KARL STORZ ICG Imaging System

K162882 · KARL STORZ Endoscopy-America, Inc. · OWN · Jan 26, 2017 · Gastroenterology, Urology

Device Facts

• Record ID: K162882
• Device Name: KARL STORZ ICG Imaging System
• Applicant: KARL STORZ Endoscopy-America, Inc.
• Product Code: OWN · Gastroenterology, Urology
• Decision Date: Jan 26, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

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. 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 during surgery; utilizes indocyanine green (ICG) dye as imaging agent. Components include HOPKINS ICG/NIR endoscope, VITOM II ICG/NIR telescope, light source with foot switch, color video camera head, and Image1S Camera Control Unit (CCU). System captures VIS and NIR light; processes signals to display fluorescence overlay on surgical field. Used in OR by surgeons for minimally invasive or open procedures; provides visual assessment of blood flow, tissue perfusion, and biliary duct anatomy. Output displayed on medical-grade HD monitor; assists surgeons in real-time intraoperative decision-making regarding tissue viability and anatomical identification. Benefits include enhanced visualization of perfusion and critical structures, potentially improving surgical outcomes.

Clinical Evidence

No clinical data. Substantial equivalence established via non-clinical bench testing and a GLP porcine animal study evaluating performance of the VITOM II ICG telescope in an open surgery laparoscopy model.

Technological Characteristics

System utilizes Xenon lamp light source, fiber-optic light cables, and silicon image sensor camera head. Supports VIS and NIR imaging. VITOM II telescope is a Class I device (21 CFR 878.4700). Connectivity via DVI-D or 3G-SDI to HD monitors. Sterilization via steam autoclave. Standards met: IEC 60601-1, IEC 60601-1-2, IEC 62471.

Indications for Use

Indicated for surgeons performing minimally invasive or open surgery requiring real-time visible and near-infrared fluorescence imaging for visual assessment of vessels, blood flow, tissue perfusion, and tissue-transfer circulation in free flaps, or visualization of major extra-hepatic bile ducts (cystic, common bile, and common hepatic ducts) as an adjunct to white light and intraoperative cholangiography.

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 Endoscopic ICG System (K152583)
• Visionsense VS3-IR System (K152204)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three profiles of human faces incorporated into the design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 26, 2017

Karl Storz Endoscopy-America, Inc. Annalisa Smullin Regulatory Affairs Specialist 2151 E. Grand Avenue El Segundo, CA 90245

Re: K162882

> 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 Dated: December 13, 2016 Received: December 14, 2016

Dear Annalisa Smullin,

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

{1}------------------------------------------------

the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

# Charles Viviano -S

For Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

### Indications for Use

510(k) Number (if known) K162882

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.

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.

| CONTINUE ON A SEPARATE PAGE IF NEEDED. | | | | |
|--------------------------------------------------|---------------------------------------------|--|--|--|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) | | | |
| Type of Use (Select one or both, as applicable) | | | | |

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

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

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 text "KARL STORZ - ENDOSKOPE" in a smaller 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 KSEA's knowledge.

| Submitter: | KARL STORZ Endoscopy-America, Inc.<br>2151 E. Grand Avenue<br>EI Segundo, CA 90245 | | KARL STORZ<br>ICG Imaging<br>System | KARL STORZ<br>Endoscopic ICG<br>System | Visionsense<br>VS3-IR System |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|---------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| Contact: | AnnaLisa Smullin<br>Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone] | | (Proposed) | (K152583) | (K152204) |
| Date of<br>Preparation: | December 13, 2016 | Manufacturer | KARL STORZ<br>Endoscopy | KARL STORZ<br>Endoscopy | Visionsense Ltd. |
| Type of 510(k)<br>Submission: | Traditional | System<br>Components | • Camera head<br>• Endoscope /<br>Telescope<br>• External light<br>source (via<br>fiber optic light<br>cable) | • Camera head<br>• Endoscope<br>• External light<br>source (via<br>fiber optic<br>light cable) | • Camera head<br>• Endoscope/<br>Telescope<br>• External light<br>source (via<br>fiber optic<br>light cable) |
| Device<br>Identification: | Trade Name: KARL STORZ ICG Imaging System<br>Classification Name: Confocal Optical Imaging | Anatomical Sites | General surgical<br>sites, major<br>extra-hepatic<br>bile ducts,<br>general tissue<br>and free flaps | General surgical<br>sites, major<br>extra-hepatic<br>bile ducts | General surgical<br>sites, brain,<br>spine, shoulder,<br>knee, general<br>tissue and free<br>flaps |
| Regulatory Class: | II | Sterilization | Steam Autoclave | Steam Autoclave | Steam Autoclave |
| Product Code: | OWN | Focal Distance of<br>Telescope | VIS: 25-75 cm<br>NIR: 20-30 cm | N/A | VIS & NIR: 20-40<br>cm |
| Regulation: | 21 CFR part 876.1500 (Endoscope and Accessories) | Imaging Agent | IR Fluorescence<br>dye (i.e.<br>indocyanine<br>green-ICG) | IR Fluorescence<br>dye (i.e.<br>indocyanine<br>green-ICG) | IR Fluorescence<br>dye (i.e.<br>indocyanine<br>green-ICG) |
| Predicate<br>Device(s): | Primary Predicate Device: KARL STORZ Endoscopic ICG System<br>(K152583) | Imaging Head | Silicon Image<br>Sensor in the<br>camera | Silicon Image<br>Sensor in the<br>camera | Silicon Image<br>Sensor in the<br>camera |
| | Second Predicate Device: Visionsense VS3-IR System (K152204) | Light Source | Xenon Lamp | Xenon Lamp | Infrared Laser |
| | These predicate devices have not been subject to a design-related<br>recall. | Imaging | Fluorescent and<br>White Light<br>Imaging | Fluorescent and<br>White Light<br>Imaging | Fluorescent and<br>White Light<br>Imaging |
| Device Description: | The KARL STORZ ICG Imaging System is used to provide real-time<br>high definition (HD) endoscopic or telescope images of visible<br>(VIS) and near-infrared (NIR) indocyanine green (ICG) dye<br>fluorescence during minimally invasive or open surgery. The<br>system components are a HOPKINS ICG/NIR Endoscope and a<br>VITOM II ICG/NIR Telescope for VIS and NIR illumination and<br>imaging, a light source with foot switch for emission of VIS and<br>NIR illumination, a color video camera head capable of capturing<br>both VIS and NIR imaging, and KARL STORZ ICG Kit. Additional<br>accessories used with the KARL STORZ ICG Imaging System | Display both<br>Visible and IR<br>Images | Yes | Yes | Yes (Overlay) |
| | include a standard fiber-optic light cable for transmission of VIS<br>and NIR light and the Image1S Camera Control Unit (CCU). All<br>components except for the VITOM II ICG/NIR Telescope were<br>cleared in K152583. The KARL STORZ ICG Imaging System can be<br>used with any medical grade HD monitor with a DVI-D or 3G-SDI<br>input. The VITOM II ICG/NIR Telescope is a Class I device under<br>21 CFR 878.4700. | Standards Met | IEC 60601-1-2<br>IEC 60601-1 | IEC 60601-1-2<br>IEC 60601-1 | IEC 60601-1-2<br>IEC 60601-1<br>IEC 60825-1 |
| 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<br>visible light as well as visual assessment of vessels, blood flow and<br>related tissue perfusion, and at least one of the major extra-<br>hepatic bile ducts (cystic duct, common bile duct and common<br>hepatic duct), using near infrared imaging. Fluorescence imagingof 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>The KARL STORZ VITOM II 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. The VITOM II ICG System is intended to provide a magnified view of the surgical field in standard white light. | | | | |
| Technological<br>Characteristics: | The KARL STORZ ICG Imaging System is substantially equivalent<br>to the KARL STORZ Endoscopic ICG System (K152583) and the<br>Visionsense VS3-IR System (K152204) in terms of its indications<br>for use, design technology, and performance specifications.<br>The main difference between the subject and the primary<br>predicate device is that the subject device includes a VITOM II<br>ICG/NIR Telescope whereas the primary predicate device only<br>consists of an endoscope. The secondary predicate device was chosen as it includes a telescope with its ICG Imaging System. | | | | |

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image contains 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 text "KARL STORZ - ENDOSKOPE" in a smaller font.

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the logo for Karl Storz Endoskope. The word "STORZ" is written in large, bold, blue letters. Below that, the words "KARL STORZ - ENDOSKOPE" are written in smaller, blue letters.

Bench and comparative testing were used to demonstrate substantial equivalence to the primary and secondary predicate devices. Therefore, the differences between the subject device and the predicate device do not raise any new issues of safety and effectiveness.

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows the logo for STORZ. The word "STORZ" is in large, bold, blue letters. Below that, in smaller blue letters, is the phrase "KARL STORZ - ENDOSKOPE".

| Non-Clinical<br>Performance Data: | The KARL STORZ ICG Imaging System has been successfully tested<br>for its functions and performance, including verification that the<br>spectral characteristics of the ICG system illumination light<br>source, light transmission system, and telescope enable a selective<br>visualization of the ICG fluorescence signal as detected by the<br>camera system.<br>The following comparative testing was conducted for the subject<br>device:<br>• UV Exposure<br>• Color Reproduction<br>• Irradiance Levels<br>• Depth Dependency<br>• Visualization of ICG Signal<br>Furthermore, a GLP animal study was successfully performed by<br>the NAMSA testing facility to evaluate the performance of the<br>KARL STORZ ICG Imaging System with the VITOM II ICG Telescope<br>in the porcine open surgery laparoscopy model.<br>The addition of the VITOM II ICG Telescope to the system does not<br>change the biocompatibility, electromagnetic compatibility,<br>electrical safety, or software validations conducted for the KARL<br>STORZ Endoscopic ICG System cleared in K152583. Cleaning<br>method validation and sterilization validation were performed on<br>the VITOM II ICG Telescope. Bench testing was performed per IEC<br>62471. |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Clinical<br>Performance Data: | Clinical testing was not required to demonstrate the substantial<br>equivalence to the predicate devices. Non-clinical bench testing<br>was sufficient to assess safety and effectiveness and to establish<br>the substantial equivalence of the modifications. |
| Conclusion: | The conclusions drawn from the non-clinical tests such as the<br>sterilization data, the bench top performance data, and the animal<br>study performance data, demonstrated that the subject device is<br>as safe as and as effective as the primary predicate device. As<br>such, we concluded that the substantial equivalence of the subject<br>and the predicate devices has been met, and the differences<br>between the subject and the predicate devices do not raise new<br>questions of safety and effectiveness. |