(153 days)
Not Found
No
The description focuses on standard video processing and hardware components, with no mention of AI, ML, or related concepts like training/test sets for algorithms.
Yes
The device description states that an "integrated working channel provides the user the ability to introduce diagnostic or therapeutic instruments into the operative site," which indicates its use in therapeutic procedures. Additionally, the "Intended Use / Indications for Use" section explicitly mentions "treatment within the urethra, bladder, ureter, and kidney."
Yes
The 'Intended Use / Indications for Use' section explicitly states that the device is "for endoscopic diagnosis and treatment within the urethra, bladder, ureter, and kidney."
No
The device description clearly outlines hardware components such as a video sensor, articulation lever, working channel, light emitting diode, light fibers, and a console. While it involves video processing, it is fundamentally a hardware device with integrated software.
Based on the provided information, the Stryker Video Ureteroscope is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside the body (in vitro).
- Stryker Video Ureteroscope Function: The description clearly states the device is used for "endoscopic diagnosis and treatment within the urethra, bladder, ureter, and kidney." This involves direct visualization and intervention inside the body.
- No Specimen Analysis: There is no mention of the device analyzing any biological specimens. Its primary function is visualization and providing access for instruments.
Therefore, the Stryker Video Ureteroscope is an in vivo (within the living body) diagnostic and therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Stryker Video Ureteroscope is designed to be used with a Stryker video system, monitor and other accessories for endoscopic diagnosis and treatment within the urethra, bladder, ureter, and kidney.
Product codes
FGB
Device Description
The Stryker Video Ureteroscope is a flexible ureteroscope with a video sensor mounted on the distal tip, which provides the user visualization of the anatomy of the kidney and other urological structures. The bending section is controlled by the user with an articulation lever, to provide control of the position of the sensor. An integrated working channel provides the user the ability to introduce diagnostic or therapeutic instruments into the operative site. A light emitting diode is mounted internally in the handle and is connected to the light fibers that are integrated into the scope, which emit light from the distal tip of the scope, providing.illumination of anatomy. The Video Ureteroscope is powered and controlled by a console, which also provides video output to displays, capture devices, and other accessories.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urethra, bladder, ureter, and kidney
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 Stryker Video Ureteroscope was tested for performance in accordance with design specifications and with the applicable performance standards. Biocompatibility was verified per ISO 10993-1:2009/Cor 1:2010 for patient contacting materials. Software was developed, tested, and verified per FDA guidance documents as well as IEC 62304:2006. Electrical Safety and Electromagnetic Compatibility were verified by testing to IEC 60601-1:1988/A1:1991/A2:1995 and IEC 60601-1-2:2007, respectively.
Bench performance testing performed on the Stryker Video Ureteroscope verifies the safety and effectiveness of the device per design specifications and acceptance criteria. Testing was performed to determine field of view, resolution, articulation performance, light output. leak integrity and other requirements based on the ISO 8600 family of standards. Please see Sec. 12 for a list of applied standards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
5900 Optical Court San Jose, CA 95138 t: 408 754 2000 f: 408 754 2521 www.stryker.com
(12/11/2 PG. 1 OF 2
Endoscopy
510(k) SUMMARY, PER 21 CFR 807.92
| 510(k) SUMMARY, PER 21 CFR 807.92 | ||
|---|---|---|
| 510(k) Owner/Sponsor: | Stryker Endoscopy | |
| Address: | 5900 Optical Court | |
| San Jose, CA 95138 | ||
| Establishment Number: | 2936485 | |
| Telephone Number: | (408) 754-2701 | |
| Contact Person: | Kevin Potgieter, RAC; Senior Regulatory Affairs Analyst | |
| Email Address: | kevin.potgieter@stryker.com | |
| Proposed Device: | Stryker Video Ureteroscope | |
| Common/Usual Name: | Flexible video endoscope with video processor | |
| Product Code: | FGB | |
| FDA Regulation Number: | 21 CFR 876.1500 - Endoscope and accessories | |
| Device Classification: | Class II | |
| Predicate Device: | Olympus Video Ureteroscope, NTSC | |
| Common/Usual Name: | Flexible video endoscope with video processor | |
| Product Code: | FGB | |
| FDA Regulation Number: | 21 CFR 876.1500 - Endoscope and accessories | |
| Device Classification: | Class II | |
| Premarket Notification: | K033651 | |
Device Description
The Stryker Video Ureteroscope is a flexible ureteroscope with a video sensor mounted on the distal tip, which provides the user visualization of the anatomy of the kidney and other urological structures. The bending section is controlled by the user with an articulation lever, to provide control of the position of the sensor. An integrated working channel provides the user the ability to introduce diagnostic or therapeutic instruments into the operative site. A light emitting diode is mounted internally in the handle and is connected to the light fibers that are integrated into the scope, which emit light from the distal tip of the scope, providing.illumination of anatomy. The Video Ureteroscope is powered and controlled by a console, which also provides video output to displays, capture devices, and other accessories.
Intended Use/Indications for Use
The Stryker Video Ureteroscope is designed to be used with a Stryker video system, monitor and other accessories for endoscopic diagnosis and treatment within the urethra, bladder, ureter, and kidney.
Technological Comparison
1
stryker®
Endoscopy
The Stryker Video Ureteroscope employs the same technological characteristics as the predicate device. The device consists of a flexible working length attached to a handle containing an articulation lever and mechanism, allowing for the user to deflect the distal portion of the ureteroscope. The distal tip contains a video sensor and light fibers as well as the distal opening of the working channel through which patient fluids and materials can be passed. Both video ureteroscopes require the use of a powered console that processes video signals for display on an external monitor. The device is powered by the control console (Flexible Control Unit, or FCU). There is a single cable that connects the video ureteroscope to the console. The predicate device requires a separate light source with fiber optic cable to provide illumination, whereas the Stryker Video Ureteroscope contains an integrated LED light source that allows for visualization. However, the fundamental technology is the same, since light fibers carry the illumination through the scope, where it is emitted at the distal tip. The Stryker Video Ureteroscope's control unit's video output can be connected to documentation devices for video or photographic records, in a similar fashion to the predicate device's compatibility with Olympus' documentation devices.
Performance Testing
The Stryker Video Ureteroscope was tested for performance in accordance with design specifications and with the applicable performance standards. Biocompatibility was verified per ISO 10993-1:2009/Cor 1:2010 for patient contacting materials. Software was developed, tested, and verified per FDA guidance documents as well as IEC 62304:2006. Electrical Safety and Electromagnetic Compatibility were verified by testing to IEC 60601-1:1988/A1:1991/A2:1995 and IEC 60601-1-2:2007, respectively.
Bench performance testing performed on the Stryker Video Ureteroscope verifies the safety and effectiveness of the device per design specifications and acceptance criteria. Testing was performed to determine field of view, resolution, articulation performance, light output. leak integrity and other requirements based on the ISO 8600 family of standards. Please see Sec. 12 for a list of applied standards.
Conclusion
The submitted information in this premarket notification is complete, and based on the indications for use, technological characteristics, performance testing and comparison to predicate devices, the Stryker Video Ureteroscope raises no new questions of safety and effectiveness.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a circular seal or logo. The seal features an abstract image of an eagle in the center. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle. The text is written in all capital letters.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609. Silver Spring, MD 20993-0002
SEP 1.2 2012
Mr. Kevin Potgieter, RAC
Senior Regulatory Affairs Analyst
Stryker Endoscopy
5900 Optical Court
SAN JOSE CA 95138
Re: K121112
Trade/Device Name: Stryker Video Ureteroscope Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FGB Dated: August 29, 2012 Received: August 30, 2012
Dear Mr. Potgieter:
We have reviewed your Section 510(k) premarket notification of intent to market the device We nave reviewed your Section 910(x) premaints is interest and are marketed in interstate for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regary manated to the Medical Device American of the Foderal Food. Duve commerce prior to May 20, 1970, the endominent with provisions of the Federal Food. Drug, devices that have been recassince in accreasing while approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act . The and Cosmetic Act (Act) that do not require approval controls provisions of the Act. The Act. The Act. The Act. The Y ou may, therefore, market the device, sacjost to the generats 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 hability adulteration. Please note: CDICT does not ovice labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (see above) in Exting major regulations affecting your device can be
it may be subject to additional controls. Extracts on an addition EDA may it may be subject to additional controls. DATISMS - Maris 800 to 898. In addition, FDA may
found in the Code of Federal Regulations, Title 21, Parts 800 to Sademi Register found in the Code of I casial Rogardering your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualles of a bases of a status of the requirements of the Act
that FDA has made a determination that your device complies . You must that FDA has made a decidimation administered by other Federal agencies. You must of any Pederal Statutes and reguirements, including, but not limited to: registration and listing af medi comply with all the Act STEquilements, morading, connovailing (reporting of medical
3
Page 2 -
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set de rice-teated adverse orionely (21 CFR Part 820); and if applicable, the electronic form in the quality byoxine (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 II you desire specific advice for your do need control correction offices/licm115809.htm for go to mup.//www.ida.gov/rtbound.brical Health's (CDRH's) Office of Compliance. Also, please the Concertion entitled, "Misbranding by reference to premarket notification" (21CFR Patt note the regulation entined, "insoluments of activerse 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 Tou may obtain other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address (000) 030 = 611 or (MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Benjamin R. Twitchell
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
4
5900 Optical Court San Jose, CA 95138 t: 408 754 2000 f: 408 754 2521 www.stryker.com
stryker®
Endoscopy
Device Name: Stryker Video Ureteroscope
510(k) Number if known: _ K / 2-11/2
Indications for Use:
The Stryker Video Ureteroscope is designed to be used with a Stryker video system, monitor and other accessories for endoscopic diagnosis and treatment within the urethra, bladder, ureter, and kidney.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR (21 CFR 801 Subpart C)
Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
, Gastro-Renal, and