(288 days)
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
| Acceptance Criteria (Test) | SLAV™ Injection Port Performance (Reported)** |
|---|---|
| Fluid Flow Rate ≥ 150 cc / min. | Passed |
| Ideal Priming Volume less than 0.1 mls | Passed |
| 100 Activations with no leaking or change in performance capabilities | Passed |
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 (
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.