· INFRARED 800 with FLOW 800 Option is a surgical microscope accessory intended to be used with a compatible surgical microscope in viewing and visual assessment of intraoperative blood flow in cerebral vascular area including, but not limited to, assessing cerebral aneurysm and vessel branch occlusion, as well as patency of very small perforating vessels. It also aids in the real-time visualization of blood flow and visual assessment of vessel types before and after Arteriovenous Malformation (AVM) surgery. Likewise, INFRARED 800 with FLOW 800 Option used during fluorescence guided surgery aids in the visual assessment of intra-operative blood flow as well as vessel patency in bypass surgical procedures in neurosurgery, plastics and reconstructive procedures and coronary artery bypass graft surgery.

· YELLOW 560 is a surgical microscope accessory intended to be used with a compatible surgical microscope in viewing and visual assessment of intraoperative blood flow in cerebral vascular area including, but not limited to, assessing cerebral aneurysm and vessel branch occlusion, as well as patency of very small perforating vessels. It also aids in the real-time visualization of blood flow and visual assessment of vessel types before and after Arteriovenous Malformation (AVM) surgery.

Device Description

Fluorescence accessories (YELLOW 560 and INFRARED 800 with FLOW 800 option) are an accessory to surgical microscope and are intended for viewing and visual assessment of intra-operative blood flow as well as aids in the real-time visualization of blood flow and visual assessment of vessel types before and after Arteriovenous Malformation (AVM) surgery. The functionality of these filters is derived from their ability to hight fluorescence emitted from tissue that has been treated with a fluorescence agent by applying appropriate wavelengths of light and utilizing selected filters. This helps a surgeon to visualize different structural body elements (such as vessels, tissue, blood flow, occlusions, aneurysms, etc.) during various intraoperative procedures. The fluorescence accessory can be activated by the user via the Graphical User Interface (GUI), foot control panel or the handgrips, for example.

For these accessories to be used with a qualified surgical microscope, the critical components of the surgical microscope need to fulfill the clinically relevant parameters for the Indications for Use of YELLOW 560 and INFRARED 800 with FLOW 800 Option.

The fluorescence accessories are embedded into the surgical microscope. The emission filter wheels are present within the head of the microscope. For filter installation into the surgical microscope, two emissions filters (one for each eyepiece) are placed into each of these filter wheel is present in front of the light source, which is installed along with the excitation filter

AI/ML Overview

The provided text is a 510(k) summary for the Carl Zeiss Meditec Inc. "Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option)". This document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study proving the device meets those criteria.

The 510(k) summary primarily addresses:

Indications for Use: The device is a surgical microscope accessory for viewing and visual assessment of intraoperative blood flow in the cerebral vascular area (e.g., assessing cerebral aneurysm, vessel branch occlusion, patency of small perforating vessels, and vessel types before/after Arteriovenous Malformation (AVM) surgery). It also aids in real-time visualization of blood flow and vessel patency in bypass surgical procedures in neurosurgery, plastics, reconstructive procedures, and coronary artery bypass graft surgery.
Technological Characteristics: Comparison to predicate devices (YELLOW 560 (K162991) and INFRARED 800 with FLOW 800 Option (K100468)) is presented, showing substantial equivalence in application, patient population, device description, fluorescent agents used, visualization of real-time images, display, physical method, fluorescence excitation/detection, white light application, camera adaption, zoom, autofocus, autogain, control system, storage, and upgrade options. Minor differences are noted and deemed not to affect substantial equivalence.
Non-Clinical Testing: A list of performance testing parameters for the system is provided, confirming that the "functional and system level testing showed that the system met the defined specifications."

Therefore, based on the provided text, a detailed table of acceptance criteria and a study proving the device meets those criteria (with specific performance metrics) cannot be fully constructed as requested. The document attests that the device met internal specifications through software verification and non-clinical system testing, but does not provide the specific numerical acceptance criteria or the study results themselves.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Cannot be fully provided as specific numerical acceptance criteria and reported device performance are not detailed in the provided document. The document states that "functional and system level testing showed that the system met the defined specifications" and lists the parameters tested. However, the values for these specifications and the results of the testing are not included.

Acceptance Criteria (Implied / Stated)	Reported Device Performance (Not detailed in document)
Brightness of fluorescence ocular image	Met defined specifications
Excitation wavelength	Met defined specifications
Excitation filter	Met defined specifications
Emission wavelength	Met defined specifications
Emission filter	Met defined specifications
Color reproduction of fluorescence ocular images	Met defined specifications
Spatial resolution of the ocular image	Met defined specifications
Color reproduction of fluorescence video images	Met defined specifications
Non-mirrored video image	Met defined specifications
Non-rotated video image	Met defined specifications
Non-deformed video image	Met defined specifications
Centered video image	Met defined specifications
Photometric resolution of video image	Met defined specifications
Signal-to-noise ratio of the video image (sensitivity)	Met defined specifications
Latency of the video image (external monitor)	Met defined specifications
Spatial resolution of the video image	Met defined specifications
Irradiance (minimum irradiance at maximum illumination)	Met defined specifications
Color reproduction of non-fluorescence ocular images	Met defined specifications
Color reproduction of non-fluorescence video images	Met defined specifications
Software performing as intended	Performed as intended

2. Sample size used for the test set and the data provenance

Sample Size: Not specified. The document mentions "non-clinical system testing" and "software verification testing" but does not provide details on the number of samples, test cases, or images used.
Data Provenance: Not specified. This appears to be internal company testing (bench testing) rather than a study involving patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/Not specified. This was a non-clinical bench and software performance testing; it does not involve expert ground truth for clinical assessment.

4. Adjudication method for the test set

Not applicable/Not specified. As noted above, this was non-clinical bench and software performance testing.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC study was mentioned. The device is an accessory to a surgical microscope providing visualization, not an AI diagnostic tool that assists human readers in interpreting images.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. The device provides "real-time visualization" and "visual assessment," which implies human interpretation of the images/data it presents. It's an accessory, not a standalone automated diagnostic algorithm. The testing described is for the functional and system performance of the accessory.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable for the non-clinical and software testing described. The "ground truth" for the performance testing would be the predefined specifications that the system components were designed to meet.

8. The sample size for the training set

Not applicable. The description does not suggest this device uses machine learning or AI that would require a "training set" in the conventional sense for image analysis. It's a fluorescence visualization system.

9. How the ground truth for the training set was established

Not applicable, as there is no mention of a training set.

Summary

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

June 20, 2023

Carl Zeiss Meditec Inc Chaitali Gawde Senior Regulatory Affairs Specialist 5300 Central Parkway Dublin, California 94568

Re: K231075

Trade/Device Name: Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option) Regulation Number: 21 CFR 892.1600 Regulation Name: Angiographic X-Ray System Regulatory Class: Class II Product Code: IZI Dated: April 14, 2023 Received: April 14, 2023

Dear Chaitali Gawde:

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

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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 https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Jessica Carr -S

Jessica Carr, PhD Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K231075

Device Name

Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option)

Indications for Use (Describe)

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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In accordance with 21 CFR 807.92 the 510(k) Summary for the Fluorescence Accessories is provided below.

1. SUBMITTER

Applicant:	Carl Zeiss Meditec AGGoeschwizer Strasse 51-52D-07745 JenaGermany
Primary Correspondent	Chaitali GawdeSenior Regulatory Affairs SpecialistCarl Zeiss Meditec, Inc.5300 Central Parkway Dublin, CA 94568(224) 300-3992 PhoneE-mail: chaitali.gawde@zeiss.com (preferred)
Secondary Correspondent	Paul SwiftHead of Regulatory and Clinical Affairs- AmericasCarl Zeiss Meditec, Inc.5300 Central Parkway Dublin, CA 94568(817) 925-8507 PhoneE-mail: paul.swift@zeiss.com

Date Prepared:

June 12, 2023

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2. DEVICE

Device Trade Name:	Fluorescence Accessories (YELLOW 560 and INFRARED 800with FLOW 800 Option)
Common Name:	Fluorescence accessories for surgical microscope
Classification:	21 CFR 892.1600 Angiographic x-ray system
Regulatory Class:	II
Product Code:	IZI

3. PREDICATE DEVICE

Predicate Device:	YELLOW 560 (K162991), INFRARED 800 with FLOW 800 Option (K100468)
Manufacturer:	Carl Zeiss Meditec AG
Classification:	21 CFR 892.1600 Angiographic x-ray system
Regulatory Class:	II
Product Code:	IZI

4. DEVICE DESCRIPTION

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INTENDED USE/INDICATIONS FOR USE ട്.

-INFRARED 800 with FLOW 800 Option is a surgical microscope accessory intended to be used with a compatible surgical microscope in viewing and visual assessment of intraoperative blood flow in cerebral vascular area including, but not limited to, assessing cerebral aneurysm and vessel branch occlusion, as well as patency of very small perforating vessels. It also aids in the real-time visualization of blood flow and visual assessment of vessel types before and after Arteriovenous Malformation (AVM) surgery. Likewise, INFRARED 800 with FLOW 800 Option used during fluorescence guided surgery aids in the visual assessment of intra-operative blood flow as well as vessel patency in bypass surgical procedures in neurosurgery, plastics and reconstructive procedures and coronary artery bypass graft surgery.
YELLOW 560 is a surgical microscope accessory intended to be used with a compatible surgical microscope in viewing and visual assessment of intraoperative blood flow in cerebral vascular area including, but not limited to, assessing cerebral aneurysm and vessel branch occlusion, as well as patency of very small perforating vessels. It also aids in the real-time visualization of blood flow and visual assessment of vessel types before and after Arteriovenous Malformation (AVM) surgery.

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COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES 6.

			Table 1. Subject to Predicate Devices Comparison Table – Indications for Use
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Attribute	Subject DeviceFluorescence Accessories	Predicate DeviceYELLOW 560 (K162991)	Predicate DeviceINFRARED 800 with FLOW800 Option (K100468)	Equivalency Analysis
Manufacturer	Carl Zeiss Meditec AG	Carl Zeiss Meditec AG	Carl Zeiss Meditec AG/ Carl Zeiss Surgical GmbH	Identical (name has been changed)
510(k)	K231075	K162991	K100468	-
ClassificationProduct Code	IZI	IZI	IZI	Identical
Regulation Number	892.1600	892.1600	892.1600	Identical
ClassificationAdvisoryCommittee	Radiology	Radiology	Radiology	Identical
Review AdvisoryCommittee	General & Plastic Surgery	General & Plastic Surgery	General & Plastic Surgery	Identical
Application	Angiography	Angiography	Angiography	Identical
Attribute	Subject DeviceFluorescence Accessories	Predicate DeviceYELLOW 560 (K162991)	Predicate DeviceINFRARED 800 with FLOW800 Option (K100468)	Equivalency Analysis
Indications for use	• INFRARED 800 withFLOW 800 Option is asurgical microscopeaccessory intended to beused with a compatiblesurgical microscope inviewing and visualassessment ofintraoperative blood flow incerebral vascular areaincluding, but not limitedto, assessing cerebralaneurysm and vessel branchocclusion, as well aspatency of very smallperforating vessels. It alsoaids in the real-timevisualization of blood flowand visual assessment ofvessel types before andafter ArteriovenousMalformation (AVM)surgery. Likewise,INFRARED 800 withFLOW Option used duringfluorescence guided surgeryaids in the visualassessment of intra-operative blood flow aswell as vessel patency inbypass surgical procedures	N/A	The Carl Zeiss SurgicalINFRARED 800 with FLOWOption is a surgical microscopeaccessory used in viewing andvisual assessment of intra-operative blood flow in thecerebral vascular area including,but not limited to, assessingcerebral aneurysm and vesselbranch occlusion, as well aspatency of very small perforatingvessels. It also aids in the real-timevisualization of blood flow andvisual assessment of vessel typesbefore and after ArteriovenousMalformation (AVM) surgery.Likewise, INFRARED 800 withFLOW Option used duringfluorescence guided surgery aidsin the visual assessment of intra-operative blood flow as well asvessel patency in bypass surgicalprocedures in neurosurgery, plasticand reconstructive procedures andcoronary artery bypass graftsurgery	Equivalent, except for some minoreditorial adjustments
Attribute	Subject DeviceFluorescence Accessories	Predicate DeviceYELLOW 560 (K162991)	Predicate DeviceINFRARED 800 with FLOW800 Option (K100468)	Equivalency Analysis
	in neurosurgery, plasticsand reconstructiveprocedures and coronaryartery bypass graft surgery
	YELLOW 560 is a surgical microscope accessory intended to be used with a compatible surgical microscope in viewing and visual assessment of intraoperative blood flow in cerebral vascular area including, but not limited to, assessing cerebral aneurysm and vessel branch occlusion, as well as patency of very small perforating vessels. It also aids in the real-time visualization of blood flow and visual assessment of vessel types before and after Arteriovenous	The ZEISS YELLOW 560 is a surgical microscope accessory used in viewing and visual assessment of intraoperative blood flow in the cerebral vascular area including, but not limited to, assessing cerebral aneurysm and vessel branch small perforating vessels. It also aids in the real-time visualization of blood flow and visual assessment of vessel types before and after Arteriovenous Malformation (AVM) surgery.	N/A	Equivalent, except for some minoreditorial adjustments
Attribute	Subject DeviceFluorescence Accessories	Predicate DeviceYELLOW 560 (K162991)	Predicate DeviceINFRARED 800 with FLOW800 Option (K100468)	Equivalency Analysis
	Malformation (AVM)surgery.
Patient Population	Patient population will be allpatients undergoing one of theabove procedures.	Patient population will be allpatients undergoing one of theabove procedures.	Patient population will be allpatients undergoing one of theabove procedures.	Identical
Device Description	Visualization system thatutilizes accessory to surgicalmicroscope for intraoperativeimaging	Accessory to surgical stereomicroscope forintraoperative imaging.	Accessory to surgical stereomicroscope for intraoperativeimaging.	Equivalent
Accessory to	Unspecified model of surgicalmicroscope	OPMI PENTERO 800/900	OPMI Pentero	EquivalentThe subject is not dependent on aspecific microscope model andenlists compatible surgicalmicroscope specifications (which fitOPMI PENTERO 800/900 amongstothers).
Fluorescent Agent	Sodium FluoresceinFLUORESCITE® may beobtained from Alcon, Inc.AK-FLUOR® may be obtainedfrom Akorn, Inc.	Sodium FluoresceinFLUORESCITE® may beobtained from Alcon, Inc.AK-FLUOR® may beobtained from Akorn, Inc.	N/A	Identical
Indocyanine Green (ICG)	Indocyanine Green (ICG)ICG may be obtained fromAkorn, Inc., Pulsion Medical	N/A	Indocyanine Green (ICG)ICG may be obtained from Akorn,Inc., Pulsion Medical Systems, orother ICG manufacturers.	Identical
Attribute	Subject DeviceFluorescence Accessories	Predicate DeviceYELLOW 560 (K162991)	Predicate DeviceINFRARED 800 with FLOW800 Option (K100468)	Equivalency Analysis
	Systems, or other ICGmanufacturers.
Result	Fluorescent image of thedistribution of the dye in thepatient's blood vessels duringthe operation.	Fluorescent image of thedistribution of the sodiumfluorescein dye in thepatient's blood vesselsduring the operation.	Fluorescent image of thedistribution of the dye in thepatient's blood vessels during theoperation. FLOW 800 providesoverview and comparisonfunctions of display and asummary of the dynamic of thefluorescent dye.	Equivalent
Visualization ofReal-Time Images	Yes	Yes	Yes	Identical
Sensor	Eyepiece/video camera (CMOS or CCDsensor) fitting with the relatedspecifications.Minimal pixel resolution:Standard Definition (720 x480)	Eyepiece/CMOS video cameraHigh-Definition resolution(1280 x 720)	CCD video camera, near-infraredsensitiveStandard Definition resolution(720 x 480)	No specific manufacturer mentioned.Specifications as found undersection 10.5.4 must be fulfilled
VisualizationMonitor, Interface	microscope Monitor	microscope Monitor	microscope Monitor	Identical
Display	Video and images are presentedon monitor. Image may also bedisplayed in the eyepiece.	Video and images arepresented on monitor. Imagemay also be displayed in theeyepiece.	Video and images are presented onmonitor. Image may also bedisplayed in the eyepiece. Picturein Picture available	Equivalent.'Picture in Picture available' deletedin the subject device as this is afunctionality of the surgicalmicroscope.
Termination of theFluorescenceAccessories	YELLOW 560: N/AINFRARED 800 with FLOWOption:	N/A (A turn off is notnecessary because theexposure is in the visiblelight and covered by the	Determined by surgeon within thefirst 5 minutes. Automatictermination after 5 minutes	Termination is not relevant for theclinical performance. 5 Minute noteis given to the surgeon
Attribute	Subject DeviceFluorescence Accessories	Predicate DeviceYELLOW 560 (K162991)	Predicate DeviceINFRARED 800 with FLOW800 Option (K100468)	Equivalency Analysis
	Termination determined bysurgeon within the first 5minutes.After 5 minutes automaticreduction of the excitation lightafter the typical duration of use(5 minutes) to the valueresulting from the limitationdepending on the workingdistance and advice to the user.	general light hazardconsideration.)
Physical Method	White light;Fluorescence	White light;Fluorescence	White light;Fluorescence	Identical
Light Source	Non-laser light source -Minimum Irradiance must bemet (see section 10.5.4)	300 Watt Xenon	300 Watt Xenon	Replaced by irradiance required foracceptable illumination
White LightApplication Filter	400 nm - 700 nm	400 nm - 700 nm	400 nm - 700 nm	Identical
FluorescenceExcitation	YELLOW 560:450-510nmBandpass filterINFRARED 800 with FLOW800 Option:400 nm to 780 nmBandpass filter	450 - 510nmBandpass filter	400 nm - 780 nmBandpass filter	Identical
FluorescenceDetection	Filter with high transmissionfrom 530 nm to 700 nm(YELLOW 560) and815 nm to 925 nm(INFRARED 800 with FLOW800 Option)	Filter with high transmissionfrom 530 nm to 700 nm	Filter with high transmission from815 nm to 925 nm	Identical
Attribute	Subject DeviceFluorescence Accessories	Predicate DeviceYELLOW 560 (K162991)	Predicate DeviceINFRARED 800 with FLOW800 Option (K100468)	Equivalency Analysis
White lightApplication	400 – 700 nm	400 – 700 nm	400 – 700 nm	Identical
Distance of imaging 200 - 625 mmhead to patient	200 – 625 mm	200 – 500 mm	200 - 500 mm	Equivalent.However, the difference in largerworking distances (500 mm and625 mm) is not relevant asfluorescence is typically used within200 - 400 mm. The increased rangeis to accommodate the white lightmode.
Camera adaption	Integrated into microscopehead	Integrated into microscopehead	Integrated into microscope head	Identical
Zoom	Motorized 6:1 or higher	Motorized 6:1	Motorized 6:1	Identical
Autodetection offluorescence influx	Yes, optional	Yes	Yes	Equivalent, comfort feature ofINFRARED 800 with FLOW 800Option
Autofocus	Yes	Yes	Yes	Identical
Autogain forrecording	Yes	Yes	Yes	Identical
Control System	Personal Computer orEmbedded Computer	Embedded Computer	Personal Computer	Identical.
Storage	HDD, DVD, SSD or othermedia	HDD, DVD	HDD, DVD	More storage type media possible.
Available asupgrade for existingmicroscopes	Yes, via Service Technician	Yes, via Service Technician	Yes, via Service Technician	Identical

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510(k) Summary K231075

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7. SUMMARY OF STUDIES

Sterilization and Shelf Life

The device is provided non-sterile. Shelf-Life is not applicable.

Biocompatibility

The device does not have patient-contacting materials; therefore, a biocompatibility assessment is not needed for this device.

Performance Testing - Bench

In order for the Fluorescence Accessories to work, they have to be installed onto a surgical microscope and a software license to the microscope has to be installed. Software verification testing has been performed to demonstrate that software is performing as intended.

Non-clinical system testing provided an evaluation of the performance of the system relevant to each of the system specifications. The functional and system level testing showed that the system met the defined specifications. To ensure that the clinically relevant parameters for the Indications for Use of the fluorescence accessories are fulfilled, the following parameters/specifications were tested:

Brightness of the fluorescence ocular image ●
Excitation wavelength .
Excitation filter
Emission wavelength ●
Emission filter .
Color reproduction of fluorescence ocular images
. Spatial resolution of the ocular image
Color reproduction of fluorescence video images .
Non-mirrored video image
Non-rotated video image ●
Non-deformed video image .
Centered video image ●
. Photometric resolution of video image
. Signal-to-noise ratio of the video image (sensitivity)
Latency of the video image (external monitor)
. Spatial resolution of the video image
. Irradiance (minimum irradiance at maximum illumination)
. Color reproduction of non-fluorescence ocular images
. Color reproduction of non-fluorescence video images

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CONCLUSION 8.

The indications for use are equivalent to the indications for use of the predicate devices; and therefore, are deemed to be equivalent in their relationship to safety and effectiveness.

The technological characteristics and risk profile of the subject device are equivalent to the predicate devices; and therefore, are deemed to be equivalent in their relationship to safety and effectiveness.

Testing methods are equivalent to those of the predicate devices; and therefore, are deemed to be equivalent in their relationship to safety and effectiveness.

Therefore, the subject device meets the requirements for substantial equivalence.

Regulation Number and Section

§ 892.1600 Angiographic x-ray system.

(a)
Identification. An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.