(130 days)
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):
| Acceptance Criteria (Implied) | Reported Device Performance (Summary) |
|---|---|
| Whole Device | |
| Appearance | Met requirements (implied by "Performance testing") |
| Dimension | Met requirements (implied by "Performance testing") |
| Access Sheath Tube | |
| Liquid leakage | Met requirements (implied by "Performance testing") |
| Peak tensile force | ≥ 15 N (at tube body, and at union of tube body and joint) |
| Friction coefficient | ≤ 0.03 |
| Toughness | Met requirements (implied by "Performance testing") |
| Resistance To Flattening | Met requirements (implied by "Performance testing") |
| Dilator Tube | |
| Strength of union of the dilator tube connector and dilator tube | Met requirements (implied by "Performance testing") |
| Resistance to flexing | Met requirements (implied by "Performance testing") |
| Compatibility | Met requirements (implied by "Performance testing") |
| Trafficability | Met requirements (implied by "Performance testing") |
| Dilator Tube Connector | Met requirements (implied by "Performance testing") |
| Biocompatibility | |
| Cytotoxicity | Met requirements (in accordance with ISO 10993-1) |
| Sensitization | Met requirements (in accordance with ISO 10993-1) |
| Irritation | Met requirements (in accordance with ISO 10993-1) |
| Acute Systemic Toxicity | Met requirements (in accordance with ISO 10993-1) |
| Pyrogenicity | Met requirements (in accordance with ISO 10993-1) |
| Sterility & Shelf-life | |
| Sterility Assurance Level (SAL) | 10^-6 (achieved via EO sterilization) |
| Shelf Life | 3 years (maintained sterility) |
| Bending Resistance | No deformations, cracks, folding, or other defective phenomena after 5cm radius bend for 1min |
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.
§ 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.