The KARL STORZ Flexible Video-Uretero- Choledochoscope System is indicated for endoscopic examination in the urinary tract and can be used percutaneously to examine the interior of the kidney, and using additional accessories, to perform various diagnostic and therapeutic procedures. The Flexible Video-Uretero-Choledochoscope System is also indicated for the examination of bile ducts, and using additional accessories, to perform various diagnostic and therapeutic procedures during cholecystectomy.
The Flexible Video-Uretero-Choledochoscope System is used for visualization purposes during diagnostic and therapeutic procedures. The system components are the Flexible Video- Uretero-Choledochoscope and the Image 1 SPIES Camera Control Unit (CCU). The Flexible Video-Uretero- Choledochoscope 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 located at the tip of the insertion shaft. The imaging sensor transfers the video signal to the Image 1 SPIES CCU via electronics in the handle. The Image1 HD CCU processes the sensor images and displays them on a standard HD display monitor.
This change is to expand the indications for the currently cleared secondary predicate Flexible Video-Uretero- Renoscope System (K141250) to allow it to also be marketed as a Choledochoscope used for examination of the bile duct and to allow the ability to percutaneously access the abdominal cavity for examination of the kidney. No changes were made to the device design as part of this update. Only the model number and applicable labeling were updated.
The provided text is a summary of a 510(k) premarket notification for a medical device, the Karl Storz Flexible Video-Uretero-Choledochoscope System. It describes the device, its indications for use, and a comparison to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way typically required for AI/ML devices.
This document pertains to a traditional medical device (an endoscope) and focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than establishing performance against quantitative acceptance criteria for an AI/ML algorithm.
Therefore, many of the requested sections about AI/ML performance, sample sizes for test/training sets, expert ground truth, adjudication methods, and MRMC studies are not applicable or cannot be extracted from this document.
However, I can provide information based on what is available in the document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes non-clinical performance data for the secondary predicate device (which is stated to be exactly the same as the current device in terms of technology and physical characteristics). It references compliance with standards rather than specific quantitative acceptance criteria or reported performance values.
| Acceptance Criteria (Standard Adherence) | Reported Device Performance |
|---|---|
| ISO 14971 (Risk Management) | System successfully tested for functions and performance. |
| ISO 8600 (Optical Characteristics: Image Quality, Illumination) | Verified. |
| IEC 60601-1 (Electrical Safety) | Performed. |
| IEC 60601-1-2 (Electromagnetic Compatibility) | Performed. |
| ISO 10993 (Biocompatibility of patient-contacting materials) | Performed. |
| Manual Cleaning Method Validation | Conducted. |
| Sterilization Process Validation | Conducted. |
2. Sample size used for the test set and the data provenance:
Not applicable/not provided. This is a traditional device submission focused on substantial equivalence, not an AI/ML study with a test set of data. The performance data refers to physical and electrical testing of the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable/not provided. Ground truth establishment with experts is not relevant for the type of device testing described (physical and electrical safety/performance).
4. Adjudication method for the test set:
Not applicable/not provided.
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 is not an AI/ML CAD device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
No. This is not an AI/ML CAD device.
7. The type of ground truth used:
For the non-clinical performance data (e.g., electrical safety, biocompatibility), the "ground truth" would be the specifications and requirements defined by the relevant international standards (e.g., IEC 60601-1, ISO 10993, ISO 8600). The device's performance was compared against these standard requirements.
8. The sample size for the training set:
Not applicable/not provided. This is not an AI/ML device.
9. How the ground truth for the training set was established:
Not applicable/not provided. This is not an AI/ML device.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 23, 2014
Karl Storz Endoscopy-America, Inc. Mike Samuels Regulatory Affairs Specialist 2151 E. Grand Avenue El Segundo, CA 90245
Re: K142556
Trade/Device Name: Flexible Video-Uretero-Choledochoscope System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Codes: FGB, FBN Dated: September 10, 2014 Received: September 11, 2014
Dear Mike Samuels,
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
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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Herbert P.
Lerner -S
for Benjamin 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) K142556
Device Name
Flexible Video-Uretero-Choledochoscope System
Indications for Use (Describe)
The KARL STORZ Flexible Video-Uretero- Choledochoscope System is indicated for endoscopic examination in the urinary tract and can be used percutaneously to examine the interior of the kidney, and using additional accessories, to perform various diagnostic and therapeutic procedures. The Flexible Video-Uretero-Choledochoscope System is also indicated for the examination of bile ducts, and using additional accessories, to perform various diagnostic and therapeutic procedures during cholecystectomy.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Image /page/3/Picture/0 description: The image shows the logo for Karl Storz Endoskope. The logo is in blue and features the word "STORZ" in large, bold letters. Below the word "STORZ" is the text "KARL STORZ - ENDOSKOPE" in a smaller font.
510(k) SUMMARY 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 AvenueEl Segundo, CA 90245 |
|---|---|
| Contact: | Mike Samuels |
| Regulatory Affairs Specialist | |
| Phone: (424) 218-8288 | |
| Fax: (424) 218-8519 | |
| Date of Preparation: | September 10, 2014 |
| Device Identification: | Trade Name: Flexible Choledochoscope |
| Common Name: Flexible Video-Uretero-CholedochoscopeSystem | |
| Classification Name: Choledochoscope and Accessories,Flexible/ Rigid | |
| Product Code: | FGB and FBN |
| Regulation: | 21 CFR part 876.1500 |
| Predicate Device(s): | The primary predicate device is the DUR-DigitalUreteroscope and Choledochoscope System (DUR®-D),K060269, manufactured by ACMI Corporation. Thesecondary predicate is the KARL STORZ Flexible Video-Uretero-Renoscope System, K141250. |
| Device Description: | The Flexible Video-Uretero-Choledochoscope System is usedfor visualization purposes during diagnostic and therapeuticprocedures. The system components are the Flexible Video-Uretero-Choledochoscope and the Image 1 SPIES CameraControl Unit (CCU). The Flexible Video-Uretero-Choledochoscope uses an LED light integrated in the handleand fiber light guides to illuminate the cavity underexamination. The video image is produced by acomplementary metal-oxide-semiconductor (CMOS)imaging sensor located at the tip of the insertion shaft. Theimaging sensor transfers the video signal to the Image 1 |
| SPIES CCU via electronics in the handle. The Image1 HDCCU processes the sensor images and displays them on astandard HD display monitor. | |
| This change is to expand the indications for the currentlycleared secondary predicate Flexible Video-Uretero-Renoscope System (K141250) to allow it to also bemarketed as a Choledochoscope used for examination of thebile duct and to allow the ability to percutaneously accessthe abdominal cavity for examination of the kidney. Nochanges were made to the device design as part of thisupdate. Only the model number and applicable labelingwere updated. | |
| Indications For Use: | The Flexible Video-Uretero-Choledochoscope System isindicated for endoscopic examination in the urinary tractand can be used percutaneously to examine the interior ofthe kidney, and using additional accessories, to performvarious diagnostic and therapeutic procedures. The FlexibleVideo-Uretero-Choledochoscope System is also indicated forthe examination of bile ducts, and using additionalaccessories, to perform various diagnostic and therapeuticprocedures during cholecystectomy. |
| TechnologicalCharacteristics: | The Karl Storz Flexible Video-Uretero-CholedochoscopeSystem has the same indications for use as the originallycleared primary predicate ACMI Corporation DUR-DigitalUreteroscope and Choledochoscope System (DUR®-D),K06026. The Flexible Video-Uretero-CholedochoscopeSystem and the secondary predicate Flexible Video-Uretero-Renoscope System (K141250), both manufactured by KARLSTORZ, are exactly the same and share the samefundamental technology and physical characteristics. Themethods of operation, design and materials used are eitheridentical or substantially equivalent to existing legallymarketed predicate devices. |
| Non-ClinicalPerformance Data: | The Flexible Video-Uretero-Choledchoscope System and thesecondary predicate Flexible Video-Uretero-RenoscopeSystem (K141250), both manufactured by KARL STORZ, areexactly the same and share the same fundamentaltechnology and physical characteristics. Therefore, theperformance data described in the cleared Flexible Video-Uretero-Renoscope System, K141250, is also applicable tothe Flexible Video-Uretero-Choledochoscope System. Nochanges were made to the device design as part of thisupdate. Only the model number and applicable labelingwere updated. The KARL STORZ secondary predicateFlexible Video-Uretero-Renoscope System has beenevaluated according to ISO 14971 risk management processand the system was successfully tested for its functions and |
| performance; including verification of optical characteristicsper ISO 8600 (image quality, illumination). Safety testingwas performed including electrical safety IEC 60601-1,electromagnetic compatibility per IEC 60601-1-2, andbiocompatibility of the patient contacting materials per ISO10993. Additional validations were conducted for themanual cleaning method, sterilization process. | |
| ClinicalPerformance Data: | Clinical testing was not required to demonstrate substantialequivalence to the predicate devices. |
| Conclusion: | The Flexible Video-Uretero-Choledochoscope System issubstantially equivalent to its predicate devices. The non-clinical testing demonstrates that the device is as safe, aseffective and performs as well as or better than the legallymarketed devices. |
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§ 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.