(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. Maximum power injection flow rate:
4F Single Lumen, 45 cm - 4 mL/sec
4F Single Lumen, 55 cm - 3.5 mL/sec
5F Single Lumen, 55 cm - 5 mL/sec
5F Dual Lumen, 45 cm - 5 mL/sec
5F Dual Lumen, 55 cm - 4 mL/sec
6F Dual Lumen, 55 cm - 5 mL/sec
The Xcela Power Injectable PICC is a peripherally inserted central catheter. It is available in single and multi-lumen configurations in a wide range of sized from 4F to 6F outside catheter diameter. It is rated for maximum power injector settings up to 325 psi and rated for maximum power injection flow rate up to 5 ml/second based on model. It is available kitted with a range of procedural accessories for user convenience. Changes from the predicate device include the addition of an oversleeve to the extension tube, a new non-valved luer design, and inclusion of maximum flow rates into the indication statement.
The provided document is a 510(k) Summary for a medical device called "Xcela Power Injectable PICC." It focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and performance data. The document does not contain information about acceptance criteria or specific studies in the context of AI/ML device performance as requested in the prompt.
Therefore, many of the requested fields cannot be filled from the provided text.
Here's an attempt to answer based only on the provided text, indicating where information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not specify quantitative acceptance criteria in terms of performance metrics (e.g., accuracy, sensitivity, specificity) for an AI/ML device. Instead, it refers to equivalence based on technological characteristics and non-clinical tests.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| PICC Functionality: Intravenous therapy, administration of fluids, medications, nutrients, blood sampling, power injection of contrast media. | The device is "intended for short- or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, and power injection of contrast media." This suggests it meets the functional intent. |
| Power Injection Flow Rate (Maximum): (Various rates depending on size/lumen) | The device is "rated for maximum power injector settings up to 325 psi" and "rated for maximum power injection flow rate up to 5 ml/second based on model." Specific rates for each configuration are listed (e.g., 4F Single Lumen, 45 cm - 4 mL/sec). |
| Technological Characteristics: Inclusion of an oversleeve, a new non-valved luer design, absence of Endexo (compared to one predicate, similar to another). | The device "incorporates changes that include: addition of an oversleeve to the extension tube, a new non-valved luer design, and inclusion of maximum flow rates into the indication statement." It does not contain Endexo, similar to K070002. |
| Non-clinical Test Compliance: Adherence to specific ISO standards and FDA guidance. | The device followed: EN ISO 10555-1:2009, EN ISO 10555-3:1997 Corrigendum 1:2002, and FDA's "Guidance on Premarket Notification [510(K)] Submissions for Short-Term and Long-Term Intravascular Catheters dated March 16, 1995." |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable. The document describes non-clinical "performance evaluation" and "non-clinical tests" but does not specify a "test set" in the context of AI/ML validation (e.g., a dataset of images or patient cases). The tests are for the physical device.
- Data Provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This is not an AI/ML device validation.
4. Adjudication method for the test set
- Not applicable.
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. This is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/ML device.
7. The type of ground truth used
- Not applicable in the AI/ML sense. The "ground truth" for this device would be established by physical and chemical testing against defined specifications and standards, confirming material properties, dimensional accuracy, flow rates, pressure resistance, and biological safety (e.g., biocompatibility testing, not detailed here but implied by compliance with standards).
8. The sample size for the training set
- Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/ML 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.”