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510(k) Data Aggregation
(56 days)
The NeoMed Urinary Catheter is intended for use in neonatal and pediatric patients to sample urine and/or facilitate urinary drainage. This catheter is NOT a Foley (balloon) type catheter. This catheter is intended for temporary use and will be in contact with the patient for less than 30 days.
The NeoMed Urinary Catheter is a silicone single lumen catheter that is used to drain urine. The device consists of the following main components: a single lumen urinary catheter, a hub, and a luer lock connector. It is available with either an orange radiopaque stripe or a natural white stripe (supplied from the barium sulfate loaded in the catheter).
The provided text describes the NeoMed Urinary Catheter and its clearance for market based on substantial equivalence to a predicate device, the CATCO Urological Catheter (K944782). The key information for acceptance criteria and the supporting study is:
1. Table of Acceptance Criteria and Reported Device Performance:
The document summarizes the acceptance criteria and performance based on equivalence to the predicate device.
| Acceptance Criteria | Reported Device Performance Statement |
|---|---|
| Method of Operation | Same method of operation as predicate: drainage of urine through a single lumen catheter. |
| Functional Equivalence | Bench testing demonstrated functional equivalence to predicate and other urinary catheters. |
| Safety and Effectiveness | Minor differences do not affect safety or effectiveness. |
| Biocompatibility | Materials have a long history of use in catheter and urethral catheter manufacture and are biocompatible. |
| Intended Use Performance | Performs its intended use of urine drainage. |
| Duration of Contact | Intended for temporary use (< 30 days). |
| Patient Population | Intended for neonatal and pediatric patients. |
| Catheter Type | NOT a Foley (balloon) type catheter. |
2. Sample Size Used for the Test Set and Data Provenance:
The document states "Bench testing has demonstrated that the NeoMed Urinary Catheter is functionally equivalent to predicate urinary catheters". However, it does not specify the sample size for this bench testing. It also does not provide information on the data provenance (e.g., country of origin, retrospective or prospective) of this testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not mention the use of experts to establish ground truth for a test set. The evaluation relies on functional equivalence to a predicate device.
4. Adjudication Method for the Test Set:
An adjudication method is not described as the evaluation is based on bench testing for functional equivalence rather than clinical studies requiring expert review or consensus.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done or mentioned. The submission is focused on substantial equivalence through bench testing, not on comparing the device's effectiveness assisted by AI with human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This device is not an AI algorithm. It is a physical medical device (urinary catheter). Therefore, a standalone performance study in the context of AI is not applicable and was not done.
7. The Type of Ground Truth Used:
The ground truth or basis for evaluation is the performance and characteristics of the predicate device (CATCO Urological Catheter, K944782) and other currently marketed urinary catheters. The device's performance is gauged against established functional criteria for such catheters and their known biocompatibility.
8. The Sample Size for the Training Set:
This device is a physical medical device, not an AI model. Therefore, the concept of a "training set" is not applicable in this context and no information is provided.
9. How the Ground Truth for the Training Set Was Established:
As this is not an AI model, the concept of a training set and its ground truth is not applicable. The device's design and manufacturing are based on established engineering principles and materials used in similar predicate devices.
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