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.

Device Description

The subject device KARL STORZ ICG System includes the following components:

VITOM EAGLE (TH201): a 3D video exoscope with 4K resolution used during open procedures for the evaluation of tissue perfusion, related tissue-transfer circulation in tissue and free flaps used in plastic, micro and reconstructive surgical procedures. The subject device VITOM EAGLE System is being indicated for use in in adults and pediatrics >1month of age.
Fiber Light Cable (495VTE): used to transmit visible and NIR light from the Power LED Rubina light source to the VITOM Eagle.
IMAGE1 Pilot (TC014): used to control the optical functions of the VITOM EAGLE.
Microscope Footswitch (TC019): alternatively used control the optical functions of the VITOM EAGLE
The Power LED Rubina light source (TL400) along with the footswitch (UF101): previously cleared in K201399, K202925 and K212695.
Imagel S Camera Control Unit (TC201US, TC304US): previously cleared in K201399, K202925 and K212695.

AI/ML Overview

The provided text describes the KARL STORZ ICG Imaging System and its acceptance criteria, along with a summary of the non-clinical performance data used to demonstrate substantial equivalence to a predicate device. However, it does not describe a study involving an AI algorithm. The device is an imaging system that uses Indocyanine Green (ICG) fluorescence for various surgical visualizations.

Here's a breakdown of the requested information based only on the provided text, heavily noting limitations due to the absence of AI-specific study details:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a non-AI imaging system without specific AI performance metrics, the acceptance criteria are generally related to the technical performance of the imaging capabilities. The document states that the KARL STORZ ICG Imaging System (subject device) was compared to the predicate VITOM II ICG/NIR telescope of the KARL STORZ ICG Imaging System (K212695). The performance was demonstrated by testing for:

Acceptance Criteria (Performance Metric)	Reported Device Performance (Subject Device vs. Predicate)
Spatial Resolution	Successfully demonstrated by comparison
Signal to Noise Ratio and Noise	Successfully demonstrated by comparison
Dynamic Range	Successfully demonstrated by comparison
Geometric Distortion	Successfully demonstrated by comparison
Depth of Field	Successfully demonstrated by comparison
Illumination Detection Uniformity	Successfully demonstrated by comparison
Latency	Successfully demonstrated by comparison
Penetration Depth	Successfully demonstrated by comparison
Simultaneous Color Contrast	Successfully demonstrated by comparison
Minimum Detectable Concentration of ICG	Successfully demonstrated by comparison
3D Zoom and Rotation	Successfully demonstrated by comparison
2D and 3D Mode Transition	Successfully demonstrated by comparison
Image Alignment	Successfully demonstrated by comparison
Photobiological Safety	Successfully demonstrated by comparison
Electrical Safety and EMC (IEC 60601-1, IEC 60601-1-2)	Follows FDA recognized consensus standards and tested accordingly

2. Sample size used for the test set and the data provenance

The document does not specify a "test set" in the context of an AI algorithm or patient data. The performance evaluation was based on non-clinical bench testing comparing the subject device's imaging capabilities to a predicate device. Therefore, there's no mention of sample size in terms of patient data or data provenance (country of origin, retrospective/prospective). The "sample" here would refer to the physical devices and controlled test scenarios.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. As this is a non-AI imaging system being evaluated via bench testing, there are no "experts" establishing ground truth for a test set of images or patient data. The ground truth for the technical performance criteria would be established by validated measurement techniques and instrumentation during the bench tests.

4. Adjudication method for the test set

Not applicable, as there is no "test set" in the context of human expert review or an AI algorithm's output. The evaluation was based on objective technical measurements.

5. 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

No. 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 the substantial equivalence of the modifications." Furthermore, this is not an AI-assisted device, so MRMC studies on AI assistance would not be relevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. The device is an imaging system, not a standalone AI algorithm. It produces images for human surgeons to interpret.

7. The type of ground truth used

For the non-clinical performance data, the ground truth was based on objective measurements from bench testing (e.g., measuring spatial resolution, signal-to-noise ratio, etc.) against established technical specifications or a predicate device's performance.

8. The sample size for the training set

Not applicable. The device does not involve an AI algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable, as there is no AI algorithm or training set.

Summary of AI-related information (or lack thereof):

The provided text describes a submission for a KARL STORZ ICG Imaging System, which is a medical device for real-time visible and near-infrared fluorescence imaging during surgery. The entire document focuses on demonstrating the substantial equivalence of this updated imaging system to a previously cleared predicate device through non-clinical bench testing. There is no mention of any artificial intelligence (AI) component, machine learning model, or any studies related to AI performance, human-in-the-loop improvements with AI, or standalone algorithm performance. Therefore, most of the questions regarding AI-specific criteria cannot be answered from the provided text.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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.

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 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. KGDr.-Karl-Storz-Straße 3478532 Tuttlingen, Germany
Contact:	Alita McElroySenior Regulatory Affairs SpecialistPhone: (424) 218-8376Fax: (424) 218-8519
Date ofPreparation:	October 24, 2023
Type of 510(k)Submission:	Traditional
DeviceIdentification:	Trade Name: KARL STORZ ICG Imaging SystemClassification Name: Endoscope and accessoriesCommon Name: Confocal Optical Imaging
RegulatoryClass:	II
Product Code:	OWN, GWG
Regulation:	21 CFR 876.1500 (Endoscope and Accessories)21 CFR 882.1480 (Neurological Endoscopes)
PredicateDevice(s):	KARL STORZ ICG Imaging System (K212695)KARL STORZ SE & Co. KG
DeviceDescription:	The subject device KARL STORZ ICG System includes the followingcomponents:1) VITOM EAGLE (TH201): a 3D video exoscope with 4K resolutionused during open procedures for the evaluation of tissue perfusion,related tissue-transfer circulation in tissue and free flaps used inplastic, micro and reconstructive surgical procedures. The subjectdevice VITOM EAGLE System is being indicated for use in in adultsand pediatrics >1month of age.2) Fiber Light Cable (495VTE): used to transmit visible and NIR lightfrom the Power LED Rubina light source to the VITOM Eagle.3) IMAGE1 Pilot (TC014): used to control the optical functions of theVITOM EAGLE.4) Microscope Footswitch (TC019): alternatively used control theoptical functions of the VITOM EAGLE5) The Power LED Rubina light source (TL400) along with thefootswitch (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.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.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 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.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.
TechnologicalCharacteristics:	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

TechnologicalCharacteristics	KARL STORZICG ImagingSystem	KARL STORZICG ImagingSystemK212695
Imaging SystemComponents	Exoscope(integrated sensor) Fiber opticlight cable Light source Footswitch Image1 SCCU IMAGE1Pilot MicroscopeFootswitch	Exoscope Fiber opticlight cable Light source Footswitch Camera head Image1 SCCU
Imaging type	White Light andFluorescentImaging	White Light andFluorescentImaging
Imaging Agent	ICG	ICG
	FocalDistance	WLi/NIR:16.9cm- 52.9cm	WLi: 25-75cmNIR: 20-30cm
	Directionof View	90°	0°
	Field ofView	19°	11°
Exoscopes	Zoom	Optical Zoom: 6xDigital Zoom: 2x	Optical Zoom: 1xDigital Zoom:2.5x
	DisplayType	2D, 3D	2D
Imager	SensorType	CMOS	CMOS
	SensorResolution	3840 x 2160p	3840 x 2160p
CCU	BrightnessControl	Yes	Yes
	EnhancementControl	Yes	Yes
	AutomaticLightSourceControl	Yes	Yes
	Shuttercontrol	Yes	Yes
	Image/Video Capture	Yes	Yes
	AdaptiveZoom	No	Yes
	DigitalOutputs	12G/3G-SDI	12G/3G-SDI
		DisplayPortDVI-D	DisplayPortDVI-D
	CommunicationInterface	KS HIVE	KS HIVE
	RemoteService	Yes	No
	Image Presentation	Displayed image iseither the VIS lightimage or the NIRimage.	Displayed image iseither the VIS lightimage or the NIRimage.
		For the NIR image,the user has threepresentations of theICG imagery tochoose from:	For the NIR image,the user has threepresentations of theICG imagery tochoose from:
		a. Overlay: Thewhite light imageis overlaid withthe NIR image.	a. Overlay: Thewhite light imageis overlaid withthe NIR image.
		The NIR imagecould either byblue or green	The NIR imagecould either byblue or green
		b. IntensityMap: Thewhite light	b. IntensityMap: The whitelight image is
		image isoverlaid with	overlaid withcolor
		colortransformed	transformedNIR image.
		NIR image.	c. Monochromatic:
		c. Monochromatic: The NIR image is indicated by the color white against a dark background.	The NIR image is indicated by the color white against a dark background.
Non-ClinicalPerformance Data:		There are no performance standards or special controls developed under Section 514 of the FD&C Act for endoscopes.However, the KARL STORZ ICG Imaging System follows the FDA recognized consensus standards and is tested according to the following standards and FDA Guidance:Electrical Safety and EMC IEC 60601-1 IEC 60601-1-2 Software Verification and Validation TestingGuidance for the Content of Premarket Submissions for Software Contained in Medical Device The performance of the subject device for NIR imaging has been successfully demonstrated by comparing to the predicate VITOM II ICG/NIR telescope of the KARL STORZ ICG Imaging System cleared under K212695 Spatial Resolution Signal to Noise Ratio and Noise Dynamic Range Geometric Distortion Depth of Field Illumination Detection Uniformity Latency Penetration Depth Simultaneous Color Contrast Minimum Detectable Concentration of ICG 3D Zoom and Rotation 2D and 3D Mode Transition Image Alignment Photobiological Safety
ClinicalPerformance 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.
SubstantialEquivalence:	The conclusions drawn from the nonclinical test demonstrate that the subject device is as safe and effective as the predicate device.

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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 text "KARL STORZ - ENDOSKOPE" in a smaller font.

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Image /page/7/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.

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.