(423 days)
These devices are intended for various non-permanent intravascular applications including pressure monitoring, fluid administration, and blood sampling.
The various SDM Central Venous Catheters consist of polyurethane bodies with zero to five polyurethane extension tubes. Except for the smallest French sizes of the single lumen devices, the catheters all contain an additional flexible polyurethane distal tip. The proximal end(s) of each catheter terminate in molded-on, fixed, female locking luers. Where present, the extension tubes are joined to the catheter body by insertmolded polyurethane and contain clamps for occluding the tubes. Many configurations are marked with centimeter markings to indicate insertion depth.
Catheters will be offered in "kits" which will include some or all of the following depending on configuration: Catheter, guidewire in dispenser, dilator, syringe, scalpel, suture wing, and introducer needle. The makeup of specific sets can be seen in the Appendix D of this 510(k) submission. These kits will be packaged in semi-rigid vacuum formed trays containing a heat-sealed, ethylene oxide permeable lids, or in standard Tyvek/Poly pouches, depending on the product configuration.
This document describes the Safe-Cath Single- and Multi-Lumen Intravascular Catheter. However, it is a 510(k) Summary of Safety and Effectiveness for a medical device and does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.
A 510(k) premarket notification is submitted to the FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed predicate device. This typically involves demonstrating "substantial equivalence" rather than presenting original clinical studies with detailed acceptance criteria and performance data in the way an AI/ML device submission would.
Therefore, I cannot provide the requested information from this document. It does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for a test set.
- Number or qualifications of experts for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study results.
- Standalone performance data for an algorithm.
- Type of ground truth used (as it's not an AI/ML device).
- Sample size for a training set (as it's not an AI/ML device).
- How ground truth for a training set was established (as it's not an AI/ML device).
The document focuses on comparing the Safe-Cath catheter to predicate devices based on intended use, materials, dimensions, and mechanical properties, to argue for substantial equivalence, not to present a study demonstrating 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).