(83 days)
The Omnifix piston syringes are intended to be used to inject fluid into, or withdraw fluids from, the body. The Omnican and Omnifix insulin syringes are intended for subcutaneous injection of insulin.
The Omnifix piston syringes consist of a graduated hollow barrel and a movable plunger with a plunger tip. One end of the barrel has a male connector (nozzle), which permits attachment to a female connector (hub). Both luer lock and luer slip nozzles are available, with centric and eccentric configurations. The Omnifix syringes will be available in 1 mL, 2 mL, 2.5 mL, 3 mL, 5 mL, 10 mL, 20 mL, 30 mL, and 50 mL volume sizes, and as a 1 mL insulin syringe. The Omnican insulin syringes have an integrated needle bonded to the nozzle end of the syringes and are graduated in units of insulin. The Omnican insulin syringes will be available in sizes of 0.5 mL and 1 mL, and with a 30 gauge needle in lengths of 8 mm and 12 mm.
The provided document is a 510(k) summary for the B. Braun Omnifix® Piston Syringes and Omnican® and Omnifix® Insulin Syringes. It states that biocompatibility and functional testing were performed to verify the safety and effectiveness of the devices. However, it does not provide specific acceptance criteria or detailed results of these tests (e.g., specific thresholds for force, volume accuracy, etc.), nor does it describe the study methodology, sample sizes, or ground truth establishment.
Based on the provided text, the exact details needed for this request (acceptance criteria, specific performance metrics, sample sizes, expert qualifications, etc.) are not available. The document primarily focuses on establishing substantial equivalence to predicate devices and detailing the device's description and intended use.
Therefore, the table and detailed answers below reflect the absence of this specific information in the provided 510(k) summary.
Acceptance Criteria and Device Performance
| Acceptance Criteria (Not explicitly stated in document) | Reported Device Performance (Not explicitly stated in document) |
|---|---|
| Biocompatibility standards met. | "Biocompatibility testing... performed to verify safety and effectiveness." (No specific results provided) |
| Functional performance standards met (e.g., consistent injection/withdrawal force, accurate volume delivery, leak-proof). | "Functional testing... performed to verify safety and effectiveness." (No specific results provided) |
| No differences from predicate devices that raise new safety/effectiveness issues. | "There are no differences between the predicate and proposed devices that raise new issues of safety and effectiveness." (Qualitative statement) |
1. A table of acceptance criteria and the reported device performance
As indicated in the table above, the 510(k) summary states that "Biocompatibility and functional testing have been performed to verify the safety and effectiveness of the Omnifix and Omnican syringes." However, it does not explicitly define specific quantitative acceptance criteria or provide detailed numerical performance results for these tests. The document focuses on the conclusion that testing was performed and demonstrated safety and effectiveness in comparison to predicate devices, rather than presenting the raw data or specific thresholds.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The 510(k) summary does not disclose the sample size used for the biocompatibility or functional testing. It also does not provide any information regarding data provenance (e.g., country of origin, retrospective or prospective nature of the 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)
The document does not mention the use of experts to establish ground truth for any testing, as the testing appears to be primarily laboratory-based functional and biocompatibility assessments, not diagnostic interpretative tasks.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no expert review or adjudication method is mentioned for establishing ground truth in this type of device submission.
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 device is a medical syringe, not an AI or imaging diagnostic device. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance would not have been performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable, as this device is a physical medical device (syringe), not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The concept of "ground truth" as typically applied in AI/diagnostic device studies (e.g., expert consensus, pathology) is not applicable here. For physical medical devices like syringes, "ground truth" would typically refer to established engineering standards, material properties, and biological responses (e.g., cell viability in biocompatibility, accurate force measurements for functional tests) rather than human expert interpretation of data. The document implies compliance with such standards through "biocompatibility and functional testing."
8. The sample size for the training set
Not applicable. This device is a physical medical device, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" for this device.
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).