Leica FL560

K170239 · Leica Microsystems (Schweiz) AG · IZI · Jul 5, 2017 · Radiology

Device Facts

• Record ID: K170239
• Device Name: Leica FL560
• Applicant: Leica Microsystems (Schweiz) AG
• Product Code: IZI · Radiology
• Decision Date: Jul 5, 2017
• Decision: SEKD
• Submission Type: Traditional
• Regulation: 21 CFR 892.1600
• Device Class: Class 2

Intended Use

The Leica FL560 is a surgical microscope accessory used in viewing fluorescence of fluorophores with an excitation peak between ~460 nm and ~500 nm (blue) and the fluorescence emission comprising the green, yellow and red spectrum in a spectral band above ~510 nm.

Device Story

Leica FL560 is a surgical microscope accessory for visualizing intra-operative blood flow in cerebral vascular surgery. It attaches to Leica surgical operating microscopes (SOM). The device uses the SOM's standard illumination light source to produce excitation light (460-500nm). An observation filter in the optics carrier enables visualization of fluorescence emission (>510nm) from a fluorophore (Fluorescein Sodium). Used in the OR by neurosurgeons and OR staff. The surgeon views the fluorescence through the microscope eyepieces to assess blood flow and vessel architecture. This real-time visualization aids in surgical decision-making, such as confirming vessel patency or identifying occlusions, potentially improving patient outcomes during neurosurgical procedures.

Clinical Evidence

No human clinical data. Evidence includes bench testing (optical/mechanical verification) and a prospective preclinical porcine study (n=18 comparative reviews). The porcine study compared the subject device (using Fluorescein Sodium) to the predicate (using ICG) for visualizing cerebrovascular blood flow. Results showed 100% confirmation of functional equivalence in visualizing blood flow and vessel architecture, with the subject device additionally enabling concurrent visualization of background anatomical structures.

Technological Characteristics

Accessory to Leica surgical operating microscopes. Materials: anodized aluminum (external). Principle: fluorescence excitation (460-500nm) and emission observation (>510nm). Energy: Xenon 400W light source. Connectivity: None (optical accessory). Sterilization: Not applicable (non-patient contacting).

Indications for Use

Indicated for viewing intra-operative blood flow in the cerebral vascular area.

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 ULT (K141136)
• Leica FL800 (K061871)
• Leica FL800 (K080612)

Reference Devices

• CIS EyeScan Portable Modular Imaging System (K092374)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

July 5, 2017

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

Leica Microsystems (Schweiz) AG Ms. Grainne Griffin Senior RA Specialist Max Schmidheiny-Strasse 201 Heerbrugg, Sankt Gallen, Switzerland 9435 CH

Re: K170239

Trade/Device Name: Leica FL560 Regulation Number: 21 CFR 892.1600 Regulation Name: Angiographic X-Ray System Regulatory Class: Class II Product Code: IZI Dated: June 5, 2017 Received: June 5, 2017

Dear Ms. Griffin:

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. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. 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

{1}------------------------------------------------

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 devicerelated adverse events) (21 CFR 803); 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.

In addition, we have determined that your device kit contains Sodium Fluorescein which is subject to regulation as a drug.

Our substantially equivalent determination does not apply to the drug component of your device. We recommend you first contact the Center for Drug Evaluation and Research before marketing your device with the drug component. For information on applicable Agency requirements for marketing this drug, we suggest you contact:

Director, Division of Drug Labeling Compliance Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, Maryland 20857 [phone]

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 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

{2}------------------------------------------------

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,

# Michael J. Hoffmann -S

for

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

#### Indications for Use

510(k) Number (if known) K170239

Device Name Leica FL560

Indications for Use (Describe)

The Leica FL560 is a surgical microscope accessory used in viewing intra-operative blood flow in the cerebral vascular area.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

## From Eye to Insight

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

#### Overview

This 510(k) summary has been prepared in accordance with the requirements of 21CFR §807.92.

| Trade Name | Leica FL560 |
|------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name | Fluorescent Angiographic System |
| Classification | Class II; Angiographic x-ray system (21 CFR 892.1600) |
| Product Code | IZI |
| Manufacturer | Leica Microsystems (Schweiz) AG., (Registration # 3003974370)<br>Max Schmidheiny-Strasse 201<br>Heerbrugg,<br>Sankt Gallen 9435,<br>Switzerland. |
| Contact Name | Grainne Griffin |
| Tel | [phone] |
| email | [e-mail] |
| Predicate Device | Primary Leica FL800 ULT – clearance K141136<br>Auxiliary Leica FL800 – clearance K061871 & K080612 |
| Preparation Date | 20th December 2016 |

#### Device Description

Similar to the predicate device (Leica FL800 ULT approved under K141136), the Leica FL560 is an accessory to the Leica Microsystems (LMS) Class I 510(k) exempt surgical operating microscope (SOM).

The Leica FL560 utilizes the illumination light source, supplied as standard with the SOM to produce excitation light which is filtered using an illumination filter (also referred to as the excitation filter) within the 460 - 500nm wavelength.

An observation filter is introduced into the observer light path within the optics carrier of the SOM to enable visualization of the resulting fluorescence emission comprising of the green, yellow and red spectrum in a spectral band above ~510nm.

{5}------------------------------------------------

Image /page/5/Picture/1 description: The image shows the logo for Leica Microsystems. The logo consists of the word "Leica" in a stylized red font, with the word "MICROSYSTEMS" in a smaller, black, sans-serif font below it. The word "Leica" is written in a cursive font, and the letters are connected.

### Device Intended Use

The Leica FL560 is a surgical microscope accessory used in viewing fluorescence of fluorophores with an excitation peak between ~460 nm and ~500 nm (blue) and the fluorescence emission comprising the green, yellow and red spectrum in a spectral band above ~510 nm.

#### Device Indication for Use

The Leica FL560 is a surgical microscope accessory used in viewing intra-operative blood flow in the cerebral vascular area.

#### Testing

Pre-clinical studies, human factors studies, electrical safety testing have been conducted to demonstrate the substantial equivalence of the Leica FL560 to the Leica FL800 ULT.

#### Summary Table

See 'Substantial Equivalence Summary Table: Comparison to Predicate Device' on following pages for a summary of all predicate and subject device comparative features and supporting substantial equivalence testing.

#### Conclusion

Based on the technological characteristics, principle of operation, intended use, environment of use, and indications for use, the Leica FL560 has been determined to be substantially equivalent to the predicate device, the Leica FL800 ULT (K141136) in terms of safety, effectiveness and performance.

{6}------------------------------------------------

# From Eye to Insight

Image /page/6/Picture/1 description: The image shows the logo for Leica Microsystems. The logo consists of the word "Leica" in a stylized red font, with a curved line underneath. Below the word "Leica" is the word "MICROSYSTEMS" in a smaller, sans-serif font. The logo is simple and modern, and the red color is eye-catching.

| | Primary Predicate | Subject Device | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device → | Leica FL800 ULT | Leica FL560 | Demonstration of |
| What↓ | (K141136) | (Proposed new accessory) | Substantial Equivalence<br>(SE) |
| | SUMMARY OF GENERAL FEATURES | | |
| Indications<br>for use | The Leica FL800 is a surgical<br>Microscope accessory used in<br>viewing intra-operative blood<br>flow in the cerebral vascular<br>area and by-pass grafts during<br>coronary artery bypass (CABG)<br>surgery, as well as blood flow<br>during plastic and reconstructive<br>surgery. | The Leica FL560 is a surgical<br>Microscope accessory used in<br>viewing intra-operative blood<br>flow in the cerebral vascular<br>area. | Identical to subset of predicate<br>indications for use |
| For use with | Standard Leica Surgical<br>Operating Microscope<br>M520 / M525 / M720 & M530<br>product range | Standard Leica M530 OH6/OHX<br>Surgical Operating Microscope<br>(Class I Exempt)<br>Note: FL560 will not be available<br>for the M520 / M525 / M720 SOM<br>as these are older models<br>scheduled for phase out | Identical to subset of predicate<br>equipment platforms |
| Device<br>Components | • Observation filter<br>• Illumination filter<br>• Filter housing ICG Filter<br>• Beam Splitter<br>• Built in Dual Video Adaptor<br>consisting of Internal NIR<br>Camera | • Observation filter<br>• Illumination filter<br>• Filter housing | Equivalent to subset of predicate<br>components (filters equivalent but<br>for different wavelength<br>specifications) |
| Software | No Software | No Software | Identical |
| Required but<br>not supplied | • Leica Surgical Microscope<br>• Recording device | • Leica Surgical Microscope | Identical to subset of predicate |
| Drug | ICG | Fluorescein Sodium<br>(fluorescein)* | Difference does not impact<br>substantial equivalence, both<br>drugs are fluorophores for<br>visualizing blood flow and have<br>longstanding FDA approvals |
| | Primary Predicate | Subject Device | |
| Device → | Leica FL800 ULT | Leica FL560 | Demonstration of |
| What↓ | (K141136) | (Proposed new accessory) | Substantial Equivalence<br>(SE) |
| | SUMMARY OF GENERAL FEATURES, CONTINUED | | |
| Illumination<br>Filter [nm] | 400 – 780nm | 460 - 500nm | Equivalent, both are band pass<br>filters with overlapping ranges |
| Observation<br>Filter [nm] | 800 – 880nm | Above ~ 510nm | Equivalent, the FL560 high pass<br>filter range contains the FL800<br>band pass filter range |
| Light Source | Xenon 300 - 400watt | Xenon 400watt | Identical to subset of predicate |
| Test Card | Pre-operative check test card | Pre-operative check test card | Equivalent |
| Procedure Kit | None supplied | FL560 procedure kit containing:<br>• AK-FLUOR (fluorescein)<br>• FL560 test card<br>• Procedure kit IFU | Difference does not impact<br>substantial equivalence |
| *Reference Device CIS EyeScan Portable Modular Imaging System, K092374, also enables visualization of fluorescein (a<br>technical feature of both the subject and reference device) for a different Indication for Use (ophthalmology imaging) but a<br>generally equivalent intended use (fluorescence vascular angiography) | | | |
| | SUMMARY OF SUPPORTING TESTING | | |
| Electrical<br>Safety | Conformance to the following<br>standards tested and confirmed:<br>• IEC 60601-1:2005: Medical<br>electrical equipment - Part 1:<br>General requirements for<br>basic safety and essential<br>performance<br>• IEC 60601-1-2:2007<br>(Modified): Medical electrical<br>equipment - Part 1-2:<br>General requirements for<br>basic safety and essential<br>performance - Collateral<br>standard: Electromagnetic<br…