(36 days)
The Fossa Ureteral Open Lumen Stent is indicated for use as an indwelling ureteral catheter to promote drainage of urine from the kidney to the bladder.
The Fossa Ureteral Open Lumen Stent set consists of a flexible, pigtail-tipped stent with: "Pusher." and optional pre-attached suture to facilitate stent removal. The stent is offered in various diameters and working lengths. The stent has two lumens open to the outside of the stent.
The provided text describes the 510(k) submission for the Fossa Ureteral Open Lumen Stent. However, it does not contain detailed information about specific acceptance criteria or an explicit study proving performance in the context of device accuracy, sensitivity, or specificity, as would be typical for AI/ML-based diagnostic devices.
The document states that the submission is a "Special 510(k): Device Modification" and relies on compliance with design control requirements and risk analysis. The performance testing conducted is primarily related to physical and mechanical properties of the stent, rather than clinical performance metrics.
Therefore, for many of the requested points, the information is not present in the provided text.
Here's a breakdown of the available and missing information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Explicitly Stated in Document) | Reported Device Performance (Explicitly Stated in Document) |
|---|---|
| Dimensional inspection (Physical dimensions) | Compliance with design specifications (implied by "certification of compliance to 21 CFR 820.30 Design Control requirements") |
| Elongation/yield strength testing | Met design requirements (implied) |
| Tensile strength testing | Met design requirements (implied) |
| Guidewire passage evaluation | Met design requirements (implied) |
| Compression strength | Met design requirements (implied) |
| Flow rate analysis | Met design requirements (implied) |
| Clinical Performance (e.g., sensitivity, specificity, accuracy) | Not provided or applicable for this type of device modification. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: Not specified. The testing mentioned appears to be bench testing on physical device samples, not a clinical test set with patient data.
- Data provenance: Not applicable, as no clinical data or test set with patient data is described.
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)
- Not applicable. Ground truth as typically defined for diagnostic or AI devices (e.g., true disease presence) is not relevant for this type of stent modification and its associated physical performance testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. There is no mention of clinical data requiring expert 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
- No. An MRMC study is not mentioned as this is a physical medical device (stent), not an AI diagnostic tool involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the physical performance testing would be the pre-defined engineering specifications and standards for each test (e.g., a specific tensile strength value that must be met).
8. The sample size for the training set
- Not applicable, as this is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established
- Not applicable, as this is not an AI/ML device requiring a training set.
Summary of what the document focuses on:
The provided document describes a Special 510(k) for a device modification (Fossa Ureteral Open Lumen Stent). The key aspects of the submission are:
- Compliance with Design Control: Fossa Medical certified compliance with 21 CFR 820.30 Design Control requirements.
- Risk Analysis: A description of the internal Risk Analysis procedure was provided.
- Performance Testing (Benchtop/Physical): Performance testing included:
- Dimensional inspection
- Elongation/yield strength testing
- Tensile strength testing
- Guidewire passage evaluation
- Compression strength
- Flow rate analysis
- Comparison to Predicate Devices: The device was deemed substantially equivalent to the Fossa Ureteral Stone Sweeper (K031292) and Fossa Double Pigtail Expanding Ureteral Stent (K021140) based on indications for use, technological characteristics, and the aforementioned performance testing.
The document emphasizes that based on these points, the device was shown to be safe and effective for its intended use as an indwelling ureteral catheter.
§ 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.