(42 days)
No
The document describes standard image processing by a Camera Control Unit (CCU) and does not mention any AI or ML capabilities, algorithms, or training/test data.
Yes
The device is indicated for performing various diagnostic and therapeutic procedures, as stated in the "Intended Use / Indications for Use" section.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is indicated for "endoscopic examination" and can be used to perform "various diagnostic and therapeutic procedures." The "Device Description" also mentions its use for "visualization purposes during diagnostic and therapeutic procedures".
No
The device description clearly outlines hardware components including a flexible scope with an integrated LED light, fiber light guides, a CMOS imaging sensor, and a Camera Control Unit (CCU) that processes the image signal. This is not a software-only device.
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 "endoscopic examination in the urinary tract" and "examination of bile ducts." This involves direct visualization of internal body cavities.
- Device Description: The description details a system for visualization using a camera and light source inserted into the body. It processes and displays images for the user to view.
- Lack of In Vitro Activity: An IVD device is designed to examine specimens outside of the body (in vitro) to provide information about a patient's health. This device operates inside the body (in vivo) for direct observation.
The device is an endoscope system used for diagnostic and therapeutic procedures within the body, not for testing samples in a lab setting.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
FGB, FBN
Device Description
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urinary tract, kidney, bile ducts
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)
The Flexible Video-Uretero-Choledchoscope System and the secondary predicate Flexible Video-Uretero-Renoscope System (K141250), both manufactured by KARL STORZ, are exactly the same and share the same fundamental technology and physical characteristics. Therefore, the performance data described in the cleared Flexible Video-Uretero-Renoscope System, K141250, is also applicable to the Flexible Video-Uretero-Choledochoscope System. No changes were made to the device design as part of this update. Only the model number and applicable labeling were updated. The KARL STORZ secondary predicate Flexible Video-Uretero-Renoscope System has been evaluated according to ISO 14971 risk management process and the system was successfully tested for its functions and performance; including verification of optical characteristics per ISO 8600 (image quality, illumination). Safety testing was performed including electrical safety IEC 60601-1, electromagnetic compatibility per IEC 60601-1-2, and biocompatibility of the patient contacting materials per ISO 10993. Additional validations were conducted for the manual cleaning method, sterilization process.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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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 the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of three human profiles facing to the right, with flowing lines beneath them, possibly representing water or movement. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
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
1
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)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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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, Inc
2151 E. Grand Avenue
El 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-Choledochoscope
System |
| | 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-Digital
Ureteroscope and Choledochoscope System (DUR®-D),
K060269, manufactured by ACMI Corporation. The
secondary predicate is the KARL STORZ Flexible Video-
Uretero-Renoscope System, K141250. |
| Device Description: | 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. |
| Indications For Use: | The 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. |
| Technological
Characteristics: | The Karl Storz Flexible Video-Uretero-Choledochoscope
System has the same indications for use as the originally
cleared primary predicate ACMI Corporation DUR-Digital
Ureteroscope and Choledochoscope System (DUR®-D),
K06026. The Flexible Video-Uretero-Choledochoscope
System and the secondary predicate Flexible Video-Uretero-
Renoscope System (K141250), both manufactured by KARL
STORZ, are exactly the same and share the same
fundamental technology and physical characteristics. The
methods of operation, design and materials used are either
identical or substantially equivalent to existing legally
marketed predicate devices. |
| Non-Clinical
Performance Data: | The Flexible Video-Uretero-Choledchoscope System and the
secondary predicate Flexible Video-Uretero-Renoscope
System (K141250), both manufactured by KARL STORZ, are
exactly the same and share the same fundamental
technology and physical characteristics. Therefore, the
performance data described in the cleared Flexible Video-
Uretero-Renoscope System, K141250, is also applicable to
the Flexible Video-Uretero-Choledochoscope System. No
changes were made to the device design as part of this
update. Only the model number and applicable labeling
were updated. The KARL STORZ secondary predicate
Flexible Video-Uretero-Renoscope System has been
evaluated according to ISO 14971 risk management process
and the system was successfully tested for its functions and |
| | performance; including verification of optical characteristics
per ISO 8600 (image quality, illumination). Safety testing
was performed including electrical safety IEC 60601-1,
electromagnetic compatibility per IEC 60601-1-2, and
biocompatibility of the patient contacting materials per ISO
10993. Additional validations were conducted for the
manual cleaning method, sterilization process. |
| Clinical
Performance Data: | Clinical testing was not required to demonstrate substantial
equivalence to the predicate devices. |
| Conclusion: | The Flexible Video-Uretero-Choledochoscope 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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