(106 days)
For vascular access devices flushing only. Sterile fluid path only. Not for use on a sterile field.
The Praxiject™ SP 0.9% NaCl prefilled syringe is a single use plastic piston syringe with a Luer lock connection fitting, prefilled to labeled volume of 10mL with 0.9% Sodium Chloride Injection, USP, with no preservatives (normal saline), and capped with a plastic tip cap. The Praxiject™ SP 0.9% NaCl prefilled syringe is designed to maintain a sterile fluid path only and is individually packaged in a clear flexible plastic film, flow-wrapped heatsealed pouch that functions only as a protective barrier (dust cover). The device is terminally sterilized by gamma irradiation.
The provided text is a 510(k) Pre-market Notification for a medical device called Praxiject™ SP 0.9% NaCl, a prefilled saline flush syringe. The document describes the device, its intended use, comparison to a predicate device, and non-clinical testing performed to demonstrate substantial equivalence. It explicitly states that "Clinical testing was not required for device evaluation."
Therefore, based on the information provided, it's not possible to answer questions related to clinical studies, human reader performance, multi-reader multi-case (MRMC) studies, or the establishment of ground truth for a test set or training set in the context of an AI/algorithm-driven device. This document describes a medical device, not an AI/ML algorithm.
However, I can extract information related to the acceptance criteria and the non-clinical study that proves the device meets those criteria, as detailed in the "Summary of Non-Clinical Testing" section.
Here's the breakdown of the acceptance criteria and reported device performance from the non-clinical testing:
Acceptance Criteria and Reported Device Performance (Non-Clinical Testing)
1. A table of acceptance criteria and the reported device performance
The document provides a table outlining performance characteristics, the applicable performance standards, and the acceptance criteria. It then states, "The design and manufacturing of the Praxiject™ SP 0.9% NaCl prefilled syringe is subject to risk assessment per ISO 14971 and verification and validation testing in conformance with regulatory guidance and consensus standards applicable to this device type." This implies that the device successfully met all listed acceptance criteria through this testing, although specific "reported device performance" values are not explicitly given in the table beyond the acceptance limits.
| Performance Characteristic | Performance Standard | Acceptance Criteria |
|---|---|---|
| 0.9% Sodium Chloride Solution | ||
| Assay | USP Sodium Chloride Injection | 0.855 – 0.945% (w/v) |
| Identification | USP Sodium and Chloride | Meets USP requirements |
| pH | USP | 4.5 – 7.0 |
| Bacterial Endotoxins | USP , USP | ≤ 0.5 USP EU/mL |
| Particulate Matter | USP | Particles ≥ 10 µm: ≤ 6000/syringe; |
| Particles ≥ 25 µm: ≤ 600/syringe | ||
| Elemental Impurities | USP and USP | Arsenic: ≤ 1.5 µg/g |
| Cadmium: ≤ 0.2 µg/g | ||
| Lead: ≤ 0.5 µg/g | ||
| Mercury: ≤ 0.3 µg/g | ||
| Iron | USP | ≤ 2 ppm |
| Appearance | USP / Visual inspection | Clear and colorless. |
| Free of foreign solid particles. | ||
| Volume | ISO 7886-1, USP | 10.0 - 11.0 mL |
| Sterility | USP | Sterile solution |
| Sterilization Method Validation | ISO 11137-1, ISO 11137-2, USP | |
| (Terminal sterilization by gamma radiation) | SAL 10-6 | |
| Shelf-life (Stability) | FDA Guidance: Shelf Life of Medical Devices (1991); FDA Guidance: Q1D Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products (2003) | Device specifications must be maintained |
| for the labeled shelf life | ||
| Syringe Design and Container closure integrity | ISO 7886-1, ISO 80369-7 / ISO 594-1 and ISO 594-2 (Adapted solution leakage test) | Conformity to standards and device |
| specifications; Label integrity; Syringe and | ||
| tip cap seal integrity (no damage, no | ||
| leakage past piston and tip cap.) | ||
| Package integrity | ISO 11607-1, ISO 11607-2, ASTM F1980, ASTM D4169, ISO 7886-1 and ISO 594-2 (Syringe and tip cap integrity verification) | No structural damage to shipping carton; |
| Label integrity; Syringe and tip cap seal | ||
| integrity (no damage, no leakage past | ||
| piston and tip cap.) | ||
| Biological Safety Evaluation | ISO 10993-1, FDA Guidance: Use of International Standard ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process (2020) | Compliant process for the evaluation of |
| external communicating devices intended | ||
| for indirect blood path contact with limited | ||
| duration | ||
| Chemical Characterization (Extractables/Leachables) | ISO 10993-18, ISO 10993-17 | |
| USP | Acceptable extractables/leachables profile; | |
| Negligible risk of health hazard | ||
| Cytotoxicity | ISO 10993-5 | Non-cytotoxic |
| Sensitization | ISO 10993-10 | Non-sensitizer |
| Irritation | ISO 10993-23 | Non-irritant |
| Hemolysis | ISO 10993-4 (ASTM F756) | Non-hemolytic |
| Acute Systemic Toxicity | ISO 10993-11 | Non-toxic |
| Pyrogenicity | ISO 10993-11 (USP ) | Non-pyrogenic |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify sample sizes for each non-clinical test beyond implication from standard compliance. These tests are typically conducted on batches of manufactured devices following established quality control procedures. Given the manufacturing details, data provenance would be MedXL Inc., Canada. The testing is prospective in nature, as it's part of the pre-market validation for the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is not an AI/ML device requiring human expert annotation or ground truth establishment in the traditional sense. The "ground truth" for non-clinical testing of a physical medical device refers to the objective, measurable properties and performance standards themselves, verified by laboratory testing protocols and validated analytical methods (e.g., chemical assays, sterility tests, physical integrity tests).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is not a study involving subjective human interpretation or multi-reader scenarios. The testing involves objective, measurable criteria.
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. The device is a prefilled saline flush syringe, not an AI-assisted diagnostic or therapeutic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The "device" itself is a physical medical product, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For non-clinical testing of this device, the "ground truth" is defined by established consensus standards and pharmacopeial specifications (e.g., USP standards, ISO standards) for chemical composition, sterility, physical integrity, and biological safety. These are objective, measurable parameters.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 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).