(29 days)
The Xcela Power Injectable PICC is indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administrations and nutrients, the sampling of blood, and for power injection of contrast media.
The Xcela PICC with PASV Valve technology is indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administrations and nutrients, the sampling of blood, and for power injection of contrast media.
The Xcela Hybrid PICC with PASY Valve technology is indicated for short or long-term 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 is 6 mL/sec.
The proposed device has identical technological characteristics and performance as the predicate intravascular catheters. Both the proposed and predicate devices are, in brief, intended for short- or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, and power injection of contrast media. available in single and multi-lumen configurations in a wide range of sizes from 3F to 6 F outside catheter diameter; rated for maximum power injector settings up to 325 psi rated for maximum power injection flow rate up to 6 ml/second based on model; and available kitted with a range of procedural accessories for user convenience. The only difference compared to the current Xcela Power Injectable PICC, Xcela PICC with PASV Valve and Xcela Hybrid PICC with PASV Valve catheters cleared via K093366, K111906 and K150527 is a change of the catheter shaft, luer and suture wing print ink.
Here's an analysis of the provided text regarding acceptance criteria and the study that proves device performance. It's important to note that this document is a 510(k) summary for a medical device and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria in the way one might for a novel AI device. Therefore, some of the requested categories (especially those related to AI algorithm performance) will not be applicable or directly found in this type of document.
Summary of Acceptance Criteria and Device Performance:
The document describes the Xcela Power Injectable PICC, Xcela PICC with PASV Valve Technology, and Xcela Hybrid PICC with PASV Valve Technology. The core premise for this 510(k) submission is that the only difference compared to previously cleared predicate devices (K093366, K111906, and K150527) is a change in the catheter shaft, luer, and suture wing print ink. Therefore, the "acceptance criteria" and "device performance" largely refer to the established performance characteristics of the predicate devices, which the modified device is expected to meet due to the minor nature of the change.
1. Table of Acceptance Criteria and Reported Device Performance:
Since this is a 510(k) for a minor modification and not a de novo device, explicit numerical acceptance criteria for each test are not listed in this summary. Instead, the document states that the modified device has "identical technological characteristics and performance as the predicate intravascular catheters." The performance aspects are implied by the types of tests performed.
| Performance Characteristic (Implied Acceptance Criteria: Equivalent to Predicate Device) | Reported Device Performance (Achieved) |
|---|---|
| Material Performance (Specific to New Components) | |
| Cytotoxicity | Performed, implied acceptable. |
| Sensitization | Performed, implied acceptable. |
| Intracutaneous Reactivity | Performed, implied acceptable. |
| Acute Systemic Toxicity | Performed, implied acceptable. |
| Materials Mediated Pyrogen | Performed, implied acceptable. |
| Subchronic Toxicity | Performed, implied acceptable. |
| Subacute Toxicity | Performed, implied acceptable. |
| Direct Contact Hemolysis | Performed, implied acceptable. |
| Extract Method Hemolysis | Performed, implied acceptable. |
| Coagulation - Partial Thromboplastin Time | Performed, implied acceptable. |
| In-Vitro Hemocompatibility | Performed, implied acceptable. |
| Complement Activation | Performed, implied acceptable. |
| Bacterial Mutagenicity - Ames Assay | Performed, implied acceptable. |
| In-Vitro Mouse Lymphoma Assay | Performed, implied acceptable. |
| In-Vivo Mouse Micronucleus Assay | Performed, implied acceptable. |
| 4 Week Implantation | Performed, implied acceptable. |
| 13 Week Implantation | Performed, implied acceptable. |
| USP Physicochemical Test for Plastics >661 |
§ 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.”