(104 days)
No
The summary describes a real-time imaging system using visible and near-infrared fluorescence. There is no mention of AI, ML, or any advanced image processing that would suggest the use of such technologies. The performance studies focus on substantial equivalence through bench, comparative, and animal testing, not on the performance metrics typically associated with AI/ML algorithms.
No
This device is an imaging system used for visualization during surgery, not for treating a disease or condition. Its intended use is diagnostic/assistive, providing visual assessment and magnified views, rather than direct therapeutic intervention.
Yes
Explanation: The device is intended for "visual assessment of vessels, blood flow and related tissue perfusion" and "evaluation of tissue perfusion," 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).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The KARL STORZ ICG Imaging System is an imaging system used during surgery to visualize structures and blood flow in real-time using fluorescence. It works by illuminating tissues with specific light and detecting the fluorescence emitted by an injected dye (ICG).
- No Sample Analysis: The device does not analyze samples taken from the body. It directly images the body during a surgical procedure.
Therefore, the device falls under the category of a surgical imaging system, not an in vitro diagnostic device.
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, 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 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.
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.
The KARL STORZ ICG Imaging System is intended to provide real-time visible and near-infrared fluorescence imaging.
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, 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 imagingof 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.
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 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
OWN
Device Description
The KARL STORZ ICG Imaging System is used to provide real-time high definition (HD) endoscopic or telescope images of visible (VIS) and near-infrared (NIR) indocyanine green (ICG) dye fluorescence during minimally invasive or open surgery. The system components are a HOPKINS ICG/NIR Endoscope and a VITOM II ICG/NIR Telescope 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 KARL STORZ ICG Kit. Additional accessories used with the KARL STORZ ICG Imaging System include a standard fiber-optic light cable for transmission of VIS and NIR light and the Image1S Camera Control Unit (CCU). All components except for the VITOM II ICG/NIR Telescope were cleared in K152583. The KARL STORZ ICG Imaging System can be used with any medical grade HD monitor with a DVI-D or 3G-SDI input. The VITOM II ICG/NIR Telescope is a Class I device under 21 CFR 878.4700.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
real-time visible (VIS) and near-infrared (NIR) fluorescence imaging, standard endoscopic visible light, near infrared imaging, fluorescent images, standard white light
Anatomical Site
General surgical sites, major extra-hepatic bile ducts, general tissue and free flaps
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeons, minimally invasive surgery, open 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)
Bench and comparative testing were used to demonstrate substantial equivalence to the primary and secondary predicate devices. Therefore, the differences between the subject device and the predicate device do not raise any new issues of safety and effectiveness.
The KARL STORZ 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 telescope enable a selective visualization of the ICG fluorescence signal as detected by the camera system.
The following comparative testing was conducted for the subject device:
• UV Exposure
• Color Reproduction
• Irradiance Levels
• Depth Dependency
• Visualization of ICG Signal
Furthermore, a GLP animal study was successfully performed by the NAMSA testing facility to evaluate the performance of the KARL STORZ ICG Imaging System with the VITOM II ICG Telescope in the porcine open surgery laparoscopy model.
The addition of the VITOM II ICG Telescope to the system does not change the biocompatibility, electromagnetic compatibility, electrical safety, or software validations conducted for the KARL STORZ Endoscopic ICG System cleared in K152583. Cleaning method validation and sterilization validation were performed on the VITOM II ICG Telescope. Bench testing was performed per IEC 62471.
Clinical testing was not required to demonstrate the substantial equivalence to the predicate devices. Non-clinical bench testing was sufficient to assess safety and effectiveness and to establish the substantial equivalence of the modifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
KARL STORZ Endoscopic ICG System (K152583), Visionsense VS3-IR System (K152204)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three profiles of human faces incorporated into the design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 26, 2017
Karl Storz Endoscopy-America, Inc. Annalisa Smullin Regulatory Affairs Specialist 2151 E. Grand Avenue El Segundo, CA 90245
Re: K162882
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 Dated: December 13, 2016 Received: December 14, 2016
Dear Annalisa Smullin,
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,
Charles Viviano -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) K162882
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, 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 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.
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.
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | ||||
|---|---|---|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) | |||
| Type of Use (Select one or both, as applicable) |
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3
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 text "KARL STORZ - ENDOSKOPE" in a smaller 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 KSEA's knowledge.
| Submitter: | KARL STORZ Endoscopy-America, Inc.
2151 E. Grand Avenue
EI Segundo, CA 90245 | | KARL STORZ
ICG Imaging
System | KARL STORZ
Endoscopic ICG
System | Visionsense
VS3-IR System |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|---------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| Contact: | AnnaLisa Smullin
Regulatory Affairs Specialist
Phone: (424) 218-8376
Fax: (424) 218-8519 | | (Proposed) | (K152583) | (K152204) |
| Date of
Preparation: | December 13, 2016 | Manufacturer | KARL STORZ
Endoscopy | KARL STORZ
Endoscopy | Visionsense Ltd. |
| Type of 510(k)
Submission: | Traditional | System
Components | • Camera head
• Endoscope /
Telescope
• External light
source (via
fiber optic light
cable) | • Camera head
• Endoscope
• External light
source (via
fiber optic
light cable) | • Camera head
• Endoscope/
Telescope
• External light
source (via
fiber optic
light cable) |
| Device
Identification: | Trade Name: KARL STORZ ICG Imaging System
Classification Name: Confocal Optical Imaging | Anatomical Sites | General surgical
sites, major
extra-hepatic
bile ducts,
general tissue
and free flaps | General surgical
sites, major
extra-hepatic
bile ducts | General surgical
sites, brain,
spine, shoulder,
knee, general
tissue and free
flaps |
| Regulatory Class: | II | Sterilization | Steam Autoclave | Steam Autoclave | Steam Autoclave |
| Product Code: | OWN | Focal Distance of
Telescope | VIS: 25-75 cm
NIR: 20-30 cm | N/A | VIS & NIR: 20-40
cm |
| Regulation: | 21 CFR part 876.1500 (Endoscope and Accessories) | Imaging Agent | IR Fluorescence
dye (i.e.
indocyanine
green-ICG) | IR Fluorescence
dye (i.e.
indocyanine
green-ICG) | IR Fluorescence
dye (i.e.
indocyanine
green-ICG) |
| Predicate
Device(s): | Primary Predicate Device: KARL STORZ Endoscopic ICG System
(K152583) | Imaging Head | Silicon Image
Sensor in the
camera | Silicon Image
Sensor in the
camera | Silicon Image
Sensor in the
camera |
| | Second Predicate Device: Visionsense VS3-IR System (K152204) | Light Source | Xenon Lamp | Xenon Lamp | Infrared Laser |
| | These predicate devices have not been subject to a design-related
recall. | Imaging | Fluorescent and
White Light
Imaging | Fluorescent and
White Light
Imaging | Fluorescent and
White Light
Imaging |
| Device Description: | The KARL STORZ ICG Imaging System is used to provide real-time
high definition (HD) endoscopic or telescope images of visible
(VIS) and near-infrared (NIR) indocyanine green (ICG) dye
fluorescence during minimally invasive or open surgery. The
system components are a HOPKINS ICG/NIR Endoscope and a
VITOM II ICG/NIR Telescope 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 KARL STORZ ICG Kit. Additional
accessories used with the KARL STORZ ICG Imaging System | Display both
Visible and IR
Images | Yes | Yes | Yes (Overlay) |
| | include a standard fiber-optic light cable for transmission of VIS
and NIR light and the Image1S Camera Control Unit (CCU). All
components except for the VITOM II ICG/NIR Telescope were
cleared in K152583. The KARL STORZ ICG Imaging System can be
used with any medical grade HD monitor with a DVI-D or 3G-SDI
input. The VITOM II ICG/NIR Telescope is a Class I device under
21 CFR 878.4700. | Standards Met | IEC 60601-1-2
IEC 60601-1 | IEC 60601-1-2
IEC 60601-1 | IEC 60601-1-2
IEC 60601-1
IEC 60825-1 |
| 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. | | | | |
| | 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 imagingof 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.
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 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. | | | | |
| Technological
Characteristics: | The KARL STORZ ICG Imaging System is substantially equivalent
to the KARL STORZ Endoscopic ICG System (K152583) and the
Visionsense VS3-IR System (K152204) in terms of its indications
for use, design technology, and performance specifications.
The main difference between the subject and the primary
predicate device is that the subject device includes a VITOM II
ICG/NIR Telescope whereas the primary predicate device only
consists of an endoscope. The secondary predicate device was chosen as it includes a telescope with its ICG Imaging System. | | | | |
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Image /page/4/Picture/0 description: The image contains 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.
5
Image /page/5/Picture/0 description: The image shows the logo for Karl Storz Endoskope. The word "STORZ" is written in large, bold, blue letters. Below that, the words "KARL STORZ - ENDOSKOPE" are written in smaller, blue letters.
Bench and comparative testing were used to demonstrate substantial equivalence to the primary and secondary predicate devices. Therefore, the differences between the subject device and the predicate device do not raise any new issues of safety and effectiveness.
6
Image /page/6/Picture/0 description: The image shows the logo for STORZ. The word "STORZ" is in large, bold, blue letters. Below that, in smaller blue letters, is the phrase "KARL STORZ - ENDOSKOPE".
| Non-Clinical
Performance Data: | The KARL STORZ 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 telescope enable a selective
visualization of the ICG fluorescence signal as detected by the
camera system.
The following comparative testing was conducted for the subject
device:
• UV Exposure
• Color Reproduction
• Irradiance Levels
• Depth Dependency
• Visualization of ICG Signal
Furthermore, a GLP animal study was successfully performed by
the NAMSA testing facility to evaluate the performance of the
KARL STORZ ICG Imaging System with the VITOM II ICG Telescope
in the porcine open surgery laparoscopy model.
The addition of the VITOM II ICG Telescope to the system does not
change the biocompatibility, electromagnetic compatibility,
electrical safety, or software validations conducted for the KARL
STORZ Endoscopic ICG System cleared in K152583. Cleaning
method validation and sterilization validation were performed on
the VITOM II ICG Telescope. Bench testing was performed per IEC
62471. |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Clinical
Performance Data: | Clinical testing was not required to demonstrate the substantial
equivalence to the predicate devices. Non-clinical bench testing
was sufficient to assess safety and effectiveness and to establish
the substantial equivalence of the modifications. |
| Conclusion: | The conclusions drawn from the non-clinical tests such as the
sterilization data, the bench top performance data, and the animal
study performance data, demonstrated that the subject device is
as safe as and as effective as the primary predicate device. As
such, we concluded that the substantial equivalence of the subject
and the predicate devices has been met, and the differences
between the subject and the predicate devices do not raise new
questions of safety and effectiveness. |