(211 days)
Genesis BPS FLU-ADMIN I.V. Sets are intended to be used to administer fluids from a container to a patient's vascular system through a needle or catheter into a vein.
The tubing assembly consists of spike and drip chamber connected to tubing with a "Y" injection site and a male luer slip. Between the tubing with a "Y" injection site and a male luer slip is a roller clamp. These sets deliver 20 drops/ml, with the exception of set model 0151C which delivers 60 drops/ml. All models ending with a "C" have a check valve. All sets are vented with the exception of model 0160, which is non-vented.
The provided document is a 510(k) summary for FLU-ADMIN I.V. SETS, which are medical devices used for administering fluids. This type of document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. As such, it focuses on comparing the new device to existing devices and proving that it performs similarly.
It does not contain information about the acceptance criteria or a study that proves the device meets specific performance criteria in the manner typically reported for AI/Machine Learning devices. The document primarily addresses the administrative and regulatory aspects of bringing the device to market, including:
- Applicant and Contact Information: Basic details about Genesis BPS, LLC.
- Device Information: Trade name, common/usual name, classification, and product codes.
- Predicate Device: Identification of previously cleared devices to which the FLU-ADMIN I.V. SETS are being compared (K11914 FLU VEN I.V. SETS and K843692 FLU VEN I.V. SET 0153-C).
- Device Description: A physical description of the tubing assembly components.
- Intended Use: The purpose of the device (administering fluids from a container to a patient's vascular system).
- FDA Correspondence: The FDA's letter granting substantial equivalence, which is a regulatory approval based on the comparison to predicate devices, not on a new clinical study with acceptance criteria for device performance.
Therefore, the requested information components related to acceptance criteria, detailed study design, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC/standalone studies for specific performance metrics cannot be extracted from this document because it is a regulatory submission for substantial equivalence rather than a detailed performance study report.
The "acceptance criteria" for this type of submission are typically that the new device has the same intended use and technological characteristics as the predicate device, or that any differences do not raise new questions of safety and effectiveness. The "study" proving this is the 510(k) submission itself, which primarily relies on comparison and compliance with general controls, rather than a novel performance study against predefined numerical targets.
§ 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.