(7 days)
The Vortex® MP Peripheral Access System is indicated for peripheral placement in the mid-arm, above the antecubital space and well below the subaxillary area, when patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling.
The Vortex® MP Peripheral 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 an non-coring needle. The catheter is offered in polyurethance and silicone models. The products are packaged in sterile trays with introduction components.
This 510(k) summary (K032754) is for a medical device, the Vortex® MP Peripheral Access System, not a software or AI-powered diagnostic device. Therefore, many of the requested criteria, such as "acceptance criteria," "reported device performance," "sample sizes for test and training sets," "ground truth establishment," "MRMC studies," or "standalone performance," are not applicable in the context of AI/software validation.
The document describes a traditional substantial equivalence determination for a physical medical device. The manufacturer is demonstrating that their new device is as safe and effective as a legally marketed predicate device, not validating a new algorithm or diagnostic tool.
Here's a breakdown of what can be extracted from the provided text, and where the information relevant to AI/software validation is missing or not applicable:
1. Table of Acceptance Criteria and Reported Device Performance:
This document does not provide explicit quantitative acceptance criteria or reported performance metrics in the way one would expect for an AI diagnostic study (e.g., sensitivity, specificity thresholds). Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to the predicate device through design evaluation and verification testing.
| Acceptance Criteria (Implicit) | Reported Device Performance (Implicit) |
|---|---|
| Safety and effectiveness substantially equivalent to predicate device | "The Vortex® MP Peripheral Access System design was evaluated through HMP risk and qualified through design verification testing following established Design Control procedures. No new questions of safety or effectiveness were raised for the Vortex® MP Peripheral Access System." |
| Maintains integrity after repeated punctures with a non-coring needle | "titanium configuration with a self sealing silicone septum designed to maintain integrity after repeated punctures with an non-coring needle." |
| Appropriate for indicated peripheral placement and venous access | Indicated for "peripheral placement in the mid-arm, above the antecubital space and well below the subaxillary area, when patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling." |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not applicable/not reported in the context of an AI/software validation. The "design verification testing" would involve engineering tests on device prototypes, the specific "sample size" of which is not detailed here.
- Data Provenance: Not applicable. This refers to the testing of a physical device, not patient data in terms of its origin (country, etc.). The testing would have been conducted by the manufacturer (Horizon Medical Products, Inc.).
- Retrospective or Prospective: Not applicable. This refers to experimental design for data collection, not the physical testing of a medical device's components.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable. Ground truth in this context would relate to the performance of the physical device components during engineering testing, typically assessed against design specifications and industry standards by engineers, not medical experts establishing a diagnostic "ground truth."
- Qualifications of Experts: Not applicable for establishing ground truth in this type of submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication Method: Not applicable. This pertains to resolving disagreements among multiple human readers for diagnostic image interpretation, which is not relevant here.
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:
- MRMC Study: No, an MRMC study was not done. This is exclusively a physical medical device.
- Effect Size of AI Improvement: Not applicable. The device does not incorporate AI for diagnostic or interpretative tasks.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable. There is no algorithm to evaluate in a standalone manner.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: For a physical device, "ground truth" would refer to established engineering and material science principles, performance specifications (e.g., septum resealability, material biocompatibility, structural integrity), and comparisons against the predicate device's known characteristics. It's not clinical "ground truth" in the diagnostic sense.
8. The sample size for the training set:
- Sample Size for Training Set: Not applicable. This device is not an AI/ML model that undergoes a "training" phase.
9. How the ground truth for the training set was established:
- How Ground Truth for 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.