(141 days)
Not Found
No
The summary mentions "clinical image processing" but does not provide any details suggesting the use of AI/ML algorithms for this processing. There are no mentions of AI, DNN, ML, training sets, test sets, or performance metrics typically associated with AI/ML models.
Yes
The device is indicated for endoscopic examination in the urinary tract and can be used to examine the interior of the kidney, and utilizing additional accessories, to perform various diagnostic and therapeutic procedures.
Yes
The device is indicated for "endoscopic examination in the urinary tract" and to "examine the interior of the kidney", which are diagnostic procedures. It can also "perform various diagnostic and therapeutic procedures" using additional accessories.
No
The device description explicitly includes a "sterile single-use disposable Flexible Ureteroscope" and a "video processor," which are hardware components. The performance studies also include biocompatibility, sterilization, electrical safety, optical, and mechanical testing, all of which are relevant to hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Ureterorenoscope System is an endoscopic device used to directly visualize the inside of the urinary tract and kidney. It is used for examination and therapeutic procedures within the body, not for testing samples outside the body.
- Intended Use: The intended use clearly states "endoscopic examination in the urinary tract" and "to examine the interior of the kidney," which are in-vivo procedures.
- Device Description: The description focuses on the physical components used for insertion and visualization within the body.
The device is a surgical/endoscopic instrument, not a diagnostic test performed on samples.
N/A
Intended Use / Indications for Use
The Ureterorenoscope System consists of a sterile single-use disposable Flexible Ureteroscope to be introduced within the urinary tract and video processor for clinical image processing. The device is indicated for endoscopic examination in the urinary tract and can be used to examine the interior of the kidney, and using additional accessories, to perform various diagnostic and therapeutic procedures.
Product codes
FGB
Device Description
The Ureterorenoscope System consists of a sterile single-use disposable Flexible Ureteroscope to be introduced within the urinary tract and endoscope operating system for clinical image processing.
Mentions image processing
The Ureterorenoscope System consists of a sterile single-use disposable Flexible Ureteroscope to be introduced within the urinary tract and video processor for clinical image processing. The Ureterorenoscope System consists of a sterile single-use disposable Flexible Ureteroscope to be introduced within the urinary tract and endoscope operating system for clinical image processing. The Ureterorenoscope System and the predicate devices are all designed to provide real-time images to the physician in order to facilitate diagnostic and therapeutic procedures in the urinary tract.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CMOS chip at the distal end of the endoscope
Anatomical Site
urinary tract, kidney
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospitals or health clinics by trained 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)
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing: Biocompatibility of the Ureterorenoscope System was evaluated in accordance with ISO 10993-1:2009 for the body contact category of "Surface – Mucosal Membrane" with a contact duration of "Limited (
§ 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/2 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font below.
July 3, 2018
Shanghai AnOing Medical Instrument CO., Ltd. Lina Fei Quality Manager 150 Cailun Road, Zhangjiang High-Tech Park Shanghai, 201210 China
Re: K180367 Trade/Device Name: Ureterorenoscope System Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FGB Dated: May 18, 2018 Received: May 29, 2018
Dear Lina Fei:
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.
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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 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.
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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Glenn B. Bell -S
for
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
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Indications for Use
510(k) Number (if known) K180367
Device Name Ureterorenoscope System
Indications for Use (Describe)
The Ureterorenoscope System consists of a sterile single-use disposable Flexible Ureteroscope to be introduced within the urinary tract and video processor for clinical image processing. The device is indicated for endoscopic examination in the urinary tract and can be used to examine the interior of the kidney, and using additional accessories, to perform various diagnostic and therapeutic procedures.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
l Submitter
Device submitter: Shanghai AnQing Medical Instrument CO., Ltd.
Room 202, 2nd Floor, No.7 Building & Room 202, 200 Floor No.4 Building, 150 Cailun Road, Zhangjiang High-Tech Park, 201210, Shanghai, China
Contact: Lina FEI, Quality Manager Phone: +86 137 7425 3128 Fax: +86 21 5019 1132 - 8004 Email: Lina@anqing-sh.com
II Device
Trade name of Device: Ureterorenoscope System Common name: Ureteroscope and Accessories, Flexible/Rigid Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscopes and Accessories Regulatory Class: II Product code: FGB
III Predicate Devices
| Trade name: | Karl Storz Flexible Video-Uretero-Renoscope System |
|---|---|
| Common name: | Ureteroscope and accessories, Flexible/Rigid |
| Classification: | Class II, 21 CFR 876.1500 |
| Product Code: | FGB |
| Premarket Notification: | K131369 |
| Trade name: | Boston Scientific Corporation LithoVue System |
|---|---|
| Common name: | Ureteroscope and accessories, Flexible/Rigid |
| Classification: | Class II, 21 CFR 876.1500 |
| Product Code: | FGB |
| Premarket Notification: | K153049 |
IV Device description
The Ureterorenoscope System consists of a sterile single-use disposable Flexible Ureteroscope to be introduced within the urinary tract and endoscope operating system for clinical image processing.
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V Device characteristics
The system consists of an EO sterilized single-use Flexible Ureteroscope and a non-sterile repeat use Video Processor. The Video processor is connected to mains power and provides power to the Flexible Ureteroscope.
The material inserted into the urine tract of the patient is TPU. The contact duration equals to the time of the Ureteroscopy, which is less than 24 hours. The biocompatibility of the material complies with ISO10993 series.
The device is intended to be used at hospitals or health clinics by trained physicians.
VI Operation principle
The Flexible Ureteroscope is inserted through the external urethral orifice and bladder during ureteroscopy. Anatomical images are transmitted to the user by the video processor with a CMOS chip at the distal end of the endoscope and the images showing on a monitor.
VII Indications for use
The Ureterorenoscope System consists of a sterile single-use disposable Flexible Ureteroscope to be introduced within the urinary tract and video processor for clinical image processing. The device is indicated for endoscopic examination in the urinary tract and can be used to examine the interior of the kidney, and using additional accessories, to perform various diagnostic and therapeutic procedures.
VIII Comparison of technological characteristics with the predicate devices
The Ureterorenoscope System has the same technological characteristics and fundamental design as the predicate devices. The Ureterorenoscope System and the predicate devices are all designed to provide real-time images to the physician in order to facilitate diagnostic and therapeutic procedures in the urinary tract. The differences between the Ureterorenoscope System and predicate devices do not alter suitability of the proposed device for its intended use.
IX Performance data
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
Biocompatibility of the Ureterorenoscope System was evaluated in accordance with ISO 10993-1:2009 for the body contact category of "Surface – Mucosal Membrane" with a contact duration of "Limited (