(138 days)
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:
| Acceptance Criteria | Reported Device Performance (YouCare Disposable Ureteral Access Sheath) | Predicate Device (Well Lead Ureteral Access Sheath) | Conclusion on Equivalence |
|---|---|---|---|
| Intended Use | To establish a conduit during endoscopic urological procedures facilitating the passage of endoscopes and other instruments into the urinary tract. | To establish a conduit during endoscopic urological procedures facilitating the passage of endoscopes and other instruments into the urinary tract. | Same |
| Regulation # | 21 CFR § 876.1500 | 21 CFR § 876.1500 | Same |
| Product Code | FED | FED | Same |
| Classification Name | Endoscope and accessories | Endoscope and accessories | Same |
| Regulatory Class | Class II | Class II | Same |
| Sterility | Yes | Yes | Same |
| Sterilization Method | EO | EO | Same |
| Single Use | Yes | Yes | Same |
| Biocompatible | Yes (Passed Cytotoxicity, Sensitization, Intracutaneous reactivity, Material mediated pyrogenicity, Acute systemic toxicity tests per ISO standards). | Yes | Same |
| Shelf Life | 3 years | 3 years | Same |
| Bending Resistance | Bending any section of the dilator, sheath tube or the assembly of sheath tube and dilator into a ring with a radius of 5cm for 1min, there should be no crease, crack or other undesirable phenomena. | Bending any section of the dilator, sheath tube or the assembly of sheath tube and dilator into a ring with a radius of 5cm for 1min, there should be no crease, crack or other undesirable phenomena. | Same |
| Coefficients of Friction | When the sheath tube is tested for friction, the friction coefficient shall not exceed 0.03. | When the sheath tube is tested for friction, the friction coefficient shall not exceed 0.03. | Same |
| Peak Tensile Force | The peak tensile force of the sheath tube and dilator should not be less than 15N. And the peak tensile force of the junction between sheath tube and sheath tube base, the dilator and center base of dilator also shall meet the requirement. | The Dilator to Hub Tensile Strength > 15N. | Same |
| Additional Performance Tests | Determining the Dimensions, Flow test, Patency, Connection, Luer taper (Details of specific thresholds/results not provided beyond "passed"). | (Implied to meet similar functional performance based on equivalence claim, specific thresholds not detailed in this excerpt for predicate) | (Implied) |
| Sheath ID | 12Fr | 10Fr, 12Fr, 14Fr | Different 1 (Considered not to raise different questions of safety/effectiveness as physicians select based on patient condition). |
| Sheath length | 45cm, 35cm | 13cm, 20cm, 28cm, 35cm, 45cm, 55cm | Different 2 (Considered not to raise different questions of safety/effectiveness as physicians select based on patient condition). |
| Primary Structure | Composed of sheath tube, sheath tube base, dilator and center base of dilator. Sheath tube base contains a backwater interface. Center base of dilator consists of upper/lower cover, fiber image channel interface F, irrigation channel interface I, equipment channel interface E, obturator, two-way water valve, needle free joint. | Comprised of three components: sheath, dilator and connector. Outer surface of the sheath has a hydrophilic coating. | Different 3 (Considered not to raise different questions of safety/effectiveness, only increases operation requirements for doctors). |
| Materials | Sheath tube: Pebax6333 SA01 MED, SUS 304, PTFE, PAM. Sheath tube base: ABS, PC. Dilator: LDPE. Center base of dilator components: ABS, PC, silica gel, POM. | Sheath Tube: PTFE, Nylon (PA), stainless steel. Outer surface: Nylon (PA). Inner surface: PTFE. Dilator: Polyethylene (PE). | Different 4 (Pebax6333 has properties of nylon; both passed biological tests, hence not raising new questions of safety/effectiveness). |
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.
§ 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.