SPY Portable Handheld Imaging (SPY-PHI) System

K192174 · Novadaq Technologies Ulc. (Now A Part of Stryker) · OWN · Nov 15, 2019 · Gastroenterology, Urology

Device Facts

• Record ID: K192174
• Device Name: SPY Portable Handheld Imaging (SPY-PHI) System
• Applicant: Novadaq Technologies Ulc. (Now A Part of Stryker)
• Product Code: OWN · Gastroenterology, Urology
• Decision Date: Nov 15, 2019
• 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, and after: vascular, gastrointestinal, organ transplant, and plastic, micro- and reconstructive surgical procedures.

Device Story

SPY-PHI System is a handheld imaging device for intraoperative fluorescence angiography. Input: near-infrared (NIR) laser light to excite intravenously administered Indocyanine green (ICG) or white light for color imaging. CMOS camera in imaging head captures fluorescent or color images. Video Processor/Illuminator (VPI) processes signals and outputs video to medical-grade monitors/recorders. Used in hospital settings by surgeons to visually assess blood flow and tissue perfusion. Output allows real-time visualization of perfusion, aiding surgical decision-making in vascular, gastrointestinal, transplant, and reconstructive procedures. Benefits include improved assessment of tissue viability and blood flow during surgery.

Clinical Evidence

No new clinical trials conducted. Safety and efficacy for pediatric patients (≥1 month) supported by clinical literature review. Literature indicated successful visualization of blood flow/perfusion; ICG dosing in pediatric patients is similar to adults, with no reported anaphylaxis or adverse events related to fluorescence imaging in the pediatric population.

Technological Characteristics

Handheld imaging head with integrated light guide cable and VPI. Uses NIR laser for fluorescence excitation and white light for color imaging. CMOS sensor. Connectivity: medical-grade video output. Standards: IEC 60601-1 (safety), IEC 60601-1-2 (EMC), IEC 60825-1 (laser safety), IEC 62304 (software lifecycle).

Indications for Use

Indicated for adult and pediatric patients (≥1 month) for intraoperative fluorescence angiography and imaging of blood flow and tissue perfusion before, during, and after vascular, gastrointestinal, organ transplant, and plastic, micro-, and reconstructive surgeries.

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 (K190729)
• SPY Portable Handheld Imaging (SPY-PHI) System (K162885)
• SPY Elite Intraoperative Perfusion Assessment System (K182907)

Submission Summary (Full Text)

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

November 15, 2019

Re: K192174

Trade/Device Name: SPY Portable Handheld Imaging (SPY-PHI) System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: OWN Dated: August 9, 2019 Received: August 12, 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 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-reporting

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combination-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 medical devices and radiation-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, MS Assistant Director, THT4A4 DHT4A: Division of General Surgery Devices OHT5: 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) K192174

#### 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 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.

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

| <div> <span style="text-decoration: overline;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> |
|----------------------------------------------------------------------------------------------------------------|
| <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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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 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)<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 8, 2019

# Predicate Device(s) Information:

| Predicate Device Trade Name | SPY Portable Handheld Imaging<br>(SPY-PHI) System | SPY Elite Intraoperative<br>Perfusion Assessment System |
|------------------------------|------------------------------------------------------------------------------------|---------------------------------------------------------|
| 510(k) Number | K190729; K162885 | K182907 |
| Submitter/510(k) Holder Name | Novadaq Technologies ULC.<br>(now a part of Stryker)/ Novadaq<br>Technologies Inc. | Novadaq Technologies ULC.<br>(now a part of Stryker) |
| Classification Name | Angiographic X-Ray System | Angiographic X-Ray System |
| Product Code and Regulation | OWN; 21 CFR § 892.1600 | IZI; 21 CFR § 892.1600 |
| Classification | Class II | Class II |

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### Device Description:

The SPY-PHI System is an imaging system used in capturing 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 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 regions 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.

## Indications for Use for 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 used 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 surqical procedures.

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# Comparison of the Indications for Use of the Subject Device and Predicate Devices:

| Subject Device<br>SPY Portable Handheld Imaging<br>(SPY-PHI) System | Predicate Device<br>SPY Portable Handheld Imaging<br>(SPY-PHI) System | Predicate Device<br>SPY Portable Handheld Imaging<br>(SPY-PHI) System | Predicate Device<br>SPY Elite Intraoperative Perfusion<br>Assessment System |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | (K190729) | (K162885) | (K182907) |
| Upon intravenous administration of SPY AGENTTM GREEN (Indocyanine green for injection, USP) the SPY-PHI System is used with SPY AGENTTM 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.<br>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 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 tissue perfusion, and related tissue-transfer circulation in tissue and free flaps used in plastic, micro- and reconstructive surgical procedures.<br>The SPY-PHI System is used with SPY AGENTTM 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. | 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 flaps used in plastic, micro-, and reconstructive surgical procedures.<br>The SPY Phi Open Field Handheld Fluorescence Imaging System is intended to provide fluorescence images for the visual assessment of blood flow in vessels and related tissue perfusion during gastrointestinal surgical procedures. | Upon intravenous administration of SPY AGENTTM GREEN (Indocyanine green for Injection, USP), the SPY Elite System is used with SPY AGENTTM GREEN to perform intraoperative fluorescence angiography. The SPY Elite System used with SPY AGENTTM GREEN is indicated for use in adult and pediatric patients one month of age and older.<br>The SPY Elite 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 surgeries. |
| Feature | Subject Device | Predicate Devices | |
| | SPY Portable Handheld<br>Imaging (SPY-PHI)<br>System | SPY Portable Handheld<br>Imaging (SPY-PHI)<br>System | SPY Elite Intraoperative<br>Perfusion Assessment<br>System |
| 510(k) Holder/<br>Manufacturer | Novadaq Technologies<br>ULC. (now a part of<br>Stryker) | Novadaq Technologies<br>ULC. (now a part of<br>Stryker)/ Novadaq<br>Technologies Inc. | Novadaq Technologies<br>ULC. (now a part of<br>Stryker) |
| Submission<br>Reference | Current Submission | K190729; K162885 | K182907 |
| Decision Date | Current Submission | 04/19/2019; 01/11/2017 | 01/23/2019 |
| Combination<br>Product | Yes | Yes | Yes |
| Product Code | OWN | OWN | IZI |
| Regulation Number | 21 CFR 892.1600 | 21 CFR 892.1600 | 21 CFR 892.1600 |
| Device<br>Classification Name | System, X-Ray,<br>Angiographic | System, X-Ray,<br>Angiographic | System, X-Ray,<br>Angiographic |
| Intended Use | Near infrared fluorescence<br>imaging for visualization of<br>blood flow and tissue<br>perfusion during surgical<br>procedures | Near infrared fluorescence<br>imaging for visualization of<br>blood flow and tissue<br>perfusion during surgical<br>procedures | Near infrared fluorescence<br>imaging for visualization of<br>blood flow and tissue<br>perfusion during surgical<br>procedures |
| Operating Principle | Full color visible light and<br>NIR fluorescence video<br>imaging. The CMOS<br>camera in the Imaging<br>Head captures the<br>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<br>and processes and<br>outputs the video image to<br>a medical grade video<br>monitor and/or video<br>recorder. | Full color visible light and<br>NIR fluorescence video<br>imaging. The CMOS<br>camera in the Imaging<br>Head captures the<br>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<br>and processes and<br>outputs the video image to<br>a medical grade video<br>monitor and/or video<br>recorder. | NIR light from the<br>illumination module in the<br>imaging console is<br>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<br>excitation light is emitted<br>and 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<br>the area of interest<br>through the bloodstream.<br>The NIR excitation light<br>emitted by the SPY Elite<br>imaging device causes the<br>ICG to fluoresce. The<br>fluorescence image signal<br>is processed and<br>simultaneously recorded in<br>computer memory and |
| Feature | Subject Device | Predicate Devices | |
| | SPY Portable Handheld<br>Imaging (SPY-PHI)<br>System | SPY Portable Handheld<br>Imaging (SPY-PHI)<br>System | SPY Elite Intraoperative<br>Perfusion Assessment<br>System |
| | | | displayed on the video<br>monitors in real time. |
| Safety Standards | IEC 60601-1 | IEC 60601-1 | IEC 60601-1 |
| | IEC 60601-1-2 | IEC 60601-1-2 | IEC 60601-1-2 |
| | IEC 60825-1 | IEC 60825-1 | IEC 60825-1 |
| Major components | SPY-PHI imager (with<br>integrated light guide<br>cable) and VPI (Video<br>Processor/ Illuminator) | SPY-PHI imager (with<br>integrated light guide<br>cable) and VPI (Video<br>Processor/ Illuminator) | Imaging console with a<br>detector (CCD camera)<br>and signal processing<br>software |
| Fluorescence<br>excitation source | NIR laser | NIR laser | NIR laser |
| Environment of Use | Hospital | Hospital | Hospital |
| Contrast imaging<br>agent | SPY AGENTTM GREEN<br>(Indocyanine green for<br>injection, USP) | SPY AGENTTM GREEN<br>(Indocyanine green for<br>injection, USP);<br>Indocyanine green (ICG) | SPY AGENTTM GREEN<br>(Indocyanine green for<br>injection, USP) |

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# Comparison of Device Characteristics of the Subject Device and the Predicate Devices:

Section 5 Page 4 of 6

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### 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 Novadag 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 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.

# Clinical Summary and Use in Pediatric Patients:

Safety and effectiveness of the SPY-PHI System for its intended use in the visualization of blood flow and tissue perfusion during various surgical procedures was assessed through a series of clinical literature evaluations to support the expansion to the cleared indications for use, including published literature references to support the expansion of existing indications for use to include pediatric patients, one (1) month of age and older.

Efficacy data obtained from published literature showed successful visualization in majority of the studies. Analysis of ICG doses administered to several pediatric subpopulations showed that the effective doses

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used in angiographic applications were similar to those administered to adult patients. Based on anecdotal clinical experience, lower doses of ICG may be effective, especially in younger patients and those with lower body weight.

None of the published literature identified anaphylaxis or any other adverse events related to SPY fluorescence imaging with ICG in pediatric patients. Overall the data suggests that there are no differences in safety and efficacy of SPY fluorescence imaging with ICG between pediatric patients (aged 1 month to 21 years) and adult patients.

## Conclusion & Summary of Substantial Equivalence

Based on the information presented in this Traditional 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 devices, the SPY Portable Handheld Imaging (SPY-PHI) System (FDA 510(K)cleared in K162885 and K190729) and the SPY Elite Intraoperative Perfusion Assessment System (FDA 510(k)-cleared in K182907)

Any minor technological or design differences between the SPY-PHI System and the predicate devices do not raise any questions related to safety or effectiveness. The proposed additional/expanded indications for use do not raise any issues related to safety or effectiveness for this device-drug combination product.