(91 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 Re-Trace Ureteral Access Sheath 10/12 Ch/Fr & Ureteral Access Sheath are line extensions of the Re-Trace Ureteral Access Sheath 12/14 Ch/Fr. All these devices comprise the following components:
- Reinforced tube/sheath .
- Introducer/dilator .
- Connector .
- Clip .
The only design addition to the 10/12 Ch/Fr reinforced tube/sheath compared to the 12/14 Cly/Fr sheath is the presence of a reinforcing Stainless Steel ring at the distal tip.
For the Ureteral Access Sheath, the introducer/dilator also only has a guidewire entry eye at the distal tip compared with guidewire entry and exit eyes and three exit holes for fluid delivery on the Re-Trace Ureteral Access Sheath introducer/dilator.
Apart from these modifications, all the Re-Trace Ureteral Access Sheath & Ureteral Access Sheath range is very similar in design.
The provided text describes a 510(k) summary for the Re-Trace Ureteral Access Sheath. It outlines the device's description, intended use, and a comparison to predicate and reference devices for establishing substantial equivalence. However, it does not include the detailed information requested regarding specific acceptance criteria, study methodologies for device performance, ground truth establishment, or human-in-the-loop studies.
This submission is for a medical device (Ureteral Access Sheath) which is typically evaluated through non-clinical performance testing and biocompatibility. The type of "acceptance criteria" and "study" described in the input prompt (e.g., sample size, ground truth, expert consensus, MRMC studies) are characteristic of studies evaluating diagnostic accuracy or clinical effectiveness for devices that generate data (like AI/ML algorithms). The Re-Trace Ureteral Access Sheath is a physical medical instrument, not a diagnostic or AI device.
Therefore, the requested information cannot be fully extracted from the provided text for this specific device.
Based on the provided text, here's what can be inferred and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Performance: | |
| Sheath/introducer/ component break force testing | Successful completion compared to predicate device |
| Friction testing | Successful completion compared to predicate device |
| Kink resistance testing | Successful completion compared to predicate device |
| Injection testing | Successful completion compared to predicate device |
| Guidewire pullout force testing | Successful completion compared to predicate device |
| Packaging testing | Successful completion compared to predicate device |
| Biocompatibility: | |
| ISO 10993 (Biocompatibility) | Successful completion on the Re-Trace Ureteral Access Sheath |
2. Sample size used for the test set and the data provenance:
- Not Applicable / Not Provided: The submission describes non-clinical performance testing and biocompatibility testing, not a clinical study involving a "test set" of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable / Not Provided: Ground truth as described (e.g., expert consensus on medical images) is not relevant to the non-clinical performance and biocompatibility testing performed for this physical device.
4. Adjudication method for the test set:
- Not Applicable / Not Provided: As there is no "test set" in the context of diagnostic accuracy, there is no adjudication method described.
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:
- Not Applicable / No: This device is a physical medical instrument, not an AI/ML diagnostic or assistive device. An MRMC study is not relevant to its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable / No: This device is not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not Applicable / Not Provided: For the performance tests, the "ground truth" would be engineering specifications and standards for device functionality and material integrity. For biocompatibility, it's compliance with ISO 10993 standards.
8. The sample size for the training set:
- Not Applicable / Not Provided: There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established:
- Not Applicable / Not Provided: There is no "training set" for this type of device.
In summary: The provided document is a 510(k) summary for a physical medical device (Ureteral Access Sheath), not a diagnostic device or an AI/ML product. The evaluation focuses on non-clinical performance testing (e.g., break force, friction, kink resistance) and biocompatibility to demonstrate substantial equivalence to a predicate device. The questions in the prompt, while relevant for AI/ML or diagnostic devices, do not directly apply to the information presented for this type of product.
§ 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.