SPY INTRAOPERATIVE IMAGING SYSTEM

• K Number: K060867
• Device Name: SPY INTRAOPERATIVE IMAGING SYSTEM
• Manufacturer: NOVADAQ TECHNOLOGIES, INC.
• Date Cleared: 2006-05-03 ( 34 days)
• Product Code: IZI
• Regulation Number: 892.1600

Intended Use

For use in intraoperative visual assessment of the coronary vasculature and bypass grafts during coronary artery bypass (CABG) surgery.

Device Description

The SPY Intraoperative Imaging System: SP2000 is indicated for use for intra-operative visual assessment of the coronary vasculature and grafts during CABG surgery. The SPY System provides the surgeon with the capability to view record and replay fluorescent images of blood vessels and bypass grafts of the A laser light source is used to illuminate the heart surface. heart. Indocyanine Green (ICG) is injected intravenously through the central venous line, bypass pump or cardioplegia line and, while coursing through the coronary arteries and grafts, the absorption of laser light causes excitation of the dye followed by emission of infrared energy. The result is a fluorescent image of the coronary vasculature. A CCD camera captures the image. These images are used to evaluate the integrity of the coronary vasculature and bypass grafts.

Predicate Devices

K042961

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the optical imaging technology and does not mention any AI or ML components. There are no mentions of image processing, AI, DNN, or ML, nor are there descriptions of training or test sets typically associated with AI/ML development.

Therapeutic

No.
The device is used for visual assessment and imaging during surgery, not for treating a disease or condition.

Diagnostic

Yes

The device is used for "intraoperative visual assessment of the coronary vasculature and bypass grafts" and "to evaluate the integrity of the coronary vasculature and bypass grafts," which are diagnostic activities.

SaMD (Software as a Medical Device)

No

The device description explicitly mentions hardware components like a laser light source and a CCD camera, and the performance studies include testing related to electrical, electromagnetic, and laser standards, indicating it is a hardware-based system with associated software.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
• Device Function: The SPY Intraoperative Imaging System: SP2000 is used for intraoperative visual assessment of the coronary vasculature and bypass grafts directly within the patient's body during surgery. It uses a fluorescent dye and imaging system to visualize blood flow in real-time.
• No Specimen Collection/Examination: The device does not involve the collection or examination of specimens taken from the body. It is used to image structures within the body.

Therefore, based on the provided information and the definition of an IVD, this device falls outside the scope of In Vitro Diagnostics. It is an imaging system used for direct visualization during a surgical procedure.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

For use in intraoperative visual assessment of the coronary vasculature and bypass grafts during coronary artery bypass (CABG) surgery.

Product codes (comma separated list FDA assigned to the subject device)

IZI

Device Description

The SPY System provides the surgeon with the capability to view record and replay fluorescent images of blood vessels and bypass grafts of the heart. A laser light source is used to illuminate the heart surface. Indocyanine Green (ICG) is injected intravenously through the central venous line, bypass pump or cardioplegia line and, while coursing through the coronary arteries and grafts, the absorption of laser light causes excitation of the dye followed by emission of infrared energy. The result is a fluorescent image of the coronary vasculature. A CCD camera captures the image. These images are used to evaluate the integrity of the coronary vasculature and bypass grafts.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Fluorescent

Anatomical Site

coronary vasculature and grafts/heart

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Surgeon, intraoperative

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)

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.

1. Electrical per IEC 60601-1 and UL2601-1
2. Electromagnetic Compatibility per IEC 60601-1-2
3. Light Emitting Laser Products per 21 CFR 1040
4. Safe Use of Lasers in Health Care Facilities per ANSI Z136.3
5. American National Standard for Safe Use of Lasers per ANSI Z136.1

In Vivo Testina:
Animal studies and human experience in 1485 CABG procedures, as of February 2006, were completed to demonstrate safety and effectiveness.

1. The exposure for the SPY System is 35 mWcm2 which is far below the MPE of 327 mW/cm2 established by ANSI for exposure to the skin.
2. Use of the SPY System does not cause any thermal damage to the heart tissue.
3. There were no changes to the electrocardiograms or arterial pressures during and following SPY use.
4. There were no acute or long-term cellular effects of using the SPY System.
5. There were no acute or long-term renal or hepatic effects of using the SPY System.
6. The SPY System was able to acquire excellent images of the entire vascular bed on each aspect of the heart.

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.

K042961

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

0

510(k) Summary

CONFIDENTIAL

3 2006 MAY

Common Name: Fluorescent Angiographic System

Classification: 21 CFR 892.1600

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

Legally Marketed Predicate Devices:

The Novadaq SPY® Intraoperative Imaging System had received FDA 510(k) clearance in January 2005 (#K042961).

Device Description:

The SPY Intraoperative Imaging System: SP2000 is indicated for use for intra-operative visual assessment of the coronary vasculature and grafts during CABG surgery.

The SPY System provides the surgeon with the capability to view record and replay fluorescent images of blood vessels and bypass grafts of the A laser light source is used to illuminate the heart surface. heart. Indocyanine Green (ICG) is injected intravenously through the central venous line, bypass pump or cardioplegia line and, while coursing through the coronary arteries and grafts, the absorption of laser light causes excitation of the dye followed by emission of infrared energy. The result is a fluorescent image of the coronary vasculature. A CCD camera captures the image. These images are used to evaluate the integrity of the coronary vasculature and bypass grafts.

No changes or modifications have been made to the device since the 510(k) clearance of this device, #K042961. This 510(k) submission entails a labeling revision that does not alter the device's intended use or alter the devices fundamental scientific technology.

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Animal studies, human experience and in vitro testing were conducted to support the safe and effective use of the SPY® System.

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.

• 1. Electrical per IEC 60601-1 and UL2601-1
• 2. Electromagnetic Compatibility per IEC 60601-1-2
• 3. Light Emitting Laser Products per 21 CFR 1040
• 4. Safe Use of Lasers in Health Care Facilities per ANSI Z136.3
• 5. American National Standard for Safe Use of Lasers per ANSI Z136.1

In Vivo Testina:

Animal studies and human experience in 1485 CABG procedures, as of February 2006, were completed to demonstrate safety and effectiveness.

• 1. The exposure for the SPY System is 35 mWcm2 which is far below the MPE of 327 mW/cm2 established by ANSI for exposure to the skin.
• 2. Use of the SPY System does not cause any thermal damage to the heart tissue.
• 3. There were no changes to the electrocardiograms or arterial pressures during and following SPY use.
• 4. There were no acute or long-term cellular effects of using the SPY System.
• 5. There were no acute or long-term renal or hepatic effects of using the SPY System.
• 6. The SPY System was able to acquire excellent images of the entire vascular bed on each aspect of the heart.

Conclusions:

The above testing demonstrates that the SPY Intra-operative Imaging System is safe and effective in imaging the coronary vasculature and bypass grafts intra-operatively and is equivalent to the predicate devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

3 2006 MAY

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

Re: K060867

Trade Name: SPY® Intraoperative Imaging System Regulation Number: 21 CFR 892.1600 Regulation Name: Angiographic X-Ray System Regulatory Class: Class II (two) Product Code: IZI Dated: March 29, 2006 Received: March 30, 2005

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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Page 2 – Ms. Allison Manners

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 (QS) 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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Afummar for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

K_060867

Device Name:

SPY® Intra-operative Imaging System: SP2000

Indications for Use:

ﻪ « « « « « « «

For use in intraoperative visual assessment of the coronary vasculature and bypass grafts during coronary artery bypass (CABG) surgery.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use_ (21 CFR 801 Subpart C)

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

Concurrence of CDRH. Office of Device Evaluation (ODE)

Blumuma

n Sign-C

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