(30 days)
The Vortex® EZ Port Access System is indicated for any patient requiring repeated access of the vascular system or other selected body site, for the delivery of medications, nutritional supplementation, fluids, blood, blood products, and sampling of blood.
The Vortex® EZ Port Access System is a device comprised of a vascular access port, a catheter, locking mechanism and introduction components. The Vortex® EZ Port is available in a Delrin port body configuration with a self sealing silicone septum designed to maintain integrity after repeated punctures with a non-coring needle. The port base is crafted of silicone so that the port can be sutured to the underlying tissue anywhere around this base. A pre-attached or a detached/attachable catheter is offered in either polyurethane or silicone models with or without a highly radiopaque tip molded on. The products are packaged in sterile trays with introduction components.
The provided text is a 510(k) summary for the Vortex® EZ Port Access System. This type of document focuses on establishing substantial equivalence to a legally marketed predicate device rather than detailing specific acceptance criteria and a study proving those criteria are met for novel device performance.
Therefore, many of the requested sections (e.g., acceptance criteria table, sample sizes for test/training sets, number and qualifications of experts for ground truth, adjudication methods, MRMC study, standalone performance, type of ground truth used, how ground truth for training set was established) are not applicable or not present in the provided document.
Here's a breakdown of what can be extracted or inferred based on the provided text, and what cannot:
1. Table of acceptance criteria and the reported device performance:
- Not applicable/Not present. The document states, "The Vortex® EZ Port Access System design was evaluated through risk analysis and qualified through design verification testing following established Design Control procedures." However, it does not provide specific acceptance criteria or the reported performance data against those criteria. It relies on substantial equivalence to predicate devices (LifePort® VTX® Access System (K010767) and LifePort® LPS 7013 (K905852)).
2. Sample size used for the test set and the data provenance:
- Not applicable/Not present. As this is a 510(k) for a device modification, clinical studies with test sets in the context of AI/imaging are not required or detailed here. The premarket notification focuses on design verification testing, which would involve engineering tests rather than patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not present. No ground truth established by experts is mentioned, as this is not an AI/imaging device.
4. Adjudication method for the test set:
- Not applicable/Not present. No adjudication method is mentioned.
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/Not present. This device is a vascular access system, not an AI-assisted diagnostic tool. Therefore, an MRMC study is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable/Not present. This is not an algorithm-based device.
7. The type of ground truth used:
- Not applicable/Not present. No ground truth in the context of clinical outcomes or pathology is used for this type of device submission. The "ground truth" for a medical device in a 510(k) context often relates to demonstrating that the device performs as intended and is safe and effective when compared to existing legally marketed devices, usually through engineering testing, biocompatibility testing, and sometimes bench or animal studies, not typically through clinical "ground truth" in the AI/diagnostics sense.
8. The sample size for the training set:
- Not applicable/Not present. This device is a physical medical device, not an AI model requiring a "training set."
9. How the ground truth for the training set was established:
- Not applicable/Not present. As above, no training set or ground truth in this context.
§ 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.