LEICA FL800

K080612 · Leica Microsystems (Schweiz) AG · IZI · May 9, 2008 · Radiology

Device Facts

• Record ID: K080612
• Device Name: LEICA FL800
• Applicant: Leica Microsystems (Schweiz) AG
• Product Code: IZI · Radiology
• Decision Date: May 9, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1600
• Device Class: Class 2

Intended 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.

Device Story

Leica FL800 is a surgical microscope accessory; functions as a fluorescent angiographic system. Device produces excitation light to resolve fluorescence from ICG (indocyanine green) agent injected into patient blood vessels. Fluorescence signal depicts blood vessel distribution during surgery. Used in OR by surgeons during CABG, plastic, and reconstructive procedures. Provides real-time visual feedback of blood flow/graft patency; assists surgeons in intraoperative decision-making; potentially improves surgical outcomes by confirming vascular perfusion.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and technological characteristics identical to the predicate device.

Technological Characteristics

Accessory to surgical microscopes; utilizes excitation light source and fluorescence detection for ICG imaging. Standalone optical system integrated with surgical microscope. No changes to design or technical specifications from predicate.

Indications for Use

Indicated for patients undergoing coronary artery bypass (CABG) surgery for viewing bypass grafts, and patients undergoing plastic and reconstructive surgery for viewing blood flow.

Regulatory Classification

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.

Predicate Devices

• Leica FL800 (K061871)
• SPY Imaging System (K071037)
• SPY Imaging System (K072222)

Submission Summary (Full Text)

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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 [phone]. 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 [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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,

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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