Search Results

The RyMed Technologies InVision-Plus CS™ with Neutral Advantage™ Technology Injection Port Systems are intended for single patient use in intravenous and blood administration sets without need for needles, thus eliminating the potential for needle-stick injuries during use.

The RyMed Technologies InVision-Plus" CS™ with Neutral Advantage™ Technology Injection Port contains silver ions and chlorhexidine, which are intended to inhibit the growth of microorganisms on the treated surfaces of the device, which include the septum and the fluid path.

The RyMed Technologies InVision-Plus® CSTM with Neutral Advantage™ Technology Injection Port has been shown to be effective for 7 days against the following microorganisms: Acinetobacter baumamnii, Methicillinresistant Staphylococcus aureus, Staphylococcus aureus, Escherichia coli, Candida albicans, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Staphylococcus epidermidis.

The subject device is not intended to treat existing infections. The device is not intended to have any effect on contaminated infusion solutions.

Correlation between in vitro antibacterial activity and any clinical effectiveness has not been tested.

The InVision-Plus® CSTM with Neutral Advantage™ Technology Injection Port Systems may be used with low pressure power injectors having a maximum pressure of 325 psi and a maximum flow rate of 10 ml/sec.

RyMed's InVision-Plus® CS™ with Neutral Advantage™ Technology features pronounced intraluminal catheter fluid pathway protection using a combination of ten mechanical design features incorporated specifically for patient protection. The Neutral Advantage™ Technology features include a smooth swabbable septum surface, septum seal integrity with no gaps or openings, a double microbial barrier, straightthrough fluid pathway, zero dead space, zero fluid displacement, low priming volume, 100% effective blood clearing, saline-only flush option and no clamping sequence or positive pressure syringe technique required.

The RyMed Technologies InVision-Plus® CS™ with Neutral Advantage™ Technology Injection Port Systems are intended for single patient use in intravenous and blood administration sets without needles, thus eliminating the potential for needle-stick injuries during use.

The RyMed Technologies InVision-Plus® CS™ with Neutral Advantage™ Technology Injection Port contains silver ions and chlorhexidine, which are intended to inhibit the growth of microorganisms on the treated surfaces of the device, which include the septum and the fluid path.

The RyMed Technologies InVision-Plus® CSTM with Neutral Advantage™ Technology Injection Port has been shown to be effective for 7 days against the following microorganisms: Acinetobacter baumannii, Methicillinresistant Staphylococcus aureus, Staphylococcus aureus, Escherichia coli, Candida albicans, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Staphylococcus epidermidis.

The subject device is not intended to treat existing infections. The device is not intended to have any effect on contaminated infusion solutions.

Correlation between in vitro antibacterial activity and any clinical effectiveness has not been tested.

The InVision-Plus® CS™ with Neutral Advantage™ Technology Injection Port Systems may be used with low pressure power injectors having a maximum pressure of 325 psi and a maximum flow rate of 10 mL/sec.

The device is offered in the following configurations:

• o Stand alone connector
• 0 Administration Sets
• o Stopcocks

The subject device is composed of materials that have been successfully and safely used in medical devices including the predicate devices. The materials used in the subject device have been subjected to and passed biocompatibility testing.

The subject device may be used with low pressure power injectors having a maximum pressure of 325 psi and a maximum flow rate of 10 mL/sec. When used with a low pressure power injector, the subject device must be secured with other devices rated for pressures up to 325 psi with a luer lock connection.

The subject devices are sterile single-use devices.

The acceptance criteria for the RyMed Technologies InVision-Plus® CS™ with Neutral Advantage™ Technology Injection Port System, as well as the study details, are derived from the provided 510(k) submission.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state a sample size for the test set in terms of a specific number of devices. However, the performance data cited appears to be from in vitro studies. The provenance is not explicitly mentioned as a country of origin, but the testing would have been conducted by or for RyMed Technologies, Inc., which is a US-based company. The nature of these tests (biocompatibility, microbial ingress, physical/mechanical) indicates they are prospective in nature, performed specifically to evaluate the device.

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

This information is not provided in the document. The studies performed (biocompatibility, microbial, physical/mechanical) rely on standardized testing methodologies and objective measurements rather than expert consensus on a 'ground truth' in the way clinical studies often do.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided. The testing described (biocompatibility, microbial, physical/mechanical) does not involve adjudication by experts as there are objective pass/fail criteria for these types of in vitro tests.

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

No, an MRMC comparative effectiveness study was not done. This device is an intravascular administration set with antimicrobial properties, not an AI-assisted diagnostic or imaging device that would typically undergo such a study.

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

Yes, the performance data described reflects standalone algorithm/device performance. The device's antimicrobial effectiveness, biocompatibility, and physical properties were tested directly, independent of a human operator's performance or interpretation.

7. The Type of Ground Truth Used

The ground truth for the performance criteria is based on objective measurements and standardized laboratory testing protocols.

• Biocompatibility: Established by adherence to ISO 10993 standards and measuring biological responses.
• Antimicrobial Effectiveness: Established by quantifying the inhibition of microbial growth on treated surfaces through laboratory incubation and enumeration methods.
• Physical/Mechanical Properties (Seal Integrity, Pressure, Flow Rate): Established by direct measurement against predefined specifications using appropriate engineering and fluid dynamics testing.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided. This device is not an AI/machine learning model, so there is no "training set" in the conventional sense. The device itself is the product being tested.

9. How the Ground Truth for the Training Set was Established

This information is not applicable. Since there is no training set as per an AI/ML model, there is no ground truth for a training set to be established.

Ask a specific question about this device

The RyMed Technologies InVision-Plus™ Injection Port Systems are intended for single patient use in intravenous and blood administration sets without need for needles, thus eliminating the potential for needle-stick injuries during use.

The RyMed Technologies INVISION-PLUS™ Injection Port Systems are composed of either a Heparin Lock Injection Port, or a Y - Injection Port that contain a specialized two part valve made from medical grade Silicone material. The female luer housing, guide washer, and heparin lock are made from medical grade plastics. The valve provides excellent fluid Flow Rates, low Priming Volumes, and reseals after extended use.

The provided document is a 510(k) premarket notification for a medical device (RyMed Technologies INVISION-PLUS™ Injection Ports), not a study report for an AI/ML device. Therefore, the specific information requested in points 2-9 (related to AI/ML study design) is not applicable or cannot be extracted from this document.

However, I can extract and present the acceptance criteria for the device and its reported performance based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance:

Ask a specific question about this device

The RyMed Technologies SLAV™ Injection Port Systems are intended for single patient use in intravenous and blood administration.

The RyMed Technologies SLAV™ Injection Port Systems are composed of either a Heparin Lock Injection Port, or a Y-Injection Site Port that contain a specialized two piece valve made from a medical grade clear plastic and a medical grade Slicone material. This specialized valve completely eliminates the use of Needles forcing compliance with the new OSHA standards of safety avoiding accidental needle stick injuries, the valve also provides excellent fluid Flow Rates, requires very low Priming Volumes, and it eliminates "dead spaces" that could entrap blood. This valve has the ability to activate injection ports a minimum of 100 times without leaking or change in its performance.

Here's an analysis of the provided text, focusing on acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document itself doesn't explicitly state "acceptance criteria" but rather "Performance Data" which implies these were the benchmarks the device needed to meet. The "Feature" table provides values (e.g., flow rate of 310-350 mls/min for SLAV™) which are even better than the pass/fail criteria listed in the performance summary. For instance, the stated flow rate of 310-350 mls/min comfortably exceeds the "≥ 150 cc / min." criterion.

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

• Sample Size for Test Set: Not explicitly stated. The document indicates tests were performed on the SLAV™ Injection Port, the BRAUN SafSite®, and the Medex Nu-Site™. However, the number of units of each device tested for these performance parameters (e.g., flow rate, priming volume, activations) is not provided.
• Data Provenance: Not explicitly stated. Given it's a pre-market notification (510k) within the US, it's reasonable to infer the data was generated in a testing environment likely within the US by or for RyMed Technologies, Inc. However, whether this was a retrospective analysis of existing data or prospectively gathered for this submission is not specified.

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

• This information is not applicable to this type of device and study. The "ground truth" for performance characteristics like flow rate, priming volume, and activation endurance is established by objective, measurable laboratory tests, not by expert consensus or interpretation.

4. Adjudication Method for the Test Set

• Not applicable. As the ground truth is based on objective laboratory measurements, there is no need for an adjudication method by human experts. The results are quantitative (e.g., flow rate in mls/min) or binary (pass/fail) based on predefined thresholds.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or interpretive devices where human readers (e.g., radiologists) are involved in interpreting outputs, and the AI's role is to assist or improve their performance. The SLAV™ Injection Port is a medical device with objective performance characteristics (e.g., flow rate, physical endurance), not an interpretive aid.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Yes, a standalone performance assessment was effectively done. The performance data presented (Fluid Flow Rate, Ideal Priming Volume, 100 Activations) reflects the intrinsic performance of the device itself, independent of human interaction beyond operating the testing equipment. There is no AI algorithm involved in the function of this device, so the concept of "algorithm only" directly translates to the device's inherent performance.

7. The Type of Ground Truth Used

• Objective Laboratory Measurements against Predetermined Thresholds: The ground truth for the performance tests was established by objective, quantifiable laboratory measurements. For example, a flow rate was measured in mls/min and compared against a threshold (≥ 150 cc/min) to determine a "Pass" or "Fail." Similarly, priming volume was measured and compared to a threshold (

Ask a specific question about this device