(43 days)
Shelly Protected Fistula Needle is part of the hemodialysis system that connects patients to the machine and provides access to patient's blood, It is also used in plasmapheresis for the same purpose. Shelly Protected Fistula Needle has a shield that when activated enclose the needle. This mechanism is intended to reduce the incidence of accidental needlesticks.
Shelly Protected Fistula Needle has a shield that when activated enclose the needle.
This document is a 510(k) clearance letter from the FDA for a medical device called the "Shelly Protected AV Fistula Needle Set." It does not contain information about acceptance criteria or a study proving device performance in the context of an AI/ML or diagnostic device. The letter is a regulatory approval, not a scientific or clinical study report. Therefore, I cannot extract the requested information.
The document primarily focuses on:
- Device Identification: Shelly Protected AV Fistula Needle Set
- Regulatory Clearance: 510(k) clearance, indicating substantial equivalence to a predicate device.
- Indications for Use: Describing the device's purpose in hemodialysis and plasmapheresis, and its safety mechanism for preventing needlesticks.
- Regulatory Compliance: Mentioning general controls and good manufacturing practices.
There is no mention of:
- Acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy).
- Any performance study results (e.g., test set sample size, data provenance, expert ground truth, adjudication methods).
- AI/ML components or comparative effectiveness studies with human readers.
- Training set details.
§ 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.