(98 days)
Not Found
No
The summary does not mention AI, ML, or related terms, and the device description focuses on standard imaging and software functionalities.
No.
This device is an imaging system used for diagnostic purposes (visualizing blood flow and tissue perfusion) and does not directly provide therapy.
No
Explanation: The device is an imaging system used during surgery to visualize blood flow and tissue perfusion. While it provides critical information to surgeons, its primary function is to enhance visualization rather than to diagnose a condition or disease. It assists in assessing the state of blood flow and tissue perfusion, which are parameters, not diagnoses themselves.
No
The device description explicitly states the system is comprised of an "Imaging Console" in addition to software components, indicating it includes hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The SPY Elite System is an imaging system used during surgery to visualize blood flow and tissue perfusion in vivo (within the living body) after the administration of an imaging agent. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for "intraoperative fluorescence angiography" and "fluorescence imaging of blood flow and tissue perfusion before, during, and after...surgeries." This is an imaging procedure performed on the patient, not a diagnostic test on a sample.
Therefore, the SPY Elite System falls under the category of an imaging device used for surgical guidance and assessment, 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 Elite System is used with SPY AGENT™ GREEN to perform intraoperative fluorescence angiography. The SPY 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 surgeries.
Product codes
IZI
Device Description
The SPY Elite System is an angiographic fluorescence imaging system which is used for nearinfrared fluorescence imaging during open surgery, with indocyanine green (ICG) as the imaging agent. The SPY Elite System allows surgeons to capture, review, print, and archive high-quality fluorescence images of blood flow in vessels, tissue and organ perfusion in realtime during various surgical procedures.
The SPY Elite System is comprised of an Imaging Console, CINEVAQ software and DICOM Send software. SPY Elite is intended to be used in conjunction with the SPY Elite Pack/Kit which contains ICG, sterile Water for Injection, a sterile equipment drape, instructions for use, and a drug product package insert.
To provide NIR fluorescence imaging, SPY Elite is used with the imaging agent, indocyanine green (ICG). Once the patient is injected with ICG imaging agent, recording can begin. The SPY Elite imaging head filters the excitation NIR light and only senses the fluorescence signal. Live images are then displayed on the device's monitors. After imaging is complete, the user can review the recorded videos with false color overlays, examine reports and raw data, or print(export still images and reports.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
NIR fluorescence imaging
Anatomical Site
vessels (micro and macro vasculature), tissue and organ
Indicated Patient Age Range
adult and pediatric patients one month of age and older
Intended User / Care Setting
surgeons / 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)
Device safety and performance were verified by tests conducted by Novadag and accredited third party laboratories. The SPY Elite System was tested in accordance with IEC 60601-1:2012, IEC 60601-1-2:2007, and IEC 60825:2007.
Safety and effectiveness of SPY Elite for visualization of blood flow and tissue perfusion, was assessed in a series of clinical literature evaluations to support the revisions 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.
Clinical publications support the safe and effective use of the subject device, in combination with ICG imaging agent, in pediatric patients (1 month to 21 years of age) for perfusion assessments during various surgical procedures.
Across 13 studies reviewed, 12 studies exceeded the success criteria of a 90% visualization rate and 10 of the studies showed a 100% visualization rate in the visualization of macrovascular blood flow in vessels. Across data reviewed from 33 studies in 2055 patients, all the studies showed more than 90% visualization rate, and 31 studies (94%) showed 100% visualization rate in the visualization of microvascular blood flow in tissues.
The results from the systematic reviews of clinical literature provide robust evidence of successful visualization of blood flow and tissue perfusion utilizing SPY Fluorescence Technology in combination with ICG during various surqical procedures. Overall, efficacy data obtained from published literature showed successful visualization in maiority of the studies.
Analysis of ICG doses administered to a number of pediatric subpopulations showed that the effective doses used in angiographic applications ranged from 1.25 - 10.0 mg ICG, with the majority of doses being in the range of 1.25 mg to 5.0 mg, similar to those administered to adult patients.
The clinical literature data demonstrates that fluorescence imaging with SPY devices in the angiographic indications of cardiovascular/vascular and plastic, micro-, and reconstructive surgical applications in infant, children and adolescent patients, aged 1 month to 21 years, were effective in visualization of blood flow and tissue perfusion.
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)
K100371, K073088, K073130, and K071619
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1600 Angiographic x-ray system.
(a)
Identification. An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
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March 2, 2020
Novadaq Technologies ULC. (now a part of Stryker) Agatha Szeliga Regulatory Affairs Manager 8329 Eastlake Drive, Unit 101 Burnaby, CA V5A 4W2
Re: K182907
Trade/Device Name: SPY Elite Intraoperative Perfusion Assessment System Regulation Number: 21 CFR 892.1600 Regulation Name: Angiographic x-ray system Regulatory Class: Class II Product Code: IZI Dated: October 16, 2018 Received: October 17, 2018
Dear Agatha Szeliga:
This letter corrects our substantially equivalent letter of January 23rd, 2019.
We have reviewed vour 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.
1
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-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 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.
Image /page/1/Picture/5 description: The image shows the name Neil R.P. Ogden in large font on the left side of the image. On the right side of the image, it says "Digitally signed by Neil R.P. Ogden" followed by the date "2020.03.02" and the time "09:47:55 -05'00'". The text on the right side of the image is smaller than the name on the left side.
Neil R. Ogden Assistant Director 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) K182907
Device Name SPY Elite System
Indications for Use (Describe)
Upon intravenous administration of SPY AGENT™ GREEN (Indocyanine green for Injection, USP), the SPY Elite System is used with SPY AGENT™ GREEN to perform intraoperative fluorescence angiography. The SPY 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 surgeries.
| 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.
| Trade Name: | SPY Elite Intraoperative Perfusion Assessment System (SPY Elite
System) |
|---------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|
| Device Model Number: | LC3000, SP3000 |
| Common Name: | Angiographic X-Ray System |
| Classification: | 21 CFR § 892.1600 |
| Classification Name: | Angiographic X-Ray System |
| 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
Email: agatha.szeliga@stryker.com |
| Date 510(k) Summary Prepared:
October 12, 2018 | |
| Predicate Device(s): | SPY System (K100371, K073088, K073130, and K071619)
(Novadaq Technologies Inc.) |
Device Description
The SPY Elite System is an angiographic fluorescence imaging system which is used for nearinfrared fluorescence imaging during open surgery, with indocyanine green (ICG) as the imaging agent. The SPY Elite System allows surgeons to capture, review, print, and archive high-quality fluorescence images of blood flow in vessels, tissue and organ perfusion in realtime during various surgical procedures.
The SPY Elite System is comprised of an Imaging Console, CINEVAQ software and DICOM Send software. SPY Elite is intended to be used in coniunction with the SPY Elite Pack/Kit which contains ICG, sterile Water for Injection, a sterile equipment drape, instructions for use, and a drug product package insert.
4
To provide NIR fluorescence imaging, SPY Elite is used with the imaging agent, indocyanine green (ICG). Once the patient is injected with ICG imaging agent, recording can begin. The SPY Elite imaging head filters the excitation NIR light and only senses the fluorescence signal. Live images are then displayed on the device's monitors. After imaging is complete, the user can review the recorded videos with false color overlays, examine reports and raw data, or print(export still images and reports.
In combination with SPY AGENT™ GREEN (Indocvanine green for Iniection, USP), the SPY Elite System is used in the visualization of vessels (micro and macro vasculature), blood flow and tissue perfusion before, during, and after various surgical procedures, in adult and pediatric patients.
Proposed Indications for Use of the SPY Elite System
Upon intravenous administration of SPY AGENT™ GREEN (Indocyanine green for Injection, USP), the SPY Elite System is used with SPY AGENT™ GREEN to perform intraoperative fluorescence angiography. The SPY 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 surgeries.
Comparison and Summary of the Indications for Use of the SPY Elite System and the Predicate Devices
The main differences in the indications for use between the SPY Elite device proposed in this 510(k)-premarket notification and the predicate device are the cross-label indications for use with SPY AGENT™ GREEN drug product, the compilation of the individual 510(k)-cleared indications for use (of the predicate devices) into one comprehensive 510(k), and expansion of the existing indications for use to include pediatrics, one (1) month of age and older.
Summary of Technological Characteristics of the SPY Elite System and Predicate Device
Based on the technological characteristics, principle of operation and fundamental scientific premise, the SPY Elite System (LC300; SP3000) has been demonstrated to be substantially equivalent to the predicate device, the SPY System (K100371, K073088, K073130, and K071619). The device presented in this premarket notification is an updated version of the predicate device - the SPY System which is FDA 510(k) cleared in K100371, K073088, K073130, and K071619. SPY Elite contains updated system control, processing and image acquisition software, in comparison to the older predicate SPY devices which contain an older type of signal processing software. The CINEVAQ software contained in SPY Elite (applicant device) is the system control software which provides the primary interface for the database, image sequence acquisition, data processing, and review functionality controls on the SPY Elite device.
The proposed device (SPY Elite System) and predicate device (SPY System) are identical in terms of the technology and mode of imaging to provide real-time NIR fluorescence imaging during open surgical procedures. Both the subject and predicate devices utilize the same mode of imaging - near infrared fluorescence imaging, with ICG as the imaging agent, used in the
5
hospital operating room. The proposed and predicate devices have the same integral components - an imaging console, a radiation source, a detector (CCD camera) and signal processing software.
The proposed SPY Elite System is substantially equivalent to the 510(k)-cleared SPY System (K100371. K073088. K073130. and K071619) in terms of its technological characteristics and mode of imaging.
Non-Clinical Performance Testing of the SPY Elite System
The SPY Elite System was designed and developed by Novadaq Technologies in accordance with the applicable requirements and standards to establish performance and safety of the device. Device safety and performance were verified by tests conducted by Novadag and accredited third party laboratories.
The SPY Elite System was tested in accordance with IEC 60601-1:2012 Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance. IEC 60601-1-2:2007 Medical Electrical Equipment - Part 1-2: General requirements for safety -Collateral standard: Electromagnetic compatibility - Requirements and testing was also conducted on the SPY Elite System and test results showed that SPY Elite conforms to the applicable requirements. Conformance of SPY Elite with IEC 60825:2007 Safety of laser products – Part 1: Equipment classification and requirements was assessed by Underwriters Laboratories Inc. (UL) and showed that SPY Elite is a Class 3R laser device with internal maximum Class 4 laser radiation.
Safety and effectiveness of SPY Elite for visualization of blood flow and tissue perfusion, was assessed in a series of clinical literature evaluations to support the revisions 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.
Clinical Summary and Use in Pediatric Patients
Clinical publications support the safe and effective use of the subject device, in combination with ICG imaging agent, in pediatric patients (1 month to 21 years of age) for perfusion assessments during various surgical procedures.
Safety and performance of the SPY Elite System and SPY AGENT™ GREEN for visualization of vessels (micro and macro vasculature), blood flow and tissue perfusion before, during, and affer vascular, gastrointestinal, organ transplant, and plastic, micro- and reconstructive surgical procedures in adult and pediatric patients was evaluated in a series of systematic summary reviews of the clinical literature to support the indications for use during these various procedures.
The results of the systematic summary reviews of clinical literature provide evidence of high success rate when SPY Fluorescence Technology was used with ICG to visualize macrovascular blood flow in vessels across a broad range of surgical procedures, and in the visualization of microvascular blood flow in tissues across a broad range of surgical procedures. Data was collected and analyzed in accordance with the statistical analyses plans provided in the Clinical Performance Section of the 510(k), and results were reported in the statistical analyses reports and meta-analyses reports. Across 13 studies reviewed, 12 studies exceeded the success criteria of a 90% visualization rate and 10 of the studies showed a 100% visualization rate in the visualization of macrovascular blood flow in vessels. Across data reviewed from 33 studies in
6
2055 patients, all the studies showed more than 90% visualization rate, and 31 studies (94%) showed 100% visualization rate in the visualization of microvascular blood flow in tissues.
The results from the systematic reviews of clinical literature provide robust evidence of successful visualization of blood flow and tissue perfusion utilizing SPY Fluorescence Technology in combination with ICG during various surqical procedures.
Overall, efficacy data obtained from published literature showed successful visualization in maiority of the studies. Analysis of ICG doses administered to a number of pediatric subpopulations showed that the effective doses used in angiographic applications ranged from 1.25 - 10.0 mg ICG, with the majority of doses being in the range of 1.25 mg to 5.0 mg, 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.
The clinical literature data demonstrates that fluorescence imaging with SPY devices in the angiographic indications of cardiovascular/vascular and plastic, micro-, and reconstructive surgical applications in infant, children and adolescent patients, aged 1 month to 21 years, were effective in visualization of blood flow and tissue perfusion.
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.
Altogether, the available clinical data and published literature support the safety and efficacy of the SPY Elite System for use in combination with SPY AGENT™ GREEN in fluorescence angiography before, during and after various surgical procedures, including use in pediatric patients 1 month of age and older.
7
Comparison of Device Characteristics of the Subject and Predicate Devices
| Company/ 510(k)
Holder | Novadaq Technologies ULC.
(Stryker) | Novadaq Technologies
Inc. | Novadaq Technologies
Inc. | Novadaq Technologies
Inc. | Novadaq Technologies
Inc. |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Brand
Name | SPY Elite System (SUBJECT
DEVICE) | SPY Intra-Operative
Imaging System
(PREDICATE DEVICE) | SPY Fluorescent
Imaging System
(PREDICATE DEVICE) | SPY Fluorescent
Imaging System
(PREDICATE DEVICE) | SPY Fluorescent
Imaging System
(PREDICATE DEVICE) |
| Model | LC3000, SP3000 | SP2001 | SP2001 | SP2001 | SP2000 |
| 510(k) | Current Submission | K100371 | K073088 | K073130 | K071619 |
| Common Name | Angiographic X-ray System | Angiographic X-ray
System | Angiographic X-ray
System | Angiographic X-ray
System | Angiographic X-ray
System |
| Product Code | IZI | IZI | IZI | IZI | IZI |
| Regulation
Number | 21 CFR § 892.1600 | 21 CFR § 892.1600 | 21 CFR § 892.1600 | 21 CFR § 892.1600 | 21 CFR § 892.1600 |
| Class | II | II | II | II | II |
| Decision date | Current Submission | 02/04/2011 | 01/10/2008 | 01/10/2008 | 11/09/2007 |
| Device
Classification
Name | System, X-Ray, Angiographic | System, X-Ray,
Angiographic | System, X-Ray,
Angiographic | System, X-Ray,
Angiographic | System, X-Ray,
Angiographic |
| Intended Use | Intraoperative fluorescence
angiography; fluorescence
imaging of blood flow and
tissue perfusion | Intraoperative
fluorescence angiography;
fluorescence imaging of
blood flow and tissue
perfusion | Intraoperative
fluorescence angiography;
fluorescence imaging of
blood flow and tissue
perfusion | Intraoperative
fluorescence angiography;
fluorescence imaging of
blood flow and tissue
perfusion | Intraoperative
fluorescence angiography;
fluorescence imaging of
blood flow and tissue
perfusion |
| Indications for
Use | Upon intravenous
administration of SPY
AGENT™ GREEN
(Indocyanine green for
Injection, USP), the SPY Elite
System is used with SPY
AGENT™ GREEN to perform
intraoperative fluorescence
angiography. The SPY Elite | The SPY System is
intended to provide
fluorescence images for
the visual assessment of
blood flow in vessels and
related tissue perfusion
during gastrointestinal
surgical procedures. | The SPY Fluorescent
Imaging 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 | The SPY Fluorescent
Imaging System is
intended to intra-
operatively enable
surgeons to visually asses
blood flow and related
tissue perfusion during
organ transplant
procedures. | The SPY Fluorescent
Imaging System is
intended to provide
fluorescent images for the
visual assessment of
blood flow in vessels and
related tissue perfusion
during cardiovascular
surgical procedures. |
8
| Company/ 510(k)
Holder | Novadaq Technologies ULC.
(Stryker) | Novadaq Technologies
Inc. | Novadaq Technologies
Inc. | Novadaq Technologies
Inc. | Novadaq Technologies
Inc. |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Brand
Name | SPY Elite System (SUBJECT
DEVICE) | SPY Intra-Operative
Imaging System
(PREDICATE DEVICE) | SPY Fluorescent
Imaging System
(PREDICATE DEVICE) | SPY Fluorescent
Imaging System
(PREDICATE DEVICE) | SPY Fluorescent
Imaging System
(PREDICATE DEVICE) |
| | 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 surgeries. | | perfusion, and related
tissue-transfer circulation
in tissue and free flaps
used in plastic, micro- and
reconstructive surgical
procedures. | | |
| Device
Description
Summary | Fluorescence imaging system
which allows surgeons to
capture, review, print, and
archive high-quality
fluorescence images of blood
flow in vessels and micro-
vessels, tissue and organ
perfusion in real time while
performing a variety of surgical
procedures. | Fluorescence imaging
system which allows
surgeons to capture,
review, print, and archive
high-quality fluorescence
images of blood flow in
vessels and micro-
vessels, tissue and organ
perfusion in real time while
performing a variety of
surgical procedures. | Fluorescence imaging
system which allows
surgeons to capture,
review, print, and archive
high-quality fluorescence
images of blood flow in
vessels and micro-
vessels, tissue and organ
perfusion in real time while
performing a variety of
surgical procedures. | Fluorescence imaging
system which allows
surgeons to capture,
review, print, and archive
high-quality fluorescence
images of blood flow in
vessels and micro-
vessels, tissue and organ
perfusion in real time while
performing a variety of
surgical procedures. | Fluorescence imaging
system which allows
surgeons to capture,
review, print, and archive
high-quality fluorescence
images of blood flow in
vessels and micro-
vessels, tissue and organ
perfusion in real time while
performing a variety of
surgical procedures. |
| Principle of
Operation | 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 | Same as subject device | Same as subject device | Same as subject device | Same as subject device |
| Company/ 510(k)
Holder | Novadaq Technologies ULC.
(Stryker) | Novadaq Technologies
Inc. | Novadaq Technologies
Inc. | Novadaq Technologies
Inc. | Novadaq Technologies
Inc. |
| Product Brand
Name | SPY Elite System (SUBJECT
DEVICE) | SPY Intra-Operative
Imaging System
(PREDICATE DEVICE) | SPY Fluorescent
Imaging System
(PREDICATE DEVICE) | SPY Fluorescent
Imaging System
(PREDICATE DEVICE) | SPY Fluorescent
Imaging System
(PREDICATE DEVICE) |
| | 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 in real time. | | | | |
| Environment of
Use | Hospital | Hospital | Hospital | Hospital | Hospital |
| System
Components | SPY Elite contains a radiation
source, a detector (CCD
camera), and signal
processing software.
The major components of SPY
Elite are:
Imaging ConsoleCINEVAQ Software
(1x) – Analysis and
Comparison
DashboardCINEVAQ Software
(2x) – Analysis
Dashboard and Case
Management for
vascular imaging
modality | SPY contains a radiation
source, a detector (CCD
camera), and signal
processing software.
The major components of
SPY are:
Imaging ConsoleHELIOS Software | SPY contains a radiation
source, a detector (CCD
camera), and signal
processing software.
The major components of
SPY are:
Imaging ConsoleHELIOS Software | SPY contains a radiation
source, a detector (CCD
camera), and signal
processing software.
The major components of
SPY are:
Imaging ConsoleHELIOS Software | SPY contains a radiation
source, a detector (CCD
camera), and signal
processing software.
The major components of
SPY are:
Imaging ConsoleDaqPac software |
| Company/ 510(k)
Holder | Novadaq Technologies ULC.
(Stryker) | Novadaq Technologies
Inc. | Novadaq Technologies
Inc. | Novadaq Technologies
Inc. | Novadaq Technologies
Inc. |
| Product Brand
Name | SPY Elite System (SUBJECT
DEVICE) | SPY Intra-Operative
Imaging System
(PREDICATE DEVICE) | SPY Fluorescent
Imaging System
(PREDICATE DEVICE) | SPY Fluorescent
Imaging System
(PREDICATE DEVICE) | SPY Fluorescent
Imaging System
(PREDICATE DEVICE) |
| | • DICOM Send
Software | | | | |
| Safety Standards | IEC 60601-1 | Same as subject device | Same as subject device | Same as subject device | Same as subject device |
| | IEC 60601-1-2 | | | | |
| | IEC 60825-1 | | | | |
| Patient
Population | Adult patients and pediatric
patients (1 month of age and
older) | Adult patients | Adult patients | Adult patients | Adult patients |
| Contrast Agent | ICG, namely SPY AGENT™
GREEN (Indocyanine green
for injection, USP) | ICG | ICG | ICG | ICG |
| Mode of Imaging | NIR fluorescence imaging | NIR fluorescence imaging | NIR fluorescence imaging | NIR fluorescence imaging | NIR fluorescence imaging |
9
10
11
Conclusions
It has been demonstrated in this Traditional 510(k) premarket notification that the SPY Elite System with the proposed cross-label indications for use is substantially equivalent to the predicate device (SPY System) in terms of safety, effectiveness and performance. This determination is based on the proposed and predicate devices having the same technological characteristics, principle of operation, intended use and environment of use. The proposed crosslabel indications for use of the SPY Elite System outlined in this summary raise no issues related to its safety and effectiveness.