LEICA FL800

K141136 · Leica Biosystems Richmond · IZI · Aug 19, 2014 · Radiology

Device Facts

• Record ID: K141136
• Device Name: LEICA FL800
• Applicant: Leica Biosystems Richmond
• Product Code: IZI · Radiology
• Decision Date: Aug 19, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1600
• Device Class: Class 2

Intended Use

The Leica FL800 is a Leica Surgical Microscope accessory used in viewing intra-operative blood flow in the cerebral vascular area, blood flow of the coronary vascular and 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 for fluorescence video angiography. It uses an excitation light source to induce fluorescence from ICG dye injected into the patient's bloodstream. The system captures near-infrared (NIR) signals via an internal NIR camera, processes the video, and displays the distribution of the dye in blood vessels. Used in ORs by surgeons during cerebral, coronary, and plastic/reconstructive procedures. The device provides real-time visual feedback of blood flow, assisting surgeons in assessing vessel patency and graft integrity. The variant (FL800 ULT) integrates the NIR camera and filters internally within the microscope assembly rather than as an external attachment, improving ergonomics and reducing the risk of external physical disturbance.

Clinical Evidence

Bench testing only. The device was tested in combination with Leica surgical microscopes to ensure no negative impact on safety and effectiveness. Conformance to electrical safety (IEC 60601-1 Edition 3:2005) and electromagnetic compatibility (IEC 60601-1-2 Edition 3:2007) was verified.

Technological Characteristics

Accessory to Leica surgical microscopes; utilizes NIR camera, ICG filters, beam splitters, and beam mirrors. Operates via fluorescence excitation. Integrated into microscope housing (internal configuration). Tested to IEC 60601-1 (Electrical Safety) and IEC 60601-1-2 (EMC).

Indications for Use

Indicated for patients undergoing cerebral vascular surgery, coronary artery bypass (CABG) surgery, or plastic and reconstructive surgery requiring intra-operative visualization of 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)
• Leica FL800 (K080612)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 19, 2014

Leica Biosystems Richmond, Inc. Barbara-Ann Conway-Myers Senior Regulatory Affairs Specialist 5205 Route 12 Richmond, Illinois 60071

Re: K141136

Trade/Device Name: Leica FL800 Regulation Number: 21 CFR 892.1600 Regulatory Name: Angiographic x-ray system Regulatory Class: Class II Product Code: IZI Dated: May 16, 2014 Received: May 21, 2014

Dear Ms. Conway-Myers:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# David Krause -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director

Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

cc: Enclosed

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## Indications for Use

510(k) Number (if known) K141136

Device Name Leica FL800

Indications for Use (Describe)

The Leica FL800 is a Leica Surgical Microscope accessory used in viewing intra-operative blood flow in the cerebral vascular area and bypass grafts during coronary artery bypass (CABG) surgery, as well as blood flow during plastic and reconstructive surgery.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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K141136

Section 5- 510(k) Summary of Safety and Effectiveness

Submitter Leica Biosystems Richmond, Inc 5205 Route 12 Richmond, IL 60071 Barbara-Ann Conway-Myers - Contact Person April 24, 2014 - Date Summary was Prepared

#### Device Name:

- Trade Name Leica FL800 ●
- Common Name - Fluorescent Angiographic System
- Classification Name System, X-Ray, Anqiographic per 21 CFR 892.1600 ●
- FDA Product Code IZI; subsequent product code is EPT (Surgical Microscope and Accessory) ●

## Devices for Which Substantial Equivalence in Claimed:

- Leica Microsystems (Schweiz) AG, Leica FL800 (K061871)
- Leica Microsystems (Schweiz) AG, Leica FL800 (K080612)

## 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 fluorescent agent ICG. The generated fluorescence signal depicts the distribution of the infra-red dye in the patient's blood vessels during the operation (fluorescence video angiography).

## Intended Use of the Device:

The Leica FL800is a Leica Surgical Microscope accessory used in viewing intra-operative blood flow in the cerebral vascular area, blood flow of the coronary vascular and bypass grafts during coronary artery bypass (CABG) surgery, as well as blood flow during plastic and 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 and K080612). Leica Microsystems seeks only to include a variant of the Leica FL800 which is a modification of the existing devices cleared under the two 510(k) mentioned above. There will be no change to the intended use of the device nor the alteration of the device's fundamental scientific technology.

The table below depicts the modifications associated with the Leica FL800 variant.

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Image /page/4/Picture/1 description: The image shows the logo for Leica Biosystems. The word "Leica" is written in a stylized red font. Below the word "Leica" is the word "BIOSYSTEMS" written in a smaller, sans-serif font. The logo is simple and modern.

| | | Proposed Accessory Description | |
|------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|-----------------------------------------------------------------|
| k061871 | K080612 | Leica FL800 | Leica FL800 ULT |
| Standard Leica M520 OH3<br>Microscope (Class I<br>exempt) | Additional Leica Surgical<br>Microscopes available for<br>use with the Leica FL800<br>as a result of extension to<br>indications for use. | Accessory to Leica Surgical Microscopes intended for defined surgeries | |
| Sony XC-E1 50 NIR (near<br>infra-red) camera (part of<br>Leica FL800 upgrade) | No change | External NIR Camera<br>ICG Filter | Dual Video Adaptor<br>consisting of<br>• Internal NIR<br>Camera |
| Leica Dual CCD Surgical<br>Microscope Camera<br>Adapter (part of Leica<br>FL800 upgrade) | No Change | Dual Video Adaptor<br>• Beam Splitter<br>• Beam Mirror | • ICG Filter<br>• Beam Splitter |
| Leica modification of<br>standard 300 Watt Xe light<br>source (part of Leica<br>FL800 upgrade) | Introduced possibility to<br>use 400Watt Xe<br>illumination as supplied on<br>some Leica Surgical<br>Microscopes | Light Source part of the Leica Surgical Microscope | |
| Leica FL800 electronic<br>control unit (part of the<br>FL800 upgrade) | No Change | No Change | No Change |
| ICG Fluorescence Dye<br>(labelled for use with the<br>Leica FL800) | No Change | Not part of the Leica System | |

## Table 1: Comparison of Predicate devices (K061871 and K080612) to the Leica FL800 variant

## Standards Used in Demonstrating Conformance

The Leica FL800 device is an accessory to the Leica surgical microscopes and as an accessory was not individually tested to any recognized standard. However, this accessary was tested in combination with the Leica surgical microscopes to demonstrate that it did not neqatively impact the safety and effectiveness of the Surgical Microscope.

For Electromagnetic Compatibility (EMC) the Leica FL800 ULT has been tested and showed conformance to standard IEC 60601-1-2 Edition 3:2007.

For Electrical Safety the Leica FL800 ULT has been tested and showed conformance to standard IEC 60601-1 Edition 3:2005.

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Image /page/5/Picture/1 description: The image shows the logo for Leica Biosystems. The logo consists of the word "Leica" in a stylized, red font. Below the word "Leica" is the word "BIOSYSTEMS" in a smaller, black font. The logo is simple and modern.

#### Conclusion

The modification of the Leica FL800 (variant) consists of the relocation of this accessory from an external configuration to an internal configuration which services 2 distinct advantages:

- It decreases the likelihood of any external disturbances to the Leica FL800 either by the surgeon . or the operating room staff.
- . The aesthetically pleasing design makes the device more ergonomic which is a value to the surgeon.

There is no alteration to either the intended use or the device's fundamental scientific technology and for this reason, Leica Microsystems seeks a Special 510k for the clearance of this device.