Search Results

No new claims or indications are made.

The proposed kit raises no new issues of safety or efficacy. In incorporating the components into a kit no modifications have been made which will affect safety or efficacy. Sterilization method and packaging are essentially the same.

The I.V. sets and transducer protectors are legally marketed as individual components. The arterial and venous bloodlines are substantially equivalent to legally marketed bloodlines. These bloodlines have been functionally tested and data provided. The blood contact materials of the arterial and venous bloodlines have been tested for biocompatibility and data provided.

The integrity of the bonded connections of the bloodlines and of the connection of the transducer protectors to the monitor lines have been tested and data provided.

While K962081 describes a medical device kit, the provided text does not contain any information regarding specific acceptance criteria, performance data, or a study that proves the device meets those criteria.

The document primarily focuses on demonstrating that the kit's components are either legally marketed individually, substantially equivalent to existing products, or have undergone basic functional and biocompatibility testing. It explicitly states, "No new claims or indications are made." This suggests that the device, as a kit, is not undergoing a novel performance evaluation but rather demonstrating the safety and equivalence of its combined components.

Therefore, I cannot fulfill your request as there is no information in the provided input about acceptance criteria or a study demonstrating performance against those criteria.

To provide the requested information, the input would need to include details such as:

• Specific performance metrics: e.g., accuracy, sensitivity, specificity, or other functional parameters.
• Target thresholds for these metrics: e.g., "sensitivity ≥ 90%."
• Study design: e.g., clinical trial, retrospective analysis, lab-based performance testing.
• Results of the study: The device's achieved performance against the defined metrics.
• Details about the data used: sample size, provenance, ground truth establishment, etc.

Without this kind of information, it's impossible to create the table or answer the specific questions about the study design and results.

Ask a specific question about this device