(56 days)
The PICC Maximal Barrier Nursing Kit with BioFlo Hybrid PICC with Endexo Technology and PASV Valve Technology is indicated for short- or long-term peripheral access to the central venous 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 NMI HPICC III is 6 mL/sec.
The PICC Maximal Barrier Nursing Kit with BioFlo PICC with Endexo 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, for central venous pressure monitoring and for power injection of contrast media.
The PICC Maximal Barrier Nursing Kit with BioFlo PICC with Endexo Technology and PASV Valve Technology is indicated for short or long-term peripheral access to the central venous 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 Maximal Barrier Nursing Kit with BioFlo Midline Catheter is indicated for short term access (
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).
This document describes a 510(k) premarket notification for "PICC Maximal Barrier Nursing Kits" by Navilyst Medical, Inc. The submission aims to demonstrate substantial equivalence to a legally marketed predicate device.
The document primarily focuses on a packaging change for the kit and vendor changes for several kit accessories. It does not detail new device performance, clinical studies for efficacy, or the development of an AI/ML model. Therefore, many of your requested points regarding acceptance criteria, study details for device performance (beyond packaging integrity), expert adjudication, AI/ML impact, and ground truth establishment are not applicable.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance / Supporting Information |
|---|---|
| Packaging Integrity and Sterility (New Packaging Configuration) | The performance evaluation was conducted in accordance with: |
- AAMI/ANSI/ISO 11607-1 Packaging for terminally sterilized medical devices-Part 1: Requirements for materials, sterile barrier systems, and packaging systems (2006)
- AAMI/ANSI/ISO 11607-2 Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes (2006)
The document states "Based on results of packaging testing performed according to recognized standards, the proposed PICC Maximal Barrier Nursing Kit is determined to be substantially equivalent to the predicate PICC Maximal Barrier Nursing Kit."
(Specific test results or quantitative performance metrics for packaging integrity are not provided in this summary but are implied to meet the standards.) |
| Equivalence to Predicate Device (Overall) | "The proposed PICC indications for use, technological characteristics, materials and operating principles are identical."
"The performance evaluation... is the result of design verification and validation activities, and risk assessment."
"Based on results of packaging testing performed according to recognized standards, the proposed PICC Maximal Barrier Nursing Kit is determined to be substantially equivalent to the predicate PICC Maximal Barrier Nursing Kit." |
2. Sample size used for the test set and the data provenance
Not applicable. This submission is for packaging and accessory vendor changes, not a new device requiring a clinical test set with patient data. The "test set" here refers to samples of the new packaging and components subjected to engineering and packaging validation tests. Specific sample sizes for these engineering tests are not provided in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This pertains to a packaging and component change, not a diagnostic or AI device requiring expert-established ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This pertains to a packaging and component change, not a diagnostic or AI device requiring adjudication of results.
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. There is no mention of AI or machine learning in this submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. There is no mention of AI or machine learning in this submission.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. For this submission, "ground truth" relates to the compliance of the new packaging and components with established engineering and regulatory standards (e.g., sterility, seal integrity, material compatibility).
8. The sample size for the training set
Not applicable. There is no mention of AI or machine learning, and therefore no training set.
9. How the ground truth for the training set was established
Not applicable. There is no mention of AI or machine learning, and therefore no training set or ground truth for it.
Summary of Device and Changes:
The device, "PICC Maximal Barrier Nursing Kits," includes various PICC catheter types (BioFlo Hybrid, BioFlo, Xcela Hybrid, Xcela) packaged with procedural aides and maximal barrier precautions. The "indications for use, technological characteristics, materials and operating principles are identical" to the predicate device. The only "differences" are a packaging change (outer tray with Tyvek lid replaced with a Tyvek/Nylon Pouch) and changes in vendors for "several kit accessories." The entire submission focuses on demonstrating that these changes do not alter the substantial equivalence to the predicate device, primarily through performance testing of the new packaging configuration against recognized international standards.
§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.
(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”