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510(k) Data Aggregation
(147 days)
MEDEFLUSH NORMAL SALINE I.V. FLUSH SYRINGE-STERILE FIELD READY
FOR USE TO MAINTAIN THE PATENCY OF IN-DWELLING INTRAVENOUS VASCULAR ACCESS DEVICES (IVAD)
The DEVICE, the subject of this 510 (k), MEDEFLUSH™ Normal Saline I. V. Flush Syringe - Sterile Field Ready (0.9% Sodium Chloride Flush Syringe, USP) will be sealed with tip cap, filled with 0.9% Sodium Chloride solution, sealed with plunger stopper, inspected, plunger rod inserted, labeled and then pouched in steam sterilizable paper pouch prior to terminally sterilization as compared to its predicate device which is sealed with tip cap, filled with 0.9% Sodium Chloride solution, sealed with plunger stopper, steam sterilized and then inspected, plunger rod inserted and labeled prior to packaging. The DEVICE will be marketed in various sizes and fill volumes similar to its predicate device.
The provided text is a 510(k) summary for the MEDEFLUSH™ Normal Saline I. V. Flush Syringe - Sterile Field Ready. This document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study with specific acceptance criteria and performance data for the device itself in terms of clinical outcomes or diagnostic accuracy.
Therefore, many of the requested categories for device evaluation (such as sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set size, etc.) are not applicable to this type of regulatory submission, as it does not involve an AI/ML-based diagnostic or prognostic device requiring such studies.
The acceptance criteria for this type of device are primarily related to its physical and chemical properties, manufacturing processes, and sterility, ensuring it functions as intended and is safe for use. The "study" proving it meets acceptance criteria is primarily an equivalence comparison to a legally marketed predicate device, coupled with quality control measures for manufacturing and sterilization.
Here's a breakdown based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance/Comparison |
|---|---|
| Intended Use | Same intended use as the Predicate Device: To maintain patency of in-dwelling intravenous vascular access devices (IVAD). |
| Device Description | Similar to predicate: Sealed with tip cap, filled with 0.9% Sodium Chloride solution, sealed with plunger stopper, plunger rod inserted, labeled. Marketed in various sizes and fill volumes (1mL-10mL fill in 6mL or 12mL syringes). |
| Sterility | Terminal sterilization after packaging in a steam sterilizable paper pouch, compared to predicate's sterilization before packaging. This is the key modification to achieve "Sterile Field Ready" status. Implicitly, sterility must meet established standards, although the specific standard is not detailed beyond "steam sterilizable paper pouch." |
| Pyrogen-free | The device shall be pyrogen free per the LAL test method for bacterial endotoxin. (This is a performance requirement, implying the device must pass this test.) |
| Packaging | Same packaging as the Predicate Device, individually packaged in a steam sterilizable paper pouch. The modification directly relates to the packaging and sterilization sequence. |
| Substantial Equivalence to Predicate Device | The core "performance" is its demonstration of substantial equivalence to Medefil, Inc. Normal Saline I. V. Flush Syringe (K091583). The proposed modification is specifically articulated: "making Normal Saline I. V. Flush Syringe ready for usage in Sterile Field." This implies that all other aspects (material, safety, efficacy for intended use) are equivalent to the predicate. |
| Material/Composition (0.9% Sodium Chloride, USP) | Implicitly meets USP standards, as it states "0.9% Sodium Chloride Flush Syringe, USP." |
2. Sample Size Used for the Test Set and the Data Provenance
This is not applicable for this type of 510(k) submission. There is no specific "test set" in the context of diagnostic performance or clinical trials. The submission relies on demonstrating substantial equivalence to a predicate device already on the market and adherence to manufacturing and sterility standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This is not applicable. Ground truth establishment by experts is relevant for diagnostic devices that interpret data (e.g., medical images). This product is a medical device for flushing IV lines.
4. Adjudication Method for the Test Set
This is not applicable.
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
This is not applicable. This device is not an AI/ML-based diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable.
7. The Type of Ground Truth Used
This is not applicable in the context of diagnostic accuracy. The "ground truth" for this device relates to:
- Established physical/chemical properties: 0.9% Sodium Chloride solution meeting USP standards.
- Sterility: Demonstrated through validated sterilization processes (e.g., steam sterilization cycle validation) and LAL testing for endotoxins.
- Functional equivalence: Comparison to the predicate device for its ability to maintain patency of IVADs, implying that its design and basic function are proven.
8. The Sample Size for the Training Set
This is not applicable. There is no "training set" as this is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established
This is not applicable.
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