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The Medical Video Endoscope is designed to be used with endo-therapy accessories such as a biopsy forceps and other ancillary equipment for endoscopy and endoscopic surgery within urinary tract and interior of the kidney.

The image processor is used with the specified endoscope designed by SEPLOU during minimally invasive surgery.

The image processor provides power and processes the images for medical electronic endoscope.

The Medical Video Endoscope system is designed to provide image solution for endoscopy and endoscopic surgery, and perform procedures in the urinary tract and interior of the kidney using appropriate accessory devices (e.g. laser fibers, forceps baskets).

The Medical Video Endoscope is a sterile Medical Video Endoscope. The Image Processor for Endoscopy is a reusable monitor.

The Medical Video Endoscope is comprised of a control body with articulation controls and accessory access ports, and a flexible insertion tube with an on-tip camera module and LED lighting source. The Image Processor processes the images from the Endoscope and outputs video signals to a display.

This document describes the FDA 510(k) clearance for the Seplou (ZHUHAI) Co., Ltd. Medical Video Endoscope System. It is important to note that this is a medical device clearance, not an AI/ML device clearance. Therefore, the information regarding AI-specific criteria like training sets, expert ground truth, and MRMC studies will not be present in this document. The provided text does not describe an AI/ML device.

Here's an analysis based on the provided document for the Medical Video Endoscope System:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a medical device and not an AI/ML system, the "acceptance criteria" discussed are related to physical, electrical, and performance standards rather than metrics like sensitivity or specificity. The "reported device performance" refers to the device's adherence to these standards.

2. Sample Sizes Used for Test Set and Data Provenance

This is not applicable as the clearance is for a physical medical device (endoscope system) and not an AI/ML algorithm that processes data. The "test set" in this context refers to the physical units and their components undergoing various engineering and performance tests, not a dataset of medical images. The data provenance would be laboratory testing data generated during the device's development and validation.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This is not applicable for a non-AI medical device clearance. Ground truth, in the context of AI/ML, refers to definitively labeled data. For this device, "ground truth" would be established through adherence to engineering standards, validated measurement techniques, and industry best practices by qualified engineers and technicians.

4. Adjudication Method for the Test Set

Not applicable for a non-AI medical device clearance. Adjudication methods like 2+1 or 3+1 are used for reconciling expert disagreements in AI ground truth labeling. For a physical device, testing outcomes are typically definitive measurements against established standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. An MRMC study is relevant for evaluating the impact of AI on human reader performance for diagnostic tasks. This device is an endoscope system, not an AI diagnostic tool.

6. Standalone (i.e. algorithm only without human-in-the loop performance) Study

Not applicable. This device is a physical endoscope system, not a standalone algorithm.

7. Type of Ground Truth Used

The "ground truth" for this medical device's performance is established by:

• International Standards: Adherence to ISO, ASTM, and IEC standards for biocompatibility, sterilization, electrical safety, EMC, optical performance, and packaging.
• Engineering Specifications: The device's measurable physical and optical properties meeting predefined design specifications.
• Comparison to Predicate Device: Demonstrating substantial equivalence to a legally marketed predicate device, implying similar performance characteristics.

8. Sample Size for the Training Set

Not applicable. This is not an AI/ML device, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable for the same reason as above.

Summary of Device and Performance:

The Seplou (ZHUHAI) Medical Video Endoscope System aims to provide an image solution for endoscopy and endoscopic surgery within the urinary tract and interior of the kidney. It consists of multiple models of flexible endoscopes and an image processor.

The device's performance has been demonstrated through a series of non-clinical tests to meet established regulatory and industry standards. This includes:

• Biocompatibility: Evaluated according to ISO 10993-1, covering cytotoxicity, sensitization, irritation, acute systemic toxicity, and material-mediated pyrogens.
• Sterilization and Shelf Life: Validated via ISO 11135:2014 for sterilization, ISO 10993-7:2008 for EO/ECH residuals, and ASTM F1980-21 for accelerated aging to support a 3-year shelf life. Package validation was also done per ISO and ASTM standards.
• Electrical Safety and EMC: Complies with IEC 60601-1 (general medical electrical equipment safety), IEC 60601-2-18 (endoscopic equipment specific safety), and IEC 60601-1-2 (electromagnetic compatibility).
• Software Verification and Validation: Conducted and documented as per FDA guidance.
• Bench Performance Testing: Included optical performance (according to ISO 8600 series, color reproduction, geometric distortion, resolution, depth of field, image intensity uniformity, noise, dynamic range compared to the predicate device) and mechanical tests (use-life of bending section, control knob, connection strength, tensile force, and corrosion resistance).

The conclusion states that these performance tests and compliance with voluntary standards confirm the substantial equivalence of the proposed Medical Video Endoscope system to its predicate device (K172098). No clinical studies were deemed necessary for this clearance.

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The Ureteral Access Sheath is used to establish a conduit during endoscopic urological procedures facilitating the passage of endoscopes and other instruments into the urinary tract. It is designed to establish a conduit for the treatment of urinary stones or other urinary diseases during the endoscopic procedures.

Ureteral Access Sheath is used to establish a conduit during endoscopic urological procedures facilitating the passage of endoscopes and other instruments into the urinary tract. The Ureteral Access Sheath provides ureteral dilation and a continuous working channel for the introduction of endoscopes and instruments during ureteral access procedures. Ureteral Access Sheath comes in two models: Tip-unbendable Ureteral Access Sheath and Tip-bendable Ureteral Access Sheath with suction. The Tip-unbendable Ureteral Access Sheath is offered in French size ranging from 10Fr to 14Fr and length 28cm to 45cm. The Tip-bendable Ureteral Access Sheath with Suction is offered in French size ranging from 10Fr to 13Fr and length 33cm to 50cm.

The Seplou (Zhuhai) Co., Ltd. Ureteral Access Sheath (K243025) is a medical device used to create a conduit in the urinary tract for endoscopic urological procedures. The device's acceptance criteria and proven performance are outlined through various tests detailed in the 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

The provided document does not explicitly state the sample sizes used for each specific performance test (biocompatibility, general performance, sterilization, shelf life). It notes that various tests were conducted.

The provenance of the data is not specified in terms of country of origin or whether it was retrospective or prospective. However, given that it is a 510(k) submission for a device manufactured by a Chinese company (SEPLOU (ZHUHAI) CO., LTD.), it is highly probable that the testing was performed in laboratories affiliated with or contracted by the manufacturer, potentially in China or other authorized testing facilities globally.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not applicable to this type of device submission. The device is a Ureteral Access Sheath, which is a physical instrument. The "ground truth" for its performance relies on objective measurements against engineering specifications and international standards, not on expert interpretations of data like in an AI/imaging study.

4. Adjudication Method for the Test Set:

This information is not applicable. Adjudication methods (like 2+1, 3+1 consensus) are typically used in clinical studies or studies involving subjective human interpretation (e.g., imaging reviews), which is not the case for the premarket testing of this physical medical device. The tests performed are objective, laboratory-based evaluations.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:

This information is not applicable. The device is a physical Ureteral Access Sheath, not an AI or imaging diagnostic tool that would involve human readers or AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

This information is not applicable. The device is a physical Ureteral Access Sheath, not an algorithm or software.

7. The Type of Ground Truth Used:

The "ground truth" for the performance of the Ureteral Access Sheath is established through:

• Compliance with International Standards: ISO (International Organization for Standardization) standards for biocompatibility and sterilization, and ASTM/DIN standards for packaging and shelf-life.
• Engineering Specifications: The manufacturer's own design specifications for dimensions, material properties, mechanical strength (fracture force, bending resistance), and functional aspects (liquid leakage, surface friction).
• Predicate Device Equivalence: The ultimate purpose of the 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device (ClearPetra Suction-Evacuation Sheath K161110) in terms of safety and effectiveness, meaning the subject device performs similarly or better than a device already proven safe and effective.

8. The Sample Size for the Training Set:

This information is not applicable. There is no "training set" for a physical medical device like a Ureteral Access Sheath. Training sets are relevant for machine learning algorithms.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable as there is no training set for this device.

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