Search Results

The LifeShield® Latex-Free GraviTech™ Flow Controller I.V. Sets are intended for use in controlling the infusion rate of I.V. fluids from a container to a patient's vascular system. The indications for use of the LifeShield® Latex-Free GraviTech™ Flow Controller I.V. Sets include intravenous infusion where a manual flow control is desired.

The LifeShield® Latex-Free GraviTech™ Flow Controller !.V. Set will consist of variations of the following components: non-DEHP plasticized polyvinyl tubing, piercing pins, fluid shut off devices, integral CLAVE® ports or prepierced injection sites, backcheck valves, semi-rigid adapters, male adapter and air filter assembly. The GraviTech™ device provides a manual flow control with head height compensation to the LifeShield® product line.

The provided document for the Hospira, Inc. LifeShield® Latex-Free GraviTech™ Flow Controller I.V. Sets (K063239) is a 510(k) summary and FDA clearance letter, which describes the device and its intended use, and states that it is substantially equivalent to predicate devices.

However, this document does not contain the specific acceptance criteria or the study that proves the device meets those criteria.

510(k) summaries typically focus on demonstrating substantial equivalence to a legally marketed predicate device rather than providing detailed performance study results with specific acceptance criteria in the public summary. While the summary states that "The LifeShield® Latex-Free GraviTech™ Flow Controller I.V. Set will meet the functional described in the product labeling, and is as safe and effective in terms of substantial equivalence as the predicates," it does not explicitly list the acceptance criteria or the specific data from a study that demonstrates this.

Therefore, I cannot provide the requested information regarding:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method for the test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done.
6. If a standalone performance study was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

This information would typically be found in a more detailed technical report or in the full 510(k) submission, which is not publicly available in this format. The provided document is a high-level summary for regulatory clearance purposes.

Ask a specific question about this device