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The Disposable Ureteral Access Sheath is used to establish a continuous conduit during urological endoscopic procedures facilitating the in and out passage of endoscopes and other instruments into the urinary tract.

The proposed device, Disposable Ureteral Access Sheath is used to establish a continuous conduit during urological endoscopic procedures facilitating the in and out passage of endoscopes and other instruments into the urinary tract.

This device is divided into five types:

• Z type Straight joint access sheath
• Y type negative suction Y joint access sheath
• W type negative suction W joint access sheath
• T type Straight joint access sheath
• C type negative suction W joint access sheath

This product consists of access sheath and dilator tube. The access sheath tube consists of access sheath tube body and access sheath joint. The surface of access sheath tube is coated with polyvidone (PVP). The dilator tube consists of dilator tube body and dilator tube connector. The access sheath tube body is made from nylon (PA), stainless steel and polytetrafluoroethylene (PTFE). The access sheath joint is made from polycarbonate (PC), acrylonitrile-butadiene-styrene copolymer (ABS) and silicone. The dilator tube body and dilator tube connector are made from PE.

The proposed devices are sterilized by Ethylene Oxide Gas to achieve a SAL of 10-6 and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of 3 years.

Based on the provided FDA 510(k) clearance letter for the Disposable Ureteral Access Sheath (K243710), the device is cleared based on non-clinical performance and biocompatibility testing, demonstrating substantial equivalence to a predicate device. There is no information about a study involving human readers or AI assistance.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" alongside specific numerical "reported device performance" values for each criterion. Instead, it lists the types of performance tests conducted and states that the results "met the standard requirements" or that certain characteristics "shall not exceed" or "shall not be less than" a specified value, implying these are the acceptance criteria.

Implied Acceptance Criteria and Performance (Based on "Comparison of Technological Characteristics" and "Non-Clinical Testing" sections):

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

• Sample Size: The document does not specify the exact sample sizes for each non-clinical performance test. It only lists the types of tests performed.
• Data Provenance: The testing was conducted as part of the regulatory submission by Shenzhen Trious Medical Technology Co., Ltd. The document refers to "Performance testing" and "Biocompatibility testing," which are typically done in a controlled laboratory setting. It does not mention retrospective or prospective data in the context of human studies for this device. The manufacturer is based in Shenzhen, China.

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

This request is not applicable to the provided document. The "ground truth" for this device's testing is based on engineering specifications, material science, and established biological safety standards (e.g., ISO and ASTM standards), not on expert clinical interpretation of medical images or data from human patients. Therefore, no human experts (e.g., radiologists) were involved in establishing "ground truth" in the way understood in diagnostic AI/image analysis studies.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods are typically used in clinical studies or expert review processes where there might be disagreements in interpretation (e.g., blinded reads, consensus reads). For non-clinical device performance testing, results are typically objective measurements against predefined specifications.

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. The document explicitly states: "No clinical study is included in this submission." Therefore, no MRMC study or AI assistance evaluation was performed or submitted.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

No. This device is a physical medical instrument (ureteral access sheath), not an AI algorithm or software. Therefore, the concept of "standalone algorithm performance" is not applicable.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

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

• Engineering Specifications: Defined physical dimensions, material properties, and mechanical strengths.
• Standardized Test Methods: Adherence to recognized international and national standards (e.g., ISO 11135, ISO 11737-1, ISO 10993-1 for biocompatibility, various ASTM standards for material properties). These standards define how performance is measured and what constitutes acceptable limits.
• Biocompatibility Definitions: Established biological responses to materials as defined by ISO 10993-1.

8. The Sample Size for the Training Set

Not applicable. This is a physical device, not an AI model or software that requires a training set.

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

Not applicable, as there is no training set for a physical device.

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The Disposable 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 product is composed of sheath tube, sheath tube base, dilator and center base of dilator. The sheath tube base contains a backwater interface. The center base of dilator consists of upper cover of dilator base, lower cover of dilator base , fiber image channel interface F, irrigation channel interface I, equipment channel interface E, obturator, two-way water valve, needle free joint. There is no guide wire. The product is sterilized by EO, it should be sterile and only for single use.

This document describes the premarket notification (510(k)) for the Disposable Ureteral Access Sheath by YouCare Technology Co., Ltd. (Wuhan). The submission aims to demonstrate substantial equivalence to a predicate device, K151084 Well Lead Ureteral Access Sheath.

No human-in-the-loop or standalone AI performance studies were conducted or are mentioned in this submission, as this device is a physical medical instrument, not an AI/software device. The "acceptance criteria" discussed here refer to the performance standards and material safety criteria for the physical device, rather than the performance of an AI algorithm.

1. A table of acceptance criteria and the reported device performance:

2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

The document does not specify exact sample sizes for each non-clinical test conducted (e.g., number of devices tested for bending resistance, friction, etc.). The non-clinical tests were conducted to assess the intrinsic properties of the device, likely a representative sample of manufactured units.

The data provenance is from YouCare Technology Co., Ltd. (Wuhan), China. The tests are non-clinical (laboratory/bench testing) and thus not applicable to retrospective or prospective human patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable as the device is a physical medical instrument, and the testing involves non-clinical performance and material safety assessments, not an AI or diagnostic algorithm requiring expert "ground truth" establishment for image interpretation or similar.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This information is not applicable for the same reasons as point 3. Testing involves objective measurements against established technical standards (e.g., tensile strength in Newtons, friction coefficients, visual inspection for defects after bending).

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:

This information is not applicable as the device is a physical medical instrument, not an AI/software device. No MRMC study was conducted or mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This information is not applicable as the device is a physical medical instrument, not an AI/software device. No standalone algorithm performance was assessed.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for this device's performance is based on established engineering standards, material specifications, and regulatory guidelines for mechanical properties, material biocompatibility, sterility, and physical dimensions. For example, testing for "Peak tensile force" has a "ground truth" defined as "not less than 15N." Biocompatibility is assessed against ISO 10993 standards.

8. The sample size for the training set:

This information is not applicable as the device is a physical medical instrument, not an AI/software device. There is no concept of a "training set" in the context of this 510(k) submission.

9. How the ground truth for the training set was established:
This information is not applicable for the same reasons as point 8.

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The Ureteral Access Sheath is intended to use in urologic endoscopic procedures to facilitate the passage of endoscopes.

The Disposable Ureteral Access Sheath is one single use device, which is provided after EO sterilization. The shelf life of Disposable Ureteral Access Sheath is 3(three) years. The Disposable Ureteral Access Sheath consists of two major components: sheath assembly and dilator assembly. Sheath assembly consists of sheath hub, the dilator assembly consists of dilator, dilator hub and dilator clip. And there is a hydrophilic coating on the surface of the sheath and dilator. The Disposable Ureteral Access Sheath is designed to provide the physician with reliable access to the urinary tract, the ability to inject fluids, and act as a conduit for device changes. Like all ureteral access sheath sets, Beyo's Disposable Ureteral Access Sheath also protects the ureter during device exchanges, thus helping reduce tissue trauma. Both the dilator and sheath are radiopaque and have a lubricous hydrophilic coating. To guide the access sheath into the body orifice, the dilator is advanced over up to a 0.038" guidewire. The device can be visualized under X-ray(fluoroscopy) during placement to confirm location. The device can accept other urological instruments with OD's compatible with the sheath's OD of 10,12 and 14 Fr. The device has two assemblies, sheath assembly and dilator assembly, the two assemblies are combined through dilator clip, the dilator can insert and withdrawn easily from sheath, The dilator assembly can be fixed on the sheath assembly.

The provided text describes a 510(k) summary for a Disposable Ureteral Access Sheath, not a medical device that uses AI or machine learning. Therefore, the document does not contain information regarding acceptance criteria and study data for an AI/ML powered medical device.

The information I can extract pertains to the acceptance criteria for the physical ureteral access sheath device and how its performance was tested to establish substantial equivalence to a predicate device.

Here's a breakdown of what is available in the document, which primarily focuses on non-clinical performance testing for a physical device:

Acceptance Criteria and Device Performance (for a physical ureteral access sheath)

1. Table of Acceptance Criteria and Reported Device Performance:

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