(87 days)
Not Found
No
The document describes image processing and quantification of fluorescence values, but there is no mention of AI or ML algorithms being used for these functions. The new software feature provides "real-time relative fluorescence quantification" and "visualization tools," which are standard image processing techniques, not necessarily indicative of AI/ML.
No.
The device is an imaging system used to visualize biological processes, not to directly treat a medical condition.
Yes
The SPY-PHI System is used to "perform intraoperative fluorescence angiography" and "fluorescence imaging of blood flow and tissue perfusion," as well as "fluorescence imaging and visualization of the lymphatic system." The new software feature enables "real-time relative fluorescence quantification" and is described as an "additional intraoperative tool to assist trained healthcare practitioners in the assessment of fluorescence response in tissue." These functions are all aimed at providing information for the assessment or identification of a disease or condition, which aligns with the definition of a diagnostic device.
No
The device description clearly states that the SPY-PHI System consists of hardware components, including an imager/imaging head and a Video Processor/Illuminator (VPI). The software feature is described as a firmware module installed on the VPI, indicating it is part of a larger hardware system.
Based on the provided text, the SPY-PHI System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of disease.
- SPY-PHI System Function: The SPY-PHI System is an imaging system used to visualize blood flow and tissue perfusion directly within the patient's body during surgical procedures. It uses a fluorescent agent administered to the patient and then images the fluorescence response.
- No Specimen Examination: The system does not involve the collection or examination of specimens outside of the body. The imaging is performed in vivo.
Therefore, the SPY-PHI System falls under the category of an in vivo imaging system rather than an In Vitro Diagnostic device.
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 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.
Product codes
IZI
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 tissue-transfer circulation for use in imaging during various surgical procedures.
The SPY-PHI System provides real-time, white-light and fluorescence imaging during surgical procedures. The system consists of a SPY-PHI imager/imaging head with an integrated light quide cable and a Video Processor/Illuminator (VPI).
Fluorescence imaging with the SPY-PHI System is achieved with the use of a fluorescence imaging agent, namely SPY AGENT™ GREEN (indocyanine green for injection, USP), which is supplied in single-use convenience kits for use in conjunction with the SPY-PHI System during surgical procedures.
During surgical procedures, SPY AGENT™ GREEN is administered to the patient. The SPY-PHI imaging head/imager provides illumination of the regions of a patient's body to be observed with near infrared (NIR) laser light to excite ICG fluorescence. Alternatively, the SPY-PHI imager provides white light illumination of the regions of a patient's body to be observed for color imaging.
The 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 SPY-PHI System is intended for use by trained healthcare professionals in the operating room.
This Traditional 510(k) premarket notification proposes a modification to the currently 510(k) cleared SPY-PHI System with the addition of a new software feature. The new software feature, referred to as the SPY-PHI Fluorescence Assessment Software, will offer real-time relative fluorescence quantification (i.e. relative fluorescence values) and visualization tools (i.e. color maps) on the SPY-PHI device. Addition of this new software feature has no impact on the current intended use of the SPY-PHI System. The SPY-PHI Fluorescence Assessment Software is a firmware module installed on the VPI component of the SPY-PHI System for use during open field surgery where fluorescence imaging is used.
The SPY-PHI Fluorescence Assessment Software enables quantification of fluorescence which may be used as an additional intraoperative tool to assist trained healthcare practitioners in the assessment of fluorescence response in tissue during various surgical procedures. The healthcare practitioner retains the ultimate responsibility for making the pertinent diagnosis based on their clinical judgment and standard practices.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Near infrared fluorescence, Full color visible light
Anatomical Site
Not Found
Indicated Patient Age Range
adult and pediatric patients one month of age and older
Intended User / Care Setting
trained healthcare professionals in the operating room
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 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 62304:2015 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 performed to assess the suitability of the design requirements of the SPY-PHI Fluorescence Assessment Software as part of the SPY-PHI System to meet user needs. The results of the design validation study support the new fluorescence assessment software of the SPY-PHI System.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
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
November 5, 2020
Re: K202244
Trade/Device Name: SPY-PHI System with SPY-PHI Fluorescence Assessment Software Regulation Number: 21 CFR 892.1600 Regulation Name: Angiographic X-Ray System Regulatory Class: Class II Product Code: IZI Dated: August 7, 2020 Received: August 10, 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
1
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, Cancer Diagnosis & Treatment Team DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K202244
Device Name
SPY Portable Handheld Imaging (SPY-PHI) System with SPY-PHI Fluorescence Assessment Software
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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Section 5 - 510(k) Summary
This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR § 807.92.
| Subject Device Trade Name: | SPY-PHI System with SPY-PHI Fluorescence Assessment
Software |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| 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: | IZI |
| Classification: | Class II |
| Manufacturer: | Novadaq Technologies ULC. (now a part of Stryker)
8329 Eastlake Drive, Unit 101
Burnaby, British Columbia
Canada, V5A 4W2 |
| Contact Name: | Agatha Szeliga
Regulatory Affairs Manager
Tel: 604-422-7516
Fax: 604-232-9841 |
Date 510(k) Summary Prepared: August 5, 2020
Predicate Device(s) Information:
| Predicate Device Trade Name | SPY Portable Handheld
Imaging (SPY-PHI) System
(primary predicate) | SPY Elite Intraoperative
Perfusion Assessment System
(secondary predicate to
support technological
differences/ software feature) |
|-------------------------------------------------------------------------------|--------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K200737 | K182907 |
| Submitter/510(k) Holder Name | Novadaq Technologies ULC.
(now a part of Stryker) | Novadaq Technologies ULC.
(now a part of Stryker) |
| Classification Name | Confocal Optical Imaging | Angiographic X-ray
System |
| Product Code and Regulation | OWN; 21 CFR § 876.1500 | IZI; 21 CFR § 892.1600 |
| Classification | Class II | Class II |
| Note: The predicate devices have not been subject to a design-related recall. | | |
4
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 provides real-time, white-light and fluorescence imaging during surgical procedures. The system consists of a SPY-PHI imager/imaging head with an integrated light quide cable and a Video Processor/Illuminator (VPI).
Fluorescence imaging with the SPY-PHI System is achieved with the use of a fluorescence imaging agent, namely SPY AGENT™ GREEN (indocyanine green for injection, USP), which is supplied in single-use convenience kits for use in conjunction with the SPY-PHI System during surgical procedures.
During surgical procedures, SPY AGENT™ GREEN is administered to the patient. The SPY-PHI imaging head/imager provides illumination of the regions of a patient's body to be observed with near infrared (NIR) laser light to excite ICG fluorescence. Alternatively, the SPY-PHI imager provides white light illumination of the regions of a patient's body to be observed for color imaging.
The 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 SPY-PHI System is intended for use by trained healthcare professionals in the operating room.
This Traditional 510(k) premarket notification proposes a modification to the currently 510(k) cleared SPY-PHI System with the addition of a new software feature. The new software feature, referred to as the SPY-PHI Fluorescence Assessment Software, will offer real-time relative fluorescence quantification (i.e. relative fluorescence values) and visualization tools (i.e. color maps) on the SPY-PHI device. Addition of this new software feature has no impact on the current intended use of the SPY-PHI System. The SPY-PHI Fluorescence Assessment Software is a firmware module installed on the VPI component of the SPY-PHI System for use during open field surgery where fluorescence imaging is used.
The SPY-PHI Fluorescence Assessment Software enables quantification of fluorescence which may be used as an additional intraoperative tool to assist trained healthcare practitioners in the assessment of fluorescence response in tissue during various surgical procedures. The healthcare practitioner retains the ultimate responsibility for making the pertinent diagnosis based on their clinical judgment and standard practices.
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 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.
5
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.
| Comparison of Device Characteristics of the Subject Device and the Predicate Devices: | ||||
|---|---|---|---|---|
| | SUBJECT DEVICE | PREDICATE DEVICE
(primary predicate) | PREDICATE DEVICE
(secondary predicate to
support technological
differences/ new software
feature) | |
|---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| Name | SPY Portable Handheld
Imaging (SPY-PHI) System
with SPY-PHI
Fluorescence Assessment
Software | SPY Portable Handheld
Imaging (SPY-PHI) System | SPY Elite Intraoperative
Perfusion Assessment
System | |
| Company/ 510(k) Holder | Novadaq Technologies
ULC. (now a part of
Stryker) | Novadaq Technologies
ULC. (now a part of
Stryker) | Novadaq Technologies
ULC. (now a part of
Stryker) | |
| Model | HH9000 | HH9000 | LC3000 | |
| 510(k) Reference | TBD (current submission) | K200737 | K182907 | |
| Product Code | IZI | OWN | IZI | |
| Regulation Number | 21 CFR 892.1600 | 21 CFR 876.1500 | 21 CFR 892.1600 | |
| Classification | Class II | Class II | Class II | |
| Combination Product | Yes | Yes | Yes | |
| Device Classification
Name | Angiographic X-ray System | Confocal Optical Imaging | Angiographic X-ray System | |
| Intended Use | Near infrared fluorescence
imaging for visualization of
blood flow and tissue
perfusion before, during and
after surgical procedures,
and intraoperative
fluorescence imaging and
visualization of the lymphatic
system, including lymphatic
vessels and lymph nodes. | Near infrared fluorescence
imaging for visualization of
blood flow and tissue
perfusion before, during and
after surgical procedures,
and intraoperative
fluorescence imaging and
visualization of the lymphatic
system, including lymphatic
vessels and lymph nodes. | Near infrared fluorescence
imaging for visualization of
blood flow and tissue
perfusion before, during
and after 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 to
perform intraoperative
fluorescence
angiography. The SPY-PHI | Upon intravenous
administration of SPY
AGENTTM GREEN
(indocyanine green for
injection, USP) the SPY-PHI
System is used with SPY
AGENTTM GREEN to
perform intraoperative
fluorescence
angiography. The SPY-PHI | Upon intravenous
administration of SPY
AGENTTM GREEN
(indocyanine green for
injection, USP) the SPY
Elite System is used with
SPY AGENTTM GREEN to
perform intraoperative
fluorescence
angiography. The SPY | |
| | SUBJECT DEVICE | PREDICATE DEVICE
(primary predicate) | PREDICATE DEVICE
(secondary predicate to
support technological
differences/ new software
feature) | |
| Name | SPY Portable Handheld
Imaging (SPY-PHI) System
with SPY-PHI
Fluorescence Assessment
Software | SPY Portable Handheld
Imaging (SPY-PHI) System | SPY Elite Intraoperative
Perfusion Assessment
System | |
| Company/ 510(k) Holder | Novadaq Technologies
ULC. (now a part of
Stryker) | Novadaq Technologies
ULC. (now a part of
Stryker) | Novadaq Technologies
ULC. (now a part of
Stryker) | |
| | System used 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. | 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. | 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
surgical procedures. | |
| Patient Population | Adult patients and pediatric
patients (1 month of age and
older) | Adult patients and pediatric
patients (1 month of age and
older) | Adult patients and pediatric
patients (1 month of age
and older) | |
| Major Device
Components | VPI (Video
Processor/Illuminator) with
upgraded firmware for the
SPY-PHI Fluorescence
Assessment Software
SPY-PHI imager (with
integrated light guide cable) | VPI (Video Processor/
Illuminator)
SPY-PHI imager (with
integrated light guide cable) | Imaging console with a
detector and signal
processing software | |
| Operating Principle | Full color visible light and
NIR fluorescence video
imaging. The imaging head | Full color visible light and
NIR fluorescence video
imaging. The imaging head | NIR light from the
illumination module in the
imaging console is | |
| | SUBJECT DEVICE | PREDICATE DEVICE
(primary predicate) | PREDICATE DEVICE
(secondary predicate to
support technological
differences/ new software
feature) | |
| Name | SPY Portable Handheld
Imaging (SPY-PHI) System
with SPY-PHI
Fluorescence Assessment
Software | SPY Portable Handheld
Imaging (SPY-PHI) System | SPY Elite Intraoperative
Perfusion Assessment
System | |
| Company/ 510(k) Holder | Novadaq Technologies
ULC. (now a part of
Stryker) | Novadaq Technologies
ULC. (now a part of
Stryker) | Novadaq Technologies
ULC. (now a part of
Stryker) | |
| | is positioned over the patient
such that the NIR excitation
light is emitted and
illuminates the area of
interest. When the patient is
injected with ICG, the ICG
binds to the plasma in the
blood and travels to the area
of interest through the
bloodstream. The 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. | is positioned over the patient
such that the NIR excitation
light is emitted and
illuminates the area of
interest. When the patient is
injected with ICG, the ICG
binds to the plasma in the
blood and travels to the area
of interest through the
bloodstream. The 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. | transmitted to the imaging
head via fiber-optic cable.
The imaging head is
positioned over the patient
such that the NIR excitation
light is emitted and
illuminates the area of
interest. When the patient
is injected with ICG, the
ICG binds to the plasma in
the blood and travels to the
area of interest through the
bloodstream. The NIR
excitation light emitted by
the SPY Elite imaging
device causes the ICG to
fluoresce. The fluorescence
image signal is processed
and simultaneously
recorded in computer
memory and displayed on
the video monitors. | |
| Safety Standards | IEC 60601-1
IEC 60601-1-2
IEC 60825-1 | IEC 60601-1
IEC 60601-1-2
IEC 60825-1 | IEC 60601-1
IEC 60601-1-2
IEC 60825-1 | |
| Environment of Use | Operating room | Operating room | Operating room | |
| Fluorescence excitation
source | NIR laser | NIR laser | NIR laser | |
| Imaging Modes | White Light SPY Overlay Color Segmented Fluorescence (CSF) Color map (raw color map and relative color map) | White Light SPY Overlay Color Segmented Fluorescence (CSF) | SPY Overlay Color Segmented Fluorescence (CSF) | |
| | | SUBJECT DEVICE | PREDICATE DEVICE
(primary predicate) | PREDICATE DEVICE
(secondary predicate to
support technological
differences/ new software
feature) |
| Name | | SPY Portable Handheld
Imaging (SPY-PHI) System
with SPY-PHI
Fluorescence Assessment
Software | SPY Portable Handheld
Imaging (SPY-PHI) System | SPY Elite Intraoperative
Perfusion Assessment
System |
| Company/ 510(k) Holder | | Novadaq Technologies
ULC. (now a part of
Stryker) | Novadaq Technologies
ULC. (now a part of
Stryker) | Novadaq Technologies
ULC. (now a part of
Stryker) |
| Fluorescence
Assessment
Features &
Tools | On-
screen
timer | On-screen timer (automatic) | Not available | On-screen timer (manual) |
| | Signal
stability
indicator | Signal stability indicator
(automatic) | Not available | Signal stability indicator
(manual) |
| | Raw
color
map | Modified Jet Map as overlay
on anatomical grayscale
image | Not available | Jet Map |
| | Relative
color
map | Modified Jet Map as overlay
on anatomical grayscale
image | Not available | Not available |
| | Referenc
e value | Available | Not available | Available |
| | Relative
value | Available | Not available | Available |
| Imaging Agent | | SPY AGENT™ GREEN
(indocyanine green for
injection, USP) | SPY AGENT™ GREEN
(indocyanine green for
injection, USP) | SPY AGENT™ GREEN
(indocyanine green for
injection, USP) |
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NOVADAQ Technologies ULC. (now a part of Stryker)
SECTION 5 - 510(k) Summary
7
NOVADAQ Technologies ULC. (now a part of Stryker)
SECTION 5 - 510(k) Summary
8
NOVADAQ Technologies ULC. (now a part of Stryker) SECTION 5 - 510(k) Summary
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 62304:2015 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.
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A design validation study was performed to assess the suitability of the design requirements of the SPY-PHI Fluorescence Assessment Software as part of the SPY-PHI System to meet user needs. The results of the design validation study support the new fluorescence assessment software of the SPY-PHI System.
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 with SPY-PHI Fluorescence Assessment Software has been demonstrated to be substantially equivalent to the predicate devices, the SPY-PHI System (FDA 510(k)-cleared in K200737) and the SPY Elite System (FDA 510(k)-cleared in K182907).
The SPY-PHI System with SPY-PHI Fluorescence Assessment Software intended for intraoperative fluorescence imaging for visualization of blood flow and tissue perfusion before, during and after various surgical procedures, does not raise any issues related to safety or effectiveness for this device when used as instructed.