(125 days)
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:
| Test Category | Acceptance Criteria/Standard | Reported Device Performance/Compliance |
|---|---|---|
| Biocompatibility | Compliance with ISO 10993-1, ISO 10993-5:2009, ISO 10993-10:2021, ISO 10993-21:2021, ISO 10993-11:2017, and USP 151. (Ensures the device is not harmful when in contact with and within the body). | Tested and Compliant: |
| Cytotoxicity | Meets ISO 10993-5:2009 standards. | |
| Intracutaneous Irritation | Meets ISO 10993-10:2021 standards. | |
| Sensitization | Meets ISO 10993-21:2021 standards. | |
| Acute Systemic Toxicity | Meets ISO 10993-11:2017 standards. | |
| Material Mediated Pyrogenicity | Meets ISO 10993-11:2017 and USP 151 standards. | |
| Performance Testing | Satisfactory performance in key functional aspects. (Ensures the device functions as intended during use). | Tested and Compliant: |
| Dimension | Performance data indicates compliance with specified dimensional requirements for sheaths ranging from 10Fr to 14Fr and lengths from 28cm to 50cm. (Specific values or ranges are not provided in the summary but are implied as meeting expectations). | |
| Compatibility | Performance data indicates compatibility for endoscopic urological procedures, facilitating the passage of endoscopes and other instruments. (Specific compatibility parameters are not detailed but are implied as satisfactory). | |
| Fracture Force | Performance data indicates the device can withstand expected forces without fracture. (Specific force thresholds are not provided but are implied as meeting safety and functional requirements). | |
| Bending Resistance | Performance data indicates appropriate bending resistance for intended use in the urinary tract, including both tip-unbendable and tip-bendable models. (Specific resistance values are not provided but are implied as meeting functional requirements). | |
| Liquid Leakage | Performance data indicates the device is free from liquid leakage, which is crucial for maintaining a sterile and functional conduit. (Specific leakage thresholds are not provided but are implied as meeting functional requirements). | |
| Surface Friction Coefficient | Performance data indicates an acceptable surface friction coefficient, important for smooth insertion and removal and minimizing tissue trauma. (Specific coefficient ranges are not provided but are implied as meeting functional requirements). | |
| Sterilization Validation | Compliance with ISO 11135:2014, ISO 11737-1:2018, ISO 11737-2:2019, ISO 10993-7:2008. (Ensures the device is sterile and free from harmful residual sterilant). | Tested and Compliant: Validated for Ethylene Oxide (EO) sterilization, ensuring the device is sterile for use and that EO residuals are within safe limits. |
| Shelf Life and Package Validation | Compliance with ISO 11607-1:2019, DIN 58953-6, ASTM F2096-11, ASTM F88/F88M-15, ASTM F1886/F1886M-16, ASTM F1929-15, ASTM D4169-22. (Ensures the sterility and integrity of the device over its shelf life and during transport). | Tested and Compliant: Validated to maintain sterility and device integrity throughout its claimed shelf life, with packaging designed to protect the device and indicate damage. (Specific shelf life duration not mentioned, but validation confirms it meets criteria). |
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.
§ 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.