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.
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.
The provided text outlines the general safety and performance testing for the SPY-PHI System but does not contain detailed acceptance criteria or results from a study that specifically proves the device meets those criteria.
Here's an analysis of what is and isn't available in the text, structured as requested:
1. Table of Acceptance Criteria and Reported Device Performance
Not available in the provided text. The document states that "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." and "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." However, it does not provide specific acceptance criteria (e.g., sensitivity, specificity, accuracy targets) or quantitative results (e.g., reported percentages for these metrics).
2. Sample Size Used for the Test Set and Data Provenance
The text mentions a "design validation study" conducted to evaluate "in vivo fluorescence imaging capability."
- Sample Size: Not specified.
- Data Provenance: The study evaluated "in vivo fluorescence imaging capability," implying human or animal subjects. However, the specific country of origin, whether it was retrospective or prospective, or the number of subjects or cases are not detailed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not available in the provided text. The study is described as evaluating "in vivo fluorescence imaging capability," but there's no mention of how ground truth was established, who the experts were, or their qualifications.
4. Adjudication Method for the Test Set
Not available in the provided text.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not available in the provided text. The document does not describe any study comparing human readers with and without AI assistance, nor does it quantify any effect size of improvement.
6. Standalone (Algorithm Only) Performance Study
Not applicable. The SPY-PHI System is described as an "imaging system" used for "intraoperative fluorescence angiography" and "visualization of the lymphatic system" with "human-in-the-loop performance" (i.e., a surgeon using the device to visualize). It is not an AI algorithm designed to interpret images autonomously. Therefore, a standalone algorithm-only performance study would not be relevant in the context of this device.
7. Type of Ground Truth Used
The text indicates a "design validation study" that "evaluated the in vivo fluorescence imaging capability of SPY-PHI for the visualization of the lymphatic system, including lymphatic vessels and lymph nodes." While "in vivo" implies real-world observation during surgical procedures, the specific type of ground truth (e.g., expert consensus based on visual assessment, pathological confirmation, or outcomes data) is not detailed.
8. Sample Size for the Training Set
Not applicable. The SPY-PHI System is a hardware imaging system, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As noted above, this is a hardware imaging system, not an AI/ML algorithm with a training set.
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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
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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
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Indications for Use
510(k) Number (if known)
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)
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Section 5 - 510(k) Summary
This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR § 807.92.
| Subject Device Trade Name: | SPY Portable Handheld Imaging (SPY-PHI) System |
|---|---|
| Device Model Number: | HH9000 |
| Common Name: | Fluorescence Angiographic System |
| Regulation: | 21 CFR § 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 101Burnaby, British ColumbiaCanada, V5A 4W2 |
| Contact Name: | Agatha SzeligaRequlatory Affairs ManagerTel: 604-422-7516Fax: 604-232-9841 |
Date 510(k) Summary Prepared: March 16, 2020
Predicate Device(s) Information:
| Predicate Device Trade Name | PINPOINT EndoscopicFluorescence Imaging System(PINPOINT System) | SPY Portable Handheld Imaging(SPY-PHI) System |
|---|---|---|
| (primary predicate for indicationsexpansion) | (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 & PlasticSurgery; Angiographic X-raySystem | Confocal Optical Imaging |
| Product Code and Regulation | GCJ; IZI 21 CFR § 876.1500 | OWN 21 CFR § 876.1500 |
| Classification | Class II | Class II |
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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.
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| Subject DeviceSPY Portable Handheld Imaging (SPY-PHI)System | Predicate Device(primary predicate for indication expansion)PINPOINT Endoscopic Fluorescence ImagingSystem(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) theSPY-PHI System is used with SPY AGENT™GREEN to perform intraoperative fluorescenceangiography. The SPY-PHI System is indicatedfor use in adult and pediatric patients one month of | Upon intravenous administration of SPY AGENT™GREEN (ICG drug product), the PINPOINTEndoscopic Fluorescence Imaging System is usedwith SPY AGENT™ GREEN to performintraoperative fluorescence angiography, and it isalso indicated for use in fluorescence imaging of | Upon intravenous administration of SPY AGENT™GREEN (indocyanine green for injection, USP) theSPY-PHI System is used with SPY AGENT™GREEN to perform intraoperative fluorescenceangiography. The SPY-PHI System used isindicated for use in adult and pediatric patients | |
| age and older. | biliary ducts, and when indicated, duringintraoperative cholangiography. | one month of age and older. | |
| The SPY-PHI System is indicated for fluorescenceimaging of blood flow and tissue perfusion before,during, and after: vascular, gastrointestinal, organtransplant, and plastic, micro- and reconstructivesurgical procedures.Upon interstitial administration of SPY AGENT™ | The PINPOINT Endoscopic Fluorescence ImagingSystem is indicated for use to provide real timeendoscopic visible and near-infrared fluorescenceimaging.The PINPOINT System enables surgeons toperform minimally invasive surgery using standardendoscope visible light as well as visual | The SPY-PHI System is indicated for fluorescenceimaging of blood flow and tissue perfusion before,during, and after: vascular, gastrointestinal, organtransplant, and plastic, micro- and reconstructivesurgical procedures. | |
| GREEN, the SPY-PHI System is used to performintraoperative fluorescence imaging andvisualization of the lymphatic system, includinglymphatic vessels and lymph nodes. | assessment of vessels, blood flow and relatedtissue perfusion, and at least one of the majorextra-hepatic bile ducts (cystic duct, common bileduct or common hepatic duct), using near-infraredimaging.Fluorescence imaging of biliary ducts with thePINPOINT System is intended for use withstandard of care white light, and when indicated,intraoperative cholangiography. The device is notintended for standalone use for biliary ductvisualization.Upon interstitial administration of SPY AGENT™GREEN (ICG drug product), the PINPOINTSystem is used to perform intraoperative | ||
| fluorescence imaging and visualization of thelymphatic system, including lymphatic vessels andlymph nodes. | |||
| Feature | Subject Device | Predicate Devices | |
| SPY Portable HandheldImaging (SPY-PHI)System | PINPOINT EndoscopicFluorescence ImagingSystem | SPY Portable HandheldImaging (SPY-PHI)System | |
| 510(k) Holder/Manufacturer | Novadaq TechnologiesULC. (now a part ofStryker) | Novadaq TechnologiesULC. (now a part ofStryker) | Novadaq TechnologiesULC. (now a part ofStryker) |
| SubmissionReference | Current Submission | K182606 | K192174 |
| Decision Date | Current Submission | 11/21/2018 | 11/15/2019 |
| CombinationProduct | No | No | Yes |
| Product Code | OWN | GCJ; IZI | OWN |
| Regulation Number | 21 CFR 876.1500 | 21 CFR 876.1500 | 21 CFR 876.1500 |
| DeviceClassification Name | Confocal Optical Imaging | Laparoscope, General &Plastic Surgery;Angiographic X-raySystem | Confocal Optical Imaging |
| Intended Use | Near infrared fluorescenceimaging for visualization ofblood flow and tissueperfusion before, duringand after surgicalprocedures, andintraoperativefluorescence imaging andvisualization of thelymphatic system,including lymphaticvessels and lymph nodes. | Near infrared fluorescenceimaging for visualization ofblood flow and tissueperfusion during surgicalprocedures, identificationof extrahepatic biliaryducts, and intraoperativefluorescence imaging andvisualization of thelymphatic system,including lymphaticvessels and lymph nodes. | Near infrared fluorescenceimaging for visualization ofblood flow and tissueperfusion before, duringand after surgicalprocedures. |
| Operating Principle | Full color visible light andNIR fluorescence videoimaging. The CMOScamera in the ImagingHead captures thefluorescent image underlaser illumination or a colorimage under white lightillumination. The VPIreceives the video signalfrom the Imaging Headand processes andoutputs the video image toa medical grade videomonitor and/or videorecorder. | Full color visible light andNIR fluorescence videoimaging. The PINPOINTcamera captures thefluorescent image underlaser illumination or a colorimage under white lightillumination. The VPIreceives the video signalfrom camera andprocesses and outputs thevideo image to a medicalgrade video monitor and/orvideo recorder. | Full color visible light andNIR fluorescence videoimaging. The CMOScamera in the ImagingHead captures thefluorescent image underlaser illumination or a colorimage under white lightillumination. The VPIreceives the video signalfrom the Imaging Headand processes andoutputs the video image toa medical grade videomonitor and/or videorecorder. |
| Safety Standards | IEC 60601-1 | IEC 60601-1 | IEC 60601-1 |
| Feature | Subject Device | Predicate Devices | |
| SPY Portable HandheldImaging (SPY-PHI)System | PINPOINT EndoscopicFluorescence ImagingSystem | SPY Portable HandheldImaging (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 (VideoProcessor/Illuminator) | VPI (VideoProcessor/Illuminator) | VPI (Video Processor/Illuminator) |
| SPY-PHI imager (withintegrated light guidecable) | CameraLight Guide CableLaparoscopes | SPY-PHI imager (withintegrated light guidecable) | |
| Imaging Modes | White Light | White Light | White Light |
| SPY | SPY | SPY | |
| Overlay | Overlay | Overlay | |
| Color SegmentedFluorescence (CSF) | Color SegmentedFluorescence (CSF) | Color SegmentedFluorescence (CSF) | |
| Fluorescenceexcitation source | NIR laser | NIR laser | NIR laser |
| Environment of Use | Hospital | Hospital | Hospital |
| Contrast imagingagent | SPY AGENT™ GREEN(indocyanine green forinjection, USP) | SPY AGENT™ GREEN(indocyanine green forinjection, USP) | SPY AGENT™ GREEN(indocyanine green forinjection, USP) |
Comparison of the Indications for Use of the Subject Device and Predicate Devices:
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Comparison of Device Characteristics of the Subject Device and the Predicate Devices:
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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.
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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.
§ 876.1500 Endoscope and accessories.
(a)
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.(b)
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.