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K Number
K991437
Device Name
WELLS JOHNSON INFUSION SYSTEM, MODEL 20-6000-00
Manufacturer
WELLS JOHNSON CO.
Date Cleared
1999-08-30

(126 days)

Product Code
FRN
Regulation Number
880.5725
Type
Traditional
Panel
HO
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

General surgical fluid irrigation and infiltration.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a medical device called the "Wells Johnson Infusion System, Model 20-6000-00." This type of letter addresses substantial equivalence to a predicate device and allows the device to be marketed. It does not typically contain detailed information about specific performance acceptance criteria or detailed study results like those found in a clinical study report or a premarket approval (PMA) application.

Therefore, for the information requested in your prompt:

  1. A table of acceptance criteria and the reported device performance: This information is not present in the provided document. The 510(k) process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, not necessarily on meeting specific performance acceptance criteria in the same way a clinical trial for a novel device would.
  2. Sample sized used for the test set and the data provenance: Not available in this document.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available in this document.
  4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not available in this document.
  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 device is an "Infusion System," which is a physical medical device, not an AI or imaging diagnostic tool that would typically involve human readers.
  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device, not an algorithm.
  7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not available in this document, as it pertains to performance studies not detailed here. The primary "ground truth" for a 510(k) is the performance of the predicate device to which it is compared for substantial equivalence.
  8. The sample size for the training set: Not applicable/available.
  9. How the ground truth for the training set was established: Not applicable/available.

In summary, the provided document is an FDA clearance letter based on substantial equivalence for a physical medical device (an infusion system). It does not contain the detailed performance study information, acceptance criteria, or ground truth establishment methods that would be typically found in a clinical study report for a diagnostic device or AI algorithm.

§ 880.5725 Infusion pump.

(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).