(24 days)
The 0.9% Sodium Chloride Injection, USP, BD Posiflush SF Flush Syringes are intended for use in maintaining patency of vascular access devices (VAD's).
The Modified Device, the subject of this 510(k), the 0.9% Sodium Chloride Injection, USP BD Posiflush SF Pre-Filled Flush Syringe was modified by changing the current individual package wrap to a package that is capable of being sterilized and will maintain sterility of the exterior of the device. This will allow the device to be used on sterile field applications. The Modified Device is manufactured of the same materials, has the same intended use and SAL of 10-6 as the Predicate Device.
The provided text describes a 510(k) premarket notification for a modified medical device, the 0.9% Sodium Chloride Injection, USP-BD Posiflush SF Flush Syringe. The modification is primarily a change in the individual package wrap to allow for sterilization and maintain sterility of the device's exterior for sterile field applications. The core device (syringe and its contents) remains unchanged from its predicate.
Based on the information provided, the following points can be extracted or inferred regarding the device's acceptance criteria and the study that proves it:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Equivalence to Predicate Device: Must perform in an equivalent manner to the predicate device in terms of safety and effectiveness. | "Design Verification tests were performed based on the risk analysis performed and the results of these tests demonstrate that the BD Posiflush SF Flush Syringe performed in an equivalent manner to the predicate device and is safe and effective when used as intended." |
| Sterility Assurance Level (SAL): Maintain SAL of 10-6. | The modified device "has the same intended use and SAL of 10-6 as the Predicate Device." |
| Purpose: Intended for use in maintaining patency of vascular access devices (VAD's). | The modified device "is intended for use in maintaining patency of vascular access devices (VAD's)." |
| Sterile Field Application: Capable of being sterilized and maintaining sterility of the exterior for sterile field applications. | The modification was made by "changing the current individual package wrap to a package that is capable of being sterilized and will maintain sterility of the exterior of the device. This will allow the device to be used on sterile field applications." |
| Material Equivalence: Manufactured of the same materials as the predicate device. | The modified device "is manufactured of the same materials... as the Predicate Device." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a sample size for a test set in the traditional sense of a clinical trial. The evaluation primarily relied on "Design Verification tests" based on a "risk analysis." These tests would likely involve laboratory or engineering testing of the package and device properties, rather than human subject testing with a specific "test set" sample size. The data provenance is not specified, but it would be from internal Becton Dickinson testing (likely in the US, given the submission to the FDA). The study is retrospective in the sense that it evaluates a modified device against an already existing predicate.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided. Given the nature of the device modification (packaging for sterile field use), "ground truth" would be established through engineering and sterility testing protocols rather than clinical expert consensus on diagnostic or outcomes data.
4. Adjudication Method for the Test Set
This information is not provided as there is no mention of an expert panel or adjudication for the design verification 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 MRMC comparative effectiveness study was done. This type of study is not relevant for this device, which is a saline flush syringe, not a diagnostic imaging or AI-assisted device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No standalone algorithm-only performance study was done. This is not an AI/algorithm-based device.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the performance claims would be based on:
- Engineering specifications and test standards: For material properties, sterile barrier integrity, and mechanical function of the syringe.
- Microbiological testing: To confirm the sterility assurance level (SAL) of 10-6 and the ability of the new packaging to maintain sterility.
- Risk analysis: Used to identify potential failure modes and determine the necessary verification tests.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that would require a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
Summary of the Study:
The study conducted to prove the device meets acceptance criteria was a Design Verification process. This process involved performing various tests based on a risk analysis. The core objective was to demonstrate that the modified device (with new packaging allowing for sterile field use) performed equivalently to the predicate device in terms of safety and effectiveness, manufactured from the same materials, met the same intended use, and maintained the same sterility assurance level (SAL of 10-6). The specific tests and their outcomes are not detailed, but the submission claims that the results "demonstrate that the BD Posiflush SF Flush Syringe performed in an equivalent manner to the predicate device and is safe and effective when used as intended." This type of study is typical for minor modifications to already approved medical devices where the changes do not impact the fundamental design or performance of the active components.
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).