(142 days)
The Dornier MAGELLAN Ureteral Access Sheath is indicated for use in endoscopic urology procedures where ureteral dilation and ureteral access is desired for injection of fluids and insertion and removal of endoscopes and related instruments. The target population is for adults only (at least 22 years old).
The Dornier MAGELLAN Ureteral Access Sheath is a two component ureteral dilatation system that provides an open conduit to the upper urinary tract to facilitate Ureteroscopy, which contains a single lumen for injection of fluids as well as passage of endoscopes and related instruments. The packaged product includes a Hydrophilic-coated Dilator with a locking mechanism and a Hydrophilic-coated sheath with hub. The Access Sheath is a sterile, single use, disposable device that allows access to the ureter to facilitate scope and urological tool passage. The Dornier MAGELLAN Ureteral Access Sheaths are constructed of a medical grade thermoplastic elastomer (Pebax®). This material has been USP Class VI tested. All colorants used are compliant with FDA standards.
This FDA 510(k) summary describes the Dornier MAGELLAN Ureteral Access Sheath, a medical device, and its substantial equivalence to a predicate device. As such, it does not detail acceptance criteria and a study that proves the device meets specific performance metrics in the way that an AI/ML device submission would. Instead, the submission focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device through a comparison of characteristics and performance tests.
Here's a breakdown of the requested information based on the provided text, and where certain details are not applicable (N/A) because this is a traditional medical device submission, not an AI/ML B.S.E submission:
Acceptance Criteria and Device Performance
The submission states that the Dornier MAGELLAN Ureteral Access Sheath underwent various performance tests, and "All testing was found to be acceptable and substantially equivalent to those of the predicate device." While specific numerical acceptance criteria are not provided in this summary, the implicit acceptance criterion for each test is that the device's performance must be comparable to, or meet the established benchmarks for, the predicate device.
Table of Acceptance Criteria and Reported Device Performance
| Test Performed | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Sterility | Performance comparable to predicate device / established standards | "All testing was found to be acceptable" |
| Packaging | Performance comparable to predicate device / established standards | "All testing was found to be acceptable" |
| Biocompatibility | Performance comparable to predicate device / established standards | "All testing was found to be acceptable" |
| Radiopacity | Performance comparable to predicate device / established standards | "All testing was found to be acceptable" |
| Sheath ID | Performance comparable to predicate device / established standards | "All testing was found to be acceptable" |
| Dilator OD | Performance comparable to predicate device / established standards | "All testing was found to be acceptable" |
| Sheath Distal Tip ID | Performance comparable to predicate device / established standards | "All testing was found to be acceptable" |
| Dilator Taper length | Performance comparable to predicate device / established standards | "All testing was found to be acceptable" |
| Kink Resistance | Performance comparable to predicate device / established standards | "All testing was found to be acceptable" |
| Assembly Flexibility-3 point bend test | Performance comparable to predicate device / established standards | "All testing was found to be acceptable" |
| Sheath/Hub Tensile | Performance comparable to predicate device / established standards | "All testing was found to be acceptable" |
| Dilator /Hub Tensile | Performance comparable to predicate device / established standards | "All testing was found to be acceptable" |
Study Details
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Sample size used for the test set and the data provenance:
This information is N/A for this type of submission. The performance data section lists the types of tests conducted (e.g., kink resistance, tensile strength), which are typically bench tests or material tests, not clinical studies with patient data. Therefore, there isn't a "test set" in the context of patient data, nor is there data provenance in terms of country of origin or retrospective/prospective in the way an AI/ML device would report it. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is N/A. The "ground truth" for these types of mechanical and material tests is defined by engineering specifications and established test methodologies, not by expert medical interpretation. -
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is N/A. Adjudication methods are relevant for clinical studies where multiple experts evaluate cases that might have ambiguous findings, which is not applicable to the performance tests listed. -
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 N/A. This device is a physical ureteral access sheath, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and the concept of "human readers improving with AI" are not relevant. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is N/A. This is a physical medical device, not an algorithm. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the performance tests described (e.g., sterility, biocompatibility, kink resistance, tensile strength), the "ground truth" is typically based on engineering specifications, material standards, and validated test methods. It's not based on expert medical consensus, pathology, or outcomes data. For example, the ground truth for "kink resistance" would be defined by a specific force or angle at which the sheath begins to kink, as measured by a standardized physical test. -
The sample size for the training set:
This information is N/A. This device does not involve a training set as it is not an AI/ML model. -
How the ground truth for the training set was established:
This information is N/A. This device does not involve a training set or ground truth establishment in the context of AI/ML.
§ 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.