Who is the manufacturer of SPY Elite Intraoperative Perfusion Assessment System?

Novadaq Technologies Ulc. (Now A Part of Stryker) filed the 510(k) submission for SPY Elite Intraoperative Perfusion Assessment System (K182907).

What is the FDA product code for SPY Elite Intraoperative Perfusion Assessment System?

IZI. It is classified under 21 CFR 892.1600 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for SPY Elite Intraoperative Perfusion Assessment System?

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

What are the predicate devices for SPY Elite Intraoperative Perfusion Assessment System?

SPY System (K100371); SPY System (K073088); SPY System (K073130); SPY System (K071619).

Who can help prepare an FDA 510(k) submission like SPY Elite Intraoperative Perfusion Assessment 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 Elite Intraoperative Perfusion Assessment System

K182907 · Novadaq Technologies Ulc. (Now A Part of Stryker) · IZI · Jan 23, 2019 · Radiology

Device Facts

Record ID	K182907
Device Name	SPY Elite Intraoperative Perfusion Assessment System
Applicant	Novadaq Technologies Ulc. (Now A Part of Stryker)
Product Code	IZI · Radiology
Decision Date	Jan 23, 2019
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1600
Device Class	Class 2
Attributes	Pediatric

Intended Use

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

Device Story

SPY Elite System is an angiographic fluorescence imaging system for open surgery. Input: NIR fluorescence signals from patient injected with Indocyanine Green (ICG). Operation: NIR light from console illuminates surgical site; ICG binds to plasma; device detects fluorescence via CCD camera; signal processing software generates real-time images. Output: Live fluorescence images displayed on monitors; recorded videos with false color overlays; still images/reports for review/export. Used in hospital OR by surgeons. Output assists in visual assessment of blood flow and tissue perfusion, aiding intraoperative decision-making. Benefits: Real-time visualization of micro/macro vasculature and tissue perfusion.

Clinical Evidence

Systematic review of 33 clinical studies (2,055 patients) supported safety and efficacy. Primary endpoint: visualization of blood flow/tissue perfusion. Results: 94% of studies (31/33) showed 100% visualization rate for microvascular flow; 10/13 studies showed 100% visualization rate for macrovascular flow. No adverse events (anaphylaxis) reported in pediatric literature. Data supports use in pediatric patients (1 month to 21 years) as equivalent to adults.

Technological Characteristics

NIR fluorescence imaging system. Components: Imaging console, CCD camera, fiber-optic cable, radiation source. Software: CINEVAQ (system control/processing), DICOM Send. Connectivity: DICOM. Standards: IEC 60601-1 (safety), IEC 60601-1-2 (EMC), IEC 60825-1 (Class 3R laser).

Indications for Use

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

Regulatory Classification

Identification

An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

SPY System (K100371)
SPY System (K073088)
SPY System (K073130)
SPY System (K071619)

Related Devices

K091515 — SPY SCOPE INTRA-OPERATIVE OPERATING SYSTEM · Novadaq Technologies, Inc. · Jul 9, 2009
K192174 — SPY Portable Handheld Imaging (SPY-PHI) System · Novadaq Technologies Ulc. (Now A Part of Stryker) · Nov 15, 2019
K073130 — SPY FLUORESCENT IMAGING SYSTEM · Novadaq Technologies, Inc. · Jan 10, 2008
K071619 — SPY FLUORESCENT IMAGING SYSTEM · Novadaq Technologies, Inc. · Nov 9, 2007
K072222 — SPY FLUORESCENT IMAGING SYSTEM · Novadaq Technologies, Inc. · Sep 7, 2007

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). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services - USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in three lines, with "FDA" being the largest and most prominent. The overall design is clean and professional, reflecting the organization's role in regulating food and drugs. March 2, 2020 Novadaq Technologies ULC. (now a part of Stryker) Agatha Szeliga Regulatory Affairs Manager 8329 Eastlake Drive, Unit 101 Burnaby, CA V5A 4W2 Re: K182907 Trade/Device Name: SPY Elite Intraoperative Perfusion Assessment System Regulation Number: 21 CFR 892.1600 Regulation Name: Angiographic x-ray system Regulatory Class: Class II Product Code: IZI Dated: October 16, 2018 Received: October 17, 2018 Dear Agatha Szeliga: This letter corrects our substantially equivalent letter of January 23rd, 2019. We have reviewed vour 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. {1}------------------------------------------------ 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-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 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. Image /page/1/Picture/5 description: The image shows the name Neil R.P. Ogden in large font on the left side of the image. On the right side of the image, it says "Digitally signed by Neil R.P. Ogden" followed by the date "2020.03.02" and the time "09:47:55 -05'00'". The text on the right side of the image is smaller than the name on the left side. Neil R. Ogden 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) K182907 Device Name SPY Elite System #### Indications for Use (Describe) Upon intravenous administration of SPY AGENT™ GREEN (Indocyanine green for Injection, USP), the SPY Elite System is used with SPY AGENT™ GREEN to perform intraoperative fluorescence angiography. The SPY Elite System used with SPY AGENT™ GREEN is indicated for use in adult and pediatric patients one month of age and older. 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. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------| | <div> × Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | #### 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. | Trade Name: | SPY Elite Intraoperative Perfusion Assessment System (SPY Elite System) | |---------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------| | Device Model Number: | LC3000, SP3000 | | Common Name: | Angiographic X-Ray System | | Classification: | 21 CFR § 892.1600 | | Classification Name: | Angiographic X-Ray System | | Product Code: | IZI | | 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 Regulatory Affairs Manager Tel: (604) 422-7516 Fax: (604) 232-9841 Email: agatha.szeliga@stryker.com | | Date 510(k) Summary Prepared: October 12, 2018 | | | Predicate Device(s): | SPY System (K100371, K073088, K073130, and K071619) (Novadaq Technologies Inc.) | ### Device Description The SPY Elite System is an angiographic fluorescence imaging system which is used for nearinfrared fluorescence imaging during open surgery, with indocyanine green (ICG) as the imaging agent. The SPY Elite System allows surgeons to capture, review, print, and archive high-quality fluorescence images of blood flow in vessels, tissue and organ perfusion in realtime during various surgical procedures. The SPY Elite System is comprised of an Imaging Console, CINEVAQ software and DICOM Send software. SPY Elite is intended to be used in coniunction with the SPY Elite Pack/Kit which contains ICG, sterile Water for Injection, a sterile equipment drape, instructions for use, and a drug product package insert. {4}------------------------------------------------ To provide NIR fluorescence imaging, SPY Elite is used with the imaging agent, indocyanine green (ICG). Once the patient is injected with ICG imaging agent, recording can begin. The SPY Elite imaging head filters the excitation NIR light and only senses the fluorescence signal. Live images are then displayed on the device's monitors. After imaging is complete, the user can review the recorded videos with false color overlays, examine reports and raw data, or print(export still images and reports. In combination with SPY AGENT™ GREEN (Indocvanine green for Iniection, USP), the SPY Elite System is used in the visualization of vessels (micro and macro vasculature), blood flow and tissue perfusion before, during, and after various surgical procedures, in adult and pediatric patients. ### Proposed Indications for Use of the SPY Elite System Upon intravenous administration of SPY AGENT™ GREEN (Indocyanine green for Injection, USP), the SPY Elite System is used with SPY AGENT™ GREEN to perform intraoperative fluorescence angiography. The SPY Elite System used with SPY AGENT™ GREEN is indicated for use in adult and pediatric patients one month of age and older. 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. ### Comparison and Summary of the Indications for Use of the SPY Elite System and the Predicate Devices The main differences in the indications for use between the SPY Elite device proposed in this 510(k)-premarket notification and the predicate device are the cross-label indications for use with SPY AGENT™ GREEN drug product, the compilation of the individual 510(k)-cleared indications for use (of the predicate devices) into one comprehensive 510(k), and expansion of the existing indications for use to include pediatrics, one (1) month of age and older. ### Summary of Technological Characteristics of the SPY Elite System and Predicate Device Based on the technological characteristics, principle of operation and fundamental scientific premise, the SPY Elite System (LC300; SP3000) has been demonstrated to be substantially equivalent to the predicate device, the SPY System (K100371, K073088, K073130, and K071619). The device presented in this premarket notification is an updated version of the predicate device - the SPY System which is FDA 510(k) cleared in K100371, K073088, K073130, and K071619. SPY Elite contains updated system control, processing and image acquisition software, in comparison to the older predicate SPY devices which contain an older type of signal processing software. The CINEVAQ software contained in SPY Elite (applicant device) is the system control software which provides the primary interface for the database, image sequence acquisition, data processing, and review functionality controls on the SPY Elite device. The proposed device (SPY Elite System) and predicate device (SPY System) are identical in terms of the technology and mode of imaging to provide real-time NIR fluorescence imaging during open surgical procedures. Both the subject and predicate devices utilize the same mode of imaging - near infrared fluorescence imaging, with ICG as the imaging agent, used in the {5}------------------------------------------------ hospital operating room. The proposed and predicate devices have the same integral components - an imaging console, a radiation source, a detector (CCD camera) and signal processing software. The proposed SPY Elite System is substantially equivalent to the 510(k)-cleared SPY System (K100371. K073088. K073130. and K071619) in terms of its technological characteristics and mode of imaging. ### Non-Clinical Performance Testing of the SPY Elite System The SPY Elite System was designed and developed by Novadaq Technologies in accordance with the applicable requirements and standards to establish performance and safety of the device. Device safety and performance were verified by tests conducted by Novadag and accredited third party laboratories. The SPY Elite System was tested in accordance with IEC 60601-1:2012 Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance. IEC 60601-1-2:2007 Medical Electrical Equipment - Part 1-2: General requirements for safety -Collateral standard: Electromagnetic compatibility - Requirements and testing was also conducted on the SPY Elite System and test results showed that SPY Elite conforms to the applicable requirements. Conformance of SPY Elite with IEC 60825:2007 Safety of laser products – Part 1: Equipment classification and requirements was assessed by Underwriters Laboratories Inc. (UL) and showed that SPY Elite is a Class 3R laser device with internal maximum Class 4 laser radiation. Safety and effectiveness of SPY Elite for visualization of blood flow and tissue perfusion, was assessed in a series of clinical literature evaluations to support the revisions 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. #### Clinical Summary and Use in Pediatric Patients Clinical publications support the safe and effective use of the subject device, in combination with ICG imaging agent, in pediatric patients (1 month to 21 years of age) for perfusion assessments during various surgical procedures. Safety and performance of the SPY Elite System and SPY AGENT™ GREEN for visualization of vessels (micro and macro vasculature), blood flow and tissue perfusion before, during, and affer vascular, gastrointestinal, organ transplant, and plastic, micro- and reconstructive surgical procedures in adult and pediatric patients was evaluated in a series of systematic summary reviews of the clinical literature to support the indications for use during these various procedures. The results of the systematic summary reviews of clinical literature provide evidence of high success rate when SPY Fluorescence Technology was used with ICG to visualize macrovascular blood flow in vessels across a broad range of surgical procedures, and in the visualization of microvascular blood flow in tissues across a broad range of surgical procedures. Data was collected and analyzed in accordance with the statistical analyses plans provided in the Clinical Performance Section of the 510(k), and results were reported in the statistical analyses reports and meta-analyses reports. Across 13 studies reviewed, 12 studies exceeded the success criteria of a 90% visualization rate and 10 of the studies showed a 100% visualization rate in the visualization of macrovascular blood flow in vessels. Across data reviewed from 33 studies in {6}------------------------------------------------ 2055 patients, all the studies showed more than 90% visualization rate, and 31 studies (94%) showed 100% visualization rate in the visualization of microvascular blood flow in tissues. The results from the systematic reviews of clinical literature provide robust evidence of successful visualization of blood flow and tissue perfusion utilizing SPY Fluorescence Technology in combination with ICG during various surqical procedures. Overall, efficacy data obtained from published literature showed successful visualization in maiority of the studies. Analysis of ICG doses administered to a number of pediatric subpopulations showed that the effective doses used in angiographic applications ranged from 1.25 - 10.0 mg ICG, with the majority of doses being in the range of 1.25 mg to 5.0 mg, 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. The clinical literature data demonstrates that fluorescence imaging with SPY devices in the angiographic indications of cardiovascular/vascular and plastic, micro-, and reconstructive surgical applications in infant, children and adolescent patients, aged 1 month to 21 years, were effective in visualization of blood flow and tissue perfusion. 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. Altogether, the available clinical data and published literature support the safety and efficacy of the SPY Elite System for use in combination with SPY AGENT™ GREEN in fluorescence angiography before, during and after various surgical procedures, including use in pediatric patients 1 month of age and older. {7}------------------------------------------------ ### Comparison of Device Characteristics of the Subject and Predicate Devices | Company/ 510(k) Holder | Novadaq Technologies ULC. (Stryker) | Novadaq Technologies Inc. | Novadaq Technologies Inc. | Novadaq Technologies Inc. | Novadaq Technologies Inc. | |----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product Brand Name | SPY Elite System (SUBJECT DEVICE) | SPY Intra-Operative Imaging System (PREDICATE DEVICE) | SPY Fluorescent Imaging System (PREDICATE DEVICE) | SPY Fluorescent Imaging System (PREDICATE DEVICE) | SPY Fluorescent Imaging System (PREDICATE DEVICE) | | Model | LC3000, SP3000 | SP2001 | SP2001 | SP2001 | SP2000 | | 510(k) | Current Submission | K100371 | K073088 | K073130 | K071619 | | Common Name | Angiographic X-ray System | Angiographic X-ray System | Angiographic X-ray System | Angiographic X-ray System | Angiographic X-ray System | | Product Code | IZI | IZI | IZI | IZI | IZI | | Regulation Number | 21 CFR § 892.1600 | 21 CFR § 892.1600 | 21 CFR § 892.1600 | 21 CFR § 892.1600 | 21 CFR § 892.1600 | | Class | II | II | II | II | II | | Decision date | Current Submission | 02/04/2011 | 01/10/2008 | 01/10/2008 | 11/09/2007 | | Device Classification Name | System, X-Ray, Angiographic | System, X-Ray, Angiographic | System, X-Ray, Angiographic | System, X-Ray, Angiographic | System, X-Ray, Angiographic | | Intended Use | Intraoperative fluorescence angiography; fluorescence imaging of blood flow and tissue perfusion | Intraoperative fluorescence angiography; fluorescence imaging of blood flow and tissue perfusion | Intraoperative fluorescence angiography; fluorescence imaging of blood flow and tissue perfusion | Intraoperative fluorescence angiography; fluorescence imaging of blood flow and tissue perfusion | Intraoperative fluorescence angiography; fluorescence imaging of blood flow and tissue perfusion | | Indications for Use | Upon intravenous administration of SPY AGENT™ GREEN (Indocyanine green for Injection, USP), the SPY Elite System is used with SPY AGENT™ GREEN to perform intraoperative fluorescence angiography. The SPY Elite | The SPY System is intended to provide fluorescence images for the visual assessment of blood flow in vessels and related tissue perfusion during gastrointestinal surgical procedures. | The SPY Fluorescent Imaging 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 | The SPY Fluorescent Imaging System is intended to intra- operatively enable surgeons to visually asses blood flow and related tissue perfusion during organ transplant procedures. | The SPY Fluorescent Imaging System is intended to provide fluorescent images for the visual assessment of blood flow in vessels and related tissue perfusion during cardiovascular surgical procedures. | {8}------------------------------------------------ | Company/ 510(k) Holder | Novadaq Technologies ULC. (Stryker) | Novadaq Technologies Inc. | Novadaq Technologies Inc. | Novadaq Technologies Inc. | Novadaq Technologies Inc. | |----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product Brand Name | SPY Elite System (SUBJECT DEVICE) | SPY Intra-Operative Imaging System (PREDICATE DEVICE) | SPY Fluorescent Imaging System (PREDICATE DEVICE) | SPY Fluorescent Imaging System (PREDICATE DEVICE) | SPY Fluorescent Imaging System (PREDICATE DEVICE) | | | System used with SPY AGENT™ GREEN is indicated for use in adult and pediatric patients one month of age and older. 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. | | perfusion, and related tissue-transfer circulation in tissue and free flaps used in plastic, micro- and reconstructive surgical procedures. | | | | Device Description Summary | Fluorescence imaging system which allows surgeons to capture, review, print, and archive high-quality fluorescence images of blood flow in vessels and micro- vessels, tissue and organ perfusion in real time while performing a variety of surgical procedures. | Fluorescence imaging system which allows surgeons to capture, review, print, and archive high-quality fluorescence images of blood flow in vessels and micro- vessels, tissue and organ perfusion in real time while performing a variety of surgical procedures. | Fluorescence imaging system which allows surgeons to capture, review, print, and archive high-quality fluorescence images of blood flow in vessels and micro- vessels, tissue and organ perfusion in real time while performing a variety of surgical procedures. | Fluorescence imaging system which allows surgeons to capture, review, print, and archive high-quality fluorescence images of blood flow in vessels and micro- vessels, tissue and organ perfusion in real time while performing a variety of surgical procedures. | Fluorescence imaging system which allows surgeons to capture, review, print, and archive high-quality fluorescence images of blood flow in vessels and micro- vessels, tissue and organ perfusion in real time while performing a variety of surgical procedures. | | Principle of Operation | NIR light from the illumination module in the imaging console is transmitted to the imaging head via fiber-optic cable. The imaging head is positioned over the patient such that the NIR excitation light is emitted and illuminates the area of interest. When the patient is injected with ICG, the ICG | Same as subject device | Same as subject device | Same as subject device | Same as subject device | | Company/ 510(k) Holder | Novadaq Technologies ULC. (Stryker) | Novadaq Technologies Inc. | Novadaq Technologies Inc. | Novadaq Technologies Inc. | Novadaq Technologies Inc. | | Product Brand Name | SPY Elite System (SUBJECT DEVICE) | SPY Intra-Operative Imaging System (PREDICATE DEVICE) | SPY Fluorescent Imaging System (PREDICATE DEVICE) | SPY Fluorescent Imaging System (PREDICATE DEVICE) | SPY Fluorescent Imaging System (PREDICATE DEVICE) | | | binds to the plasma in the blood and travels to the area of interest through the bloodstream. The NIR excitation light emitted by the SPY Elite imaging device causes the ICG to fluoresce. The fluorescence image signal is processed and simultaneously recorded in computer memory and displayed on the video monitors in real time. | | | | | | Environment of Use | Hospital | Hospital | Hospital | Hospital | Hospital | | System Components | SPY Elite contains a radiation source, a detector (CCD camera), and signal processing software. The major components of SPY Elite are: Imaging ConsoleCINEVAQ Software (1x) – Analysis and Comparison DashboardCINEVAQ Software (2x) – Analysis Dashboard and Case Management for vascular imaging modality | SPY contains a radiation source, a detector (CCD camera), and signal processing software. The major components of SPY are: Imaging ConsoleHELIOS Software | SPY contains a radiation source, a detector (CCD camera), and signal processing software. The major components of SPY are: Imaging ConsoleHELIOS Software | SPY contains a radiation source, a detector (CCD camera), and signal processing software. The major components of SPY are: Imaging ConsoleHELIOS Software | SPY contains a radiation source, a detector (CCD camera), and signal processing software. The major components of SPY are: Imaging ConsoleDaqPac software | | Company/ 510(k) Holder | Novadaq Technologies ULC. (Stryker) | Novadaq Technologies Inc. | Novadaq Technologies Inc. | Novadaq Technologies Inc. | Novadaq Technologies Inc. | | Product Brand Name | SPY Elite System (SUBJECT DEVICE) | SPY Intra-Operative Imaging System (PREDICATE DEVICE) | SPY Fluorescent Imaging System (PREDICATE DEVICE) | SPY Fluorescent Imaging System (PREDICATE DEVICE) | SPY Fluorescent Imaging System (PREDICATE DEVICE) | | | • DICOM Send Software | | | | | | Safety Standards | IEC 60601-1 | Same as subject device | Same as subject device | Same as subject device | Same as subject device | | | IEC 60601-1-2 | | | | | | | IEC 60825-1 | | | | | | Patient Population | Adult patients and pediatric patients (1 month of age and older) | Adult patients | Adult patients | Adult patients | Adult patients | | Contrast Agent | ICG, namely SPY AGENT™ GREEN (Indocyanine green for injection, USP) | ICG | ICG | ICG | ICG | | Mode of Imaging | NIR fluorescence imaging | NIR fluorescence imaging | NIR fluorescence imaging | NIR fluorescence imaging | NIR fluorescence imaging | {9}------------------------------------------------ {10}------------------------------------------------ {11}------------------------------------------------ ## Conclusions It has been demonstrated in this Traditional 510(k) premarket notification that the SPY Elite System with the proposed cross-label indications for use is substantially equivalent to the predicate device (SPY System) in terms of safety, effectiveness and performance. This determination is based on the proposed and predicate devices having the same technological characteristics, principle of operation, intended use and environment of use. The proposed crosslabel indications for use of the SPY Elite System outlined in this summary raise no issues related to its safety and effectiveness.