(88 days)
The SafeStep® MAX™ Power-Injectable Infusion Set device is an intravascular administration set with a non-coring right angle needle and manually activated needlestick 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.
The SafeStep® 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 SafeStep® 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 is 5 ml/s for 19 gauge and 20 gauge needles, and 2 ml/s for 22 gauge needles.
The SafeStep® MAX™ Power-Injectable Infusion Set is a standard non-coring Huber type needle and administration set with an integral safety needlestick prevention feature.
The SafeStep® 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 SafeStep® 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 is 5 ml/s for 19 gauge and 20 gauge needles. and 2 ml/s for 22 gauge needles.
The device functions in a similar manner to all the predicate devices. The insertion site is prepared and the device is primed using a 10 ml syringe containing normal saline and inserted into the port septum. Patency is confirmed and the device is dressed per institutional protocol. Removal of the device is accomplished by flushing per institutional protocol, stabilizing the base of the device by securely holding the base down and firmly pulling the textured handle up until you feel a firm stop and the needle is locked into the safety position. Dispose the set into a sharps container.
The provided text describes the SafeStep® MAX™ Power-Injectable Infusion Set and its substantial equivalence to predicate devices, focusing on its safety and effectiveness. However, it does not contain a specific table of acceptance criteria with reported device performance alongside the criteria. The document only generally states that "The SafeStep® MAX™ Power-Injectable Infusion Set met all established acceptance criteria for performance testing and design verification testing."
Therefore, I cannot generate the table as requested.
Regarding other points, here's what can be extracted:
- Sample size used for the test set and the data provenance: Not explicitly stated. The document mentions "Verification testing was performed according to protocols based on the above-referenced guidance document recommendations and additional standards" and "Performance data gathered in design verification testing." However, specific sample sizes or data provenance (e.g., country of origin, retrospective/prospective) are not detailed.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This document pertains to a medical device's physical and functional performance, not diagnostic imaging or clinical judgment where expert consensus on "ground truth" would be established. The "ground truth" here is the performance against established engineering and safety standards.
- Adjudication method for the test set: Not applicable for this type of device submission.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a physical medical device, not an AI or diagnostic imaging system involving human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device.
- The type of ground truth used: For this device, the "ground truth" is based on established engineering standards, guidance documents (e.g., FDA's guidance for Intravascular Administration Sets and Medical Devices with Sharps Injury Prevention Features), and ISO standards (ISO 11135, ISO 11137, ISO-10993). Performance against these standards serves as the benchmark for safety and effectiveness.
- The sample size for the training set: Not applicable. This is not a machine learning or AI-based device, so there is no "training set."
- How the ground truth for the training set was established: Not applicable.
§ 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.