(26 days)
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 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.
The provided text describes a 510(k) premarket notification for a medical device called "Flexible Ureterorenoscope." This document is a regulatory submission to the FDA proving substantial equivalence to a predicate device, not a study of an AI/ML algorithm. Therefore, many of the requested details, such as AI-specific acceptance criteria, test set Ground Truth establishment, MRMC studies, or training set information, are not applicable to this kind of device and its regulatory pathway.
The device discussed is a standard medical instrument, an endoscope, not an AI-powered diagnostic or therapeutic device. The "study" mentioned refers to non-clinical performance data and testing to demonstrate that the modified device performs comparably to its predicate and meets safety standards, not a clinical trial involving AI.
Here's an attempt to answer the questions based on the provided text, highlighting where the requested AI-specific information is not applicable:
1. A table of acceptance criteria and the reported device performance
The document states that the device passed all testing in accordance with internal requirements and applicable standards. The acceptance criteria are generally implied to be the successful demonstration that the device's characteristics (mechanical, optical, material, etc.) are equivalent to or better than the predicate device and meet relevant regulatory standards. Specific numerical acceptance criteria were not explicitly provided in the summary, but rather implied by the statement "passed all the testing in accordance with internal requirements and applicable standards to support substantial equivalence of the subject device."
| Test Category | Specific Tests | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Mechanical Performance | Tensile strength at joints/connections, coaxiality, deflection endurance, withstand of channel. | Met internal requirements and applicable standards. | Passed all tests. |
| Biocompatibility | Cytotoxicity (ISO 10993-5), Irritation (ISO 10993-10), Sensitization (ISO 10993-10), Acute Systemic Toxicity (ISO 10993-11), Material-mediated pyrogenicity (ISO 10993-11). | Met ISO 10993-1 and FDA Guidance requirements for Limited (< 24 hours) contact. | Performed according to standards and found acceptable. |
| Sterilization | EO Sterilization validation (ISO 11135:2014 half-cycle method), EO/ECH residual test (ISO 10993-7:2008). | Achieved SAL 10-6 and met residual limits. | Validation successful, residuals within limits. |
| Packaging Integrity | Package validation (ISO 11607-1:2019, ISO 11607-2:2019), Environmental conditioning (ASTM D4169-16), Transportation Simulation (ASTM D4169-16), Seal strength (F88/88M-15), Seal integrity (ASTM F 1929-15). | Maintained sterility and package integrity after simulated shipping and testing. | Package validation demonstrated integrity. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The text describes non-clinical performance testing of a physical device. It does not refer to a "test set" in the context of a dataset for an algorithm. There is no information regarding sample sizes for human subjects or origin of data (e.g., retrospective/prospective, country of origin) because clinical studies were not required for this submission. The testing was performed on physical samples of the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This question is not applicable. "Ground truth" in the context of expert review for medical image analysis or similar AI applications is not relevant here. The ground truth for device performance is based on established engineering standards, material science, and biocompatibility protocols.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods like 2+1 or 3+1 refer to agreement among human readers for establishing ground truth in clinical data, which is not what was done for this device.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No. An MRMC study was not stated or implied. This type of study would be relevant for an AI-assisted diagnostic or decision-support system, which this device is not. The document explicitly states: "The subject of this premarket submission, did not require clinical studies to support substantial equivalence."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This question is not applicable. The device is a physical endoscope that is used by a human operator; it is not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for demonstrating substantial equivalence for this device is based on:
- Compliance with recognized international standards (e.g., ISO, ASTM).
- Demonstration of physical and optical characteristics being equivalent or better than the predicate device.
- Successful completion of specific mechanical, biocompatibility, sterilization, and packaging tests based on established laboratory protocols.
No diagnostic or clinical outcomes ground truth was established by experts for this submission.
8. The sample size for the training set
This question is not applicable. There is no "training set" as this is a physical medical device, not an AI/ML algorithm requiring training data.
9. How the ground truth for the training set was established
This question is not applicable for the same reason as above.
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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.
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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) 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
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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, 201201Shanghai, China |
| Contact Person: | Shuwen FanRA ManagerShanghai AnQing Medical Instrument Co., Ltd.Tel: +86-21-61117375ra_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 (PrimaryPredicate 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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- 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 MedicalInstrument 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 subjectdevice |
| Working Channel Diameter | ≥1.2 mm (3.6Fr) | Same |
| Insertion Section length | 670mm | Same as subjectdevice |
| 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 Luerconnector with stopcockforirrigation and a built-in workingchannel port for insertionofflexible 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 (< 24 hours):
- Cytotoxicity per ISO 10993-5:2009/(R) 2014 ●
- Irritation per ISO 10993-10:2010 ●
- Sensitization per ISO 10993-10:2010 ●
- Acute Systemic Toxicity per ISO 10993-11:2017
- Material-mediated pyrogenicity per ISO 10993-11:2017
Sterilization
The sterilization method has been validated to ISO 11135:2014 half-cycle method, which has thereby determined the routine control and monitoring parameters.
EO/ECH residual test was performed according to ISO 10993-7:2008.
Simulated Shipping distribution followed by sterile packaging integrity test
Package validation was conducted according to ISO 11607-1:2019 and ISO 11607- 2:2019, and
- Environmental conditioning ASTM D4169-16
- Transportation Simulation ASTM D4169-16 ●
- Seal strength F88/88M-15 ●
- Seal integrity ASTM F 1929-15
Substantial Equivalence:
The intended use, operating principles, technological characteristics and features are similar, if not identical, between that subject device and the predicate device, Flexible Ureterorenoscope (K220159). The minor difference between the subject and predicate device that does not raise new or different questions on safety and effectiveness are listed above in Technological Characteristics section.
As demonstrated by the comparisons, the differences do not raise different questions of safety and effectiveness because the intended use, operating principles, technological characteristics, and features are similar, if not identical. Both subject device and predicate device also comply with identical standards and safety testing, where applicable.
Substantial equivalence to the effectiveness of the subject device is supported by the comparison of the performance characteristics including, but not limited to the performance testing listed above.
Summary of Clinical Tests:
The subject of this premarket submission, did not require clinical studies to support substantial equivalence.
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AnQing Medical Premarket Notification Special 510(k) Flexible Ureterorenoscope Section 5 510K Summary
Conclusion:
The conclusions drawn from the nonclinical tests demonstrate that the subject device, the Flexible Ureterorenoscope (Model: US31E-12-EU; US31E-12-US) is substantially equivalent to the predicate device.
§ 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.