymphatic<br>system, including lymphatic<br>vessels and lymph nodes. | Elite System used with SPY<br>AGENT GREEN is<br>indicated for use in adult<br>and pediatric patients one<br>month of age and older.<br>The SPY Elite System is<br>indicated for fluorescence<br>imaging of blood flow and<br>tissue perfusion before,<br>during, and after: vascular,<br>gastrointestinal, organ<br>transplant, and plastic,<br>micro- and reconstructive<br>surgical procedures. | |
| Patient Population | Adult patients and pediatric<br>patients (1 month of age and<br>older) | Adult patients and pediatric<br>patients (1 month of age and<br>older) | Adult patients and pediatric<br>patients (1 month of age<br>and older) | |
| Major Device<br>Components | VPI (Video<br>Processor/Illuminator) with<br>upgraded firmware for the<br>SPY-PHI Fluorescence<br>Assessment Software<br>SPY-PHI imager (with<br>integrated light guide cable) | VPI (Video Processor/<br>Illuminator)<br>SPY-PHI imager (with<br>integrated light guide cable) | Imaging console with a<br>detector and signal<br>processing software | |
| Operating Principle | Full color visible light and<br>NIR fluorescence video<br>imaging. The imaging head | Full color visible light and<br>NIR fluorescence video<br>imaging. The imaging head | NIR light from the<br>illumination module in the<br>imaging console is | |
| | SUBJECT DEVICE | PREDICATE DEVICE<br>(primary predicate) | PREDICATE DEVICE<br>(secondary predicate to<br>support technological<br>differences/ new software<br>feature) | |
| Name | SPY Portable Handheld<br>Imaging (SPY-PHI) System<br>with SPY-PHI<br>Fluorescence Assessment<br>Software | SPY Portable Handheld<br>Imaging (SPY-PHI) System | SPY Elite Intraoperative<br>Perfusion Assessment<br>System | |
| Company/ 510(k) Holder | Novadaq Technologies<br>ULC. (now a part of<br>Stryker) | Novadaq Technologies<br>ULC. (now a part of<br>Stryker) | Novadaq Technologies<br>ULC. (now a part of<br>Stryker) | |
| | is positioned over the patient<br>such that the NIR excitation<br>light is emitted and<br>illuminates the area of<br>interest. When the patient is<br>injected with ICG, the ICG<br>binds to the plasma in the<br>blood and travels to the area<br>of interest through the<br>bloodstream. The camera in<br>the Imaging Head captures<br>the fluorescent image under<br>laser illumination or a color<br>image under white light<br>illumination. The VPI<br>receives the video signal<br>from the Imaging Head and<br>processes and outputs the<br>video image to a medical<br>grade video monitor and/or<br>video recorder. | is positioned over the patient<br>such that the NIR excitation<br>light is emitted and<br>illuminates the area of<br>interest. When the patient is<br>injected with ICG, the ICG<br>binds to the plasma in the<br>blood and travels to the area<br>of interest through the<br>bloodstream. The camera in<br>the Imaging Head captures<br>the fluorescent image under<br>laser illumination or a color<br>image under white light<br>illumination. The VPI<br>receives the video signal<br>from the Imaging Head and<br>processes and outputs the<br>video image to a medical<br>grade video monitor and/or<br>video recorder. | transmitted to the imaging<br>head via fiber-optic cable.<br>The imaging head is<br>positioned over the patient<br>such that the NIR excitation<br>light is emitted and<br>illuminates the area of<br>interest. When the patient<br>is injected with ICG, the<br>ICG binds to the plasma in<br>the blood and travels to the<br>area of interest through the<br>bloodstream. The NIR<br>excitation light emitted by<br>the SPY Elite imaging<br>device causes the ICG to<br>fluoresce. The fluorescence<br>image signal is processed<br>and simultaneously<br>recorded in computer<br>memory and displayed on<br>the video monitors. | |
| Safety Standards | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60825-1 | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60825-1 | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60825-1 | |
| Environment of Use | Operating room | Operating room | Operating room | |
| Fluorescence excitation<br>source | NIR laser | NIR laser | NIR laser | |
| Imaging Modes | White Light SPY Overlay Color Segmented Fluorescence (CSF) Color map (raw color map and relative color map) | White Light SPY Overlay Color Segmented Fluorescence (CSF) | SPY Overlay Color Segmented Fluorescence (CSF) | |
| | | SUBJECT DEVICE | PREDICATE DEVICE<br>(primary predicate) | PREDICATE DEVICE<br>(secondary predicate to<br>support technological<br>differences/ new software<br>feature) |
| Name | | SPY Portable Handheld<br>Imaging (SPY-PHI) System<br>with SPY-PHI<br>Fluorescence Assessment<br>Software | SPY Portable Handheld<br>Imaging (SPY-PHI) System | SPY Elite Intraoperative<br>Perfusion Assessment<br>System |
| Company/ 510(k) Holder | | Novadaq Technologies<br>ULC. (now a part of<br>Stryker) | Novadaq Technologies<br>ULC. (now a part of<br>Stryker) | Novadaq Technologies<br>ULC. (now a part of<br>Stryker) |
| Fluorescence<br>Assessment<br>Features &<br>Tools | On-<br>screen<br>timer | On-screen timer (automatic) | Not available…