(147 days)
As indicated in 21 CFR 880.5200, to sample blood, monitor blood pressure, or administer fluids intravenously. These catheters may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused, and duration of therapy.
The ANGIOCATH® AUTOGUARD™ and INSYTE® AUTOGUARD™ catheters provide a shielding mechanism intended to reduce the incidence of accidental needle sticks. When the activation button is depressed by the clinician, the needle is withdrawn into the shield.
The subject catheter is a short term, single use intravascular catheter of various gauges and lengths which is designed to provide access to the vascular system. The catheter unit is provided with a mechanism which allows the needle to be shielded following placement of the catheter.
I am sorry, but the provided text does not contain information about the acceptance criteria or a study that proves the device meets specific acceptance criteria. The document is a 510(k) notification for a medical device (intravascular catheter) from Becton Dickinson, focusing on establishing substantial equivalence to a predicate device.
It primarily includes:
- Submitter's information
- Device name and classification
- Identification of predicate device
- Description of the device
- Statement of intended use
- Comparison of technological characteristics to the predicate device
- FDA's response indicating substantial equivalence
- Final indications for use statement
There are no details provided regarding:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for any test sets.
- Number or qualifications of experts used for ground truth.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for a training set.
- How ground truth for a training set was established.
This document serves as a regulatory clearance document based on substantial equivalence, not a detailed technical report of a performance study 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).