(26 days)
No
The summary describes a standard endoscope and video processor system with no mention of AI or ML capabilities for image analysis, diagnosis, or other functions. The performance studies focus on mechanical, biocompatibility, and sterilization aspects, not algorithmic performance.
Yes
The device description explicitly states, "It can also be used in conjunction with endoscopic accessories to perform various diagnostic and therapeutic procedures in the urinary tract."
Yes
The device is intended to be used with endoscopic accessories to perform various diagnostic procedures in the urinary tract, which explicitly aligns with the definition of a diagnostic device.
No
The device description clearly outlines a physical, single-use endoscope with a handle, insertion section, and connector, containing hardware components like a CMOS sensor, LEDs, and a working channel. While it interacts with a video processor (which likely contains software), the device itself is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to visualize organs, cavities, and canals in the urinary tract and to perform diagnostic and therapeutic procedures within the urinary tract. This involves direct visualization and intervention within the body.
- Device Description: The device is a flexible endoscope with a camera (CMOS sensor) for capturing images inside the body. It is used with a video processor to display these images.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (such as blood, urine, or tissue) to detect diseases, conditions, or infections. This device does not perform tests on samples outside the body.
The device is a medical device used for direct visualization and intervention within the body, which falls under the category of endoscopic devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Flexible Ureterorenoscope is intended to be used to visualize organs, cavities and canals in the urinary tract (urethra, bladder, ureter, calyces and renal papillae) via transurethral access routes. It can also be used in conjunction with endoscopic accessories to perform various diagnostic and therapeutic procedures in the urinary tract.
Product codes (comma separated list FDA assigned to the subject device)
FGB
Device Description
The Flexible Ureterorenoscope (Model: US31E-12-EU; US31E-12-US) is intended to be used with the Video Processor (cleared in K211169). The Flexible Ureterorenoscope is inserted through the natural orifice urethra and when used with the compatible Video Processor and monitor, the endoscope system can be operated as intended and indicated. The Flexible Ureterorenoscope is a single-use endoscope, which consists of a Handle, an Insertion Section, and an Endoscope Connector. The handle includes a deflection lever, a working channel port for accessory devices and a Luer port for irrigation. The insertion section contains one working channel and wiring to transmit the image signals to the Video Processor. The distal bending section of the insertion is controlled by the user via the deflection lever on the handle. The distal end of the insertion contains a CMOS sensor for capturing image and transmitting it to the Video Processor, LEDs for illumination, and the distal opening of the working channel. The endoscope connects the endoscope handle to the video processor, which provides power and processes video signals from the endoscope. Same as the predicate, the subject device is also provided in 2 deflection versions (US/EU deflection), which is the only difference between the two proposed models.
Mechanism of action:
The light emitted by the LED cold light source at the distal tip of the disposable Flexible Ureterorenoscope is irradiated into the body cavity, and the light reflected from the cavity enters the optical system and is captured by the CMOS image sensor. The CMOS acquisition image is controlled by the CMOS drive circuit, and the RGB video signal is output to the Video Processor via the VI circuit. The Video Processor receives video signals from the endoscope, processes the video signals, and outputs the processed video signal to the attached monitor. The video processor also controls the brightness of the LEDs on the endoscope.
Flexible Ureterorenoscope has the following physical and performance characteristics:
- Maneuverable tip controlled by the user
- Flexible insertion cord
- Camera and LED light source at the distal tip
- Sterilized by Ethylene Oxide
- For single use
The subject device is a simplified alternative to the predicate device by adopting the handle of the The handle design of the subject device is different from the predicate on the reference device. following:
- Same as the reference device, the subject device has no video/photo pushbutton or deflection lever lock on the handle.
- Same as the reference device, the subject device adopts a built-in Luer connector with a stopcock for irrigation and a built-in working channel port for insertion of flexible auxiliary instruments whereas the predicate supports a detachable T-Luer for both irrigation of flexible auxiliary instruments.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urinary tract (urethra, bladder, ureter, calyces and renal papillae)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Healthcare facility/hospital
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 subject of this premarket submission, did not require clinical studies to support substantial equivalence.
Non-Clinical Performance Data: As part of demonstrating substantial equivalence to the predicate, a risk analysis was completed to identify the risks associated with the modification on the endoscope handle and secondary package dimensions. Verification testing were conducted to evaluate the modifications. The following tests associated with the device modifications were performed on the subject device according to methods and acceptance criteria outlined in the predicate. The subject device passed all the testing in accordance with internal requirements and applicable standards to support substantial equivalence of the subject device.
Mechanical Performance: Mechanical characteristics were tested and include tensile strength at joints/connections, coaxiality, deflection endurance, withstand of channel.
Biocompatibility Summary: The biocompatibility evaluation for the patient contacting components of the Flexible Ureterorenoscope was performed according to ISO 10993-1 and FDA Guidance. The following tests were conducted based on contact category of "Surface – Breached or Compromised Surface" 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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October 5, 2022
Shanghai AnQing Medical Instrument Co., Ltd. Shuwen Fan RA Manager 3 & 4 Floor, No.2 Building, 366 Huiging Rd, East Zhangjiang High-Tech Park Shanghai, 201201 China
Re: K222737 Trade/Device Name: Flexible Ureterorenoscope Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II
Product Code: FGB Dated: September 9, 2022 Received: September 9, 2022
Dear Shuwen Fan:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark J. Antonino, M.S. Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: OMB No. 0910-0120 Food and Drug Administration Expiration Date: 06/30/2023 Indications for Use See PRA Statement below.
510(k) Number (if known)
K222737 Device Name
Flexible Ureterorenoscope
Indications for Use (Describe)
The Flexible Ureterorenoscope is intended to be used to visualize organs, cavities and canals in the urinary tract (urethra, bladder, ureter, calyces and renal papillae) via transurethral access routes. It can also be used in conjunction with endoscopic accessories to perform various diagnostic and therapeutic procedures in the urinary tract.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number.
FORM FDA 3881 (6/20)
Page 1 of 1
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510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date Prepared: | Sep. 27th, 2022 |
|---|---|
| Manufacturer: | Shanghai AnQing Medical Instrument Co., Ltd. |
| 3 & 4 Floor, No.2 Building, 366 Huiqing Rd, | |
| East Zhangjiang High-Tech Park, 201201 | |
| Shanghai, China | |
| Contact Person: | Shuwen Fan |
| RA Manager | |
| Shanghai AnQing Medical Instrument Co., Ltd. | |
| Tel: +86-21-61117375 | |
| ra_dept@anqing-sh.com | |
| Type of 510k Submission: | Special |
Identification of the Device:
| Proprietary/Trade Name: | Flexible Ureterorenoscope |
|---|---|
| Model: | US31E-12-EU, US31E-12-US |
| Common or Usual Name: | Ureteroscope and accessories, flexible/rigic |
| Classification Name: | Endoscope and accessories |
| Regulatory Number: | 21 CFR Part 876.1500 |
| Product Code: | FGB |
| Device Class: | Class II |
| Review Panel: | Gastroenterology/Urology |
Identification of the Legally Marketed Predicate Device:
| Predicate# | Predicate Trade Name (Primary
Predicate is listed first) | Product Code |
|------------|----------------------------------------------------------------|--------------|
| K220159 | Flexible Ureterorenoscope (Model:
US31D-12-EU; US31D-12-US) | FGB |
The above predicates have not been subject to a design-related recall.
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K22737
Identification of the Reference Device:
| Reference# | Reference Trade Name | Product Code |
|---|---|---|
| K201293 | Ureterorenoscope System | FGB |
Device Description Summary:
The Flexible Ureterorenoscope (Model: US31E-12-EU; US31E-12-US) is intended to be used with the Video Processor (cleared in K211169). The Flexible Ureterorenoscope is inserted through the natural orifice urethra and when used with the compatible Video Processor and monitor, the endoscope system can be operated as intended and indicated. The Flexible Ureterorenoscope is a single-use endoscope, which consists of a Handle, an Insertion Section, and an Endoscope Connector. The handle includes a deflection lever, a working channel port for accessory devices and a Luer port for irrigation. The insertion section contains one working channel and wiring to transmit the image signals to the Video Processor. The distal bending section of the insertion is controlled by the user via the deflection lever on the handle. The distal end of the insertion contains a CMOS sensor for capturing image and transmitting it to the Video Processor, LEDs for illumination, and the distal opening of the working channel. The endoscope connects the endoscope handle to the video processor, which provides power and processes video signals from the endoscope. Same as the predicate, the subject device is also provided in 2 deflection versions (US/EU deflection), which is the only difference between the two proposed models.
Mechanism of action:
The light emitted by the LED cold light source at the distal tip of the disposable Flexible Ureterorenoscope is irradiated into the body cavity, and the light reflected from the cavity enters the optical system and is captured by the CMOS image sensor. The CMOS acquisition image is controlled by the CMOS drive circuit, and the RGB video signal is output to the Video Processor via the VI circuit. The Video Processor receives video signals from the endoscope, processes the video signals, and outputs the processed video signal to the attached monitor. The video processor also controls the brightness of the LEDs on the endoscope.
Flexible Ureterorenoscope has the following physical and performance characteristics:
- Maneuverable tip controlled by the user ●
- Flexible insertion cord
- Camera and LED light source at the distal tip
- Sterilized by Ethylene Oxide
- For single use
The subject device is a simplified alternative to the predicate device by adopting the handle of the The handle design of the subject device is different from the predicate on the reference device. following:
- Same as the reference device, the subject device has no video/photo pushbutton or deflection lever lock on the handle.
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Image /page/5/Picture/0 description: The image contains the logo for Innovex Anqing Medical. The logo is purple and features a stylized image of a document with a leaf design on the left. The text "INNOVEX" is in a sans-serif font, with a registered trademark symbol to the right, and "Anqing Medical" is in a larger, bolder font below.
- Same as the reference device, the subject device adopts a built-in Luer connector with a stopcock for irrigation and a built-in working channel port for insertion of flexible auxiliary instruments whereas the predicate supports a detachable T-Luer for both irrigation of flexible auxiliary instruments.
Intended Use/Indications for Use:
The Flexible Ureterorenoscope is intended to be used to visualize organs, cavities and canals in the urinary tract (urethra, bladder, ureter, calyces and renal papillae) via transurethral access routes. It can also be used in conjunction with endoscopic accessories to perform various diagnostic and therapeutic procedures in the urinary tract.
Indications for use Comparison:
The subject device has same indication for use in comparison to the predicate device.
Technological Characteristics:
The subject device is a modification of the predicate device, US31D-12-EU/US, cleared via K220159 and also incorporates handle design features of the reference device, US31A-12 and US31B-12, cleared via K201293.
The subject and predicate device have the same fundamental technology, physical characteristics, optical characteristics, number of uses, and sterilization. A comparison between the proposed device and predicate device is included in the table below:
| | Subject Device | Predicate Device,
K220159 |
|---------------------------|-------------------------------------------------|------------------------------|
| 510(K) Submitter | Shanghai AnQing Medical
Instrument Co., Ltd. | Same |
| Classification Regulation | 21 CFR Part 876.1500 | Same |
| Classification and Code | Class II, FGB | Same |
| | Physical Characteristics | |
| Type of Scope | Flexible | Same |
| Distal end outer diameter | ≤3.2mm (9.6Fr) | Same as subject
device |
| Working Channel Diameter | ≥1.2 mm (3.6Fr) | Same |
| Insertion Section length | 670mm | Same as subject
device |
| Deflection | ≥275°up/275°down | Same |
Comparison Table: Subject vs. Predicate Device
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AnQing Medical Premarket Notification Special 510(k) Flexible Ureterorenoscope Section 5 510K Summary
| Subject Device | Predicate Device, K220159 | |
|---|---|---|
| Optical Characteristics | ||
| Type of Imager | CMOS | Same |
| Direction of View | forward | Same |
| Field of View | 110° | Same |
| Depth of Field | 3mm~100mm | Same |
| Light Source | Internal LED | Same |
| Material/ Design Characteristics | ||
| Photo/video push button | No. | Yes |
| Detachable T-Luer | No. | |
| The device adopts a built-in Luer | ||
| connector with stopcock | ||
| for | ||
| irrigation and a built-in working | ||
| channel port for insertion | ||
| of | ||
| flexible auxiliary instruments. | Yes | |
| Deflection Lever Lock | No | Yes |
| Sterilization Methods | ||
| Number of Users | Single-Use | Same |
| Sterilization | EO Sterilized, | |
| SAL 10-6 | Same | |
| Technological Characteristics | ||
| Environment of use | Healthcare facility/hospital | Same |
| Energy source | Electricity | Same |
Non-Clinical Performance Data:
As part of demonstrating substantial equivalence to the predicate, a risk analysis was completed to identify the risks associated with the modification on the endoscope handle and secondary package dimensions. Verification testing were conducted to evaluate the modifications. The following tests associated with the device modifications were performed on the subject device according to methods and acceptance criteria outlined in the predicate. The subject device passed all the testing in accordance with internal requirements and applicable standards to support substantial equivalence of the subject device.
Mechanical Performance
Mechanical characteristics were tested and include tensile strength at joints/connections, coaxiality, deflection endurance, withstand of channel.
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K222737 Page 5 of 6
Biocompatibility Summary
The biocompatibility evaluation for the patient contacting components of the Flexible Ureterorenoscope was performed according to ISO 10993-1 and FDA Guidance. The following tests were conducted based on contact category of "Surface – Breached or Compromised Surface" with a contact duration of "Limited (