(19 days)
The Vaxcel™ w/ PASV® Port device is intended for use in patients who require long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, antibiotics, chemotherapy, analgesics, nutritional therapy, and blood products. The device is also indicated for blood specimen withdrawal.
The device is available in standard and mini port configurations made of either Titanium or Polysulfone materials.
The presented text is a 510(k) summary for the Vaxcel™ with PASV® implantable port system. This document outlines the device's intended use, classification, and a summary of substantial equivalence to predicate devices, focusing on biocompatibility and performance. It does not provide details of a clinical study with acceptance criteria and device performance in the way a diagnostic or treatment efficacy study would.
Instead, the submission demonstrates substantial equivalence to already legally marketed predicate devices. This means the device is considered as safe and effective as a legally marketed device that does not require premarket approval.
Therefore, many of the specific questions about clinical study details, such as sample size for test sets, number of experts for ground truth, adjudication methods, MRMC studies, and standalone performance, are not applicable in the context of this 510(k) submission.
Here's the information that can be extracted or deduced from the provided text:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Demonstrated Equivalency) | Reported Device Performance (Summary) |
|---|---|
| Biocompatibility: Meet ISO 10993 standards | All data demonstrate this device is biocompatible for its intended use. |
| Substantial Equivalence: To predicate devices | All data gathered demonstrate this device as substantially equivalent. No new issues of safety or efficacy have been raised. |
| Intended Use: As per predicate devices | Intended for long-term central venous access for administration of fluids and blood specimen withdrawal. |
| Performance: As per predicate devices | (Implicitly, the device performs similarly to the predicate devices for its intended use.) |
2. Sample size used for the test set and the data provenance: Not applicable. This is a 510(k) substantial equivalence submission, not a stand-alone clinical study with a defined test set as would be for a diagnostic or treatment device. The "testing" referred to is likely in-vitro testing for biocompatibility and engineering performance comparisons to the predicate, rather than human subject testing in the traditional sense for effectiveness.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for a substantial equivalence submission of this nature. The determination of "ground truth" here is based on regulatory assessment of the device's design, materials, and intended use compared to predicate devices, supported by engineering and biocompatibility data.
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-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is an implantable port system, not a software algorithm.
7. The type of ground truth used:
- Predicate Device Performance: The primary "ground truth" for this 510(k) is the established safety and effectiveness of the legally marketed predicate devices (Vaxcel™ Implantable port system, PASV® implantable port system, Vaxcel™ with PASV® PICC).
- Biocompatibility Standards: ISO 10993 standards serve as the "ground truth" for biocompatibility assessment.
8. The sample size for the training set: Not applicable. There is no concept of a "training set" in this type of device submission.
9. How the ground truth for the training set was established: Not applicable.
§ 880.5965 Subcutaneous, implanted, intravascular infusion port and catheter.
(a)
Identification. A subcutaneous, implanted, intravascular infusion port and catheter is a device that consists of a subcutaneous, implanted reservoir that connects to a long-term intravascular catheter. The device allows for repeated access to the vascular system for the infusion of fluids and medications and the sampling of blood. The device consists of a portal body with a resealable septum and outlet made of metal, plastic, or combination of these materials and a long-term intravascular catheter is either preattached to the port or attached to the port at the time of device placement. The device is available in various profiles and sizes and can be of a single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on 510(k) Submissions for Implanted Infusion Ports,” FDA October 1990.