(90 days)
OSPREY Closed IV Catheter System (OspreyV2) is an intravascular catheter intended to be inserted into the patient's vascular system for short-term use to sample blood pressure, or administer fluids intravenously. Blood is contained within the device during the catheter insertion of blood exposure. This catheter may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure.
The OSPREY Closed IV Catheter System (OspreyV2) is suitable for use with power injectors rated for a maximum of 325 psi when connected to male luer lock.
The OPREY Closed IV Catheter System (OspreyV2) is a single use, sterile intravascular catheter designed to be inserted into a patient's vascular system to sample blood, monitor blood pressure, or administer fluids intravenously for short-term (
The provided text describes the regulatory clearance (510(k)) for the OSPREY Closed IV Catheter System (OspreyV2) and includes a comparison to predicate devices, but it does not contain information about acceptance criteria and a study proving the device meets those criteria in the context of AI/ML performance.
Instead, the document details:
- Device Description and Intended Use: The OspreyV2 is an intravascular catheter for short-term use, blood sampling, pressure monitoring, and fluid administration, including compatibility with power injectors up to 325 psi.
- Comparison to Predicate Devices: It highlights similarities and differences with two predicate devices (OSPREY PERIPHERAL IV Catheter System and Nexiva Closed IV Catheter System) in terms of classification, indications for use, critical procedural steps, materials of construction, design characteristics, and performance attributes like flow rate.
- Performance Data (Bench Tests): The document states that bench tests were conducted to verify the device met design specifications and supported substantial equivalence, referencing a list of ISO and ASTM standards (e.g., ISO 10555-1, ISO 23908 for sharps injury protection, ISO 8536-4 for infusion equipment).
- Biocompatibility Testing: It confirms biocompatibility evaluation per ISO 10993 series standards.
- Sterilization and Packaging Validation: It outlines validation per ISO and ASTM standards.
- Absence of Clinical Testing: Explicitly states that no clinical testing was performed as it was not required to demonstrate substantial equivalence to the predicate device.
Therefore, I cannot populate the requested table and provide details about acceptance criteria or a study with AI/ML performance data because this information is not present in the provided text. The document focuses on regulatory clearance based on substantial equivalence to existing devices through non-clinical (bench) testing and material/design comparisons, not on validating an AI/ML algorithm's diagnostic or predictive performance against specific acceptance criteria.
§ 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).