Search Results

The Signal Catheter is a 16 French, 2-way silicone Foley catheter, designed to be inserted into the bladder through the urethra to drain urine. The unique signal balloon included in the catheter hub is designed to inflate during excessive pressure in the retention balloon. This typically occurs when the retention balloon is constricted and cannot be inflated at the nominal inflation pressure of the catheter. In this case, the signal balloon inflates to alleviate the fluid and resulting pressure in the retention balloon.

AI/ML Overview

The Signal Catheter is a medical device for urological bladder drainage. Based on the provided 510(k) summary, here's an analysis of its acceptance criteria and the supporting study information:

1. A table of acceptance criteria and the reported device performance:

The document acts as a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than explicitly stating acceptance criteria and direct performance metrics in a readily quantifiable "reported device performance" table format for a novel performance claim. However, it does indicate the studies performed and their objectives. The "acceptance criteria" here are implicitly linked to compliance with recognized standards and successful demonstration of substantial equivalence.

Acceptance Criteria (Implied)	Reported Device Performance (Summary)
Biocompatibility: Meet biological safety standards for patient-contacting materials.	Patient contacting material was subjected to biocompatibility testing according to the recommendations of ISO 10993-1. (Implies successful completion and meeting the standard's requirements, as it supports substantial equivalence).
Dimensional Verification: Conform to design specifications.	Performance testing included dimensional verification. (Implies successful verification that dimensions are as designed and comparable to predicate, as it supports substantial equivalence).
Functional and Performance Testing: Device operates as intended, particularly its unique "signal balloon" mechanism to alleviate pressure.	Performance testing included functional and performance testing. The "signal balloon" in the catheter hub inflates during excessive pressure in the retention balloon, alleviating fluid and pressure. This technological characteristic underwent testing to ensure substantial equivalence. (Implies that the mechanism functions as designed and demonstrates comparable performance to predicates in terms of function).
Compliance to ASTM F623: Meet standard performance specifications for Foley Catheters.	Performance testing showed compliance to ASTM F623 Standard Performance Specification for Foley Catheter requirements. (Implies successful adherence to all relevant criteria within this standard).
Compliance to EN 1616: Meet standards for sterile urethral catheters for single use.	Performance testing showed compliance to EN 1616 Sterile urethral catheters for single use. (Implies successful adherence to all relevant criteria within this standard).
Overall Safety and Effectiveness: Does not raise new issues of safety or effectiveness compared to predicates.	The results of these tests indicate that the Signal Catheter is substantially equivalent to the predicate devices. "Based on the testing performed... it can be concluded that the subject device does not raise new issues of safety or effectiveness compared to the predicate devices." (This is the overarching conclusion based on all non-clinical tests).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document primarily describes non-clinical (bench) testing. For such tests, the concept of "sample size for the test set" is usually described in terms of the number of tested devices or batches, which is not explicitly provided in this summary. The data provenance (country of origin, retrospective/prospective) is not applicable or provided for these types of non-clinical tests in this summary.

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 applicable to the non-clinical (bench) testing described. "Ground truth" established by experts is typically relevant for clinical studies or studies involving diagnostic accuracy, which were not performed here.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable to the non-clinical (bench) testing described. Adjudication methods are usually used in clinical studies for disagreement resolution among expert readers.

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 such study was done or is referenced. This device is a catheter, not an AI-powered diagnostic tool, so MRMC studies involving human readers and AI assistance are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical medical device (catheter), not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical tests performed:

Biocompatibility: The "ground truth" is compliance with ISO 10993-1, which is a recognized international standard based on established scientific principles for biological evaluation.
Dimensional Verification: The "ground truth" is the engineering design specifications and possibly comparative measurements to predicate devices.
Functional and Performance Testing: The "ground truth" is the designed functional specification of the device (e.g., the signal balloon inflates under specific pressure conditions) and compliance with performance standards like ASTM F623 and EN 1616. These standards themselves define the "ground truth" for acceptable performance.

8. The sample size for the training set

Not applicable. This device is a physical medical device, not a machine learning algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable, as no training set was used.

Ask a Question

Ask a specific question about this device

Page 1 of 1