(162 days)
The Praxiject™ 0.9% NaCl prefilled syringe with 0.9% Sodium Chloride Injection, USP, is intended only for flushing vascular access devices. May be placed on a sterile field.
The Praxiject™ 0.9% NaCl prefilled syringe is a single use plastic piston syringe with a Luer lock connection fitting, prefilled to labeled volume with 0.9% Sodium Chloride Injection, USP, with no preservatives (normal saline), and capped with a plastic tip cap. Each prefilled syringe is individually packaged in a heat-sealed pouch and terminally sterilized by gamma irradiation.
The provided text is a 510(k) summary for the Praxiject™ 0.9% NaCl prefilled syringe, a medical device. It describes the device, its intended use, and comparative non-clinical testing performed to demonstrate substantial equivalence to a predicate device.
Here's the information extracted from the document regarding acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance:
| Test Methodology / Standard | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| Visual inspection of pouch seals per ASTM F1886 | To verify pouch seal integrity | No visible unsealed areas, channels/pathway across width of seal, tears/holes: Reject on detection. Undersealed areas, oversealed areas (hard/brittle seal), narrow seals: non defective seal width should be greater than 67% of nominal seal width. | Conforms |
| Bubble emission test of pouch per ASTM D3078 | To verify the integrity of the product packaging (pouch) | No leaks (no bubbles emitted upon immersion, no fluid inside the package). | Conforms |
| Visual inspection of prefilled syringe for damage | To ensure the prefilled syringe is not damaged in a way that would prevent its use | No critical damage (consistent with instructions for use); no leaks. | Conforms |
| Test for liquid leakage and resistance of luer lock fitting | To ensure the prefilled syringe is adequately sealed | No leaks; no cracks. | Conforms |
| Test for integrity of printed label per ASTM F2250 | To verify the integrity of the printed information is adequate for the intended use environment | Print must remain defined and legible, color must not lighten, ink must not run (Slight smudging of ink or transfer to swab is allowable). | Conforms |
| Test of formulation per Sodium Chloride Injection USP monograph: | To verify formulation of the Sodium Chloride solution meets the USP requirements | Assay of Sodium Chloride: 0.855 to 0.945% NaCl | Conforms |
| - pH per USP | pH: 4.5 to 7.0 | Conforms | |
| - Identification of Sodium and Chloride per USP | Identification: Successful identification | Conforms | |
| - Particulate matter per USP | Particulate matter: ≥ 10μm: ≤ 6000 part/syringe; ≥ 25μm: ≤ 600 part/syringe | Conforms | |
| - Bacterial Endotoxins per USP | Bacterial Endotoxins: ≤ 0.5 EU/mL | Conforms | |
| - Elemental Impurities (Heavy Metals) per USP/ (Class I elements) | Elemental Impurities: Arsenic: ≤ 1.5μg/g; Cadmium: ≤ 0.2μg/g; Mercury: ≤ 0.3μg/g; Lead: ≤ 0.5μg/g | Conforms | |
| - Iron per USP | Iron: ≤ 2ppm | Conforms | |
| Distribution cycle (Transport) Validation per ASTM D4169, Distribution Cycle 13 | To ensure the packaging maintains product integrity under anticipated shipping and handling conditions | Packaging and syringe integrity per ISO 11607-1 | Conforms |
| Sterilization Validation | To establish the minimum irradiation dose required to render the product sterile | 10-6 SAL per ISO 11137-2 | Conforms |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the specific sample sizes used for each individual test. It lists "non-clinical testing" as the study type. The reference to standards like ASTM and USP monographs implies that the testing was performed on physical samples of the device and its packaging.
- Data Provenance: The tests are described as "non-clinical testing" performed by MedXL Inc. The country of origin of the data is not specifically stated, but the manufacturer's address is in Pointe-Claire, Quebec, Canada. The data is retrospective as it was performed prior to the submission of the 510(k).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable. The studies performed are non-clinical (physical and chemical tests) and do not involve human interpretation or the establishment of ground truth by experts in a clinical context. The "ground truth" is determined by the results of the standardized tests against their defined acceptance criteria.
4. Adjudication method for the test set:
Not applicable. This concept applies to studies involving human interpretation or subjective assessments, which is not the case for these non-clinical 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:
Not applicable. This is a non-clinical device (prefilled saline syringe) and does not involve AI assistance, human readers, or clinical effectiveness studies in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device does not involve algorithms or AI.
7. The type of ground truth used:
The "ground truth" for the non-clinical tests is established by pre-defined, objective acceptance criteria derived from recognized industry standards (ASTM, ISO) and pharmaceutical monographs (USP). For example, the definition of an acceptable seal, specific chemical concentrations, or maximum particulate matter levels.
8. The sample size for the training set:
Not applicable. This device is not an AI/ML device, so there is no training set in the conventional sense.
9. How the ground truth for the training set was established:
Not applicable. As there is no training set, this question is not relevant.
§ 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).