(160 days)
No
The summary describes a surgical microscope accessory that uses fluorescence for visualization. There is no mention of AI, ML, image processing, or any related concepts in the device description, intended use, or performance studies.
No.
The device is an accessory to a surgical microscope providing visualization capabilities, not directly treating a disease or condition.
No
Explanation: The device is described as a surgical microscope accessory used for viewing intra-operative blood flow, which aids in surgical procedures rather than diagnosing a condition. Its function is to visualize existing physiological processes (blood flow) with the aid of a fluorescent dye, not to provide a diagnosis of a disease state.
No
The device is described as a surgical microscope accessory that utilizes illumination light sources, filters, and optics to enable visualization of fluorescence. This description clearly indicates the presence of hardware components.
Based on the provided information, the Leica FL560 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is "viewing intra-operative blood flow in the cerebral vascular area." This is a direct observation of physiological processes within the body during surgery.
- Device Description: The device is an accessory to a surgical operating microscope and uses fluorescence to visualize blood flow in vivo (within a living organism).
- Lack of In Vitro Testing: The performance studies describe preclinical testing on a porcine model and human factors testing in a simulated operating room using a phantom. There is no mention of testing biological samples outside of the body.
- Nature of the Measurement: The device is visualizing blood flow directly within the patient's vascular system, not analyzing a sample taken from the patient.
IVD devices are designed to examine specimens derived from the human body (such as blood, urine, or tissue) in vitro (outside of the body) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The Leica FL560 does not fit this definition. It is a surgical imaging accessory used for in vivo visualization.
N/A
Intended Use / Indications for Use
The Leica FL560 is a surgical microscope accessory used in viewing intra-operative blood flow in the cerebral vascular area.
Product codes (comma separated list FDA assigned to the subject device)
IZI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluorescence
Anatomical Site
cerebral vascular area
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Neurosurgeons, nurses/techs in a simulated operating room and involved typical work flow scenarios.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Bench Testing:
- Summary of Test Objective and Design: In house design verification testing was performed on FL560 to ensure that mechanical and functional requirements including design specifications were met. This was a protocol-driven verification with pre-established pass/fail criteria, ties to design specification and other quality and design control documents, and significant experiential basis drawn from the 10-year marketing history of predicate device FL800. As is typical for design verification, this was a one-arm study using only the subject device FL560 on microscope platform M530 OH6 and assessed vs. historical experience with predicate FL800 (historical control).
- Subject Device: Filter specification: Filters were optically (spectrally), mechanically and geometrically assessed. Optical performance regarding spectral transmission and sufficiency of pass-through illumination was verified. Mechanical: The Leica FL560 assembly geometric, mechanical, and functional integration into the Leica Microsystems M530 OH6 Surgical Operating Microscope was verified. Labeling: Product labels and User Manual were reviewed for completeness, understandability, and accuracy.
Preclinical Testing:
- Summary of Test Objective and Design: A contracted, protocol-driven comparative preclinical study was prospectively performed to confirm that the subject device FL560 enabled viewing of intra-operative blood flow in the cerebrovascular area in a manner that was functionally equivalent to predicate device FL800ULT. Testing was completed at the University of Mainz, Germany Institute of Neurosurgical Pathology by neurosurgeons and veterinarians using test cases, pass/fail criteria, and independent scoring assessments that were predefined within the protocol.
- Subject Device: 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 FL80ULT systems. Data was collected using Fluorescein Sodium (FS) 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.
Human Factors Testing:
- Summary of Test Objectives and Design: Human factors and usability testing was completed at the University of Utah Department of Neurosurgery using pre-defined test cases and objective pass/fail criteria pre-defined within the protocol. Two distinct user groups (neurosurgeons, nurses/techs) were assessed for their ability to perform specific clinical use demands. 15 users per group were assessed via observational analysis. The 10-year marketing history of predicate device FL800 and the FL560 risk analysis provided the basis for establishing key test elements and acceptance criteria. The study was conducted in a simulated operating room and involved typical work flow scenarios including certain troubleshooting scenarios related to safety-critical tasks. Testing was conducted using a Leica Surgical Microscope fitted with the Leica FL560 module and using a cerebral vascular aneurysm phantom model flushed in with fluorescein and water in an alternating manner. Studies were conducted to reflect standard use cases, parameter adjustments, and interfaces encountered during routine use of the Leica FL560 module by surgeons and operating room personnel. The study was designed in accordance with the published FDA guidance "draft Guidance for Industry and Food and Drug Administration Staff – Applying Human Factors and Usability Engineering to Optimize Medical Device Design, 2011.
- Subject Device: Neurosurgeons performed tasks with the optics carrier (with control handle) containing the Leica FL560 observation filter and representative of their product interaction within the sterile field during surgery. Circulating nurses performed tasks utilizing the interface screen outside of the sterile field before and during surgery. Both groups performed test card verifications of FL560 function in accordance with User.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench Testing:
- Study Type: Design verification testing (one-arm study)
- Key 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 460 nm and 500 nm and an observation peak above 510 nm was achieved. Review of FL560 test results vs. historical experience with predicate FL800 and vs. current QC standards for FL800 established that FL560 has functionally equivalent ability to produce excitation and observation peaks for use in viewing fluorescence of fluorophores intraoperatively on a Leica surgical microscope platform.
Preclinical Testing:
- Study Type: Comparative preclinical study
- Key Results: 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 Testing:
- Study Type: Human factors and usability testing
- Sample Size: 15 users per group (neurosurgeons, nurses/techs)
- Key Results: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Leica FL800 ULT – clearance K141136, Leica FL800 – clearance K061871, K080612
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
CIS EyeScan Portable Modular Imaging System, K092374
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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 (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.
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 (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
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)
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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) |
| Max Schmidheiny-Strasse 201 | |
| Heerbrugg, | |
| Sankt Gallen 9435, | |
| Switzerland. | |
| Contact Name | Grainne Griffin |
| Tel | +353 86 7710135 |
| grainne.griffin@leica-microsystems.com | |
| Predicate Device | Primary Leica FL800 ULT – clearance K141136 |
| 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 |
| (SE) | |||
| SUMMARY OF GENERAL FEATURES | |||
| Indications | |||
| for use | The Leica FL800 is a surgical | ||
| Microscope accessory used in | |||
| viewing intra-operative blood | |||
| flow in the cerebral vascular | |||
| area and by-pass grafts during | |||
| coronary artery bypass (CABG) | |||
| surgery, as well as blood flow | |||
| during plastic and reconstructive | |||
| surgery. | The Leica FL560 is a surgical | ||
| Microscope accessory used in | |||
| viewing intra-operative blood | |||
| flow in the cerebral vascular | |||
| area. | Identical to subset of predicate | ||
| indications for use | |||
| For use with | Standard Leica Surgical | ||
| Operating Microscope | |||
| M520 / M525 / M720 & M530 | |||
| product range | Standard Leica M530 OH6/OHX | ||
| Surgical Operating Microscope | |||
| (Class I Exempt) | |||
| Note: FL560 will not be available | |||
| for the M520 / M525 / M720 SOM | |||
| as these are older models | |||
| scheduled for phase out | Identical to subset of predicate | ||
| equipment platforms | |||
| Device | |||
| Components | • Observation filter | ||
| • Illumination filter | |||
| • Filter housing ICG Filter | |||
| • Beam Splitter | |||
| • Built in Dual Video Adaptor | |||
| consisting of Internal NIR | |||
| Camera | • Observation filter | ||
| • Illumination filter | |||
| • Filter housing | Equivalent to subset of predicate | ||
| components (filters equivalent but | |||
| for different wavelength | |||
| specifications) | |||
| Software | No Software | No Software | Identical |
| Required but | |||
| not supplied | • Leica Surgical Microscope | ||
| • Recording device | • Leica Surgical Microscope | Identical to subset of predicate | |
| Drug | ICG | Fluorescein Sodium | |
| (fluorescein)* | Difference does not impact | ||
| substantial equivalence, both | |||
| drugs are fluorophores for | |||
| visualizing blood flow and have | |||
| longstanding 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 | |||
| Illumination | |||
| Filter [nm] | 400 – 780nm | 460 - 500nm | Equivalent, both are band pass |
| filters with overlapping ranges | |||
| Observation | |||
| Filter [nm] | 800 – 880nm | Above ~ 510nm | Equivalent, the FL560 high pass |
| filter range contains the FL800 | |||
| 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: | |
| • AK-FLUOR (fluorescein) | |||
| • FL560 test card | |||
| • Procedure kit IFU | Difference does not impact | ||
| substantial equivalence | |||
| *Reference Device CIS EyeScan Portable Modular Imaging System, K092374, also enables visualization of fluorescein (a | |||
| technical feature of both the subject and reference device) for a different Indication for Use (ophthalmology imaging) but a | |||
| generally equivalent intended use (fluorescence vascular angiography) | |||
| SUMMARY OF SUPPORTING TESTING | |||
| Electrical | |||
| Safety | Conformance to the following | ||
| standards tested and confirmed: | |||
| • IEC 60601-1:2005: Medical | |||
| electrical equipment - Part 1: | |||
| General requirements for | |||
| basic safety and essential | |||
| performance | |||
| • IEC 60601-1-2:2007 | |||
| (Modified): Medical electrical | |||
| equipment - Part 1-2: | |||
| General requirements for | |||
| basic safety and essential | |||
| performance - Collateral | |||
| standard: Electromagnetic | |||
| compatibility - Requirements | |||
| and tests | |||
| • IEC 60601-1-6:2010-06: | |||
| Medical electrical equipment |
- Part 1-6: General
requirements for basic safety
and essential performance - | Conformance to the following
standards tested and confirmed:
• IEC 60601-1:2005: Medical
electrical equipment - Part 1:
General requirements for
basic safety and essential
performance
• IEC 60601-1-2:2007
(Modified): Medical electrical
equipment - Part 1-2:
General requirements for
basic safety and essential
performance - Collateral
standard: Electromagnetic
compatibility - Requirements
and tests
• IEC 60601-1-6:2010-06:
Medical electrical equipment - Part 1-6: General
requirements for basic safety
and essential performance - | Identical, both met all acceptance
criteria |
| | Primary Predicate | Subject Device | |
| Device → | Leica FL800 ULT
(K141136) | Leica FL560
(Proposed new accessory) | Demonstration of
Substantial Equivalence
(SE) |
| | SUMMARY OF SUPPORTING TESTING, CONTINUED | | |
| Bench | Summary of Test Objective and Design: In house design verification
testing was performed on FL560 to ensure that mechanical and
functional requirements including design specifications were met.
This was a protocol-driven verification with pre-established pass/fail
criteria, ties to design specification and other quality and design control
documents, and significant experiential basis drawn from the 10-year
marketing history of predicate device FL800.
As is typical for design verification, this was a one-arm study using
only the subject device FL560 on microscope platform M530 OH6 and
assessed vs. historical experience with predicate FL800 (historical
control).
Predicate Device:
Historical controls via marketing
and CAPA experience with
predicate device FL800 were
utilized instead of direct
comparative testing. | Subject Device:
Filter specification: Filters
were optically (spectrally),
mechanically and
geometrically assessed.
Optical performance
regarding spectral
transmission and sufficiency
of pass-through illumination
was verified. Mechanical: The Leica
FL560 assembly geometric,
mechanical, and functional
integration into the Leica
Microsystems M530 OH6
Surgical Operating
Microscope was verified. Labeling: Product labels and
User Manual were reviewed
for completeness,
understandability, and
accuracy. | Equivalent
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 460 nm
and 500 nm and an observation
peak above 510 nm was
achieved.
Review of FL560 test results vs.
historical experience with
predicate FL800 and vs. current
QC standards for FL800
established that FL560 has
functionally equivalent ability to
produce excitation and
observation peaks for use in
viewing fluorescence of
fluorophores intraoperatively on a
Leica surgical microscope
platform. |
| 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, 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 prospectively performed to confirm
that the subject device FL560 enabled viewing of intra-operative blood
flow in the cerebrovascular area in a manner that was functionally
equivalent to predicate device FL800ULT.
Testing was completed at the University of Mainz, Germany Institute of
Neurosurgical Pathology by neurosurgeons and veterinarians using
test cases, pass/fail criteria, and independent scoring assessments
that were predefined within the protocol.
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 FL80ULT systems. | | Results Summary:
Equivalent
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 |
| | 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
Leica FL560 on the same porcine
model and using Fluorescein
Sodium (FS) fluorescent dye | Subject Device: Data was
collected using Fluorescein
Sodium (FS) 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. | 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. |
| | Primary Predicate | Subject Device | |
| Device → | Leica FL800 ULT
(K141136) | Leica FL560
(Proposed new accessory) | Demonstration of
Substantial Equivalence
(SE) |
| | SUMMARY OF SUPPORTING TESTING, CONTINUED | | |
| Human
Factors | Summary of Test Objectives and Design: Human factors and usability
testing was completed at the University of Utah Department of
Neurosurgery using pre-defined test cases and objective pass/fail
criteria pre-defined within the protocol. Two distinct user groups
(neurosurgeons, nurses/techs) were assessed for their ability to
perform specific clinical use demands. 15 users per group were
assessed via observational analysis. The 10-year marketing history of
predicate device FL800 and the FL560 risk analysis provided the basis
for establishing key test elements and acceptance criteria.
The study was conducted in a simulated operating room and involved
typical work flow scenarios including certain troubleshooting scenarios
related to safety-critical tasks. Testing was conducted using a Leica
Surgical Microscope fitted with the Leica FL560 module and using a
cerebral vascular aneurysm phantom model flushed in with fluorescein
and water in an alternating manner. Studies were conducted to reflect
standard use cases, parameter adjustments, and interfaces
encountered during routine use of the Leica FL560 module by
surgeons and operating room personnel.
The study was designed in accordance with the published FDA
guidance "draft Guidance for Industry and Food and Drug
Administration Staff – Applying Human Factors and Usability
Engineering to Optimize Medical Device Design, 2011. | Results Summary:
Equivalent
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. | |
| | Predicate Device:
Historical controls via
marketing and CAPA
experience with
predicate device
FL800 were utilized
instead of direct
comparative testing. | Subject Device:
Neurosurgeons performed tasks with the
optics carrier (with control handle) containing
the Leica FL560 observation filter and
representative of their product interaction
within the sterile field during surgery.
Circulating nurses performed tasks utilizing
the interface screen outside of the sterile
field before and during surgery.
Both groups performed test card verifications
of FL560 function in accordance with User | |
Substantial Equivalence Summary Table: Comparison to Predicate Device
7
Image /page/7/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.
8
Image /page/8/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, black, sans-serif font. The logo is simple and modern.
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, black, sans-serif font. The logo is simple and modern.
10
From Eye to Insight
Image /page/10/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, sans-serif font underneath. The red color of the "Leica" text is vibrant and eye-catching, while the smaller "MICROSYSTEMS" text provides context for the brand.