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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.

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.

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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.

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.

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