(150 days)
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.
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.
The provided document describes the KARL STORZ Flexible Video-Neuro-Endoscope System. It does not contain information about an AI-powered device or a study involving human readers or AI assistance. The document focuses on the substantial equivalence of the neuro-endoscope system to a predicate device through non-clinical bench testing and biocompatibility assessments. Therefore, I cannot extract information related to AI performance, human reader improvement with AI assistance, or related metrics.
However, I can provide the acceptance criteria and study findings for the non-AI device presented in the document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Test / Verification | Acceptance Criterion Description | Reported Device Performance |
|---|---|---|---|
| Optical Performance | Field of view | Verified optical requirements | Pass |
| Distortion | Verified optical requirements | Pass | |
| Resolution | Verified optical requirements | Pass | |
| Image Quality | White Balance | Verified white balance | Pass |
| Color Accuracy | Verified color accuracy | Pass | |
| Temporal Noise | Does not exceed specified limit | Pass | |
| Spatial Noise | Does not exceed specified limit | Pass | |
| Illumination/Sensitivity | Minimum Response | Sufficient brightness for surgical functions under worst-case conditions | Pass |
| AE Step Response | Smooth transition (no excessive 'ringing') and acceptable transition time from dark to light scene | Pass | |
| Exposure Brightness | Luminance output within acceptable limits for each of the five available Brightness settings | Pass | |
| Illumination | Functional performance and light output specification | Pass | |
| Mechanical Performance | Dimensions | Verified mechanical requirements | Pass |
| Deflection | Verified mechanical requirements | Pass | |
| Bend radii | Verified mechanical requirements | Pass | |
| Weight | Verified mechanical requirements | Pass | |
| User Interface | Camera Head Button | Correct response to button presses | Pass |
| Biocompatibility | Cytotoxicity | Performed according to ISO 10993-5 and FDA Guidance | Pass (Biological-toxicological safety not affected) |
| Sensitization | Performed according to ISO 10993-11 and FDA Guidance | Pass (Biological-toxicological safety not affected) | |
| Irritation | Performed according to ISO 10993-11 and FDA Guidance | Pass (Biological-toxicological safety not affected) | |
| Systemic Toxicity | Performed according to ISO 10993-10 and FDA Guidance | Pass (Biological-toxicological safety not affected) | |
| Sterilization | 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 |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in terms of patient data or images. The evaluation was done through non-clinical bench testing and biocompatibility testing on the device itself and its materials. There is no information regarding the country of origin of data or whether it was retrospective or prospective, as it did not involve clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The evaluation was primarily engineering and laboratory-based, focusing on performance specifications and material compatibility, not expert interpretation of clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There was no clinical test set requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No. This device is a neuro-endoscope, which is a viewing and access tool, not an AI-assisted diagnostic or interpretive system. Therefore, no MRMC study or AI-related effectiveness assessment was conducted or reported.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. There is no algorithm or AI component in this device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the non-clinical tests was established by predefined engineering specifications, performance limits, and standardized testing methods (e.g., ISO 10993 standards for biocompatibility, specific sterilization cycle parameters).
8. The sample size for the training set
Not applicable. There is no training set mentioned as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable. No training set or associated ground truth was established for this device.
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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.
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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
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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 AvenueEI Segundo, CA 90245 |
|---|---|
| Contact: | Nozomi YagiRegulatory Affairs SpecialistPhone: (424) 218-8351Fax: (424) 218-8519 |
| Date ofPreparation: | September 15, 2016 |
| Type of 510(k)Submission: | Traditional |
| DeviceIdentification: | Trade Name: KARL STORZ Flexible Video-Neuro-EndoscopeSystemClassification Name: Endoscope, Neurological (21 CFR Part882.1480) |
| Regulatory Class: | II |
| Product Code: | GWG |
| GuidanceDocument: | Not Applicable for GWG product code |
| RecognizedConsensusStandards: | Not Applicable for GWG product code |
| PredicateDevice(s): | Predicate Device: KARL STORZ Endoscopy-America's KSEANeuro-Fiberscope (K002788)The predicate device has not been subject to a design-related recall. |
| DeviceDescription: | The Flexible Video-Neuro-Endoscope System is a videoscopeindicated for viewing and providing access during cranialdiagnostic and therapeutic procedures. The system consists of theKARL 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 isintended for providing visualization and access during cranialdiagnostic and therapeutic procedures. |
| elliptical shaped distal tip (minor diameter is 2.4 mm and majordiameter is 3.2 mm). The shaft has a Pellathane (polyurethane)cover and contains a PTFE working channel with an I.D. of 1.2mm. The working channel length is 519 mm. Both instrument andirrigation ports have stopcocks, and there are no check valves orother restrictions to prevent the back flow within any point of thefluid path. The Video Neuroscope's direction of view is 0° and thedirection of view is 90°. The distal tip houses the CMOS(complementary metal oxide semiconductor) imaging sensor, andthe illumination is provided by two glass fiber light bundles, whoseLED 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 todeflect 270 degrees in the UP/DOWN direction. Next to thedeflection lever is three control buttons (“Select", "Left (Up)", and"Right (Down)") that provide a remote means for the user tointeract with the IMAGE1 SPIES CCU and can be programmed toinitiate specific functions such as white balance, image capture,zoom, and access to CCU setup menu. Once set by user, the controlbutton assignment is retained after the system being switched onand off. LED (Light Emitting Diode) is integrated in the handpiece,and it is used to provide illumination of the anatomy underexamination. The light is transmitted from the LED to the distal tipvia two glass fiber light bundles. The raw data captured at the distaltip CMOS imaging sensor is converted to a standard NTSC(National Television System Committee) video signal by theprinted circuit board (PCB), also housed in the handpiece. | |
| Indications ForUse: | The KARL STORZ Flexible Video-Neuro-Endoscope System isindicated to provide visualization and access during cranialdiagnostic and therapeutic procedures such as tumor biopsy andresection, hydrocephalus treatment, endoscopic thirdventriculostomy with choroid plexus cauterization (ETV/CPC),endoscopic third ventriculostomy, cyst fenestration, and aqueductexploration. |
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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.
| TechnologicalCharacteristics: | Comparison Table: Subject vs. Predicate Device | ||
|---|---|---|---|
| Subject Device | Primary predicate Device,K002788 | ||
| Flexible Video-Neuro-Endoscope System | KSEA Neuro-Fiberscope | ||
| Indication for Use | |||
| Indications forUse | The KARL STORZ FlexibleVideo-Neuro-EndoscopeSystem is indicated to providevisualization and access duringcranial diagnostic andtherapeutic procedures such astumor biopsy and resection,hydrocephalus treatment,endoscopic thirdventriculostomy with choroidplexus cauterization(ETV/CPC), endoscopic thirdventriculostomy, cystfenestration, and aqueductexploration. | The Neuro-Fiberscope isindicated for use in viewingthe ventricles and cavities ofthe brain. | |
| Design | |||
| Type of scope | Flexible | Same as the subject device | |
| Distal TipDiameter | 3.2 mm x 2.4 mm | 3.6 mm | |
| Outer ShaftDiameter | 2.9 mm | 3.7 mm | |
| Working ShaftLength | 350 mm | 340 mm | |
| WorkingChannelDiameter | 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 | |
| WorkingChannelMaterial | PTFE | PTFE | |
| Sterilization | |||
| Sterilization | STERRAD NX "Advanced"CycleSTERRAD 100NX "Flex" or"DUO" CycleSTERIS SYSTEM 1E (SS1E)Standard Programmed CycleV-PRO maX "Flexible" CycleV-PRO 60 "Flexible" CycleEthylene Oxide (EtO) Gas | EtO Gas |
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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-ClinicalPerformanceData: | Bench Testing Summary | ||
|---|---|---|---|
| Verification Test | Test Method Summary | Result | |
| Optical | The test verified optical requirements for field ofview, distortion and resolution. | Pass | |
| White Balance andColor Accuracy | The test verified white balance and color accuracy. | Pass | |
| Temporal andSpatial Noise | The test verified that the spatial noise and temporalnoise does not exceed the limit specified in thedevice product specification under 'maximum gain'conditions. | Pass | |
| Minimum Response | The test verified the minimum responsemeasurement such that the sensitivity of the cameraand the maximum intensity of the internal lightsource combine to ensure that the customer, underworst case distance-from-target conditions, has abright enough scene to perform surgical functions. | Pass | |
| AE Step Response | The test verified that when the scene changessuddenly from dark to light the transition does nothave excessive 'ringing' (overshoot and undershoot)and that the transition happens in an acceptableamount of time, as defined in the productspecification for the device under test. | Pass | |
| ExposureBrightness | The test verified that a given camera system'sluminance output (brightness level) is within theacceptable limits for each of the five availableBrightness settings. | Pass | |
| Illumination | The test verified the functional performance andlight output specification. | Pass | |
| Mechanical | The test verified the mechanical requirements fordimensions, deflection, bend radii and weight. | Pass | |
| Camera HeadButton | The test verified that when a user presses the headbuttons on an attached videoendoscope the modularsystem correctly responds. | Pass | |
| Biocompatibility SummaryThe biocompatibility evaluation for the patient contacting components of theneuroscope was performed according to ISO 10993-1 and FDA Guidance. Thefollowing 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 materialsused 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 methodResiduals 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.
| ClinicalPerformanceData: | Clinical testing was not required to demonstrate the substantialequivalence to the predicate devices. Non-clinical bench testing wassufficient to establish the substantial equivalence of themodifications. |
|---|---|
| Conclusion: | The conclusions drawn from the nonclinical tests demonstrate thatthe subject device, KARL STORZ Flexible Video-Neuro-Endoscope System performs as well as or better than the legallymarketed predicate devices, one of which is currently marketed forthe same intended use. |
§ 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).