(95 days)
The Disposable Ureteral Guide Sheath is used to establish a conduit during endoscopic urological procedures facilitating the passage of endoscopes and other instruments into the urinary tract
The propose device, Disposable Ureteral Guide Sheath is used to establish a conduit during endoscopic urological procedures facilitating the passage of endoscopes and other instruments into the urinary tract. This device is divided into 4 types: Straight type (ZSR-UA), Y type (ZSR-UAY), W type (ZSR-UAW), Cross type (ZSR-UAC). The device is composed of guide sheath and dilator.The guide sheath consists of guide sheath tube and connector (straight, Y-shaped, W-shaped and cross-shaped). 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.
The provided text describes the 510(k) premarket notification for a medical device called the "Disposable Ureteral Guide Sheath." It primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance and biocompatibility testing. The document does not detail a study proving the device meets acceptance criteria related to AI/algorithm performance or human reader improvement.
Therefore, I cannot provide information on acceptance criteria for AI performance, sample sizes for AI test sets, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment for AI. These sections are not relevant to the provided text.
However, I can extract information regarding the non-clinical performance testing acceptance criteria and results as described in the document.
1. Table of Acceptance Criteria and Reported Device Performance
For non-clinical performance testing, the document refers to compliance with standards. The 'Discussion' section under 'Comparison of technological characteristics with the predicate devices' (Table 1) provides some insight into the performance aspects considered, although explicit numerical acceptance criteria are not always stated, rather the outcome of testing.
| Acceptance Criteria Category | Specific Test/Characteristic | Acceptance Criteria (Implicit from discussion) | Reported Device Performance (Implicit from discussion) |
|---|---|---|---|
| Performance - Bending Resistance | Guiding sheath tube and dilating tube bending (90° in both directions, 20 repetitions) | Tube body free of cracks, creases, and fractures; coating free of falling off; steel wire not separated from inner/outer rubber layers. | "The guiding sheath tube and the dilating tube were bent 90 ° in both directions... After 20 times of repetition, the tube body was free of cracks, creases, cracks and fractures, the coating was free of falling off, and the steel wire was not separated from the inner and outer rubber layers." (Meets criteria) |
| Performance - Coefficient of Friction (Hydrophilic) | After dipping in water, friction force | Not more than 0.5 N for static friction; average dynamic friction force of 25 repeated tests not greater than 0.5 N. | "After being dipped in water, the surface is smooth, and the friction force is not more than 0.5 N; The average dynamic friction force of 25 repeated tests shall not be greater than 0.5 N." (Meets criteria) |
| Performance - Peak Tensile Force | Joint between guiding sheath tube/dilating tube and connector | Able to bear a force of ≥ 20 N for 15s without breaking. | "The joint between the guiding sheath tube and the tube body of the dilating tube and the connector shall be able to bear a force of ≥ 20 N and shall not break for 15 s;" (Meets criteria) |
| Performance - Fracture Force (Locked connector) | Guiding sheath tube connector and expansion tube connector locked | Minimum fracture force ≥ 15N for 15s without breaking. | "The fracture force test shall be carried out when the guiding sheath tube connector and the expansion tube connector are locked. The minimum fracture force shall be ≥ 15N and shall not break for 15 s." (Meets criteria) |
| Biocompatibility | Cytotoxicity, Sensitization, Irritation, Acute Systemic, Pyrogenicity | Compliance with ISO 10993-1. | "Biocompatibility of the Disposable Ureteral Guide Sheath was evaluated in accordance with the FDA guidance "Use of International Standard ISO 10993-1"" and lists the specific tests. Implies successful completion ("this difference will not raise any issues in safety and effectiveness"). |
| Sterility & Shelf-life | Sterility Assurance Level (SAL), Packaging Integrity | SAL of 10-6 upon sterilization; maintenance of sterility for 3 years shelf life. | "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." (Meets criteria) |
| General Performance | Overall performance for all physical characteristics not explicitly detailed above | Meets requirements of relevant standards (e.g., EN 1618 for catheters). | "All performance of the subject device has been tested according to relevant standards and meets the requirements of the standards..." |
2. Sample Size Used for the Test Set and Data Provenance
This document describes non-clinical engineering and bench testing, not a clinical study involving a "test set" of patient data in the way an AI/ML device would.
- Sample Size: Not explicitly stated as a grand total for testing. For specific tests like "Coefficient of Friction," it mentions "25 repeated tests." For "Bending Resistance," it mentions "20 times of repetition."
- Data Provenance: This is bench test data, not patient data. The country of origin for the manufacturing company is Dongguan ZSR Biomedical technology Company Limited, China. The testing would have been conducted as part of their device development and validation process. It is neither retrospective nor prospective in the context of patient data studies; it's product validation testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is not a study involving expert readers establishing ground truth for diagnostic accuracy, but rather bench testing against engineering specifications and industry standards.
4. Adjudication Method for the Test Set
Not applicable. This is not a study involving human interpretation or clinical adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. This document does not pertain to an AI-assisted diagnostic device, nor does it describe an MRMC study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No. This document does not pertain to an algorithm, AI, or software device. It is for a physical medical device.
7. The Type of Ground Truth Used
The "ground truth" for the performance testing described would be the engineering specifications and industry standards (e.g., specific force values for tensile strength, visual inspection for defects after bending, a defined Sterility Assurance Level). For biocompatibility, the 'ground truth' is compliance with the ISO 10993 series of standards.
8. The Sample Size for the Training Set
Not applicable. This is for a physical device, not an AI/ML algorithm requiring a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. There is no training set for this type of 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.