(89 days)
Not Found
No
The document describes image processing but does not mention AI, ML, or any related technologies like deep learning or neural networks. The performance studies focus on bench testing and literature review, not AI/ML model validation.
No
The device is an imaging system designed to provide enhanced visualization during surgery, aiding surgeons in assessing anatomy. It is not intended to treat or prevent a disease or condition itself.
Yes
The device is intended for "visual assessment of vessels, blood flow and related tissue perfusion" and "fluorescence imaging of biliary ducts," which are diagnostic activities.
No
The device description explicitly lists multiple hardware components including endoscopes, telescopes, a light source, a camera head, and a Camera Control Unit (CCU). While the CCU performs image processing, the system is not solely software.
Based on the provided information, the KARL STORZ ICG Imaging System is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use and device description clearly state that this system is used for real-time imaging during surgical procedures on the patient's body (vessels, bile ducts, cranial structures, tissue flaps). It is not analyzing samples taken from the body.
- The system provides visual assessment and imaging. While it uses a dye (ICG), the system itself is an imaging tool to visualize the distribution and behavior of the dye within the living tissue, not to perform a diagnostic test on a biological sample.
The device is an imaging system used for surgical guidance and visualization, not for performing diagnostic tests on in vitro samples.
N/A
Intended Use / Indications for 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, 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.
Product codes
GWG, OWN
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
near-infrared (NIR) fluorescence, visible (VIS)
Anatomical Site
vessels, blood flow, tissue perfusion, major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct), cranial, endonasal skull base, tissue and free flaps.
Indicated Patient Age Range
Adults and pediatrics. For endonasal skull base surgery in adults and pediatrics > 6 years of age.
Intended User / Care Setting
Surgeons, minimally invasive surgery, cranial neurosurgery, endonasal skull base surgery, plastic, micro- and reconstructive surgical procedures.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Data: Bench testing was performed to verify and validate 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 Imaging System in pediatrics. Clinical performance is not required to demonstrate substantial equivalence to the predicate devices. Non-clinical bench testing was sufficient to establish substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
KARL STORZ ICG Imaging System (K171238), KSEA Neuroendoscopes and Accessories (K021050)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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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.
1
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
2
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.
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.
| 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, Inc
2151 E. Grand Avenue
EI Segundo, CA 90245 |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Winkie Wong
Senior Regulatory Affairs Specialist
424-218-8379
424-218-8519 |
| Date of Preparation: | January 15, 2018 |
| Type of 510(k)
Submission: | Traditional |
| Device Identification: | Trade Name: KARL STORZ ICG Imaging System
Classification Name: Neurological Endoscope |
| Product Code: | GWG, OWN |
| Regulation: | 21 CFR 876.1480 (Neurological Endoscope) |
| Predicate Device(s): | KARL STORZ ICG Imaging System (K171238) – Primary
KSEA Neuroendoscopes and Accessories (K021050) – Secondary
The 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 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. |
| | |
| 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 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 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 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 |
| Technological
Characteristics: | 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.
The KARL STORZ ICG Imaging System includes the following
components 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 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. Visualization and navigation is performed
initially using VIS imaging. NIR imaging is selected when visual
assessment and/or confirmation of vessels, blood flow or tissue
perfusion is desired. |
| Non-Clinical
Performance 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 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 Imaging
System in pediatrics. |
| Substantial
Equivalence: | 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. |
| | 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. |
| | Bench and comparative testing were used to demonstrate
substantial equivalence to the predicate devices. Clinical
published literatures were used to support the expanded
indications for NIR imaging in neuro- and endonasal skull base
surgeries as well as the use of the KARL STORZ ICG Imaging
system in pediatrics. Therefore, the differences between the
subject device and the predicate device do not raise any new
issues of safety and effectiveness. |
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| Standard Performance Parameters Comparison: | |||
|---|---|---|---|
| KARL STORZ | |||
| ICG Imaging | |||
| System | KARL STORZ | ||
| ICG System | KS Neuro- | ||
| endoscopes | |||
| and | |||
| Accessories | |||
| Subject | |||
| Device | Primary | ||
| Predicate | |||
| Device | Secondary | ||
| Predicate | |||
| Device | |||
| K162882 | K021050 | ||
| (D1) | |||
| Endoscope | |||
| Type | Rigid, rod lens | Rigid, rod lens | Rigid, rod lens |
| (D2) | |||
| Endoscope | |||
| Diameters | 4mm, 5mm & 10mm | 5mm & 10mm | 2.7mm, 4mm & 4.8mm |
| (D3) | |||
| Direction of | |||
| View | 0°, 30°, 45° | 0°, 30° | 0°, 30°, 45° |
| (D4) | |||
| Working | |||
| Length | 18cm (4mm) | ||
| 29cm (5mm) | |||
| 31cm (10mm) | 29cm (5mm) | ||
| 31cm (10mm) | 18 or 20 cm | ||
| Depth of | |||
| Field | 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 |
| Imaging | |||
| Agent | ICG | ICG | N/A |
9
| | Light Source
Compatibility | Xenon | Xenon | Xenon |
|--------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------|-------|-------|
| Bibliography | Published literatures were used to support the expanded
indications for NIR imaging in neuro- and endonasal skull base
surgeries as well as the use of the KARL STORZ ICG Imaging
system 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 of
Intranasal 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 for
Intraoperative 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 Fluorescence
Endoscopy at Endonasal Transsphenoidal Surgery for an Intracavernous Sinus
Dermoid 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 the
Indocyanine Green Fluorescence Endoscope in Endonasal Transsphenoidal
Surgery. 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). Endoscopic
Skull Base Surgery in the Pediatric Patient, Endoscopy - Innovative Uses and
Emerging 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 Case
Series, 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 Fluorescence
Imaging to Pediatric Hepatoblastoma Surgery. In: Kusano M., Kokudo N., | | | |
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| | Toi M., Kaibori M. (eds) (2016) ICG Fluorescence Imaging and
Navigation Surgery. Springer, Tokyo, ICG Fluorescence Imaging and
Navigation Surgery pp343-350., https://doi.org/10.1007/978-4-431-55528-
5_31 |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Clinical Performance
Data: | Clinical performance is not required to demonstrate substantial
equivalence to the predicate devices. Non-clinical bench testing
was sufficient to establish substantial equivalence. |
| Conclusion: | The KARL STORZ ICG Imaging System is substantially equivalent
to its predicate devices. The non-clinical testing and supporting
clinical literatures demonstrate that the device is as safe and
effective as the legally marketed devices. |