Who is the manufacturer of SPY Portable Handheld Imaging (SPY-PHI) System?

Novadaq Technologies Ulc. (Now A Part of Stryker) filed the 510(k) submission for SPY Portable Handheld Imaging (SPY-PHI) System (K200737).

What is the FDA product code for SPY Portable Handheld Imaging (SPY-PHI) System?

OWN. It is classified under 21 CFR 876.1500 as a Class 2 device in the Gastroenterology, Urology panel.

What is the regulatory pathway for SPY Portable Handheld Imaging (SPY-PHI) System?

510(k) clearance (submission type: Traditional).

What are the predicate devices for SPY Portable Handheld Imaging (SPY-PHI) System?

PINPOINT Endoscopic Fluorescence Imaging System (K182606); SPY Portable Handheld Imaging (SPY-PHI) System (K192174).

Who can help prepare an FDA 510(k) submission like SPY Portable Handheld Imaging (SPY-PHI) System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

SPY Portable Handheld Imaging (SPY-PHI) System

K200737 · Novadaq Technologies Ulc. (Now A Part of Stryker) · OWN · May 21, 2020 · Gastroenterology, Urology

Device Facts

Record ID	K200737
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	May 21, 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 System captures fluorescent and color images for intraoperative assessment of blood flow, tissue perfusion, and lymphatic structures. System comprises handheld/arm-mounted Imaging Head (CMOS camera, NIR laser, white light) and Video Processor/Illuminator (VPI). Surgeon injects SPY AGENT GREEN (ICG) intravenously or interstitially; NIR laser excites ICG fluorescence. CMOS camera captures fluorescent/color signals; VPI processes data for display on medical-grade monitor. Used in hospital surgical settings by physicians. Output provides real-time visual feedback on perfusion and lymphatic anatomy, aiding surgical decision-making and potentially improving patient outcomes in reconstructive/vascular procedures.

Clinical Evidence

Bench testing only. Conformance to IEC 60601-1, IEC 60601-1-2, and IEC 60825-1 verified. Design validation study confirmed in vivo fluorescence imaging capability for lymphatic system visualization.

Technological Characteristics

Components: Imaging Head (CMOS camera, NIR laser, white light) and VPI. Connectivity: Medical-grade video output. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60825-1, IEC 62304. Imaging modes: White light, SPY, Overlay, Color Segmented Fluorescence (CSF).

Indications for Use

Indicated for adult and pediatric patients (≥1 month) for intraoperative fluorescence angiography (IV administration) and visualization of the lymphatic system/vessels/nodes (interstitial administration) during vascular, GI, organ transplant, and plastic/micro/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

PINPOINT Endoscopic Fluorescence Imaging System (K182606)
SPY Portable Handheld Imaging (SPY-PHI) System (K192174)

Related Devices

K202244 — SPY-PHI System with SPY-PHI Fluorescence Assessment Software · Novadaq Technologies Ulc. (Now A Part of Stryker) · Nov 5, 2020
K230727 — SPY Portable Handheld Imaging (SPY-PHI) System · Novadaq Technologies Ulc (A Part of Stryker) · Jun 5, 2023
K192174 — SPY Portable Handheld Imaging (SPY-PHI) System · Novadaq Technologies Ulc. (Now A Part of Stryker) · Nov 15, 2019
K190729 — SPY Portable Handheld Imaging (SPY-PHI) System · Novadaq Technologies Ulc. (Now A Part of Stryker) · Apr 19, 2019
K162885 — SPY Phi Open Field Handheld Fluorescence Imaging System · Novadaq Technologies, Inc. · Jan 11, 2017

Submission Summary (Full Text)

{0}------------------------------------------------ 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 May 21, 2020 ## Re: K200737 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, IZI, GCJ Dated: March 20, 2020 Received: March 23, 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 {1}------------------------------------------------ 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. Neil R.P. Ogden Assistant Director THT4A4 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) K200737 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. 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) | | |-------------------------------------------------|--| |-------------------------------------------------|--| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 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 § 876.1500 | | Classification Name: | Confocal Optical Imaging | | 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 101 Burnaby, British Columbia Canada, V5A 4W2 | | Contact Name: | Agatha Szeliga Requlatory Affairs Manager Tel: 604-422-7516 Fax: 604-232-9841 | #### Date 510(k) Summary Prepared: March 16, 2020 #### Predicate Device(s) Information: | Predicate Device Trade Name | PINPOINT Endoscopic Fluorescence Imaging System (PINPOINT System) | SPY Portable Handheld Imaging (SPY-PHI) System | |------------------------------|-------------------------------------------------------------------------|------------------------------------------------------| | | (primary predicate for indications expansion) | (secondary predicate) | | 510(k) Number | K182606 | K192174 | | Submitter/510(k) Holder Name | Novadaq Technologies ULC. (now a part of Stryker) | Novadaq Technologies ULC. (now a part of Stryker) | | Classification Name | Laparoscope, General & Plastic Surgery; Angiographic X-ray System | Confocal Optical Imaging | | Product Code and Regulation | GCJ; IZI 21 CFR § 876.1500 | OWN 21 CFR § 876.1500 | | Classification | Class II | Class II | {4}------------------------------------------------ #### 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 consists of the following main components: Imaging Head/ Imager (HH9030) with an integrated light quide cable and the Video Processor/Illuminator (VPI) (PC9001). SPY AGENT™ GREEN (indocyanine green for injection, USP) 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 SPY AGENT™ GREEN 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 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 anqiography. The SPY-PHI System is indicated for use in adult and pediatric patients one month of aqe 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. {5}------------------------------------------------ | Subject Device SPY Portable Handheld Imaging (SPY-PHI) System | Predicate Device (primary predicate for indication expansion) PINPOINT Endoscopic Fluorescence Imaging System (K182606) | Predicate Device (secondary predicate) SPY Portable Handheld Imaging (SPY-PHI) System (K192174) | | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 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 | Upon intravenous administration of SPY AGENT™ GREEN (ICG drug product), the PINPOINT Endoscopic Fluorescence Imaging System is used with SPY AGENT™ GREEN to perform intraoperative fluorescence angiography, and it is also indicated for use in fluorescence imaging of | 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 | | | age and older. | biliary ducts, and when indicated, during intraoperative cholangiography. | 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™ | The PINPOINT Endoscopic Fluorescence Imaging System is indicated for use to provide real time endoscopic visible and near-infrared fluorescence imaging. The PINPOINT System enables surgeons to perform minimally invasive surgery using standard endoscope visible light as well as visual | 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. | | | GREEN, the SPY-PHI System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes. | assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct or common hepatic duct), using near-infrared imaging. Fluorescence imaging of biliary ducts with the PINPOINT System is intended for use with standard of care white light, and when indicated, intraoperative cholangiography. The device is not intended for standalone use for biliary duct visualization. Upon interstitial administration of SPY AGENT™ GREEN (ICG drug product), the PINPOINT System is used to perform intraoperative | | | | | fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes. | | | | Feature | Subject Device | Predicate Devices | | | | SPY Portable Handheld Imaging (SPY-PHI) System | PINPOINT Endoscopic Fluorescence Imaging System | SPY Portable Handheld Imaging (SPY-PHI) System | | 510(k) Holder/ Manufacturer | Novadaq Technologies ULC. (now a part of Stryker) | Novadaq Technologies ULC. (now a part of Stryker) | Novadaq Technologies ULC. (now a part of Stryker) | | Submission Reference | Current Submission | K182606 | K192174 | | Decision Date | Current Submission | 11/21/2018 | 11/15/2019 | | Combination Product | No | No | Yes | | Product Code | OWN | GCJ; IZI | OWN | | Regulation Number | 21 CFR 876.1500 | 21 CFR 876.1500 | 21 CFR 876.1500 | | Device Classification Name | Confocal Optical Imaging | Laparoscope, General & Plastic Surgery; Angiographic X-ray System | Confocal Optical Imaging | | Intended Use | Near infrared fluorescence imaging for visualization of blood flow and tissue perfusion before, during and after surgical procedures, and intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes. | Near infrared fluorescence imaging for visualization of blood flow and tissue perfusion during surgical procedures, identification of extrahepatic biliary ducts, and intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes. | Near infrared fluorescence imaging for visualization of blood flow and tissue perfusion before, during and after surgical procedures. | | Operating Principle | Full color visible light and NIR fluorescence video imaging. The 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. | Full color visible light and NIR fluorescence video imaging. The PINPOINT camera captures the fluorescent image under laser illumination or a color image under white light illumination. The VPI receives the video signal from camera and processes and outputs the video image to a medical grade video monitor and/or video recorder. | Full color visible light and NIR fluorescence video imaging. The 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. | | Safety Standards | IEC 60601-1 | IEC 60601-1 | IEC 60601-1 | | Feature | Subject Device | Predicate Devices | | | | SPY Portable Handheld Imaging (SPY-PHI) System | PINPOINT Endoscopic Fluorescence Imaging System | SPY Portable Handheld Imaging (SPY-PHI) System | | | IEC 60601-1-2 | IEC 60601-1-2 | IEC 60601-1-2 | | | IEC 60825-1 | IEC 60825-1 | IEC 60825-1 | | | | IEC 60601-2-18 | | | Major components | VPI (Video Processor/Illuminator) | VPI (Video Processor/Illuminator) | VPI (Video Processor/ Illuminator) | | | SPY-PHI imager (with integrated light guide cable) | Camera Light Guide Cable Laparoscopes | SPY-PHI imager (with integrated light guide cable) | | Imaging Modes | White Light | White Light | White Light | | | SPY | SPY | SPY | | | Overlay | Overlay | Overlay | | | Color Segmented Fluorescence (CSF) | Color Segmented Fluorescence (CSF) | Color Segmented Fluorescence (CSF) | | Fluorescence excitation source | NIR laser | NIR laser | NIR laser | | Environment of Use | Hospital | Hospital | Hospital | | Contrast imaging agent | SPY AGENT™ GREEN (indocyanine green for injection, USP) | SPY AGENT™ GREEN (indocyanine green for injection, USP) | SPY AGENT™ GREEN (indocyanine green for injection, USP) | ### Comparison of the Indications for Use of the Subject Device and Predicate Devices: {6}------------------------------------------------ # Comparison of Device Characteristics of the Subject Device and the Predicate Devices: {7}------------------------------------------------ # Performance Testing of the SPY-PHI System: The SPY-PHI System was designed and developed in accordance with the applicable requirements and standards to establish performance and safety of the device's safety and performance were verified, including testing conducted by 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 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. A design validation study was conducted to assess the suitability of the design requirements of the SPY-PHI System to meet user needs and evaluated the in vivo fluorescence imaging capability of SPY-PHI for the visualization of the lymphatic system, including lymphatic vessels and lymph nodes. The results of the validation study support the proposed expanded indications for use for the SPY-PHI System. {8}------------------------------------------------ ### 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 demonstrated to be substantially equivalent to the predicate devices, the PINPOINT Endoscopic Fluorescence Imaging System (FDA 510(k)-cleared in K182606) and the SPY Portable Handheld Imaging (SPY-PHI) System (FDA 510(k)cleared in K192174). The proposed expanded indications for use of the SPY-PHI System for intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes using SPY AGENT™ GREEN do not raise any issues related to safety or effectiveness for this device when used as instructed.