(247 days)
The MedSource IV Safety Catheter is indicated to sample blood or administer fluids intravenously. The MedSource IV Safety Catheter may be used for any patient population with consideration given to adequacy for the vascular anatomy appropriateness for the solution being administered and duration of the therapy.
The MedSource IV Safety Catheter is a safety medical device used for inserting a catheter into a patient's body for purpose of delivery of fluids or drainage of fluids from the patient's body. This device is engineered to protect healthcare workers using it against accidental needle stick injury and exposure to parts of the device that have come in contact with patient's blood or other body fluids, and have hence been potentially contaminated with infectious agents. In addition this device also secures the needle (used to insert the catheter) in an enclosed chamber, thus protecting healthcare and other personnel from exposure to patient body fluids after the device has been discarded postuse.
The device comprises a sharp needle attached to a hub which projects into a chamber. In the 'unactivated' state prior to insertion, the needle and hub are 'locked' in position. There exists a retraction mechanism for 'unlocking' the needle such that on activation of this mechanism it is withdrawn and completely enclosed within the chamber. This mechanism for retracting the needle preferably includes a coiled spring or other elastic components. The retraction mechanism is activated by the user using only one hand by means of a lever or 'switch'.
The provided text is a 510(k) Summary for the MedSource IV Safety Catheter, which is a medical device and not an AI/ML product. Therefore, many of the requested elements pertaining to AI/ML device studies (such as sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth types) are not applicable to this document.
However, I can extract the acceptance criteria and performance data as presented for this traditional medical device.
1. Table of Acceptance Criteria and Reported Device Performance:
The document performs a comparison to a predicate device (Becton Dickinson Angiocath Autogaurd, K984059) to demonstrate substantial equivalence. The "acceptance criteria" for the MedSource IV Safety Catheter are implied by its performance being equivalent to or better than the predicate device's established performance, as well as compliance with specific ISO and ASTM standards.
| Comparison Point | Acceptance Criteria (Predicate Device Performance) | Reported Device Performance (MedSource IV Safety Catheter) |
|---|---|---|
| Chemical Tests | ||
| Volatile Residue |
§ 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).