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510(k) Data Aggregation
(37 days)
The syringe is intended to inject or withdraw fluids from the body.
The Monoject 12 mL Syringe is a standard piston syringe without needle. It consists of 3 parts; a calibrated hollow barrel, with a moveable plunger and attached gasket. The barrel is made from polypropylene and is designed with clear graduation for easy use. The barrel nozzle has an ISO 594 compliant male 6% taper luer lock tip for fitting any female luer taper hub that is also ISO 594 compliant. The plunger is made from polypropylene. The gasket is made from thermoplastic elastomer material. The syringe is individually packaged in a peel blister that ensures the sterility of the device until the package is opened. This is a single use only device. An inner box contains 100 devices, and the outer box contains 10 inner boxes. This syringe is sterilized by gamma irradiation.
The provided text describes the 510(k) summary for the Monoject 12mL Syringe (K130049). It details the device's characteristics, intended use, and the non-clinical tests performed to demonstrate its safety and effectiveness.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance:
The document lists various performance tests conducted. It implies that the acceptance criteria for these tests would be compliance with established standards or achieving results comparable to the predicate device. The reported performance is that the device meets these criteria and performs equivalently to the predicate device.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Physical Characteristics | Equivalent to predicate device |
| Liquid Leakage | Tests conducted, results and conclusions included (implying compliance) |
| Air Leakage | Tests conducted, results and conclusions included (implying compliance) |
| Separation Force | Tests conducted, results and conclusions included (implying compliance) |
| Unscrewing Torque | Tests conducted, results and conclusions included (implying compliance) |
| Ease of Assembly | Tests conducted, results and conclusions included (implying compliance) |
| Resistance to Overriding | Tests conducted, results and conclusions included (implying compliance) |
| Stress Cracking | Tests conducted, results and conclusions included (implying compliance) |
| Tolerance on Graduation Capacity | Tests conducted, results and conclusions included (implying compliance) |
| Maximum Dead Space | Tests conducted, results and conclusions included (implying compliance) |
| Air Leakage past Syringe Piston (during aspiration and for separation of piston and plunger) | Tests conducted, results and conclusions included (implying compliance) |
| Air and Liquid Leakage at Piston (under compression) | Tests conducted, results and conclusions included (implying compliance) |
| Minimum Over Length of Scale to Nominal Capacity Mark | Tests conducted, results and conclusions included (implying compliance) |
| Force Required to Operate Plunger | Tests conducted, results and conclusions included (implying compliance) |
| Material/Sterility | |
| Individual Package Integrity | Tests conducted, results and conclusions included (implying compliance) |
| Chemical Testing | Tests conducted, results and conclusions included (implying compliance) |
| Bacterial Endotoxin Testing | Tests conducted, results and conclusions included (implying compliance) |
| Biocompatibility Testing | Tests conducted, results and conclusions included (implying compliance) |
| Operational Mode | Equivalent to predicate device |
| Basic Scientific Technology | Equivalent to predicate device |
| Intended Use | Equivalent to predicate device |
| Overall Conclusion | Performs equivalent to the predicate device and is safe and effective when used as intended. |
2. Sample size used for the test set and the data provenance:
The document states that "Performance testing was conducted to verify that the device is safe and effective for its intended use." However, it does not specify the sample size used for any of the performance tests. It also does not mention the data provenance (e.g., country of origin, retrospective or prospective) for these tests. This information is typically detailed in the full test reports that are part of the submission but not included in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document describes non-clinical performance testing, which generally refers to laboratory or bench testing of the device itself against established standards or specifications. This type of testing typically does not involve human experts establishing a "ground truth" in the way clinical studies or diagnostic AI studies would. Therefore, this information is not applicable to the described study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
As mentioned above, the testing described is non-clinical performance testing. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies, particularly for diagnostic devices where subjective interpretation of results might be involved. Since this is for a syringe, a physical medical device, such adjudication methods are not applicable. The results of the performance tests are generally objective measurements against predefined specifications.
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 is a physical medical device (syringe), not an AI or diagnostic device. Therefore, an MRMC comparative effectiveness study involving human readers with or without AI assistance is not applicable and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Again, this is a physical medical device, not an algorithm or AI system. Therefore, a standalone algorithm performance study is not applicable and was not performed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the non-clinical performance tests, the "ground truth" is established by technical specifications, industry standards (e.g., ISO 594 for luer taper), and internal design requirements. For example, the "ground truth" for liquid leakage is "no leakage" when tested under specified conditions, or for force required to operate plunger, it's a specific range of force. There isn't a "pathology" or "outcomes data" type of ground truth for a syringe's physical performance.
8. The sample size for the training set:
As this is a physical medical device, there is no "training set" in the context of machine learning or AI. The design and manufacturing processes are honed through engineering principles and quality control, not through training data.
9. How the ground truth for the training set was established:
Since there is no training set (as per point 8), this question is not applicable.
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