YELLOW 560 Fluorescence Module
Device Facts
| Record ID | K162991 |
|---|---|
| Device Name | YELLOW 560 Fluorescence Module |
| Applicant | Carl Zeiss Meditec, AG |
| Product Code | IZI · Radiology |
| Decision Date | Jul 24, 2017 |
| Decision | SESD |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1600 |
| Device Class | Class 2 |
| Attributes | Real-World Evidence |
Real-World Evidence
| Submission | Device | Sponsor | RWD Sources | RWE Use Summary | Key Tags |
|---|---|---|---|---|---|
| K162991 · Jul 24, 2017 | YELLOW 560 Fluorescence Module | Carl Zeiss Meditec, AG | Peer-reviewed clinical literature | The sponsor utilized a review of published clinical literature to demonstrate the effective intraoperative use of the YELLOW 560 Fluorescence Module for blood flow visualization in neurovascular surgery, including AVM and aneurysm procedures. | Clinical literature review; Neurovascular surgery; Intraoperative blood flow assessment; Sodium fluorescein angiography |
Clinical Evidence
| Study Design | Population | Comparator | Key Endpoints |
|---|---|---|---|
| Review of clinical literature; Literature review of clinical cases | Patients undergoing neurovascular surgery (AVM and aneurysm) | INFRARED 800 with FLOW 800 option (ICG) | Visualization of blood flow, assessment of vessel patency, and vessel type identification |
Indications for Use
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 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
YELLOW 560 Fluorescence Module is a surgical microscope accessory for OPMI PENTERO 800/900 systems. It enables intraoperative visualization of blood flow using sodium fluorescein dye. The module inserts excitation filters (460-500 nm) into the illumination path and emission filters (540-690 nm) into the optical viewing path to detect fluorescent signals. Operated by surgeons via handgrip or foot control during neurovascular procedures. The system captures, displays, records, and replays fluorescent images. By visualizing blood flow and vessel patency in real-time, it assists surgeons in assessing cerebral aneurysms, vessel branch occlusions, and perforating vessels, and evaluating AVMs. This aids clinical decision-making during surgery, potentially improving surgical outcomes by confirming vessel integrity.
Clinical Evidence
Clinical evidence consists of a literature review of peer-reviewed studies demonstrating effective intraoperative use of YELLOW 560 with sodium fluorescein in cerebrovascular surgery (AVM and aneurysm). Studies confirm real-time visualization of blood flow, vessel types, and patency. One comparative study evaluated YELLOW 560 (fluorescein) versus INFRARED 800 (ICG) in the same patients, showing complementary utility: YELLOW 560 provides superior visualization at high magnification in deep fields, while INFRARED 800 is beneficial for small branching/perforating vessels. No new safety concerns identified.
Technological Characteristics
Accessory to OPMI PENTERO 800/900 surgical stereo microscopes. Utilizes excitation (460-500 nm) and emission (540-690 nm) optical filters to detect sodium fluorescein fluorescence. Integrated into existing microscope light path. Controlled via microscope handgrip or foot switch. Complies with IEC 60601-1, IEC 60601-1-2, IEC 62471, and IEC 60825-1 standards.
Indications for Use
Indicated for patients undergoing neurovascular surgery, including AVM and aneurysm repair, requiring intraoperative visualization of blood flow and vessel patency.
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
- INFRARED 800 with FLOW 800 option (K100468)
- Leica FL800 (K061871)
- Heidelberg Retina Angiograph FA/ICGA (HRA/C) (K971671)
Reference Devices
- SPY Intra Operative Imaging System: SP2000 (K072222)
Submission Summary (Full Text)
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### 510(K) SUMMARY
#### 5 510(K) SUMMARY
#### 510(k) SUMMARY ( as per 21 CFR §807.92)
#### YELLOW 560 Fluorescence Module
### GENERAL INFORMATION
| Manufacturer: | Carl Zeiss Meditec AG<br>Goeschwitzer Strasse 51-52<br>D-07745 Jena, Germany<br>+49 3641220-667 (phone)<br>+49 3641220-282 (fax)<br>Establishment Registration Number: 9615030 |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mandy Ambrecht<br>Staff Regulatory Affairs Specialist<br>Carl Zeiss Meditec, Inc.<br>5160 Hacienda Drive<br>Dublin, CA 94568<br>(925) 557-4561 Phone<br>(925) 557-4259 Fax<br>E-mail: mandy.ambrecht@zeiss.com |
| Date prepared: | July 21, 2017 |
| Device | System, X-Ray, Angiographic |
| Classification: | 21 CFR 892.1600 |
| Product Code and Class: | IZI - class II |
| Common Name: | Angiographic x-ray system |
| Trade/Proprietary Name: | YELLOW 560 Fluorescence Module |
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## 510(K) SUMMARY
#### PREDICATE DEVICES
| Company | Device |
|-----------------------------|--------------------------------------------------------|
| Carl Zeiss Surgical GmbH | INFRARED 800 with FLOW 800 option (K100468) |
| Leica Microsystems | Leica FL800 (K061871) |
| Heidelberg Engineering GmbH | Heidelberg Retina Angiograph FA/ICGA (HRA/C) (K971671) |
| <b>Reference Device</b> | |
| Novadaq Technologies, Inc. | SPY Intra Operative Imaging System: SP2000 (K072222) |
#### INDICATIONS FOR USE (21 CFR §807.92(a)(5))
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 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(21 CFR §807.92(a)(4))
The YELLOW 560 Fluorescence Module is an accessory to the ZEISS surgical microscope OPMI PENTERO 800 and OPMI PENTERO 900 for visualizing blood flow intraoperatively. The YELLOW 560 Fluorescence Module integrated into the OPMI PENTERO 800 / OPMI PENTERO 900 surgical microscope allows the surgical microscope to produce filtered light to illuminate the fluorescence properties of the sodium fluorescein dye and to detect the emitted fluorescent signal to examine the human vascular system during surgery. This is achieved by placing a filter in the illumination path and a second filter in the optical (viewing) path.
The filters of the YELLOW 560 Fluorescence Module are optimized to deliver excitation
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### 510(K) SUMMARY
wavelengths ranging from 460 to 500 nm and to emphasize fluorescence signals in wavelengths ranging from 540 to 690 nm that typically correspond to the excitation and emission spectrum of sodium fluorescein. The option to place the filters for YELLOW 560 is controlled via either the handgrip of the surgical microscope or the foot control.
Sodium fluorescein may be used as a fluorescence contrast agent to examine arteriovenous malformations (AVM), aneurysms, and vessel anastomoses. The dye helps to visualize intraoperative blood flow and vessel patency. Sodium fluorescein can be used as contrast agent with YELLOW 560 without changes to the formulation, mode of action, approved dose or route of administration.
#### RISK MANAGEMENT AND GENERAL SAFETY AND EFFECTIVENESS
The device labeling contains instructions for use and any necessary cautions and warnings to provide for safe and effective use of the device. The YELLOW 560 Fluorescence Module description is integrated in the user manual of the OPMI PENTERO 800 / OPMI PENTERO 900 as it is an accessory to these devices.
Risk management is ensured via a risk analysis. which is used to identify potential hazards and mitigations. These potential hazards are controlled by design means (hardware and software means), protection measures and user instructions. To confirm that the measures are effective and that the product meets its intended uses, verification of requirements and standards, and validation of the clinical workflow was performed. Carl Zeiss Meditec adheres to recognized and established industry practice and relevant international standards where indicated.
#### TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE (21 CFR §807.92(a) (6)):
The YELLOW560 Fluorescence Module is substantially equivalent to the primary predicate device, INFRARED 800 with FLOW 800 option (K100468). Each system utilizes the same surgical stereo microscope system. Each device utilizes a fluorescent agent to visualize blood flow and the fluorescence of the dye is displayed by using emission and excitation filters.
The indications for use for the YELLOW 560 Fluorescence Module is a subset of the previously cleared indications for INFRARED 800 with FLOW 800 option. The technological characteristics and operating principles of the YELLOW 560 Fluorescence Module are the same as that of the predicate device.
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The YELLOW 560 Fluorescence Module and INFRARED 800 with FLOW 800 option are both accessories to the OPMI PENTERO 800 and OPMI PENTERO 900 surgical microscopes. The microscope itself including the light source is identical. Both accessories (YELLOW 560 Fluorescence Module and INFRARED 800 with FLOW 800) have the same basic functions for viewing, recording, and replaying fluorescent images.
YELLOW 560 is an accessory to a surgical microscope, as is Leica's FL800 (K061871). Both offer functions regarding viewing, recording and replaying of fluorescent videos, both use illumination conditions for excitation and detection realized by filter and sensor specifications, and both use a fluorescent agent, Sodium Fluorescein with YELLOW 560 and Indocyanine Green (ICG) with Leica's FL800.
The YELLOW 560 utilizes a surgical stereo microscope while the Heidelberg Retina Angiograph (HRA) (K971671) uses a confocal laser scanning angiography system. While the systems are different, they each have the functions for viewing and recording fluorescent images. Both devices use Sodium Fluorescein as a contrast agent to visualize vascular structures - HRA for ophthalmic indications and YELLOW 560 for neurovascular indications. Both devices use filters that enable fluorescent images to be visualized after Sodium Fluorescein has been used as a fluorescent agent.
YELLOW 560 and Novadaq's SPY SP2000 (K072222) both provide the surgeon with the capability to view, record and replay fluorescent images of blood vessels. Both use a light source to illuminate the surface. Both use a fluorescent agent: Sodium Fluorescein with YELLOW 560 and Indocyanine Green (ICG) with Novadaq SPY. A fluorescent image results from the absorption of light causing excitation of the dye followed by emission of infrared energy. Both systems use a camera to capture the image. These images may then be used to evaluate the integrity of the vasculature.
Evaluation performed on the YELLOW 560 Fluorescence Module supports the indications for use statement and demonstrates that the device is substantially equivalent to the predicate devices and does not raise new questions regarding safety and effectiveness.
### SUBSTANTIAL EQUIVALENCE TO PREDICATE (21 CFR §807.92(B)(1)):
The OPMI PENTERO 800 / OPMI PENTERO 900 with YELLOW 560 Fluorescence Module has been tested to meet the product requirements (PRS) and software requirements (SRS) and is considered to be substantially equivalent to the predicates as indicated above.
#### Verification Testing to Standards
YELLOW 560 Fluorescence Module was designed and verified to the applicable standards. Testing was conducted on the YELLOW 560 Fluorescence Module and it was found to perform as intended. Each function and/or feature was tested by means of an appropriate test case or test specification.
Testing with the YELLOW 560 Fluorescence Module integrated in the OPMI PENTERO 900
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### 510(K) SUMMARY
surgical microscope has been conducted to demonstrate conformance to the following standards:
- ANSI / AAMI 60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and ● A2:2010/(R)2012 (3rd Edition) Electrical equipment -- Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2: 2014 Medical electrical equipment Part 1-2: General requirements for . basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests (EMC)
- IEC 62471:2006 Photobiological safety of lamps and lamp systems
- IEC 60825-1:2007 Safety of laser products Part 1: Equipment classification, and ● requirements [Including: Technical Corrigendum 1 (2008), Interpretation Sheet 1 (2007), Interpretation Sheet 2 (2007)]
#### Bench Testing
Internal verification testing was conducted to verify the optical performance of the YELLOW 560 Fluorescence Module, its fluorescent target and the system performance of the YELLOW 560 Fluorescence Module as integrated into the OPMI PENTERO 800 and PENTERO 900. The results indicate that the YELLOW 560 Fluorescence Module met all the requirements.
#### Verification and Validation
In addition to systems testing, software verification activities completed were divided into three phases:
- Tests accompanying development (including code inspections)
- . Integration test phase - stabilization phase
- System verification .
Validation and usability testing was conducted with the YELLOW 560 Fluorescence Module in conjunction with the OPMI PENTERO surgical microscope to ensure that the medical device meets the product and user requirements and to support a determination of substantial equivalence to the predicate devices.
Verification and validation activities were successfully completed and prove that the YELLOW 560 Fluorescence Module meets its requirements and performs as intended.
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### 510(K) SUMMARY
#### Clinical Evaluation
Clinical data on YELLOW 560 has been collected by various researchers and is reported in the clinical literature. A review of the clinical literature that discusses the relevant studies has been included in this Premarket Notification. The review includes citations from peerreviewed medical literature demonstrating the effective intraoperative use of the YELLOW 560 Fluorescence Module in sodium fluorescein angiography in the cerebrovascular area, especially in arteriovenous malformation (AVM) and aneurysm surgery.
One clinical publication provides a comparison of the YELLOW 560 Fluorescence Module used in combination with sodium fluorescein and the predicate device INFRARED 800 with FLOW 800 option used in combination with Indocyanine Green (ICG) in aneurysm surgery in the same patients.
In particular, the literature provides evidence of the effective real-time visualization of blood flow and visual assessment of vessel types in AVM surgery by the use of YELLOW 560. Moreover, it was demonstrated that YELLOW 560 was effectively used in the visual assessment of intraoperative blood flow in assessing cerebral aneurysms, vessel branch occlusion, as well as patency of very small perforating vessels in neurosurgery.
Comparing ICG videoangiography using INFRARED 800 with FLOW 800 option and fluorescein angiography using YELLOW 560, each technique exhibited specific attributes. YELLOW 560 provided an improved visualization of vasculature at high magnification in deep surgical fields and can be used within the full range of magnification whereas the INFRARED 800 with FLOW 800 option was considered especially beneficial for detection of blood flow within branching and small perforating vessels.
Specifically, the clinical literature supports the indications for use in demonstrating that the YELLOW 560 Fluorescence Module can be used and is beneficial:
- 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 occlusion, as well as patency of very small perforating vessels.
- to aid in the real-time visualization of blood flow and visual assessment of vessel types before and after arteriovenous malformation (AVM) surgery.
In summary, fluorescence angiography in the cerebrovascular area using the YELLOW 560 Fluorescence Module and INFRARED 800 with FLOW 800 option is considered comparable in terms of safety and effectiveness. Both methods are considered to be complementary to each other.
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### 510(K) SUMMARY
#### 510(K) SUMMARY (21 CFR §807.92(C)):
Based on the successful verification and validation testing and clinical literature review, it is Carl Zeiss Meditec AG's opinion that the YELLOW 560 Fluorescence Module, as an accessory to the OPMI PENTERO 800 / OPMI PENTERO 900 surgical microscope, does not introduce any new potential safety risks and is substantially equivalent to, and performs as well as, the predicate devices.
Additionally, all testing deemed necessary was conducted on the YELLOW 560 Fluorescence Module integrated into the OPMI PENTERO 800 / OPMI PENTERO 900 surgical microscope to ensure that the device is as safe and effective when used in accordance with its Instructions for Use as the predicate devices.
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Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 24, 2017
Carl Zeiss Meditec Ag % Mandy Ambrecht Staff Regulatory Affairs Specialist Carl Zeiss Meditec, Inc. 5160 Hacienda Drive Dublin, California 94568
Re: K162991
Trade/Device Name: Yellow 560 Fluorescence Module Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: IZI Dated: June 22, 2017 Received: June 23, 2017
Dear Mandy Ambrecht:
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. 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 (reporting of medical device
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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
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