SPY Portable Handheld Imaging (SPY-PHI) System

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June 5, 2023 Novadaq Technologies ULC (a part of Stryker) Cara Cahill Manager, Regulatory Affairs 8329 Eastlake Drive, Unit 101 Burnaby, British Columbia V5A 4W2 Canada Re: K230727 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: IZI Dated: March 15, 2023 Received: March 16, 2023 Dear Cara Cahill: 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). 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Sincerely, Jessica Carr -S Jessica Carr, Ph.D. Acting Assistant Director 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K230727 #### 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-PH 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. Upon intradermal administration of SPY AGENT GREEN, the SPY-PHI System is indicated for fluorescence imaging of lymph nodes and delineation of lymphatic vessels during lymphatic mapping in adults with breast cancer for which this procedure is a component of intraoperative management. | Type of Use (Select one or both, as applicable) | | |---------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------| | <div style="text-align:left;"> <span style="padding-right:5px">☒</span>Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div style="text-align:left;"> <span style="padding-right:5px">☐</span>Over-The-Counter Use (21 CFR 801 Subpart C)</div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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The word is written in all lowercase letters. ## 510(k) Summary This 510(k) Summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 C.F.R Part 807.92(c) ## Submitter: | Applicant | Novadaq Technologies ULC (A Part of Stryker)<br>8329 Eastlake Drive, Unit 101<br>Burnaby, British Columbia V5A 4W2, Canada | |----------------|----------------------------------------------------------------------------------------------------------------------------| | Contact Person | Cara Cahill<br>Manager, Regulatory Affairs<br>Phone: (408) 754-2473<br>Email: cara.cahill@stryker.com | | Date Prepared | May 10, 2023 | #### Subject Device: | Name of Device | SPY Portable Handheld Imaging (SPY-PHI) System | |----------------------|------------------------------------------------| | Common or Usual Name | Fluorescence Angiographic System | | Classification Name | Angiographic X-Ray System, 21 CFR 892.1600 | | Regulatory Class | Class II | | Product Code | IZI | | 510(k) Review Panel: | Radiology | ## Predicate Device: | Predicate Devices | Manufacturer | |----------------------------------------------------------------------------|-------------------------------------------------| | SPY-PHI System with SPY-PHI Fluorescence Assessment<br>Software (K202244)* | Novadaq Technologies ULC<br>(A Part of Stryker) | | SPY Portable Handheld Imaging (SPY-PHI) System<br>(K200737) | Novadaq Technologies ULC<br>(A Part of Stryker) | *primary predicate ## Device Description: The SPY-PHI System is a real-time white-light and near-infrared illumination/ fluorescence imaging system used during open-field surgical procedures. Near-infrared illumination is used for fluorescence imaging using SPY AGENT® GREEN for the visual assessment of blood flow, tissue perfusion and visualization of the lymphatic system, including lymphatic vessels and lymph nodes. It consists of the SPY Portable Handheld Imager/ imaging head with an integrated light guide and camera cable and the Video Processor/ Illuminator. Additionally, SPY-QP Fluorescence Assessment Software is provided as an optional upgrade to the SPY-PHI System that enables relative quantification of NIR fluorescence. {4}------------------------------------------------ # Indications for Use: | Item | Subject Device | Predicate Device | | |--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------| | | SPY Portable Handheld Imaging (SPY-PHI)<br>System | SPY Portable Handheld Imaging<br>(SPY-PHI) System | | | Intended Use | Visible white light and near-infrared illumination<br>during open-field surgical procedures. | Same as subject device | | | Indications for Use | Upon intravenous administration of SPY AGENT<br>GREEN (indocyanine green for injection, USP), the<br>SPY-PHI System is used with SPY AGENT GREEN<br>to perform intraoperative fluorescence angiography.<br>The SPY-PHI System is indicated for use in adult and<br>pediatric patients one month of age and older.<br>The SPY-PHI System is indicated for fluorescence<br>imaging of blood flow and tissue perfusion before,<br>during, and after: vascular, gastrointestinal, organ<br>transplant, and plastic, micro- and reconstructive<br>surgical procedures.<br>Upon interstitial administration of SPY AGENT<br>GREEN, the SPY-PHI System is used to perform<br>intraoperative fluorescence imaging and visualization<br>of the lymphatic system, including lymphatic vessels<br>and lymph nodes.<br>Upon intradermal administration of SPY AGENT<br>GREEN, the SPY-PHI System is indicated for<br>fluorescence imaging of lymph nodes and delineation<br>of lymphatic vessels during lymphatic mapping in<br>adults with breast cancer for which this procedure is a<br>component of intraoperative management. | Upon intravenous administration<br>of SPY AGENT GREEN<br>(indocyanine green for injection,<br>USP) the SPY-PHI System is used<br>with SPY AGENT GREEN to<br>perform intraoperative<br>fluorescence angiography. The<br>SPY-PHI System is indicated for<br>use in adult and pediatric patients<br>one month of age and older.<br>The SPY-PHI System is indicated<br>for fluorescence imaging of blood<br>flow and tissue perfusion before,<br>during, and after: vascular,<br>gastrointestinal, organ transplant,<br>and plastic, micro- and<br>reconstructive surgical procedures.<br>Upon interstitial administration of<br>SPY AGENT GREEN, the SPY-<br>PHI System is used to perform<br>intraoperative fluorescence<br>imaging and visualization of the<br>lymphatic system, including<br>lymphatic vessels and lymph<br>nodes. | | | Feature | Subject Device | Predicate Device | | | Feature | SPY Portable Handheld Imaging (SPY-PHI) System | SPY Portable Handheld Imaging (SPY-PHI) System | | | Manufacturer | Novadaq Technologies ULC. (a part of Stryker) | Same as subject device | | | Submission Reference | Current Submission | K202244, K200737 | | | Imaging System Type | Open-Field | Same as subject device | | | Imaging Modes | White Light<br>Near-Infrared:<br>- Overlay Mode1<br>- SPY Mode (Contrast) 1<br>- SPY Color Segmented Fluorescence (CSF) | Same as subject device | | | Principles of Operation | Via Imager, light is transmitted through the Light Cable and projected to illuminate the surgical site/ area of interest. The light emitted and reflected from the surgical site/ area of interest (aside from NIR excitation light, which is blocked by an internal rejection filter) is acquired by the Imager, projected onto the image sensor and converted to a digital signal. The digital signal is transmitted via the Camera Cable to the VPI which receives the optical image information, processes the information, and outputs it to digital video. | Same as subject device | | | System Components | SPY-PHI Imager<br>Video Processor/ Illuminator<br>SPY-QP Fluorescence Assessment Software | Same as subject device | | | Safety Standards | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-1-6<br>IEC 60825-1 | Same as subject device | | | Optical<br>Imaging<br>Specifications | Dynamic Range | The user shall be able to visualize SPY AGENT GREEN in physiology applications. The response on the system monitor to the minimum clinically relevant concentration of SPY AGENT GREEN shall be at least 6.9(ΔE), and the system response to the maximum clinically relevant concentration shall be at least twice that at low concentrations. | Same as subject device | | | Localization | The user shall be able to visualize SPY AGENT GREEN in anatomy applications. The response on the system monitor shall be at least 10.35 (ΔΕ) under clinically relevant conditions. | Same as subject device | | SPY-PHI Imager | Image Sensor: CMOS image sensor | Same as subject device | | | Video Processor/ Illuminator | Light Source/ RGB LEDs | Same as subject device | | | Feature | Subject Device | | Predicate Device | | | SPY Portable Handheld Imaging (SPY- | | SPY Portable Handheld | | | PHI) System | | Imaging (SPY-PHI) System | | | Laser Safety | Class 3R | Same as subject device | | | Class | | | | | Wavelengths | White Light: | Same as subject device | | | | 400 nm – 700 nm | | | | | Near-infrared: 805 nm | | | | Imaging | Digital | Same as subject device | | | Processing/ | | | | | Video Output | | | | | Resolution | 1080p (1920x1080) | Same as subject device | | | Frame Rate | 60 Hz | Same as subject device | | Imaging Agent | | SPY AGENT GREEN (indocyanine green for | Same as subject device | | | injection, USP) | | | {5}------------------------------------------------ # Comparison of Technological Characteristics with the Predicate Device: {6}------------------------------------------------ 1 SPY Mode (Contrast) and Overlay Mode are recommended for use in breast lymphatic mapping. {7}------------------------------------------------ ## Performance Testing: | Test | Method | Result | |----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------| | Electromagnetic<br>Compatibility | In accordance with IEC 60601-1-2:2014, Medical electrical<br>equipment, Part 1. General requirements for safety, 2. Collateral<br>standard: Electromagnetic compatibility - Requirements and tests | PASS | | Electrical Safety | In accordance with:<br>• IEC 60601-1:2005+A1:2012, Medical electrical equipment, Part 1.<br>General requirements for safety and essential performance; &<br>applicable national deviations<br>• IEC 60601-1-6:2020-07, Medical electrical equipment - Part 1-6:<br>General requirements for basic safety and essential performance | PASS | | Laser Safety | In accordance with IEC 60825-1:2014, Safety of laser products - Part<br>1: Equipment classification and requirements | PASS | | Usability | In accordance with IEC62366-1:2015, Medical devices -- Part 1:<br>Application of usability engineering to medical devices | PASS | | Performance Testing - Bench | In accordance with design input specifications including optical<br>imaging performance specifications | PASS | | Software | In accordance with IEC 62304:2006, Medical device software -<br>Software life cycle processes | PASS | Note: The device is not patient contacting. Therefore, biocompatibility does not apply. ## Performance Testing - Clinical: The Novadaq Technologies ULC-sponsored FILM-B Clinical Study was performed under an IDE (G170109), in accordance with 21 CFR 812. FILM-B was a single-arm, prospective. multi-center, open-label study in subjects with early stage breast cancers with clinically negative nodal status and who were scheduled for surgery that included clinically indicated sentinel lymph node biopsy with technetium 99m radioactive colloid (Tc99m). Subjects received Tc99m the day before or the day of surgery and SPY AGENT GREEN was injected into the identified breast of subjects at the beginning of the operative procedure. All subjects received the injection into a single breast. A total of 152 subjects were enrolled in the study. Lymphatic mapping was performed intraoperatively using the SPY-PHI System and a handheld gamma probe, or the surgeon's visual and palpation examination. The resected tissues were evaluated by histopathology to confirm presence of lymph nodes. The FILM-B study design resulted in unbiased, quality, reliable and repeatable data for use in the evaluation of the effectiveness and safety of SPY AGENT GREEN and SPY-PHI in identifying lymph nodes during lymphatic mapping and sentinel lymph node biopsy in subjects with earlystage breast ca…