(88 days)
No
The summary describes image processing (digitally combining video streams) but does not mention AI, ML, or any related concepts like training sets, test sets, or performance metrics typically associated with AI/ML algorithms. The performance studies focus on functional equivalence and usability compared to a predicate device.
No
The device is used for "viewing intra-operative blood flow and related tissue perfusion" and "allows the surgical microscope to produce excitation light and resolve fluorescent emission". It is a diagnostic tool, not a therapeutic one.
Yes
Explanation: The device is described as allowing the surgical microscope to produce excitation light and resolve fluorescent emission from a fluorescent agent to depict the distribution of the infra-red dye in the patient's blood vessels during surgery. This function directly provides information about the patient's physiological state (blood flow/perfusion), which is diagnostic in nature. While it's an accessory for a surgical microscope, its primary purpose is to provide critical visual information for decision-making during surgery.
No
The device description explicitly states that the GLOW800 is an "accessory to the Leica Microsystems (LMS) Class I 510(k) exempt surgical operating microscope (SOM)" and that it "allows the surgical microscope to produce excitation light and resolve fluorescent emission". This indicates the device includes hardware components (filters, potentially light sources or detectors) that interact with the microscope hardware, not just software processing of data.
Based on the provided information, the GLOW800 device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine specimens outside of the body.
- GLOW800 Function: The GLOW800 is a surgical microscope accessory used during surgery to visualize blood flow and tissue perfusion within the patient's body using a fluorescent agent (ICG). It is a non-contact, non-invasive device that aids the surgeon in real-time visualization during the procedure.
The GLOW800 is a medical device used for in vivo imaging and visualization during surgical procedures, not for testing samples in vitro.
N/A
Intended Use / Indications for Use
The GLOW800 is a Leica Surgical Microscope accessory used in viewing intra-operative blood flow and related tissue perfusion in the cerebral vascular region as well as blood flow following plastic and reconstructive surgery and coronary artery bypass grafting (CABG).
Product codes
IZI
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluorescence video angiography, Near Infra-red (NIR) video stream, Visible Light (VL) video stream
Anatomical Site
Cerebral vascular region, blood flow following plastic and reconstructive surgery and coronary artery bypass grafting (CABG)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgical setting, involving neurosurgeons, nurses/techs, and other allied health professionals.
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
Human factors and usability testing was completed at the Mt. Sinai Medical Center Neurosurgery Simulation Core, Annenberg Building, New York, 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. In all 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 marketing history of predicate device FL800 ULT and the GLOW800 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 GLOW800 module and using a cerebral vascular aneurysm phantom model flushed in with ICG and water in an alternating manner. Studies were conducted to reflect standard use cases, parameter adjustments, and interfaces encountered during routine use of the GLOW800 module by surgeons and operating room personnel.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench Testing:
Summary of Test Objective and Design: In house design verification testing was performed on GLOW800 to ensure that software, 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 GLOW800 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 GLOW800 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.
Results Summary: Equivalent. 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. Review of GLOW800 test results vs. historical experience with predicate FL800ULT and vs. current QC standards for FL800 established that the GLOW800 has functionally equivalent ability to produce excitation and observation peaks for use in viewing fluorescence of fluorophores intraoperatively on a Leica surgical microscope platform. 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. This included recovery from faults and errors.
Preclinical Testing:
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: Equivalent. 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 additionally enabled visualization of anatomical structures within the surgical field of view.
Human Factors Testing:
Summary of Test Objectives and Design: Human factors and usability testing was completed at the Mt. Sinai Medical Center Neurosurgery Simulation Core, Annenberg Building, New York, 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. In all 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 marketing history of predicate device FL800 ULT and the GLOW800 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 GLOW800 module and using a cerebral vascular aneurysm phantom model flushed in with ICG and water in an alternating manner. Studies were conducted to reflect standard use cases, parameter adjustments, and interfaces encountered during routine use of the GLOW800 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 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 GLOW800 and associated User Manual instructions to be intuitive and simple.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
100% confirmation for visualization of intra-operative blood flow and vessel architecture in preclinical study.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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)
The GLOW800 is a Leica Surgical Microscope accessory used in viewing intra-operative blood flow and related tissue perfusion in the cerebral vascular region as well as blood flow following plastic and reconstructive surgery and coronary artery bypass grafting (CABG).
Type of Use (Select one or both, as applicable)
| ☑ 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)
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K181537 Traditional 510(k) Summary
Subject Device
| Trade Name | GLOW800 |
|---|---|
| Common Name | Fluorescent Angiographic System |
| Classification | Class II; Angiographic X-ray System, 21 CFR 892.1600 |
| Product Code | IZI |
| Submitter Name | Leica Microsystems (Schweiz) AG. |
| Submitter Address | Max Schmidheiny-Strasse 201 |
| Heerbrugg, | |
| Sankt Gallen 9435, Switzerland | |
| Telephone Number | +41 71 726 32 45 |
| Preparation Date | September 7th, 2018 |
| Predicate Device | K141136 Leica FL800 ULT and FL800 |
| 21 CFR 892.1600, system, x-ray, angiographic, IZI product code |
Device Description
Similar to the predicate device (Leica FL800 most recently cleared under K141136 and previously in K061871 and K080612), the GLOW800 is an accessory to the Leica Microsystems (LMS) Class I 510(k) exempt surgical operating microscope (SOM).
The GLOW800, a non-contact, non-invasive device similar to its predicate, allows the surgical microscope to produce excitation light and resolve fluorescent emission from the fluorescent agent Indocyanine green (ICG). The generated fluorescence signal depicts the distribution of the infra-red dye in the patient's blood vessels during the surgical procedure (fluorescence video angiography). The ICG fluorescence peak is captured for display on the SOM screen. Using an additional camera to capture the visible light (VL) video stream and digitally combining with the Near Infra-red (NIR) video stream presents a high definition display of the surgical site as a pseudocoloured combined image of the same field of view (FOV), which includes anatomical information.
The GLOW800 utilizes the illumination light source, supplied as standard with the SOM to produce excitation light which is filtered using an illumination filter (also referred to as the excitation filter) within the 750 and 800 spectral wavelength range.
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Device Intended Use
The GLOW800 is a surgical microscope accessory used in viewing fluorescence of fluorophores with an excitation peak between ~750 nm and ~800 nm and the fluorescence emission in a spectral band above ~800 nm.
Device Indication for Use
The GLOW800 is a Leica Surgical Microscope accessory used in viewing intra-operative blood flow and related tissue perfusion in the cerebral vascular region as well as blood flow following plastic and reconstructive surgery and coronary artery bypass grafting (CABG).
Non-Clinical, Bench, and Clinical Performance Testing
Pre-clinical studies, human factors studies, electrical safety and in-house been conducted to demonstrate the substantial equivalence of the GLOW800 to the predicate Leica FL800 ULT. Please see the Comparison Table below for testing information and summaries of the test methods which were used to demonstrate substantial equivalence to the predicate.
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Substantial Equivalence Summary Table: Comparison to Predicate Device
| Primary Predicate | Subject Device | Comment | |
|---|---|---|---|
| Device → | Leica FL800 | GLOW800 | Substantial Equivalence |
| What↓ | K141136 | K181537 | (SE) Discussion |
| SUMMARY OF GENERAL FEATURES | |||
| Indications | |||
| 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 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). | Similar; Proposed IFU involves | ||
| expansion of the cleared IFU | |||
| For use with | Standard Leica surgical | ||
| microscope (Class I 510(k) | |||
| exempt M520 / M525 / M720 & | |||
| M530 product range | Standard Leica surgical | ||
| microscope (Class I 510(k) | |||
| exempt) M530 product range | 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 No Software | Observation filter Illumination filter Filter housing ICG Filter Beam splitter Built in Dual Video Adaptor | ||
| consisting of internal NIR | |||
| camera and visible light | |||
| camera GLOW800 Software V 1.1 | Equivalent to subset of predicate | ||
| components. The GLOW800 | |||
| introduces additional visible light | |||
| camera to provide anatomical | |||
| information. | |||
| 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. | |||
| In addition, comparative | |||
| evaluations confirmed that the | |||
| GLOW800 software enabled | |||
| visualization of background | |||
| anatomical structures. | |||
| Primary Predicate | Subject Device | ||
| Device → | Leica FL800 | ||
| K141136 | GLOW800 | ||
| K181537 | Demonstration of | ||
| What↓ | Substantial Equivalence | ||
| (SE) | |||
| SUMMARY OF GENERAL FEATURES- CONTINUED | |||
| Required but | |||
| not supplied | • Leica surgical microscope | ||
| • Recording device | • Identical to subset of | ||
| predicate equipment – no | |||
| recording device required | Identical to predicate | ||
| Drug | ICG | Same | Identical to predicate |
| 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 |
| Device → | Primary Predicate | Subject Device | Demonstration of
Substantial Equivalence
(SE) |
| What↓ | Leica FL800
K141136 | GLOW800
K181537 | |
| | SUMMARY OF GENERAL FEATURES- CONTINUED | | |
| Bench | Summary of Test Objective and Design: In house design verification
testing was performed on GLOW800 to ensure that software, 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 GLOW800 on microscope platform M530 OH6 and
assessed vs. historical experience with predicate FL800 (historical
control). | | 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 750
nm and 800 nm and an
observation peak above 800
nm was achieved.
Review of GLOW800 test
results vs. historical experience
with predicate FL800ULT and
vs. current QC standards for
FL800 established that the
GLOW800 has functionally
equivalent ability to produce
excitation and observation
peaks for use in viewing
fluorescence of fluorophores
intraoperatively on a Leica
surgical microscope platform.
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. This
included recovery from faults
and errors. |
| | Predicate Device:
Historical controls via marketing
and 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 GLOW800
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. | |
| | 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:
Equivalent
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 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 | | | |
| Human
Factors | Summary of Test Objectives and Design: Human factors and usability
testing was completed at the Mt. Sinai Medical Center Neurosurgery
Simulation Core, Annenberg Building, New York, 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. In
all 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 marketing
history of predicate device FL800 ULT and the GLOW800 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 GLOW800 module and using a
cerebral vascular aneurysm phantom model flushed in with ICG and
water in an alternating manner. Studies were conducted to reflect
standard use cases, parameter adjustments, and interfaces
encountered during routine use of the GLOW800 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.
Predicate Device:
Historical controls via marketing
and experience with predicate
device FL800 were utilized
instead of direct comparative
testing. | Subject Device:
All participants performed tasks
using the surgical operating
microscope equipped with the
GLOW800 accessory and
representative of their product
interaction during surgery for pre-
operative set-up activities and
intra-operative adjustments. | Results Summary:
Equivalent
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 GLOW800 and
associated User Manual
instructions to be intuitive and
simple. |
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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.
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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.
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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.
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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.