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 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.

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 Description

The subject device, KARL STORZ ICG Imaging System includes the following components: 4mm, 5mm & 10mm HOPKINS ICG/NIR Endoscopes, VITOM II ICG Telescope, Image1 S Rubina Camera head, Power LED Rubina light source, footswitch, Fiber Light Cables, Image1 S CCU.

The expanded indication for visualization of the lymphatic vessel is only to the Endoscopic ICG system that includes the 4mm, 5mm & 10mm HOPKINS ICG/NIR Endoscopes.

The addition of the reprocessing modalities is to the 4mm, 5mm & 10mm HOPKINS ICG/NIR Endoscopes and the VITOM II ICG/NIR telescope.

The endoscopes/telescope are intended to be connected to the optical coupler of the camera head, which connects to the CCU for image processing, as well as to the light source via compatible light cable as the source of illumination to allow visualization of internal anatomy. The users can switch between WLi (standard white light) mode, for visualization of the endoscopic and microscopic procedures and NIR (Near Infrared) mode to detect ICG presence.

The KARL STORZ ICG Imaging System can be used with any medical grade monitor with a DVI-D or 12G/3G-SDI input.

AI/ML Overview

The provided text describes a 510(k) submission for the KARL STORZ ICG Imaging System (K202925). It outlines the device's intended use and compares it to predicate devices to establish substantial equivalence. However, this document does not contain information about acceptance criteria, clinical study results, sample sizes for training or test sets, number/qualifications of experts, adjudication methods, MRMC studies, or standalone algorithm performance.

The document explicitly states: "Clinical testing was not required to demonstrate the substantial equivalence to the predicate devices. Non-clinical bench testing was sufficient to establish substantial equivalence of the expanded indications." This indicates that the regulatory clearance for this device was based on non-clinical data and comparison to existing predicate devices, rather than a clinical study with detailed performance metrics against predefined acceptance criteria for AI/ML performance.

Therefore, I cannot provide the requested information about acceptance criteria and study proving device performance as it is not present in the provided text.

To answer your request precisely, based on the provided document, the following information is NOT available:

A table of acceptance criteria and the reported device performance: Not provided. The submission relies on substantial equivalence to predicates based on non-clinical data.
Sample sizes used for the test set and the data provenance: Not provided, as clinical testing was not performed for this clearance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided, as clinical testing and ground truth establishment for AI/ML performance are not detailed.
Adjudication method for the test set: Not provided.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not provided. The submission focuses on the imaging system itself, not an AI component assisting human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not provided. The device is an imaging system, not an AI algorithm with standalone performance metrics mentioned.
The type of ground truth used: Not provided.
The sample size for the training set: Not provided.
How the ground truth for the training set was established: Not provided.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath in a smaller font.

KARL STORZ Endoscopy America, Inc. Alita McElroy Regulatory Affairs Specialist 2151 E. Grand Avenue El Segundo, California 90245

December 17, 2020

Re: K202925

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 28, 2020 Received: September 29, 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.

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

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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,

Neil R. P. Ogden 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

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Indications for Use

510(k) Number (if known) K202925

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.

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)
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Image /page/3/Picture/0 description: The image shows the 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.

K202925 KARL STORZ Premarket Notification KARL STORZ ICG Imaging System 510(k) Summary

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.2151 E. Grand AvenueEI Segundo, CA 90245
Contact:	Alita McElroyRegulatory Affairs SpecialistPhone: (424) 218-8376Fax: (424) 218-8519
510(k) Number:	K202925
Date ofPreparation:	December 16, 2020
Type of 510(k)Submission:	Traditional
Trade Name:	KARL STORZ ICG Imaging System
Common Name:	Confocal Optical Imaging
RegulatoryClass:	II
Product Code:	OWN, GWG
ClassificationNumber andName:	21 CFR 876.1500 (Endoscope and Accessories)21 CFR 882.1480 (Neurological Endoscopes)
PredicateDevice(s):	PINPOINT Endoscopic Fluorescence Imaging System (K182606)-PrimaryKARL STORZ ICG Imaging System (K201399)- Secondary
DeviceDescription:	The subject device, KARL STORZ ICG Imaging System includes thefollowing components :4mm, 5mm & 10mm HOPKINS ICG/NIR EndoscopesVITOM II ICG TelescopeImage1 S Rubina Camera headPower LED Rubina light source, footswitchFiber Light CablesImage1 S CCU
	The expanded indication for visualization of the lymphatic vessel isonly to the Endoscopic ICG system that includes the 4mm, 5mm &10mm HOPKINS ICG/NIR Endoscopes.The addition of the reprocessing modalities is to the 4mm, 5mm &10mm HOPKINS ICG/NIR Endoscopes and the VITOM II ICG/NIRtelescope.
	The endoscopes/telescope are intended to be connected to the opticalcoupler of the camera head, which connects to the CCU for imageprocessing, as well as to the light source via compatible light cable asthe source of illumination to allow visualization of internal anatomy.The users can switch between WLi (standard white light) mode, forvisualization of the endoscopic and microscopic procedures and NIR(Near Infrared) mode to detect ICG presence.
	The KARL STORZ ICG Imaging System can be used with anymedical grade monitor with a DVI-D or 12G/3G-SDI input.
Intended Use	The KARL STORZ ICG Imaging System is intended to provide real-time visible and near-infrared fluorescence imaging.
Indications forUse:	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 itsapproved label, the KARL STORZ Endoscopic ICG System enablessurgeons to perform minimally invasive surgery using standardendoscopic visible light as well as visual assessment of vessels, bloodflow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct and common hepaticduct), using near infrared imaging. Fluorescence imaging of biliaryducts with the KARL STORZ Endoscopic ICG System is intended foruse with standard of care white light and, when indicated,intraoperative cholangiography. The device is not intended forstandalone use for biliary duct visualization.
	Additionally, the KARL STORZ Endoscopic ICG System enablessurgeon to perform minimally invasive cranial neurosurgery in adultsand pediatrics and endonasal skull base surgery in adults andpediatrics > 6 years of age using standard endoscopic visible light aswell as visual assessment of vessels, blood flow and related tissueperfusion using near infrared imaging.
Comparison ofIndication forUse:	and viewing fluorescent images for the visual assessment of bloodflow, as an adjunctive method for the evaluation of tissue perfusion,and related tissue-transfer circulation in tissue and free flaps used inplastic, micro- and reconstructive surgical procedures. The VITOM IIfield in standard white light.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.
	The subject device includes the endoscopic system (4mm, 5mm &10mm HOPKINS ICG/NIR Endoscopes) for fluorescence imaging andvisualization of the lymphatic system in addition to the already clearedminimally invasive procedures, neurosurgery, endonasal skull basesurgery.The primary predicate device only includes the endoscopic system forfluorescence imaging and visualization of the lymphatic system andfor minimally invasive procedures. The difference in the indicationdoes not raise new issues of safety and effectiveness because theprimary predicate device is chosen to only support the expandedindication of the subject device i.e imaging and visualization of thelymphatic system as the other indications of the subject device havebeen previously cleared.
	The subject device includes imaging and visualization of the lymphaticsystem in addition to the already cleared minimally invasiveprocedures, neurosurgery, endonasal skull base surgery, whereas thesecondary predicate device is only indicated for minimally invasivesurgery, neurosurgery and endonasal skull base surgery. Thedifference in indication does not raise new issues of safety andeffectiveness because the secondary predicate is chosen due to its identical intended use, operating principles and technological characteristics.
TechnologicalCharacteristics:	The KARL STORZ ICG Imaging System is substantially equivalent tothe legally marketed primary predicate device, PINPOINT EndoscopicFluorescence Imaging System cleared under K182606 and thesecondary predicate device, KARL STORZ ICG Imaging Systemcleared under K201399.The primary predicate was chosen to support the expanded indicationfor imaging and visualization of the lymphatic system. The subject andprimary predicate device are identical in terms of intended use andmode of imaging to provide real time visible (VIS) and near-infraredfluorescence (NIR) imaging. The subject and primary predicatedevices have the same integral components – a light source and lightcable for outputting light, a camera control unit for processing NIRand VIS light images, a camera head and rigid endoscopes for VIS andNIR light illumination and imaging. The main differences between thesubject primary predicate devices include the following:The subject device can output a 4K image to the monitor whilethe primary predicate device outputs a high definition image. The subject device uses a LED light source for NIR imagingwhereas the predicate device provides NIR light using laserdiode. In NIR mode, the subject device displays either one of thethree ICG presentations whereas the primary predicate devicegenerates a parallel display showing four simultaneous imageson the monitor. The subject and secondary devices have identical intended use,operating principles, technological characteristics. The differencesbetween the subject device and the cleared KARL STORZ ICGImaging System are the expanded indication for use of the ICGEndoscopic System (4mm, 5mm & 10mm HOPKINS ICG/NIRendoscopes) for imaging and visualization of the lymphatic system andthe addition of sterilization modalities to the ICG scopes (4mm, 5mm,10mm HOPKINS ICG/NIR Endoscopes and VITOM II ICG/NIRtelescope).
Non-ClinicalPerformanceData:	There are no performance standards or special controls developedunder Section 514 of the FD&C Act for endoscopes.However, the KARL STORZ ICG Imaging System follows the FDArecognized consensus standards and is tested according to thefollowing standards and FDA Guidance: Electrical Safety and EMC

	o IEC 60601-1o IEC 60601-1-2o IEC 60601-2-18• ISO Endoscopic Standardso ISO 8600-1o ISO 8600-3o ISO 8600-4o ISO 8600-5o ISO 8600-6
	The expansion of the indication of the subject device does not changethe biocompatibility, electrical safety, electromagnetic compatibility,or software validations and remain identical since last clearance(K201399).
	Sterilization validations of the additional modalities were conductedfor the HOPKINS ICG/NIR Endoscopes and the VITOM II ICG/NIRtelescopes.
	The performance of the subject device, KARL STORZ ICG ImagingSystem for VIS imaging has been verified and previously cleared inK201399 as the expanded indication for fluorescence imaging andvisualization of the lymphatic system does not affect its performancein white light mode.The photobiological safety of the subject device per the FDArecognized standard IEC 62471 has been verified and previouslycleared in K201399.
	The performance of the subject device for NIR imaging has beendemonstrated by comparing to the primary predicate device,PINPOINT Endoscopic Fluorescence Imaging System to support theexpanded indication for fluorescent imaging and visualization of thelymphatic system
ClinicalPerformanceData:	Clinical testing was not required to demonstrate the substantialequivalence to the predicate devices. Non-clinical bench testing wassufficient to establish substantial equivalence of the expandedindications.
Conclusion:	The conclusions drawn from the cleaning and sterilization data(Section 17), Software Data (Section 19), Electrical Safety and EMCdata (Section 20), as well as the Bench Top Performance Data (Section21) demonstrated that the subject device is as safe and as effective as

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Image /page/4/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/5/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/6/Picture/0 description: The image contains the logo for Karl Storz Endoskope. The word "STORZ" is in large, bold, blue letters. Below that, in smaller blue letters, is the phrase "KARL STORZ - ENDOSKOPE".

K202925 KARL STORZ Premarket Notification KARL STORZ ICG Imaging System 510(k) Summary

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Image /page/7/Picture/0 description: The image shows the logo for Karl Storz Endoskope. The word "STORZ" is in large, bold, blue letters. Below that, the words "KARL STORZ - ENDOSKOPE" are in smaller, blue letters. The logo is simple and professional.

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Image /page/8/Picture/0 description: The image is a logo for Karl Storz Endoskope. The word "STORZ" is in large, bold, blue letters. Below that, the words "KARL STORZ - ENDOSKOPE" are in smaller, blue letters.

K202925 KARL STORZ Premarket Notification KARL STORZ ICG Imaging System 510(k) Summary

the primary and secondary predicate devices. As such, we concluded that the substantial equivalence of the subject and the predicate devices has been met, and the differences between the subject and predicate do not raise new questions of safety and effectiveness.

Regulation Number and Section

§ 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.