(63 days)
The Neo Med Single Lumen Umbilical Catheter is intended for use in neonatal and pediatric patients to sample blood , monitor blood parties of administer Fluids intravenously
The NeoMed Single Lumen Umbilical Catheter is a silicone single lumen catheter with natural white barium sulfate included for radiopacity.
The device consists of the following main components: a single lumen umbilical catheter, a hub, and a luer lock connector, and 3 way stopcock with 2 female type connectors.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility | Materials that come in direct contact with the patient have a long history of use in umbilical catheter manufacture and are biocompatible according to ISO 10993. |
| Functional Equivalence | Functional test results demonstrate that the NeoMed Single Lumen Umbilical Catheter performs its intended use and is equivalent to the predicate device. |
| Safety and Effectiveness | Bench testing has demonstrated that the NeoMed Single Lumen Umbilical Catheter is functionally equivalent to predicate umbilical catheters currently on the market and that any minor differences do not affect safety or effectiveness. |
| Substantial Equivalence | The NeoMed Single Lumen Umbilical Catheter is substantially equivalent to the CATCO Umbilical Vessel Catheter cleared under K944368. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify a sample size for a test set. This submission relies on "bench testing" and a comparison to a predicate device, rather than a clinical study with a distinct test dataset. The data provenance is also not explicitly stated as the evaluation is based on bench testing of the new device and comparison to an established predicate.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable or provided. The evaluation is based on bench testing of the device itself and comparison to a predicate, not on human interpretation or "ground truth" derived from expert consensus on a test set of data.
4. Adjudication Method for the Test Set
This information is not applicable or provided. As there's no defined "test set" requiring expert evaluation, no adjudication method would have been used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No, an MRMC comparative effectiveness study was not done. The submission focuses on substantial equivalence based on bench testing and material biocompatibility.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in a sense. The "performance data" described refers to standalone testing of the device itself through "bench testing." This is a medical device, not an AI algorithm, so the concept of an "algorithm only" study doesn't directly apply here. However, the evaluation of the device's functional integrity is conducted independently.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The "ground truth" for this device is established primarily through engineering specifications, material science standards (ISO 10993 for biocompatibility), and functional performance metrics demonstrated through bench testing. The "truth" is whether the physical device meets these established performance and safety requirements. The predicate device's established performance serves as a comparative "ground truth" for equivalence.
8. The Sample Size for the Training Set
This information is not applicable or provided. This is not an AI/machine learning device that involves training sets.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable or provided. As this is not an AI/machine learning device, there is no "training set" or corresponding ground truth establishment in that context.
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).