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K Number
K972854
Device Name
PROTOS I.V. ADMINISTRATION SET (15 DROPS/ML) I4070S/(60 DROPS/ML)I4670S PRELIMINARY
Manufacturer
GLOBE ENT., INC.
Date Cleared
1997-12-17

(138 days)

Product Code
FPA
Regulation Number
880.5440
Type
Traditional
Panel
HO
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

For the delivery of I.V. solutions by or on the order of a physician or other licensed practitioner.

Device Description

PROTOS® I.V. Administration Set (15 Drops/ML) and (60 Drops/ML)

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA regarding an IV administration set. This type of document does not typically contain the detailed acceptance criteria and study results that would be used to prove a device meets those criteria.

510(k) clearances are primarily based on demonstrating substantial equivalence to an already legally marketed predicate device, rather than detailed performance studies proving specific acceptance criteria. The letter confirms that Globe Enterprises, Incorporated's PROTOS® I.V. Administration Set is substantially equivalent to existing devices.

Therefore, for your request, I must state that the provided document does not contain the information necessary to fulfill items 1 through 9.

Specifically:

  1. A table of acceptance criteria and the reported device performance: Not present. The letter is a regulatory approval, not a performance report.
  2. Sample sized used for the test set and the data provenance: Not present.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
  4. Adjudication method: Not present.
  5. 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 not an AI/imaging device.
  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/imaging device.
  7. The type of ground truth used: Not present.
  8. The sample size for the training set: Not applicable. This device is not an algorithm requiring a training set.
  9. 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.