Single-Use Video Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3, RP-U-C06S9, RP-U-C06S3)
K262488 · Guangzhou Red Pine Medical Instrument Co., Ltd. · FGB · Sep 9, 2026 · Gastroenterology, Urology
Device Facts
Record ID
K262488
Device Name
Single-Use Video Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3, RP-U-C06S9, RP-U-C06S3)
Applicant
Guangzhou Red Pine Medical Instrument Co., Ltd.
Product Code
FGB · Gastroenterology, Urology
Decision Date
Sep 9, 2026
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.1500
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The device has been developed to be used with endoscopic accessories and Endoscopic Video Image Processor for endoscopy and endoscopic surgery within urinary tract and interior of the ureter and kidney.
Device Story
Single-use flexible ureterorenoscope; designed for visualization and surgical access within urinary tract, ureter, and kidney. Device connects to external Endoscopic Video Image Processor (RP-IPD-V2000EF or RP-IPD-V1000F) to capture and display video/images. Operated by physicians in hospital settings. Features flexible insertion tube with bending section for navigation; includes instrument channel for accessory passage. Provides real-time visual feedback to clinician for diagnostic or therapeutic procedures; facilitates minimally invasive interventions. Benefits include reduced risk of cross-contamination due to single-use design and improved maneuverability via smaller insertion diameter compared to predicate.
Clinical Evidence
No clinical data. Substantial equivalence supported by non-clinical bench testing, including optical performance (ISO 8600), mechanical performance, biocompatibility (ISO 10993-1), electrical safety/EMC (IEC 60601 series), and sterilization validation (ISO 11135).
Technological Characteristics
Flexible endoscope; single-use. Materials evaluated per ISO 10993-1. Sterilized via ISO 11135. Connectivity: Wired connection to external image processor. Dimensions: 6.3Fr insertion portion; 3.0Fr instrument channel. Bending angle: 285° up/down. Optical: 125° FOV, 3-50mm DOF. Electrical safety per IEC 60601-1/2-18; EMC per IEC 60601-1-2.
Indications for Use
Indicated for endoscopy and endoscopic surgery within the urinary tract, ureter, and kidney in adult patients. Used in conjunction with endoscopic accessories and compatible Endoscopic Video Image Processors.
Regulatory Classification
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.
Special Controls
*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.
In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls:
1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following:
1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures.
2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use.
3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use.
2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes.
3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches
4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error.
5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program.
(6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms.
(7) Labeling must include:
(i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified;
(ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA;
(iii) Identification of compatible devices;
(iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification;
(v) Reprocessing instructions for reusable components;
(vi) A shelf life for any sterile components;
(vii) A description of the device-specific use training program;
(viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and
(ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance.
(8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include:
(i) Device motion accuracy and repeatability;
(ii) System testing;
(iii) Instrument reliability;
(iv) Crosstalk;
(v) Table motion control;
(vi) Thermal effects on tissue;
(vii) User-device interface performance;
(viii) Workspace access testing; and
(ix) Performance testing with compatible devices.
(9) Software verification, validation, and hazard analysis must be performed.
(10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed.
(11) Performance data must demonstrate the sterility of all patient-contacting device components.
(12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life.
(13) Performance data must validate the reprocessing instructions for the reusable components of the device.
(14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible.
(15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic.
(16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information:
(i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and
(ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.
Predicate Devices
Single-Use Video Flexible Ureterorenoscope (RP-U-C03R9, RP-U-C03R3, RP-U-C06S9, RP-U-C03S3) (K251951)
Submission Summary (Full Text)
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FDA U.S. FOOD & DRUG ADMINISTRATION
September 9, 2026
Guangzhou Red Pine Medical Instrument Co., Ltd.
Ping Yang
Regulatory Affairs Manager
12 F, #87 Luoxuan Ave., Guangzhou International Bioisland, Huangpu District
Guangzhou, Guangdong 510000
China
Re: K262488
Trade/Device Name: Single-Use Video Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3, RP-U-C06S9, RP-U-C06S3)
Regulation Number: 21 CFR 876.1500
Regulation Name: Endoscope And Accessories
Regulatory Class: Class II
Product Code: FGB
Dated: July 20, 2026
Received: July 20, 2026
Dear Ping Yang:
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 (the 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 available 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.
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-
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assistance/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 R. Kreitz -S
for Mark Antonino
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 | | |
| --- | --- | --- |
| Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K262488 | ? |
| Please provide the device trade name(s). | | ? |
| Single-Use Video Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3, RP-U-C06S9, RP-U-C06S3) | | |
| Please provide your Indications for Use below. | | ? |
| The device has been developed to be used with endoscopic accessories and Endoscopic Video Image Processor for endoscopy and endoscopic surgery within urinary tract and interior of the ureter and kidney. | | |
| Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? |
| Please select the age group(s) for which the device(s) is to be used. | ☐ Neonates/Newborns (Birth to < 29 days old) ☐ Infants (29 days old to < 2 years old) ☐ Children (2 years old to < 12 years old) ☐ Adolescents (12 years old to < 22 years old) ☑ Adults (22 years old and greater) | ? |
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# 510(k) Summary
# I. Contact Details
Submitter Name: Guangzhou Red Pine Medical Instrument Co., Ltd.
Submitter Address: 12 F, No.87 Luoxuan Avenue, Guangzhou International Bioisland, Huangpu District Guangzhou Guangdong 510000 China
Submitter Contact Telephone: +86 13902971205
Submitter Contact: Mr. Weihua Yang
Submitter Contact Email: regulation@gzredpine.com
Correspondent Name: Guangzhou Red Pine Medical Instrument Co., Ltd.
Correspondent Address: 12 F, No.87 Luoxuan Avenue, Guangzhou International Bioisland, Huangpu District Guangzhou Guangdong 510000 China
Correspondent Contact Telephone: +86 18565651640
Correspondent Contact: Ms. Ping Yang
Correspondent Contact Email: regulation@gzredpine.com
Date prepared: September 3, 2026
# II. Subject Device
Device Trade Name: Single-Use Video Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3, RP-U-C06S9, RP-U-C06S3);
Common Name: Ureteroscope and accessories
Regulation Name: Endoscope and accessories
Regulation Number: 21 CFR 876.1500
Classification Name: Ureteroscope and accessories, flexible/rigid
Product Code: FGB
# III. Legally Marketed Predicate Device
Predicate 510(k) Number: K251951
Device name: Single-Use Video Flexible Ureterorenoscope (RP-U-C03R9, RP-U-C03R3, RP-U-C03S9, RP-U-C03S3);
Product Code: FGB
Note: This predicate device has not been subject to a design-related recall.
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#### IV. Device Description Summary
The Single-Use Video Flexible Ureterorenoscope is a sterile single-use and flexible endoscope intended for endoscopy and endoscopic surgery within urinary tract and interior of the ureter and kidney. The ureterorenoscope has been designed to be used with two models of Endoscopic Video Image Processor: the RP-IPD-V2000EF and the RP-IPD-V1000F. These two processor models are the same as those used with the predicate device, which was cleared under K251951. Therefore, the compatible image processors are identical between the proposed device and the predicate device.
#### V. Indications for use
The device has been developed to be used with endoscopic accessories and Endoscopic Video Image Processor for endoscopy and endoscopic surgery within urinary tract and interior of the ureter and kidney.
#### VI. Indications for Use Comparison
The indication for use (IFU) of the proposed device and the predicate device are identical.
#### VII. Technological Comparison
The proposed device contains an identical principle of operation, target population, working length, bending angle, field of view (FOV), Depth of Field (DOF), Direction of View (DOV) to the predicate device. Minimum instrument channel width of the proposed device is also extremely close to the predicate device.
The main configuration, OD of flexible insertion portion, maximum insertion portion width of the proposed device are slightly different to the predicate device. These differences do not raise new question on safety and effectiveness of the proposed device based on the comparison test report of the proposed device and predicate device. See the following table 1 and table 2 for the detailed comparison information.
Table 1. General Comparison
| Item | Subject Device | Predicate Device K251951 | Remark |
| --- | --- | --- | --- |
| Product Code | FGB | FGB | Same |
| Regulation No. | 876.1500 | 876.1500 | Same |
| Class | II | II | Same |
| Manufacturer | Guangzhou Red Pine Medical Instrument Co.,Ltd. | Guangzhou Red Pine Medical Instrument Co.,Ltd. | / |
| Indications for Use | The device has been developed to be used with endoscopic accessories and Endoscopic Video Image Processor for endoscopy and endoscopic surgery within urinary tract and interior of the ureter and kidney. | The device has been developed to be used with endoscopic accessories such as a biopsy forceps and Endoscopic Video Image Processor for endoscopy and endoscopic surgery within urinary tract and interior of the ureter and kidney. | Same |
| Principles of Operation | The endoscope has a long, thin, flexible tube to enter the patient's body and capture the video and image of inside of the patient's body. | The endoscope has a long, thin, flexible tube to enter the patient's body and capture the video and image of inside of the patient's body. | Same |
| Main Configuration | Single-Use Video Flexible Ureterorenoscope | Single-Use Video Flexible Ureterorenoscope | Similar Analysis 1 |
| | / | Endoscopic Video Image Processor RP-IPD-V2000EF | |
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| | / | Endoscopic Video Image Processor RP-IPD-V1000F | |
| --- | --- | --- | --- |
| Single use/ Reuse | Endoscope: Single use | Endoscope: Single use Image Processor: Reuse | |
| Sterile | Yes | Yes, for the endoscope | Same |
| Target Population | Adult | Adult | Same |
| Where used | Hospitals | Hospitals | Same |
| Label/Labeling | Conform with 21CFR Part 801 | Conform with 21CFR Part 801 | Same |
Table 2: Specifications Comparison
| Item | Proposed Device | Predicate Device K251951 | Remark |
| --- | --- | --- | --- |
| Model | RP-U-C06R9,RP-U-C06R3, RP-U-C06S9, RP-U-C06S3 | RP-U-C03R9,RP-U-C03R3, RP-U-C03S9, RP-U-C03S3 | / |
| OD of flexible insertion portion | Φ2.1mm(6.3Fr) | Φ2.50 mm (7.5 Fr) | Similar Analysis 2 |
| Maximum Insertion Portion Width | 2.1mm(6.3Fr) | 2.75 mm (8.25 Fr) | Similar Analysis 3 |
| Minimum Instrument Channel Width | 1.0mm (3.0Fr) | 1.10 mm (3.3 Fr) | Similar Analysis 4 |
| Working Length | 670 mm, tolerance: ±3% | 670 mm, tolerance: ±3% | Same |
| Bending Angle | Up 285°, Down 285° tolerance ±15° | Up 285°, Down 285° tolerance ±15° | Same |
| Field of View | 125°, tolerance: ±15% | 120°, tolerance: ±15% | Similar Analysis 5 |
| Depth of Field | 3~50mm, tolerance ± 10° | 3~50mm, tolerance ± 10° | Same |
| Direction of View | 0°, tolerance:± 10° | 0°, tolerance:± 10° | Same |
Similar Analysis 1-Main configuration
This submission covers only the Single-Use Video Flexible Ureterorenoscope, not the Endoscopic Video Image Processor. The compatible image processors are identical to those of the predicate device, which have been cleared under K251951. Therefore, the difference will not affect the safety and effectiveness of the proposed device.
Similar Analysis 2- Outer Diameter (OD) of flexible insertion portion
The OD of the flexible insertion portion of proposed device is similar to the predicate device. The diameter meets the industrial standard.
In addition, the nominal value of the proposed device is less than that of the predicate device. The smaller OD of flexible insertion portion, the better the cross ability. Therefore, the difference do not affect the safety and effectiveness of the proposed device.
Similar Analysis 3- Maximum Insertion Portion Width
The Maximum Insertion Portion Width of the proposed device is similar to the predicate device. The diameter meets the industrial standard.
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In addition, the nominal value of the proposed device is less than that of the predicate device. The smaller maximum insertion portion width, the better the cross ability. Therefore, the difference do not affect the safety and effectiveness of the proposed device.
Similar Analysis 4- Minimum Instrument Channel Width
The Minimum Instrument Channel Width of the proposed device is similar to the predicate device. The diameter meets the industrial standard.
Based on the test result of Mechanical Performance Comparison Test Report, the water delivery system test values of the proposed device demonstrate equivalent performance compared to the predicate device, and the size of the endoscopic accessories used in conjunction with the proposed device and the predicate device are the same, it can be considered that the minimum width of instrument channel of the proposed device is equivalent to that of the predicate device.
Similar Analysis 5- Field of View
The Field of View of the proposed device is similar as the predicate device.
Based on the test result of Comparison Test Report for Field of View, the measured values are also similar. Therefore, the performance of the proposed device is substantially equivalent to that of the predicate device.
### VIII. Non-Clinical Tests Summary
1. Performance testing:
The performance testing was conducted on the two ureterorenoscope systems—each comprising the proposed ureterorenoscope combined with one of the processors (RP-IPD-V2000EF or RP-IPD-V1000F), and the performance testing includes optical performance and mechanical performance.
The performance testing includes ISO 8600 test, and the ISO 8600 test results demonstrated that the proposed system complies with the standard requirements.
The optical performance testing includes direction of view, field of view, depth of field, resolution, signal-to-noise ratio, geometric distortion, image intensity uniformity, dynamic range and color performance.
The mechanical performance testing includes basic size, surface and edges, water delivery system, bending control system, sealing performance, compatibility with accessories, fatigue test of rocker and bending section, tensile strength of insertion portion, performance of cable connector, comprehensive performance of luer connector.
2. Performance comparative testing:
The performance comparative testing was conducted on the proposed Ureterorenoscope system and the predicate system, the performance testing includes optical performance and mechanical performance.
The performance comparative testing includes ISO 8600 test, and the ISO 8600 test results demonstrated that the proposed system complies with the standard requirements.
The optical performance testing includes direction of view, field of view, depth of field, resolution, signal-to-noise ratio, geometric distortion, image intensity uniformity, dynamic range and color performance.
The mechanical performance testing includes basic size, surface and edges, water delivery system,
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bending control system, sealing performance, fatigue test of rocker and bending section, tensile strength of insertion portion and performance of cable connector. And the image quality evaluation is performed.
The test results demonstrate that the optical performance and mechanical performance of the proposed system is similar as those of the predicate device.
The Performance Comparative Testing and Performance Testing were completed and the results proved that the proposed device and the predicate device have same or similar design features and performance specifications.
# 3. Biocompatibility testing:
Biocompatibility of the Single-Use Video Flexible Ureterorenoscope was evaluated per ISO 10993-1. The FDA guidance, "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," was used.
# 4. Sterilization and Shelf life testing:
The Single-Use Video Flexible Ureterorenoscope contains a shelf life of 3 years. Sterilization was validated in accordance with ISO 11135:2014. Shelf life testing was conducted in accordance with ASTM F1980-21. Package validation was conducted according to ASTM F1886/F1886M-16, ASTM D4169-23, ASTM F1929-23, and ASTM F88/F88-23.
# 5. Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing was conducted on the Single-Use Video Flexible Ureterorenoscope and Endoscopic Video Image Processors (RP-IPD-V2000EF and RP-IPD-V1000F) in accordance with IEC 60601-1:2005/AMD1:2012/AMD2:2020, IEC 60601-2-18:2009, and IEC 60601-1-2:2014+A1:2020.
# IX. Clinical Evidence
N/A.
# X. Conclusion
The results of nonclinical performance testing demonstrate that the subject device is as safe and effective as the predicate device to support substantial equivalence.
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Narrow by SaMD (Software as a Medical Device), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
