KARL STORZ ICG Imaging System

K232857 · Karl Storz SE & CO. KG · OWN · Nov 6, 2023 · Gastroenterology, Urology

Device Facts

• Record ID: K232857
• Device Name: KARL STORZ ICG Imaging System
• Applicant: Karl Storz SE & CO. KG
• Product Code: OWN · Gastroenterology, Urology
• Decision Date: Nov 6, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: AI/ML, Pediatric

Intended Use

The KARL STORZ ICG Imaging System is intended to provide real-time visible (VIS) and near-infrared (NIR) fluorescence imaging. Upon intravenous administration and use of ICG consistent with its approved label, the KARL STORZ Endoscopic ICG System enables surgeons to perform minimally invasive surgery using standard endoscopic 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 and common hepatic duct), using near infrared imaging of biliary ducts with the KARL STORZ Endoscopic ICG System is intended for use with standard of care white light and, when indicated, intraoperative cholangiography. The device is not intended for biliary duct visualization. Additionally, the KARL STORZ Endoscopic ICG System enables surgeon to perform minimally invasive cranial neurosurgery in adults and pediatrics and endonasal skull base surgery in adults and pediatrics > 6 years of age using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion using near infrared imaging. The KARL STORZ VITOM ICG System is intended for capturing fluorescent images for the visual assessment of blood flow, as an adjunctive method for the evaluation of tissue perfusion, and related tissue-transfer circulation in tissue and free flaps used in plastic, micro- and reconstructive surgical procedures in adults and pediatrics >1month of age. The VITOM ICG System is intended to provide a magnified view of the surgical field. Upon interstitial administration and use of ICG consistent with its approved label, the KARL STORZ Endoscopic ICG System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.

Device Story

System provides real-time visible and near-infrared (NIR) fluorescence imaging using ICG dye. Components include VITOM EAGLE 3D 4K video exoscope, fiber light cable, Power LED Rubina light source, IMAGE1 Pilot, and IMAGE1 S Camera Control Unit (CCU). Used in OR by surgeons for minimally invasive surgery, cranial neurosurgery, endonasal skull base surgery, and plastic/reconstructive procedures. Device captures fluorescent images to assess blood flow, tissue perfusion, and lymphatic structures. Output displayed on monitors; surgeon uses visual feedback to guide surgical interventions, evaluate tissue viability, and identify anatomical structures. System supports 2D/3D imaging, overlay modes, intensity maps, and monochromatic NIR views. Remote service capability included.

Clinical Evidence

No clinical data. Substantial equivalence established via non-clinical bench testing, including spatial resolution, signal-to-noise ratio, dynamic range, geometric distortion, depth of field, illumination uniformity, latency, penetration depth, simultaneous color contrast, minimum detectable ICG concentration, 3D zoom/rotation, mode transition, image alignment, and photobiological safety.

Technological Characteristics

Exoscope with integrated CMOS sensor (3840x2160p). Fiber optic light transmission. Energy source: Power LED Rubina. Connectivity: 12G/3G-SDI, DisplayPort, DVI-D, KS HIVE interface. Software-controlled CCU for image processing (overlay, intensity map, monochromatic). Sterilization: compatible with standard endoscopic reprocessing protocols. Standards: IEC 60601-1, IEC 60601-1-2.

Indications for Use

Indicated for real-time VIS/NIR fluorescence imaging during minimally invasive surgery. Used for visual assessment of vessels, blood flow, and tissue perfusion in adults and pediatrics (>1 month for VITOM ICG; >6 years for endonasal skull base surgery). Includes visualization of biliary ducts (adjunctive to cholangiography) and lymphatic system (vessels/nodes).

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• KARL STORZ ICG Imaging System (K212695)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

November 6, 2023

Karl Storz SE & Co. Kg Alita McElroy Senior Regulatory Affairs Specialist Dr.-Karl-Storz-Straße 34 Baden-Wurttemberg Tuttlingen, 78532 Germany

Re: K232857

Trade/Device Name: KARL STORZ ICG Imaging System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: OWN, GWG Dated: September 13, 2023 Received: September 15, 2023

Dear Alita McElroy:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 ([e-mail]) or phone [phone] or 301-796-7100).

> Sincerely, Jessica Carr -S

Jessica Carr, PhD 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

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## Indications for Use

510(k) Number (if known) K232857

Device Name KARL STORZ ICG Imaging System

### Indications for Use (Describe)

The KARL STORZ ICG Imaging System is intended to provide real-time visible (VIS) and near-infrared (NIR) fluorescence imaging.

Upon intravenous administration and use of ICG consistent with its approved label, the KARL STORZ Endoscopic ICG System enables surgeons to perform minimally invasive surgery using standard endoscopic 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 and common hepatic duct), using near infrared imaging of biliary ducts with the KARL STORZ Endoscopic ICG System is intended for use with standard of care white light and, when indicated, intraoperative cholangiography. The device is not intended for biliary duct visualization.

Additionally, the KARL STORZ Endoscopic ICG System enables surgeon to perform minimally invasive cranial neurosurgery in adults and pediatrics and endonasal skull base surgery in adults and pediatrics > 6 years of age using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion using near infrared imaging.

The KARL STORZ VITOM ICG System is intended for capturing fluorescent images for the visual assessment of blood flow, as an adjunctive method for the evaluation of tissue perfusion, and related tissue-transfer circulation in tissue and free flaps used in plastic, micro- and reconstructive surgical procedures in adults and pediatrics >Imonth of age. The VITOM ICG System is intended to provide a magnified view of the surgical field.

Upon interstitial administration and use of ICG consistent with its approved label, the KARL STORZ Endoscopic ICG System 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) | |
|-----------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| <div style="display:flex; align-items:center;"><span style="font-size:20px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div style="display:flex; align-items:center;"><span style="font-size:20px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C)</div> |

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Image /page/3/Picture/0 description: The image shows the logo for Karl Storz Endoskope. The logo is in blue and features the word "STORZ" in large, bold letters. Below the word "STORZ" is the phrase "KARL STORZ - ENDOSKOPE" in a smaller, sans-serif font.

# 510(k) Summary

This 510(k) Summary is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92. All data included in this document is accurate and complete to the best of KARL STORZ SE & Co. KG knowledge.

| Submitter: | KARL STORZ SE & Co. KG<br>Dr.-Karl-Storz-Straße 34<br>78532 Tuttlingen, Germany |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Alita McElroy<br>Senior Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone] |
| Date of<br>Preparation: | October 24, 2023 |
| Type of 510(k)<br>Submission: | Traditional |
| Device<br>Identification: | Trade Name: KARL STORZ ICG Imaging System<br>Classification Name: Endoscope and accessories<br>Common Name: Confocal Optical Imaging |
| Regulatory<br>Class: | II |
| Product Code: | OWN, GWG |
| Regulation: | 21 CFR 876.1500 (Endoscope and Accessories)<br>21 CFR 882.1480 (Neurological Endoscopes) |
| Predicate<br>Device(s): | KARL STORZ ICG Imaging System (K212695)<br>KARL STORZ SE & Co. KG |
| Device<br>Description: | The subject device KARL STORZ ICG System includes the following<br>components:<br>1) VITOM EAGLE (TH201): a 3D video exoscope with 4K resolution<br>used during open procedures for the evaluation of tissue perfusion,<br>related tissue-transfer circulation in tissue and free flaps used in<br>plastic, micro and reconstructive surgical procedures. The subject<br>device VITOM EAGLE System is being indicated for use in in adults<br>and pediatrics >1month of age.<br>2) Fiber Light Cable (495VTE): used to transmit visible and NIR light<br>from the Power LED Rubina light source to the VITOM Eagle.<br>3) IMAGE1 Pilot (TC014): used to control the optical functions of the<br>VITOM EAGLE.<br>4) Microscope Footswitch (TC019): alternatively used control the<br>optical functions of the VITOM EAGLE<br>5) The Power LED Rubina light source (TL400) along with the<br>footswitch (UF101): previously cleared in K201399, K202925 and |
| | K212695. |
| | 6) Imagel S Camera Control Unit (TC201US, TC304US): previously cleared in K201399, K202925 and K212695. |
| Intended Use | The KARL STORZ ICG Imaging System is intended to provide real- time visible and near-infrared fluorescence imaging. |
| Indications for Use: | The KARL STORZ ICG Imaging System is intended to provide real- time visible (VIS) and near-infrared (NIR) fluorescence imaging.<br><br>Upon intravenous administration and use of ICG consistent with its approved label, the KARL STORZ Endoscopic ICG System enables surgeons to perform minimally invasive surgery using standard endoscopic 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 and common hepatic duct), using near infrared imaging.<br><br>Fluorescence imaging of biliary ducts with the KARL STORZ Endoscopic ICG System 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.<br><br>Additionally, the KARL STORZ Endoscopic ICG System enables surgeon to perform minimally invasive cranial neurosurgery in adults and pediatrics and endonasal skull base surgery in adults and pediatrics > 6 years of age using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion using near infrared imaging.<br><br>The KARL STORZ VITOM ICG System is intended for capturing and viewing fluorescent images for the visual assessment of blood flow, as an adjunctive method for the evaluation of tissue perfusion, and related tissue-transfer circulation in tissue and free flaps used in plastic, micro- and reconstructive surgical procedures in adults and pediatrics >1month of age. The VITOM ICG System is intended to provide a magnified view of the surgical field.<br><br>Upon interstitial administration and use of ICG consistent with its approved label, the KARL STORZ Endoscopic ICG System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes. |
| Technological<br>Characteristics: | The following comparison table summarizes the technological characteristics between the subject and predicate devices: |

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Image /page/4/Picture/0 description: The image contains the logo for Karl Storz Endoskope. The word "STORZ" is in large, bold, blue letters at the top. Below that, the words "KARL STORZ - ENDOSKOPE" are written in smaller, blue letters.

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Image /page/5/Picture/0 description: The image is a logo for Karl Storz Endoskope. The word "STORZ" is written in large, bold, blue letters. Below the word "STORZ" is the phrase "KARL STORZ - ENDOSKOPE" in smaller, blue letters. The logo is simple and professional, and it is likely used to represent the company on its products and marketing materials.

K232857 KARL STORZ ICG Imaging System 510(k) Summary

| Technological<br>Characteristics | KARL STORZ<br>ICG Imaging<br>System | KARL STORZ<br>ICG Imaging<br>System<br>K212695 | |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| Imaging System<br>Components | Exoscope<br>(integrated sensor) Fiber optic<br>light cable Light source Footswitch Image1 S<br>CCU IMAGE1<br>Pilot Microscope<br>Footswitch | Exoscope Fiber optic<br>light cable Light source Footswitch Camera head Image1 S<br>CCU | |
| Imaging type | White Light and<br>Fluorescent<br>Imaging | White Light and<br>Fluorescent<br>Imaging | |
| Imaging Agent | ICG | ICG | |
| | Focal<br>Distance | WLi/NIR:<br>16.9cm- 52.9cm | WLi: 25-75cm<br>NIR: 20-30cm |
| | Direction<br>of View | 90° | 0° |
| | Field of<br>View | 19° | 11° |
| Exo<br>sco<br>pes | Zoom | Optical Zoom: 6x<br>Digital Zoom: 2x | Optical Zoom: 1x<br>Digital Zoom:<br>2.5x |
| | Display<br>Type | 2D, 3D | 2D |
| Imager | Sensor<br>Type | CMOS | CMOS |
| | Sensor<br>Resolution | 3840 x 2160p | 3840 x 2160p |
| CCU | Brightness<br>Control | Yes | Yes |
| | Enhancement<br>Control | Yes | Yes |
| | Automatic<br>Light<br>Source<br>Control | Yes | Yes |
| | Shutter<br>control | Yes | Yes |
| | Image/Vid<br>eo Capture | Yes | Yes |
| | Adaptive<br>Zoom | No | Yes |
| | Digital<br>Outputs | 12G/3G-SDI | 12G/3G-SDI |
| | | DisplayPort<br>DVI-D | DisplayPort<br>DVI-D |
| | Communic<br>ation<br>Interface | KS HIVE | KS HIVE |
| | Remote<br>Service | Yes | No |
| | Image Presentation | Displayed image is<br>either the VIS light<br>image or the NIR<br>image. | Displayed image is<br>either the VIS light<br>image or the NIR<br>image. |
| | | For the NIR image,<br>the user has three<br>presentations of the<br>ICG imagery to<br>choose from: | For the NIR image,<br>the user has three<br>presentations of the<br>ICG imagery to<br>choose from: |
| | | a. Overlay: The<br>white light image<br>is overlaid with<br>the NIR image. | a. Overlay: The<br>white light image<br>is overlaid with<br>the NIR image. |
| | | The NIR image<br>could either by<br>blue or green | The NIR image<br>could either by<br>blue or green |
| | | b. Intensity<br>Map: The<br>white light | b. Intensity<br>Map: The white<br>light image is |
| | | image is<br>overlaid with…