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.
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.
The SPY Elite System, an angiographic fluorescence imaging system, has established its performance through non-clinical testing and clinical literature evaluations.
Here is a summary of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Visualization Rate (Macrovascular Blood Flow) | Across 13 studies reviewed, 12 exceeded 90% visualization rate (10 showed 100% visualization rate). |
| Visualization Rate (Microvascular Blood Flow) | Across 33 studies (2055 patients), all showed >90% visualization rate (31 studies (94%) showed 100% visualization rate). |
| Safety and Efficacy in Pediatric Patients (1 month to 21 years) | Clinical literature demonstrated effective visualization of blood flow and tissue perfusion with no identified anaphylaxis or other adverse events related to SPY fluorescence imaging with ICG in pediatric patients. The data suggested no differences in safety and efficacy between pediatric and adult patients. |
| Compliance with Safety Standards | The SPY Elite System was tested in accordance with IEC 60601-1:2012, IEC 60601-1-2:2007, and IEC 60825-1:2007. Test results showed conformance to applicable requirements. |
2. Sample Sizes Used for the Test Set and Data Provenance
The "test set" for performance evaluation appears to be composed of aggregated patient data from published clinical literature.
- Sample Size:
- Macrovascular blood flow: Data from 13 studies.
- Microvascular blood flow: Data from 33 studies involving 2055 patients.
- Data Provenance: The data is retrospective, derived from systematic summary reviews of existing clinical literature. The country of origin of this literature is not specified, but typically such reviews encompass international publications.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not explicitly state the number of experts used to establish ground truth for the test set from the clinical literature reviews, nor their specific qualifications (e.g., "radiologist with 10 years of experience"). However, the assessment of the clinical literature was conducted through "systematic summary reviews," implying a rigorous process, likely involving experts in the relevant surgical fields and medical literature analysis. The ground truth itself is derived from the reported clinical outcomes in these published studies.
4. Adjudication Method for the Test Set
The document describes "systematic summary reviews of the clinical literature" and "meta-analyses reports." This suggests a systematic approach to evaluating and synthesizing findings across multiple studies. While a specific method like "2+1" or "3+1" is not explicitly mentioned for individual case adjudication, the process of systematic review inherently involves methods to assess study quality, consistency, and synthesize results, which acts as a form of adjudication in a meta-analysis context.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned comparing human readers with AI assistance versus without AI assistance. The device in question (SPY Elite System) is a fluorescence imaging system that aids surgeons in visualizing blood flow and tissue perfusion; it is not, as described here, an AI-powered diagnostic algorithm intended to work in conjunction with human readers to interpret images. Its function is to provide real-time visual information.
6. Standalone (Algorithm Only) Performance Study
The SPY Elite System is an imaging device that provides visual information in real-time. It is used "in combination with SPY AGENT™ GREEN" (Indocyanine green for Injection, USP). Its performance is inherently linked to this combination and human interpretation of the images. Therefore, a "standalone algorithm only" performance study in the typical sense of an AI model predicting outcomes without human-in-the-loop is not applicable here, as the device's purpose is to enhance human intraoperative visualization. The "visualization rate" mentioned in the performance table reflects the ability of the system to display the required information.
7. Type of Ground Truth Used
The ground truth used for performance evaluation is based on clinical outcomes and observations reported in published medical literature. Specifically, it pertains to the successful visualization of macrovascular blood flow, microvascular blood flow, and tissue perfusion during various surgical procedures, as observed and documented by clinicians in those studies. It also includes the absence of adverse events related to the imaging process.
8. Sample Size for the Training Set
The document primarily focuses on validating the device against existing clinical literature and non-clinical standards. It does not describe a "training set" in the context of an AI/machine learning model developed by the manufacturer. The device is an imaging system, and its development would typically involve engineering and optical design validations, not data-driven model training. The clinical literature reviews served as evidence for its clinical utility and safety, not for training an algorithm.
9. How the Ground Truth for the Training Set Was Established
As no "training set" for an AI algorithm is mentioned, this question is not applicable in the context of the provided information. The device is a medical imaging system, not an AI diagnostic tool that requires a training set and corresponding ground truth. Its performance validation relies on demonstrating its ability to accurately capture and display fluorescence signals as confirmed by clinicians in clinical use (as documented in literature) and its adherence to relevant safety and performance standards.
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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.
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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
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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) | |
|---|---|
| × Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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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.
| Trade Name: | SPY Elite Intraoperative Perfusion Assessment System (SPY EliteSystem) |
|---|---|
| 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 101Burnaby, British ColumbiaCanada V5A 4W2 |
| Contact Name: | Agatha SzeligaRegulatory Affairs ManagerTel: (604) 422-7516Fax: (604) 232-9841Email: 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.
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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
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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
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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.
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Comparison of Device Characteristics of the Subject and Predicate Devices
| Company/ 510(k)Holder | Novadaq Technologies ULC.(Stryker) | Novadaq TechnologiesInc. | Novadaq TechnologiesInc. | Novadaq TechnologiesInc. | Novadaq TechnologiesInc. |
|---|---|---|---|---|---|
| Product BrandName | SPY Elite System (SUBJECTDEVICE) | SPY Intra-OperativeImaging System(PREDICATE DEVICE) | SPY FluorescentImaging System(PREDICATE DEVICE) | SPY FluorescentImaging System(PREDICATE DEVICE) | SPY FluorescentImaging 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-raySystem | Angiographic X-raySystem | Angiographic X-raySystem | Angiographic X-raySystem |
| Product Code | IZI | IZI | IZI | IZI | IZI |
| RegulationNumber | 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 |
| DeviceClassificationName | System, X-Ray, Angiographic | System, X-Ray,Angiographic | System, X-Ray,Angiographic | System, X-Ray,Angiographic | System, X-Ray,Angiographic |
| Intended Use | Intraoperative fluorescenceangiography; fluorescenceimaging of blood flow andtissue perfusion | Intraoperativefluorescence angiography;fluorescence imaging ofblood flow and tissueperfusion | Intraoperativefluorescence angiography;fluorescence imaging ofblood flow and tissueperfusion | Intraoperativefluorescence angiography;fluorescence imaging ofblood flow and tissueperfusion | Intraoperativefluorescence angiography;fluorescence imaging ofblood flow and tissueperfusion |
| Indications forUse | Upon intravenousadministration of SPYAGENT™ GREEN(Indocyanine green forInjection, USP), the SPY EliteSystem is used with SPYAGENT™ GREEN to performintraoperative fluorescenceangiography. The SPY Elite | The SPY System isintended to providefluorescence images forthe visual assessment ofblood flow in vessels andrelated tissue perfusionduring gastrointestinalsurgical procedures. | The SPY FluorescentImaging System is animaging system used incapturing and viewingfluorescent images for thevisual assessment ofblood flow as anadjunctive method for theevaluation of tissue | The SPY FluorescentImaging System isintended to intra-operatively enablesurgeons to visually assesblood flow and relatedtissue perfusion duringorgan transplantprocedures. | The SPY FluorescentImaging System isintended to providefluorescent images for thevisual assessment ofblood flow in vessels andrelated tissue perfusionduring cardiovascularsurgical procedures. |
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| Company/ 510(k)Holder | Novadaq Technologies ULC.(Stryker) | Novadaq TechnologiesInc. | Novadaq TechnologiesInc. | Novadaq TechnologiesInc. | Novadaq TechnologiesInc. |
|---|---|---|---|---|---|
| Product BrandName | SPY Elite System (SUBJECTDEVICE) | SPY Intra-OperativeImaging System(PREDICATE DEVICE) | SPY FluorescentImaging System(PREDICATE DEVICE) | SPY FluorescentImaging System(PREDICATE DEVICE) | SPY FluorescentImaging System(PREDICATE DEVICE) |
| System used with SPYAGENT™ GREEN is indicatedfor use in adult and pediatricpatients one month of age andolder. The SPY Elite System isindicated for fluorescenceimaging of blood flow andtissue perfusion before,during, and after: vascular,gastrointestinal, organtransplant, and plastic, micro-and reconstructive surgeries. | perfusion, and relatedtissue-transfer circulationin tissue and free flapsused in plastic, micro- andreconstructive surgicalprocedures. | ||||
| DeviceDescriptionSummary | Fluorescence imaging systemwhich allows surgeons tocapture, review, print, andarchive high-qualityfluorescence images of bloodflow in vessels and micro-vessels, tissue and organperfusion in real time whileperforming a variety of surgicalprocedures. | Fluorescence imagingsystem which allowssurgeons to capture,review, print, and archivehigh-quality fluorescenceimages of blood flow invessels and micro-vessels, tissue and organperfusion in real time whileperforming a variety ofsurgical procedures. | Fluorescence imagingsystem which allowssurgeons to capture,review, print, and archivehigh-quality fluorescenceimages of blood flow invessels and micro-vessels, tissue and organperfusion in real time whileperforming a variety ofsurgical procedures. | Fluorescence imagingsystem which allowssurgeons to capture,review, print, and archivehigh-quality fluorescenceimages of blood flow invessels and micro-vessels, tissue and organperfusion in real time whileperforming a variety ofsurgical procedures. | Fluorescence imagingsystem which allowssurgeons to capture,review, print, and archivehigh-quality fluorescenceimages of blood flow invessels and micro-vessels, tissue and organperfusion in real time whileperforming a variety ofsurgical procedures. |
| Principle ofOperation | NIR light from the illuminationmodule in the imaging consoleis transmitted to the imaginghead via fiber-optic cable. Theimaging head is positionedover the patient such that theNIR excitation light is emittedand illuminates the area ofinterest. When the patient isinjected 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 TechnologiesInc. | Novadaq TechnologiesInc. | Novadaq TechnologiesInc. | Novadaq TechnologiesInc. |
| Product BrandName | SPY Elite System (SUBJECTDEVICE) | SPY Intra-OperativeImaging System(PREDICATE DEVICE) | SPY FluorescentImaging System(PREDICATE DEVICE) | SPY FluorescentImaging System(PREDICATE DEVICE) | SPY FluorescentImaging System(PREDICATE DEVICE) |
| binds to the plasma in theblood and travels to the areaof interest through thebloodstream. The NIRexcitation light emitted by theSPY Elite imaging devicecauses the ICG to fluoresce.The fluorescence image signalis processed andsimultaneously recorded incomputer memory anddisplayed on the videomonitors in real time. | |||||
| Environment ofUse | Hospital | Hospital | Hospital | Hospital | Hospital |
| SystemComponents | SPY Elite contains a radiationsource, a detector (CCDcamera), and signalprocessing software.The major components of SPYElite are:Imaging ConsoleCINEVAQ Software(1x) – Analysis andComparisonDashboardCINEVAQ Software(2x) – AnalysisDashboard and CaseManagement forvascular imagingmodality | SPY contains a radiationsource, a detector (CCDcamera), and signalprocessing software.The major components ofSPY are:Imaging ConsoleHELIOS Software | SPY contains a radiationsource, a detector (CCDcamera), and signalprocessing software.The major components ofSPY are:Imaging ConsoleHELIOS Software | SPY contains a radiationsource, a detector (CCDcamera), and signalprocessing software.The major components ofSPY are:Imaging ConsoleHELIOS Software | SPY contains a radiationsource, a detector (CCDcamera), and signalprocessing software.The major components ofSPY are:Imaging ConsoleDaqPac software |
| Company/ 510(k)Holder | Novadaq Technologies ULC.(Stryker) | Novadaq TechnologiesInc. | Novadaq TechnologiesInc. | Novadaq TechnologiesInc. | Novadaq TechnologiesInc. |
| Product BrandName | SPY Elite System (SUBJECTDEVICE) | SPY Intra-OperativeImaging System(PREDICATE DEVICE) | SPY FluorescentImaging System(PREDICATE DEVICE) | SPY FluorescentImaging System(PREDICATE DEVICE) | SPY FluorescentImaging System(PREDICATE DEVICE) |
| • DICOM SendSoftware | |||||
| 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 | |||||
| PatientPopulation | Adult patients and pediatricpatients (1 month of age andolder) | Adult patients | Adult patients | Adult patients | Adult patients |
| Contrast Agent | ICG, namely SPY AGENT™GREEN (Indocyanine greenfor injection, USP) | ICG | ICG | ICG | ICG |
| Mode of Imaging | NIR fluorescence imaging | NIR fluorescence imaging | NIR fluorescence imaging | NIR fluorescence imaging | NIR fluorescence imaging |
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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.
§ 892.1600 Angiographic x-ray system.
(a)
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.(b)
Classification. Class II.