(160 days)
The Leica FL560 is a surgical microscope accessory used in viewing intra-operative blood flow in the cerebral vascular area.
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.
Here's a summary of the acceptance criteria and the study details for the Leica FL560, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present acceptance criteria in a quantitative table format with specific thresholds. Instead, it describes acceptance as achieving "functional equivalence" to the predicate device (Leica FL800 ULT) in various aspects. The reported performance confirms this equivalence.
| Aspect | Acceptance Criteria (Implied) | Reported Device Performance (Leica FL560) |
|---|---|---|
| Electrical Safety | Conformance to IEC 60601-1:2005 (basic safety and essential performance), IEC 60601-1-2:2007 (electromagnetic compatibility), and IEC 60601-1-6:2010-06 (general requirements for basic safety and essential performance - usability). | Identical to predicate; both met all acceptance criteria. |
| Bench Testing (Functional) | Mechanical and functional requirements (design specifications) met. Optical performance (spectral transmission, sufficiency of pass-through illumination) verified. Mechanical integration verified. Labeling reviewed for completeness, understandability, and accuracy. Ability to produce excitation peak between 460-500 nm and observation peak above 510 nm verified. | All tests met pre-established acceptance criteria. Verification of (technical) Intended Use to produce light transference for an excitation peak between 460 nm and 500 nm and an observation peak above 510 nm was achieved. Functionally equivalent ability to produce excitation and observation peaks for use in viewing fluorescence of fluorophores intraoperatively on a Leica surgical microscope platform, based on review of FL560 test results vs. historical experience with predicate FL800 and QC standards for FL800. |
| Biocompatibility | Not patient contacting; only external surface is anodized aluminum, so ISO 10993 testing not applicable. | Identical to predicate; not patient contacting, only external surface is anodized aluminum, so ISO 10993 testing is not applicable. |
| Preclinical (Functional Equivalence for Blood Flow Visualization) | Ability to enable viewing of intra-operative blood flow in the cerebrovascular area in a manner that is functionally equivalent to the predicate device FL800ULT. Visual clarity and ability to discern vascular structures. (Predefined test cases, pass/fail criteria, and independent scoring assessments). | The testing confirmed that the Leica FL560 meets the Indications for Use and provides functionally equivalent flow visualization to FL800ULT. All individual evaluations of comparative images confirmed that the Leica FL560 enabled visualization of intra-operative blood flow and vessel architecture in the cerebrovascular area in a functionally equivalent manner to the predicate device Leica FL800 ULT (n=18 comparative reviews, 100% confirmation). The FL560 additionally enabled concurrent visualization of background anatomical structures. |
| Human Factors / Usability | Usability equivalent to Leica's prior experience with FL800. Key functions performable by 100% of users in both neurosurgeon and nurse/tech groups. Consistent visualization of test card fluorescence and fluorescein fluorescence in a phantom vascular model. (Pre-defined test cases and objective pass/fail criteria). | Human factors testing confirmed that the FL560 usability was equivalent to Leica prior experience with FL800. Similar controls and interfaces enabled 100% of users in both groups to perform key functions. FL560 consistently visualized test card fluorescence and fluorescein fluorescence in a phantom vascular model. |
2. Sample Size Used for the Test Set and Data Provenance
- Bench Testing: The document states this was a "one-arm study using only the subject device FL560 on microscope platform M530 OH6". The sample size for filters is mentioned as being tested (optically, mechanically, geometrically assessed), but specific numbers are not provided. The data provenance is internal design verification testing ("in-house").
- Preclinical Testing:
- Sample Size: "Six comparative image sets of the same cerebrovascular anatomy in either non-occluded (patent, native) or occluded (clipped) status and representative of neurosurgical procedures were visualized by both the FL560 and FL800ULT systems." This refers to the cases. The report also states "(n=18 comparative reviews, 100% confirmation)", which implies 3 observations per comparative image set (6 sets * 3 observations = 18 reviews).
- Data Provenance: Prospective animal study conducted at the University of Mainz, Germany Institute of Neurosurgical Pathology, using a porcine model.
- Human Factors Testing:
- Sample Size: "15 users per group were assessed via observational analysis." There were two distinct user groups (neurosurgeons, nurses/techs), so a total of 30 users.
- Data Provenance: Prospective study conducted at the University of Utah Department of Neurosurgery, using a simulated operating room and a cerebral vascular aneurysm phantom model.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Preclinical Testing: "Testing was completed at the University of Mainz, Germany Institute of Neurosurgical Pathology by neurosurgeons and veterinarians". The specific number of each is not given, but multiple experts from each specialization were involved. Their qualifications are stated as "neurosurgeons and veterinarians".
- Human Factors Testing: This study focused on usability and performance by the users themselves rather than establishing a diagnostic ground truth. The "experts" involved were the primary users: "neurosurgeons" and "nurses/techs". The number of each was 15. The study itself was designed in accordance with FDA guidance for human factors.
4. Adjudication Method for the Test Set
- Preclinical Testing: "independent scoring assessments that were predefined within the protocol." The specific adjudication method (e.g., 2+1, 3+1) is not detailed, but it implies multiple experts evaluating the images.
- Human Factors Testing: This study involved "observational analysis" with "objective pass/fail criteria pre-defined within the protocol." It doesn't describe a separate adjudication process for ground truth establishment, but rather for performance of tasks by the users.
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
The studies described are not MRMC comparative effectiveness studies comparing human readers with and without AI assistance. The Leica FL560 is a surgical microscope accessory for viewing fluorescence, not an AI-powered diagnostic tool. The preclinical study was a comparative functional equivalence study between two devices (FL560 vs. FL800ULT) for blood flow visualization, and the human factors study assessed usability.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable. The Leica FL560 is a hardware accessory for a surgical microscope. It does not contain an "algorithm" as typically referred to in AI/standalone performance studies. Its performance is entirely dependent on human-in-the-loop operation, as it provides visual information to the surgeon.
7. The Type of Ground Truth Used
- Preclinical Testing: The ground truth for evaluating blood flow visualization was established by the experts (neurosurgeons and veterinarians) observing the same cerebrovascular anatomy in known "non-occluded (patent, native) or occluded (clipped) status". This can be considered expert consensus with known physiological status/surgical intervention. The comparison was between the images produced by the two devices, FL560 vs FL800ULT, in relation to the actual blood flow patterns in the porcine model.
- Human Factors Testing: The "ground truth" here related to the correct and safe operation of the device and the visibility of fluorescein. This was established by "pre-defined test cases and objective pass/fail criteria" and successful visualization in a "cerebral vascular aneurysm phantom model". This is effectively known device functionality and phantom model characteristics.
8. The Sample Size for the Training Set
This information is not applicable. The Leica FL560 is a medical device accessory, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no AI model or training set involved.
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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
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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 (301) 594-0101
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 (800) 638-2041 or (301) 796-7100 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.
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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 (800) 638-2041 or (301) 796-7100 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
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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)
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From Eye to Insight
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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)Max Schmidheiny-Strasse 201Heerbrugg,Sankt Gallen 9435,Switzerland. |
| Contact Name | Grainne Griffin |
| Tel | +353 86 7710135 |
| grainne.griffin@leica-microsystems.com | |
| Predicate Device | Primary Leica FL800 ULT – clearance K141136Auxiliary 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.
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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.
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From Eye to Insight
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| Primary Predicate | Subject Device | ||
|---|---|---|---|
| Device → | Leica FL800 ULT | Leica FL560 | Demonstration of |
| What↓ | (K141136) | (Proposed new accessory) | Substantial Equivalence(SE) |
| SUMMARY OF GENERAL FEATURES | |||
| Indicationsfor use | The Leica FL800 is a surgicalMicroscope accessory used inviewing intra-operative bloodflow in the cerebral vasculararea and by-pass grafts duringcoronary artery bypass (CABG)surgery, as well as blood flowduring plastic and reconstructivesurgery. | The Leica FL560 is a surgicalMicroscope accessory used inviewing intra-operative bloodflow in the cerebral vasculararea. | Identical to subset of predicateindications for use |
| For use with | Standard Leica SurgicalOperating MicroscopeM520 / M525 / M720 & M530product range | Standard Leica M530 OH6/OHXSurgical Operating Microscope(Class I Exempt)Note: FL560 will not be availablefor the M520 / M525 / M720 SOMas these are older modelsscheduled for phase out | 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 | • Observation filter• Illumination filter• Filter housing | Equivalent to subset of predicatecomponents (filters equivalent butfor different wavelengthspecifications) |
| Software | No Software | No Software | Identical |
| Required butnot supplied | • Leica Surgical Microscope• Recording device | • Leica Surgical Microscope | Identical to subset of predicate |
| Drug | ICG | Fluorescein Sodium(fluorescein)* | Difference does not impactsubstantial equivalence, bothdrugs are fluorophores forvisualizing blood flow and havelongstanding FDA approvals |
| Primary Predicate | Subject Device | ||
| Device → | Leica FL800 ULT | Leica FL560 | Demonstration of |
| What↓ | (K141136) | (Proposed new accessory) | Substantial Equivalence(SE) |
| SUMMARY OF GENERAL FEATURES, CONTINUED | |||
| IlluminationFilter [nm] | 400 – 780nm | 460 - 500nm | Equivalent, both are band passfilters with overlapping ranges |
| ObservationFilter [nm] | 800 – 880nm | Above ~ 510nm | Equivalent, the FL560 high passfilter range contains the FL800band 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:• AK-FLUOR (fluorescein)• FL560 test card• Procedure kit IFU | Difference does not impactsubstantial equivalence |
| *Reference Device CIS EyeScan Portable Modular Imaging System, K092374, also enables visualization of fluorescein (atechnical feature of both the subject and reference device) for a different Indication for Use (ophthalmology imaging) but agenerally equivalent intended use (fluorescence vascular angiography) | |||
| SUMMARY OF SUPPORTING TESTING | |||
| 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 |
| Primary Predicate | Subject Device | ||
| Device → | Leica FL800 ULT(K141136) | Leica FL560(Proposed new accessory) | Demonstration ofSubstantial Equivalence(SE) |
| SUMMARY OF SUPPORTING TESTING, CONTINUED | |||
| Bench | Summary of Test Objective and Design: In house design verificationtesting was performed on FL560 to ensure that mechanical andfunctional 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 usingonly the subject device FL560 on microscope platform M530 OH6 andassessed vs. historical experience with predicate FL800 (historicalcontrol).Predicate Device:Historical controls via marketingand CAPA experience withpredicate device FL800 wereutilized instead of directcomparative testing. | Subject Device:Filter specification: Filterswere optically (spectrally),mechanically andgeometrically assessed.Optical performanceregarding spectraltransmission and sufficiencyof pass-through illuminationwas verified. Mechanical: The LeicaFL560 assembly geometric,mechanical, and functionalintegration into the LeicaMicrosystems M530 OH6Surgical OperatingMicroscope was verified. Labeling: Product labels andUser Manual were reviewedfor completeness,understandability, andaccuracy. | EquivalentResults: All tests completed mettheir pre-established acceptancecriteria. Specifically, verificationof (technical) Intended Use toproduce light transference for anexcitation peak between 460 nmand 500 nm and an observationpeak above 510 nm wasachieved.Review of FL560 test results vs.historical experience withpredicate FL800 and vs. currentQC standards for FL800established that FL560 hasfunctionally equivalent ability toproduce excitation andobservation peaks for use inviewing fluorescence offluorophores intraoperatively on aLeica surgical microscopeplatform. |
| Device → | Primary Predicate | Subject Device | Demonstration of |
| What↓ | Leica FL800 ULT(K141136) | Leica FL560(Proposed new accessory) | Substantial Equivalence(SE) |
| SUMMARY OF SUPPORTING TESTING, CONTINUED | |||
| Bio-compatibility | Not patient contacting, onlyexternal surface is anodizedaluminum, so ISO 10993 testingis not applicable | Not patient contacting, onlyexternal surface is anodizedaluminum, so ISO 10993 testingis not applicable | Identical |
| Preclinical | Summary of Test Objective and Design: A contracted, protocol-drivencomparative preclinical study was prospectively performed to confirmthat the subject device FL560 enabled viewing of intra-operative bloodflow in the cerebrovascular area in a manner that was functionallyequivalent to predicate device FL800ULT.Testing was completed at the University of Mainz, Germany Institute ofNeurosurgical Pathology by neurosurgeons and veterinarians usingtest cases, pass/fail criteria, and independent scoring assessmentsthat were predefined within the protocol.Six comparative image sets of the same cerebrovascular anatomy ineither non-occluded (patent, native) or occluded (clipped) status andrepresentative of neurosurgical procedures were visualized by both theFL560 and FL80ULT systems. | Results Summary:EquivalentThe testing confirmed that theLeica FL560 meets theIndications for Use and providesfunctionally equivalent flowvisualization to FL800ULT.All individual evaluations ofcomparative images confirmedthat the Leica FL560 enabledvisualization of intra-operativeblood flow and vesselarchitecture in the | |
| Predicate Device: Data wascollected using indocyaninegreen (ICG) fluorescent dyeintroduced into the vascularsystem of a porcine model.Data regarding the ability tovisualize blood flow and vascularstructures was collected andcompared directly to datacollected with the subject deviceLeica FL560 on the same porcinemodel and using FluoresceinSodium (FS) fluorescent dye | Subject Device: Data wascollected using FluoresceinSodium (FS) fluorescent dyeintroduced into the vascularsystem of a porcine model.Data regarding the ability tovisualize blood flow and vascularstructures was collected andcompared directly to datacollected with the predicatedevice Leica FL800ULT on thesame porcine model and usingICG fluorescent dye. | cerebrovascular area in afunctionally equivalent manner tothe predicate device Leica FL800ULT (n=18 comparative reviews,100% confirmation).The FL560 additionally enabledconcurrent visualization ofbackground anatomicalstructures. | |
| Primary Predicate | Subject Device | ||
| Device → | Leica FL800 ULT(K141136) | Leica FL560(Proposed new accessory) | Demonstration ofSubstantial Equivalence(SE) |
| SUMMARY OF SUPPORTING TESTING, CONTINUED | |||
| HumanFactors | Summary of Test Objectives and Design: Human factors and usabilitytesting was completed at the University of Utah Department ofNeurosurgery using pre-defined test cases and objective pass/failcriteria pre-defined within the protocol. Two distinct user groups(neurosurgeons, nurses/techs) were assessed for their ability toperform specific clinical use demands. 15 users per group wereassessed via observational analysis. The 10-year marketing history ofpredicate device FL800 and the FL560 risk analysis provided the basisfor establishing key test elements and acceptance criteria.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 Leica FL560 module and using acerebral vascular aneurysm phantom model flushed in with fluoresceinand water in an alternating manner. Studies were conducted to reflectstandard use cases, parameter adjustments, and interfacesencountered during routine use of the Leica FL560 module bysurgeons and 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. | Results Summary:EquivalentHuman factors testing confirmedthat the FL560 usability wasequivalent to Leica priorexperience with FL800.Similar controls and interfacesenabled 100% of users in bothgroups to perform key functions.FL560 consistently visualized testcard fluorescence and fluoresceinfluorescence in a phantomvascular model. | |
| Predicate Device:Historical controls viamarketing and CAPAexperience withpredicate deviceFL800 were utilizedinstead of directcomparative testing. | Subject Device:Neurosurgeons performed tasks with theoptics carrier (with control handle) containingthe Leica FL560 observation filter andrepresentative of their product interactionwithin the sterile field during surgery.Circulating nurses performed tasks utilizingthe interface screen outside of the sterilefield before and during surgery.Both groups performed test card verificationsof FL560 function in accordance with User |
Substantial Equivalence Summary Table: Comparison to Predicate Device
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From Eye to Insight
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§ 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.