(265 days)
The Jet Power Injectable PICC is indicated for short term or long term peripheral access to the central venous system for intravenous therapy and power injection of contrast media, and allows for central venous pressure monitoring. For blood sampling, infusion, or therapies, use a 4F or larger catheter.
The maximum recommended infusion rate varies by catheter. The maximum recommended infusion rate for the 3F Jet Power Injectable PICC is 1cc/sec and 5.0cc/sec for the 4F and 5F Jet Power Injectable PICC.
A family of trimmable peripherally inserted central catheters made from specially formulated biocompatible medical grade materials. Catheters are packaged in a tray with accessories necessary for a percutaneous microintroducer introduction (Modified Seldinger or Seldinger Technique).
This document is a 510(k) Pre-market Notification for the Jet Power Injectable PICC, demonstrating its substantial equivalence to a predicate device (Pro-PICC® CT). The information provided focuses on the safety and performance of the medical device itself, rather than an AI/ML algorithm. Therefore, many of the requested fields related to AI/ML studies are not applicable.
Here's an analysis of the provided text in relation to your request:
Acceptance Criteria and Study for a Medical Device (Non-AI/ML context):
The "acceptance criteria" for a medical device cleared via the 510(k) pathway are generally demonstrated through substantial equivalence to a legally marketed predicate device. This involves showing that the new device is as safe and effective as the predicate. The "study" for this type of device typically involves a combination of bench testing, biocompatibility testing, and sterilization validation, rather than clinical efficacy studies on patient data that would be relevant for AI/ML performance.
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly present a table of "acceptance criteria" and "reported device performance" in the way one would for an AI/ML model's metrics (e.g., sensitivity, specificity). Instead, it lists the bench testing standards and the outcome (e.g., "Passed Per Internal Requirements", testing against specific ISO/ASTM standards).
Here's an interpretation of the requested table based on the provided "Performance Standards" (Table 6.2) and "Biocompatibility" sections:
| Acceptance Criteria (Relevant Standards/Tests) | Reported Device Performance (Outcome) |
|---|---|
| Liquid Leakage (EN ISO 10555-1:2009) | Tested and presumably passed (implied by 510(k) clearance) |
| Air Leakage (EN ISO 10555-1:2009) | Tested and presumably passed |
| Force at Break (EN ISO 10555-1:2009) | Tested and presumably passed |
| Gravity Flow (EN ISO 10555-1:2009) | Tested and presumably passed |
| Chemical Exposure (EN ISO 10555-1:2009) | Tested and presumably passed |
| Max Static Burst (EN ISO 10555-1:2009) | Tested and presumably passed |
| Power Injection (EN ISO 10555-1:2009) | Tested and presumably passed |
| Elongation (EN ISO 10555-1:2009) | Tested and presumably passed |
| Accelerated Aging (ASTM F 1980:2016) | Tested and presumably passed |
| Suture Wing Integrity | Passed Per Internal Requirements |
| Pump Flow Rate | Tested and presumably passed |
| Priming Volume | Tested and presumably passed |
| Catheter Collapse Test | Tested and presumably passed |
| Catheter Stiffness | Tested and presumably passed |
| Interaction Testing | Tested and presumably passed |
| Simulated Use | Tested and presumably passed |
| Tip Displacement During Power Injection | Tested and presumably passed |
| Power Injection Flow Rate | Tested and presumably passed |
| Dynamic Failure | Tested and presumably passed |
| Power Injection Simulation Testing | Tested and presumably passed |
| Cyclic Flexure / Kink Test | Tested and presumably passed |
| Biocompatibility (ISO 10993-1, -5, -10, -11, -3, -6, -4, ASTM F756, OECD Guidelines, USP) | Performed on final finished device, outcomes not explicitly detailed but implied to be compliant for permanent contact with circulating blood. |
| Sterilization Validation (ANSI/AAMI/ISO 11135-1:2014, AAMI TIR 28:2009(R)2013) | SAL is 10-6 |
| ETO Residual Level (AAMI/ANSI/ISO 10993-7:2008) | Maximum level less than 4 mg/device |
| Pyrogen Test Method (ANSI/AAMI ST72:2011) | Non-pyrogenic |
| Endotoxin (ANSI/AAMI ST72:2011) | Maximum level is 20 EU/device |
| Shelf Life (ASTM 1980F:2016, EN ISO 10555-1) | Tested and presumably passed |
For AI/ML Specific Questions (N/A for this document):
- Sample size used for the test set and the data provenance: Not applicable. This is not an AI/ML study involving a test set of data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for a medical device like this is conformance to engineering and biocompatibility standards and comparison to a predicate device.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
§ 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.”