(139 days)
The AMSafe® Pre-Filled Normal Saline Flush Syringe, is intended for use in flushing compatible intravenous administration sets and indwelling intravenous access devices. Use according to the recommendations of the manufacturer for the appropriate device.
AMSafe® Pre-Filled Normal Saline Flush Syringe is a polypropylene plastic syringe filled with 0.9% sodium chloride for injection, USP, and capped with a polypropylene syringe tip cap.
This document describes the premarket notification (510(k)) for the AMSafe® Pre-Filled Normal Saline Flush Syringe. The information provided outlines the device's technical characteristics, intended use, and comparison to a legally marketed predicate device (K183473). The study performed is a non-clinical bench testing study, not an AI/ML-based clinical study, therefore, many of the requested elements for an AI/ML study (e.g., sample size for test set, number of experts, MRMC study, training set details) are not applicable.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria and reported device performance are detailed in "Table 5-2" on page 6 of the document.
| ID# | Test | Method | Acceptance Criteria | Conclusion |
|---|---|---|---|---|
| 1 | Physical testing of syringe | ISO7886-1 ISO80369-7 | ISO7886-1 ISO80369-7 | Pass |
| Integrity test of package | ASTM F2338-09 | No leakage | Pass | |
| Dimension test | ISO80369-7 | ISO80369-7 | Pass | |
| Lubricant of syringe test | ISO7886-1 | ISO7886-1 | Pass | |
| Dead space test | ISO7886-1 | ISO7886-1 | Pass | |
| Limits of acidity or alkalinity of syringe | ISO7886-1 | ISO7886-1 | Pass | |
| 2 | Sodium Chloride Injection, USP Testing | |||
| pH value | USP | PH: 4.5-7.0 | Pass | |
| Chemical Identification Tests | USP | USP | Pass | |
| 0.9% normal saline content test | USP6-466 | 0.86% -- 0.94% | Pass | |
| Oxidizable substance test | USP6-471 | USP6-471 | Pass | |
| Iron test | USP | USP | ||
| Calcium | USP | USP | Pass | |
| Carbonate | USP | USP | Pass | |
| Sulfate | USP | USP | Pass | |
| Total organic carbon | USP | USP | Pass | |
| Limits of extractable metals | USP USP | USP USP | Pass | |
| 3 | Particulate matter | USP | ≥10um, ≤6000 ≥25um, ≤600 | Pass |
| 4 | Biocompatibility testing | |||
| Bacterial endotoxins test | USP | Bacterial endotoxins≤0.5EU/mL | Pass | |
| Acute systemic toxicity | ISO10993-11 | No systemic toxicity | Pass | |
| Intracutaneous reactivity | ISO10993-10 | Non-irritant | Pass | |
| Pyrogen test | ISO10993-11 | Non-pyrogen | Pass | |
| Skin sensitization | ISO10993-10 | Non-sensitizer | Pass | |
| In vitro cytotoxicity | ISO10993-5 | Non-cytotoxic | Pass | |
| In vitro hemolysis properties | ASTM F756-17 | Non-hemolytic | Pass |
Additionally, shelf life was evaluated:
- Test: Shelf life
- Method: ASTM F1980-16
- Acceptance Criteria/Conclusion: Verify that the device will remain within specification during the prescribed shelf life when stored under labeled conditions. (Implied Pass, as per overall conclusion).
2. Sample Size Used for the Test Set and Data Provenance
The document describes non-clinical bench testing of manufacturing characteristics and chemical composition, not an AI/ML-based study with a "test set" composed of patient data. Therefore, the concept of sample size for a test set (e.g., number of images, patient records) and data provenance (country of origin, retrospective/prospective) as typically understood for AI/ML studies are not applicable. The tests were performed on samples of the device itself. The specific number of units tested for each criterion is not provided, but it would typically be a predetermined number based on the statistical requirements of the specific test methods (e.g., ISO, ASTM, USP standards).
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not Applicable. This was a bench study, not an AI/ML study requiring expert labeling of data. The "ground truth" for these tests are the established physical, chemical, and biological standards and methodologies outlined in the referenced ISO, ASTM, and USP documents.
4. Adjudication Method for the Test Set
Not Applicable. This was a bench study; there was no human-in-the-loop expert adjudication process as would be typical for AI/ML algorithm evaluation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC study was not done. This is a review of a physical medical device (pre-filled syringe), not an AI/ML diagnostic or assistive tool where human reader performance would be a relevant metric.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
Not Applicable. This document describes the performance of a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical tests is based on established industry standards and pharmacopeial specifications. This includes:
- Physical Properties: Standards like ISO7886-1, ISO80369-7, ASTM F2338-09.
- Chemical Composition: United States Pharmacopeia (USP) monographs such as USP, USP, USP6-466, USP6-471, USP, USP, USP, USP.
- Biocompatibility: ISO10993 series (ISO10993-11, ISO10993-10, ISO10993-5) and ASTM F756-17.
- Sterility Assurance: The mention of 10-6 SAL (Sterility Assurance Level) indicates adherence to established sterilization standards.
8. The Sample Size for the Training Set
Not Applicable. This is a physical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. As there is no training set for a physical device, there is no ground truth establishment process in that context.
§ 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).