K190729 · Novadaq Technologies Ulc. (Now A Part of Stryker) · OWN · Apr 19, 2019 · Gastroenterology, Urology
Device Facts
Record ID
K190729
Device Name
SPY Portable Handheld Imaging (SPY-PHI) System
Applicant
Novadaq Technologies Ulc. (Now A Part of Stryker)
Product Code
OWN · Gastroenterology, Urology
Decision Date
Apr 19, 2019
Decision
SESD
Submission Type
Special
Regulation
21 CFR 876.1500
Device Class
Class 2
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 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.
Device Story
SPY-PHI is a handheld fluorescence imaging system for intraoperative assessment of blood flow and tissue perfusion. System components include an imaging head (with CMOS camera and NIR laser/white light illumination) and a video processor/illuminator (VPI). During surgery, clinician administers Indocyanine green (ICG) intravenously; device illuminates tissue with NIR laser to excite ICG fluorescence or white light for color imaging. CMOS camera captures video signals; VPI processes and outputs images to a medical-grade monitor. Used by surgeons in OR settings to visualize perfusion in tissue/free flaps and gastrointestinal vessels. Real-time visual feedback assists surgeons in evaluating tissue viability and blood flow, potentially improving surgical outcomes.
Clinical Evidence
Bench testing only. Conformance verified against IEC 60601-1 (safety), IEC 60601-1-2 (EMC), and IEC 60825-1 (laser safety). Software verified per IEC 62304. Compatibility testing performed for SPY-PHI with SPY AGENT™ GREEN.
Technological Characteristics
Handheld imaging head with integrated light guide; VPI processor. CMOS color sensor. NIR laser excitation source. White light and NIR fluorescence imaging modes. Connectivity: video output to medical-grade monitor/recorder. Software developed per IEC 62304. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60825-1.
Indications for Use
Indicated for patients undergoing plastic, micro-, reconstructive, or gastrointestinal surgical procedures requiring visual assessment of blood flow and tissue perfusion via intravenous administration of Indocyanine green (SPY AGENT™ GREEN).
Regulatory Classification
Identification
An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.
Special Controls
*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls:
1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following:
1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures.
2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use.
3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use.
2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes.
3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches
4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error.
5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program.
(6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms.
(7) Labeling must include:
(i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified;
(ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA;
(iii) Identification of compatible devices;
(iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification;
(v) Reprocessing instructions for reusable components;
(vi) A shelf life for any sterile components;
(vii) A description of the device-specific use training program;
(viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and
(ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance.
(8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include:
(i) Device motion accuracy and repeatability;
(ii) System testing;
(iii) Instrument reliability;
(iv) Crosstalk;
(v) Table motion control;
(vi) Thermal effects on tissue;
(vii) User-device interface performance;
(viii) Workspace access testing; and
(ix) Performance testing with compatible devices.
(9) Software verification, validation, and hazard analysis must be performed.
(10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed.
(11) Performance data must demonstrate the sterility of all patient-contacting device components.
(12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life.
(13) Performance data must validate the reprocessing instructions for the reusable components of the device.
(14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible.
(15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic.
(16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information:
(i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and
(ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.
Predicate Devices
SPY PHI Open Field Handheld Fluorescence Imaging System (K162885)
Submission Summary (Full Text)
{0}------------------------------------------------
#### 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)<br>8329 Eastlake Drive, Unit 101<br>Burnaby, British Columbia<br>Canada, V5A 4W2 |
| Contact Name: | Agatha Szeliga<br>Regulatory Affairs Manager<br>Tel: 604-422-7516<br>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<br>Fluorescence Imaging System |
| 510(k) Holder/<br>Manufacturer | Novadaq Technologies ULC. (now a part of Stryker) | Novadaq Technologies Inc. |
| Submission<br>Reference | Current Submission | K162885 |
| Combination<br>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<br>Fluorescence Imaging System |
| | tissue perfusion, and related tissue-<br>transfer circulation in tissue and free<br>flaps used in plastic, micro- and<br>reconstructive surgical procedures.<br>The SPY-PHI System is used with<br>SPY AGENTTM GREEN to provide<br>fluorescence images for the visual<br>assessment of blood flow in vessels<br>and related tissue perfusion before,<br>during and after gastrointestinal | flaps used in plastic, micro-, and<br>reconstructive surgical procedures.<br>The SPY Phi Open Field Handheld<br>Fluorescence Imaging System is<br>intended to provide fluorescence<br>images for the visual assessment of<br>blood flow in vessels and related tissue<br>perfusion during gastrointestinal<br>surgical procedures. |
| Operating Principle | surgical procedures.<br>Full color visible light and NIR<br>fluorescence video imaging. The<br>CMOS camera in the Imaging Head<br>captures the fluorescent image under<br>laser illumination or a color image<br>under white light illumination. The VPI | Full color visible light and NIR<br>fluorescence video imaging. The<br>CMOS camera in the Imaging Head<br>captures the fluorescent image under<br>laser illumination or a color image under<br>white light illumination. The VPI |
| | receives the video signal from the<br>Imaging Head and processes and<br>outputs the video image to a medical<br>grade video monitor and/or video<br>recorder. | receives the video signal from the<br>Imaging Head and processes and<br>outputs the video image to a medical<br>grade video monitor and/or video<br>recorder. |
| Major components | SPY-PHI imager (with integrated light<br>guide cable) and VPI (Video<br>Processor/ Illuminator) | SPY-PHI imager, light guide cable, VPI<br>(Video Processor/ Illuminator) |
| Illumination/imaging<br>modes | White light and NIR fluorescence | White light and NIR fluorescence |
| Image sensor type | Color CMOS | Color CMOS |
| Fluorescence<br>excitation source | NIR laser | NIR laser |
| Contrast imaging<br>agent | SPY AGENTTM GREEN (Indocyanine<br>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.
{4}------------------------------------------------
# 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)
| | <span> <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|--|-----------------------------------------------------------------------------------------------------------------|
| | <span> <span>☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
### 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."
{5}------------------------------------------------
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
