(149 days)
Flush Syringe (Prefilled 0.9% normal saline solution) is intended for use in flushing compatible intravenous administration sets and indwelling intravenous access devices.
Flush Syringe (Prefilled 0.9% normal saline solution) is a polypropylene plastic syringe filled with 0.9% sodium chloride for injection, USP, and capped with a polypropylene syringe tip cap. The Flush Syringe (Prefilled 0.9% normal saline solution) consists of barrel, plunger, gasket and thread stopper which is used after the intended purpose is achieved to cover the barrel tip of the device. The Flush Syringe (Prefilled 0.9% normal saline solution) is sterile, non-pyrogenic and for single use.
The provided document describes the acceptance criteria and a summary of non-clinical testing for the "Flush Syringe (Prefilled 0.9% normal saline solution)". This is a medical device, and the testing outlined is for its safety and performance, not for an AI model. Therefore, many of the requested fields related to AI/algorithm performance (e.g., effect size of human readers with AI assistance, standalone algorithm performance, training set details) are not applicable.
Here's the information extracted from the provided text, focusing on the device's acceptance criteria and the study proving it:
1. A table of acceptance criteria and the reported device performance
| ID# | Test | Method | Acceptance criteria | Conclusion |
|---|---|---|---|---|
| 1. Physical testing of syringe | ||||
| Physical testing of syringe | ISO 7886-1, ISO 11040-8, ISO 80369-7 | ISO7886-1 ISO80369-7 | Pass | |
| Integrity test of package | ASTM F2338-09 | No leakage | Pass | |
| Dimension test | ISO 80369-7 | ISO80369-7 | Pass | |
| Lubricant of syringe test | ISO 7886-1 | ISO7886-1 | Pass | |
| Dead space test | ISO 7886-1 | ISO7886-1 | Pass | |
| Limits of acidity or alkalinity of syringe | ISO 7886-1 | ISO7886-1 | Pass | |
| 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 | USP 6-466 | 0.86% - 0.94% | Pass | |
| Oxidizable substance test | VP200 | VP200 | Pass | |
| 2. | 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 acute systemic toxicity | Pass | |
| Intra-cutaneous reactivity | ISO10993-10 | Non-irritant | Pass | |
| Skin sensitization | ISO10993-10 | Non-sensitizer | Pass | |
| In vitro cytotoxicity | ISO10993-5 | Non-cytotoxic | Pass | |
| Material Mediated Pyrogenicity | ISO 10993-11 | No pyrogenicity | Pass | |
| Genotoxicity (Bacterial Reverse Mutation Test) | ISO 10993-3 | No Genotoxicity | Pass | |
| Implantation | ISO 10993-6 | No evidence of local tissue effects | Pass | |
| In vitro hemolysis properties | ASTM F756-17 | Non-hemolytic | Pass | |
| 5. Package Integrity Test | ||||
| Sealing Strength | ASTM F88/F88M and EN 868-5 | Should not be less than 1.2N | Pass | |
| Dye Penetration Test | ASTM F 1929 | Should be no evidence of leakage | Pass | |
| Vacuum decay test | ASTM F 2338 | There should be no water present inside the pouch | Pass | |
| Shelf Life | Shelf life evaluation | ASTM F1980-16 | Device within specification for 3 years | Pass |
2. Sample size 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 the exact sample sizes for each test conducted. It only lists the tests performed, the methods used, and the acceptance criteria. The provenance of the samples (e.g., country of origin, retrospective/prospective) is also not mentioned. These tests are laboratory-based non-clinical tests rather than studies involving patient data.
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 a medical device, and the performance testing is based on established international and national standards and laboratory methods, not expert interpretation of outputs like in AI/CAD systems.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or for establishing ground truth in AI model evaluations, not for the direct physical and chemical testing of a sterile medical device.
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 document is for the premarket notification of a physical medical device (flush syringe), not an AI or CAD system. Thus, no MRMC study or AI-related effectiveness is discussed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device is established by adherence to recognized consensus standards and validated chemical/physical testing methods (e.g., ISO, ASTM, USP). The acceptance criteria for each test (e.g., pH range, bacterial endotoxin limits, physical strength) serve as the objective ground truth.
8. The sample size for the training set
Not applicable. This device is not an AI model, so there is no training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set for a physical medical device.
§ 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).