Search Results

The Vortex® CT 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 the sampling of blood.

When used with non Y site LifeGuard Safety infusion sets in 20 Ga or 19Ga sizes, the Vortex® CT Port Access System is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/sec.

The LifeGuard® Safety Infusion Set is indicated for use in the administration of fluids and drugs, as well as blood sampling through surgically implanted vascular ports.

When used with the Vortex® CT Port Access System, the LifeGuard® Safety Infusion Set is also indicated for power injection of contrast media into the central venous system. For power injection of contrast media, only models LG-19-75, LG-19-100, LG-20-75, LG-20-100, and LG-20-150 may be used at a maximum infusion rate of Sml/sec.

The Vortex® CT Port is a Titanium port with a self sealing silicone rubber septum designed to maintain integrity after punctures with a non-coring needle. The port has a hollow area, or reservoir, under the septum through which fluid passes during infusion or aspiration. The Vortex design features a proprietary reservoir with rounded walls giving it a toroidal shape. The outlet stem is located tangential to the reservoir wall allows fluid to pass between the reservoir and the catheter. The Vortex® Port Access systems offer models with single lumen 7.5 French to 9.6 French catheters made from either polyurethane or silicone. The catheters all contain radiopacifiers, and depth markings.

The LifeGuard safety infusion set is a port access needle set with an integrated proprietary safety feature to prevent re-bound injury. The safety infusion set includes a huber needle, a winged housing, non-DEHP PVC extension legs, and a luer standard connector.

This document describes the non-clinical performance data for the Vortex® CT Port Access System and LifeGuard® Safety Infusion Set, which is a medical device for vascular access and power injection of contrast media.

Here's the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide specific "reported device performance" values for each test, but rather indicates that the tests were performed to establish substantial equivalence, safety, and effectiveness. The "Required Results" column from the provided table serves as the acceptance criteria.

The study concludes that "The non-clinical tests demonstrate that the device is as safe, as effective for the modified intended use." This statement implies that the device met all the required results set as acceptance criteria for the non-clinical tests.

2. Sample Size Used for the Test Set and the Data Provenance

• Test Set Sample Sizes:
  • Sterilization exposure: All
  • Physiological exposure: All
  • Power injection Performance Test: 18
  • Simulated Power Injection: 30
  • Dynamic Failure Test: 18
  • Static Burst Test: 18
  • Life Cycle Power Injection Test: 10
  • Cyclic testing: 30, 10 cycles per port
  • Port Patency Verification: 5
  • Port Occlusion Test: 10
  • Puncture Life: 2
• Data Provenance: The data is from non-clinical testing. There is no mention of country of origin for the data (as it's laboratory-based testing, not human patient data) and it is inherently prospective as it involves conducting specific tests on the devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. This is a submission for a physical medical device (Vortex® CT Port Access System and LifeGuard® Safety Infusion Set) and the testing performed is non-clinical/pre-clinical (laboratory-based physical and performance testing), not involving human interpretative tasks or diagnostic assessment. Therefore, no experts were used to establish ground truth in the context of diagnostic accuracy, and no qualifications of such experts are relevant.

4. Adjudication Method for the Test Set

Not applicable, for the same reasons as point 3. The tests are objective physical and performance measurements with defined pass/fail criteria, not subjective assessments requiring adjudication.

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 device is a physical medical port and infusion set, not an AI or imaging diagnostic tool. Therefore, MRMC studies and AI assistance are not relevant to its evaluation.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This device is a physical medical product, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the non-clinical tests is based on pre-defined engineering specifications and performance requirements. These are objective, measurable outcomes (e.g., "no bursts, leaks, / plastic deformations allowed," "meet expected flow rate and pressure withstand requirements," "withstand 10 cycles").

8. The sample size for the training set

Not applicable. Since this is a physical medical device and not an AI/machine learning model, there is no "training set."

9. How the ground truth for the training set was established

Not applicable, for the same reason as point 8.

Ask a specific question about this device

The HuberPRO ™ Safety Huber Infusion Set is intended to administer solutions and medications into vascular implant ports. In addition, to minimize the risk of accidental needle stick injury after use, the attached safety guard fully encapulates the needle when manually activated during withdrawal.

The device consists of a Protector cap, female Luer lock, PVC tubing, two each 4 inch, or one 8 inch tubing length and ( .3 mm) ID, a pinch clamp, with and without a needle free y- site, a butterfly wing, a safety needle guard, an AISI 304 (19ga., 20ga., 22ga.) stainless steel needle, and a needle sheath.

The provided text is a 510(k) premarket notification summary for a medical device, the "HuberPRO™ Safety Huber Infusion Set." This type of submission focuses on demonstrating substantial equivalence to pre-existing devices rather than detailing specific studies with acceptance criteria for device performance in a clinical or diagnostic setting. Therefore, the document does not describe acceptance criteria for device performance or a study proving the device meets those criteria in the way one might expect for an AI/machine learning medical device.

Instead, the document asserts: "Based on the fact that the HuberPRO™ Safety Huber Infusion Sets utilizes similar and equivalent designs, components, manufacturing Processes as currently legally marketed Products, the Safety Huber Infusion Set is safe and effective when used as intended." This statement serves as the justification for its safety and effectiveness, relying on the substantial equivalence principle rather than new performance data with discrete acceptance criteria.

Consequently, I cannot fill out the requested table and sections as they pertain to performance metrics and studies typical for AI/ML devices. The information simply isn't present in this 510(k) document.

Ask a specific question about this device