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, or 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 Description

The KARL STORZ ICG Imaging System is used to provide real-time high-definition (HD) endoscopic or telescopic images of visible (VIS) and near-infrared (NIR) indocyanine green (ICG) dye fluorescence during minimally invasive, neuro- and endonasal skull base surgery as well as plastic, micro- and reconstructive surgical procedures in general and pediatric populations.

The overall system includes a 4mm HOPKINS ICG/NIR Endoscope (0°, 30° or 45°) for use in neuro- and endonasal skull base surgery, a 5mm & 10mm HOPKINS ICG/NIR Endoscope (0° or 30°) for use in minimally invasive procedures and a VITOM II ICG/NIR Telescope for use in plastic, micro- and reconstructive surgical procedures for VIS and NIR illumination and imaging, a light source with foot switch for emission of VIS and NIR illumination, a color video camera head capable of capturing both VIS and NIR imaging, and a KARL STORZ ICG Kit. Additional accessories used with the KARL STORZ ICG Imaging System include two standards fiber-optic light cables for transmission of VIS and NIR light and the Image1 S Camera Control Unit (CCU). The KARL STORZ ICG Imaging System can be used with any medical grade HD monitor with a DVI-D or 3G-SDI input.

AI/ML Overview

The provided text, K180146, describes the KARL STORZ ICG Imaging System, an endoscopic device for real-time visible and near-infrared fluorescence imaging, particularly for assessing vessels, blood flow, and tissue perfusion. The submission is a 510(k) for a modified device, primarily adding a 4mm endoscope for neuro- and endonasal skull base surgery in adults and pediatrics.

Based on the document, here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily defined by adherence to established standards for medical devices and demonstration of equivalence to predicate devices through bench testing and literature review. The document does not provide specific quantitative acceptance criteria for clinical performance (e.g., a specific sensitivity or specificity for detecting blood flow issues). Instead, it relies on demonstrating that the device meets its design specifications and performs comparably to the predicate devices and that the expanded indications are supported by existing clinical literature.

Parameter	Acceptance Criteria (Implied)	Reported Device Performance
Safety	Compliance with Electrical Safety and EMC standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18).	"KARL STORZ ICG Imaging System follows the FDA recognized consensus standards and is tested according to the following standards: Electrical Safety and EMC IEC 60601-1 IEC 60601-1-2 IEC 60601-2-18"
	Compliance with Biocompatibility standards (ISO 10993) including systemic toxicity, intracutaneous irritation, maximization sensitization, mucosal irritation.	"Biocompatibility (ISO 10993) – Systemic toxicity, Intracutaneous irritation, Maximization sensitization, Mucosal Irritation" (indicating it was tested for these)
	Reprocessing (Cleaning and Steam Sterilization) validation according to AAMI and ISO standards (AAMI TIR30:2011, AAMI TIR 12:2010, ANSI/AAMI/ISO 14937:2009, ANSI/AAMI ST9:2010/A4:2013, ISO TS 15883:2005).	"Reprocessing (Cleaning and Steam Sterilization) – AAMI TIR30:2011 AAMI TIR 12:2010 ANSI/AAMI/ISO 14937:2009 ANSI/AAMI ST9:2010/A4:2013 ISO TS 15883:2005 Processing/Reprocessing Medical Device in Health Care Settings: Validation Methods and Labeling" (indicating testing was performed)
Performance	Meeting design specifications through performance testing for: Color Performance, Detection Linearity, Distortion, Dynamic Range, Illumination, Resolution, SNR & Sensitivity, Depth of Field, UV Exposure, Irradiance, Color Reproduction.	"Performance Testing – Color Performance, Detection Linearity, Distortion, Dynamic Range, Illumination, Resolution, SNR & Sensitivity, Depth of Field, UV Exposure, Irradiance, Color Reproduction" and "Additional bench testing was performed to ensure the device met its design specifications. The bench testing performed verified and validated that the KARL STORZ ICG Imaging System has met all its design specification..."
	Substantial equivalence to predicate device (K171238) regarding intended use, design, technology, and performance specifications, specifically supporting the addition of 4mm endoscopes. Expected to have similar performance characteristics for parameters like Endoscope Type, Direction of View, Field of View, Imaging Type, Imaging Agent, Light Source Compatibility. Depth of Field could differ based on new endoscopes but must be acceptable for intended use.	"The KARL STORZ ICG Imaging System is a modification of and substantially equivalent to the primary predicate, KARL STORZ Imaging System (K171238), in regards to its intended use, design, technology, and performance specifications. The main difference between the subject and primary predicate device is the addition of the 4mm HOPKINS ICG/NIR Endoscopes to the KARL STORZ Endoscopic ICG System to be used in neuro- and endonasal skull base surgery in adults and pediatrics." Comparative Table:
Endoscope Type	Rigid, rod lens	Rigid, rod lens
Endoscope Diameters	4mm, 5mm & 10mm	5mm & 10mm
Direction of View	0°, 30°, 45°	0°, 30°
Working Length	18cm (4mm), 29cm (5mm), 31cm (10mm)	29cm (5mm), 31cm (10mm)
Depth of Field	8mm – 38mm	30mm - 80mm (5mm), 30mm – 110mm (10mm)
Field of View	80°	74°
Imaging Type	Visible and near-infrared imaging	Visible and near-infrared imaging
Imaging Agent	ICG	ICG
Light Source Compatibility	Xenon	Xenon
	Substantial equivalence to secondary predicate (K021050) regarding intended use (VIS imaging), design, technology, and performance, specifically regarding the addition of a filter for NIR imaging. Expected to have similar performance characteristics.	"The KARL STORZ ICG Imaging System is also substantial equivalent to the secondary predicate, KSEA Neuroendoscope & Accessories, in regards to its intended use (VIS imaging), design, technology, and performance specifications. The main difference between the subject and secondary predicate device is the addition of filter located at the eyepiece of the endoscope for the purpose of NIR imaging." Comparative Table:
Endoscope Type	Rigid, rod lens	Rigid, rod lens
Endoscope Diameters	4mm, 5mm & 10mm	2.7mm, 4mm & 4.8mm
Direction of View	0°, 30°, 45°	0°, 30°, 45°
Working Length	18cm (4mm), 29cm (5mm), 31cm (10mm)	18 or 20 cm
Depth of Field	8mm – 38mm	8mm – 38mm
Field of View	80°	80°
Imaging Type	Visible and near-infrared imaging	Visible Imaging
Imaging Agent	ICG	N/A
Light Source Compatibility	Xenon	Xenon
Expanded Indications	Clinical support for NIR imaging in neuro- and endonasal skull base surgeries, and for use in pediatric populations.	"Clinical published literatures were provided to support the effectiveness of NIR imaging in the neuro- and endonasal skull base surgeries as well as the use of the KARL STORZ ICG Imaging System in pediatrics." (References provided in bibliography).

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

The document explicitly states: "Clinical performance is not required to demonstrate substantial equivalence to the predicate devices. Non-clinical bench testing was sufficient to establish substantial equivalence."

Therefore, there appears to be no specific "test set" of patient data for evaluating algorithm performance in the way one would for an AI/ML device. The evaluation relies on:

Bench testing: This refers to laboratory-based functional and safety testing of the device hardware and software. The sample size for this is not specified in terms of "patients" or "cases" but rather in terms of components or test conditions. The provenance is internal to the manufacturer's testing facility.
Clinical Literature: Published studies from various sources were used to support the expanded indications for use in neuro- and endonasal skull base surgeries and in pediatric populations. The provenance of this data is from the respective published articles (e.g., Journal of Neurological Surgery Part B, Neurologia Medico-Chirurgica). These are retrospective studies conducted by various researchers, not specifically "prospective" studies for this particular 510(k) submission.

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

Since no specific clinical "test set" for algorithm performance was used, there is no mention of experts for ground truth establishment in that context. The "ground truth" for the device's functional performance was established through engineering and quality control testing against design specifications and relevant standards. For the expanded indications, the "ground truth" is derived from the established scientific and clinical evidence presented in the published literature.

4. Adjudication method for the test set

Not applicable, as no clinical test set requiring expert adjudication for ground truth was generated for this submission.

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 MRMC study was conducted or referenced in this submission. This device is an imaging system (hardware and associated software), not an AI-based diagnostic algorithm intended to assist human readers in image interpretation. Its purpose is to generate the imaging data (visible and NIR fluorescence), not to interpret it in an AI-assisted manner.

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

Not applicable. The device itself is a tool for image acquisition, primarily used by surgeons for visual assessment during procedures. It does not perform an automated, standalone diagnostic algorithm.

7. The type of ground truth used

For device performance validation: The ground truth was established by engineering design specifications and compliance with recognized industry standards (IEC, ISO, AAMI). This involved direct measurement and verification against established physical and electrical parameters.
For expanded indications: The ground truth was established by published clinical literature related to the effectiveness and safety of NIR imaging using ICG in the specified surgical fields and pediatric populations. This relies on the expert consensus and evidence presented in those scientific publications.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a "training set" of data for learning. Its functionality is based on established optical and electronic principles.

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

Not applicable. As there is no AI/ML training set, there is no ground truth establishment for it.

Summary

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April 17, 2018

KARL STORZ Endoscopy America, Inc. Winkie Wong Senior Regulatory Affairs Specialist 2151 E. Grand Avenue El Segundo, California 90245

Re: K180146

Trade/Device Name: KARL STORZ ICG Imaging System Regulation Number: 21 CFR 882.1480 Regulation Name: Neurological Endoscope Regulatory Class: Class II Product Code: GWG, OWN Dated: January 16, 2018 Received: January 18, 2018

Dear Ms. Wong:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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.

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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.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael J. Hoffmann -S

Carlos L. Peña, PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K180146

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 contains the logo for Karl Storz Endoskope. The word "STORZ" is in large, bold, blue letters. Below that, the words "KARL STORZ - ENDOSKOPE" are written in smaller, blue letters.

510(k) SUMMARY

This summary of 510(k) safety and effectiveness information 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.

Applicant:	KARL STORZ Endoscopy-America, Inc2151 E. Grand AvenueEI Segundo, CA 90245
Contact:	Winkie WongSenior Regulatory Affairs Specialist424-218-8379424-218-8519
Date of Preparation:	January 15, 2018
Type of 510(k)Submission:	Traditional
Device Identification:	Trade Name: KARL STORZ ICG Imaging SystemClassification Name: Neurological Endoscope
Product Code:	GWG, OWN
Regulation:	21 CFR 876.1480 (Neurological Endoscope)
Predicate Device(s):	KARL STORZ ICG Imaging System (K171238) – PrimaryKSEA Neuroendoscopes and Accessories (K021050) – SecondaryThe above predicate has not been subject to any recall
Device Description:	The KARL STORZ ICG Imaging System is used to provide real-time high-definition (HD) endoscopic or telescopic images ofvisible (VIS) and near-infrared (NIR) indocyanine green (ICG) dyefluorescence during minimally invasive, neuro- and endonasalskull base surgery as well as plastic, micro- and reconstructivesurgical procedures in general and pediatric populations.
	The overall system includes a 4mm HOPKINS ICG/NIR Endoscope(0°, 30° or 45°) for use in neuro- and endonasal skull basesurgery, a 5mm & 10mm HOPKINS ICG/NIR Endoscope (0° or30°) for use in minimally invasive procedures and a VITOM IIICG/NIR Telescope for use in plastic, micro- and reconstructivesurgical procedures for VIS and NIR illumination and imaging, alight source with foot switch for emission of VIS and NIRillumination, a color video camera head capable of capturing bothVIS and NIR imaging, and a KARL STORZ ICG Kit. Additionalaccessories used with the KARL STORZ ICG Imaging Systeminclude two standards fiber-optic light cables for transmission ofVIS and NIR light and the Image1 S Camera Control Unit (CCU).The KARL STORZ ICG Imaging System can be used with anymedical grade HD monitor with a DVI-D or 3G-SDI input.

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 Endoscopic ICG System enables surgeons toperform minimally invasive surgery using standard endoscopicvisible light as well as visual assessment of vessels, blood flowand related tissue perfusion, or at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct and commonhepatic duct), using near infrared imaging. Fluorescence imagingof biliary ducts with the KARL STORZ Endoscopic ICG System isintended for use with standard of care white light and, whenindicated, intraoperative cholangiography. The device is notintended for standalone use for biliary duct visualization.Additionally, the KARL STORZ Endoscopic ICG System enablessurgeon to perform minimally invasive cranial neurosurgery inadults and pediatrics and endonasal skull base surgery in adultsand pediatrics > 6 years of age using standard endoscopic visiblelight as well as visual assessment of vessels, blood flow andrelated tissue perfusion using near infrared imaging.The KARL STORZ VITOM II ICG System is intended for capturingand viewing fluorescent images for the visual assessment ofblood flow, as an adjunctive method for the evaluation of tissueperfusion, and related tissue-transfer circulation in tissue and
TechnologicalCharacteristics:	free flaps used in plastic, micro- and reconstructive surgicalprocedures. The VITOM II ICG System is intended to provide amagnified view of the surgical field in standard white light.The KARL STORZ ICG Imaging System includes the followingcomponents and accessories:4mm, 5mm & 10mm HOPKINS ICG/NIR Endoscopes VITOM II ICG Telescope Camera Head (H3Z-FI) Fiber optic Light Cables Light Source Image1 S CCU The endoscopes/telescope are intended to be connected to theoptical coupler of the camera head, which connects to the CCU forimage processing, as well as to the light source via compatiblelight cable as the source of illumination to allow visualization ofinternal anatomy. Visualization and navigation is performedinitially using VIS imaging. NIR imaging is selected when visualassessment and/or confirmation of vessels, blood flow or tissueperfusion is desired.
Non-ClinicalPerformance Data:	There are no performance standards or special controlsdeveloped under 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 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 Biocompatibility (ISO 10993)

	Systemic toxicity Intracutaneous irritation Maximization sensitization Mucosal Irritation Software Verification and Validation Testing Guidance for the Content of Premarket Submissions for Software Contained in Medical Device Level of concern: Moderate Performance Testing Color Performance Detection Linearity Distortion Dynamic Range Illumination Resolution SNR & Sensitivity Depth of Field UV Exposure Irradiance Color Reproduction Reprocessing (Cleaning and Steam Sterilization) AAMI TIR30:2011 AAMI TIR 12:2010 ANSI/AAMI/ISO 14937:2009 ANSI/AAMI ST9:2010/A4:2013 ISO TS 15883:2005 Processing/Reprocessing Medical Device in Health Care Settings: Validation Methods and Labeling Additional bench testing was performed to ensure the device met its design specifications.The bench testing performed verified and validated that the KARL STORZ ICG Imaging System has met all its design specification and is substantially equivalent to its predicate devices.
Clinical Performance Data:	Clinical published literatures were provided to support the effectiveness of NIR imaging in the neuro- and endonasal skull
	base surgeries as well as the use of the KARL STORZ ICG ImagingSystem in pediatrics.
SubstantialEquivalence:	The KARL STORZ ICG Imaging System is a modification of andsubstantially equivalent to the primary predicate, KARL STORZImaging System (K171238), in regards to its intended use, design,technology, and performance specifications.
	The main difference between the subject and primary predicatedevice is the addition of the 4mm HOPKINS ICG/NIR Endoscopesto the KARL STORZ Endoscopic ICG System to be used in neuro-and endonasal skull base surgery in adults and pediatrics.
	The KARL STORZ ICG Imaging System is also substantialequivalent to the secondary predicate, KSEA Neuroendoscope &Accessories, in regards to its intended use (VIS imaging), design,technology, and performance specifications.
	The main difference between the subject and secondarypredicate device is the addition of filter located at the eyepiece ofthe endoscope for the purpose of NIR imaging.
	Bench and comparative testing were used to demonstratesubstantial equivalence to the predicate devices. Clinicalpublished literatures were used to support the expandedindications for NIR imaging in neuro- and endonasal skull basesurgeries as well as the use of the KARL STORZ ICG Imagingsystem in pediatrics. Therefore, the differences between thesubject device and the predicate device do not raise any newissues of safety and effectiveness.

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Standard Performance Parameters Comparison:
	KARL STORZICG ImagingSystem	KARL STORZICG System	KS Neuro-endoscopesandAccessories
	SubjectDevice	PrimaryPredicateDevice	SecondaryPredicateDevice
		K162882	K021050
(D1)EndoscopeType	Rigid, rod lens	Rigid, rod lens	Rigid, rod lens
(D2)EndoscopeDiameters	4mm, 5mm & 10mm	5mm & 10mm	2.7mm, 4mm & 4.8mm
(D3)Direction ofView	0°, 30°, 45°	0°, 30°	0°, 30°, 45°
(D4)WorkingLength	18cm (4mm)29cm (5mm)31cm (10mm)	29cm (5mm)31cm (10mm)	18 or 20 cm
Depth ofField	8mm – 38mm	30mm - 80mm (5mm)30mm – 110mm (10mm)	8mm – 38mm
Field of View	80°	74°	80°
Imaging Type	Visible and near-infrared imaging	Visible and near-infrared imaging	Visible Imaging
ImagingAgent	ICG	ICG	N/A

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	Light SourceCompatibility	Xenon	Xenon	Xenon
Bibliography	Published literatures were used to support the expandedindications for NIR imaging in neuro- and endonasal skull basesurgeries as well as the use of the KARL STORZ ICG Imagingsystem in pediatrics.
	NIR Imaging in Neuro and Endonasal Skull Base Surgery:
	Geltzeiler M, Nakassa ACI, Setty P, Zenonos G, Hebert A, Wang E,Fernandez-Miranda J, Snyderman C, Gardner P. (2017). Evaluation ofIntranasal Flap Perfusion by Intraoperative ICG Fluorescence Angiography.Journal of Neurological Surgery Part B: Skull Base. 78. S1-S156. 10.1055/s-0037-1600668.
	Nakassa ACI, Wang E, Fernandez-Miranda J, Snyderman C, Gardner P.(2017). Usefulness of Indocyanine Green Fluorescence Endoscopy forIntraoperative Differentiation of Intracranial Tumors and Adjacent Structures.Journal of Neurological Surgery Part B: Skull Base. 78. S1-S156. 10.1055/s-0037-1600677.
	Hide T, Yano S, Kuratsu J. (2014) Indocyanine Green FluorescenceEndoscopy at Endonasal Transsphenoidal Surgery for an Intracavernous SinusDermoid Cyst: Case Report. Neurologia Medico-Chirurgica. .54(12):999-1003.doi:10.2176/nmc.cr.2014-0087.
	Hide T, Yano S, Shinojima N, Kuratsu J. (2015) Usefulness of theIndocyanine Green Fluorescence Endoscope in Endonasal TranssphenoidalSurgery. Journal of Neurological Surgery. Published online February 27,2015; DOI: 10.3171/2014.9.JNS14599
	Pediatric Use of subject device:
	Patrick C. Walz, Charles A. Elmaraghy and Kris R. Jatana (2015). EndoscopicSkull Base Surgery in the Pediatric Patient, Endoscopy - Innovative Uses andEmerging Technologies, Associate Prof. Somchai Amornyotin (Ed.), InTech,DOI: 10.5772/60555. Available from:https://www.intechopen.com/books/endoscopy-innovative-uses-and-emerging-technologies/endoscopic-skull-base-surgery-in-the-pediatric-patient
	Alessandro Fiorindi, Alessandro Boaro, Giulia Del Moro, Pierluigi Longatti;Fluorescein-Guided Neuroendoscopy for Intraventricular Lesions: A CaseSeries, Operative Neurosurgery, Volume 13, Issue 2, 1 April 2017, Pages 173–181, https://doi.org/10.1093/ons/opw008.
	Yamamichi T, Oue T, Yonekura T, Owari M, Nakahata K, Umeda S, Nara K,Ueno T, Uehara S, Usui N. Clinical application of indocyanine green (ICG)fluorescent imaging of hepatoblastoma. J Pediatr Surg. 2015 May;50(5):833-6.doi: 10.1016/j.jpedsurg.2015.01.014. Epub 2015 Feb 3,https://www.ncbi.nlm.nih.gov/pubmed/25783395
	Kitagawa N. (2016) Application of Indocyanine Green FluorescenceImaging to Pediatric Hepatoblastoma Surgery. In: Kusano M., Kokudo N.,

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	Toi M., Kaibori M. (eds) (2016) ICG Fluorescence Imaging andNavigation Surgery. Springer, Tokyo, ICG Fluorescence Imaging andNavigation Surgery pp343-350., https://doi.org/10.1007/978-4-431-55528-5_31
Clinical PerformanceData:	Clinical performance is not required to demonstrate substantialequivalence to the predicate devices. Non-clinical bench testingwas sufficient to establish substantial equivalence.
Conclusion:	The KARL STORZ ICG Imaging System is substantially equivalentto its predicate devices. The non-clinical testing and supportingclinical literatures demonstrate that the device is as safe andeffective as the legally marketed devices.

Regulation Number and Section

§ 882.1480 Neurological endoscope.

(a)
Identification. A neurological endoscope is an instrument with a light source used to view the inside of the ventricles of the brain.(b)
Classification. Class II (performance standards).