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 perfusion, and related tissuetransfer circulation in tissue and free flaps used in plastic, micro- and reconstructive surgical procedures.

Device Description

The SPY Fluorescent Imaging System used in plastic, micro, and reconstructive surgery indication consists of 2 components: the SP2001 Imaging Device and the SPY Paq. The SP2001 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, a computer with keyboard and optical mouse, an electronics enclosure, and a printer. The SPY System provides the surgeon with the capability to view, record, and replay fluorescent images of blood flow in vessels and organs. A laser light source is used to illuminate the area of interest. In order to obtain the images, ICG is injected intravenously through the central or peripheral venous line. While the ICG is passing through the vessels, the absorption of laser light causes excitation of the ICG dye, followed by the emission of infrared energy. A CCD camera of the SP2000 Imaging Device captures the infrared emission, resulting in a fluorescent image of blood flow and related tissue perfusion. These images are used to evaluate the integrity of native and grafted vasculature and blood flow in the organs. The SP2001 Imaging Device represents minor modifications of the SP2000 Imaging Device: The maximum recording time for image sequences captured has been extended to 60 seconds from the 34 seconds of the SP2000 Imaging Device. An ability to move the SP2001 camera head in horizontal plane during image sequence acquisition has been implemented. A variable Laser Power Attenuator has been added to the device to permit laser illumination at power levels lower or equal to the laser power level of the SP2000 Imaging Device. New HELIOS software has been developed to support the SPY System in its plastic, micro-, and reconstructive surgery indication.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the SPY® Fluorescent Imaging System (SP2001 Imaging Device) based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

It's important to note that this 510(k) submission (K073088) is for a device modification (SP2001) of an already cleared device (SP2000). The primary focus of the testing described is to demonstrate that the modifications do not introduce any new safety concerns and that the modified device remains substantially equivalent to its predicate device, while enhancing functionality for plastic, micro-, and reconstructive surgery. Therefore, the "acceptance criteria" are generally related to safety and the ability to produce high-quality images as demonstrated by previous studies and the current assessment of the modifications.

Acceptance Criteria (Inferred from testing and safety claims)	Reported Device Performance
Safety - Electrical, EMC, Laser Standards Compliance: Device must conform to relevant safety standards.	The SPY System "successfully met all of the requirements for these standards" (IEC 60601-1, UL2601-1, IEC 60601-1-2, 21 CFR 1040, ANSI Z136.3, ANSI Z136.1).
Safety - Thermal Damage (Human): Use of the SPY System and its modifications should not cause thermal damage to the area of interest, even after repeated imaging sequences.	"Use of the SPY® System does not cause any thermal damage to the area of interest, even after repeated imaging sequences." This is supported by pig studies showing no increase in myocardial tissue temperature and the calculated exposure for SP2001 (31.2 mW/cm2) being well below the maximum permissible exposure (MPE) of 326 mW/cm2 established by ANSI for skin exposure. The extended recording time (60 seconds) does not affect the MPE value.
Safety - Physiological Effects (Human): No adverse acute or long-term cellular, renal, hepatic, or cardiovascular effects (e.g., changes in ECGs, arterial pressures) from device use.	"The SPY System has been used in over 7000 vascular procedures in humans and there have been no reports of adverse acute or long-term cellular, renal or hepatic effects." Additionally, for the heart, "there were no changes in electrocardiograms or arterial pressures during and/or following the use of SPY System." Pig studies supported these findings: "It was possible to perform multiple imaging sequences with no detrimental effects on heart function, coronary flow or peripheral pressure." and "There were no acute or long-term cellular effects of using the SPY System." and "There were no acute or long-term renal or hepatic effects of using the SPY System."
Image Quality & Resolution (Human): The device should produce high-quality and resolution images of the entire vascular bed of the area of interest, including the ability to visualize blood flow, tissue perfusion, and related tissue-transfer circulation. The SP2001 enhancements should support this for larger/extended areas (e.g., flaps).	"The data from intra-operative imaging in CABG, cardiovascular, as well as in plastic, micro-, reconstructive surgery demonstrated the clinical utility of the device in producing high quality and resolution images of the entire vascular bed of the area of interest." The ability to move the camera head horizontally and extended recording time in SP2001 implicitly support imaging larger/extended areas to view the entire cycle of blood flow. Pig studies showed: "The SPY System was able to acquire high quality images of the entire vascular bed on each area of interest." 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." and "The SPY System is capable of imaging through the skin to provide a visual assessment of dermal and subdermal blood flow."
Clinical Utility/Effectiveness (Human): The system should provide useful clinical information, such as identifying the need for graft revision (in CABG as an example of previous indications and general utility).	"The literature reports that the SPY System was able to non-invasively, quickly and safely identify 17 conduits in 311 patients that required revision during the surgical procedures. In all cases the lack of patency was visualized clearly by the SPY System..." This is from prior clearances but supports the general clinical utility of the SPY system design.
Functional Enhancements (SP2001): The modifications (e.g., extended recording time, horizontal camera movement, variable laser power, new software) should provide increased functionality without compromising safety or effectiveness.	"The modifications of the SP2000 Imaging Device were introduced to provide the end users the increased functionality for using the SPY System in the plastic, micro-, and reconstructive surgery." The submission states "the modifications do not introduce any additional or new concerns regarding the safety and use of the device." The HELIOS™ software is described as concentrating on a suitable interface and not altering how the device is used, implying it maintains the previous functionality and safety.

2. Sample Sizes Used for the Test Set and Data Provenance

Since this filing is primarily about a modification to an already cleared device and relies heavily on previously submitted data and widespread clinical use, there isn't a single "test set" in the traditional sense for this specific 510(k). The data provenance is a combination:

Human Clinical Experience:
- Sample Size: Over 7000 vascular procedures (cumulative across all indications for prior clearances).
- Data Provenance: Commercially available in the United States, Japan, Europe, and Canada. This indicates both prospective and retrospective data collection over time in a real-world clinical setting.
- Specific Example from Literature Review: 311 patients where 17 conduits required revision. This is from published peer-reviewed articles.
Animal Studies (for original 510(k) and foundational safety):
- Sample Size: Six pig studies.
- Data Provenance: Not specified, but likely conducted by the manufacturer or research partners. These were "to support the original traditional 510(k) premarket notification" (K042961).
In Vitro Testing: Not applicable to "test set" in this context, but refers to laboratory testing for standards compliance (electrical, EMC, laser).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The concept of a formalized "ground truth" derived from a specific number of experts for a single test set, as might be common in AI/algorithm validation, is not explicitly detailed in this 510(k) for the SP2001 device modification.

Human Clinical Experience: The "ground truth" arises from the clinical outcomes and the surgical decisions made by operating surgeons based on the visual assessment provided by the SPY System. For instance, in the 311 patients where 17 conduits required revision, the surgeon's decision to revise implicitly serves as an "expert ground truth" that the device correctly informed. The "experts" are the surgeons using the device. Their qualifications are not specified beyond being "surgeons" performing vascular, plastic, micro-, and reconstructive procedures.
Animal Studies: The "ground truth" would have been established by direct observation and physiological measurements in the pig studies (e.g., no detrimental effects on heart function, coronary flow, myocardial tissue temperature). The experts would be the researchers and veterinarians conducting those studies.

4. Adjudication Method for the Test Set

Again, given the nature of a device modification relying on existing clinical experience, a formal adjudication method (like 2+1 or 3+1 used in AI studies) for a dedicated "test set" is not described.

Clinical Use: Clinical decisions in surgery are inherently "adjudicated" by the practicing surgeon's judgment and experience, often incorporating other diagnostic information, physical examination, and surgical observation, not solely the device output. The device is described as an "adjunctive method."
Literature Reports: The reported clinical utility from peer-reviewed articles would reflect consensus findings within the broader medical community, implying a form of expert review and publication acceptance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study that specifically measures the effect size of human readers improving with this device (SP2001) vs. without AI assistance is not explicitly mentioned or described in this 510(k) summary.

The SPY System is an imaging device that provides visual information to the surgeon, not an AI-driven diagnostic algorithm that provides interpretation or assistance in the way modern AI tools do. Its improvements are primarily in extending the visual capabilities (longer recording, wider field of view) for the human user.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

No, a standalone performance study in the context of an algorithm or AI is not applicable or described. The SPY® Fluorescent Imaging System is an imaging tool designed for human-in-the-loop visual assessment. It captures images; it does not interpret them standalone.

7. The Type of Ground Truth Used

The ground truth used is predominantly a combination of:

Clinical Outcomes/Surgical Decision-Making: For humans, the ultimate "ground truth" for assessing tissue perfusion and blood flow is whether the surgical procedure is successful, whether revisions are needed, and the subsequent patient outcomes. Decisions made by surgeons based on the images are a direct form of clinical ground truth about the physiological state.
Physiological Measurements/Direct Observation (Animal Studies): In the pig studies, the ground truth was established by direct physiological measurements and observations of heart function, coronary flow, myocardial temperature, etc.
Pathology/Histology/Outcomes Data: While not explicitly stated for every case, the implications of successful graft revisions (reducing myocardial infarctions, morbidity, mortality) suggest that long-term outcomes and potentially pathological findings (e.g., if a graft failed) would serve as ultimate ground truth checks.

8. The Sample Size for the Training Set

No training set is mentioned as this device is not an AI/ML algorithm requiring a training set. It is a hardware and software system for image acquisition and display.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for an AI/ML algorithm.

Summary

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510(k) Summary

K073088

Trade Name:	SPY® Fluorescent Imaging System
Device Model Number:	SP2001
Common Name:	Fluorescent Angiographic System
Classification:	21 CFR 892.1600
Product Code:	90 IZI
Classification:	Class II
Manufacturer:	Novadaq Technologies Inc.2585 Skymark AvenueSuite 306Mississauga, OntarioCanadaL4W 4L5905.629.3822 ext. 240
Contact Name:	Allison MannersVice President, Regulatory and Clinical Affairs

Date 510(k) Summary Prepared: October 29, 2007

Legally Marketed Predicate Devices:

The Novadaq® SPY Fluorescent Imaging System (SPY System) with the SP2000 Imaging Device had received initial FDA 510(k) clearance for market use during coronary artery bypass graft (CABG) surgery in January 2005 (K042961). Subsequent 510(k) clearance was obtained in May 2006 (K060867) for a labeling change, followed by a clearance for use in plastic, micro- and reconstructive surgery in January 2007 (K063345), and a clearance for use of an alternative brand of fluorescent ICG agent in coronary artery bypass surgery in May 2007 (K071037), as well as in the plastic, micro-, and reconstructive surgery in September 2007 (K072222), pending drug approval.

The Leica FL800 had received FDA 510(k) clearance for market in September 2006 (K061871). The Leica FL800 is intended for use to allow neurosurgeons to view blood flow.

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Device Description:

The SPY Fluorescent Imaging System is currently cleared for use:

For intra-operative visual assessment of the coronary vasculature . and bypass grafts during CABG surgery.
. As 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 in tissue and free flaps used in plastic, microand reconstructive surgical procedures.

In addition to these cleared indications for use, a traditional 510(k) submission is currently under review (K071619) at the FDA with expected default clearance date of October 31, 2007. That submission revises the indication for use in CABG surgery, and seeks clearance for the use of SPY System to provide fluorescent images for the visual assessment of blood flow in vessels and related tissue perfusion during cardiovascular surgical procedures.

The Novadaq® Technologies SPY® Fluorescent Imaging System used in plastic, micro, and reconstructive surgery indication consists of 2 components:

· the SP2001 Imaging Device
· the SPY Paq®

The SPY Paqs are available in 2 configurations dependent on the intended indication for use'. Each SPY Pag contains sufficient number of ICG, custom sterile drapes called Novadrape®, and diluent for 6 imaging procedures. Each configuration of SPY Paq has a unique part number assigned to it, and different Instructions for Use exist for the two types of SPY Pags. The different Instructions for Use also have unique part numbers for ease of assembly of the Pags and guidance for the end user.

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

1 Novadaq provides 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 a kit that contains 6 x 25 mg vials of ICG and 6 diluents used to dissolve the ICG. Two IC-Green kits constitute a 6 procedure SPY Paq for the plastic, micro-, and reconstructive surgery indication, with two vials of ICG and two diluents being used in imaging throughout a surgical procedure. Two vials of ICG are required for each imaging procedure to secure a sufficient amount of ICG necessary for the recommended number and volumes of injections. Additionally, IC-Green solution has to be used within 6 hours from reconstitution, and the duration of complex plastic, micro-, and reconstructive surgical procedures often exceeds 6 hours. This results in the separation between the initial and final sets of injections exceeding 6 hours, necessitating reconstitution of a second IC-Green vial.

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a flat panel display, a computer with keyboard and optical mouse, an electronics enclosure, and a printer.

The SPY® System provides the surgeon with the capability to view, record, and replay fluorescent images of blood flow in vessels and organs. A laser light source is used to illuminate the area of interest. In order to obtain the images, ICG is injected intravenously through the central or peripheral venous line. bypass pump, cardioplegia line, or down a coronary graft. While the ICG is passing through the vessels, the absorption of laser light causes excitation of the ICG dye, followed by the emission of infrared energy. A CCD camera of the SP2000 Imaging Device captures the infrared emission, resulting in a fluorescent image of blood flow and related tissue perfusion. These images are used to evaluate the integrity of native and grafted vasculature and blood flow in the organs.

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) K042961, the 510(k) premarket notification K060867 submitted for a label change for this device, the 510(k) clearance K063345 for use in the plastic, micro- and reconstructive surgery, and the clearances K071037 and K072222 for use of an alternative brand of fluorescent dye - ICG PULSION® in May 2007 and September 2007, pending drug approval.

The SP2001 Imaging Device

The SP2001 Imaging Device represents minor modifications of the SP2000 Imaging Device:

· The maximum recording time for image sequences captured has been extended to 60 seconds from the 34 seconds of the SP2000 Imaging Device. This modification has been carried out to permit the users to observe the entire cycle of blood flow in the area of interest under imaging; namely the arterial inflow, the perfusion, and the venous outflow.
An ability to move the SP2001 camera head in horizontal plane during . image sequence acquisition has been implemented. This modification has been carried out to permit the users to image the area larger than the 7.6 cm x 7.6 cm which is imaged by a stationary camera of the SP2000 Imaging Device. This feature is very desirable, given that a flap can be large or extended.
A variable Laser Power Attenuator has been added to the device to permit . laser illumination at power levels lower or equal to the laser power level of the SP2000 Imaging Device. This modification has been carried out to permit the SP2001 operators to lower laser intensity, in case the signal from the area of interest would be saturating the sensitivity of the camera.
New HELIOS ™ software has been developed to support the SPY System . in its plastic, micro-, and reconstructive surgery indication. The structure and workflow of the HELIOS software is based on the cleared DaqPac

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software. The HELIOS software concentrated on the providing the user with the most suitable interface and it did not alter the wav that the device is used.

The modifications of the SP2000 Imaging Device were introduced to provide the end users the increased functionality for using the SPY System in the plastic, micro-, and reconstructive surgery.

It is demonstrated in Section 10 - Device Description that the modifications do not introduce any additional or new concerns regarding the safety and use of the device.

SPY® Systems intended for use solely in cardiovascular surgery utilize the SP2000 Imaging Device. SPY Systems intended for use in the plastic, micro-, and reconstructive surgery utilize the SP2001 Imaging Device.

Proposed Intended Use of the SPY Svstem:

This premarket 510(k) notification is being made to obtain clearance for the device modification.

The currently cleared and proposed indications for use in CABG and cardiovascular surgery, as well as in plastic, micro-, and reconstructive surgery, and cardiovascular surgery are not being amended in any way with this submission.

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 (K042961),

The information contained within this Traditional premarket notification 510(k) demonstrates the utility of the SPY System in plastic, micro-, and reconstructive surgery. This information has been previously submitted together with the cleared 510(k) notifications K063345 and K072222.

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.

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1. Electrical per IEC 60601-1 and UL2601-1
1. Electromagnetic Compatibility per IEC 60601-1-2
1. Light Emitting Laser Products per 21 CFR 1040
1. Safe Use of Lasers in Health Care Facilities per ANSI Z136.3
1. 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 7000 vascular procedures in humans and there have been no reports of adverse acute or long-term cellular, renal or hepatic effects. The data from intra-operative imaging in CABG, cardiovascular, as well as in plastic, micro-, reconstructive surgery demonstrated the clinical utility of the device in producing high quality and resolution images of the entire vascular bed of the area of interest.

Results from the use of the SPY System has been the subject of 15 peer reviewed journal articles, 13 related to its use in cardiac surgery and 2 related to its use in transplantation kidney and liver surgeries. 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 required revision during the surgical procedures. In all cases the lack of patency was visualized clearly by the SPY System using doses of ICG well below the maximum dose approved for human use. It allowed the surgeon to revise the graft, decreasing subsequent myocardial infarctions and the morbidity and mortality associated with poor graft patency. Cardiac, renal and hepatic functions were monitored during use of the SPY System and there were no reported adverse effects.

To support the original traditional 510(k) premarket notification, the system was used in six pig studies. These studies demonstrated that:

1. 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.
1. It was possible to perform multiple imaging sequences with no detrimental effects on heart function, coronary flow or peripheral pressure.
1. It was possible to acquire images with no increase in myocardial tissue temperature.
1. 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.

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Therefore, in totality, the in vivo evidence shows that:

The exposure for the SP2001 Imaging Device at the imaging 1. distance of 30 cm is 31.2 mW/cm2 which is far below the maximum permissible exposure (MPE) of 326 mW/cm2 established by ANSI for exposure to the skin. The exposure remains below the MPE value as long as the camera head of SP2001 is not advanced closer than 5 cm from the region of interest imaged. The extension of the recording time to 60 seconds does not affect the MPE value.
Use of the SPY® System does not cause any thermal damage to 2. the area of interest, even after repeated imaging sequences.
ന് For the heart, there were no changes in electrocardiograms or arterial pressures during and/or following the use of SPY System.
ব There were no acute or long-term cellular effects of using the SPY System.
1. There were no acute or long-term renal or hepatic effects of using the SPY System.
റ. The SPY System was able to acquire high quality images of the entire vascular bed on each area of interest.
1. The SPY System is capable of imaging through the skin to provide a visual assessment of dermal and subdermal blood flow.

Conclusions:

The documentation provided in this Traditional 510(k) Notification demonstrates that the SP2001 modification of the SP2000 Imaging Device component SPY Fluorescent Imaging System results in a device equivalent to predicate devices. The SPY System including the SP2001 Imaging Device can be 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 in tissue and free flaps used in plastic, micro- and reconstructive surgical procedures.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Public Health Service

JAN 10 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Allison Manners Vice President, Regulatory and Clinical Affairs Novadaq Technologies, Inc. 2585 Skymark Avenue, Suite 306 Mississauga, Ontario, L4W 4L5 CANADA

Re: K073088

Trade/Device Name: SPY® Fluorescent Imaging System: SP2001 Imaging Device Regulation Number: 21 CFR 892.1600 Regulation Name: Angiographic x-ray system Regulatory Class: II Product Code: IZI Dated: October 30, 2007 Received: November 1, 2007

Dear Ms. Manners:

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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510/k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Nancy C Brogdon

Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known): KOJ3088

Device Name:

SPY® Fluorescent Imaging System: SP2001 Imaging Device

Indications for Use:

Prescription Use _____________________________________________________________________________________________________________________________________________________________

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Arnal M. White

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 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.