(284 days)
510k exempt
No
The document describes a fluorescence imaging system that uses standard optical and electronic components. While it mentions "signal processing of the image data," there is no mention of AI, ML, deep learning, or any related concepts in the intended use, device description, or performance studies. The focus is on the hardware and the use of ICG dye for visualization.
No.
This device is an imaging system used to visualize structures during surgery, not to treat a medical condition.
No
The system is used for intraoperative fluorescence imaging and visualization. While it aids surgeons in visual assessment and imaging, it does not analyze or interpret patient data to provide a diagnosis or aid in determining a patient's medical condition. It's a visualization tool, not a diagnostic one.
No
The device description explicitly lists hardware components such as a camera head, rigid endoscope, light source, light cables, foot switch, and camera controller. While it includes image processing software, it is an integral part of a larger hardware system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: System green is an imaging system used during surgery to visualize structures within the body using fluorescence. It works by exciting a dye (ICG) that is administered to the patient. This is an in vivo (within the living body) imaging technique, not an in vitro test performed on samples outside the body.
- Intended Use: The intended use clearly describes intraoperative fluorescence angiography, imaging of biliary ducts, and visualization of the lymphatic system within the patient.
- Device Description: The device description details components like a camera head, endoscope, light source, and controller, all used for capturing images inside the body.
Therefore, System green is an in vivo imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Upon intravenous administration of TRADENAME (ICG drug product), System green is used with TRADENAME (ICG drug product) to perform intraoperative fluorescence angiography, and it is also indicated for use in fluorescence imaging of biliary ducts, and when indicated, during intraoperative cholangiography.
System green is indicated for use to provide real time endoscopic visible and near-infrared fluorescence imaging. System green enables surgeons to perform minimally invasive surgery using standard endoscope visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct or common hepatic duct), using near-infrared imaging.
Fluorescence imaging of biliary ducts with System green is intended for use with standard of care white light, and when indicated, intraoperative cholangiography.
The device is not intended for standalone use for biliary duct visualization.
Upon interstitial administration of TRADENAME (ICG drug product), System green is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes
Product codes (comma separated list FDA assigned to the subject device)
FET, GCJ
Device Description
System green combines the camera head, the rigid endoscope, the light source including light cables and a foot switch and the camera controller. The camera head is connected via a standard camera cable while the connection between the camera controller and light source is possible via a LAN (Ethernet) connection cable. This is the precondition for the video in fluorescence mode.
The camera head is further connected to the rigid endoscope via a snap-on locking mechanism. The rigid endoscope is further coupled via the fiber light source, which can also be connected to an optional foot switch.
System green allows for fluorescence imaging by exciting indocyanine green (ICG), a dye (FDA approved drug, not included in this submission) that is applied intravenously or interstitially in the body. Fluorescence imaging and white light imaging is possible with the same system setup at the same time. The NIR images can only be displayed as overlay pictures with the NIR information added to the white light image. The white light image can also be displayed on its own.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Endoscopic visible light, Near-infrared fluorescence imaging
Anatomical Site
Biliary ducts (cystic duct, common bile duct or common hepatic duct), Vessels, Lymphatic system (lymphatic vessels and lymph nodes)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeons in a healthcare facility or hospital.
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)
Non-clinical Performance Testing:
- Electromagnetic Compatibility and Electrical Safety: Proved compliance with IEC 60601-1, IEC 60601-1-6, IEC 60601-1-2, and IEC 60601-2-18 standards.
- Photobiological safety testing: According to IEC 62471, product assigned to risk group 2.
- NIR power and wavelength spectrum: Measured and verified.
- Temperature safety testing: At the distal end of the PANOVIEW Ultra telescope, found to be within specified limits according to IEC 60601-2-18.
- Tightness: Logic HD camera head green achieved IPX7 according to IEC 60529, suitable for steam sterilization.
- Transport simulation: According to ISO 11607-1 and ASTM D4169, confirmed suitable packaging and no safety/performance concerns after transport.
Animal Testing:
- Evaluated effectiveness and performance in a pre-clinical model and assessed the risk of incorrect fluorescence.
- Key results: Subject device met all specified acceptance criteria and performance with respect to the risk of incorrect fluorescence was confirmed. Effectiveness as described in the indications for use was verified.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
K182606, 510k exempt, 510k exempt, K200617, K200617, K180583, K203226
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.
510k exempt
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
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
June 14, 2022
Richard Wolf Medical Instruments Corporation Michael Loiterman US Head of Regulatory - OA/OC 353 Corporate Woods Parkway Vernon Hills, Illinois 60061
Re: K212808
Trade/Device Name: Logic Hd camera head green, System green Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: FET, GCJ Dated: September 2, 2021 Received: September 3, 2021
Dear Michael Loiterman:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 (OS) 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 mediation-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,
For Purva Pandya 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
510(k) Number (if known) K212808
Device Name System Green
Indications for Use (Describe)
Upon intravenous administration of TRADENAME (ICG drug product), System green is used with TRADENAME (ICG drug product) to perform intraoperative fluorescence angiography, and it is also indicated for use in fluorescence imaging of biliary ducts, and when indicated, during intraoperative cholangiography.
System green is indicated for use to provide real time endoscopic visible and near-infrared fluorescence imaging. System green enables surgeons to perform minimally invasive surgery using standard endoscope visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct or common hepatic duct), using near-infrared imaging.
Fluorescence imaging of biliary ducts with System green is intended for use with standard of care white light, and when indicated, intraoperative cholangiography.
The device is not intended for standalone use for biliary duct visualization.
Upon interstitial administration of TRADENAME (ICG drug product), System green is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
3
510(k) Number (if known) K212808
Device Name Light Source LED Green
Indications for Use (Describe)
ICG light sources
The products are used for providing white light and near-infrared light for diagnostic and therapeutic application, specifically in endoscopy.
The Light source LED green ENDOLIGHT can be used to provide real time endoscopic imaging using standard endoscope visible light and near-infrared fluorescence imaging, this enables surgeons to perform:
-
· Minimally invasive surgery.
· Visual assessments of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct or common hepatic duct), using near-infrared imaging. -
· Intraoperative cholangiography.
Upon intravenous administration of TRADENAME (ICG drug product), ICG light sources can be used with System green to perform: -
· Intraoperative fluorescence angiography.
-
· Fluorescence imaging of biliary ducts, and when indicated during intraoperative cholangiography.
Upon interstitial administration of TRADENAME (ICG drug product), ICG light sources can be used with System green to perform:
· Intraoperative fluorescence imaging and visualization of the lymphatic vessels and lymph nodes.
The Light source LED green ENDOLIGHT is not intended for standalone use for biliary duct visualization.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
☐ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
4
510(k) Number (if known) K212808
Device Name Fiber Light Cable
Indications for Use (Describe)
Light cable
The products are used to transmit light in the visible spectral range from the light source to the application-specific instrument set.
Fiber Light Cables are used to provide real time endoscopic imaging standard endoscopic visible light and nearinfrared fluorescence imaging, this enables surgeons to perform:
· Minimally invasive surgery.
· Visual assessments of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct or common hepatic duct), using near-infrared imaging.
· Intraoperative cholangiography.
Upon intravenous administration of TRADENAME (ICG drug product), fiber light cables can be used with System green to perform:
· Intraoperative fluorescence angiography.
· Fluorescence imaging of biliary ducts, and when indicated during intraoperative cholangiography.
Upon interstitial administration of TRADENAME (ICG drug product), fiber light cables can be used with System green to perform:
• Intraoperative fluorescence imaging and visualization of the lymphatic vessels and lymph nodes.
Light cables are not intended for standalone use for biliary duct visualization.
Adapter for light cable
The products are used to connect light guides to light sources or endoscopes.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
5
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
6
510(k) Number (if known) K212808
Device Name
Logic HD Camera Controller and Logic 4K Camera Controller
Indications for Use (Describe)
Camera Controller
The Logic HD Camera Controller 552510x and the Logic 4K Camera Controller 5525301 have been designed for highdefinition video endoscopy and can be used for both diagnostic and therapeutic interventions.
The Camera Controllers are used in conjunction with other video equipment and endoscopic accessories.
The Logic HD Camera Controller and the Logic 4K Camera Controller can be used to provide real time endoscopic imaging using standard endoscope visible light and near-infrared fluorescence imaging, this enables surgeons to perform: · Minimally invasive surgery.
· Visual assessments of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct or common hepatic duct), using near-infrared imaging.
· Intraoperative cholangiography.
Upon intravenous administration of TRADENAME (ICG drug product), Camera Controllers can be used with System green to perform:
· Intraoperative fluorescence angiography.
· Fluorescence imaging of biliary ducts, and when indicated during intraoperative cholangiography.
Upon interstitial administration of TRADENAME (ICG drug product), Camera Controllers can be used with System green to perform:
• Intraoperative fluorescence imaging and visualization of the lymphatic vessels and lymph nodes.
Camera Controllers are not intended for standalone use for biliary duct visualization.
| Type of Use (Select one or both, as applicable) | ||
|---|---|---|
| ☑ Research Use (Part 21 CFR 201 Subpart D)☐ Over-The-Counter Use (21 CFR 201 Subpart G) | ☑ Research Use (Part 21 CFR 201 Subpart D) | ☐ Over-The-Counter Use (21 CFR 201 Subpart G) |
| ☑ Research Use (Part 21 CFR 201 Subpart D) | ☐ Over-The-Counter Use (21 CFR 201 Subpart G) |
Prescription Use (Part 21 CFR 801 Subpart D)
|__ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
7
510(k) Number (if known) K212808
Device Name Logic HD Camera Head Green
Indications for Use (Describe)
The Logic HD camera head green is used to provide real time endoscopic imaging using standard endoscope visible light and near-infrared fluorescence imaging, this enables surgeons to perform:
-
· Minimally invasive surgery.
· Visual assessments of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct or common hepatic duct), using near-infrared imaging. -
· Intraoperative cholangiography.
Upon intravenous administration of TRADENAME (ICG drug product), Logic HD camera head green can be used with System green to perform:
· Intraoperative fluorescence angiography.
· Fluorescence imaging of biliary ducts, and when indicated during intraoperative cholangiography.
Upon interstitial administration of TRADENAME (ICG drug product), Logic HD camera head green can be used with System green to perform:
• Intraoperative fluorescence imaging and visualization of the lymphatic vessels and lymph nodes.
The Logic HD camera head green is not intended for standalone use for biliary duct visualization.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
8
510(k) Number (if known) K212808
Device Name
PANOVIEW ULTRA Telescopes 10 mm
Indications for Use (Describe)
PANOVIEW ULTRA Telescopes are used to provide real time endoscopic imaging using standard endoscopic visible light and near-infrared fluorescence imaging, this enables surgeons to perform:
- · Minimally invasive surgery.
· Visual assessments of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct or common hepatic duct), using near-infrared imaging.
· Intraoperative cholangiography.
Upon intravenous administration of TRADENAME (ICG drug product), PANOVIEW ULTRA Telescopes can be used with System green to perform:
· Intraoperative fluorescence angiography.
· Fluorescence imaging of biliary ducts, and when indicated during intraoperative cholangiography.
Upon interstitial administration of TRADENAME (ICG drug product), PANOVIEW ULTRA Telescopes can be used with System green to perform:
• Intraoperative fluorescence imaging and visualization of the lymphatic vessels and lymph nodes.
PANOVIEW ULTRA Telescopes are not intended for standalone use for biliary duct visualization
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
9
Image /page/9/Picture/2 description: The image shows the logo for Richard Wolf. The words "RICHARD" and "WOLF" are stacked on top of each other, with "RICHARD" in black and "WOLF" in red. To the right of the text is a square with rounded corners, inside of which is a stylized drawing of a wolf standing next to a surgical instrument.
5 510(k) Summary
l Submitter
Richard Wolf Medical Instruments Corporation 353 Corporate Woods Parkway Vernon Hills, IL 60046
Phone:(847) 913 1113 Fax: (847) 913 0924
Contact Person, Title: Mr. Stefan D Heffner Date Prepared: March 15, 2022
Legal Manufacturer
Richard Wolf GmbH Pforzheimer Straße 32 75438 Knittlingen
10
Image /page/10/Picture/1 description: The image contains the words "RICHARD WOLF" in a stylized font. The word "RICHARD" is in a smaller, sans-serif font above the word "WOLF", which is in a larger, bolder, red font. To the right of the words is a logo featuring a stylized image of a wolf standing next to a pole, all enclosed in a rounded square.
ll Device
Table 5 .1: Devices for which clearance is requested.
| Brand name | Trade name | Model No. | Device
classification
name | Regulation
Number and
Name | Product Code | Device Class | Review Panel |
|------------|--------------------------------------------------------|---------------------|-------------------------------------------------|----------------------------------|--------------|--------------|--------------------------------|
| ENDOCAM | System green | System green | N/A | N/A | N/A | N/A | N/A |
| ENDOLIGHT | Light Source LED Green
Foot Control
Rockerswitch | 5165002
2030.105 | Led light
source | 876.1500 | NTN | II | Gastro-enterology /
Urology |
| | | | Laparoscope,
General &
Plastic
Surgery | 876.1500
892.1600 | GCJ
IZI | | General & Plastic
Surgery |
| | | | System, X-ray,
Angiographic | | | | Radiology |
11
Image /page/11/Picture/1 description: The image contains the words "RICHARD WOLF" in a stylized font. The word "RICHARD" is in a smaller, black font above the word "WOLF", which is in a larger, red font. To the right of the text is a square box with rounded corners, containing a drawing of a dog with a vertical line going through it.
5-3
| Brand name | Trade name | Model No. | Device
classification
name | Regulation
Number and
Name | Product Code | Device Class | Review Panel |
|------------|--------------------------------|-----------|------------------------------------------------------------------------------|----------------------------------|--------------|--------------|--------------------------------|
| FUSION | Fiber Light Cable Ø5mm TL 2.3M | 806550xx | Accessories,
photographic,
for endoscope
(exclude light
sources) | 876.1500 | FEM | I | Gastro-enterology /
Urology |
| | Fiber Light Cable Ø5mm TL 2.3M | | | 876.1500 | GCJ | II | General & Plastic
Surgery |
| | Fiber Light Cable Ø5mm TL 2.3M | | Laparoscope,
General &
Plastic
Surgery | 892.1600 | IZI | II | Radiology |
| | | | System, X-ray,
Angiographic | | | | |
12
Image /page/12/Picture/1 description: The image contains the words "RICHARD WOLF" in a stylized font. The word "RICHARD" is in a simple, sans-serif font, while the word "WOLF" is in a bold, blocky font and is colored in red. To the right of the text is a logo featuring a stylized wolf head with a surgical instrument, possibly an endoscope, running through it. The logo is enclosed in a rounded square.
| Brand name | Trade name | Model No. | Device classification name | Regulation Number and Name | Product Code | Device Class | Review Panel |
|---|---|---|---|---|---|---|---|
| ENDOCAM | Logic HD Camera Controller | 552510x | Endoscope | ||||
| Video Imaging | |||||||
| System/ | |||||||
| Component | |||||||
| Laparoscope, | |||||||
| General & | |||||||
| Plastic | |||||||
| Surgery | |||||||
| System, X-ray, | |||||||
| Angiographic | 876.1500 | ||||||
| 876.1500 | |||||||
| 892.1600 | FET | ||||||
| GCJ | |||||||
| IZI | II | Gastro-enterology / | |||||
| Urology | |||||||
| General & Plastic | |||||||
| Surgery | |||||||
| Radiology | |||||||
| ENDOCAM | Logic 4K Camera Controller | 5525301 | Endoscope | ||||
| Video Imaging | |||||||
| System/ | |||||||
| Component | |||||||
| Laparoscope, | |||||||
| General & | |||||||
| Plastic | |||||||
| Surgery | |||||||
| System, X-ray, | |||||||
| Angiographic | 876.1500 | ||||||
| 876.1500 | |||||||
| 892.1600 | FET | ||||||
| GCJ | |||||||
| IZI | II | Gastro-enterology / | |||||
| Urology | |||||||
| General & Plastic | |||||||
| Surgery | |||||||
| Radiology | |||||||
| Brand name | Trade name | Model No. | Device classification name | Regulation Number and Name | Product Code | Device Class | Review Panel |
| ENDOCAM | Logic HD camera head green | 85525812 | Endoscope | ||||
| Video Imaging | |||||||
| System/ | |||||||
| Component | 876.1500 | FET | II | Gastro-enterology / | |||
| Urology | |||||||
| 876.1500 | GCJ | General & Plastic | |||||
| Surgery | |||||||
| Laparoscope, | |||||||
| General & | |||||||
| Plastic | |||||||
| Surgery | 892.1600 | IZI | Radiology | ||||
| System, X-ray, | |||||||
| Angiographic |
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5-5
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page/page(s)
5-6
| Brand name | Trade name | Model No. | Device classification name | Regulation Number and Name | Product Code | Device Class | Review Panel |
|---|---|---|---|---|---|---|---|
| PANOVIEW Ultra telescopes | TELESCOPE 0° Ø 10MM WL 305MM | Rigid Endoscope | 876.1500 | GCM | II | Gastro-enterology / Urology | |
| TELESCOPE 30° Ø 10MM WL 305MM | 876.1500 | GCJ | General & Plastic Surgery | ||||
| TELESCOPE 50° Ø 10MM WL 305MM | Laparoscope, General & Plastic Surgery | 876.1500 | HET | General & Plastic Surgery | |||
| TELESCOPE 0° Ø 10MM WL 440MM | 893446x | Laparo-scope Gyneco-logic | 892.1600 | IZI | Radiology | ||
| TELESCOPE 30° Ø 10MM WL 440MM | 893444x6 | System, X-ray, Angiographic | |||||
| TELESCOPE 50° Ø 10MM WL 440MM |
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111 Predicate Device
Table 1: List of predicate devices
Name of Predicate Device: PINPOINT Endoscopic Fluorescence Imaging System (PC9000) 510(k) Number: K182606 Regulatory Class: II Product Code: GCJ, IZI Manufacturer: Novadaq Technologies ULC (now a part of Stryker)
The predicate has been subject to a design related recall (Recall Event ID 87540). This recall has no influence on the current submission as the product that was subject of the recall was the imaging processor which is not part of the comparison within this submission.
Name of Predicate Device: Light Source LED 2.1 80W 510(k) Number : 510k exempt Regulatory Class: II Product Code: NTN Manufacturer: Richard Wolf GmbH
The predicate has not been subject to a design related recall
Name of Predicate Device: FIBER LIGHT CABLE Ø 5MM TL 2.3M / 3M / 3.5M 510(k) Number : 510k exempt Regulatory Class: I Product Code: FEM Manufacturer: Richard Wolf GmbH
The predicate has not been subject to a design related recall. Name of Predicate Device: Logic HD Camera Controller 510(k) Number : K200617 Requlatory Class: II Product Code: FET Manufacturer: Richard Wolf GmbH
The predicate has not been subject to a design related recall. Name of Predicate Device: Logic 4K Camera Controller 510(k) Number : K200617 Requlatory Class: II Product Code: FET Manufacturer: Richard Wolf GmbH
The predicate has not been subject to a design related recall. Name of Predicate Device: Logic 4K Camera Head 510(k) Number : K180583 Regulatory Class: II Product Code: FET Manufacturer: Richard Wolf GmbH
The predicate has not been subject to a design related recall. Name of Predicate Device: Panoview Ultra telescopes 10mm 510(k) Number : K203226 Regulatory Class: II Product Code: GCM / GCJ /HET Manufacturer: Richard Wolf GmbH
The predicate has not been subject to a design related recall.
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Reference Devices
Table 2: List of reference devices
Name of Reference Device: Fiber Light Cable Ø4.5MM TL 3.6M 510(k) Number : 510k exempt Regulatory Class: I Product Code: FEM Manufacturer: Richard Wolf GmbH
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Subject Device Description - System green 5.1
5.1.1 Device Identification
| Brand name | Trade name | Type number |
|---|---|---|
| ENDOCAM | System green | System green |
5.1.2 Device characteristics
Software
System green includes component devices with software.
Materials with patient contact
Component devices of System green have direct tissue/patient contact.
Single use / reusable
All parts of System green are reusable.
Delivered sterile / non-sterile
All parts of System green are provided non-sterile to the user.
5.1.3 Environment of Use
System green is designed for use in a healthcare facility or hospital.
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5.1.4 Brief written description of the device
System green combines the camera head, the rigid endoscope, the light source including light cables and a foot switch and the camera controller. The camera head is connected via a standard camera cable while the connection between the camera controller and light source is possible via a LAN (Ethernet) connection cable. This is the precondition for the video in fluorescence mode.
The camera head is further connected to the rigid endoscope via a snap-on locking mechanism. The rigid endoscope is further coupled via the fiber light source, which can also be connected to an optional foot switch.
System green allows for fluorescence imaging by exciting indocyanine green (ICG), a dye (FDA approved drug, not included in this submission) that is applied intravenously or interstitially in the body. Fluorescence imaging and white light imaging is possible with the same system setup at the same time. The NIR images can only be displayed as overlay pictures with the NIR information added to the white light image. The white light image can also be displayed on its own.
Materials of Use 5.1.5
The materials of System green are listed in the corresponding submissions of each main part.
Key Performance Characteristics 5.1.6
The Key Performance characteristic of System green is the visualization with standard of care visible light and near infrared imaging.
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Subject Device Description - Light Source LED Green 5.2
5.2.1 Device Identification
| Brand name | Trade name | Type number |
|---|---|---|
| ENDOLIGHT | Light Source LED | |
| Green and | ||
| Foot Control | ||
| Rockerswitch | 5165002 | |
| 2030.105 |
5.2.2 Device characteristics
Software
Light Source LED Green includes Software.
Materials with patient contact
Light Source LED Green does not have any direct tissue/patient contact.
Single use / reusable
Light Source LED Green is reusable.
Delivered sterile / non-sterile
Light Source LED Green is provided non-sterile to the user.
5.2.3 Environment of Use
Light Source LED Green is designed for use in a healthcare facility or hospital.
5.2.4 Brief written description of the device
The light source is used for diagnostic and therapeutic endoscopic procedures. The use of LED illuminants generates light that is transported from the light source to the endoscope by a light guide cable, thus enabling adequate illumination of the surgical field.
It is used in combination with a camera control unit as well as a suitable camera head, a fiber optic cable, and an endoscope specifically for near-infrared (NIR) endoscopy.
5.2.5 Materials of Use
Metal housing
5.2.6 Key Performance Characteristics
The Key Performance characteristic of Light Source LED Green is providing white light and nearinfrared light.
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Subject Device Description - Fiber Light Cable 5.3
5.3.1 Device Identification
| Brand name | Trade name | Type number |
|---|---|---|
| FUSION | Fiber Light Cable Ø5mm TL | |
| 2.3M | 80655023 | |
| FUSION | Fiber Light Cable Ø5mm TL | |
| 3M | 80655030 | |
| FUSION | Fiber Light Cable Ø5mm TL | |
| 3.5M | 80655035 |
5.3.2 Device characteristics
Software
Fiber Light Cable does not include Software.
Materials with patient contact
Fiber Light Cable does not have any direct or indirect tissue/patient contact.
Single use / reusable
Fiber Light Cable is reusable.
Delivered sterile / non-sterile
Fiber Light Cable is provided non-sterile to the user.
5.3.3 Environment of Use
Fiber Light Cable is designed for use in a healthcare facility or hospital.
5.3.4 Brief written description of the device
The products are used to transmit light from the light source to the application-specific instrument set.
5.3.5 Materials of Use
Optical glass, Plastic, Silicone, Stainless Steel.
5.3.6 Key Performance Characteristics
The Key Performance characteristic of Light Source LED Green is transmitting light.
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Subject Device Description - Logic HD Camera Controller 5.4
5.4.1 Device Identification
| Brand name | Trade name | Type number |
|---|---|---|
| ENDOCAM | Logic HD Camera Controller | 5525101 |
| 5525102 | ||
| 5525103 | ||
| 5525104 | ||
| 5525105 | ||
| 5525106 | ||
| 5525107 | ||
| 5525108 |
5.4.2 Device characteristics
Software
Logic HD Camera Controller includes Software
Materials with patient contact
Logic HD Camera Controller does not have any direct tissue/patient contact.
Single use / reusable
Logic HD Camera Controller is reusable.
Delivered sterile / non-sterile
Logic HD Camera Controller is provided non-sterile to the user.
5.4.3 Environment of Use
Logic HD Camera Controller is designed for use in a healthcare facility or hospital.
5.4.4 Brief written description of the device
The products are used for displaying the image of natural or artificial hollow spaces obtained by an endoscope within the scope of diagnostic or therapeutic endoscopy.
5.4.5 Materials of Use
Metal housing
5.4.6 Key Performance Characteristics
The Key Performance characteristics of Logic HD Camera Controller are image recording and signal processing of the image data.
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Subject Device Description - Logic 4K Camera Controller 5.5
5.5.1 Device Identification
| Table 5.6: Subject device | ||
|---|---|---|
| Brand name | Trade name | Type number |
| ENDOCAM | Logic 4K Camera Controller | 5525301 |
5.5.2 Device characteristics
Software
Logic 4K Camera Controller includes Software
Materials with patient contact
Logic 4K Camera Controller does not have any direct tissue/patient contact.
Single use / reusable
Logic 4K Camera Controller is reusable.
Delivered sterile / non-sterile
Logic 4K Camera Controller is provided non-sterile to the user.
5.5.3 Environment of Use
Logic 4K Camera Controller is designed for use in a healthcare facility or hospital.
Brief written description of the device 5.5.4
The products are used for displaying the image of natural or artificial hollow spaces obtained by an endoscope within the scope of diagnostic or therapeutic endoscopy.
5.5.5 Materials of Use
Metal housing
5.5.6 Key Performance Characteristics
The Key Performance characteristics of Logic 4K Camera Controller are image recording and signal processing of the image data.
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Subject Device Description - Logic HD camera head green 5.6
5.6.1 Device Identification
| Brand name | Trade name | Type number |
|---|---|---|
| ENDOCAM | Logic HD camera head | |
| green | 85525812 |
The Logic HD camera head green has been designed to convert the image of the inside of the body, generated by an endoscope, into an electrical signal which is passed on to a camera controller, and to optically filter the excitation light within the scope of the ICG fluorescence imaging diagnostic procedure.
5.6.2 Device characteristics
Software
The Logic HD camera head green does not include software.
Materials with patient contact
The Logic HD camera head green does not have any direct tissue/patient contact.
Single use / reusable
The Logic HD camera head green is reusable.
Delivered sterile / non-sterile
Logic HD camera head green provided non-sterile to the user.
5.6.3 Environment of Use
The Logic HD camera head green is designed for use in a healthcare facility or hospital.
5.6.4 Brief written description of the device
The camera head serves as a link between the endoscope and the camera controller. The image generated by the attached endoscope is passed on via the camera head to the corresponding camera controller where it is processed.
The Logic HD camera head green is used for diagnostic interventions with white light and near infrared light. When operated in combination with further products of the "green" model line, the Logic HD camera head green can be used for visualizing the fluorescence of a dye in the near infrared (NIR) range (indocyanine (ICG)).
5.6.5 Materials of Use
Plastic, Silicone, Stainless Steel, Metal, Optical glass.
5.6.6 Key Performance Characteristics
The Key Performance characteristic of the camera head is detecting the light at a certain wavelength and converting this information into electrical signals for further processing.
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Subject Device Description Panoview Ultra telescopes 5.7
5.7.1 Device Identification
| Brand name | Trade name | Type number |
|---|---|---|
| PANOVIEW | ||
| Ultra | ||
| telescopes | TELESCOPE 0° Ø 10MM WL | |
| 305MM | 8934461 | |
| TELESCOPE 30° Ø 10MM WL | ||
| 305MM | 8934462 | |
| TELESCOPE 50° Ø 10MM WL | ||
| 305MM | 8934463 | |
| TELESCOPE 0° Ø 10MM WL | ||
| 440MM | 89344416 | |
| TELESCOPE 30° Ø 10MM WL | ||
| 440MM | 89344426 | |
| TELESCOPE 50° Ø 10MM WL | ||
| 440MM | 89344436 |
5.7.2 Device characteristics
Software
PANOVIEW Ultra telescopes do not include Software
Materials with patient contact
PANOVIEW Ultra telescopes do have direct or indirect tissue/patient contact.
Single use / reusable
PANOVIEW Ultra telescopes are reusable.
Delivered sterile / non-sterile
PANOVIEW Ultra telescopes are provided non-sterile to the user.
5.7.3 Environment of Use
PANOVIEW Ultra telescopes are designed for use in a healthcare facility or hospital.
5.7.4 Brief written description of the device
The 10 mm PANOVIEW Ultra Telescopes are rigid endoscopes with fixed evepiece, integrated light guide, optical system, cold light connector, with screw-on adapter for fiber light cables and with color coding ring for direction of view.
5.7.5 Materials of Use
Optical glass, Stainless steel
5.7.6 Key Performance Characteristics
The Key Performance characteristic of the PANOVIEW Ultra telescopes is to provide real time endoscopic images.
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5.8.1 System Green
Upon intravenous administration of TRADENAME (ICG drug product), System green is used with TRADENAME (ICG drug product) to perform intraoperative fluorescence angiography, and it is also indicated for use in fluorescence imaging of biliary ducts, and when indicated, during intraoperative cholangiography.
System green is indicated for use to provide real time endoscopic visible and near-infrared fluorescence imaging. System green enables surgeons to perform minimally invasive surgery using standard endoscope visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct or common hepatic duct), using near-infrared imaging.
Fluorescence imaging of biliary ducts with System green is intended for use with standard of care white light, and when indicated, intraoperative cholangiography.
The device is not intended for standalone use for biliary duct visualization.
Upon interstitial administration of TRADENAME (ICG drug product), System green is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes
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Image /page/26/Picture/1 description: The image contains the logo for Richard Wolf. The words "RICHARD" and "WOLF" are stacked on top of each other, with "RICHARD" in black and "WOLF" in red. To the right of the text is a square with rounded corners, inside of which is a stylized drawing of a dog standing next to a pole.
5.8.2 Light Source LED Green
ICG light sources
The products are used for providing white light and near-infrared light for diagnostic and therapeutic application, specifically in endoscopy.
The Light source LED green ENDOLIGHT can be used to provide real time endoscopic imaging using standard endoscope visible light and near-infrared fluorescence imaging, this enables surgeons to perform:
- Minimally invasive surgery. .
- . Visual assessments of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct or common hepatic duct), using near-infrared imaging.
- Intraoperative cholangiography.
Upon intravenous administration of TRADENAME (ICG drug product), ICG light sources can be used with System green to perform:
- Intraoperative fluorescence angiography. ●
- Fluorescence imaging of biliary ducts, and when indicated during intraoperative cholangiography. ●
Upon interstitial administration of TRADENAME (ICG drug product), ICG light sources can be used with System green to perform:
- . Intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.
The Light source LED green ENDOLIGHT is not intended for standalone use for biliary duct visualization.
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Fiber Light Cables 5.8.3
Light cable
The products are used to transmit light in the visible spectral range from the light source to the application-specific instrument set.
Fiber Light Cables are used to provide real time endoscopic imaging using standard endoscopic visible light and near-infrared fluorescence imaging, this enables surgeons to perform:
- . Minimally invasive surgery.
- . Visual assessments of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct or common hepatic duct), using near-infrared imaging.
- Intraoperative cholangiography.
Upon intravenous administration of TRADENAME (ICG drug product), fiber light cables can be used with System green to perform:
- Intraoperative fluorescence angiography.
- Fluorescence imaging of biliary ducts, and when indicated during intraoperative . cholangiography.
Upon interstitial administration of TRADENAME (ICG drug product), fiber light cables can be used with System green to perform:
- . Intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.
Light cables are not intended for standalone use for biliary duct visualization.
Adapter for light cable
The products are used to connect light guides to light sources or endoscopes.
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5.8.4 Logic HD Camera Controller and Logic 4K Camera Controller
Camera Controller
The Logic HD Camera Controller 552510x and the Logic 4K Camera Controller 5525301 have been designed for high-definition video endoscopy and can be used for both diagnostic and therapeutic interventions.
The Camera Controllers are used in conjunction with other video equipment and endoscopic accessories.
The Logic HD Camera Controller and the Logic 4K Camera Controller can be used to provide real time endoscopic imaging using standard endoscope visible light and near-infrared fluorescence imaging, this enables surgeons to perform:
- . Minimally invasive surgery.
- Visual assessments of vessels, blood flow and related tissue perfusion, and at least one of the . major extra-hepatic bile ducts (cystic duct, common bile duct or common hepatic duct), using near-infrared imaging.
- . Intraoperative cholangiography.
Upon intravenous administration of TRADENAME (ICG drug product), Camera Controllers can be used with System green to perform:
- Intraoperative fluorescence angiography. ●
- . Fluorescence imaging of biliary ducts, and when indicated during intraoperative cholangiography.
Upon interstitial administration of TRADENAME (ICG drug product), Camera Controllers can be used with System green to perform:
- Intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.
Camera Controllers are not intended for standalone use for biliary duct visualization.
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5.8.5 Logic HD camera head green
The Logic HD camera head green is used to provide real time endoscopic imaging using standard endoscope visible light and near-infrared fluorescence imaging, this enables surgeons to perform:
- Minimally invasive surgery.
- . Visual assessments of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct or common hepatic duct), using nearinfrared imaqing.
- . Intraoperative cholangiography.
Upon intravenous administration of TRADENAME (ICG drug product), Logic HD camera head green can be used with System green to perform:
- Intraoperative fluorescence angiography.
- . Fluorescence imaging of biliary ducts, and when indicated during intraoperative cholangiography.
Upon interstitial administration of TRADENAME (ICG drug product), Logic HD camera head green can be used with System green to perform:
- Intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic . vessels and lymph nodes.
The Logic HD camera head green is not intended for standalone use for biliary duct visualization.
5.8.6 PANOVIEW Ultra telescopes
PANOVIEW ULTRA Telescopes are used to provide real time endoscopic imaging using standard endoscopic visible light and near-infrared fluorescence imaging, this enables surgeons to perform:
- . Minimally invasive surgery.
- . Visual assessments of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct or common hepatic duct), using near-infrared imaging.
- . Intraoperative cholangiography.
Upon intravenous administration of TRADENAME (ICG drug product), PANOVIEW ULTRA Telescopes can be used with System green to perform:
- Intraoperative fluorescence angiography.
- . Fluorescence imaging of biliary ducts, and when indicated during intraoperative cholangiography.
Upon interstitial administration of TRADENAME (ICG drug product), PANOVIEW ULTRA Telescopes can be used with System green to perform:
- . Intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.
PANOVIEW ULTRA Telescopes are not intended for standalone use for biliary duct visualization.
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Image /page/30/Picture/1 description: The image contains the words "RICHARD WOLF" in a stylized font. The word "RICHARD" is in a smaller, sans-serif font above the word "WOLF", which is in a larger, bolder, red font. To the right of the words is a square logo with rounded corners, containing a stylized drawing of a wolf's head and a vertical line with a small, three-pronged shape at the bottom.
5.9 Comparison of Technological Characteristics with the Predicate Device
For each component device, two predicate devices were used. The primary predicate device was the PINPOINT device, which was used to cover the new indications for use in the context of System green.
As secondary predicate device, a Richard Wolf device was selected to cover any differences in technology between the subject component device and the primary predicate device. Therefore, the comparability of the subject devices with the predicate devices is ensured for all component devices.
5.10 Summary of Performance Testing
5.10.1 Non-clinical Performance Testing
5.10.1.1 Electromagnetic Compatibility and Electrical Safety
Electromagnetic compatibility and electrical safety testing proved compliance with the following standards for the component devices of System Green
-
. IEC 60601-1:2005 + CORR. 1:2006 + CORR. 2:2007 + AM1:2012 (or IEC 60601-1:2012 reprint recognition number 19-4): Medical electrical equipment Part 1:
including national differences according to National Standard AAMI/IEC 60601-1:2005 + AMD 1:2012 United States of America ANSI/AAMI ES60601-1:2005 / A2:2010 corresponding to ANSI/AAMI ES60601-1:2005/(R):2012 and A1:2012, C1:2009(R)2012 and A2:2010/(R)2012 -
IEC 60601-1-6:2010, AMD1:2013 (recognition number 5-89) for use in conjunction with IEC . 62366:2007, AMD1:2014 and IEC 60601-1:2005, COR1:2006, COR2:2007, AMD1: 2012 or equivalent consolidated version IEC 60601-1:2012 (Edition 3.1)
-
. IEC 60601-1-2:2014 (recognition number 19-8) Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
-
. IEC 60601-2-18:2009 (Third Edition) (recognition number 9-114) Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment
5.10.1.2 Performance Testing
Photobiological safety testing according to IEC 62471 was conducted by an accredited testing laboratory. The product under test was assigned to risk group 2.
NIR power and wavelength spectrum of the Light Source LED Green was measured and verified.
Temperature safety testing at the distal end of the PANOVIEW Ultra telescope was performed and found to be within the specified limits according to IEC 60601-2-18.
Tightness of the Logic HD camera head green with a minimum protection degree of IPX7 according to IEC 60529 was ensured. The tightness of the camera head was determined to be suitable for steam sterilization.
To demonstrate that functionality is still given after specified storage and transport conditions, transport simulation according to ISO 11607-1 and ASTM D4169 was performed. Functional testing before and after transport confirmed that the packaging is suitable and is not subject to safety or performance concerns.
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5.10.2 Animal Testing
Animal testing was performed to evaluate the effectiveness and performance of System green in a pre-clinical model as well as to evaluate the risk of incorrect fluorescence using the subject device. The test results show that the subject device met all specified acceptance criteria set out for the animal testing, and that the performance of the device with respect to the risk of incorrect fluorescence has been confirmed.
Animal testing verified the effectiveness as described in the indications for use.
5.11 Conclusion
System green and its component device has similar indications for use as the predicate device PINPOINT and the predicate devices from Richard Wolf.
The nonclinical tests demonstrate that the devices are as safe and as effective as the legally marketed device.
Therefore, System green and the component devices were deemed substantially equivalent to the legally marketed devices.