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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.

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