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

K231075 · Carl Zeiss Meditec, Inc. · IZI · Jun 20, 2023 · Radiology

Device Facts

• Record ID: K231075
• Device Name: Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option)
• Applicant: Carl Zeiss Meditec, Inc.
• Product Code: IZI · Radiology
• Decision Date: Jun 20, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1600
• Device Class: Class 2

Intended 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.

Device Story

Fluorescence accessories (YELLOW 560 and INFRARED 800 with FLOW 800) are surgical microscope attachments. They use specific excitation light wavelengths and emission filters to visualize fluorescent agents (Sodium Fluorescein or Indocyanine Green) in tissue. The system captures real-time video/images via the microscope's camera (CMOS/CCD) and displays them on a monitor or through the eyepiece. Operated by surgeons during procedures, the device aids in assessing blood flow, vessel patency, and structural elements like aneurysms or AVMs. The system includes automated features like fluorescence influx detection, autofocus, and autogain. By providing real-time visual feedback on vascular perfusion, the device assists surgeons in intraoperative decision-making, potentially improving surgical outcomes in neurovascular and bypass procedures.

Clinical Evidence

Bench testing only. No clinical data provided. System performance was validated against defined specifications including brightness, excitation/emission wavelengths, spatial resolution, signal-to-noise ratio, latency, and color reproduction of both ocular and video images.

Technological Characteristics

Surgical microscope accessory consisting of excitation and emission filter wheels. Light source: Non-laser (minimum irradiance requirements). Imaging: CMOS/CCD camera, motorized 6:1 zoom, 200-625 mm working distance. Connectivity: Integrated into microscope head, controlled via GUI, foot control, or handgrips. Software: Embedded or PC-based control system. Sterilization: Non-sterile.

Indications for Use

Indicated for patients undergoing neurosurgery, plastics, reconstructive, or coronary artery bypass graft surgery requiring intraoperative visualization of blood flow, vessel patency, or assessment of cerebral vascular structures (e.g., aneurysms, AVMs, perforating vessels).

Regulatory Classification

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.

Predicate Devices

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

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

· 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)

| <div> <span> <span style="text-decoration: line-through;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |
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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 AG<br>Goeschwizer Strasse 51-52<br>D-07745 Jena<br>Germany |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Correspondent | Chaitali Gawde<br>Senior Regulatory Affairs Specialist<br>Carl Zeiss Meditec, Inc.<br>5300 Central Parkway Dublin, CA 94568<br>[phone] Phone<br>E-mail: [e-mail] (preferred) |
| Secondary Correspondent | Paul Swift<br>Head of Regulatory and Clinical Affairs- Americas<br>Carl Zeiss Meditec, Inc.<br>5300 Central Parkway Dublin, CA 94568<br>[phone] Phone<br>E-mail: [e-mail] |

Date Prepared:

June 12, 2023

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#### 2. DEVICE

| Device Trade Name: | Fluorescence Accessories (YELLOW 560 and INFRARED 800<br>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

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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 Device<br>Fluorescence Accessories | Predicate Device<br>YELLOW 560 (K162991) | Predicate Device<br>INFRARED 800 with FLOW<br>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<br>Product Code | IZI | IZI | IZI | Identical |
| Regulation Number | 892.1600 | 892.1600 | 892.1600 | Identical |
| Classification<br>Advisory<br>Committee | Radiology | Radiology | Radiology | Identical |
| Review Advisory<br>Committee | General & Plastic Surgery | General & Plastic Surgery | General & Plastic Surgery | Identical |
| Application | Angiography | Angiography | Angiography | Identical |
| Attribute | Subject Device<br>Fluorescence Accessories | Predicate Device<br>YELLOW 560 (K162991) | Predicate Device<br>INFRARED 800 with FLOW<br>800 Option (K100468) | Equivalency Analysis |
| Indications for use | • INFRARED 800 with<br>FLOW 800 Option is a<br>surgical microscope<br>accessory intended to be<br>used with a compatible<br>surgical microscope in<br>viewing and visual<br>assessment of<br>intraoperative blood flow in<br>cerebral vascular area<br>including, but not limited<br>to, assessing cerebral<br>aneurysm and vessel branch<br>occlusion, as well as<br>patency of very small<br>perforating vessels. It also<br>aids in the real-time<br>visualization of blood flow<br>and visual assessment of<br>vessel types before and<br>after Arteriovenous<br>Malformation (AVM)<br>surgery. Likewise,<br>INFRARED 800 with<br>FLOW Option used during<br>fluorescence guided surgery<br>aids in the visual<br>assessment of intra-<br>operative blood flow as<br>well as vessel patency in<br>bypass surgical procedures | N/A | The Carl Zeiss Surgical<br>INFRARED 800 with FLOW<br>Option is a surgical microscope<br>accessory used in viewing and<br>visual assessment of intra-<br>operative blood flow in the<br>cerebral vascular area including,<br>but not limited to, assessing<br>cerebral aneurysm and vessel<br>branch occlusion, as well as<br>patency of very small perforating<br>vessels. It also aids in the real-time<br>visualization of blood flow and<br>visual assessment of vessel types<br>before and after Arteriovenous<br>Malformation (AVM) surgery.<br>Likewise, INFRARED 800 with<br>FLOW Option used during<br>fluorescence guided surgery aids<br>in the visual assessment of intra-<br>operative blood flow as well as<br>vessel patency in bypass surgical<br>procedures in neurosurgery, plastic<br>and reconstructive procedures and<br>coronary artery bypass graft<br>surgery | Equivalent, except for some minor<br>editorial adjustments |
| Attribute | Subject Device<br>Fluorescence Accessories | Predicate Device<br>YELLOW 560 (K162991) | Predicate Device<br>INFRARED 800 with FLOW<br>800 Option (K100468) | Equivalency Analysis |
| | in neurosurgery, plastics<br>and reconstructive<br>procedures and coronary<br>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<br>editorial adjustments |
| Attribute | Subject Device<br>Fluorescence Accessories | Predicate Device<br>YELLOW 560 (K162991) | Predicate Device<br>INFRARED 800 with FLOW<br>800 Option (K100468) | Equivalency Analysis |
| | Malformation (AVM)<br>surgery. | | | |
| Patient Population | Patient population will be all<br>patients undergoing one of the<br>above procedures. | Patient population will be all<br>patients undergoing one of the<br>above procedures. | Patient population will be all<br>patients undergoing one of the<br>above procedures. | Identical |
| Device Description | Visualization system that<br>utilizes accessory to surgical<br>microscope for intraoperative<br>imaging | Accessory to surgical stereo<br>microscope for<br>intraoperative imaging. | Accessory to surgical stereo<br>microscope for intraoperative<br>imaging. | Equivalent |
| Accessory to | Unspecified model of surgical<br>microscope | OPMI PENTERO 800/900 | OPMI Pentero | Equivalent<br>The subject is not dependent on a<br>specific microscope model and<br>enlists compatible surgical<br>microscope specifications (which fit<br>OPMI PENTERO 800/900 amongst<br>others). |
| Fluorescent Agent | Sodium Fluorescein<br>FLUORESCITE® may be<br>obtained from Alcon, Inc.<br>AK-FLUOR® may be obtained<br>from Akorn, Inc. | Sodium Fluorescein<br>FLUORESCITE® may be<br>obtained from Alcon, Inc.<br>AK-FLUOR® may be<br>obtained from Akorn, Inc. | N/A | Identical |
| Indocyanine Green (ICG) | Indocyanine Green (ICG)<br>ICG may be obtained from<br>Akorn, Inc., Pulsion Medical | N/A | Indocyanine Green (ICG)<br>ICG may be obtained from Akorn,<br>Inc., Pulsion Medical Systems, or<br>other ICG manufacturers. | Identical |
| Attribute | Subject Device<br>Fluorescence Accessories | Predicate Device<br>YELLOW 560 (K162991) | Predicate Device<br>INFRARED 800 with FLOW<br>800 Option (K100468) | Equivalency Analysis |
| | Systems, or other ICG<br>manufacturers. | | | |
| Result | Fluorescent image of the<br>distribution of the dye in the<br>patient's blood vessels during<br>the operation. | Fluorescent image of the<br>distribution of the sodium<br>fluorescein dye in the<br>patient's blood vessels<br>during the operation. | Fluorescent image of the<br>distribution of the dye in the<br>patient's blood vessels during the<br>operation. FLOW 800 provides<br>overview and comparison<br>functions of display and a<br>summary of the dynamic of the<br>fluorescent dye. | Equivalent |
| Visualization of<br>Real-Time Images | Yes | Yes | Yes | Identical |
| Sensor | Eyepiece/<br>video camera (CMOS or CCD<br>sensor) fitting with the related<br>specifications.<br>Minimal pixel resolution:<br>Standard Definition (720 x<br>480) | Eyepiece/<br>CMOS video camera<br>High-Definition resolution<br>(1280 x 720) | CCD video camera, near-infrared<br>sensitive<br>Standard Definition resolution<br>(720 x 480) | No specific manufacturer mentioned.<br>Specifications as found under<br>section 10.5.4 must be fulfilled |
| Visualization<br>Monitor, Interface | microscope Monitor | microscope Monitor | microscope Monitor | Identical |
| Display | Video and images are presented<br>on monitor. Image may also be<br>displayed in the eyepiece. | Video and images are<br>presented on monitor. Image<br>may also be displayed in the<br>eyepiece. | Video and images are presented on<br>monitor. Image may also be<br>displayed in the eyepiece. Picture<br>in Picture available…