(210 days)
The AMSafe® 0.9% Sodium Chloride 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 cap. The device will be terminally sterilized by gamma radiation sterilization. The device will be marketed as a 12mL syringe with a 3mL, 5mL, or 10mL fill volume, and a 20mL syringe with 20mL fill volume. The products are in two different packages, one is poly blister package and the entire packaged device are gamma radiation sterilized for sterile delivery to a sterile field; another is PP wrapper as a dust cover for non-sterile field. The solution is sterile normal saline for injection and meets the requirements of USP.
This document is a 510(k) Premarket Notification from the FDA regarding a medical device, the AMSafe® Pre-Filled Normal Saline Flush Syringe. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a clinical study of an AI-powered diagnostic device. Therefore, much of the requested information regarding acceptance criteria and study design for an AI device is not applicable to this document.
However, I can extract information related to the device's acceptance criteria for performance (bench testing) and the testing done to prove it meets those criteria.
Here's an attempt to answer your questions based only on the provided text, recognizing its limitations for an "AI-powered diagnostic device":
Device: AMSafe® Pre-Filled Normal Saline Flush Syringe
Type of Device: Prefilled plastic piston syringe with 0.9% sodium chloride for injection, USP, intended for flushing intravenous administration sets and indwelling intravenous access devices. This is a medical device, not an AI-powered diagnostic device.
Study Type: Non-clinical (bench) testing to demonstrate substantial equivalence to a predicate device. No clinical study with human subjects, AI assistance, or MRMC design was conducted.
1. A table of acceptance criteria and the reported device performance
| ID# | Test | Method | Acceptance Criteria | Reported Device Performance (Result/Conclusion) |
|---|---|---|---|---|
| 1 | Plastic syringe | ISO7886-2017 | ISO7886-2017 | Conforms/Pass |
| Sodium Chloride Injection, USP Testing | ||||
| 2 | pH value | USP40 | pH: 4.5 – 7.0 | Pass |
| Limits of extractable metals of saline solution | USP, | USP, | Pass | |
| Chemical Identification Tests | USP | USP | Pass | |
| 0.9% normal saline content test | VP200 | 0.86% -- 0.94% | Pass | |
| Oxidizable substance test | VP200 | VP200 | Pass | |
| Iron test | USP40 | USP40 | ||
| Calcium | USP40 | USP40 | Pass | |
| Carbonate | USP40 | USP40 | Pass | |
| Sulfate | USP40 | USP40 | Pass | |
| Particulate matter | USP 40 | ≥10um, ≤6000; ≥25um, ≤600. | Pass | |
| 3 | Biocompatibility testing | |||
| Bacterial endotoxins test | USP40 | Bacterial endotoxins ≤ 0.25 EU/mL | Pass | |
| Acute system toxicity | ISO10993-11 | The device extracts did not elicit a systemic response | Pass | |
| Irritation / Intracutaneous reactivity | ISO10993-10 | Non-irritant | Pass | |
| Material-mediated pyrogenicity | ISO10993-11 | Non-pyrogenic response | Pass | |
| Sensitization | ISO10993-10 | Non-sensitizer | Pass | |
| Cytotoxicity | ISO10993-5 | Non-cytotoxic | Pass | |
| Hemolysis | ISO10993-4 (ASTM F756) | Non-hemolytic | Pass | |
| Chemical characterization | USP, USP | Acceptable extractable / leachable profile | Pass | |
| 4 | Blister package integrity | |||
| Seal strength test | ASTM F88/F88M-15 | Should not be less than 2 N/inch | Pass | |
| Dye integrity test | ASTM F1929-15 | ASTM F1929-15 | Pass |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: The document describes "non-clinical testing" and lists various tests, each presumably with its own sample size of syringes or solution, but these specific sample sizes are not detailed in the provided text.
- Data Provenance: The tests are standard industry bench tests (e.g., ISO, USP, ASTM standards). The country of origin for the data is not explicitly stated within the context of the testing, but the company is Amsino International Inc., based in Pomona, CA, USA, suggesting testing likely occurred in or for a US regulatory submission. The data is from prospective bench testing, not retrospective or prospective clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This device is not an AI diagnostic, so there is no concept of "ground truth" derived from expert consensus of images/data in the way it applies to AI devices. The "ground truth" for the performance tests (e.g., pH, chemical content, sterility) is established by the specified reference standards (USP, ISO, ASTM) and the inherent measurable properties of the device and its contents. The results are objective, quantitative measurements following validated methods, not subjective interpretations by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as this is not an AI diagnostic device requiring human expert adjudication of diagnostic outcomes. The results are objective measurements against pre-defined 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:
- No, an MRMC comparative effectiveness study was not done. This device is a pre-filled saline syringe, not an AI-powered diagnostic. This type of study is irrelevant to its purpose and regulatory pathway.
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. The tests performed are standalone bench tests of the physical and chemical properties of the syringe and its contents.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for these tests is based on established scientific and engineering standards and methods (e.g., USP monographs for chemical purity and content, ISO standards for device properties, ASTM for packaging). It is a direct measurement against defined physical, chemical, and biological specifications, not a diagnostic ground truth derived from expert consensus, pathology, or outcomes data.
8. The sample size for the training set:
- Not applicable. This is not an AI/machine learning device; therefore, there is no concept of a "training set."
9. How the ground truth for the training set was established:
- Not applicable. As there is no training set for this type of device, no ground truth needed to be established for it.
§ 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).