(197 days)
The Karl Storz Flexible Video-Uretero-Renoscope System is indicated for endoscopic examination in the urinary tract and can be used to examine the interior of the kidney, and using additional accessories, to perform various diagnostic and therapeutic procedures.
The Flexible Video-Uretero-Renoscope System is used for visualization purposes during diagnostic and therapeutic procedures. The crucial components of the system are the Flexible Video-Uretero-Renoscope and the Image 1 HD Camera Control Unit. The Flexible Video-Uretero-Renoscope uses an LED light integrated in the handle and fiber light guides to illuminate the cavity under examination. The video image is produced by a complementary metal-oxide-semiconductor (CMOS) imaging sensor is located at the tip of the insertion shaft. The imaging sensor transfers the video signal to the Image1 HD CCU via electronics in the handle. The Image1 HD CCU processes the sensor images and displays them on a standard SD or HD monitor. The Karl Storz Flexible Video-Uretero-Renoscope System is a Class II device under 21 CFR 876.1500.
The provided text describes a 510(k) summary for the Karl Storz Flexible Video-Uretero-Renoscope System. This device is not an AI/ML medical device, therefore, the information requested in the prompt related to acceptance criteria for AI performance, sample sizes for test/training sets, ground truth establishment, expert adjudication, or MRMC studies for AI devices is not applicable.
The document focuses on demonstrating substantial equivalence to predicate devices through technical characteristics comparison and non-clinical performance and safety testing.
Here's the relevant information that can be extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria in a table; rather, it refers to successful testing against established standards. The performance is summarized qualitatively.
| Test Category | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Non-Clinical Performance Data | Meets relevant standards for optical and mechanical characteristics | "Successfully tested for its functions and performance, including verification of optical characteristics per ISO 8600 (image quality, illumination) and mechanical characteristics (bend, deflection, articulation), leak testing, and insertion testing)." |
| Safety Testing | Meets relevant standards for electrical safety, EMC, and biocompatibility | "Safety testing was performed including electrical safety IEC 60601-1 and IEC 60601-2-18, electromagnetic compatibility per IEC 60601-1-2 and biocompatibility of the patient contacting materials per ISO 10993." |
| Additional Validations | Demonstrated effectiveness for software, cleaning, and sterilization | "Additional validations were conducted for the system software, the manual cleaning method, sterilization process, and sterilant rinsing efficacy." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a medical device for visualization, not an AI/ML device that uses data for a test set. The validation methods involved physical device testing, not data analysis sets.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. There is no mention of expert-established ground truth related to diagnostic performance or image interpretation, as the device is for direct visualization.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is not an AI/ML diagnostic device with a 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
Not applicable. This is not an AI-assisted device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an endoscope system that is used with a human in the loop for live visualization and procedures.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for this device would be its physical and optical performance characteristics as measured against engineering specifications and international standards (e.g., ISO 8600, IEC 60601 series).
8. The sample size for the training set
Not applicable. This is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established
Not applicable.
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Image /page/0/Picture/2 description: The image shows the logo for Karl Storz Endoskope. The logo is in black and white and features the word "STORZ" in large, bold letters. Below the word "STORZ" is the phrase "KARL STORZ - ENDOSKOP" in smaller letters.
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92. All data included in this document is accurate and complete to the best of KSEA's knowledge.
| Applicant: | Karl Storz Endoscopy-America, Inc2151 E. Grand AvenueEI Segundo, CA 90245 |
|---|---|
| Contact: | Leigh SpottenRegulatory Affairs ManagerPhone: 424-218-8738 |
| Device Identification: | Trade Name:Karl Storz Flexible Video-Uretero-Renoscope SystemCommon Name:Ureteroscope and Accessories, Flexible RigidClassification Name:Endoscope and Accessories |
| Date of Preparation | April 22, 2013 |
| Regulation: | 21 CFR 876.1500 |
| Product Code: | FGB |
| Predicate Devices: | The Karl Storz Flexible Video-Uretero-Renoscope System issubstantially equivalent to the ACMI Dur-Digital Ureteroscopeand Choledochoscope System (K060269, including the InvisioDigital Controller) and the Karl Storz Imaging , New CameraArchitecture (NCA) Video Imaging System (K003325) |
| Indications For Use: | The Karl Storz Flexible Video-Uretero-Renoscope System isindicated for endoscopic examination in the urinary tract andcan be used to examine the interior of the kidney, and usingadditional accessories, to perform various diagnostic andtherapeutic procedures. |
| Device Description: | The Flexible Video-Uretero-Renoscope System is used forvisualization purposes during diagnostic and therapeuticprocedures. The crucial components of the system are theFlexible Video-Uretero-Renoscope and the Image 1 HD CameraControl Unit. The Flexible Video-Uretero-Renoscope uses anLED light integrated in the handle and fiber light guides toilluminate the cavity under examination. The video image isproduced by a complementary metal-oxide-semiconductor(CMOS) imaging sensor is located at the tip of the insertionshaft. The imaging sensor transfers the video signal to theImage1 HD CCU via electronics in the handle. The Image1 HDCCU processes the sensor images and displays them on astandard SD or HD monitor. The Karl Storz Flexible Video-Uretero-Renoscope System is a Class II device under 21 CFR876.1500. |
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Technological Characteristics:
| Device Name | Karl Storz Flexible Video-Uretero-Renoscope System (SubjectDevice) | ACMI DUR-Digital Ureteroscope andCholedochosope System(Predicate) K060269 |
|---|---|---|
| Digital video technology | CMOS | CMOS |
| Illumination Source | LED | LED |
| Field of View (Diagonal) | 90 | 80 |
| Outer Shaft Diameter (mm) | 2.9 | 3.1 |
| Working Length (mm) | 700 | 650 |
| Working Channel Diameter(mm) | 1.2 | 1.2 |
| Up/Down Deflection (°) | Up: 270 | Up: 250 |
| Down: 270 | Down: 250 | |
| Field of View | 90° | 80° |
| Direction of View | 0° | 9° |
| Device Name | Image1 HD HUB CCU(Subject Device) | Invisio Digital Controller(Predicate Device) K060269 |
|---|---|---|
| Brightness Control | Yes | Yes |
| Enhancement Control(contrast and definition) | Yes | Yes |
| Shutter Speed | 1/60 - 1/17000 sec | 1/60 - 1/10000 sec |
| White Balance | Yes | Yes |
| Zoom | Yes | Yes |
| Output Formats | NTSC/PAL/VGA/DVI/SDI | NTSC/PAL/VGA/DVI |
| Image/Video Capture | Yes | No |
| Device Name | Image1 HD HUB CCU(Subject Device) | Karl Storz New Camera ArchitectureCCU (Predicate Device), K003325 |
|---|---|---|
| Video Format Inputs(Cameras) | SD and HD | SD |
| Video Format Outputs | SD and HD | SD |
| Brightness Control | Yes | Yes |
| Enhancement Control(contrast and definition) | Yes | Yes |
| Shutter Speed | 1/60 - 1/17000 sec | 1/60 - 1/17000 sec |
| White Balance | Yes | Yes |
| Zoom | Yes | Yes |
| Output Formats | Analog and DigitalNTSC/PAL/VGA/DVI/SDI | Analog - NTSC/PAL/VGA/ |
| Image/Video Capture | Yes (with ICM) | No |
| Camera Head Configurable | Yes | Yes |
Technological Comparison Summary
The Karl Storz Flexible Video-Uretero-Renoscope System is has the same indications for use, methods of operation, design and materials used are either identical or substantially equivalent to existing legally marketed predicate devices.
The Karl Storz Flexible Video-Uretero-Renoscope System has been Non-Clinical successfully tested for its functions and performance, including Performance Data: verification of optical characteristics per ISO 8600 (image quality,
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illumination) and mechanical characteristics (bend, deflection, articulation), leak testing, and insertion testing). Safety testing was performed including electrical safety IEC 60601-1 and IEC 60601-2-18, electromagnetic compatibility per IEC 60601-1-2 and biocompatibility of the patient contacting materials per ISO 10993. Additional validations were conducted for the system software, the manual cleaning method, sterilization process, and sterilant rinsing efficacy.
Conclusion:
The Karl Storz Flexible Video-Uretero-Renoscope System is substantially equivalent to its predicate devices. The non-clinical testing demonstrates that the device is as safe, as effective and performs as well as or better than the legally marketed devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized representation of a human figure embracing a double helix. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 26, 2013
Karl Storz Endoscopy America, Inc. Leigh Spotten Regulatory Affairs Manager 2151 E. Grand Avenue El Segunado, CA 90245
Re: K 131369
Trade/Device Name: Flexible Video-Uretero-Renoscope System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FGB Dated: October 23, 2013 Received: October 25, 2013
Dear Leigh Spotten,
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. Iisting 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
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Page 2 - Leigh Spotten
medical device-related 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Herbert P. Lerner -S
for
Benjamin R. Fisher, Ph.D: Director Division of Reproductive, Gastro-Renal. and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: Flexible Video-Uretero-Renoscope System
Indications for Use:
The Karl Storz Flexible Video-Uretero-Renoscope System is indicated for endoscopic examination in the urinary tract and can be used to examine the interior of the kidney, and using additional accessories, to perform various diagnostic and therapeutic procedures.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
·
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Herbert P.Lerner=S
2013.11.26 08:01:10 -05'00'
§ 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.