(150 days)
No
The summary describes a standard video endoscope system with image capture and basic control functions. There is no mention of AI, ML, or advanced image processing that would suggest the use of such technologies.
Yes
The device is used for "therapeutic procedures such as tumor biopsy and resection, hydrocephalus treatment, endoscopic third ventriculostomy with choroid plexus cauterization (ETV/CPC), endoscopic third ventriculostomy, cyst fenestration, and aqueduct exploration."
Yes
The "Intended Use / Indications for Use" states that the device is indicated for "cranial diagnostic and therapeutic procedures". Specifically, it mentions "tumor biopsy", "hydrocephalus treatment", "cyst fenestration", and "aqueduct exploration", all of which involve diagnosis as part of the procedure or as the primary purpose. The "Device Description" also reiterates its indication for "cranial diagnostic and therapeutic procedures".
No
The device description clearly details physical hardware components such as a videoscope with a working shaft, distal tip, handpiece, CMOS sensor, glass fiber light bundles, and a printed circuit board (PCB). It also mentions mechanical and sterilization validation testing, which are associated with hardware devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "cranial diagnostic and therapeutic procedures" such as "tumor biopsy and resection, hydrocephalus treatment, endoscopic third ventriculostomy," etc. These are procedures performed on the patient's body, not on samples taken from the patient's body.
- Device Description: The description details a videoscope used for viewing and providing access during these procedures. It describes the physical components used for visualization and manipulation within the cranial cavity.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, urine, etc.) or providing information about a patient's health status based on such analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is an endoscopic system used for direct visualization and intervention within the body.
N/A
Intended Use / Indications for Use
The KARL STORZ Flexible Video-Neuro-Endoscope System is indication and access during cranial diagnostic and therapeutic procedures such as tumor biopsy and resection, hydrocephalus treatment, endoscopic third ventriculostomy with choroid plexus cauterization (ETV/CPC), endoscopic third ventriculostomy, cyst fenestration, and aqueduct exploration.
Product codes
GWG
Device Description
The Flexible Video-Neuro-Endoscope System is a videoscope indicated for viewing and providing access during cranial diagnostic and therapeutic procedures. The system consists of the KARL STORZ Flexible Video-Neuro-Endoscope (Model Number: 11161V) and the IMAGE1 SPIES Camera Control Unit (CCU), which has been cleared in K160044.KARL STORZ Flexible Video-Neuro-Endoscope's working shaft is 350 mm long with 8.5 Fr elliptical shaped distal tip (minor diameter is 2.4 mm and major diameter is 3.2 mm). The shaft has a Pellathane (polyurethane) cover and contains a PTFE working channel with an I.D. of 1.2 mm. The working channel length is 519 mm. Both instrument and irrigation ports have stopcocks, and there are no check valves or other restrictions to prevent the back flow within any point of the fluid path. The Video Neuroscope's direction of view is 0° and the direction of view is 90°. The distal tip houses the CMOS (complementary metal oxide semiconductor) imaging sensor, and the illumination is provided by two glass fiber light bundles, whose LED light source is located in the handpiece.
In the handpiece of the KARL STORZ Flexible Neuro-endoscope, the user will find a deflection lever, which allows the distal tip to deflect 270 degrees in the UP/DOWN direction. Next to the deflection lever is three control buttons (“Select", "Left (Up)", and "Right (Down)") that provide a remote means for the user to interact with the IMAGE1 SPIES CCU and can be programmed to initiate specific functions such as white balance, image capture, zoom, and access to CCU setup menu. Once set by user, the control button assignment is retained after the system being switched on and off. LED (Light Emitting Diode) is integrated in the handpiece, and it is used to provide illumination of the anatomy under examination. The light is transmitted from the LED to the distal tip via two glass fiber light bundles. The raw data captured at the distal tip CMOS imaging sensor is converted to a standard NTSC (National Television System Committee) video signal by the printed circuit board (PCB), also housed in the handpiece.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cranial
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 Summary):
- Optical: The test verified optical requirements for field of view, distortion and resolution. Result: Pass
- White Balance and Color Accuracy: The test verified white balance and color accuracy. Result: Pass
- Temporal and Spatial Noise: The test verified that the spatial noise and temporal noise does not exceed the limit specified in the device product specification under 'maximum gain' conditions. Result: Pass
- Minimum Response: The test verified the minimum response measurement such that the sensitivity of the camera and the maximum intensity of the internal light source combine to ensure that the customer, under worst case distance-from-target conditions, has a bright enough scene to perform surgical functions. Result: Pass
- AE Step Response: The test verified that when the scene changes suddenly from dark to light the transition does not have excessive 'ringing' (overshoot and undershoot) and that the transition happens in an acceptable amount of time, as defined in the product specification for the device under test. Result: Pass
- Exposure Brightness: The test verified that a given camera system's luminance output (brightness level) is within the acceptable limits for each of the five available Brightness settings. Result: Pass
- Illumination: The test verified the functional performance and light output specification. Result: Pass
- Mechanical: The test verified the mechanical requirements for dimensions, deflection, bend radii and weight. Result: Pass
- Camera Head Button: The test verified that when a user presses the head buttons on an attached videoendoscope the modular system correctly responds. Result: Pass
Biocompatibility Summary:
- Tests conducted: Cytotoxicity (ISO 10993-5), Sensitization (ISO 10993-11), Irritation (ISO 10993-11), Systemic Toxicity (ISO 10993-10).
- Result: The biological-toxicological safety of the patient is not affected by the materials used in the tested items.
Sterilization Validation Summary:
- STERRAD NX/100NX: SAL=10^6, Half cycle method. Result: Pass
- V-PRO maX and V-PRO 60: SAL=10^6, Half cycle method. Result: Pass
- STERIS SYSTEM 1E: Complete liquid chemical sterilization. Result: Pass
- 100% Ethylene Oxide: SAL=10^6, Half cycle method. Residuals per ANSI/AAMI/ISO 109937:2008. Result: Pass
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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).
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 17, 2016
KARL STORZ Endoscopy-America, Inc. Ms. Nozomi Yagi Regulatory Affairs Specialist 2151 E. Grand Avenue El Segundo, California 90245
Re: K16112
Trade/Device Name: KARL STORZ Flexible Video-Neuro-Endoscope System Regulation Number: 21 CFR 882.1480 Regulation Name: Neurological Endoscope Regulatory Class: Class II Product Code: GWG Dated: August 18, 2016 Received: August 19, 2016
Dear Ms. Yagi:
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 the quality systems (QS) 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
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,
Carlos L. Pena -50/Δ
Carlos L. Peña, PhD, MS 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) K161112
Device Name
KARL STORZ Flexible Video-Neuro-Endoscope System
Indications for Use (Describe)
The KARL STORZ Flexible Video-Neuro-Endoscope System is indication and access during cranial diagnostic and therapeutic procedures such as tumor biopsy and resection, hydrocephalus treatment, endoscopic third ventriculostomy with choroid plexus cauterization (ETV/CPC), endoscopic third ventriculostomy, cyst fenestration, and aqueduct exploration.
| 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 STORZ. The word "STORZ" is written in large, bold, blue letters. Below the word "STORZ" is the text "KARL STORZ - ENDOSKOPE", also in blue.
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 |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Nozomi Yagi
Regulatory Affairs Specialist
Phone: (424) 218-8351
Fax: (424) 218-8519 |
| Date of
Preparation: | September 15, 2016 |
| Type of 510(k)
Submission: | Traditional |
| Device
Identification: | Trade Name: KARL STORZ Flexible Video-Neuro-Endoscope
System
Classification Name: Endoscope, Neurological (21 CFR Part
882.1480) |
| Regulatory Class: | II |
| Product Code: | GWG |
| Guidance
Document: | Not Applicable for GWG product code |
| Recognized
Consensus
Standards: | Not Applicable for GWG product code |
| Predicate
Device(s): | Predicate Device: KARL STORZ Endoscopy-America's KSEA
Neuro-Fiberscope (K002788)
The predicate device has not been subject to a design-related recall. |
| Device
Description: | The Flexible Video-Neuro-Endoscope System is a videoscope
indicated for viewing and providing access during cranial
diagnostic and therapeutic procedures. The system consists of the
KARL STORZ Flexible Video-Neuro-Endoscope (Model Number:
11161V) and the IMAGE1 SPIES Camera Control Unit (CCU),
which has been cleared in K160044.KARL STORZ Flexible Video-
Neuro-Endoscope's working shaft is 350 mm long with 8.5 Fr |
| Intended Use: | The KARL STORZ Flexible Video-Neuro-Endoscope System is
intended for providing visualization and access during cranial
diagnostic and therapeutic procedures. |
| | elliptical shaped distal tip (minor diameter is 2.4 mm and major
diameter is 3.2 mm). The shaft has a Pellathane (polyurethane)
cover and contains a PTFE working channel with an I.D. of 1.2
mm. The working channel length is 519 mm. Both instrument and
irrigation ports have stopcocks, and there are no check valves or
other restrictions to prevent the back flow within any point of the
fluid path. The Video Neuroscope's direction of view is 0° and the
direction of view is 90°. The distal tip houses the CMOS
(complementary metal oxide semiconductor) imaging sensor, and
the illumination is provided by two glass fiber light bundles, whose
LED light source is located in the handpiece.
In the handpiece of the KARL STORZ Flexible Neuro-endoscope,
the user will find a deflection lever, which allows the distal tip to
deflect 270 degrees in the UP/DOWN direction. Next to the
deflection lever is three control buttons (“Select", "Left (Up)", and
"Right (Down)") that provide a remote means for the user to
interact with the IMAGE1 SPIES CCU and can be programmed to
initiate specific functions such as white balance, image capture,
zoom, and access to CCU setup menu. Once set by user, the control
button assignment is retained after the system being switched on
and off. LED (Light Emitting Diode) is integrated in the handpiece,
and it is used to provide illumination of the anatomy under
examination. The light is transmitted from the LED to the distal tip
via two glass fiber light bundles. The raw data captured at the distal
tip CMOS imaging sensor is converted to a standard NTSC
(National Television System Committee) video signal by the
printed circuit board (PCB), also housed in the handpiece. |
| Indications For
Use: | The KARL STORZ Flexible Video-Neuro-Endoscope System is
indicated to provide visualization and access during cranial
diagnostic and therapeutic procedures such as tumor biopsy and
resection, hydrocephalus treatment, endoscopic third
ventriculostomy with choroid plexus cauterization (ETV/CPC),
endoscopic third ventriculostomy, cyst fenestration, and aqueduct
exploration. |
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Image /page/4/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, it says "KARL STORZ - ENDOSKOPE."
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Image /page/5/Picture/0 description: The image shows the logo for STORZ. The logo is in blue and consists of the word "STORZ" in large, bold letters. Below the word "STORZ" is the phrase "KARL STORZ - ENDOSKOPE" in smaller letters.
| Technological
| Characteristics: | Comparison Table: Subject vs. Predicate Device | ||
|---|---|---|---|
| Subject Device | Primary predicate Device, | ||
| K002788 | |||
| Flexible Video-Neuro- | |||
| Endoscope System | KSEA Neuro-Fiberscope | ||
| Indication for Use | |||
| Indications for | |||
| Use | The KARL STORZ Flexible | ||
| Video-Neuro-Endoscope | |||
| System is indicated to provide | |||
| visualization and access during | |||
| cranial diagnostic and | |||
| therapeutic procedures such as | |||
| tumor biopsy and resection, | |||
| hydrocephalus treatment, | |||
| endoscopic third | |||
| ventriculostomy with choroid | |||
| plexus cauterization | |||
| (ETV/CPC), endoscopic third | |||
| ventriculostomy, cyst | |||
| fenestration, and aqueduct | |||
| exploration. | The Neuro-Fiberscope is | ||
| indicated for use in viewing | |||
| the ventricles and cavities of | |||
| the brain. | |||
| Design | |||
| Type of scope | Flexible | Same as the subject device | |
| Distal Tip | |||
| Diameter | 3.2 mm x 2.4 mm | 3.6 mm | |
| Outer Shaft | |||
| Diameter | 2.9 mm | 3.7 mm | |
| Working Shaft | |||
| Length | 350 mm | 340 mm | |
| Working | |||
| Channel | |||
| Diameter | 1.2 mm | 1.5 mm | |
| Deflection (°) | Up: 270° | ||
| Down: 270° | Up: 180° | ||
| Down: 100° | |||
| Type of Imager | CMOS chip | Fiberscope | |
| Material | |||
| Shaft Material | Pellethane | polyurethane | |
| Working | |||
| Channel | |||
| Material | PTFE | PTFE | |
| Sterilization | |||
| Sterilization | STERRAD NX "Advanced" | ||
| Cycle | |||
| STERRAD 100NX "Flex" or | |||
| "DUO" Cycle | |||
| STERIS SYSTEM 1E (SS1E) | |||
| Standard Programmed Cycle | |||
| V-PRO maX "Flexible" Cycle | |||
| V-PRO 60 "Flexible" Cycle | |||
| Ethylene Oxide (EtO) Gas | EtO Gas |
6
Image /page/6/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 a smaller font.
| Non-Clinical
Performance
| Data: | Bench Testing Summary | ||
|---|---|---|---|
| Verification Test | Test Method Summary | Result | |
| Optical | The test verified optical requirements for field of | ||
| view, distortion and resolution. | Pass | ||
| White Balance and | |||
| Color Accuracy | The test verified white balance and color accuracy. | Pass | |
| Temporal and | |||
| Spatial Noise | The test verified that the spatial noise and temporal | ||
| noise does not exceed the limit specified in the | |||
| device product specification under 'maximum gain' | |||
| conditions. | Pass | ||
| Minimum Response | The test verified the minimum response | ||
| measurement such that the sensitivity of the camera | |||
| and the maximum intensity of the internal light | |||
| source combine to ensure that the customer, under | |||
| worst case distance-from-target conditions, has a | |||
| bright enough scene to perform surgical functions. | Pass | ||
| AE Step Response | The test verified that when the scene changes | ||
| suddenly from dark to light the transition does not | |||
| have excessive 'ringing' (overshoot and undershoot) | |||
| and that the transition happens in an acceptable | |||
| amount of time, as defined in the product | |||
| specification for the device under test. | Pass | ||
| Exposure | |||
| Brightness | The test verified that a given camera system's | ||
| luminance output (brightness level) is within the | |||
| acceptable limits for each of the five available | |||
| Brightness settings. | Pass | ||
| Illumination | The test verified the functional performance and | ||
| light output specification. | Pass | ||
| Mechanical | The test verified the mechanical requirements for | ||
| dimensions, deflection, bend radii and weight. | Pass | ||
| Camera Head | |||
| Button | The test verified that when a user presses the head | ||
| buttons on an attached videoendoscope the modular | |||
| system correctly responds. | Pass | ||
| Biocompatibility Summary | |||
| The biocompatibility evaluation for the patient contacting components of the | |||
| neuroscope was performed according to ISO 10993-1 and FDA Guidance. The | |||
| following tests were conducted on the KARL STORZ Flexible Video-Neuro- | |||
| Endoscope, based contact type and duration: | |||
| Cytotoxicity (ISO 10993-5) | |||
| Sensitization (ISO 10993-11) | |||
| Irritation (ISO 10993-11) | |||
| Systemic Toxicity (ISO 10993-10) | |||
| The biological-toxicological safety of the patient is not affected by the materials | |||
| used in the tested items. | |||
| Sterilization Validation Summary | |||
| Test | Test Method Summary | Result | |
| STERRAD NX/100NX | SAL=10 6, Half cycle method | Pass | |
| V-PRO maX and V-PRO 60 | SAL=10 6, Half cycle method | Pass | |
| STERIS SYSTEM 1E | Complete liquid chemical sterilization | Pass | |
| 100% Ethylene Oxide | SAL=10 6, Half cycle method | ||
| Residuals per ANSI/AAMI/ISO 109937:2008 | Pass |
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Image /page/7/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.
| 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, KARL STORZ Flexible Video-Neuro-
Endoscope System performs as well as or better than the legally
marketed predicate devices, one of which is currently marketed for
the same intended use. |