(24 days)
The Xcela™ Hybrid 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 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.
The Xcela™ Hybrid PICC with PASVTM Valve Technology are flexible radiopaque catheters with suture wings for catheter securement, extension tubes(s) which connect to proximally located luer lock adapter(s) with two pressure activated safety valves (PASV™), available in a triple lumen configuration; a reverse tapered shaft to aid in staunching bleeding at the insertion site and a non-valved lumen for central venous pressure monitoring. The lumens are differentiated by proximally located colored extension tube clamps and/or colored luer adaptors, with gauge descriptor, if the lumen is rated for power injection the maximum power injection flow rates, and "NO CT" for non-power injectable lumens. The Xcela™ Hybrid PICC with PASV™ Valve Technology is designed with the option of being used with power injectors for the administration of contrast media for imaging studies such as Computerized Tomography (CT) scans and Magnetic Resonance Imaging (MRIs). The catheters are available as single, sterile packages with a variety of procedural accessories in standard kit configurations and as a convenience to suite specific clinical needs.
Here's an analysis of the provided text regarding the acceptance criteria and study for the XCELA™ HYBRID PICC WITH PASV™ VALVE TECHNOLOGY:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test Objective) | Reported Device Performance |
|---|---|
| Product Labeling: Verify catheter is labeled correctly. | PASS |
| Central Venous Pressure Monitoring: Verify that catheter can monitor central venous pressure (Non-Valved Lumen Only). | PASS |
| Luer Connection: Verify luer to EN 1707. | PASS |
| Assembly Leak Strength: Verify the catheter assembly does not leak simulating the method in ISO 10555-1 clause 4.6.1. | PASS |
| Assembly Aspiration Strength (Closed Ended): Verify catheter assembly does not leak simulating the method in ISO 10555-1 clause 4.6.2. | PASS |
| Assembly Aspiration Strength (Open Ended): Verify the catheter assembly does not leak simulating the method in ISO 10555-1 clause 4.6.2. | PASS |
| Priming Volume: Verify the priming volume of the catheter. | PASS |
| Power Injection Flow Rate: Verify the catheter can meet its labeled flow rate. | PASS |
| Power Injection Multiple Injections: Verify catheter can withstand multiple simulated use injections at the maximum target flow rate. | PASS |
| Static Burst: Verify catheter does not leak/burst when taken to failure below the minimum requirement. | PASS |
| Oversleeve to PASV™ Valve Housing and Hybrid Luer Tensile Strength: Verify force at break of the valve housing to oversleeve and hybrid luer to oversleeve simulating the method in ISO 10555-1 clause 4.5 and ISO 10555-3 clause 4.7. | PASS |
| Gravity Flow Rate: Verify gravity flow rate of the catheter simulating the method in ISO 10555-3 clause 4.6. | PASS |
| Long term Extension Tube Life (Non-valved lumen): Verify effectiveness of extension tube to undergo repeat clamping without cracking or leaking. | PASS |
| Long Term Clamp Life (Non-Valved lumen): Verify effectiveness of clamp to undergo repeat clamping without cracking. | PASS |
| Long Term Clamp Life Compatibility with Extension Tube (non-Valved lumen): Verify effectiveness of clamp and extension tube to not leak after repeat clamping. | PASS |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size for the individual tests. It only states that "Performance Testing – Proposed 6F Triple Lumen Hybrid PICC with PASV™" was conducted. The data provenance is not explicitly mentioned (e.g., country of origin, retrospective or prospective), but given the nature of the tests (benchtop performance), it's implied to be laboratory-based testing rather than clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this type of device submission. The "ground truth" for these performance tests is established by objective engineering and scientific measurements against predetermined standards (e.g., ISO standards, manufacturer specifications) rather than expert interpretation of images or patient outcomes.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for studies involving human interpretation or clinical endpoints, where disagreements might arise. For the performance tests listed, the results are objective measurements (e.g., pass/fail based on a threshold).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of medical images. The Xcela™ Hybrid PICC is a medical device for vascular access, and its performance evaluation focuses on its physical and functional integrity.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone (algorithm only) performance study was not done. This concept applies to AI/ML algorithms where the algorithm's performance is assessed independently of human interaction. The Xcela™ Hybrid PICC is a physical medical device, not an AI algorithm. Its performance is inherent to its design and manufacturing.
7. The Type of Ground Truth Used
The ground truth for the performance tests is based on engineering specifications and established international standards (EN ISO 10555-1:2009, EN ISO 10555-3:1997 COR 2002) and FDA guidance documents. These standards define the acceptable range of performance for each characteristic (e.g., leak strength, flow rate, tensile strength). The "PASS" result indicates that the device met these objective, pre-defined criteria.
8. The Sample Size for the Training Set
This information is not applicable. Training sets are used for machine learning models. The Xcela™ Hybrid PICC is a physical device, not an AI/ML system.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no training set for this device.
§ 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.”