(239 days)
0.9% Sodium Chloride Injection, USP prefilled syringes are intended for flushing of IV catheters and IV tubing only.
Not Found
I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, or any studies related to the 0.9% Sodium Chloride Injection, USP.
The document is a US FDA 510(k) clearance letter for the device, which essentially states that the FDA has reviewed the manufacturer's premarket notification and determined the device is "substantially equivalent" to legally marketed predicate devices. It outlines regulatory information, requirements, and contact details, but it does not include any performance data or study details.
Therefore, I cannot provide the requested information, including:
- A table of acceptance criteria and reported device performance
- Sample size used for the test set and data provenance
- Number of experts and their qualifications for ground truth
- Adjudication method
- MRMC comparative effectiveness study
- Standalone performance study
- Type of ground truth used
- Sample size for the training set
- How ground truth for the training set was established
§ 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).