(111 days)
Not Found
Not Found
No
The document describes a standard video endoscopy system for urological procedures and does not mention any AI or ML components or functionalities.
Yes
The device is described as providing "therapeutic access" for the treatment of urological conditions.
No
The device is used for visual examination and treatment, providing optical visualization for physicians, but it does not perform any diagnostic analysis or interpretation on its own.
No
The device description explicitly mentions hardware components like the Video-Urethro-Cystoscope, CCU, and Light source, indicating it is a system with physical hardware, not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "visual examination and treatment of a variety of urological endoscopic procedures" and to "provide optical visualization via a video monitor and therapeutic access." This describes a device used directly on or in the patient for visualization and intervention.
- Device Description: The description focuses on the physical components and their use in a system for endoscopic procedures.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) in vitro (outside the body) to provide diagnostic information. IVDs are typically used to detect, measure, or identify substances or characteristics in these samples.
This device is clearly intended for in vivo use (within the living body) for direct visualization and therapeutic procedures.
N/A
Intended Use / Indications for Use
The Karl Storz Video-Urethro-Cystoscope System is intended for use by physicians in the visual examination and treatment of a variety of urological endoscopic procedures. The Video-Urethro-Cystoscope is intended to provide optical visualization via a video monitor and therapeutic access.
Product codes
FBO
Device Description
The KARL STORZ Flexible Video-Urethro-Cystoscope System is use of the Video-Urethro-Cystoscope with Karl Storz CCU and Karl Storz Light source. The body contact portions of the Video-Urethro-Cystoscope are composed of materials used in other Karl Storz devices which have a long history of biocompatibility for human use and are commonly used in medical devices for a wide range of applications.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
optical visualization
Anatomical Site
urological
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physicians
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
Image /page/0/Picture/0 description: The image shows a logo with the word "STORZ" in large, bold letters. There is a circle in the middle of the word. Below "STORZ" is the text "Karl Storz Endoscopy" in a smaller font. The background of the image is a textured pattern.
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.
600 Corporate Pointe Drive
Culver City, CA 90230
(310) 338-8100 | JAN 1 7 200 |
|------------------------|---------------------------------------------------------------------------------------------------------------------|-------------|
| Contact: | Monika Campbell
Senior Regulatory Affairs Specialist | |
| Device Identification: | Common Name: Video-Urethro-Cystoscope System
Trade Name: Karl Storz Flexible Video-Urethro
-Cystoscope System | |
Indication: The Karl Storz Video-Urethro-Cystoscope System is intended for use by physicians in the visual examination and treatment of a variety of urological endoscopic procedures. The Video-Urethro-Cystoscope is intended to provide optical visualization via a video monitor and therapeutic access.
Device Description: The KARL STORZ Flexible Video-Urethro-Cystoscope System is use of the Video-Urethro-Cystoscope with Karl Storz CCU and Karl Storz Light source. The body contact portions of the Video-Urethro-Cystoscope are composed of materials used in other Karl Storz devices which have a long history of biocompatibility for human use and are commonly used in medical devices for a wide range of applications.
The Karl Storz Video-Urethro-Cystoscope System is substantially Substantial Equivalence: equivalent to the predicate devices since the basic features and intended uses are similar. The minor differences between the Karl Storz Video-Urethro-Cystoscope System and the predicate devices raise no new issues of safety and effectiveness, as these differences have no effect on the performance, function or intended use of these devices.
Signature: Mhinda Campbell
Monika Campbell Senior Regulatory Affairs Specialist
1
Image /page/1/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's emblem in the center. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines representing the branches of the department. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Ms. Susie Chen Director, Regulatory and Legal Affairs Karl Storz Endoscopy-America, Inc. 600 Corporate Point, 5th Floor CULVER CITY CA 90230
JAN 1 7 2007
Re: K062918
Trade/Device Name: Video Urethro-Cystoscope Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FBO Dated: January 3, 2007 Received: January 5, 2007
Dear Ms. Chen:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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.
Image /page/1/Picture/10 description: The image shows a circular logo for the FDA Centennial, celebrating 1906-2006. The letters "FDA" are prominently displayed in the center of the logo. Below the letters, the word "Centennial" is written in cursive. The logo is surrounded by a circular border with text and stars.
Protesting and Promoting Public Health
2
Page 2 -
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely vours.
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indication for Use
510(k) Number (if known):
Device Name: Karl Storz Flexible Video-Urethro-Cystoscope System
Indications for Use: The Karl Storz Video-Urethro-Cystoscope System is intended for use by physicians in the visual examination and treatment of a variety of urological endoscopic procedures. The Video-Urethro-Cystoscope is intended to provide optical visualization via a video monitor and therapeutic access.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDE!D)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use:
(Per 21 CFR 801.Subpart D) AND/OR Over-The-Counter Use:
(21 CFR 801 Subpart C)
(21 CFR 801 Subpart C)
==============================================================================================================================================================================
Nancy C Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K62918