(66 days)
The 0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringes and 0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SF Syringes are intended to be used only for the flushing of indwelling vascular access devices. Catalog Number 306547 10 mL 0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringes are generally compatible for use with syringe pumps.
The 0.9% Sodium Chloride Injection, USP, BD PosiFlush" SP and SF Syringe (also referred to as BD PosiFlush " SP and SF Syringe) is a three-piece, sterile, single use syringe with a 6% (luer) connector prefilled with 0.9% sodium chloride injection, USP, and sealed with a tip cap. The BD PosiFlush™ SP Syringe is provided with a sterile fluid path, and the BD PosiFlush™ SF Syringe is provided externally sterile for use on a sterile field. Both configurations are sterilized via moist heat. The modified BD PosiFlush™ SP Syringe and BD PosiFlush™ SF Syringe, the subject of this 510(k), includes a new resin material in the barrel of the prefilled syringe.
The provided text describes a 510(k) summary for the BD PosiFlush™ SP and SF Syringes, which are prefilled syringes containing 0.9% sodium chloride for flushing vascular access devices. The submission focuses on a change in the resin material for the syringe barrel and asserts substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text, while noting the absence of information typically found in AI/algorithm-focused submissions:
1. Table of Acceptance Criteria and Reported Device Performance
This product is a medical device (prefilled syringe), not an AI/algorithm. Therefore, the "device performance" here refers to the physical and chemical properties of the syringe and its contents, not a diagnostic accuracy or algorithmic output. The performance is assessed relative to a predicate device or established standards.
| Performance Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Functional Testing | ||
| Container Closure Integrity | No Dye in Solution | |
| No Leakage in the luer well or tip threads | ||
| No Leakage Past the Stopper Ribs | ||
| No Dye Between Stopper Ribs | Performed in an equivalent manner to the predicate device and is safe and effective when used as intended. (Implies all criteria were met. Specific results are not detailed in this summary for each test). | |
| Break Loose Force | Equivalence to Predicate | Performed in an equivalent manner to the predicate device. |
| Break Out Force | Equivalence to Predicate | Performed in an equivalent manner to the predicate device. |
| Sustaining Force | Equivalence to Predicate | Performed in an equivalent manner to the predicate device. |
| Retaining Ring Force | Equivalence to Predicate | Performed in an equivalent manner to the predicate device. |
| Tip Cap Removal Force | Equivalence to Predicate | Performed in an equivalent manner to the predicate device. |
| Sodium Chloride Injection, USP, Testing | Per USP Monograph, Sodium Chloride Injection | Performed in an equivalent manner to the predicate device and is safe and effective when used as intended. (Implies all criteria were met. Specific results are not detailed in this summary for each test). |
| Bacterial Endotoxin | Met USP Monograph requirements. | |
| Particulate Matter | Met USP Monograph requirements. | |
| Assay of NaCl | Met USP Monograph requirements. | |
| Heavy Metals | Met USP Monograph requirements. | |
| Iron | Met USP Monograph requirements. | |
| pH | Met USP Monograph requirements. | |
| Biocompatibility Testing | Per ISO10993 Series | |
| LC/DAD/MS, GC-MS, ICP; acceptable extractable test. | Performed in an equivalent manner to the predicate device and is safe and effective when used as intended. (Implies all criteria were met, specifically acceptable extractable test as specified). |
Note: The reported device performance generally states "performed in an equivalent manner to the predicate device and is safe and effective when used as intended" or implies meeting USP Monograph requirements. Specific quantitative results for each test are not detailed in this summary.
Absent Information (Typical for AI/Algorithm Studies)
The following information is not applicable or not provided in this 510(k) summary because the device is a physical medical device (syringe with saline), not an AI/algorithm.
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for a physical device. Testing involves batches of syringes, not a "test set" of data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for physical device testing is based on established engineering and chemical standards.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable, as this is not an AI device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): For a physical device, ground truth is based on established engineering specifications, chemical analysis standards (e.g., USP Monograph), and biocompatibility standards (e.g., ISO 10993).
- The sample size for the training set: Not applicable (no AI/algorithm).
- How the ground truth for the training set was established: Not applicable (no AI/algorithm).
Conclusion of the Study (Non-Clinical Testing)
The company performed non-clinical testing based on a risk analysis. The results of these tests demonstrated that the modified BD PosiFlush™ SP and SF Syringe performed in an equivalent manner to the predicate device. This equivalence, combined with adherence to established standards (USP Monograph, ISO 10993 series), is deemed sufficient to prove the device's safety and effectiveness.
Clinical testing was explicitly stated as "not required" for this submission.
The conclusion is that the device has been validated to meet the established performance criteria based on non-clinical tests, and performs as safely and effectively as the legally marketed predicate devices.
§ 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).