Search Results

This product is used for temporary urethral catheterization or indwelling catheterization and bladder irrigation.

The Silicone Foley Catheter uses the pressure of the bladder to excrete urine. The balloon of the catheter can be inflated and fixed the catheter in place after being injected with a sterile liquid. Foley catheter (2-way) can be used for bladder drainage, and Foley catheter (3-way) also can be used for bladder irrigation. Female type Foley Catheter is equipped with the advancer which can be used instead of tweezers during the catheterization. The Silicone Foley Catheter is for single use, is intended for short-term (less than 14 days) use, and is provided with sterile.

The provided text describes a 510(k) premarket notification for a medical device, the Silicone Foley Catheter (K182463). This type of submission aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, rather than proving its safety and effectiveness through extensive clinical trials as an FDA approval would. Therefore, the information typically requested in your prompt (acceptance criteria, specific study designs, sample sizes, expert ground truth, MRMC studies, standalone performance with effect sizes, ground truth types for training and test sets) is generally not present in a 510(k) summary for this type of device.

Instead, the submission focuses on non-clinical testing to demonstrate that the new device performs comparably to the predicate and meets relevant standards.

Here's an analysis based on the provided document, addressing your points where information is available or noting its absence:

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

The document does not explicitly provide a table of acceptance criteria with corresponding device performance metrics in the format you requested for a diagnostic AI device. Instead, it lists various non-clinical tests and states that "Results demonstrate that the device is safe and effective in meeting user requirements in accordance with its intended use."

The non-clinical testing includes:

• Bench testing of functional performance: This would involve testing physical characteristics and function against established standards (e.g., ASTM F623-99(2013), ISO 2859-1:1999, ISO 8536-4:2010, USP). The acceptance criteria would be defined within these standards and company specifications, but these specific criteria and the detailed performance results are not provided in this summary.
• Biocompatibility testing: Compliance with ISO 10993 series (e.g., ISO 10993-3, -5, -6, -9, -10, -11) would set the acceptance criteria for material safety. The results are summarized as meeting requirements.
• Sterilization validation: Compliance with ISO 11135, ISO 11138, ISO 10993-7, ISO 11737 series.
• Shelf life validation: This would involve stability testing over time to ensure the device remains safe and effective (e.g., ASTM F623-99(2013)).
• Simulation Shipment validation: Compliance with ASTM F88, F1929, F1886.

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 provided. For a device like a Foley catheter, "test sets" in the context of diagnostic AI performance studies (as implied by your prompt) are not typically used. The testing would involve physical samples of the catheter for bench, biocompatibility, and sterilization tests. The number of samples for these tests is standard for regulatory submissions but not detailed here.

The document mentions "Clinical Evaluation Report, CER-FC-001(A2)" and "Silicone Foley Catheter Post Market Clinical Follow-Up Study, PMCF-2018-01(A1)". While these suggest some clinical data, the summary does not detail sample sizes, data provenance, or whether this constitutes a "test set" in the diagnostic AI sense.

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 and therefore not provided. For a physical device like a Foley catheter, the concept of "ground truth" established by experts for a test set (as in image interpretation for AI) does not directly apply. Performance is determined by objective physical and biological tests against established standards.

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

This information is not applicable and therefore not provided. Adjudication methods are typically relevant for human interpretation tasks, especially in diagnostic AI studies.

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 performed or is mentioned. MRMC studies are specific to evaluating AI in diagnostic image interpretation or similar tasks where human interaction with AI is a factor. This device is a physical medical device.

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

This information is not applicable. The device is a physical catheter, not an algorithm.

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

As mentioned, the concept of "ground truth" as you've defined it for diagnostic AI does not directly apply. For a physical device, ground truth would be established through:

• Functional specifications: The device must meet predefined physical dimensions, strength, flow rates, balloon inflation characteristics, etc., as per engineering designs and adopted standards.
• Biocompatibility standards: The materials used must not cause adverse biological reactions, verified through in vitro and in vivo tests following ISO 10993.
• Sterility assurance: The device must be sterile, verified through sterilization validation and bioburden testing.
• Clinical outcomes (implied): The mentioned Clinical Evaluation Report and Post Market Clinical Follow-Up Study would evaluate patient outcomes related to device use, but the details are not provided here.

8. The sample size for the training set

This information is not applicable. The device is a physical product, not an AI algorithm trained on data.

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

This information is not applicable for the same reason as point 8.

In summary:

The provided document is a 510(k) summary for a physical medical device. The regulatory pathway for this type of device primarily relies on demonstrating substantial equivalence to a predicate device through non-clinical performance and safety testing, rather than the extensive clinical efficacy studies typical for novel therapies or the rigorous diagnostic performance studies for AI algorithms that your questions implicitly assume.

The "device performance" relies on meeting established international and national standards for physical characteristics, biocompatibility, and sterility, which are evaluated through a battery of non-clinical tests. Clinical data is mentioned (CER, PMCF), suggesting real-world performance observation, but details on methodologies, sample sizes, and specific clinical endpoints are not included in this summary.

Ask a specific question about this device

Two-way Disposable Silicone Foley Catheterization for bladder drainage and urological use only; the indwelling time is no more than 30 days.

Three-way Disposable Silicone Foley Catheterization for bladder drainage and bladder irrigation for urological use only; the indwelling time is no more than 30 days.

The Silicone Foley Catheter for single use is designed as an intermittent pathway for drainage and irrigation of the bladder. The device is made of silicone. The catheter is provided sterile in a variety of lengths and sizes.

The provided document is a 510(k) premarket notification for a medical device (Silicone Foley Catheter for single use). Such submissions are designed to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to prove specific performance against a detailed set of acceptance criteria in the manner requested for an AI/ML powered device.

Therefore, much of the requested information regarding acceptance criteria, specific study design for proving performance, and expert ground truth establishment for AI/ML devices is not applicable to this traditional medical device submission.

Here's an analysis based on the information provided in the document:

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

For a traditional medical device like a Foley catheter, "acceptance criteria" are typically defined by recognized standards and benchmarks set by the predicate device, rather than a quantifiable performance metric for an AI system. The document focuses on demonstrating substantial equivalence to a predicate device.

The "performance" is implicitly demonstrated through adherence to relevant standards and direct comparison of specifications with the predicate.

2. Sample size used for the test set and the data provenance

• Test Set Sample Size: The document does not specify exact sample sizes for each non-clinical test (e.g., how many catheters were tested for biocompatibility or physical performance). It only states that the tests were "conducted" and "evaluated." For a traditional device, testing is typically done on a representative sample to ensure consistency and compliance with standards.
• Data Provenance: The tests are non-clinical (laboratory-based performance and biocompatibility). The manufacturer is CHANGZHOU RONGXIN MEDICINE MINIMAL INVASION TECHNOLOGY CO., LTD., located in China. The data would originate from their internal testing or third-party labs they commissioned. The studies are by nature prospective as they are specifically conducted to support market clearance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable. For a traditional catheter, "ground truth" is established by adherence to engineering specifications, material science, and performance standards, not by expert human interpretation of medical images or data (as would be the case for an AI/ML device). The "experts" involved would be engineers, material scientists, and quality assurance personnel performing the tests according to established protocols.

4. Adjudication method for the test set

Not applicable in the context of a traditional device. Adjudication methods (like 2+1, 3+1 for consensus readings) are relevant for subjective human interpretations, particularly in medical image analysis for AI. For device testing, results are typically objective measurements or pass/fail criteria according to a standard.

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. This device is a physical medical device, not an AI/ML software. Therefore, no MRMC study or AI assistance evaluation was performed.

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

Not applicable. This query refers to AI/ML algorithm performance. The device is a physical catheter.

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

As mentioned in point 3, the concept of "ground truth" as applied to AI/ML or diagnostic studies is not directly transferable here. Instead, compliance with recognized industry standards (e.g., ASTM, EN, ISO for biocompatibility) and direct comparison to the predicate device's established specifications serve as the "ground truth" for substantial equivalence.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm. There is no "training set."

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

Not applicable. There is no training set as this is not an AI/ML device.

Ask a specific question about this device