(20 days)
The V-Cath® PICC is indicated for the patient that requires repeated access for infusion or injection therapy. It can also be used for blood sampling although a 3.8FR or larger catheter is recommended.
Not Found
This is a medical device clearance letter for the V-Cath® PICC (Peripherally Inserted Central Catheter) from 1998. The document primarily serves to confirm that the device is substantially equivalent to legally marketed predicate devices.
Crucially, this document is a regulatory clearance letter and not a study report or clinical trial summary. Therefore, it does not contain the detailed information requested regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or expert evaluations. It simply indicates that the device has been cleared for marketing based on a determination of substantial equivalence.
Here's why the requested information cannot be extracted from the provided text:
- Acceptance Criteria & Reported Performance: Regulatory clearance letters typically don't detail the performance metrics or acceptance criteria used in specific verification or validation studies. They generally conclude that the device meets safety and effectiveness requirements based on comparison to a predicate device.
- Sample Size & Data Provenance: There's no mention of specific studies, sample sizes, or data provenance.
- Experts & Adjudication: There's no information about experts, ground truth establishment, or adjudication methods.
- MRMC Study: No mention of a multi-reader multi-case comparative effectiveness study.
- Standalone Performance: No details on standalone algorithm performance, as this device is a physical catheter, not an AI or software algorithm.
- Type of Ground Truth: Not applicable in this context.
- Training Set Sample Size & Ground Truth: Not applicable for a physical medical device.
In summary, the provided document does not contain the information necessary to complete the requested table and study details. It is a regulatory notification of clearance, not a technical report detailing performance criteria and study outcomes.
§ 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).