(148 days)
Blood Transfusion Set is used to administer blood from a container (plastic bag or glass bottle) to a patient's vascular system through a needle or catheter inserted into a vein.
The proposed device is plastic, disposable and sterile blood transfusion set, which is intended to be used to administer the blood from the container to a patient's vascular system through a needle or catheter inserted into a vein via gravity method.
The blood transfusion set consists of protective cap of the closure-piercing device, closure piercing device, tubing, drip, flow regulator, transfusion needle and needle sheath. In addition, there are two kinds of the transfusion set, one has a drug-adding feature and the other hasn't.
There are two specifications of transfusion needle, which are 0.9# transfusion needle and 1.2# transfusion needle.
The proposed device is provided sterilized.
The provided text describes a 510(k) submission for a Blood Transfusion Set, and thus there is no information about acceptance criteria or a study proving that a device meets acceptance criteria. The document is a premarket notification for a medical device seeking substantial equivalence to a predicate device.
Specifically:
- No acceptance criteria or device performance table is provided. The document states that "Laboratory testing was conducted to validate and verify that Blood Transfusion Set met all design specifications and was substantially equivalent to the predicate device," but it does not specify what those design specifications or acceptance criteria were, nor does it report specific performance metrics.
- No information on sample size for test sets or data provenance is available. No clinical or performance study details are included in this summary.
- No information on experts for ground truth or adjudication methods is available. There is no mention of a ground truth in the context of this device's submission, as it relates to a physical device rather than an AI or diagnostic algorithm.
- No MRMC comparative effectiveness study or standalone algorithm performance study was mentioned. These types of studies are typically relevant for AI/ML-based diagnostic devices, which is not the case here.
- The type of ground truth used is not applicable/not mentioned. For a physical device like a blood transfusion set, "ground truth" would not be established in the same way as for a diagnostic algorithm. The validation would likely involve engineering and biocompatibility testing against predefined standards.
- No information on training set sample size or how ground truth was established for a training set is available. This is not relevant for the type of device described.
In summary, the provided document is a 510(k) summary for a Blood Transfusion Set, focusing on its description, intended use, and substantial equivalence to a predicate device, rather than detailed performance studies or AI-specific validation criteria.
§ 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.