(264 days)
No
The summary describes a real-time endoscopic imaging system using visible and near-infrared light with ICG dye. There is no mention of AI, ML, deep learning, image processing beyond basic capture, or any data training/testing that would indicate the use of AI/ML.
No
The device is an imaging system designed to visualize vessels, blood flow, and bile ducts during minimally invasive surgery. It does not directly treat or prevent a disease or condition, which is the definition of a therapeutic device.
No
The device is an imaging system used to visualize anatomical structures (vessels, bile ducts) with visible and near-infrared fluorescence, aiding surgeons during minimally invasive procedures. It provides real-time visual assessment but is not described as interpreting or diagnosing conditions based on these images. Its function is to enhance visualization of certain structures by making them fluoresce with ICG, not to provide a diagnosis itself.
No
The device description explicitly lists multiple hardware components including rigid endoscopes, a light source, a video camera head, and accessories like a fiber-optic light cable and a Camera Control Unit (CCU). The performance studies also include testing of hardware components like the illumination system and camera system.
Based on the provided information, the KARL STORZ Endoscopic ICG Imaging System is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze specimens taken from the human body. The intended use and device description clearly state that this system is used for real-time imaging during minimally invasive surgery, directly visualizing structures within the body (vessels, bile ducts, etc.). It does not involve the analysis of samples like blood, urine, or tissue outside of the body.
- The system uses imaging modalities (visible light and near-infrared fluorescence) to visualize structures in situ. This is characteristic of imaging devices used during surgical procedures, not IVDs.
- The device description focuses on the imaging components and their function in capturing light and fluorescence within the body.
Therefore, the KARL STORZ Endoscopic ICG Imaging System falls under the category of a surgical imaging device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The KARL STORZ Endoscopic ICG Imaging System is intended to provide real-time endoscopic visible and nearinfrared fluorescence imaging. The KARL STORZ ICG Imaging 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 Imaging 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.
Product codes (comma separated list FDA assigned to the subject device)
OWN
Device Description
The KARL STORZ Endoscopic ICG Imaging System is used to provide real-time high definition (HD) endoscopic video images of visible (VIS) and near-infrared (NIR) indocyanine green (ICG) dye fluorescence during minimally invasive surgery. The system components are rigid ICG Endoscopes for VIS and NIR illumination and imaging, a light source with foot switch for emission of VIS and NIR illumination, a 3 CCD (charge coupled device) color video camera head capable of capturing both VIS and NIR imaging, and KARL STORZ Indocyanine Green (ICG Kit). Additional accessories used with the KARL STORZ Endoscopic ICG Imaging System include a standard fiber-optic light cable for transmission of VIS and NIR light and the Image 1 SPIES Camera Control Unit (CCU) cleared in K131953. The KARL STORZ Endoscopic ICG Imaging System can be used with any medical grade HD monitor with a DVI-D or 3G-SDI input. The KARL STORZ Endoscopic ICG Imaging System is a Class II device under 21 CFR 876.1500.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
endoscopic visible and near-infrared fluorescence imaging
Anatomical Site
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)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeons to perform minimally invasive surgery
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)
The KARL STORZ Endoscopic ICG Imaging System has been successfully tested for its functions and performance, including verification that the spectral characteristics of the ICG system illumination light source, light transmission system and endoscope enable a selective visualization of the ICG fluorescence signal as detected by the camera system. Furthermore, a GLP animal study was successfully performed by the NAMSA testing facility to evaluate the performance of the KARL STORZ Endoscopic ICG Imaging System in the porcine minimally-invasive laparoscopy model. Safety testing was performed including electrical safety IEC 60601-1 and 60601-2-18, electromagnetic compatibility per IEC 60601-1-2, and biocompatibility of the patient contacting materials per ISO 10993. Additional validations were conducted for system software, the manual cleaning method, and the sterilization process.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 31, 2016
Karl Storz Endoscopy-America, Inc. Winkie Wong Senior Regulatory Affairs Specialist 2151 E. Grand Avenue El Segundo, CA 90245
Re: K152583 Trade/Device Name: Karl Storz Endoscopic ICG Imaging System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: OWN Dated: April 13, 2016 Received: April 15, 2016
Dear Winkie 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Herbert P. Lerner -S
for
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K152583
Device Name
KARL STORZ Endoscopic ICG Imaging System
Indications for Use (Describe)
The KARL STORZ Endoscopic ICG Imaging System is intended to provide real-time endoscopic visible and nearinfrared fluorescence imaging. The KARL STORZ ICG Imaging System enables surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile duct, common bile duct and common hepatic duct), using near-infrared imaging.
Fluorescence imaging of biliary ducts with the KARL STORZ Endoscopic ICG Imaging 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
|X 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 word "STORZ" is in large, bold, blue letters. Below that, the words "KARL STORZ - ENDOSKOPE" are in smaller, blue letters.
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
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
El Segundo, CA 90245 |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Winkie Wong
Senior Regulatory Affairs Specialist |
| | Phone: (424) 218-8379
Fax: (424) 218-8519 |
| Date of Preparation: | May 18th, 2016 |
| Device Identification: | Trade Name: KARL STORZ Endoscopic ICG Imaging System
Common Name: Endoscopic Video Imaging System
Classification Name: Endoscope and accessories |
| Product Code: | OWN |
| Regulation: | 21 CFR part 876.1500 (Endoscope and Accessories) |
| Predicate Device(s): | The KARL STORZ Endoscopic ICG Imaging System is
substantially equivalent to the Intuitive Surgical® da Vinci®
Fluorescence Imaging Vision System (K124031), marketed
by Intuitive Surgical, Inc. |
| Indications For Use: | The KARL STORZ Endoscopic ICG Imaging System is
intended to provide real-time endoscopic visible and near-
infrared fluorescence imaging. The KARL STORZ ICG
Imaging 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 Imaging 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. |
4
| Device Description: | The KARL STORZ Endoscopic ICG Imaging System is used to
provide real-time high definition (HD) endoscopic video
images of visible (VIS) and near-infrared (NIR) indocyanine
green (ICG) dye fluorescence during minimally invasive
surgery. The system components are rigid ICG Endoscopes
for VIS and NIR illumination and imaging, a light source with
foot switch for emission of VIS and NIR illumination, a 3 CCD
(charge coupled device) color video camera head capable of
capturing both VIS and NIR imaging, and KARL STORZ
Indocyanine Green (ICG Kit). Additional accessories used
with the KARL STORZ Endoscopic ICG Imaging System
include a standard fiber-optic light cable for transmission of
VIS and NIR light and the Image 1 SPIES Camera Control
Unit (CCU) cleared in K131953. The KARL STORZ Endoscopic
ICG Imaging System can be used with any medical grade HD
monitor with a DVI-D or 3G-SDI input. The KARL STORZ
Endoscopic ICG Imaging System is a Class II device under
21 CFR 876.1500. |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological Comparison Summary: | The KARL STORZ Endoscopic ICG Imaging System is
substantially equivalent to the Intuitive Surgical® da Vinci®
Fluorescence Imaging Vision System (K124031) in terms of
its indications for use, design technology and performance
specification.
The differences between the subject and predicate device
are:
The subject device uses a Filtered Xenon Light source
whereas the Predicate (da Vinci) uses a Laser Diode
during NIR Illumination Mode. The subject device projects 2D fluorescence image on
a dichromatic background whereas the predicate
device (da Vinci) projects 3D fluorescence image on a
monochromatic background in NIR Illumination Mode. Bench and comparative testing were used to demonstrate
substantial equivalence to the predicate Intuitive Surgical®
da Vinci® Fluorescence Imaging Vision System, K124031.
Therefore, the differences between the subject device and
the predicate device do not raise any new issues of safety
and effectiveness. |
| Non-Clinical
Performance Data: | The KARL STORZ Endoscopic ICG Imaging System has been
successfully tested for its functions and performance,
including verification that the spectral characteristics of the
ICG system illumination light source, light transmission
system and endoscope enable a selective visualization of the
ICG fluorescence signal as detected by the camera system.
Furthermore, a GLP animal study was successfully performed
by the NAMSA testing facility to evaluate the performance of
the KARL STORZ Endoscopic ICG Imaging System in the |
5
| porcine minimally-invasive laparoscopy model. Safety testing was performed including electrical safety IEC 60601-1 and 60601-2-18, electromagnetic compatibility per IEC 60601-1-2, and biocompatibility of the patient contacting materials per ISO 10993. Additional validations were conducted for system software, the manual cleaning method, and the sterilization process. | |
|---|---|
| Clinical Performance Data: | Clinical testing was not required to demonstrate substantial equivalence to the predicate device. |
| Conclusion: | The KARL STORZ Endoscopic ICG Imaging System is substantially equivalent to the predicate Intuitive Surgical® da Vinci® Fluorescence Imaging Vision System (K124031) with regards to device design, materials, operational principles, and performance characteristics. The non-clinical testing demonstrates that the device is as safe, as effective and performs as well as or better than the legally marketed device. |