(234 days)
Not Found
No
The description focuses on standard endoscopic technology (CMOS sensor, fiber optics, monitor) and does not mention any AI/ML components or image processing beyond basic video capture and display. The performance studies are standard bench and safety tests, not AI/ML validation studies.
Yes
The "Intended Use / Indications for Use" states that the device is used for "diagnostic and therapeutic endoscopic procedures."
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "used to provide visualization and operative access during diagnostic and therapeutic endoscopic procedures."
No
The device description clearly outlines hardware components including an endoscope with a handle, shaft, video connector cable, LED, glass fiber light bundles, CMOS imaging sensor, luer connector, working channel, and a monitor. While software is mentioned for validation, the device is fundamentally a hardware system with integrated software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide visualization and operative access during diagnostic and therapeutic endoscopic procedures of the lower urinary tract including the bladder and urethra." This describes a device used for direct visualization and intervention within the body, not for testing samples taken from the body.
- Device Description: The description details an endoscope system that captures images from within the body using a CMOS sensor and displays them on a monitor. This is consistent with an endoscopic device used for direct examination.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on these samples to diagnose a condition. The device's function is purely observational and provides access for procedures.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Flexible CMOS Video-Cysto-Urethroscope is used to provide visualization and operative access during diagnostic and therapeutic endoscopic procedures of the lower urinary tract including the bladder and urethra.
Product codes (comma separated list FDA assigned to the subject device)
FBO
Device Description
The Flexible CMOS-Video-Cysto-Urethroscope system consists of an endoscope and a monitor. The endoscope is a single device and can be said to be made up of an instrument handle, a shaft and a video connector cable. The handle has three camera control buttons, a deflection control lever and a luer connector to the working channel. An LED located in the handle and is use to provide the illumination for visualization of the anatomy under examination. The light is transmitted from the LED to the distal tip via glass fiber light bundles, where it is used to illuminate the body cavity under examination. The CMOS imaging sensor is located at the distaltip of the endoscope shaft captures the reflected light and converts it to a standard NTSC video signal. The luer connector and working channel are used as an introduction port for irrigation fluid and endoscopic instruments. The 8402ZX monitor provides visualization of the image being captured by the CMOS chip in the endoscope. During the procedure, the physician can use the control buttons on the monitor to perform functions, such as video and single image capture.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CMOS imaging sensor
Anatomical Site
lower urinary tract including the bladder and urethra
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)
Bench testing (non-clinical) were conducted to verify the performance of the Flexible CMOS-Video-Cysto-Urethroscope. Design verification testing was conducted to evaluate the mechanical, optical and illumination performance. Basic safety and performance testing was performed in accordance with IEC 60601-1-2 and IEC 60601-1-2 and IEC 60601-2-18. The Karl Storz flexible CMOS Video-Cysto-Urethroscope was validated for the cleaning instructions provided in the Instruction for Use manual. The Flexible CMOS-Video-Cysto-Urethroscope has been validated for high level disinfection (HLD) with Resert XL and sterilization with STERRAD 100NX to provide a sterility assurance level of 100°. The device is provided nonsterile. The patient contacting part of the device was evaluated for biocompatibility per ISO 10993-1:2009. The risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971. The software in the device was validated as per the Software verification Testing.
Testing demonstrated that the device is as safe & effective and performs as well as or better than the predicate devices
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.
0
| Submitter: | KARL STORZ Endoscopy America Inc. |
|---|---|
| Date of Preparation: | May 8, 2013 |
| Sponsor Company Name: | KARL STORZ Endoscopy America Inc. (KSEA) |
| Phone Number: | (424) 218 8322 |
| Street Address: | 2151 East Grand Avenue |
| Fax Number: | (424) 218 8519 |
| City: | El Segundo |
| State: | California |
| Country: | USA |
| Zip Code: | 90245 |
| Prepared By: | Shiven Gandhi |
|---|---|
| Contact Title: | Regulatory Submission Specialist |
| Email Address: | shiven.gandhi@karlstorz.com |
| Manufacturing Company Name: | Karl Storz Endovision, Inc. |
|---|---|
| Establishment Registration Number: | 1221826 |
| Street Address: | 91 Carpenter Hill Rd |
| City: | Charlton |
| State/Province: | MA |
| Country: | USA |
| Zip Code: | 01507 |
| Manufacturing Company Name: | Karl Storz Video Endoscopy Estonia |
|---|---|
| Establishment Registration Number: | 3004644065 |
| Street Address: | Akadeemia Tee 21 A |
| City: | Tallinn |
| State/Province: | Estonia |
| Country: | Europe |
| Zip Code: | 12618 |
| Classification Name: | Cysto Urethroscope |
|---|---|
| ---------------------- | -------------------- |
Information about devices to which Substantial Equivalence is claimed:
| 510 (K) Number | Trade/ Proprietary Name/Model Number | Manufacturer/ |
|---|---|---|
| K062918 | Flexible Video-Urethro-Cystoscope System | Karl Storz GmbH & Co. KG |
| K945185 | Flexible Fiber Optic Cystoscope | Karl Storz GmbH & Co. KG |
510(K) Summary of Safety and Effectiveness
Page 1 of 4
1
Introduction:
Device Trade Name: Classification Name: Regulation Number: Product Code:
Flexible CMOS-Video-Cysto-Urethroscope Cysto Urethroscope 21 CFR 876.1500 FBO
Device Description:
The Flexible CMOS-Video-Cysto-Urethroscope system consists of an endoscope and a monitor. The endoscope is a single device and can be said to be made up of an instrument handle, a shaft and a video connector cable. The handle has three camera control buttons, a deflection control lever and a luer connector to the working channel. An LED located in the handle and is use to provide the illumination for visualization of the anatomy under examination. The light is transmitted from the LED to the distal tip via glass fiber light bundles, where it is used to illuminate the body cavity under examination. The CMOS imaging sensor is located at the distaltip of the endoscope shaft captures the reflected light and converts it to a standard NTSC video signal. The luer connector and working channel are used as an introduction port for irrigation fluid and endoscopic instruments. The 8402ZX monitor provides visualization of the image being captured by the CMOS chip in the endoscope. During the procedure, the physician can use the control buttons on the monitor to perform functions, such as video and single image capture.
Indication for Use
The flexible CMOS Video-Cysto-Urethroscope is used to provide visualization and operative access during diagnostic and therapeutic endoscopic procedures of the lower urinary tract including the bladder and urethra.
Summary of Substantial Equivalence:
The Flexible CMOS-Video-Cysto-Urethroscope system is substantially equivalent to the existing 510(k) cleared devices on the market i.e. Karl Storz's Video-Urethro-Cystoscope System (K945185 cleared January 17, 2007) and Karl Storz's Flexible Fiber Optic Cystoscope (K062918 cleared May 3, 1995). The indication for use of the Flexible CMOS-Video-Cysto-Urethroscope is identical to the predicate devices. The Flexible CMOS-Video-Cysto-Urethroscope does not incorporate any special technology or characteristics when compared to its predicate devices.
2
Technological Characteristics:
| Parameter | Flexible CMOS-Video-
Cysto-Urethroscope
(Subject Device) | Flexible Video-
Urethro-Cystoscope
(Predicate Device) | Flexible Fiber
Optic Cystoscope
(Predicate Device) |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant | KARL STORZ
Endoscopy America
Inc. | KARL STORZ
Endoscopy America
Inc. | KARL STORZ
Endoscopy America
Inc. |
| 510(k) number | Not yet assigned | K062918 | K945185 |
| Intended Use | The flexible CMOS
Video-Cysto-
Urethroscope is used
to provide
visualization and
operative access
during diagnostic and
therapeutic
endoscopic
procedures of the
lower urinary tract
including the bladder
and urethra | 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 | Provide visual and
operative access
during examination,
diagnosis and
treatment of
disorders in the
interior of the bladder
and urethra. |
| Imaging technology | CMOS chip at distal tip | CCD chip at distal tip | Fiber optic |
| Illumination Source | LED | External Light
Source | External Light
Source |
| Distal Tip (mm)
[Outer Diameter] | 5.5 | 5.5 | 5.2 |
| Shaft Diameter (mm) | 5.3 | 5.3 | 5.25 |
| Working Channel
Diameter (mm) | 2.2 | 2.2 | 2.33 |
| Working Length (mm) | 370 | 370 | 370 |
| Deflection (°) | 210 up°/ 140° down | 210 up°/ 140° down | 210 up°/ 140° down |
.
ﺘ
3
Performing Testing
Bench testing (non-clinical) were conducted to verify the performance of the Flexible CMOS-Video-Cysto-Urethroscope. Design verification testing was conducted to evaluate the mechanical, optical and illumination performance. Basic safety and performance testing was performed in accordance with IEC 60601-1-2 and IEC 60601-1-2 and IEC 60601-2-18. The Karl Storz flexible CMOS Video-Cysto-Urethroscope was validated for the cleaning instructions provided in the Instruction for Use manual. The Flexible CMOS-Video-Cysto-Urethroscope has been validated for high level disinfection (HLD) with Resert XL and sterilization with STERRAD 100NX to provide a sterility assurance level of 100°. The device is provided nonsterile. The patient contacting part of the device was evaluated for biocompatibility per ISO 10993-1:2009. The risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971. The software in the device was validated as per the Software verification Testing.
Performance standards under section 514 of the Code of Federal Regulations Title 21 have not been developed for this device however the manufacturer complies with the following voluntary standards:
- IEC 60601-1
- IEC 60601-1-2 ■
- IEC 60601-2-18 트
- 트 ISO 8600-1
- ISO 8600-3 ●
- 트 ISO 8600-4
Testing demonstrated that the device is as safe & effective and performs as well as or better than the predicate devices
Conclusion:
The Karl Storz Flexible CMOS-Video-Cysto-Urethroscope is substantially equivalent to the predicate device mentioned above and the non-clinical performance testing demonstrates that the device is as safe and effective and performs as well as or better than the legally marketed devices
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 2, 2014
KARL STORZ Endoscopy-America, Inc. Shiven Gandhi Regulatory Submission Specialist 2151 E. Grand Avenue El Segundo, CA 90245
- K131364 Re:
Trade/Device Name: Flexible CMOS-Video-Cysto-Urethroscope Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FBO Dated: November 22, 2013 Received: November 25, 2013
Dear Shiven Gandhi,
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.
5
Page 2 - Shiven Gandhi
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 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/ReportalProblem/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/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Benjamin Fisher -S
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
6
Indication for Use
510(k) Number (if known): Not yet assigned K131364
Device Name: Flexible CMOS-Video-Cysto-Urethroscope
Indication for use: The Flexible CMOS Video-Cysto-Urethroscope is used to provide visualization and operative access during diagnostic and therapeutic endoscopic procedures of the lower urinary tract including the bladder and urethra.
Prescription Use ____________________________________________________________________________________________________________________________________________________________ AND/OR (Part 21 CFR 801.109 i.e. Subpart D)
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)
Benjamin 2014.01.02 14:05 00-05-00
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