(63 days)
The ReTrace Ureteral Access Sheath is used 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 comprised of the following components: 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 and orange clip is fitted on the proximal end of the sheath. The introducer 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. This submission expands the product line to include 28 cm long and 55 cm long sheaths with inner diameters of 10 and 12 Fr.
The provided text describes a 510(k) premarket notification for a medical device, the ReTrace Ureteral Access Sheath. This specific submission is for an expansion of the product line, including new lengths and diameters of the existing device.
Based on the information provided, this document does not contain the details of a study that proves the device meets specific acceptance criteria in the manner requested by the prompt. The submission is a "Special 510(k) Summary" which aims to demonstrate substantial equivalence to previously cleared predicate devices (K140523 and K123675) for new sizes of the ReTrace Ureteral Access Sheath, rather than presenting a de novo clinical study with specific acceptance criteria related to accuracy, sensitivity, or specificity.
Therefore, many of the requested sections about acceptance criteria, device performance, sample sizes, ground truth establishment, expert involvement, and MRMC studies are not applicable to the content of this document.
However, I can extract the information related to the device's mechanical and sterilization testing which serves as "performance data" in the context of this 510(k) submission for demonstrating substantial equivalence.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in the format of a clinical trial (e.g., sensitivity > X%, specificity > Y%). Instead, it lists mechanical tests performed to ensure the new device variations maintain equivalence to the predicate devices. The "reported device performance" is essentially that these tests were completed successfully and support substantial equivalence.
| Test Category | Specific Test / Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Mechanical Testing | Visual | Conformance to visual specifications | Completed (implies conformance) |
| Dimensional verification | Conformance to specified dimensions (10/12 Fr ID, 28/55 cm L) | Completed (implies conformance) | |
| Guidewire pullout force | Maintain appropriate force for safe use | Completed (implies satisfactory performance) | |
| Device integrity and functionality | Device remains intact and functions as intended | Completed (implies satisfactory performance) | |
| Simulated use | Performs as expected in simulated surgical environment | Completed (implies satisfactory performance) | |
| Viscous fluid | Maintains patency and allows passage of viscous fluid | Completed (implies satisfactory performance) | |
| Kink resistance | Resists kinking during use | Completed (implies satisfactory performance) | |
| Shelf life testing to support 5 years | Maintains mechanical and functional properties for 5 years | Completed (supports 5 years shelf life) | |
| Biocompatibility | Biocompatibility | Device materials are biocompatible (no additional testing needed due to predicate) | No additional testing provided, relies on predicate's data |
| Sterilization | Sterilization (Ethylene Oxide - Microbial Assurance) | Sterility Assurance Level (SAL) of 10⁻⁶ | Demonstrated SAL of 10⁻⁶ in a validated cycle |
2. Sample Size Used for the Test Set and Data Provenance:
- The document does not specify sample sizes for the mechanical or sterilization testing. These types of tests typically involve a defined number of units per batch or configuration, but the specific numbers are not disclosed.
- Data Provenance: The tests are conducted internally by the manufacturer (Coloplast A/S, based in Denmark, with a US contact in Minneapolis) as part of their design control and quality system. It is laboratory-based testing, not clinical data from patients.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- This is not applicable as the document describes mechanical and sterilization testing, not studies requiring expert review of patient data to establish "ground truth." The "ground truth" for these tests are objective measurements against engineering specifications.
4. Adjudication Method for the Test Set:
- This is not applicable for mechanical and sterilization testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
- No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No animal studies or clinical testing were provided to support substantial equivalence between the subject and predicate devices." This is a regulatory pathway (510(k)) that, for this specific device and modification, relies on non-clinical data to demonstrate substantial equivalence, not comparative effectiveness.
6. If a Standalone (Algorithm Only Without Human-in-the-loop Performance) Was Done:
- This is not applicable. The device is a physical medical instrument (ureteral access sheath), not an algorithm or AI software. Therefore, there's no "standalone algorithm" performance to assess.
7. The Type of Ground Truth Used:
- The "ground truth" for the mechanical and sterilization testing referenced is based on engineering specifications, international standards, and validated methods for device performance and sterility. For example, a "guidewire pullout force" test would have an engineering specification for the minimum acceptable force, and the test result confirms it meets that specification.
8. The Sample Size for the Training Set:
- This is not applicable as there is no "training set" in the context of an AI/algorithm. The device is a physical medical instrument.
9. How the Ground Truth for the Training Set Was Established:
- This is not applicable as there is no "training set."
Summary of Key Findings from the Document:
The document is a regulatory submission demonstrating substantial equivalence for new sizes of an existing medical device. It relies on non-clinical (mechanical and sterilization) testing to show that the new sizes perform similarly to the predicate devices and do not raise new questions of safety or effectiveness. It explicitly states that no animal or clinical studies were conducted for this specific submission to support substantial equivalence.
§ 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.