(28 days)
Not Found
No
The summary does not mention AI, ML, or any related terms, nor does it describe any features or performance metrics typically associated with AI/ML-powered devices.
No.
The device is used for visual assessment during surgery, which is a diagnostic or imaging function, not a therapeutic intervention.
Yes
The device is used for "intraoperative visual assessment of the coronary vasculature and bypass grafts," which involves evaluating the current state of these structures to inform surgical decisions, fitting the definition of a diagnostic device.
No
The device description explicitly states it consists of two components: the SPY Imaging Device and the SPY Paq®, indicating hardware components are involved.
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 outside of the body ("in vitro").
- Device Function: The description clearly states the device is used for "intraoperative visual assessment of the coronary vasculature and bypass grafts during coronary artery bypass (CABG) surgery." This involves imaging the structures within the patient's body during surgery.
- Input Modality: The input modality is a "Fluorescent Angiographic System," which is an imaging technique performed on the living patient.
- Anatomical Site: The anatomical site is the "coronary vasculature and bypass grafts," which are internal structures.
The device is an in vivo imaging system used during surgery, not a test performed on a sample outside the body.
N/A
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
90 IZI
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.
The Novadaq Technologies SPY Intra-operative Imaging System consists of 2 components:
- · the SPY Imaging Device; and
- = the SPY Paq®
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary vasculature and bypass grafts
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
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
8071037
510(k) Summary
| Trade Name: | SPY® Intra-operative Imaging System | |
|---|---|---|
| Model Number: | SP2000 | MAY 10 200 |
| Common Name: | Fluorescent Angiographic System | |
| Classification: | 21 CFR 892.1600 | |
| Product Code: | 90 IZI | |
| 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: April 9, 2007
Legally Marketed Predicate Devices:
The Novadaq SPY Imaging System had received FDA 510(k) clearance for market in January 2005 (K042961) and subsequently received 510(k) clearance for a labeling change in May 2006 (K060867).
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.
The Novadaq Technologies SPY Intra-operative Imaging System consists of 2 components:
- · the SPY Imaging Device; and
- = the SPY Paq®
1
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 0 2007
Ms. Allison Manners Vice President, Regulatory and Clinical Affairs Novadaq Technologies Inc. 2585 Skymark Avenue Suite 306 Mississauga, Ontario Canada L4W 4L5
Re: K071037
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: April 11, 2007 Received: April 12, 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). You may not market this device, however, until such time as the new drug application for the drug indocyanine green manufactured by PULSION® Medical Systems is approved for human use by The Center for Drug Evaluation and Research, FDA. When the device is marketed, it will be subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (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.
However, you are responsible to determine that the medical devices you use as components in the SPY® Intraoperative Imaging System have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the Act), or were on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments.
Image /page/1/Picture/10 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name encircling a symbol composed of four stylized human profiles facing right. The profiles are stacked vertically, with the top profile being the largest and each subsequent profile decreasing in size. The overall design is simple and conveys a sense of unity and service.
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Page 2 – Ms. Allison Manners
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations,
Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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 510(k) premarket notification subject to approval of the indocyanine green manufactured by PULSION® Medical Systems. 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (800) 638-2041 or (240) 276-3150,
or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Blommer for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known):
SPY® Intra-operative Imaging System: SP2000 Device Name:
Indications for Use:
For use in intraoperative visual assessment of the coronary vasculature and bypass grafts during coronary artery bypass (CABG) surgery.
Prescription 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)
Blammima
Division of Cardio 510ik) Nu
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