Search Results

The IV Stands and accessories are intended for hanging IV and other solution bags which are being administered to patients. The IV Stands are also used for hanging or supporting Infusion Pumps and other items that are used during IV administration, surgery, or patient care.

The Clinton Industries, Inc. IV Stands consist of a series of poles that are affixed to a base. The poles can telescope to various heights. The bases come in various sizes, depending on the pole used. The IV Stands are purchased with hooks for holding IV or other solution bags. The are either 2 or 4 hooks that are affixed to the top of the poles. The IV poles are chrome-plated steel. Each IV Stand consists of two poles with one fitting inside the other and telescoping to various heights. The telescoping portion of the poles is held in place by either a twist lock design or a compression knob. The bases are steel or aluminum with various coatings. Casters are affixed to the bases for movement of the stands. The following accessories are marketed with the IV Stands: Guidance Handle, Drainage Bag Hook, Utility Console Tray, Dual Pump Holder, Multi-pump Holder.

This document is a 510(k) premarket notification for IV Stands and Accessories from Clinton Industries, Inc., submitted to the FDA in 1998. The purpose of this submission is to demonstrate substantial equivalence to legally marketed predicate devices.

Here's an analysis based on your request, highlighting that this is a medical device substantial equivalence claim, not a study evaluating AI software or diagnostic performance. Therefore, many of your requested fields related to AI performance, ground truth, and expert adjudication are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device (IV Stands), "acceptance criteria" are typically met by demonstrating that the device has the same fundamental technological characteristics and intended use as a predicate device already on the market. The "performance" is implicitly accepted if these characteristics are shown to be equivalent and safe. There are no specific quantitative metrics like sensitivity or specificity for an IV Stand.

2. Sample Size Used for the Test Set and Data Provenance

• Not Applicable. This is not a study assessing diagnostic performance or AI. The "test set" here refers to the comparison of the new device's specifications against those of existing predicate devices.
• The data provenance is from the design specifications of the Clinton Industries IV Stands and the publicly available 510(k) summaries for The Brewer Company's IV Stands (K823270 and K850245).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Not Applicable. Ground truth in the context of IV stands refers to their basic engineering and functional specifications, which are objective. There isn't "ground truth" to be established by experts in the same way there would be for image interpretation. The "experts" involved are the design engineers and regulatory professionals from Clinton Industries and potentially FDA reviewers who evaluate the technical specifications against the predicate devices.

4. Adjudication Method for the Test Set

• Not Applicable. There is no "adjudication" in the sense of resolving disagreements among experts on a diagnostic outcome. The comparison is based on objective, verifiable physical and functional characteristics. The FDA's review process serves as the "adjudication" of substantial equivalence.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Not Applicable. This is not a diagnostic device involving human readers or AI.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

• Not Applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

• For this submission, the "ground truth" is the objective physical and functional specifications of the predicate IV stands as documented in their 510(k) submissions. The new device's specifications are compared directly against these documented characteristics.

8. The Sample Size for the Training Set

• Not Applicable. There is no "training set" as this is not an AI or machine learning device. The design of the Clinton Industries IV Stands is based on established engineering principles and the design of existing, legally marketed IV stands.

9. How the Ground Truth for the Training Set Was Established

• Not Applicable. As there's no training set, there's no ground truth to be established for it.

Ask a specific question about this device