(59 days)
Not Found
No
The description focuses on standard imaging and video processing, with no mention of AI, ML, or related concepts.
No.
The device is used for imaging and visualization to assist in diagnosis and procedural guidance, not for directly treating a disease or condition.
Yes
The device aids in the visual assessment of blood flow and tissue perfusion, and visualization of the lymphatic system, which are diagnostic indicators for various medical conditions and surgical procedures.
No
The device description explicitly lists hardware components: an Imaging Head/Imager (HH9030) and a Video Processor/Illuminator (VPI) (PC9001).
Based on the provided information, the SPY-PHI System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, outside of the body to provide information for diagnosis, monitoring, or screening.
- SPY-PHI System Function: The SPY-PHI System is an in vivo imaging system. It is used to visualize blood flow, tissue perfusion, and the lymphatic system within the patient's body during surgical procedures. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it is for "intraoperative fluorescence angiography" and "fluorescence imaging of blood flow and tissue perfusion" and "visualization of the lymphatic system" in patients.
Therefore, the SPY-PHI System falls under the category of an in vivo imaging device, not 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, 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 (comma separated list FDA assigned to the subject device)
OWN, IZI, GCJ
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluorescence imaging, White light imaging
Anatomical Site
Not Found
Indicated Patient Age Range
adult and pediatric patients one month of age and older.
Intended User / Care Setting
Hospital
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)
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.
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.
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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
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 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
2
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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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 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 101 | |
| Burnaby, British Columbia | |
| Canada, V5A 4W2 | |
| Contact Name: | Agatha Szeliga |
| Requlatory Affairs Manager | |
| Tel: 604-422-7516 | |
| Fax: 604-232-9841 |
Date 510(k) Summary Prepared: March 16, 2020
Predicate Device(s) Information:
| Predicate Device Trade Name | PINPOINT Endoscopic
Fluorescence Imaging System
(PINPOINT System) | SPY Portable Handheld Imaging
(SPY-PHI) System |
|------------------------------|-------------------------------------------------------------------------|------------------------------------------------------|
| | (primary predicate for indications
expansion) | (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 & Plastic
Surgery; Angiographic X-ray
System | Confocal Optical Imaging |
| Product Code and Regulation | GCJ; IZI 21 CFR § 876.1500 | OWN 21 CFR § 876.1500 |
| Classification | Class II | Class II |
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 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.
5
| Subject Device
SPY Portable Handheld Imaging (SPY-PHI)
System | Predicate Device
(primary predicate for indication expansion)
PINPOINT Endoscopic Fluorescence Imaging
System
(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) 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 | Upon intravenous administration of SPY AGENT™
GREEN (ICG drug product), the PINPOINT
Endoscopic Fluorescence Imaging System is used
with SPY AGENT™ GREEN to perform
intraoperative fluorescence angiography, and it is
also indicated for use in fluorescence imaging of | 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 used is
indicated for use in adult and pediatric patients | |
| age and older. | biliary ducts, and when indicated, during
intraoperative cholangiography. | 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™ | The PINPOINT Endoscopic Fluorescence Imaging
System is indicated for use to provide real time
endoscopic visible and near-infrared fluorescence
imaging.
The PINPOINT System enables surgeons to
perform minimally invasive surgery using standard
endoscope visible light as well as visual | 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. | |
| GREEN, the SPY-PHI System is used to perform
intraoperative fluorescence imaging and
visualization of the lymphatic system, including
lymphatic vessels and lymph nodes. | assessment of vessels, blood flow and related
tissue perfusion, and at least one of the major
extra-hepatic bile ducts (cystic duct, common bile
duct or common hepatic duct), using near-infrared
imaging.
Fluorescence imaging of biliary ducts with the
PINPOINT System is intended for use with
standard of care white light, and when indicated,
intraoperative cholangiography. The device is not
intended for standalone use for biliary duct
visualization.
Upon interstitial administration of SPY AGENT™
GREEN (ICG drug product), the PINPOINT
System is used to perform intraoperative | | |
| | fluorescence imaging and visualization of the
lymphatic system, including lymphatic vessels and
lymph nodes. | | |
| Feature | Subject Device | Predicate Devices | |
| | SPY Portable Handheld
Imaging (SPY-PHI)
System | PINPOINT Endoscopic
Fluorescence Imaging
System | SPY Portable Handheld
Imaging (SPY-PHI)
System |
| 510(k) Holder/
Manufacturer | Novadaq Technologies
ULC. (now a part of
Stryker) | Novadaq Technologies
ULC. (now a part of
Stryker) | Novadaq Technologies
ULC. (now a part of
Stryker) |
| Submission
Reference | Current Submission | K182606 | K192174 |
| Decision Date | Current Submission | 11/21/2018 | 11/15/2019 |
| Combination
Product | No | No | Yes |
| Product Code | OWN | GCJ; IZI | OWN |
| Regulation Number | 21 CFR 876.1500 | 21 CFR 876.1500 | 21 CFR 876.1500 |
| Device
Classification Name | Confocal Optical Imaging | Laparoscope, General &
Plastic Surgery;
Angiographic X-ray
System | Confocal Optical Imaging |
| 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 during surgical
procedures, identification
of extrahepatic biliary
ducts, 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. |
| Operating Principle | 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. | Full color visible light and
NIR fluorescence video
imaging. The PINPOINT
camera captures the
fluorescent image under
laser illumination or a color
image under white light
illumination. The VPI
receives the video signal
from camera and
processes and outputs the
video image to a medical
grade video monitor and/or
video recorder. | 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. |
| Safety Standards | IEC 60601-1 | IEC 60601-1 | IEC 60601-1 |
| Feature | Subject Device | Predicate Devices | |
| | SPY Portable Handheld
Imaging (SPY-PHI)
System | PINPOINT Endoscopic
Fluorescence Imaging
System | SPY Portable Handheld
Imaging (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 (Video
Processor/Illuminator) | VPI (Video
Processor/Illuminator) | VPI (Video Processor/
Illuminator) |
| | SPY-PHI imager (with
integrated light guide
cable) | Camera
Light Guide Cable
Laparoscopes | SPY-PHI imager (with
integrated light guide
cable) |
| Imaging Modes | White Light | White Light | White Light |
| | SPY | SPY | SPY |
| | Overlay | Overlay | Overlay |
| | Color Segmented
Fluorescence (CSF) | Color Segmented
Fluorescence (CSF) | Color Segmented
Fluorescence (CSF) |
| Fluorescence
excitation source | NIR laser | NIR laser | NIR laser |
| Environment of Use | Hospital | Hospital | Hospital |
| Contrast 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) |
Comparison of the Indications for Use of the Subject Device and Predicate Devices:
6
Comparison of Device Characteristics of the Subject Device and the Predicate Devices:
7
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.
8
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.