GLOW800

K181537 · Leica Microsystems (Schweiz) AG · IZI · Sep 7, 2018 · Radiology

Device Facts

• Record ID: K181537
• Device Name: GLOW800
• Applicant: Leica Microsystems (Schweiz) AG
• Product Code: IZI · Radiology
• Decision Date: Sep 7, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1600
• Device Class: Class 2

Intended Use

The GLOW800 is a surgical microscope accessory used in viewing fluorescence of fluorophores with an excitation peak between ~750 nm and ~800 nm and the fluorescence emission in a spectral band above ~800 nm.

Device Story

GLOW800 is a non-contact, non-invasive surgical microscope accessory; integrates with Leica surgical operating microscopes. Device uses standard microscope illumination to produce excitation light (750-800 nm) to induce fluorescence from Indocyanine green (ICG) dye in patient blood vessels. System captures NIR fluorescence and visible light (VL) video streams; digitally combines streams to present high-definition, pseudocolored overlay of surgical site on microscope screen. Operated by surgeons/OR staff in clinical settings. Output provides real-time visualization of blood flow and vessel architecture; aids intra-operative decision-making by confirming perfusion and anatomical detail. Benefits include improved visualization of vascular structures during neurosurgical, reconstructive, and bypass procedures.

Clinical Evidence

No human clinical trials. Evidence includes bench testing and a comparative porcine study (n=8). Porcine study compared GLOW800 to FL800 ULT using ICG dye in cerebral vascular models; 18 comparative reviews confirmed 100% functional equivalence in visualizing blood flow and vessel architecture. Bench testing verified spectral transmission, mechanical integration, and software robustness. Human factors study (n=21 surgeons, n=15 nurses/techs) confirmed usability equivalent to predicate.

Technological Characteristics

Accessory to surgical microscope; anodized aluminum construction. Sensing: NIR camera and visible light camera. Illumination: standard microscope light source with 750-800 nm excitation filter. Connectivity: integrated into Leica M530 OH6 microscope platform. Software: GLOW800 V 1.1. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6.

Indications for Use

Indicated for viewing intra-operative blood flow and related tissue perfusion in the cerebral vascular region, plastic and reconstructive surgery, and coronary artery bypass grafting (CABG).

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 and FL800 (K141136)

Submission Summary (Full Text)

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September 7, 2018

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Leica Microsystems (Schweiz) AG Georges Hakim Director RA/QA Max Schmidheiny-Strasse 201 Heerbrugg, 9435 Ch

Re: K181537

Trade/Device Name: GLOW800 Regulation Number: 21 CFR 892.1600 Regulation Name: Angiographic X-Ray System Regulatory Class: Class II Product Code: IZI Dated: June 11, 2018 Received: June 11, 2018

Dear Georges Hakim:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination. product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

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https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Jay R. Gupta -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

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#### Indications for Use

510(k) Number (if known) K181537

Device Name GLOW800

Indications for Use (Describe)

The GLOW800 is a Leica Surgical Microscope accessory used in viewing intra-operative blood flow and related tissue perfusion in the cerebral vascular region as well as blood flow following plastic and reconstructive surgery and coronary artery bypass grafting (CABG).

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

| <span style="font-size: 10pt;"> <span style="text-decoration: overline;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|------------------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-size: 10pt;"> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

| X Prescription Use (Part 21 CFR 801 Subpart D)

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

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### K181537 Traditional 510(k) Summary

### Subject Device

| Trade Name | GLOW800 |
|-------------------|-----------------------------------------------------------------------------------------------------|
| Common Name | Fluorescent Angiographic System |
| Classification | Class II; Angiographic X-ray System, 21 CFR 892.1600 |
| Product Code | IZI |
| Submitter Name | Leica Microsystems (Schweiz) AG. |
| Submitter Address | Max Schmidheiny-Strasse 201<br>Heerbrugg,<br>Sankt Gallen 9435, Switzerland |
| Telephone Number | [phone] |
| Preparation Date | September 7th, 2018 |
| Predicate Device | K141136 Leica FL800 ULT and FL800<br>21 CFR 892.1600, system, x-ray, angiographic, IZI product code |

### Device Description

Similar to the predicate device (Leica FL800 most recently cleared under K141136 and previously in K061871 and K080612), the GLOW800 is an accessory to the Leica Microsystems (LMS) Class I 510(k) exempt surgical operating microscope (SOM).

The GLOW800, a non-contact, non-invasive device similar to its predicate, allows the surgical microscope to produce excitation light and resolve fluorescent emission from the fluorescent agent Indocyanine green (ICG). The generated fluorescence signal depicts the distribution of the infra-red dye in the patient's blood vessels during the surgical procedure (fluorescence video angiography). The ICG fluorescence peak is captured for display on the SOM screen. Using an additional camera to capture the visible light (VL) video stream and digitally combining with the Near Infra-red (NIR) video stream presents a high definition display of the surgical site as a pseudocoloured combined image of the same field of view (FOV), which includes anatomical information.

The GLOW800 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 750 and 800 spectral wavelength range.

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### Device Intended Use

The GLOW800 is a surgical microscope accessory used in viewing fluorescence of fluorophores with an excitation peak between ~750 nm and ~800 nm and the fluorescence emission in a spectral band above ~800 nm.

#### Device Indication for Use

The GLOW800 is a Leica Surgical Microscope accessory used in viewing intra-operative blood flow and related tissue perfusion in the cerebral vascular region as well as blood flow following plastic and reconstructive surgery and coronary artery bypass grafting (CABG).

#### Non-Clinical, Bench, and Clinical Performance Testing

Pre-clinical studies, human factors studies, electrical safety and in-house been conducted to demonstrate the substantial equivalence of the GLOW800 to the predicate Leica FL800 ULT. Please see the Comparison Table below for testing information and summaries of the test methods which were used to demonstrate substantial equivalence to the predicate.

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### Substantial Equivalence Summary Table: Comparison to Predicate Device

| | Primary Predicate | Subject Device | Comment |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device → | Leica FL800 | GLOW800 | Substantial Equivalence |
| What↓ | K141136 | K181537 | (SE) Discussion |
| | SUMMARY OF GENERAL FEATURES | | |
| Indications<br>for use | The Leica FL800 is a surgical<br>microscope accessory used in<br>viewing intra-operative blood flow<br>in the cerebral vascular area and<br>by-pass grafts during coronary<br>artery bypass (CABG) surgery,<br>as well as blood flow during<br>plastic and reconstructive<br>surgery. | The GLOW800 is a Leica<br>Surgical Microscope accessory<br>used in viewing intra-operative<br>blood flow and related tissue<br>perfusion in the cerebral vascular<br>region as well as blood flow<br>following plastic and<br>reconstructive surgery and<br>coronary artery bypass grafting<br>(CABG). | Similar; Proposed IFU involves<br>expansion of the cleared IFU |
| For use with | Standard Leica surgical<br>microscope (Class I 510(k)<br>exempt M520 / M525 / M720 &<br>M530 product range | Standard Leica surgical<br>microscope (Class I 510(k)<br>exempt) M530 product range | Identical to subset of predicate<br>equipment platforms |
| Device<br>Components | Observation filter Illumination filter Filter housing ICG Filter Beam splitter Built in dual video adaptor<br>consisting of Internal NIR<br>camera No Software | Observation filter Illumination filter Filter housing ICG Filter Beam splitter Built in Dual Video Adaptor<br>consisting of internal NIR<br>camera and visible light<br>camera GLOW800 Software V 1.1 | Equivalent to subset of predicate<br>components. The GLOW800<br>introduces additional visible light<br>camera to provide anatomical<br>information.<br>Individual evaluations of<br>comparative images confirmed<br>that the GLOW800 enabled<br>visualization of intra-operative<br>blood flow and vessel<br>architecture in a functionally<br>equivalent manner to the<br>predicate device Leica FL800<br>ULT.<br>In addition, comparative<br>evaluations confirmed that the<br>GLOW800 software enabled<br>visualization of background<br>anatomical structures. |
| | Primary Predicate | Subject Device | |
| Device → | Leica FL800<br>K141136 | GLOW800<br>K181537 | Demonstration of |
| What↓ | | | Substantial Equivalence<br>(SE) |
| | SUMMARY OF GENERAL FEATURES- CONTINUED | | |
| Required but<br>not supplied | • Leica surgical microscope<br>• Recording device | • Identical to subset of<br>predicate equipment – no<br>recording device required | Identical to predicate |
| Drug | ICG | Same | Identical to predicate |
| 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>compatibility - Requirements<br>and tests<br>• IEC 60601-1-6:2010-06:<br>Medical electrical equipment<br>- Part 1-6: General<br>requirements for basic safety<br>and essential performance | 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>compatibility - Requirements<br>and tests<br>• IEC 60601-1-6:2010-06:<br>Medical electrical equipment<br>- Part 1-6: General<br>requirements for basic safety<br>and essential performance - | Identical, both met all acceptance<br>criteria |
| Device → | Primary Predicate | Subject Device | Demonstration of<br>Substantial Equivalence<br>(SE) |
| What↓ | Leica FL800<br>K141136 | GLOW800<br>K181537 | |
| | SUMMARY OF GENERAL FEATURES- CONTINUED | | |
| Bench | Summary of Test Objective and Design: In house design verification<br>testing was performed on GLOW800 to ensure that software, mechanical<br>and functional requirements including design specifications were met.<br><br>This was a protocol-driven verification with pre-established pass/fail<br>criteria, ties to design specification and other quality and design control<br>documents, and significant experiential basis drawn from the 10-year<br>marketing history of predicate device FL800.<br><br>As is typical for design verification, this was a one-arm study using only<br>the subject device GLOW800 on microscope platform M530 OH6 and<br>assessed vs. historical experience with predicate FL800 (historical<br>control). | | Equivalent<br>Results: All tests completed<br>met their pre-established<br>acceptance criteria.<br>Specifically, verification of<br>(technical) Intended Use to<br>produce light transference for<br>an excitation peak between 750<br>nm and 800 nm and an<br>observation peak above 800<br>nm was achieved.<br><br>Review of GLOW800 test<br>results vs. historical experience<br>with predicate FL800ULT and<br>vs. current QC standards for<br>FL800 established that the<br>GLOW800 has functionally<br>equivalent ability to produce<br>excitation and observation<br>peaks for use in viewing<br>fluorescence of fluorophores<br>intraoperatively on a Leica<br>surgical microscope platform.<br>Software functional system<br>level testing and robustness<br>testing were performed, where<br>robustness tests verified that<br>the system performs required<br>tasks correctly and that unusual<br>or unexpected conditions were<br>handled in a safe manner. This<br>included recovery from faults<br>and errors. |
| | Predicate Device:<br>Historical controls via marketing<br>and experience with predicate<br>device FL800 were utilized<br>instead of direct comparative<br>testing. | Subject Device:<br>• Filter specification: Filters were<br>optically (spectrally),<br>mechanically and geometrically<br>assessed. Optical performance<br>regarding spectral transmission<br>and sufficiency of pass-through<br>illumination was verified.<br><br>• Mechanical: The GLOW800<br>assembly, geometric,<br>mechanical, and functional<br>integration into the Leica<br>Microsystems M530 OH6<br>surgical operating microscope<br>was verified.<br><br>• Labeling: Product labels and<br>user manual were reviewed for<br>completeness,<br>understandability, and<br>accuracy. | |
| | Primary Predicate…