(219 days)
No
The description focuses on standard endoscopic technology, image capture via a CMOS sensor, and video processing. There is no mention of AI, ML, or advanced image analysis beyond basic processing.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device can be used in conjunction with endoscopic accessories to "perform various diagnostic and therapeutic procedures in the urinary tract."
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended to be used to visualize organs, cavities, and canals in the urinary tract... for the purpose of diagnosis and treatment." This clearly indicates its role in obtaining information for diagnostic purposes.
No
The device description clearly details a physical endoscope with a handle, insertion section, CMOS sensor, LEDs, and a working channel. It also mentions mechanical and optical performance testing, biocompatibility, and sterilization, all indicative of a hardware device. While it connects to a video processor (which likely contains software), the device itself is a physical instrument.
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 perform diagnostic and therapeutic procedures in the urinary tract. This involves direct visualization and intervention within the body.
- Device Description: The device is described as an endoscope used for providing endoscopic imaging of the ureter and renal pelvis. It's a tool for direct observation and manipulation within the body.
- Mechanism of Action: The mechanism involves light irradiation and image capture within the body cavity.
- Lack of In Vitro Activity: An IVD is a medical device that is intended to be used in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety and compatibility of potential donors and recipients, or to monitor therapeutic measures. This device does not perform any tests on specimens outside of the body.
The device is clearly an endoscopic device used for direct visualization and intervention within the human body, which falls under a different regulatory category than IVDs.
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
FGB
Device Description
The Flexible Ureterorenoscope (Model: US31D-12-EU, US31D-12-US) is an endoscope which is used with the Video Processor (Model: EOS-H-01) (FDA cleared K211169) produced by AnQing for providing endoscopic imaging of the ureter and the renal pelvis for the purpose of diagnosis and treatment. The 2 proposed models are identical except the deflection versions, which is opposite from each other (EU version or US version).
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 lever lock, a push button for picture taking/video recording and a Luer port for insertion of accessory devices and irrigation to the working channel. 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 section 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 connector connects the endoscope handle to the video processor, which provides power and processes video signals from the endoscope.
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
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)
Summary of Non-Clinical Tests:
Electrical Safety and Electromagnetic Compatibility Summary
The electrical safety and EMC data included in the submission is in compliance with the following FDA recognized standards:
•ANSI/AAMI ES: 60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012
•IEC 60601-2-18:2009
•IEC 60601-1-2:2014
Bench Testing Summary
Photobiological safety
The LEDs in submitted Ureterorenoscope were tested according to the following FDA recognized standards:
•IEC 62471:2006 Medical electrical equipment, Photobiological safety of lamps and lamp systems
Mechanical and Optical Performance
The Flexible Ureterorenoscope was designed to comply with applicable parts of ISO 8600. Optical measurements were performed according to applicable part of ISO 8600 standard.
Mechanical characteristics were tested and include leakage tightness, bending. deflection endurance, and tensile strength testing.
In addition, comparative testing related to image quality parameters including Color performance (color reproduction), optical performance (resolution, depth of field and image intensity uniformity, distortion), and dynamic range test was performed for submitted Flexible Ureterorenoscope and the predicate device to support substantial equivalence.
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 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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Image /page/0/Picture/0 description: The image shows 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 26, 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: K220159
Trade/Device Name: Flexible Ureterorenoscope Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FGB Dated: July 27, 2022 Received: July 27, 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.
1
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); 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 (OS) 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 medical devices and radiation-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,
Reginald K. Avery, Ph.D. Acting 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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K220159
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) |
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Image /page/3/Picture/1 description: The image contains a logo for a company called "Innovex Anqing Medical". The logo features the word "Innovex" in a bold, sans-serif font, with the word "Anqing Medical" appearing below it in a slightly smaller font. To the left of the text is a purple square with a white, stylized leaf design inside. A curved line extends from the top of the square over the word "Innovex".
510(k) Summary
| Date Prepared: | Aug. 18th, 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 Fax: +86-21-61117374 ra_dept@anqing-sh.com
Identification of the Device:
| Proprietary/Trade Name: | Flexible Ureterorenoscope |
|---|---|
| Model: | US31D-12-EU, US31D-12-US |
| Common or Usual Name: | Ureteroscope and accessories, flexible/rigid |
| 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:
| Trade Name: | Ureterorenoscope System |
|---|---|
| Classification Name: | Endoscope and accessories |
| Regulatory Number: | 21 CFR Part 876.1500 |
| Product Code: | FGB |
| Device Class: | Class II |
| Review Panel: | Gastroenterology/Urology |
| Submitter/510(k) Holder: | Shanghai AnQing Medical Instrument Co., Ltd |
| Clearance: | K201293 (cleared July 24, 2020) |
| This predicate has not been subject to a design-related recall. |
Device Description:
The Flexible Ureterorenoscope (Model: US31D-12-EU, US31D-12-US) is an endoscope which is used with the Video Processor (Model: EOS-H-01) (FDA cleared
4
Image /page/4/Picture/1 description: The image shows the logo for Innovex Anqing Medical. The logo is purple and white. On the left side of the logo is a purple square with a white leaf design. To the right of the square is the word "INNOVEX" in a sans-serif font, with the words "Anqing Medical" below it.
#K211169) produced by AnQing for providing endoscopic imaging of the ureter and the renal pelvis for the purpose of diagnosis and treatment. The 2 proposed models are identical except the deflection versions, which is opposite from each other (EU version or US version).
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 lever lock, a push button for picture taking/video recording and a Luer port for insertion of accessory devices and irrigation to the working channel. 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 section 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 connector connects the endoscope handle to the video processor, which provides power and processes video signals from the endoscope.
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
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.
Comparison with Predicate Device:
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Image /page/5/Picture/1 description: The image shows a logo for a company called "Innovex Anqing Medical". The logo has a purple graphic on the left side, which looks like a stylized leaf or wing. To the right of the graphic, the word "Innovex" is written in a bold, sans-serif font, with "Anqing Medical" written in a smaller font below it. The overall design is clean and modern.
The Flexible Ureterorenoscope and its predicate device, the Shanghai AnQing Medical Ureterorenoscope System (K201293), have the same intended use, sterilization Methods and similar physical characteristics, optical characteristics.
Substantial Equivalence:
The Flexible Ureterorenoscope employs the same fundamental scientific technology as its predicate devices, as below table:
| | Subject Device | Predicate Device,
K201293 | Comparison |
|-----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|
| Indications For 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. | The Ureterorenoscope
System consists of a
sterile single-use
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. | Same.
See Note2. |
| | Physical Characteristics | | |
| Type
of
Scope | Flexible | Flexible | Same |
| Distal
end
outer
diameter | ≤3.2mm (9.6Fr) | ≤3.1mm (9.3 Fr) | Similar |
| Insertion
Section
length | 670mm | 650mm | Similar |
| | Subject Device | Predicate Device, K201293 | Comparison |
| Deflection | ≥275°up/275°down | ≥275°up/275°down | Same |
| | Optical Characteristics | | |
| Type of Imager | CMOS | CMOS | Same |
| Direction of View | forward | forward | Same |
| Field of View | 110° | 110° | Same |
| Depth of Field | 3mm100mm | 3mm100mm | Same |
| Light Source | Internal LED | Internal LED | Same |
| | Patient Contacting Materials | | |
| General material type of main patient- contact part | Pebax, polyamide, Stainless Steel, Epoxy glue, glass, Polycarbonate, PTFE, PET | Pebax, PTFE, LCP, TPU, Fluoro elastomers, Epoxy glue, glass | Different See Note 1. |
| | Sterilization Methods | | |
| Number of Users | Single-Use | Single-Use | Same |
| Sterilization | EO Sterilized, SAL 10-6 | EO Sterilized, SAL 10-6 | Same |
| | Technological Characteristics | | |
| Environmen t of use | Healthcare facility/hospital | Healthcare facility/hospital | Same |
| Energy source | Electricity | Electricity | Same |
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Image /page/6/Picture/1 description: The image shows the logo for Innovex Anqing Medical. The logo is purple and white. On the left side of the logo is a purple graphic that looks like a leaf. To the right of the graphic is the word "INNOVEX" in a sans-serif font. Below "INNOVEX" is the text "Anqing Medical" in a larger, bolder font.
Note :
- The subject and predicate devices have the same fundamental technology, direction of view, depth of field, light source, type of imager, number of uses and sterilization method. The subject ureterorenoscope differs from the predicate in insertion section length, distal end outer diameter and patient-contacting materials. These differences do not raise different questions of safety and effectiveness as compared to the predicate, and can be evaluated through performance testing.
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Image /page/7/Picture/1 description: The image shows the logo for Innovex Anqing Medical. The logo features the word "INNOVEX" in a bold, sans-serif font, with the word "Anqing MEDICAL" in a smaller, bolder font below it. To the left of the text is a stylized graphic of a leaf or wing in a purple color. The logo has a clean and professional design.
| Subject Device | Predicate Device, K201293 | Comparison |
|---|---|---|
| 2. The indications for use statement for the subject ureterorenoscope is very similar to | ||
| that of the predicate device. A slightly different wording is chosen and specific | ||
| anatomical locations within the urinary tract are listed. The differences do not alter the | ||
| intended use of the device nor do they raise different questions of safety and | ||
| effectiveness of the device relative to the predicate. |
Summary of Testing:
Summary of Non-Clinical Tests:
Electrical Safety and Electromagnetic Compatibility Summary
The electrical safety and EMC data included in the submission is in compliance with the following FDA recognized standards:
•ANSI/AAMI ES: 60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012
- ・IEC 60601-2-18:2009
·IEC 60601-1-2:2014
Bench Testing Summary
Photobiological safety
The LEDs in submitted Ureterorenoscope were tested according to the following FDA recognized standards:
· IEC 62471:2006 Medical electrical equipment, Photobiological safety of lamps and lamp systems
Mechanical and Optical Performance
The Flexible Ureterorenoscope was designed to comply with applicable parts of ISO 8600. Optical measurements were performed according to applicable part of ISO 8600 standard.
Mechanical characteristics were tested and include leakage tightness, bending. deflection endurance, and tensile strength testing.
In addition, comparative testing related to image quality parameters including Color performance (color reproduction), optical performance (resolution, depth of field and image intensity uniformity, distortion), and dynamic range test was performed for submitted Flexible Ureterorenoscope and the predicate device to support substantial equivalence.
Biocompatibility Summarv
The biocompatibility evaluation for the patient contacting components of the Flexible Ureterorenoscope was performed according to ISO 10993-1 and FDA Guidance. The
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Image /page/8/Picture/1 description: The image shows the logo for Innovex Anqing Medical. The logo features the text "INNOVEX Anqing Medical" in a stylized font. The word "INNOVEX" is in a larger, bolder font than "Anqing Medical". Above the text is a graphic element that resembles a stylized leaf or wing shape. The color scheme of the logo is primarily purple.
following tests were conducted based contact category of "Surface-Breached or compromised surface" with a contact duration of "Limited (