(265 days)
The PowerLoc MAX® Power-Injectable Infusion Set is an intravascular administration set with a non-coring right angle needle and manually activated needle stick prevention safety mechanism which reduces the risk of accidental needlestick injuries by shielding the needle is used to access surgically implanted vascular ports.
The PowerLoc MAX® Power-Injectable Infusion Set is indicated for use in the administration of fluids and drugs, as well as blood sampling through surgically implanted vascular ports.
When used with ports that are indicated for power injection of contrast media into the central venous system, the PowerLoc MAX® Power-Injectable Infusion Set is also indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate at 11.8 cPs is 5 ml/s for 19 gauge and 20 gauge needles, and 2 ml/s for 22 gauge needles.
The SafeStep® Huber Needle Set is a device intended for insertion into the septum of a subcutaneously implanted port and for the infusion of fluids into the port. The SafeStep® Huber Needle safety feature is manually activated during needle removal, and is designed to aid in the prevention of accidental needlesticks.
The PowerLoc MAX® Power-Injectable Infusion Set is a standard non-coring intravascular administration set with a non-coring Huber type right angle needle and a manually activated needle-stick prevention safety mechanism which reduces the risk of accidental needlestick injuries by shielding the needle. The device is used to access surgically implanted vascular ports and is indicated for use in the administration of fluids and drugs, as well as blood sampling. The PowerLoc MAX® Power-Injectable Infusion Set is also indicated for power injection of contrast media into the central venous system only through an implanted port that is also indicated for power injection. The maximum recommended infusion rate at 11.8 cPs is 5 ml/s for 19 gauge and 20 gauge needles and 2 ml/s for 22 gauge needles. The PowerLoc MAX® Power-Injectable Infusion Set is offered with and without a Y-site.
The SafeStep® Huber Needle Set is a standard right angle Huber needle and administration set with a needlestick prevention feature, designed for use with a vascular access infusion system. It is manufactured with conventional medical grade, biocompatible materials. The SafeStep® Huber Needle Set operates as a standard Huber needle with the addition of a safety feature to aid in the prevention of needlestick injuries to the health practitioner. The SafeStep® Huber Needle Set is offered with and without a Y-site.
The stabilization device is intended for use as an accessory to the subject PowerLoc MAX® and SafeStep® infusion sets, and is supplied pre-loaded with the subject devices. It is placed centrally over the implanted port so that the base surrounds the implanted port under the skin. The infusion set needle handle is pressed down until the needle has entered the port septum, then the stabilization device is lifted off of the needle. The stabilization device is then discarded per hospital protocol.
The provided document is a 510(k) summary for medical devices (PowerLoc MAX® Power-Injectable Infusion Set and SafeStep® Huber Needle Set). It details the regulatory clearance for these devices. However, the document does not contain information about acceptance criteria and studies proving the device meets these criteria in the context of an AI/algorithm-driven device.
The "Performance Tests" section details a series of tests conducted to ensure the device's physical and functional performance, materials, and safety in relation to its intended use as an intravascular administration set. These tests include:
- Slide Force testing (to ensure easy needle slide within the stabilization device).
- Stabilization Device Removal Force testing (to ensure easy removal of the stabilization device).
- Acceptability of the Stabilization Device (clinical acceptability of placement).
- Acceptability of GuardIVa® with Stabilization Device (validation of antimicrobial dressing use).
- Various ISO standards compliance (e.g., sharps injury protection, infusion equipment, biocompatibility, sterilization, packaging, luer fittings, needle tubing, intravascular catheters, and hypodermic needles).
- FDA Guidance compliance (e.g., sharps injury prevention features, MR compatibility).
- Risk management (FMEA) in accordance with BS EN ISO 14971:2012.
The document states: "The subject devices met all predetermined acceptance criteria derived from the above listed references and demonstrated substantially equivalent performance as compared to the cited predicate devices."
Therefore, it is not possible to extract the requested information (sample size for test/training set, data provenance, number/qualification of experts, adjudication method, MRMC study, standalone performance, type of ground truth) because the supplied document describes the regulatory approval of a physical medical device (infusion set/needle) and not an AI/algorithm-driven device.
The questions posed relate to the validation of AI/ML-based medical devices, which involve different types of studies (e.g., diagnostic accuracy, reader studies) and data considerations than those detailed for this hardware device.
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.