(168 days)
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.
| Test Description | Sample Size | Required Results (Acceptance Criteria) | Reported Device Performance |
|---|---|---|---|
| Sterilization exposure | All | All samples must be capable of withstanding a 2X sterilization cycle | Not explicitly stated; "non-clinical tests demonstrate that the device is as safe, as effective" implies compliance. |
| Physiological exposure | All | All samples must be capable of withstanding physiological conditioning | Not explicitly stated; "non-clinical tests demonstrate that the device is as safe, as effective" implies compliance. |
| Power injection Performance Test | 18 | Maximum Pressure: $(U-X)/s \geq k$ where k = 1.96 for an AQL level of 0.65; Catheter material failure: no bursts, leaks, / plastic deformations allowed | Not explicitly stated; "non-clinical tests demonstrate that the device is as safe, as effective" implies compliance. |
| Simulated Power Injection | 30 | All samples must meet expected flow rate and pressure withstand requirements | Not explicitly stated; "non-clinical tests demonstrate that the device is as safe, as effective" implies compliance. |
| Dynamic Failure Test | 18 | Data shall be gathered to support label claims and determine the operational safety factor. | Not explicitly stated; "non-clinical tests demonstrate that the device is as safe, as effective" implies compliance. |
| Static Burst Test | 18 | Data shall be gathered to support label claims. | Not explicitly stated; "non-clinical tests demonstrate that the device is as safe, as effective" implies compliance. |
| Life Cycle Power Injection Test | 10 | Catheter material failure: no bursts, leaks, / plastic deformations allowed | Not explicitly stated; "non-clinical tests demonstrate that the device is as safe, as effective" implies compliance. |
| Cyclic testing | 30, 10 cycles per port | All samples must withstand 10 cycles without leaking or bursting. The expected maximum number of power injection cycles is 5. | Not explicitly stated; "non-clinical tests demonstrate that the device is as safe, as effective" implies compliance. |
| Port Patency Verification | 5 | Blood return must be easily and empirically verifiable to establish safety of power injection | Not explicitly stated; "non-clinical tests demonstrate that the device is as safe, as effective" implies compliance. |
| Port Occlusion Test | 10 | Data shall be gathered to support label claims. | Not explicitly stated; "non-clinical tests demonstrate that the device is as safe, as effective" implies compliance. |
| Puncture Life | 2 | Establish label claim for largest needle likely to be used during power injection | Not explicitly stated; "non-clinical tests demonstrate that the device is as safe, as effective" implies compliance. |
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.
§ 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.