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).

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.

AI/ML Overview

The provided text describes the regulatory clearance for the GLOW800 device, comparing it to a predicate device (Leica FL800 ULT). The crucial information regarding acceptance criteria and study results comes primarily from the "Substantial Equivalence Summary Table: Comparison to Predicate Device" and the "Non-Clinical, Bench, and Clinical Performance Testing" sections.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Key Takeaway: The GLOW800 device did not undergo a study with pre-defined quantitative acceptance criteria for its performance in the way one might expect for an AI/algorithm-driven device. Instead, the "acceptance criteria" were based on demonstrating functional equivalence to a predicate device through various non-clinical (bench) and preclinical (animal model) studies, and human factors testing. The primary "performance" metric was qualitative assessment (visualization ability) by experts.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Stated Goal / Test Objective)	Reported Device Performance and How it Meets Criteria
Bench Testing: Ensure software, mechanical, and functional requirements (including design specifications) are met. Produce light transference for an excitation peak between ~750 nm and ~800 nm and an observation peak above ~800 nm. Demonstrate functionally equivalent ability to produce excitation and observation peaks for viewing fluorescence. Ensure robustness (correct task performance, safe handling of unusual/unexpected conditions, recovery from faults/errors).	Results: "All tests completed met their pre-established acceptance criteria." Specifically, "verification of (technical) Intended Use to produce light transference for an excitation peak between 750 nm and 800 nm and an observation peak above 800 nm was achieved." "GLOW800 has functionally equivalent ability to produce excitation and observation peaks for use in viewing fluorescence of fluorophores intraoperatively." "Software functional system level testing and robustness testing were performed, where robustness tests verified that the system performs required tasks correctly and that unusual or unexpected conditions were handled in a safe manner." Filters were optically, mechanically, and geometrically assessed, and optical performance was verified. Mechanical integration verified. Labeling reviewed for completeness, understandability, and accuracy.
Preclinical Study (Porcine Model): Confirm the GLOW800 enables viewing of intra-operative blood flow in a manner functionally equivalent to the predicate device (FL800 ULT) and demonstrates visualization of the capillary bed in the cerebral vascular region. Qualitatively assess visualization.	Results: "The testing confirmed that the GLOW800 meets the Indications for Use and provides functionally equivalent flow visualization to FL800ULT." "All individual evaluations of comparative images confirmed that the GLOW800 enabled visualization of intra-operative blood flow and vessel architecture in a functionally equivalent manner to the predicate device Leica FL800 ULT (n=18 comparative reviews, 100% confirmation)." The GLOW800 also "enabled visualization of anatomical structures within the surgical field of view."
Human Factors Testing: Assess user ability to perform specific clinical use demands (pre-operative setup, intra-operative adjustments, troubleshooting). Confirm usability equivalent to predicate.	Results: "Human factors testing confirmed that the GLOW800 usability was equivalent to prior experience with Leica FL800." "Similar controls and interfaces enabled 100% of users in both groups to perform key functions." "GLOW800 consistently visualized test card fluorescence and ICG fluorescence in a phantom vascular model and background detail was clearly visible." Users found the device and manual "intuitive and simple."
Electrical Safety: Conformance to IEC 60601-1:2005, IEC 60601-1-2:2007 (Modified), IEC 60601-1-6:2010-06.	Results: "Identical, both met all acceptance criteria" (referring to both predicate and subject device meeting these standards).

2. Sample Sizes Used for the Test Set and Data Provenance

Bench Testing: Described as "one-arm study using only the subject device GLOW800 on microscope platform M530 OH6 and assessed vs. historical experience with predicate FL800 (historical control)." No specific sample size for the "test set" in terms of number of devices tested is explicitly stated, but it implies a single GLOW800 unit was extensively tested against pre-established criteria and historical data.
Preclinical Study:
- Sample Size: 8 pigs.
- Data Provenance: Conducted at the University of Mainz, Germany Institute of Neurosurgical Pathology. This was a direct comparative test, not a retrospective assessment.
Human Factors Testing:
- Sample Size: 21 surgeons and 15 nurses/other allied health professionals.
- Data Provenance: Conducted at the Mt. Sinai Medical Center Neurosurgery Simulation Core, Annenberg Building, New York. This was a prospective study in a simulated operating room environment.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Preclinical Study (Porcine Model):
- Ground truth was based on "independent scoring assessments predefined within the protocol."
- Experts involved in the assessment were "cardiovascular surgeon, neurosurgeons and veterinarians." The number of each type of expert is not specified, nor is their specific experience level (e.g., "10 years of experience").
- The results state "n=18 comparative reviews," implying 18 assessments of the image sets. It's unclear if this means 18 different experts, or 18 reviews conducted by a smaller group of experts. Given the "independent scoring assessments" and the stated types of experts, it suggests multiple experts.
Human Factors Testing: The "ground truth" for human factors was based on the ability of users (surgeons, nurses/techs) to perform tasks correctly and intuitively, assessed via "observational analysis." The primary "experts" here were the observers assessing performance against the predefined tasks and acceptance criteria, but their specific qualifications are not detailed beyond "observers."

4. Adjudication Method for the Test Set

Preclinical Study: "Independent scoring assessments predefined within the protocol." This suggests that multiple experts made assessments, but the specific adjudication method (e.g., majority vote, consensus meeting, 2+1, 3+1) is not specified beyond being "independent."
Human Factors Testing: "Observational analysis" with "pre-defined test cases and objective pass/fail criteria." No specific adjudication method among observers is mentioned, but the outcomes (e.g., "100% of users... perform key functions") suggest clear-cut observations rather than needing complex adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No MRMC study was done in the context of AI assistance.
The GLOW800 is a hardware accessory (optical system, camera, and basic software for combining images), not an AI/algorithm. Its purpose is to visualize blood flow, not to interpret or provide diagnostic insights based on that visualization. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply to this device submission.
The "comparative effectiveness" was primarily demonstrated by showing functional equivalence between the new device and a predicate optical device, meaning the new device provides similar or better visual information.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is largely irrelevant as the GLOW800 is a hardware device (an accessory to a surgical microscope) designed for human use, not a standalone algorithm. Its "performance" is inherently tied to its ability to present visual information to a human operator.
The "bench testing" does cover aspects of the device's technical performance (e.g., optical specifications, software functionality) in a "standalone" or de-coupled manner, ensuring it correctly processes and displays information.

7. The Type of Ground Truth Used

Bench Testing: Internal design specifications, historical performance data of the predicate device, and "experiential basis" from prior device marketing history.
Preclinical Study: The "actual" blood flow and vessel architecture in the porcine model (as visualized by the predicate device and assessed by expert observation of both devices' outputs) served as the de facto ground truth. The goal was functional equivalence in visualization, not an independent "pathology" ground truth of true blood flow given the real-time nature of the imaging.
Human Factors Testing: Pre-defined "objective pass/fail criteria" for task performance and qualitative assessment of usability.

8. The Sample Size for the Training Set

No "training set" (in the context of machine learning) is mentioned or implied, as this device does not appear to employ machine learning or AI algorithms requiring a training phase.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no mention of a training set for an AI/ML algorithm.

Summary

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

September 7, 2018

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

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

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

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

Indications for Use

510(k) Number (if known) K181537

Device Name GLOW800

Indications for Use (Describe)

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

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

| 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 PRAStaff@fda.hhs.gov

"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."

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

Image /page/3/Picture/1 description: The image shows the logo for Leica Microsystems. The word "Leica" is written in a stylized red font, with a swoosh underlining it. Below "Leica" is the word "MICROSYSTEMS" in a smaller, black, sans-serif font. The logo is simple and recognizable.

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 201Heerbrugg,Sankt Gallen 9435, Switzerland
Telephone Number	+41 71 726 32 45
Preparation Date	September 7th, 2018
Predicate Device	K141136 Leica FL800 ULT and FL80021 CFR 892.1600, system, x-ray, angiographic, IZI product code

Device Description

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

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

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

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.

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

Image /page/5/Picture/1 description: The image contains 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 underneath. The Leica part of the logo is more prominent due to its color and larger size.

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
Indicationsfor use	The Leica FL800 is a surgicalmicroscope accessory used inviewing intra-operative blood flowin the cerebral vascular area andby-pass grafts during coronaryartery bypass (CABG) surgery,as well as blood flow duringplastic and reconstructivesurgery.	The GLOW800 is a LeicaSurgical Microscope accessoryused in viewing intra-operativeblood flow and related tissueperfusion in the cerebral vascularregion as well as blood flowfollowing plastic andreconstructive surgery andcoronary artery bypass grafting(CABG).	Similar; Proposed IFU involvesexpansion of the cleared IFU
For use with	Standard Leica surgicalmicroscope (Class I 510(k)exempt M520 / M525 / M720 &M530 product range	Standard Leica surgicalmicroscope (Class I 510(k)exempt) M530 product range	Identical to subset of predicateequipment platforms
DeviceComponents	Observation filter Illumination filter Filter housing ICG Filter Beam splitter Built in dual video adaptorconsisting of Internal NIRcamera No Software	Observation filter Illumination filter Filter housing ICG Filter Beam splitter Built in Dual Video Adaptorconsisting of internal NIRcamera and visible lightcamera GLOW800 Software V 1.1	Equivalent to subset of predicatecomponents. The GLOW800introduces additional visible lightcamera to provide anatomicalinformation.Individual evaluations ofcomparative images confirmedthat the GLOW800 enabledvisualization of intra-operativeblood flow and vesselarchitecture in a functionallyequivalent manner to thepredicate device Leica FL800ULT.In addition, comparativeevaluations confirmed that theGLOW800 software enabledvisualization of backgroundanatomical structures.
	Primary Predicate	Subject Device
Device →	Leica FL800K141136	GLOW800K181537	Demonstration of
What↓			Substantial Equivalence(SE)
	SUMMARY OF GENERAL FEATURES- CONTINUED
Required butnot supplied	• Leica surgical microscope• Recording device	• Identical to subset ofpredicate equipment – norecording device required	Identical to predicate
Drug	ICG	Same	Identical to predicate
ElectricalSafety	Conformance to the followingstandards tested and confirmed:• IEC 60601-1:2005: Medicalelectrical equipment - Part 1:General requirements forbasic safety and essentialperformance• IEC 60601-1-2:2007(Modified): Medical electricalequipment - Part 1-2:General requirements forbasic safety and essentialperformance - Collateralstandard: Electromagneticcompatibility - Requirementsand tests• IEC 60601-1-6:2010-06:Medical electrical equipment- Part 1-6: Generalrequirements for basic safetyand essential performance	Conformance to the followingstandards tested and confirmed:• IEC 60601-1:2005: Medicalelectrical equipment - Part 1:General requirements forbasic safety and essentialperformance• IEC 60601-1-2:2007(Modified): Medical electricalequipment - Part 1-2:General requirements forbasic safety and essentialperformance - Collateralstandard: Electromagneticcompatibility - Requirementsand tests• IEC 60601-1-6:2010-06:Medical electrical equipment- Part 1-6: Generalrequirements for basic safetyand essential performance -	Identical, both met all acceptancecriteria
Device →	Primary Predicate	Subject Device	Demonstration ofSubstantial Equivalence(SE)
What↓	Leica FL800K141136	GLOW800K181537
	SUMMARY OF GENERAL FEATURES- CONTINUED
Bench	Summary of Test Objective and Design: In house design verificationtesting was performed on GLOW800 to ensure that software, mechanicaland functional requirements including design specifications were met.This was a protocol-driven verification with pre-established pass/failcriteria, ties to design specification and other quality and design controldocuments, and significant experiential basis drawn from the 10-yearmarketing history of predicate device FL800.As is typical for design verification, this was a one-arm study using onlythe subject device GLOW800 on microscope platform M530 OH6 andassessed vs. historical experience with predicate FL800 (historicalcontrol).		EquivalentResults: All tests completedmet their pre-establishedacceptance criteria.Specifically, verification of(technical) Intended Use toproduce light transference foran excitation peak between 750nm and 800 nm and anobservation peak above 800nm was achieved.Review of GLOW800 testresults vs. historical experiencewith predicate FL800ULT andvs. current QC standards forFL800 established that theGLOW800 has functionallyequivalent ability to produceexcitation and observationpeaks for use in viewingfluorescence of fluorophoresintraoperatively on a Leicasurgical microscope platform.Software functional systemlevel testing and robustnesstesting were performed, whererobustness tests verified thatthe system performs requiredtasks correctly and that unusualor unexpected conditions werehandled in a safe manner. Thisincluded recovery from faultsand errors.
	Predicate Device:Historical controls via marketingand experience with predicatedevice FL800 were utilizedinstead of direct comparativetesting.	Subject Device:• Filter specification: Filters wereoptically (spectrally),mechanically and geometricallyassessed. Optical performanceregarding spectral transmissionand sufficiency of pass-throughillumination was verified.• Mechanical: The GLOW800assembly, geometric,mechanical, and functionalintegration into the LeicaMicrosystems M530 OH6surgical operating microscopewas verified.• Labeling: Product labels anduser manual were reviewed forcompleteness,understandability, andaccuracy.
	Primary Predicate	Subject Device
Device →	Leica FL800	GLOW800	Demonstration of
What↓	K141136	K181537	Substantial Equivalence(SE)
	SUMMARY OF SUPPORTING TESTING, CONTINUED
Bio-compatibility	Not patient contacting, only external surface is anodized aluminum, so ISO 10993 testing is not applicable	Not patient contacting, only external surface is anodized aluminum, so ISO 10993 testing is not applicable	Identical
Preclinical	Summary of Test Objective and Design: A contracted, protocol-driven comparative preclinical study was performed involving 8 pigs to confirm that the subject device GLOW800 enabled viewing of intra-operative blood flow in a manner that was functionally equivalent to predicate device FL800 ULT and demonstrated visualization of the capillary bed in the cerebral vascular region.Testing was completed at the University of Mainz, Germany Institute of Neurosurgical Pathology by cardiovascular surgeon, neurosurgeons and veterinarians using test cases, pass/fail criteria, and independent scoring assessments predefined within the protocol.Six comparative image sets of the same anatomy in either non-occluded (patent, native) or occluded (clipped) status and representative of surgical procedures were visualized by both the GLOW800 and FL80 ULT systems.	Subject Device: Data was collected using indocyanine green (ICG) fluorescent dye introduced into the vascular system of a porcine model..Data regarding the ability to visualize blood flow and vascular structures was collected and compared directly to data collected with the predicate device Leica FL800ULT on the same porcine model and using ICG fluorescent dye.	Results Summary:EquivalentThe testing confirmed that the GLOW800 meets the Indications for Use and provides functionally equivalent flow visualization to FL800ULT.All individual evaluations of comparative images confirmed that the GLOW800 enabled visualization of intra-operative blood flow and vessel architecture in a functionally equivalent manner to the predicate device Leica FL800 ULT (n=18 comparative reviews, 100% confirmation).The GLOW800 additionally enabled visualization of anatomical structures within the surgical field of view.
	Predicate Device: Data was collected using indocyanine green (ICG) fluorescent dye introduced into the vascular system of a porcine model.Data regarding the ability to visualize blood flow and vascular structures was collected and compared directly to data collected with the subject device GLOW800 on the same porcine model using the same fluorescent dye.
	Primary Predicate	Subject Device
Device →	Leica FL800	GLOW800	Demonstration of
What↓	K141136	K181537	Substantial Equivalence(SE)
SUMMARY OF SUPPORTING TESTING, CONTINUED
HumanFactors	Summary of Test Objectives and Design: Human factors and usabilitytesting was completed at the Mt. Sinai Medical Center NeurosurgerySimulation Core, Annenberg Building, New York, using pre-defined testcases and objective pass/fail criteria pre-defined within the protocol.Two distinct user groups (neurosurgeons, nurses/techs) wereassessed for their ability to perform specific clinical use demands. Inall 21 surgeons and 15 nurses and other allied health professionals(including physician's assistants and neurosurgery researchers)were assessed via observational analysis. The 10-year marketinghistory of predicate device FL800 ULT and the GLOW800 risk analysisprovided the basis for establishing key test elements and acceptancecriteria.The study was conducted in a simulated operating room and involvedtypical work flow scenarios including certain troubleshooting scenariosrelated to safety-critical tasks. Testing was conducted using a LeicaSurgical Microscope fitted with the GLOW800 module and using acerebral vascular aneurysm phantom model flushed in with ICG andwater in an alternating manner. Studies were conducted to reflectstandard use cases, parameter adjustments, and interfacesencountered during routine use of the GLOW800 module by surgeonsand operating room personnel.The study was designed in accordance with the published FDAguidance "draft Guidance for Industry and Food and DrugAdministration Staff - Applying Human Factors and UsabilityEngineering to Optimize Medical Device Design, 2011.Predicate Device:Historical controls via marketingand experience with predicatedevice FL800 were utilizedinstead of direct comparativetesting.	Subject Device:All participants performed tasksusing the surgical operatingmicroscope equipped with theGLOW800 accessory andrepresentative of their productinteraction during surgery for pre-operative set-up activities andintra-operative adjustments.	Results Summary:EquivalentHuman factors testing confirmedthat the GLOW800 usability wasequivalent to prior experiencewith Leica FL800.Similar controls and interfacesenabled 100% of users in bothgroups to perform key functions.GLOW800 consistently visualizedtest card fluorescence and ICGfluorescence in a phantomvascular model and backgrounddetail was clearly visible.Users found the GLOW800 andassociated User Manualinstructions to be intuitive andsimple.

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

Image /page/6/Picture/1 description: The image contains the logo for Leica Microsystems. The word "Leica" is written in a stylized red font. Below the word "Leica" is the word "MICROSYSTEMS" written in a smaller, sans-serif font. The logo is simple and clean, with the red color of "Leica" standing out.

{7}------------------------------------------------

Image /page/7/Picture/1 description: The image shows the logo for Leica Microsystems. The word "Leica" is written in a stylized, red font. Below the word "Leica" is the word "MICROSYSTEMS" written in a smaller, black font.

{8}------------------------------------------------

Image /page/8/Picture/1 description: The image contains the logo for Leica Microsystems. The logo features the word "Leica" in a stylized, red font. Below the word "Leica" is the word "MICROSYSTEMS" in a smaller, black font. The logo is simple and clean, with a focus on the company name.

{9}------------------------------------------------

Image /page/9/Picture/1 description: The image shows the logo for Leica Microsystems. The logo consists of the word "Leica" in a stylized red font. Below the word "Leica" is the word "MICROSYSTEMS" in a smaller, sans-serif font. The logo is simple and recognizable.

{10}------------------------------------------------

Image /page/10/Picture/1 description: The image shows the logo for Leica Microsystems. The word "Leica" is written in a stylized red font. Below the word "Leica" is the word "MICROSYSTEMS" written in a smaller, black, sans-serif font. The logo is simple and recognizable.

Conclusion

Based on the technological characteristics, principle of operation, intended use, environment of use, and indications for use, the GLOW800 has been determined to be substantially equivalent to the predicate device, the Leica FL800 ULT (K141136) in terms of safety, effectiveness and performance.

Regulation Number and Section

§ 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.