TUBETECH IV Administration Set

• K Number: K162951
• Device Name: TUBETECH IV Administration Set
• Manufacturer: Douglas Medical Products, Inc.
• Date Cleared: 2017-07-28 ( 277 days)
• Product Code: FPA
• Regulation Number: 880.5440
• Type: Traditional
• Panel: HO
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

For the administration of fluids from a container into the patient vascular system through a vascular access device.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text from the FDA letter pertains to a 510(k) premarket notification for an "TUBETECH® IV Administration Set," which is a medical device for administering fluids. It does not contain any information about a study proving that a device meets acceptance criteria for an AI/ML-based medical device.

Therefore, I cannot extract the following information from the given text:

1. A table of acceptance criteria and the reported device performance: The document describes a physical medical device (IV administration set), not an AI/ML device with performance metrics.
2. Sample sizes used for the test set and the data provenance: Not applicable to this device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document is a routine FDA clearance letter confirming substantial equivalence of a general hospital device to a predicate device, focusing on regulatory compliance rather than performance study results for an AI/ML product.

Regulation Number and Section

§ 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.