(149 days)
K#042961, K#060867, K#071037
K#061871
No
The description focuses on standard imaging technology (CCD camera, laser light source) and the use of a fluorescent dye. There is no mention of AI, ML, or advanced image processing beyond capturing and displaying the fluorescent images. The performance studies described are related to safety and image quality, not algorithmic performance.
No.
The device is intended for diagnostic imaging to assess blood flow and tissue perfusion, not for direct treatment or therapy.
Yes
The device provides visual assessment of blood flow and tissue perfusion, and the images are used to evaluate the integrity of coronary vasculature and blood flow, which are diagnostic purposes.
No
The device description clearly outlines hardware components like an imaging head with a CCD camera, laser light source, motion sensor, distance sensor, articulating arm, mobile cart, flat panel display, computer, electronics enclosure, and printer. It also includes a consumable kit (SPY Paq) with ICG and diluent. This is not a software-only device.
Based on the provided information, the SPY Fluorescent Imaging System is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to provide fluorescent images for the visual assessment of blood flow and tissue perfusion during surgical procedures. This involves imaging the patient's internal structures directly, not analyzing samples taken from the body.
- Device Description: The system consists of an imaging device and a dye (ICG) that is injected intravenously into the patient. The imaging device then captures the fluorescence emitted from the dye within the patient's body.
- Mechanism of Action: The system works by visualizing the movement of a dye within the patient's circulatory system. This is an in vivo process (within a living organism), not an in vitro process (outside of a living organism, typically in a lab setting).
- Anatomical Site: The system is used to image vessels and tissue within the patient.
- Lack of Sample Analysis: There is no mention of collecting and analyzing samples (like blood, urine, tissue biopsies, etc.) in a laboratory setting.
IVDs are typically used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The SPY system is used for real-time visualization within the patient during surgery.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
90 IZI
Device Description
The Novadaq® Technologies SPY® Fluorescent Imaging System consists of 2 components:
- · the SP2000 Imaging Device; and
- = the SPY Paq®
The SPY Pag constitutes a 6 procedure kit. Each SPY Pag contains The Sir I aq constitution a o procours ... " procedures ... " leG and diluent to carry out 6 cardiovascular imaging procedures. Novadaq provides the ICG as it is sold by the manufacturer and does not adulterate the integrity of the original packaging or labeling. IC-Green™ (Akorn, Inc.) is packaged in an IC-Green kit that contains 6 x 25 mg vials of ICG along with 6 x 10 ml ampules of Aqueous Solvent.
The SP2000 Imaging Device
The SP2000 Imaging Device consists of an imaging head containing a charge coupled device (CCD) camera, a laser light source, motion sensor and distance sensor attached via an articulating arm to a mobile cart. The mobile cart contains a flat panel display, computer, electronics enclosure and printer.
The SPY System provides the surgeon with the capability to view record and replay fluorescent images of blood flow in vessels and bypass grafts of the heart. A laser light source is used to illuminate the area of interest. ICG is injected intravenously through the central venous line, bypass pump, cardioplegia line and coronary graft and while it is passing through the vessels, the absorption of laser light causes excitation of the dye followed by emission of infrared energy. The result is a fluorescent image of blood flow and related tissue perfusion in the vessels. A CCD camera captures the image. These images are used to evaluate the integrity of the coronary vasculature and blood flow in the heart and bypass grafts.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluorescent Imaging
Anatomical Site
vessels and related tissue perfusion during cardiovascular surgical procedures including: coronary vasculature, bypass grafts, heart, aortic valve, ascending aorta, entire vascular bed, extremities.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeons
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)
Animal studies, human experience and in vitro testing were conducted to support the safe and effective use of the SPY System in its original premarket notification 510(k) application (K#042961).
In Vitro Testing:
Testing of the SPY System was completed in conformance with the following standards. The SPY System successfully met all of the requirements for these standards.
-
- Electrical per IEC 60601-1 and UL2601-1
-
- Electromagnetic Compatibility per IEC 60601-1-2
-
- Light Emitting Laser Products per 21 CFR 1040
-
- Safe Use of Lasers in Health Care Facilities per ANSI Z136.3
-
- American National Standard for Safe Use of Lasers per ANSI Z136.1
In Vivo Testing:
The SPY System is commercially available in the United States of America, Japan, Europe and Canada. To date, the SPY System has been used in over 4000 CABG procedures in humans and there have been no reports of adverse acute or long-term cellular, renal or hepatic effects.
The literature reports that the SPY System was able to non-invasively, quickly and safely identify 17 conduits in 311 patients that reguired revision during the surgical procedures. In all cases the lack of patency was visualized clearly by the SPY System allowing the surgeon to revise the graft thus decreasing subsequent myocardial infarctions and the morbidity and mortality associated with poor graft patency. Cardiac, renal and he atic function were monitored during use of the SPY System and there were no reported adverse effects.
To support the original premarket notification 510(k) application, the system was used in six pig studies. These studies demonstrated that:
-
- it was possible to acquire high quality images in a simple and reproducible manner using small doses of ICG well below the concentrations approved for human use;
-
- it was possible to perform multiple imaging sequences with no detrimental effects on heart function, coronary flow or peripheral pressure; and
-
- it was possible to acquire images with no increase in myocardial tissue temperature; and
-
- it was possible to visualize all of the coronary beds with high quality images even when the heart was in a vertical position for visualizing posterior arteries.
Therefore, the in vivo evidence shows that:
- The exposure for the SPY® System is 35 mW/cm² which is far 1. below the maximum permissible exposure of 327 mW/cm2 established by ANSI for exposure to the skin.
- Use of the SPY System does not cause any thermal damage to 2. the area of interest, even after repeated imaging sequences.
-
- For the heart, there were no changes in electrocardiograms or arterial pressures during and/or following SPY use.
-
- There were no acute or long-term cellular effects of using the SPY System.
-
- There were no acute or long-term renal or hepatic effects of using the SPY System.
-
- The SPY System was able to acquire high quality images of the entire vascular bed on each area of interest.
-
- The SPY System is capable of imaging through the skin to provide a visual assessment of dermal and subdermal blood flow.
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.
K#042961, K#060867, K#071037
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.
K#061871
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
§ 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
1115
510(k) Summary
| Trade Name: | SPY® Fluorescent Imaging System | |
|---|---|---|
| Model Number: | SP2000 | |
| Common Name: | Fluorescent Angiographic System | |
| Classification: | 21 CFR 892.1600 | |
| Product Code: | 90 IZI | NOV 0 9 2007 |
| Classification: | Class II | |
| Manufacturer: | Novadaq Technologies Inc. | |
| 2585 Skymark Avenue | ||
| Suite 306 | ||
| Mississauga, Ontario | ||
| Canada | ||
| L4W 4L5 | ||
| 905.629.3822 ext. 240 | ||
| Contact Name: | Allison Manners | |
| Vice President - Regulatory and Clinical Affairs |
Date 510(k) Summary Prepared: October 31, 2007
Legally Marketed Predicate Devices:
The Novadaq® SPY Fluorescent Imaging System (SPY System) had received FDA 510(k) clearance for market in January 2005 (K#042961), subsequent 510(k) clearances for a labeling change in May 2006 (K#060867) and use of an alternative brand of fluorescent dye in May 2007, pending drug approval (K#071037).
The Leica FL800 had received FDA 510(k) clearance for market in September 2006 (K#061871). The Leica FL800 is intended for use to allow neurosurgeons to view blood flow.
Device Description:
The SPY Imaging System: SP2000 is currently cleared for intraoperative visual assessment of the coronary vasculature and grafts during coronary artery bypass graft (CABG) surgery.
1
K071619
p215
The Novadaq® Technologies SPY® Fluorescent Imaging System consists of 2 components:
- · the SP2000 Imaging Device; and
- = the SPY Paq®
The SPY Pag constitutes a 6 procedure kit. Each SPY Pag contains The Sir I aq constitution a o procours ... " procedures ... " leG and diluent to carry out 6 cardiovascular imaging procedures. Novadaq provides the ICG as it is sold by the manufacturer and does not adulterate the integrity of the original packaging or labeling. IC-Green™ (Akorn, Inc.) is packaged in an IC-Green kit that contains 6 x 25 mg vials of ICG along with 6 x 10 ml ampules of Aqueous Solvent.
The SP2000 Imaging Device
The SP2000 Imaging Device consists of an imaging head containing a charge coupled device (CCD) camera, a laser light source, motion sensor and distance sensor attached via an articulating arm to a mobile cart. The mobile cart contains a flat panel display, computer, electronics enclosure and printer.
The SPY System provides the surgeon with the capability to view record and replay fluorescent images of blood flow in vessels and bypass grafts of the heart. A laser light source is used to illuminate the area of interest. ICG is injected intravenously through the central venous line, bypass pump, cardioplegia line and coronary graft and while it is passing through the vessels, the absorption of laser light causes excitation of the dye followed by emission of infrared energy. The result is a fluorescent image of blood flow and related tissue perfusion in the vessels. A CCD camera captures the image. These images are used to evaluate the integrity of the coronary vasculature and blood flow in the heart and bypass grafts.
There have been no significant changes or modifications made to the SP2000 Imaging device since the original 510(k) clearance in January 2005, premarket notification 510(k) K#042961, or for the 510(k) submitted for a label change for this device, K#060867.
This 510(k) submission describes a proposed change in intended use that does not alter the devices fundamental scientific technology or characteristics in anyway.
2
2071619
p 3/5
Proposed Intended Use of the SPY System:
This premarket notification 510(k) application is being made to revise the indications for use.
In addition to the already cleared indication for use of the SPY® System, the System is also intended to provide fluorescent images for the visual assessment of blood flow in vessels and related tissue perfusion during cardiovascular surgical procedures.
Testing:
Animal studies, human experience and in vitro testing were conducted to support the safe and effective use of the SPY System in its original premarket notification 510(k) application (K#042961).
In Vitro Testing:
Testing of the SPY System was completed in conformance with the following standards. The SPY System successfully met all of the requirements for these standards.
-
- Electrical per IEC 60601-1 and UL2601-1
-
- Electromagnetic Compatibility per IEC 60601-1-2
-
- Light Emitting Laser Products per 21 CFR 1040
-
- Safe Use of Lasers in Health Care Facilities per ANSI Z136.3
-
- American National Standard for Safe Use of Lasers per ANSI Z136.1
In Vivo Testing:
The SPY System is commercially available in the United States of America, Japan, Europe and Canada. To date, the SPY System has been used in over 4000 CABG procedures in humans and there have been no reports of adverse acute or long-term cellular, renal or hepatic effects. Along with the data from intra-operative imaging in CABG surgery, the use of the SPY System in plastic, micro- or reconstructive and other vasular surgery demonstrates the clinical utility of the device in producing bigh quality and resolution images of the entire vascular bed of the point of interest.
The SPY® System was originally cleared by the FDA for use in intraoperative visual assessment of the coronary vasculature and bypass grafts during CABG surgery. During the period that the SPY System has been placed in surgical units, several cardiovascular surgeons have made use of the SPY System for purposes other than the original indication. The present application seeks clearance for this broader range of cardiovascular indications, including but not limited to that already cleared for CABG surgery. Specifically, the SPY System has been used to:
3
- Assess the coronary vasculature and related myocardial perfusion .
- To assess delivery of cardioplegia o
- To assess the impact of procedures involving the aortic valve o and/or ascending aorta on coronary artery function
- o Following heart transplant
- Confirm blood flow through vessels branching off the aorta . following surgical procedures on the descending aorta
- Confirm blood flow through vessels following vascular procedures .
- Carotid endarterectomy o
- Peripheral vascular procedures o
- Assess perfusion of extremities without skin incision .
Examples and the rationale for each of these indications are described in more detail in Section 19 of this traditional 510(k) premarket notification.
Results from the use of the SPY System has been the subject of 12 peer reviewed journal articles, 10 related to its use in cardiac surgery and 2 related to its use in transplantation surgeries, namely kidney and liver Please refer to the bibliography in Section 19 - Clinical for a listing of all relevant journal articles.
The literature reports that the SPY System was able to non-invasively, quickly and safely identify 17 conduits in 311 patients that reguired revision during the surgical procedures. In all cases the lack of patency was visualized clearly by the SPY System using doses of ICG wel below that approved for human use, allowing the surgeon to revise the graft thus decreasing subsequent myocardial infarctions and the morbidity and mortality associated with poor graft patency. Cardiac, renal and he atic function were monitored during use of the SPY System and there were no reported adverse effects.
To support the original premarket notification 510(k) application, the system was used in six pig studies. These studies demonstrated that:
-
- it was possible to acquire high quality images in a simple and reproducible manner using small doses of ICG well below the concentrations approved for human use;
-
- it was possible to perform multiple imaging sequences with no detrimental effects on heart function, coronary flow or peripheral pressure; and
-
- it was possible to acquire images with no increase in myocardial tissue temperature; and
-
- it was possible to visualize all of the coronary beds with high quality images even when the heart was in a vertical position for visualizing posterior arteries.
4