(15 days)
The Vortex® MP Vascular Access System is indicated for central venous placement (either peripheral or chest placement) when patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling.
The Vortex® MP Vascular Access System is a device comprised of a vascular access port, a catheter, locking mechanism and introduction components. The Vortex MP® Port is available in a titanium configuration with a self sealing silicone septum designed to maintain integrity after repeated punctures with a non-coring needle. The catheter is offered in polyurethane and silicone models. The products are packaged in sterile trays with introduction components.
The provided document is a 510(k) Pre-market Notification for a device modification of the Horizon Medical Products, Inc. Vortex® MP Vascular Access System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving the device meets specific performance acceptance criteria through clinical studies as would typically be described for a novel device or AI/ML product.
Therefore, many of the requested categories (such as sample sizes for test sets, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, and large-scale training set details) are not applicable to this type of regulatory submission. The submission focuses on design verification testing to ensure the modified device maintains the same performance and safety profile as its predicate.
Here's an analysis based on the information available:
Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
Summary: The submission states that the Vortex® MP Vascular Access System was evaluated through HMP risk analysis and qualified through design verification testing following established Design Control procedures. The conclusion is that "No new questions of safety or effectiveness were raised for the Vortex MP Vascular Access System."
This indicates that the "acceptance criteria" were met by demonstrating that the modified device's performance aligns with the predicate device (Horizon Medical Products Vortex® MP Peripheral Access System, K032754) through engineering and design verification tests, rather than a clinical trial with specific performance metrics like sensitivity/specificity often seen in AI/ML device evaluations.
1. Table of Acceptance Criteria and Reported Device Performance
Given this is a 510(k) for a modification and an "equivalent device" claim, explicit acceptance criteria with quantitative performance metrics for a clinical study are not provided in this summary. The "acceptance criteria" are implied to be adherence to design specifications and safety/effectiveness equivalence to the predicate device.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Functional equivalence to predicate device (Vortex® MP Peripheral Access System K032754) | "The subject and predicate devices utilize the identical fundamental scientific technology and are identical in configuration and dimensions. The subject and predicate devices are substantially similar in materials of construction." |
| Safety and Effectiveness maintained after modification | "The Vortex MP Vascular Access System was evaluated through HMP risk analysis and qualified through design verification testing following established Design Control procedures. No new questions of safety or effectiveness were raised for the Vortex MP Vascular Access System." |
| Self-sealing septum integrity after repeated punctures | "The Vortex MP® Port is... designed to maintain integrity after repeated punctures with a non-coring needle." (This is a design feature, its performance likely verified during design testing). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. The document refers to "design verification testing," which typically involves engineering bench testing, material testing, and functional testing on a sample of devices, rather than a clinical test set with patient data. The quantity of devices tested is not specified in this summary.
- Data Provenance: Not applicable. No patient data or clinical data provenance is mentioned.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. This type of submission does not involve expert adjudication of a test set in the way an AI/ML product would.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. No test set requiring adjudication by experts is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is not relevant for a 510(k) general device modification.
6. If a Standalone Study was Done
- Standalone Study: Not applicable. The term "standalone" performance typically refers to the algorithmic performance of an AI system without human interaction. This document describes a physical medical device.
7. The Type of Ground Truth Used
- Type of Ground Truth: For the "design verification testing," the ground truth would be defined by engineering specifications, material standards, and performance benchmarks derived from the predicate device and relevant industry standards. It is not based on "expert consensus, pathology, or outcomes data" in a clinical sense.
8. The Sample Size for the Training Set
- Sample Size: Not applicable. There is no concept of a "training set" for this type of physical device modification submission.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth Was Established: Not applicable, as there is no training set.
§ 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.