HOPKINS ICG/NIR 10mm Ridgid Endoscope (modified) 0°, 30°, 45°, HOPKIN ICG/NIR 5mm Ridgid Endoscope (modified) 0°, 30°, 45°, HOPKIN ICG/NIR 4mm Ridgid Endoscope 0°, 30°, 45°, VITOM II ICG/NIR Telescope, Power LED Rubina Light Source, Foot Switch, Fiber Optic Light Cable, Image S CCU, Image S 4U Rubina Camera Head

K201399 · Karl Storz-Endoscopy-America, Inc. · OWN · Aug 17, 2020 · Gastroenterology, Urology

Device Facts

• Record ID: K201399
• Device Name: HOPKINS ICG/NIR 10mm Ridgid Endoscope (modified) 0°, 30°, 45°, HOPKIN ICG/NIR 5mm Ridgid Endoscope (modified) 0°, 30°, 45°, HOPKIN ICG/NIR 4mm Ridgid Endoscope 0°, 30°, 45°, VITOM II ICG/NIR Telescope, Power LED Rubina Light Source, Foot Switch, Fiber Optic Light Cable, Image S CCU, Image S 4U Rubina Camera Head
• Applicant: Karl Storz-Endoscopy-America, Inc.
• Product Code: OWN · Gastroenterology, Urology
• Decision Date: Aug 17, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The KARL STORZ ICG Imaging System is intended to provide real-time visible (VIS) and near-infrared (NIR) fluorescence imaging. 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 duct, common bile duct and common hepatic duct), using near infrared imaging. 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. 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 II ICG System is intended for capturing fluorescent mages 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. The VITOM II ICG System is intended to provide a magnified view of the surgical field in standard white light.

Device Story

System provides real-time visible (VIS) and near-infrared (NIR) fluorescence imaging for minimally invasive surgery. Inputs: optical signals captured via rigid endoscopes or VITOM II telescopes. Transformation: 2-chip 4K camera head with separate CMOS sensors for white light and NIR; Image1 S Connect II/4U-Link CCU processes signals; dual LED light source (white/NIR). Outputs: 4K video on monitor; modes include Overlay (white light + NIR), Intensity Map (color-transformed NIR), and Monochromatic (NIR white against dark). Used in OR by surgeons for intraoperative assessment of blood flow, tissue perfusion, and biliary anatomy. Benefits: real-time visualization of perfusion and structures to guide surgical decision-making.

Clinical Evidence

No clinical data. Substantial equivalence established via non-clinical bench testing, including electrical safety (IEC 60601-1, IEC 60601-1-2), endoscopic standards (ISO 8600 series), and performance testing (depth of field, latency, dynamic range, SNR, sensitivity, spatial resolution, color reproduction, illumination uniformity, and photobiological safety).

Technological Characteristics

Components: 4mm/5mm/10mm rigid endoscopes, VITOM II telescopes, Image1 S 4U Rubina camera head, Image1 S Connect II/4U-Link CCU, Power LED Rubina light source. Sensing: 2-chip CMOS (4K). Illumination: Dual LED (White/NIR 720-810 nm). Connectivity: 12G/3G-SDI, DisplayPort, DVI-D, KS HIVE interface. Sterilization: Validated cleaning/sterilization for camera head.

Indications for Use

Indicated for minimally invasive surgery in adults and pediatrics (cranial neurosurgery) and adults and pediatrics > 6 years (endonasal skull base surgery) for visual assessment of vessels, blood flow, tissue perfusion, and biliary ducts (cystic, common bile, common hepatic). Also indicated for plastic, micro-, and reconstructive surgery for evaluation of tissue perfusion and free flaps. Not for standalone biliary duct visualization.

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 (K180146)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the image is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Karl Storz-Endoscopy-America, Inc. Alita McElroy Regulatory Affairs Specialist 2151 E. Grand Avenue El Segundo, California 90245

August 17, 2020

### Re: K201399

Trade/Device Name: HOPKINS ICG/NIR 10mm Ridgid Endoscope (modified) 0, 30, 45, HOPKIN ICG/NIR 5mm Ridgid Endoscope (modified) 0. 30. 45. HOPKIN ICG/NIR 4mm Ridgid Endoscope 0, 30, 45, VITOM II ICG/NIR Telescope, Power LED Rubina Light Source, Foot Switch, Fiber Optic Light Cable, Image S CCU, Image S 4U Rubina Camera Head

Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: OWN, GWG Dated: May 27, 2020 Received: May 28, 2020

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 (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.

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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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about 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.

Neil R.P. Ogden Assistant Director, THT4A4 DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K201399

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.

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 duct, common bile duct and common hepatic duct), using near infrared imaging. 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.

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 II ICG System is intended for capturing fluorescent mages 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. The VITOM II ICG System is intended to provide a magnified view of the surgical field in standard white light.

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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Image /page/3/Picture/0 description: The image is 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 smaller letters. The logo is simple and professional, and it is likely used to represent the company on its products and marketing materials.

# 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 KSEA's knowledge.

| Submitter: | KARL STORZ Endoscopy-America, Inc.<br>2151 E. Grand Avenue<br>EI Segundo, CA 90245 |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Alita McElroy<br>Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone] |
| Date of<br>Preparation: | May 27, 2020 |
| Type of 510(k)<br>Submission: | Traditional |
| 510(k) Number: | K201399 |
| Device<br>Identification: | Trade Name: KARL STORZ ICG Imaging System<br>Classification 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 (K180146) |
| Device<br>Description: | The modified KARL STORZ ICG Imaging System includes the<br>following components:<br>Modified 10mm and 5mm HOPKINS ICG/NIR Rigid<br>i)<br>Endoscopes (0°, 30°, 45°): have an improved optical<br>design with the white light and NIR images in good<br>focus simultaneously.<br>ii)<br>Power LED Rubina Light Source and Footswitch: The<br>light source has two LEDs, white light and NIR.<br>iii)<br>Image1 S 4U Rubina Camera Head: uses a 2 chip 4K<br>camera head that houses 2 CMOS sensors: one for<br>white light and the other for NIR.<br>Camera Control Unit: Image1 S Connect II (TC201US)<br>iv)<br>and Image1 S 4U- Link (TC304US): is used with the |
| | Image1 S 4U Rubina Camera Head to output a 4K<br>image to the monitor. |
| Intended Use | The KARL STORZ ICG Imaging System is intended to provide real-<br>time visible and near-infrared fluorescence imaging. |
| Indications for<br>Use: | The KARL STORZ ICG Imaging System is intended to provide real-<br>time visible (VIS) and near-infrared (NIR) fluorescence imaging. |
| | The KARL STORZ Endoscopic ICG System enables surgeons to<br>perform minimally invasive surgery using standard endoscopic visible<br>light as well as visual assessment of vessels, blood flow and related<br>tissue perfusion, and at least one of the major extra-hepatic bile ducts<br>(cystic duct, common bile duct and common hepatic duct), using near<br>infrared imaging. Fluorescence imaging of biliary ducts with the<br>KARL STORZ Endoscopic ICG System is intended for use with<br>standard of care white light and, when indicated, intraoperative<br>cholangiography. The device is not intended for standalone use for<br>biliary duct visualization. |
| | Additionally, the KARL STORZ Endoscopic ICG System enables<br>surgeon to perform minimally invasive cranial neurosurgery in adults<br>and pediatrics and endonasal skull base surgery in adults and<br>pediatrics > 6 years of age using standard endoscopic visible light as<br>well as visual assessment of vessels, blood flow and related tissue<br>perfusion using near infrared imaging. |
| | The KARL STORZ VITOM II ICG System is intended for capturing<br>and viewing fluorescent images for the visual assessment of blood<br>flow, as an adjunctive method for the evaluation of tissue perfusion,<br>and related tissue-transfer circulation in tissue and free flaps used in<br>plastic, micro- and reconstructive surgical procedures. The VITOM II<br>ICG System is intended to provide a magnified view of the surgical<br>field in standard white light. |
| Technological<br>Characteristics: | The clinical application for the subject KARL STORZ ICG Imaging<br>System is identical to the cleared KARL STORZ ICG Imaging<br>System, K180146. |
| | The 4mm, 5mm & 10mm Endoscopes and VITOM ICG telescopes<br>connected to the optical coupler of the Image1 S 4U Rubina camera<br>head, which connects to the Image1 S Camera Control Unit for image<br>processing, as well as to the Power LED Rubina light source light |

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Image /page/4/Picture/0 description: The image shows the logo for Karl Storz Endoskope. The word "STORZ" is in large, bold, blue letters on the top line. The words "KARL STORZ - ENDOSKOPE" are in smaller, blue letters on the second line.

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Image /page/5/Picture/0 description: The image is a logo for Karl Storz Endoskope. The logo is blue and features the word "STORZ" in large, bold letters. Below the word "STORZ" is the phrase "KARL STORZ - ENDOSKOPE" in smaller letters.

| Technological Characteristics | KARL STORZ ICG<br>Imaging System<br>Subject Device | KARL STORZ<br>ICG System<br>Predicate Device<br>K180146 | |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Endoscopes<br>(5mm and<br>10mm) | Direction of<br>View | 0°, 30°, 45° | 0°, 30° |
| | Working<br>Length | 29cm (5mm, 0°,<br>30°, 45°)<br>31cm (10mm, 0°,<br>30°, 45°)<br>42cm (10mm 45°) | 29cm (5mm, 0°,<br>30°)<br>31cm (10mm,<br>0°, 30°) |
| Camera<br>Head | Imager Type | 2-chip CMOS (one<br>for WLi and one for<br>ICG) | 3- chip CCD<br>sensors (one for<br>each red, green<br>and blue) |
| | Number of<br>Pixels | 3840 x 2160p | 1920 x 1080p |
| Camera<br>Control<br>Unit | Zoom | 1x, 1.2x, 1.5x,<br>1.75x, 2x, 2.25x,<br>2.5x | 1x, 1.2x, 1.5x,<br>1.75x, 2x |
| | Adaptive Zoom | Yes | No |
| | Digital Outputs | 12G/3G-SDI<br>DisplayPort<br>DVI-D | 3G-SDI<br>DVI-D |
| | Communication<br>Interface | KS HIVE | SCB |
| Light<br>Source | Light Source<br>Type | Dual LEDs | Xenon 300W<br>lamp |
| | NIR Light | Filtered LED<br>Output: 720-810 nm | Filtered Xenon<br>lamp<br>Output: 690-790<br>nm |
| | Image Presentation | Displayed image is<br>either the VIS light<br>image or the NIR<br>image.<br>For the NIR image,<br>the user has three<br>presentations of the<br>ICG imagery to<br>choose from:<br>a. Overlay: The<br>white light image is<br>overlaid with the<br>NIR image. The<br>NIR image could<br>either by blue or<br>green<br>b. Intensity Map:<br>The white light<br>image is overlaid<br>with color<br>transformed NIR<br>image.<br>c. Monochromatic:<br>The NIR image is<br>indicated by the<br>color white against<br>a dark background. | Displayed image<br>is either the VIS<br>light image or<br>the NIR image.<br>The blue NIR<br>image is overlaid<br>over remnant<br>red-green<br>background. |
| Non-Clinical<br>Performance<br>Data: | There are no performance standards or special controls developed<br>under Section 514 of the FD&C Act for endoscopes.<br>However, the KARL STORZ ICG Imaging System follows the FDA<br>recognized consensus standards and is tested according to the<br>following standards and FDA Guidance: | | |

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Image /page/6/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 smaller letters.

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Image /page/7/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 font.

| | Electrical Safety and EMC IEC 60601-1 IEC 60601-1-2 IEC 60601-2-18 ISO Endoscopic Standards ISO 8600-1 ISO 8600-3 ISO 8600-4 ISO 8600-5 ISO 8600-6 Software Verification and Validation Testing Guidance for the Content of Premarket Submissions for Software Contained in Medical Device Level of concern: Moderate Cleaning and sterilization validations were conducted for the Image1 S 4U Rubina camera head.<br>Additional bench testing listed below was performed to ensure the device met its design specifications. Depth of Field Distortion Latency Dynamic Range Signal to Noise Ratio (SNR) & Sensitivity Spatial Resolution Color Reproduction and Color Contrast Enhancement Illumination Detection Uniformity Detection Linearity Direction of View Field of View Zoom Characterization Penetration Depth ICG Contrast Concentration Sensitivity Color Rendering Coregisteration Photobiological Safety (UV Exposure and Distal Irradiance) |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Clinical<br>Performance<br>Data: | Clinical testing was not required to demonstrate the substantial equivalence to the predicate devices. Non-clinical bench testing was sufficient to establish the substantial equivalence of the modifications. |
| Substantial<br>Equivalence: | The conclusions drawn from the cleaning and sterilization data<br>(Section 17), Software Data (Section 19), Electrical Safety and EMC<br>data (Section 20), as well as the Bench Top Performance Data (Section<br>21) demonstrated that the subject device is as safe and as effective as<br>the predicate device. |
| | As such, we concluded that the substantial equivalence of the subject<br>and the predicate device has been met, and the differences between the<br>subject and predicate do not raise new questions of safety and<br>effectiveness. |

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Image /page/8/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 with a circle in the middle of the "O". Below the word "STORZ" is the text "KARL STORZ - ENDOSKOPE" in a smaller, sans-serif font.