(205 days)
Pentaflush saline 0.9% NaCl prefilled syringe is intended only for flushing in situ vascular access devices. May be placed on a sterile field. Pentaflush saline 0.9% NaCl prefilled syringe is intended for single patient and single use only.
The PentaFlush saline 0.9% NaCl prefilled syringe is a single-use device intended only for flushing in-situ vascular access devices. It is a polypropylene syringe containing an isotonic solution of sterile and non-pyrogenic 0.9% sodium chloride solution. These are ready for use devices that can be placed on sterile field. The product is available in volumes of 3ml, 5ml and 10ml of saline solution in 10 ml syringes, which has a larger diameter in order to avoid that, with the same force applied on the shaft button, the higher pressure generated in the 3ml capacities may cause the vascular catheter to rupture. What differentiates the three versions is the graduated scale, whose maximum capacity coincides with the nominal capacity of each version (3ml, 5ml and 10ml). In all capacities Luer Lock connector of the barrel is closed with a cap. The barrel is filled with a 0.9% NaCl isotonic solution, sterile, pyrogen-free, up to the nominal capacity of the scale; an acitotoxic synthetic rubber piston is assembled to the polypropylene plunger, whose fiducial line is positioned at the nominal capacity of the syringe. The primary packaging of PentaFlush pre-filled syringes can be in: a blister of medical paper and PE/PE peel, or an aluminum pouch of PET/ALL/PE peel. PentaFlush saline 0.9% NaCl prefilled syringes are used only by healthcare professionals, is intended for single patient and single use only. Does not contain preservatives. Not made with natural rubber latex. Rx Only.
This document describes the non-clinical testing for the PentaFlush saline 0.9% NaCl prefilled syringe. This device is an "Intravascular catheter" (Product Code: NGT) used for flushing in-situ vascular access devices. The study conducted is a non-clinical study to demonstrate conformance to applicable standards.
Here's the breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Standards | Acceptance Criteria | Reported Performance |
|---|---|---|---|
| Mechanical Testing/Stability | |||
| Visual inspection of pouch seals | ASTM F1886/F1886M-16 | No defect of the integrity of seals must be found | Conforms |
| Bubble emission test of pouch | EN 868-5 Annex C | No leaks | Conforms |
| Visual inspection of prefilled syringe | ISO 7886-1 | No damage, no leak (consistent with instructions for use) | Conforms |
| Test for liquid leakage and resistance of luer lock fitting | EN ISO 80369-7 | No leaks; no cracks | Conforms |
| Test for integrity of printed label | ASTM F2250 | Print must remain defined and legible, color must not lighten, ink must not run | Conforms |
| Distribution cycle (Transport) | ASTM D4169, ISO 11607-1 | The integrity of the packaging must be preserved | Conforms |
| Chemical Testing | |||
| Assay of Sodium Chloride | USP monograph | 0.855 to 0.945% NaCl | Conforms |
| pH | USP | 4.5 to 7.0 | Conforms |
| Identification of Sodium and Chloride | USP | Successful identification | Conforms |
| Sub-visible particulate matter | USP | ≥ 10µm: ≤6000 part/syringe; ≥ 25µm: ≤ 600 part/syringe | Conforms |
| Elemental Impurities (Heavy Metals) | USP / | Arsenic: ≤ 1.5µg/g; Cadmium: ≤ 0.2µg/g; Mercury: ≤ 0.3µg/g; Lead: ≤ 0.5µg/g | Conforms |
| Iron | USP | Iron: ≤ 2ppm | Conforms |
| Sterilization | |||
| Bacterial Endotoxins | USP | ≤ 0.5 EU/mL | Conforms |
| Sterilization Validation | ISO 11137-2 | 10-6 SAL | Conforms |
| Biocompatibility | |||
| Cytotoxicity | ISO 10993-5 | Non-cytotoxic | Conforms |
| Skin-sensitization | ISO 10993-10 | Non-sensitizer | Conforms |
| Intracutaneous Reactivity | ISO 10993-10 | Non-irritant | Conforms |
| Acute systemic toxicity | ISO 10993-11 | No systemic toxicity | Conforms |
| Pyrogenicity (material-mediated) | ISO 10993-11 (USP ) | No material mediated response observed | Conforms |
| Hemolysis | ISO 10993-4 (ASTM F756-17) | Non-hemolytic | Conforms |
| Tests for interaction with blood | ISO 10993-4 | No interaction with blood | Conforms |
2. Sample size used for the test set and the data provenance
The document describes non-clinical testing performed on the device itself and its components. It does not refer to a "test set" in the context of patient data or clinical samples. The tests mentioned are laboratory-based and generally involve a specified number of samples of the device and its materials as required by the referenced standards. The data provenance is Pentaferte Italia S.r.l., based in Italy. The tests are prospective in the sense that they are conducted on the manufactured device to verify its compliance with standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This point is not applicable to the provided document. The study described is a non-clinical, laboratory-based testing of a medical device's physical, chemical, and biological properties according to established international standards. The "ground truth" is determined by the specific criteria outlined in each standard for each test, not by expert consensus on clinical data.
4. Adjudication method for the test set
This point is not applicable to the provided document. Adjudication methods like 2+1 or 3+1 typically refer to clinical studies involving multiple readers for interpreting medical images or data. The non-clinical tests described have predefined pass/fail criteria based on the relevant standards.
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 point is not applicable. The device is a prefilled saline syringe, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This point is not applicable. The device is a medical product (prefilled saline syringe), not an algorithm.
7. The type of ground truth used
The ground truth used for these non-clinical tests is based on established international and national standards and monographs. For example, USP monographs for chemical assays, ISO standards for biocompatibility and sterilization, and ASTM standards for mechanical testing. These standards define the acceptable limits and methodologies against which the device performance is measured.
8. The sample size for the training set
This point is not applicable. The study is a non-clinical performance verification, not a study involving machine learning or AI that would require a training set.
9. How the ground truth for the training set was established
This point is not applicable for the reasons mentioned in point 8.
§ 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).