Predicate Devices

YELLOW 560 (K162991), INFRARED 800 with FLOW 800 Option (K100468)

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a fluorescence accessory for a surgical microscope that uses filters and light to visualize blood flow. There is no mention of AI or ML in the intended use, device description, or performance studies. The functionality is based on optical principles and user activation.

Therapeutic

No
The device is described as an accessory to a surgical microscope intended for viewing and visual assessment of blood flow and vessels, aiding the surgeon in visualization during procedures rather than directly treating a condition.

Diagnostic

Yes

The device aids in the "viewing and visual assessment of intraoperative blood flow" and "assessing cerebral aneurysm and vessel branch occlusion, as well as patency of very small perforating vessels," which involves identifying and evaluating a medical condition.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the device is a "surgical microscope accessory" and describes physical components like "emission filter wheels" and filters installed in the microscope head. This indicates it is a hardware device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an In Vitro Diagnostic (IVD).

Here's why:

IVDs are used to examine specimens derived from the human body. The intended use and device description clearly state that this device is a surgical microscope accessory used for viewing and visual assessment of intraoperative blood flow directly within the patient's body. It does not analyze samples taken from the body.
The device is used during surgical procedures. IVDs are typically used in laboratory settings or at the point of care for diagnostic purposes based on analyzing biological samples.
The device relies on fluorescence emitted from tissue within the body. It's not analyzing the chemical or biological properties of a sample in a test tube or on a slide.

The device is a surgical imaging accessory that aids the surgeon in visualizing structures and blood flow during surgery. This falls under the category of medical devices used for visualization and guidance during procedures, not for in vitro diagnostic testing.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

· 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.

Product codes (comma separated list FDA assigned to the subject device)

IZI

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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Fluorescent image of the distribution of the dye in the patient's blood vessels during the operation.

Anatomical Site

cerebral vascular area

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Prescription Use

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

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

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

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Signal-to-noise ratio of the video image (sensitivity)

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.

YELLOW 560 (K162991), INFRARED 800 with FLOW 800 Option (K100468)

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.

Not Found

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

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.

Summary

0

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

1

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

2

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)

· 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.

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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3

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

1. SUBMITTER

| Applicant: | Carl Zeiss Meditec AG
Goeschwizer Strasse 51-52
D-07745 Jena
Germany |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Correspondent | Chaitali Gawde
Senior Regulatory Affairs Specialist
Carl Zeiss Meditec, Inc.
5300 Central Parkway Dublin, CA 94568
(224) 300-3992 Phone
E-mail: chaitali.gawde@zeiss.com (preferred) |
| Secondary Correspondent | Paul Swift
Head of Regulatory and Clinical Affairs- Americas
Carl Zeiss Meditec, Inc.
5300 Central Parkway Dublin, CA 94568
(817) 925-8507 Phone
E-mail: paul.swift@zeiss.com |

Date Prepared:

June 12, 2023

4

2. DEVICE

| Device Trade Name: | Fluorescence Accessories (YELLOW 560 and INFRARED 800
with 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

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

5

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.

6

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES 6.

			Table 1. Subject to Predicate Devices Comparison Table – Indications for Use
--	--	--	------------------------------------------------------------------------------

| Attribute | Subject Device
Fluorescence Accessories | Predicate Device
YELLOW 560 (K162991) | Predicate Device
INFRARED 800 with FLOW
800 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 | - |
| Classification
Product Code | IZI | IZI | IZI | Identical |
| Regulation Number | 892.1600 | 892.1600 | 892.1600 | Identical |
| Classification
Advisory
Committee | Radiology | Radiology | Radiology | Identical |
| Review Advisory
Committee | General & Plastic Surgery | General & Plastic Surgery | General & Plastic Surgery | Identical |
| Application | Angiography | Angiography | Angiography | Identical |
| Attribute | Subject Device
Fluorescence Accessories | Predicate Device
YELLOW 560 (K162991) | Predicate Device
INFRARED 800 with FLOW
800 Option (K100468) | Equivalency Analysis |
| Indications for use | • 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 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 | N/A | The Carl Zeiss Surgical
INFRARED 800 with FLOW
Option is a surgical microscope
accessory used in viewing and
visual assessment of intra-
operative blood flow in the
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 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, plastic
and reconstructive procedures and
coronary artery bypass graft
surgery | Equivalent, except for some minor
editorial adjustments |
| Attribute | Subject Device
Fluorescence Accessories | Predicate Device
YELLOW 560 (K162991) | Predicate Device
INFRARED 800 with FLOW
800 Option (K100468) | Equivalency Analysis |
| | 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 | 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 minor
editorial adjustments |
| Attribute | Subject Device
Fluorescence Accessories | Predicate Device
YELLOW 560 (K162991) | Predicate Device
INFRARED 800 with FLOW
800 Option (K100468) | Equivalency Analysis |
| | Malformation (AVM)
surgery. | | | |
| Patient Population | Patient population will be all
patients undergoing one of the
above procedures. | Patient population will be all
patients undergoing one of the
above procedures. | Patient population will be all
patients undergoing one of the
above procedures. | Identical |
| Device Description | Visualization system that
utilizes accessory to surgical
microscope for intraoperative
imaging | Accessory to surgical stereo
microscope for
intraoperative imaging. | Accessory to surgical stereo
microscope for intraoperative
imaging. | Equivalent |
| Accessory to | Unspecified model of surgical
microscope | OPMI PENTERO 800/900 | OPMI Pentero | Equivalent
The subject is not dependent on a
specific microscope model and
enlists compatible surgical
microscope specifications (which fit
OPMI PENTERO 800/900 amongst
others). |
| Fluorescent Agent | Sodium Fluorescein
FLUORESCITE® may be
obtained from Alcon, Inc.
AK-FLUOR® may be obtained
from Akorn, Inc. | Sodium Fluorescein
FLUORESCITE® may be
obtained from Alcon, Inc.
AK-FLUOR® may be
obtained from Akorn, Inc. | N/A | Identical |
| Indocyanine Green (ICG) | Indocyanine Green (ICG)
ICG may be obtained from
Akorn, Inc., Pulsion Medical | N/A | Indocyanine Green (ICG)
ICG may be obtained from Akorn,
Inc., Pulsion Medical Systems, or
other ICG manufacturers. | Identical |
| Attribute | Subject Device
Fluorescence Accessories | Predicate Device
YELLOW 560 (K162991) | Predicate Device
INFRARED 800 with FLOW
800 Option (K100468) | Equivalency Analysis |
| | Systems, or other ICG
manufacturers. | | | |
| Result | Fluorescent image of the
distribution of the dye in the
patient's blood vessels during
the operation. | Fluorescent image of the
distribution of the sodium
fluorescein dye in the
patient's blood vessels
during the operation. | Fluorescent image of the
distribution of the dye in the
patient's blood vessels during the
operation. FLOW 800 provides
overview and comparison
functions of display and a
summary of the dynamic of the
fluorescent dye. | Equivalent |
| Visualization of
Real-Time Images | Yes | Yes | Yes | Identical |
| Sensor | Eyepiece/
video camera (CMOS or CCD
sensor) fitting with the related
specifications.
Minimal pixel resolution:
Standard Definition (720 x
480) | Eyepiece/
CMOS video camera
High-Definition resolution
(1280 x 720) | CCD video camera, near-infrared
sensitive
Standard Definition resolution
(720 x 480) | No specific manufacturer mentioned.
Specifications as found under
section 10.5.4 must be fulfilled |
| Visualization
Monitor, Interface | microscope Monitor | microscope Monitor | microscope Monitor | Identical |
| Display | Video and images are presented
on monitor. Image may also be
displayed in the eyepiece. | Video and images are
presented on monitor. Image
may also be displayed in the
eyepiece. | Video and images are presented on
monitor. Image may also be
displayed in the eyepiece. Picture
in Picture available | Equivalent.
'Picture in Picture available' deleted
in the subject device as this is a
functionality of the surgical
microscope. |
| Termination of the
Fluorescence
Accessories | YELLOW 560: N/A
INFRARED 800 with FLOW
Option: | N/A (A turn off is not
necessary because the
exposure is in the visible
light and covered by the | Determined by surgeon within the
first 5 minutes. Automatic
termination after 5 minutes | Termination is not relevant for the
clinical performance. 5 Minute note
is given to the surgeon |
| Attribute | Subject Device
Fluorescence Accessories | Predicate Device
YELLOW 560 (K162991) | Predicate Device
INFRARED 800 with FLOW
800 Option (K100468) | Equivalency Analysis |
| | Termination determined by
surgeon within the first 5
minutes.
After 5 minutes automatic
reduction of the excitation light
after the typical duration of use
(5 minutes) to the value
resulting from the limitation
depending on the working
distance and advice to the user. | general light hazard
consideration.) | | |
| Physical Method | White light;
Fluorescence | White light;
Fluorescence | White light;
Fluorescence | Identical |
| Light Source | Non-laser light source -
Minimum Irradiance must be
met (see section 10.5.4) | 300 Watt Xenon | 300 Watt Xenon | Replaced by irradiance required for
acceptable illumination |
| White Light
Application Filter | 400 nm - 700 nm | 400 nm - 700 nm | 400 nm - 700 nm | Identical |
| Fluorescence
Excitation | YELLOW 560:
450-510nm
Bandpass filter

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510(k) Summary K231075

Page 5 of 12

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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

14

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.