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The NMI HPICC III is indicated for short- or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients, the sampling of blood, and for central venous pressure monitoring and for power injection of contrast media. Non-valved lumens are indicated for central venous pressure monitoring. The maximum power injection flow rate for the NMI HPICC III is 6 mL/sec.

The NMI PICC III is indicated for short- or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids. medications and nutrients, the sampling of blood, for central venous pressure monitoring and for power injection of contrast media.

The NMI PICC III with PASV Vale Technology is indicated for short- or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients, the sampling of blood, and for power injection of contrast media.

for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients, the sampling of blood, and for power injection of contrast media. Non-valved lumens are indicated for central venous pressure monitoring. The maximum power injection flow rate for the Xcela Hybrid PICC with PASV Valve Technology is 6 mL/sec.

for short or long-term peripheral access to the central venous system for intravenous therapy. including but not limited to, the administration of fluids, medications and nutrients, the sampling of blood, and for power injection of contrast media.

The PICC Maximal Barrier Nursing Kit is a packaging configuration containing a specified NMI PICC, along with (1) procedural aides typically used for PICC placement and (2) maximal barrier precaution devices based upon recommendations of Center of Disease Control and Prevention (CDC).

The Navilyst Medical PICC Maximal Barrier Nursing Kit is a medical device that combines a Peripherally Inserted Central Catheter (PICC) with procedural aides and maximal barrier precaution devices. The 510(k) premarket notification K131038 states that the device's performance evaluation was conducted based on a risk analysis and included testing in accordance with national/international standards and FDA guidance documents.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the sample sizes used for the packaging standards testing or EO sterilization testing. It mentions that "All packaging is manufactured from packaging materials that are well characterized and commonly used in the medical industry." However, it does not specify the number of units tested.

The data provenance is not specified in terms of country of origin or whether it was retrospective or prospective. The studies were conducted by Navilyst Medical.

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

This information is not provided in the document. The performance evaluation relied on standardized testing, not expert-based ground truth for the device's main components. The "maximal barrier precaution devices" are based on recommendations from the Center of Disease Control and Prevention (CDC), implying general clinical best practices rather than specific expert review of test outcomes.

4. Adjudication Method for the Test Set:

An adjudication method (such as 2+1 or 3+1) is not mentioned in the document. The testing described (packaging, sterilization) typically relies on objective measurements against established standards, rather than subjective expert review requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic devices involving human interpretation of results, which is not applicable to the PICC Maximal Barrier Nursing Kit, whose performance is primarily evaluated through physical and biological property testing.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

This question is not applicable as the PICC Maximal Barrier Nursing Kit is a physical medical device, not an algorithm or AI system. Its performance relates to its physical characteristics, sterility, and packaging integrity, not software performance.

7. The Type of Ground Truth Used:

The ground truth used for this device's evaluation was primarily established by national/international standards and recognized FDA guidance documents. For example, ISO 10993-7 sets acceptance limits for ethylene oxide residuals, and ISO 11607 outlines requirements for packaging systems. The "successful results" indicate that the device met these objective, pre-defined criteria.

8. The Sample Size for the Training Set:

This question is not applicable as there is no "training set" for this device. The device is not based on a learning algorithm that requires training data.

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

This question is not applicable as there is no training set for this device.

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