(111 days)
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 ReTrace Ureteral Access Sheath is a sterile, single use device that is inserted over a guidewire into the upper or lower urinary tract of patients requiring ureteroscopic procedure sin a hospital environment. The ReTrace Ureteral Access Sheath consists of:
- Reinforced tube/sheath
- Introducer/dilator
- Connector
- Clip
The reinforced polymeric introducer sheath includes a hydrophilic coating on the exterior and a lubricious inner surface. The sheath is reinforced to provide kink resistance. The distal tip of the sheath is fitted with a radiopaque ring. A white connector is fitted on the proximal end of the sheath and an orange connector is on the proximal end of the introducer to allow the two components to be attached.
The dilator is fitted with a Luer connector on the proximal end and has a hydrophilic coating on the distal end. A guidewire entry and exit eye and exit holes for fluid delivery are located at the distal end of the introducer. The dilator protrudes out the distal end and allows for a gradual enlargement of the passage if needed and improves trackability along the guidewire. Once in the desired location, the dilator is removed to establish a hollow conduit for insertion of endoscopes and other instruments into and out of the urinary tract.
The ReTrace Ureteral Access Sheaths are available in two diameters 10/12 Fr and 12/14 Fr. Lengths range between 28 and 55 cm.
This submission is for modifications to device materials, labeling, packaging, and connector design.
Here's a breakdown of the acceptance criteria and study information based solely on the provided text.
Crucial Note: The provided document is a 510(k) summary for a medical device (Ureteral Access Sheath) that underwent modifications. This means the primary argument for clearance is substantial equivalence to a previously cleared predicate device, rather than proving efficacy from scratch with a new device. Therefore, the details requested in your prompt regarding AI/ML models (e.g., training/test sets, human reader studies, ground truth establishment by experts) are generally not applicable to this type of device clearance. The performance data focuses on demonstrating that the modifications do not negatively impact the device's basic safety and function compared to the original cleared version.
Acceptance Criteria and Reported Device Performance
Given this is a 510(k) for a modified device, the "acceptance criteria" are implicitly that the modified device performs comparably to the predicate device in relevant mechanical, biocompatibility, and sterilization tests, and the modifications do not raise new questions of safety or effectiveness. The reported performance is that the device met these criteria.
| Acceptance Criteria (Implied for Device Modification) | Reported Device Performance (Summary) |
|---|---|
| Biocompatibility: Meets established standards (ISO 10993-1). | "Biocompatibility testing was conducted based upon ISO 10993-1 (2018)... Meets Standard." |
| Mechanical Performance: Maintains integrity and functionality as per design specifications. | "Mechanical testing was completed in support of the substantial equivalence determination and changes to the product line." This includes: Visual Inspection, Dimensional Inspection, Viscous fluid test, Simulated use test, Compatibility with accessories, Compatibility with Solutions, Peelability test, Tensile strength on introducer, Tensile strength between introducer and luer, Tensile strength between connector and sheath, Folding resistance on sheath, Radiopacity test on introducer, Friction test on sheath, Friction test on introducer tip, No perforation test, Tip flexibility, Nitinol tube compression / position. |
| Sterilization Efficacy: Achieves a Sterility Assurance Level (SAL) of 10⁻⁶. | "The ReTrace Ureteral Sheaths are sterilized using ethylene oxide in a validated cycle demonstrating a microbial assurance level of 10⁻⁶." |
| Packaging Integrity: Maintains sterility and product integrity through shelf life. | "Packaging testing included dye penetration testing, peel strength, peelability and visual inspection including through five year simulated accelerated aging." |
| Shelf Life: Supports a 5-year shelf life. | "Shelf life testing to support 5 years." (Across various tests) |
Study Details (Based on Provided Text)
-
Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a number of devices for each test. The document lists types of mechanical tests performed (e.g., tensile strength, friction tests) which implicitly involve testing multiple samples, but the exact quantity is not given.
- Data Provenance: Not specified regarding country of origin. The studies are non-clinical testing (mechanical, biocompatibility, sterilization, packaging) and not human subject data. Thus, the concept of "retrospective or prospective" human data does not apply here.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This document describes the clearance of a physical medical device (Ureteral Access Sheath) through non-clinical performance testing for substantial equivalence after modifications. It is not an AI/ML device that requires expert-established ground truth for a test set. The "ground truth" for these tests is defined by the technical specifications, standards (like ISO 10993-1), and acceptable performance parameters for the device.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. Again, this pertains to expert review of data, typically in AI/ML performance studies. Here, the "adjudication" is whether the device passed specific engineering and performance tests, which would be determined by laboratory results and quality system procedures, not expert consensus on ambiguous data.
-
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. This type of study (MRMC, human readers with/without AI) is specifically for AI-powered diagnostic/interpretive devices. The Retrace Ureteral Access Sheath is a physical, mechanical medical device.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical device, not an algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance testing is defined by engineering specifications, industry standards (e.g., ISO 10993-1), and established test methodologies to ensure the device's physical and functional properties meet design requirements and maintain equivalency to the predicate device.
-
The sample size for the training set:
- Not Applicable. This is not an AI/ML device with a training set.
-
How the ground truth for the training set was established:
- Not Applicable. As above, no training set for an AI/ML model.
Summary of why AI/ML related questions are not addressed:
The provided text is a 510(k) summary for a physical, mechanical medical device (a Ureteral Access Sheath) that underwent modifications. The FDA clearance pathway for such devices, especially when arguing substantial equivalence, relies heavily on non-clinical performance testing (biocompatibility, mechanical integrity, sterilization validation, packaging) to demonstrate that the device is as safe and effective as a legally marketed predicate device. It does not involve AI/ML components, diagnostic interpretation, or human reader studies. Therefore, many of the questions asked in your prompt are not relevant to the content of this specific FDA submission.
§ 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.