(29 days)
Not Found
No
The description focuses on standard video processing and image capture without mentioning any AI/ML algorithms for analysis or interpretation.
No
The device is described as an imaging system used for visual assessment and evaluation, not for treating or preventing a disease or condition.
Yes
The device is used for the "visual assessment of blood flow as an adjunctive method for the evaluation of tissue perfusion" and "to provide fluorescence images for the visual assessment of blood flow in vessels and related tissue perfusion," which are diagnostic functions.
No
The device description explicitly lists hardware components: Imaging Head/Imager (HH9030) and Video Processor/Illuminator (VPI) (PC9001).
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body (like blood, urine, tissue) outside of the body. The SPY-PHI System, on the other hand, is an imaging system used during surgical procedures to visualize blood flow and tissue perfusion within the patient's body using fluorescence.
- The intended use and device description clearly state that the system is used for in vivo imaging. It captures and views fluorescence images of tissue and vessels directly on the patient.
- The system uses an intravenously administered contrast agent (ICG) and external illumination to visualize physiological processes in situ. This is characteristic of in vivo imaging, not in vitro diagnostics.
Therefore, the SPY-PHI System falls under the category of medical imaging devices used for in vivo assessment, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Upon intravenous administration of SPY AGENT™ GREEN (Indocyanine green for injection, USP) the SPY-PHI System is used with SPY AGENT™ GREEN in capturing and viewing fluorescence images for the visual assessment of blood flow as an adjunctive method for the evaluation of tissue perfusion, and related tissue-transfer circulation in tissue and free flaps used in plastic, micro- and reconstructive surgical procedures.
The SPY-PHI System is used with SPY AGENT™ GREEN to provide fluorescence images for the visual assessment of blood flow in vessels and related tissue perfusion before, during and after gastrointestinal surgical procedures.
Product codes
OWN
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 in tissue and free flaps used during plastic, micro-, reconstructive, and gastrointestinal surgical procedures.
The SPY-PHI System consists of the following main components: Imaging Head/ Imager (HH9030) with an integrated light guide cable and the Video Processor/Illuminator (VPI) (PC9001).
Indocyanine green (ICG) 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 ICG fluorescence. Alternatively, the Imaging Head provides white light illumination of the reqions 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluorescence Imaging, Color imaging (White Light)
Anatomical Site
Tissue and free flaps; Vessels
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The SPY-PHI System was designed and developed by Novadaq Technologies Inc. in accordance with the applicable requirements and standards to establish performance and safety of the device's safety and performance were verified by tests conducted by Novadaq and 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 - 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.
Additionally, bench testing was performed to demonstrate compatibility of the SPY-PHI System with Stryker ICG - SPY AGENT™ GREEN (Indocyanine green for injection, USP).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Section 5 - 510(k) Summary K190729
This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR § 807.92.
| Trade Name: | SPY Portable Handheld Imaging (SPY-PHI) System |
|---|---|
| Device Model Number: | HH9000 |
| Common Name: | Fluorescence Angiographic System |
| Regulation: | 21 CFR § 892.1600 |
| Classification Name: | Angiographic X-Ray System |
| FDA 510(k) Review Panel: | General and Plastic Surgery |
| Product Code: | OWN |
| Classification: | Class II |
| Manufacturer: | Novadaq Technologies ULC. (now a part of Stryker) |
| 8329 Eastlake Drive, Unit 101 | |
| Burnaby, British Columbia | |
| Canada, V5A 4W2 | |
| Contact Name: | Agatha Szeliga |
| Regulatory Affairs Manager | |
| Tel: 604-422-7516 | |
| Fax: 604-232-9841 | |
| Date 510(k) Summary Prepared: | March 5, 2019 |
Predicate Device:
| Device Trade Name: | SPY PHI Open Field Handheld Fluorescence Imaging System |
|---|---|
| 510(k) Reference: | K162885 |
| Submitter Name: | Novadaq Technologies Inc. |
| Device Common Name: | Fluorescence Angiographic System |
| Product Code/Regulation: | OWN/ 21 CFR § 892.1600 |
| Classification: | Class II |
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 in tissue and free flaps used during plastic, micro-, reconstructive, and gastrointestinal surgical procedures.
The SPY-PHI System consists of the following main components: Imaging Head/ Imager (HH9030) with an integrated light guide cable and the Video Processor/Illuminator (VPI) (PC9001).
1
Indocyanine green (ICG) 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 ICG fluorescence. Alternatively, the Imaging Head provides white light illumination of the reqions 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 for 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 in capturing and viewing fluorescence images for the visual assessment of blood flow as an adjunctive method for the evaluation of tissue perfusion, and related tissue-transfer circulation in tissue and free flaps used in plastic, micro- and reconstructive surgical procedures.
The SPY-PHI System is used with SPY AGENT™ GREEN to provide fluorescence images for the visual assessment of blood flow in vessels and related tissue perfusion before, during and after gastrointestinal surgical procedures.
| Feature | Subject Device | Predicate Device |
|---|---|---|
| SPY-PHI System | SPY PHI Open Field Handheld | |
| Fluorescence Imaging System | ||
| 510(k) Holder/ | ||
| Manufacturer | Novadaq Technologies ULC. (now a part of Stryker) | Novadaq Technologies Inc. |
| Submission | ||
| Reference | Current Submission | K162885 |
| Combination | ||
| Product | Yes | Yes |
| Product Code | OWN | OWN |
| Regulation | 21 CFR 876.1500 | 21 CFR 876.1500 |
| Intended Use | Near infrared fluorescence imaging for visualization of blood flow and tissue perfusion during surgical procedures | Near infrared fluorescence imaging for visualization of blood flow and tissue perfusion during surgical procedures |
| Indications for Use | Upon intravenous administration of SPY AGENTTM GREEN (Indocyanine green for injection, USP) the SPY-PHI System is used with SPY AGENTTM GREEN in capturing and viewing fluorescence images for the visual assessment of blood flow as an adjunctive method for the evaluation of | The SPY Phi Open Field Handheld Fluorescence Imaging System is an imaging system used in capturing and viewing fluorescence images for the visual assessment of blood flow as an adjunctive method for the evaluation of tissue perfusion, and related tissue-transfer circulation in tissue and free |
Comparison of Technological Characteristics with the Predicate Device:
2
| Feature | Subject Device | Predicate Device |
|---|---|---|
| SPY-PHI System | SPY PHI Open Field Handheld | |
| Fluorescence Imaging System | ||
| tissue perfusion, and related tissue- | ||
| transfer circulation in tissue and free | ||
| flaps used in plastic, micro- and | ||
| reconstructive surgical procedures. | ||
| The SPY-PHI System is used with | ||
| SPY AGENTTM GREEN to provide | ||
| fluorescence images for the visual | ||
| assessment of blood flow in vessels | ||
| and related tissue perfusion before, | ||
| during and after gastrointestinal | flaps used in plastic, micro-, and | |
| reconstructive surgical procedures. | ||
| The SPY Phi Open Field Handheld | ||
| Fluorescence Imaging System is | ||
| intended to provide fluorescence | ||
| images for the visual assessment of | ||
| blood flow in vessels and related tissue | ||
| perfusion during gastrointestinal | ||
| surgical procedures. | ||
| Operating Principle | surgical procedures. | |
| Full color visible light and NIR | ||
| fluorescence video imaging. The | ||
| CMOS camera in the Imaging Head | ||
| captures the fluorescent image under | ||
| laser illumination or a color image | ||
| under white light illumination. The VPI | Full color visible light and NIR | |
| fluorescence video imaging. The | ||
| CMOS camera in the Imaging Head | ||
| captures the fluorescent image under | ||
| laser illumination or a color image under | ||
| white light illumination. The VPI | ||
| receives the video signal from the | ||
| Imaging Head and processes and | ||
| outputs the video image to a medical | ||
| grade video monitor and/or video | ||
| recorder. | 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. | ||
| Major components | SPY-PHI imager (with integrated light | |
| guide cable) and VPI (Video | ||
| Processor/ Illuminator) | SPY-PHI imager, light guide cable, VPI | |
| (Video Processor/ Illuminator) | ||
| Illumination/imaging | ||
| modes | White light and NIR fluorescence | White light and NIR fluorescence |
| Image sensor type | Color CMOS | Color CMOS |
| Fluorescence | ||
| excitation source | NIR laser | NIR laser |
| Contrast imaging | ||
| agent | SPY AGENTTM GREEN (Indocyanine | |
| green for injection, USP) | Indocyanine green (ICG) |
Performance Testing of the SPY-PHI System:
The SPY-PHI System was designed and developed by Novadaq Technologies Inc. in accordance with the applicable requirements and standards to establish performance and safety of the device's safety and performance were verified by tests conducted by Novadaq and 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 - Software life-cycle processes. It
3
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.
Additionally, bench testing was performed to demonstrate compatibility of the SPY-PHI System with Stryker ICG - SPY AGENT™ GREEN (Indocyanine green for injection, USP).
Conclusion & Summary of Substantial Equivalence
Based on the information presented in this Special 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 determined to be substantially equivalent to the predicate device, the SPY PHI Open Field Handheld Fluorescence Imaging System (FDA 510(k)-cleared in K162885).
Any minor technological or design differences between the SPY-PHI System and its predicate do not raise any questions related to safety or effectiveness. The proposed change to the labeling, proposing use of the SPY-PHI System with Stryker's brand of ICG - SPY AGENT™ GREEN (Indocyanine green for injection, USP), does not raise any issues related to safety or effectiveness for this device-drug combination product.
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Indications for Use
510(k) Number (if known) K190729
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 in capturing and viewing fluorescence images for the visual assessment of blood flow as an adjunctive method for the evaluation of tissue transfer circulation in tissue and free flaps used in plastic, micro- and reconstructive surgical procedures.
The SPY-PHI System is used with SPY AGENT™ GREEN to provide fluorescence images for the visual assessment of blood flow in vessels and related tissue perfusion before, during and after gastrointestinal surgical procedures.
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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Image /page/5/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, V5A 4W2 Ca
April 19, 2019
Re: K190729
Trade/Device Name: SPY Portable Handheld Imaging (SPY-PHI) System Regulation Number: 21 CFR 892.1600 Regulation Name: Angiographic X-Ray System Regulatory Class: Class II Product Code: OWN Dated: March 20, 2019 Received: March 21, 2019
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
6
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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, fi 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Binita S. Ashar, M.D., M.B.A., F.A.C.S. For Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health