Search Results

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.

Device Description

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.

AI/ML Overview

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<	Performed, implied acceptable.
Catheter Shaft Print Integrity	Performed, implied acceptable.
Functional Performance (Inherited from Predicate; "Acceptable" is implied)
Power Injection Flow Rate	Max. power injection flow rate up to 6 ml/second (depending on model); specific rates for each model are listed in the 'Indications for Use' (e.g., 4F Single Lumen - 45cm length: 4 mL/sec; 6F Dual Lumen - 55cm length: 5 mL/sec). Note: The Hybrid PICC with PASV Valve explicitly states a max of 6mL/sec for non-valved lumens.
Static Burst Strength	Testing performed on predicate, results applicable.
Multiple Power Injections	Testing performed on predicate, results applicable.
Gravity Flow Rate	Testing performed on predicate, results applicable.
Catheter Length	Testing performed on predicate, results applicable.
Priming Volume	Testing performed on predicate, results applicable.
Dimensional Verification (ID, OD, Length)	Testing performed on predicate, results applicable.
Catheter Kink/Flex Resistance (Elongation, Stiffness, Flex Life Strength)	Testing performed on predicate, results applicable.
Alcohol Compatibility	Testing performed on predicate, results applicable.
Catheter Marking & Identification/Radiopacity Testing	Testing performed on predicate, results applicable. (Note: Specific print integrity test done for the modified device also, but overall marking/radiopacity is covered.)
Tensile Testing (Catheter and Assembly)	Testing performed on predicate, results applicable.
Valve Performance (for PASV and Hybrid models)	Testing performed on predicate, results applicable.
Leak Strength	Testing performed on predicate, results applicable.
Aspiration Strength	Testing performed on predicate, results applicable.
Vesicant Testing	Testing performed on predicate, results applicable.
Compatibility Testing	Testing performed on predicate, results applicable.

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

Sample Size: Not explicitly stated in terms of number of units tested for each specific test in this summary. The tests performed are typical for medical device bench testing.
Data Provenance: The new tests (biocompatibility and print integrity) were conducted by Navilyst Medical, Inc. (the submitter). The performance data for all other characteristics relies on studies previously conducted on the predicate devices (K093366, K111906, K150527), which were also manufactured by Navilyst Medical. Thus, the data provenance is from the manufacturer's internal testing. Not applicable for country of origin in this context, as it's bench testing. The data is effectively retrospective for the predicate device performance.

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

This question is not applicable to this type of device submission. The "ground truth" here is based on engineering specifications, standardized test methods (e.g., ISO, FDA guidance), and objective measurement. There are no "experts" establishing ground truth in the sense of clinical interpretation for a diagnostic AI.

4. Adjudication Method for the Test Set:

Not applicable. This is not a clinical study involving human judgment or interpretation. Performance is measured against physical and chemical standards.

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:

This question is not applicable. This device is a physical medical catheter, not an AI or diagnostic imaging device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

This question is not applicable. This device is a physical medical catheter, not an AI or diagnostic imaging device.

7. The Type of Ground Truth Used:

The ground truth used for validating the performance of the catheter is based on:

Established engineering specifications and design requirements.
International standards (e.g., EN ISO 10555-1, EN ISO 10555-3).
FDA guidance documents (e.g., "Guidance on Premarket Notification [510(K)] Submissions for Short-Term and Long-Term Intravascular Catheters," G95-1 for biocompatibility).
Objective physical and chemical measurements obtained through laboratory testing (e.g., flow rate measurements, burst strength, toxicity assays).

8. The Sample Size for the Training Set:

This question is not applicable. This device is a physical medical catheter and does not involve AI or machine learning algorithms that require a "training set."

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

This question is not applicable for the reasons stated above.

Ask a Question

Ask a specific question about this device

Page 1 of 1