(66 days)
No
The summary describes a fluorescence imaging system accessory for a surgical microscope and does not mention any AI or ML capabilities.
No
The device is a diagnostic accessory that aids in visualizing blood flow through fluorescence video angiography during surgery; it does not directly treat or cure any condition.
Yes
The device is used to visualize blood flow, which helps surgeons assess bypass grafts and blood vessels. This assessment is a form of diagnosis as it provides information about the patient's physiological state to guide surgical decisions.
No
The device description explicitly states it is an "accessory to the Leica surgical microscopes" and "allows the surgical microscope to produce excitation light and resolve fluorescence light". This indicates it is a hardware component that interacts with the microscope, not a standalone software application.
Based on the provided information, the Leica FL800 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for viewing bypass grafts and blood flow during surgery in a living patient. This is an in vivo application, not an in vitro (outside the body) diagnostic test.
- Device Description: The device works by exciting a fluorescent agent in the patient's blood vessels and capturing the resulting fluorescence signal. This is a direct interaction with the patient's body.
- Lack of IVD Characteristics: IVD devices typically involve analyzing samples (blood, urine, tissue, etc.) outside the body to diagnose, monitor, or screen for diseases or conditions. The Leica FL800 does not perform this type of analysis.
The Leica FL800 is a surgical imaging accessory used to visualize physiological processes in vivo during surgery.
N/A
Intended Use / Indications for Use
The Leica FL800 is a surgical microscope accessory used in viewing bypass grafts during coronary artery bypass (CABG) surgery, as well as blood flow during plastic and reconstructive surgery.
Product codes
IZI
Device Description
The Leica FL800 device is an accessory to the Leica surgical microscopes. It allows the surgical microscope to produce excitation light and resolve fluorescence light from the fluorescont agent ICG. The generated fluorescence signal depicts the distribution of the infrared doct in the patient's blood vessels during the operation (fluorescence video angiography),
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
K 080612
Section III - 510(k) Summary of Safety and Effectiveness
Submitter:
Sybron Dental Specialties, Inc. 1717 West Collins Drive Orange, CA 92656 Colleen Boswell - Contact Person
MAY - 9 2008
Date Summary Prepared: Fobruary 2008
Device Name:
- Trade Name - Leica FL800
- Common Name Fluorescent Angiographic System .
- Classification Name System, X-ray, Angiographic per 21 Clik 892.1600 .
Devices for Which Substantial Equivalence is Claimed:
- Leica Microsystems, Inc., Leica FL800 (K061871). .
- Novadaq Technologics, Inc., SPY Imaging System (K071037 and K072222). .
Device Description:
The Leica FL800 device is an accessory to the Leica surgical microscopes. It allows the surgical microscope to produce excitation light and resolve fluorescence light from the fluorescont agent ICG. The generated fluorescence signal depicts the distribution of the infrared doct in the patient's blood vessels during the operation (fluorescence video angiography),
Intended Use of the Device:
The Leica FL800 is a surgical microscopc accessory used in vicwing bypass grafts during coronary artery bypass (CABG) surgery, as well as blood flow during planstianand reconstructive surgery.
Substantial Equivalence:
The Leica FL800 is an existing device which was granted market clearance by the FDA following the submission of a 510(k) pre-market notification (K061871). I cica Microsystems seeks only an extension of use into coronary vascular and bypass surgery, as well as plastic and reconstructive surgery. There will be no change to the device design, function or technical characteristics.
The Leica I'L800 is substantially cquivalent in intended use, indications and lechnical characteristics as the Spy Imaging System.
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Section IV - Substantial Equivalence
The table on the following page compares the Leica FL800 to two (2) other legally marketed Class II devices which were granted marketing clearance by FDA following the submission of a 510(k) pre-market notification. The 510(k) numbers for the predicate devices are the following:
- Leica FL800 510(k) No. K061871 dated September 20, 2006. .
- Spy Imaging System -- 510(k) No. K071037 dated May 10, 2007 and K072222 . dated September 7, 2007.
The Leica FL800 is an existing device which was granted market clearance by the FDA following the submission of a 510(k) pre-market notification. Leica Microsystems seeks only an extension of use into coronary vascular and bypass surgery, as well as plastic and reconstructive surgery.
Representative labeling for the Spy Imaging System to which equivalence is being claimed is also included on the following pages. The Leica FL800 is substantially equivalent in intended use, indications and technical characteristics as the Spy Imaging System.
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Image /page/2/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 its wings spread, along with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular fashion around the eagle. The logo is in black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Leica Microsystems (Schweiz) AG % Sybron Dental Specialties, Inc. Ms. Colleen Boswell Regulatory Affairs 1717 W. Collins Avenue Orange, California 92867
Re: K080612
Trade/Device Name: Leica FL800 Regulation Number: 21 CFR 892.1600 Regulation Name: Angiographic x-ray system Regulatory Class: II Product Code: IZI Dated: February 22, 2008 Received: March 4, 2008
Dear Ms. Boswell:
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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
MAY - 9 2008
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.
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
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Page 2 - Ms. Collecn Boswell
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. 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,
Mark M. Mellersen
Mark N. Melkerson Director Division of General, Restorative and Neurological 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 080612
Device Name: Leica FL800
Indications for Use:
The Leica FL800 is a surgical microscope accessory used in viewing bypass grafts during coronary artery bypass (CABG) surgery, as well as blood flow during plastic and reconstructive surgery.
Prescription Use
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW TIIIS LINE - CONTINUE ON ANOTHER PAGE II NEEDED)
Concurrence of CDRII, Office of Device Evaluation (ODL)
Neil RE Olen for nxm
(Division Sign-Off Division of General, Restorative, and Neurological Devices
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(080612 510(k) Number_________________________________________________________________________________________________________________________________________________________________
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