(100 days)
The BackStop Catheter is indicated for use by physicians for facilitating access to the urinary tract, either through a retrograde or antegrade route, and may be used in conjunction with a guidewire or for the injection of fluid into the urinary tract.
The BackStop Catheter is a 100cm, 3F single lumen radiopaque catheter to facilitate access to the urinary tract. The catheter is inserted over a guidewire or through the working channel of an ureteroscope and is progressed through the urinary tract to the desired ureter location. Once in place fluid may be injected via the catheter. The device is a single lumen catheter with a stainless steel braid and a standard female luer lock hub on the proximal end.
The provided text describes the BackStop Catheter and outlines its substantial equivalence to a predicate device based on performance standards and a description of the device itself. However, it does not contain a study that establishes specific acceptance criteria for device performance or provides data on how the device meets those criteria.
Therefore, I cannot provide the requested table, sample sizes, expert qualifications, or details about a comparative effectiveness study.
Here's what I can extract from the provided text about the device and its regulatory submission:
1. A table of acceptance criteria and the reported device performance:
This information is not present in the provided document. The document lists performance standards related to packaging, biological evaluation, and sterilization, which are general manufacturing and safety standards, not specific performance criteria for the device's function (e.g., access facilitation, fluid injection).
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not present in the provided document. The document describes the device and its indications but does not offer any data from a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not present in the provided document. There is no mention of a test set or ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not present in the provided document. There is no mention of any test set or adjudication.
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:
This information is not present in the provided document. The BackStop Catheter is a urological catheter, not an AI-assisted diagnostic or therapeutic device. Therefore, an MRMC study with human readers and AI assistance would not be applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This information is not present in the provided document. As a physical medical device, the concept of "standalone algorithm only" performance does not apply.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
This information is not present in the provided document. No ground truth is mentioned.
8. The sample size for the training set:
This information is not present in the provided document. No training set is mentioned as this is a physical medical device, not an AI model.
9. How the ground truth for the training set was established:
This information is not present in the provided document. No training set or ground truth for it is mentioned.
Summary of what is available in the text:
- Proprietary Name: BackStop Catheter
- Classification Name: Urological Catheters and Accessories
- Common Name: Urological Catheter
- Classification: Class II
- Regulation Number: 876.5130
- Product Code: KOD
- Indications for Use: "The BackStop Catheter is indicated for use by physicians for facilitating access to the urinary tract, either through a retrograde or antegrade route, and may be used in conjunction with a guidewire or for the injection of fluid into the urinary tract."
- Description of Device: "The BackStop Catheter is a 100cm, 3F single lumen radiopaque catheter to facilitate access to the urinary tract. The catheter is inserted over a guidewire or through the working channel of an ureteroscope and is progressed through the urinary tract to the desired ureter location. Once in place fluid may be injected via the catheter. The device is a single lumen catheter with a stainless steel braid and a standard female luer lock hub on the proximal end."
- Performance Standards (General Device Manufacturing/Safety):
- AAMI / ANSI / ISO 11607-1:2006 (Packaging)
- AAMI / ANSI / ISO 10993-1:2003(E) (Biological evaluation)
- AAMI / ANSI / ISO 11137-1:2006 (Sterilization - development, validation)
- AAMI / ANSI / ISO 11137-2:2006 (Sterilization - dose)
- Predicate Device: Imager II Urology Torque Catheter (510(k) Number: K011965)
This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through comparison of indications, technological characteristics, and conformance to recognized safety and manufacturing standards, rather than providing detailed clinical study results with specific performance thresholds.
§ 876.5130 Urological catheter and accessories.
(a)
Identification. A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).(b)
Classification. (1) Class II (performance standards).(2) Class I for the ureteral stylet (guidewire), stylet for gastrourological catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.