(82 days)
No
The document describes image processing and different display modes, but there is no mention of AI, ML, or any algorithms that learn or adapt from data. The focus is on hardware and different visualization options.
No.
The device is an imaging system designed to provide visual assessment and information to aid surgeons, not to directly treat a disease or condition.
Yes
The device aids surgeons in the "visual assessment of vessels, blood flow and related tissue perfusion" and "visual assessment of blood flow, as an adjunctive method for the evaluation of tissue perfusion." While it doesn't provide a direct diagnosis, it offers visual information that contributes to a surgeon's diagnostic understanding during various procedures. Additionally, the device processes images and presents ICG imagery in different formats (Overlay, Intensity Map, Monochromatic), which are functionalities typical of diagnostic tools that interpret and present data for clinical assessment.
No
The device description explicitly lists hardware components such as videoscopes, endoscopes, telescopes, camera heads, and light sources, indicating it is a hardware-based imaging system with associated software for image processing.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens obtained from the human body. The description of the KARL STORZ ICG Imaging System clearly states its intended use is for real-time imaging during surgical procedures to visualize internal anatomy, vessels, blood flow, tissue perfusion, bile ducts, and the lymphatic system within the patient's body.
- The device uses imaging modalities (VIS and NIR fluorescence) and is applied directly to the patient or the surgical field. This is characteristic of an in vivo imaging system, not an in vitro diagnostic device which analyzes samples outside the body.
- The device description focuses on the imaging system components, endoscopes, and light sources. This aligns with surgical imaging equipment, not laboratory equipment used for analyzing biological samples.
Therefore, the KARL STORZ ICG Imaging System is a surgical imaging device, not an IVD.
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.
Upon intravenous administration and use of ICG consistent with its approved label, the KARL STORZ Endoscopic ICG System enables surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct), using near infrared imaging. Fluorescence imaging of biliary ducts with the KARL STORZ Endoscopic ICG System is intended for use with standard of care white light and, when indicated, intraoperative cholangiography. The device is not intended for 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 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.
Upon interstitial administration and use of ICG consistent with its approved label, the KARL STORZ Endoscopic ICG System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.
Product codes
OWN, GWG
Device Description
The modified KARL STORZ ICG Imaging System is identical to the KARL STORZ ICG Imaging System recently cleared under K202925. The modified KARL STORZ ICG Imaging System now includes the following components: TIPCAM®1 Rubina Videoscope (0°, 30°): a 3D image capable videoendoscope with 2D auto-leveling (auto-rotation) and 2D auto-switch display modes.
The 4mm, 5mm & 10mm Endoscopes and VITOM ICG telescopes connected to the optical coupler of the Image1 S 4U Rubina camera head, and the TIPCAM®1 Rubina Videoendoscope which connects to the Image1 S Camera Control Unit for image processing, as well as to the Power LED Rubina light source 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.
For the NIR image, the user has three presentations of the ICG imagery to choose from:
a. Overlay: The white light image is overlaid with the NIR image. The NIR image could either by blue or green
b. Intensity Map: The white light image is overlaid with color transformed NIR image.
c. Monochromatic: The NIR image is indicated by the color white against a dark background.
The KARL STORZ ICG Imaging System can output a 4K image to the monitor 12G/3G-SDI, DVI-D and DisplayPort digital outputs and also offers 7 increments of zoom ranging from 1x to 2.5x.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
real-time visible (VIS) and near-infrared (NIR) 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), tissue and free flaps, lymphatic system, including lymphatic vessels and lymph nodes.
Indicated Patient Age Range
adults and pediatrics and endonasal skull base surgery in adults and pediatrics > 6 years of age.
Intended User / Care Setting
surgeons, 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)
Non-Clinical Performance Data:
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
Software Verification and Validation Testing
• Guidance for the Content of Premarket Submissions for Software Contained in Medical Device
• Level of concern: Moderate
Cleaning and sterilization validations were conducted for the Image1 S 4U Rubina camera head.
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 device.
Clinical Performance Data:
Clinical testing was not required to demonstrate the substantial equivalence to the predicate devices. Non-clinical bench testing was sufficient to establish the substantial equivalence of the modifications.
Conclusion:
The conclusions drawn from the nonclinical tests demonstrate that the subject device, the KARL STORZ ICG Imaging System performs as well as or better than the predicate devices that are currently marketed for the same intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the words "FDA U.S. FOOD & DRUG ADMINISTRATION".
KARL STORZ Endoscopy America Mario Trujillo Regulatoary Affairs Specialist 2151 E. Grand Avenue El Segundo, California 90245
November 15, 2021
Re: K212695
Trade/Device Name: KARL STORZ ICG Imaging System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: OWN. GWG Dated: October 28, 2021 Received: October 29, 2021
Dear Mario Trujillo:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/ofdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Neil R.P. Ogden Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K212695
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.
Upon intravenous administration and use of ICG consistent with its approved label, the KARL STORZ Endoscopic ICG System enables surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct), using near infrared imaging. Fluorescence imaging of biliary ducts with the KARL STORZ Endoscopic ICG System is intended for use with standard of care white light and, when indicated, intraoperative cholangiography. The device is not intended for 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 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.
Upon interstitial administration and use of ICG consistent with its approved label, the KARL STORZ Endoscopic ICG System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.
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 is a logo for Karl Storz Endoskope. The logo is blue and features the word "STORZ" in large, bold letters. Below the word "STORZ" is the phrase "KARL STORZ - ENDOSKOPE" in smaller letters. The logo is simple and professional, and it is likely used to represent the company on its products and marketing materials.
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 and the FDA guidance document titled "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]" issued on July 28, 2014. All data included in this document is accurate and complete to the best of KARL STORZ SE & Co. KG knowledge.
| Submitter: | KARL STORZ SE & Co. KG
Dr.-Karl-Storz-Straße 34
78532 Tuttlingen, Germany |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Mario Trujillo
Regulatory Affairs Specialist
Tel.: (424) 218-8481
Email: Mario.Trujillo@karlstorz.com |
| Date of Preparation: | October 21, 2021 |
| Type of 510(k) Submission: | Traditional |
| Device Identification: | Trade Name: KARL STORZ ICG Imaging System
Classification Name: Confocal Optical Imaging
21 CFR 876.1500 (Endoscope and Accessories)
21 CFR 882.1480 (Neurological Endoscopes) |
| Regulatory Class: | 2 |
| Product Code: | OWN, GWG |
| Guidance Document: | Not Applicable |
| Predicate Device: | Primary predicate device KARL STORZ ICG Imaging System
(K202925). Secondary predicate device: KARL STORZ ICG Imaging
System (K180146). Reference device: TIPCAM1 Rubina Video
Endoscope System (K201526) |
| Device Description: | The modified KARL STORZ ICG Imaging System is identical to the
KARL STORZ ICG Imaging System recently cleared under K202925.
The modified KARL STORZ ICG Imaging System now includes the
following components:
TIPCAM®1 Rubina Videoscope (0°, 30°): a 3D image capable
videoendoscope with 2D auto-leveling (auto-rotation) and 2D auto-
switch display modes. |
| Intended Use: | The KARL STORZ ICG Imaging System is intended to provide real-
time visible and near-infrared fluorescence imaging. |
4
Image /page/4/Picture/0 description: The image is a logo for Karl Storz Endoskope. The word "STORZ" is in large, bold, blue letters on the top line. The bottom line says "KARL STORZ - ENDOSKOPE" in smaller, blue letters.
| Indications For Use: | The KARL STORZ ICG Imaging System is intended to provide real-
time visible (VIS) and near-infrared (NIR) fluorescence imaging.
Upon intravenous administration and use of ICG consistent with its
approved label, the KARL STORZ Endoscopic ICG System enables
surgeons to perform minimally invasive surgery using standard
endoscopic visible light as well as visual assessment of vessels, blood
flow and related tissue perfusion, and at least one of the major extra-
hepatic bile ducts (cystic duct, common bile duct and common
hepatic duct), using near infrared imaging. Fluorescence imaging of
biliary ducts with the KARL STORZ Endoscopic ICG System is
intended for use with standard of care white light and, when
indicated, intraoperative cholangiography. The device is not
intended for standalone use for biliary duct visualization.
Additionally, the KARL STORZ Endoscopic ICG System enables
surgeon to perform minimally invasive cranial neurosurgery in
adults and pediatrics and endonasal skull base surgery in adults and
pediatrics > 6 years of age using standard endoscopic visible light as
well as visual assessment of vessels, blood flow and related tissue
perfusion using near infrared imaging.
The KARL STORZ VITOM 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.
Upon interstitial administration and use of ICG consistent with its
approved label, the KARL STORZ Endoscopic ICG System is used to
perform intraoperative fluorescence imaging and visualization of
the lymphatic system, including lymphatic vessels and lymph nodes. |
| ---------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
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Image /page/5/Picture/0 description: The image shows the logo for Karl Storz Endoskope. The logo is in blue and features the word "STORZ" in large, bold letters. Below the word "STORZ" is the phrase "KARL STORZ - ENDOSKOPE" in smaller letters.
| Technological
Characteristics: | The clinical application for the subject KARL STORZ ICG Imaging
System is identical to the cleared KARL STORZ ICG Imaging System,
K202925. |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The 4mm, 5mm & 10mm Endoscopes and VITOM ICG telescopes
connected to the optical coupler of the Image1 S 4U Rubina camera
head, and the TIPCAM®1 Rubina Videoendoscope which connects to
the Image1 S Camera Control Unit for image processing, as well as to
the Power LED Rubina light source 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. |
| | For the NIR image, the user has three presentations of the ICG
imagery to choose from: |
| | a. Overlay: The white light image is overlaid with the NIR image.
The NIR image could either by blue or green |
| | b. Intensity Map: The white light image is overlaid with color
transformed NIR image. |
| | c. Monochromatic: The NIR image is indicated by the color white
against a dark background. |
| | The KARL STORZ ICG Imaging System can output a 4K image to the
monitor 12G/3G-SDI, DVI-D and DisplayPort digital outputs and also
offers 7 increments of zoom ranging from 1x to 2.5x. |
| | The reference device, TIPCAM1 Rubina Video Endoscope System, is
identical in design and materials of construction to the subject
device. The only difference is that the ICG functionality was not
included as part of K201526. |
| 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, as well as the
primary, secondary and reference devices follow the FDA
recognized consensus standards and is tested according to the
following standards and FDA Guidance: |
| | Electrical Safety and EMC
•
o IEC 60601-1
o IEC 60601-1-2
o IEC 60601-2-18 |
| | ISO Endoscopic Standards
•
o ISO 8600-1
o ISO 8600-3
o ISO 8600-4
o ISO 8600-5 |
| | o ISO 8600-6 |
| | •
Software Verification and Validation Testing
o Guidance for the Content of Premarket Submissions for |
| | Software Contained in Medical Device |
| | o Level of concern: Moderate |
| | Cleaning and sterilization validations were conducted for the
Image1 S 4U Rubina camera head. |
| | 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
device. |
| | Conformance to these standards was not the basis upon which
substantial equivalence was determined. |
| Clinical Performance
Data: | Clinical testing was not required to demonstrate the substantial
equivalence to the predicate devices. Non-clinical bench testing was
sufficient to establish the substantial equivalence of the
modifications. |
| Conclusion: | The conclusions drawn from the nonclinical tests demonstrate that
the subject device, the KARL STORZ ICG Imaging System performs as
well as or better than the predicate devices that are currently
marketed for the same intended use. |
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Image /page/6/Picture/0 description: The image is a logo for Karl Storz Endoskope. The logo is in blue and features the word "STORZ" in large, bold letters. Below the word "STORZ" is the phrase "KARL STORZ - ENDOSKOPE" in smaller letters.