(95 days)
No
The description focuses on standard imaging and video processing technology, with no mention of AI, ML, or related concepts.
No
The device is an imaging system intended for diagnostic purposes (visual assessment of blood flow and tissue perfusion) and does not directly provide therapy.
Yes
The device performs intraoperative fluorescence angiography for the visual assessment of blood flow and tissue perfusion, which are used to evaluate the physiological state for surgical procedures.
No
The device description explicitly states that the SPY-PHI System consists of hardware components, including an Imaging Head/Imager and a Video Processor/Illuminator.
Based on the provided information, the SPY-PHI System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: An IVD device is used to examine specimens derived from the human body (like blood, urine, or tissue) in vitro (outside 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 and tissue perfusion within the patient's body during surgical procedures. It uses a fluorescent agent (ICG) injected intravenously into the patient and then images the fluorescence emitted from within the patient's tissues.
The device description and intended use clearly indicate that the SPY-PHI System is used for direct imaging of the patient's body during surgery, not for testing samples outside the body.
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.
Product codes
OWN
Device Description
The SPY-PHI System is an imaging system used in capturing 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 guide cable and the Video Processor/Illuminator (VPI) (PC9001).
Indocyanine green (ICG) is injected intravenously into the patient. The Imaging Head may be either handheld or attached to a mechanical arm and provides illumination of the regions of a patient's body to be observed with near infrared laser light to excite ICG fluorescence. Alternatively, the Imaging Head provides white light illumination of the 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, Full color visible light, NIR fluorescence video 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)
Safety and effectiveness of the SPY-PHI System for its intended use in the visualization of blood flow and tissue perfusion during various surgical procedures was assessed through a series of clinical literature evaluations to support the expansion to the cleared indications for use, including published literature references to support the expansion of existing indications for use to include pediatric patients, one (1) month of age and older.
Efficacy data obtained from published literature showed successful visualization in majority of the studies. Analysis of ICG doses administered to several pediatric subpopulations showed that the effective doses used in angiographic applications were similar to those administered to adult patients. Based on anecdotal clinical experience, lower doses of ICG may be effective, especially in younger patients and those with lower body weight.
None of the published literature identified anaphylaxis or any other adverse events related to SPY fluorescence imaging with ICG in pediatric patients. Overall the data suggests that there are no differences in safety and efficacy of SPY fluorescence imaging with ICG between pediatric patients (aged 1 month to 21 years) and adult patients.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
0
Image /page/0/Picture/0 description: The image contains 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
November 15, 2019
Re: K192174
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 Dated: August 9, 2019 Received: August 12, 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 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-reporting
1
combination-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 medical devices and radiation-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, MS Assistant Director, THT4A4 DHT4A: Division of General Surgery Devices OHT5: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K192174
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.
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 Portable Handheld Imaging (SPY-PHI) System |
|---|---|
| Device Model Number: | HH9000 |
| Common Name: | Fluorescence Angiographic System |
| Regulation: | 21 CFR § 892.1600 |
| Classification Name: | Angiographic X-Ray System |
| FDA 510(k) Review Panel: | General and Plastic Surgery |
| Product Code: | OWN |
| Classification: | Class II |
| Manufacturer: | Novadaq Technologies ULC. (now a part of Stryker) |
| 8329 Eastlake Drive, Unit 101 | |
| Burnaby, British Columbia | |
| Canada, V5A 4W2 | |
| Contact Name: | Agatha Szeliga |
| Regulatory Affairs Manager | |
| Tel: 604-422-7516 | |
| Fax: 604-232-9841 |
Date 510(k) Summary Prepared: August 8, 2019
Predicate Device(s) Information:
| Predicate Device Trade Name | SPY Portable Handheld Imaging
(SPY-PHI) System | SPY Elite Intraoperative
Perfusion Assessment System |
|------------------------------|------------------------------------------------------------------------------------|---------------------------------------------------------|
| 510(k) Number | K190729; K162885 | K182907 |
| Submitter/510(k) Holder Name | Novadaq Technologies ULC.
(now a part of Stryker)/ Novadaq
Technologies Inc. | Novadaq Technologies ULC.
(now a part of Stryker) |
| Classification Name | Angiographic X-Ray System | Angiographic X-Ray System |
| Product Code and Regulation | OWN; 21 CFR § 892.1600 | IZI; 21 CFR § 892.1600 |
| Classification | Class II | Class II |
4
Device Description:
The SPY-PHI System is an imaging system used in capturing 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 guide cable and the Video Processor/Illuminator (VPI) (PC9001).
Indocyanine green (ICG) is injected intravenously into the patient. The Imaging Head may be either handheld or attached to a mechanical arm and provides illumination of the regions of a patient's body to be observed with near infrared laser light to excite ICG fluorescence. Alternatively, the Imaging Head provides white light illumination of the 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 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 to perform intraoperative fluorescence angiography. The SPY-PHI 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 surqical procedures.
5
Comparison of the Indications for Use of the Subject Device and Predicate Devices:
| Subject Device
SPY Portable Handheld Imaging
(SPY-PHI) System | Predicate Device
SPY Portable Handheld Imaging
(SPY-PHI) System | Predicate Device
SPY Portable Handheld Imaging
(SPY-PHI) System | Predicate Device
SPY Elite Intraoperative Perfusion
Assessment System |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | (K190729) | (K162885) | (K182907) |
| 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 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 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 tissue perfusion, and related tissue-transfer circulation in tissue and free flaps used in plastic, micro- and reconstructive surgical procedures.
The SPY-PHI System is used with SPY AGENTTM GREEN to provide fluorescence images for the visual assessment of blood flow in vessels and related tissue perfusion before, during and after gastrointestinal surgical procedures. | 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 flaps used in plastic, micro-, and reconstructive surgical procedures.
The SPY Phi Open Field Handheld Fluorescence Imaging System is intended to provide fluorescence images for the visual assessment of blood flow in vessels and related tissue perfusion during gastrointestinal surgical procedures. | 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 Elite System used with SPY AGENTTM 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 surgeries. |
| Feature | Subject Device | Predicate Devices | |
| | SPY Portable Handheld
Imaging (SPY-PHI)
System | SPY Portable Handheld
Imaging (SPY-PHI)
System | SPY Elite Intraoperative
Perfusion Assessment
System |
| 510(k) Holder/
Manufacturer | Novadaq Technologies
ULC. (now a part of
Stryker) | Novadaq Technologies
ULC. (now a part of
Stryker)/ Novadaq
Technologies Inc. | Novadaq Technologies
ULC. (now a part of
Stryker) |
| Submission
Reference | Current Submission | K190729; K162885 | K182907 |
| Decision Date | Current Submission | 04/19/2019; 01/11/2017 | 01/23/2019 |
| Combination
Product | Yes | Yes | Yes |
| Product Code | OWN | OWN | IZI |
| Regulation Number | 21 CFR 892.1600 | 21 CFR 892.1600 | 21 CFR 892.1600 |
| Device
Classification Name | System, X-Ray,
Angiographic | System, X-Ray,
Angiographic | System, X-Ray,
Angiographic |
| 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 | Near infrared fluorescence
imaging for visualization of
blood flow and tissue
perfusion during 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 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. | NIR light from the
illumination module in the
imaging console is
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 |
| Feature | Subject Device | Predicate Devices | |
| | SPY Portable Handheld
Imaging (SPY-PHI)
System | SPY Portable Handheld
Imaging (SPY-PHI)
System | SPY Elite Intraoperative
Perfusion Assessment
System |
| | | | displayed on the video
monitors in real time. |
| Safety Standards | IEC 60601-1 | IEC 60601-1 | IEC 60601-1 |
| | IEC 60601-1-2 | IEC 60601-1-2 | IEC 60601-1-2 |
| | IEC 60825-1 | IEC 60825-1 | IEC 60825-1 |
| Major components | SPY-PHI imager (with
integrated light guide
cable) and VPI (Video
Processor/ Illuminator) | SPY-PHI imager (with
integrated light guide
cable) and VPI (Video
Processor/ Illuminator) | Imaging console with a
detector (CCD camera)
and signal processing
software |
| Fluorescence
excitation source | NIR laser | NIR laser | NIR laser |
| Environment of Use | Hospital | Hospital | Hospital |
| Contrast imaging
agent | SPY AGENTTM GREEN
(Indocyanine green for
injection, USP) | SPY AGENTTM GREEN
(Indocyanine green for
injection, USP);
Indocyanine green (ICG) | SPY AGENTTM GREEN
(Indocyanine green for
injection, USP) |
6
Comparison of Device Characteristics of the Subject Device and the Predicate Devices:
Section 5 Page 4 of 6
7
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 Novadag and accredited third-party laboratories.
SPY-PHI was tested and determined to be in conformance with IEC 60601-1:2006 Medical Electrical Equipment – Part 1: General requirements for basic safety and essential performance, IEC 60601-1-2 (4th edition) and IEC 60825:2007 Safety of laser products -- Part 1: Equipment classification and requirements.
An assessment of the SPY-PHI system software was conducted to demonstrate conformance with the applicable requirements of IEC 62304:2006 Medical device software - Software life-cycle processes. It has been demonstrated that all processes and activities necessary for the safe design and maintenance of SPY-PHI software are performed in accordance with the standard.
Clinical Summary and Use in Pediatric Patients:
Safety and effectiveness of the SPY-PHI System for its intended use in the visualization of blood flow and tissue perfusion during various surgical procedures was assessed through a series of clinical literature evaluations to support the expansion to the cleared indications for use, including published literature references to support the expansion of existing indications for use to include pediatric patients, one (1) month of age and older.
Efficacy data obtained from published literature showed successful visualization in majority of the studies. Analysis of ICG doses administered to several pediatric subpopulations showed that the effective doses
8
used in angiographic applications were similar to those administered to adult patients. Based on anecdotal clinical experience, lower doses of ICG may be effective, especially in younger patients and those with lower body weight.
None of the published literature identified anaphylaxis or any other adverse events related to SPY fluorescence imaging with ICG in pediatric patients. Overall the data suggests that there are no differences in safety and efficacy of SPY fluorescence imaging with ICG between pediatric patients (aged 1 month to 21 years) and adult patients.
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 determined to be substantially equivalent to the predicate devices, the SPY Portable Handheld Imaging (SPY-PHI) System (FDA 510(K)cleared in K162885 and K190729) and the SPY Elite Intraoperative Perfusion Assessment System (FDA 510(k)-cleared in K182907)
Any minor technological or design differences between the SPY-PHI System and the predicate devices do not raise any questions related to safety or effectiveness. The proposed additional/expanded indications for use do not raise any issues related to safety or effectiveness for this device-drug combination product.