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510(k) Data Aggregation
(118 days)
The B.Braun Omnifix® Low Dead Space Luer Lock Syringes are intended to be used to inject fluid into, or withdraw fluids from the body. Single use only, disposable.
The Omnifix® Low Dead Space (LDS) Luer Lock Syringes consist of a graduated hollow barrel and a movable plunger (piston) with a plunger tip. One end of the barrel has a male connector (nozzle), which permits attachment to a female connector (hub) and a needle. The luer lock nozzle has a centric configuration. The Omnifix ® Low Dead Space (LDS) syringes will be available in 1 mL and 2 mL.
This document is a 510(k) premarket notification from the FDA, granting B. Braun Medical Inc. the ability to market their Omnifix® Low Dead Space Luer Lock Syringe. This type of FDA clearance relies on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving a device meets specific clinical performance criteria for accuracy or diagnostic capability, as would be the case for AI/ML-driven diagnostic devices.
Therefore, the requested information regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of an AI/ML device (e.g., sensitivity, specificity, MRMC studies, expert consensus ground truth) does not apply to this specific FDA clearance document for a medical syringe.
The document describes nonclinical testing performed to demonstrate that the device performs as intended and supports substantial equivalence. This is primarily focused on confirming the physical and material properties of the syringe meet relevant industry standards and are comparable to the predicate device.
However, I can extract the information provided about the device's characteristics and the nonclinical tests performed, which serve as the basis for its clearance, in a quasi-table format, and explain why other requested information (like MRMC, expert consensus, etc.) is not relevant here.
Based on the provided FDA 510(k) summary for the Omnifix® Low Dead Space Luer Lock Syringe, here's an analysis tailored to the prompt's request, focusing on what is relevant and explaining why other aspects are not applicable:
This FDA clearance is for a physical medical device (syringe), not an AI/ML-driven diagnostic or assistive technology. Therefore, many of the standard "acceptance criteria" and "study types" typically discussed for AI/ML devices (e.g., sensitivity, specificity, human reader improvement, expert consensus for ground truth on images) are not applicable to this submission.
Instead, the "acceptance criteria" for this syringe are primarily based on meeting recognized international standards (ISO standards) and demonstrating substantial equivalence to a legally marketed predicate device through nonclinical (bench) testing.
Table of "Acceptance Criteria" (via ISO Standards and Equivalence) and Reported Device Performance
| Acceptance Criterion | Description (as applied to a syringe) | Reported Device Performance / Assessment |
|---|---|---|
| Indications for Use (Equivalence) | The device is intended to be used to inject fluid into, or withdraw fluids from, the body, matching the predicate. | The proposed device's Indications for Use are identical to the predicate device the B. Braun Omnifix® Piston Syringes (K071459). |
| Material Composition (Equivalence) | Materials used (polypropylene, polyisoprene, silicone fluid) are comparable to the predicate. | Syringe barrel: Polypropylene. Syringe plunger: Polypropylene or Polystyrene. Plunger tip (piston): Polyisoprene. Lubricant: Silicone fluid. These match the predicate device. |
| Sizes (Equivalence) | Available in 1 mL and 2 mL. | Matches corresponding sizes available in the predicate device (predicate also has other sizes). |
| Syringe Tip Configurations (Equivalence) | Centric tip, luer lock. | Comparable to predicate, which also has centric and eccentric tips, luer slip and luer lock versions. Proposed device is a specific configuration subset of the predicate capabilities. |
| Markings (Standard Compliance) | Graduated scale markings meet requirements of ISO 7886-1:2017. | Testing confirms compliance with ISO 7886-1:2017. (Predicate met an older version: ISO 7886-1:1993 and ISO 8537:1991). |
| Maximum Low Dead Space Volume Specification (Performance) | The unique "low dead space" feature specifies a volume of ≤ 0.023 mL or 67% less than ISO 7886-1:2017 requirement. | The document states the device meets ISO 7886-1:2017, and highlights its "low dead space" volume as significantly better than the standard requirement. |
| Barrel Transparency (Equivalence) | Translucent barrel. | Matches the predicate device's translucent barrel. |
| Sterilization (Equivalence & Validation) | Sterilized by Ethylene Oxide. | Matches predicate's sterilization method. Sterilization Validation in accordance with ISO 11135:2014 was successfully completed. |
| Biocompatibility (Standard Compliance) | Materials are biocompatible in accordance with ISO 10993-1:2018. | Testing confirms compliance with ISO 10993-1:2018. |
| Sterilization Residuals (Standard Compliance) | Ethylene oxide residuals are within acceptable limits per ISO 10993-7:2008. | Testing confirms compliance with ISO 10993-7:2008. |
| Connector Conformance (Standard Compliance) | Luer lock connectors meet ISO 80369-7:2016 and ISO 80369-20:2015. | Testing confirms compliance with ISO 80369-7:2016 and ISO 80369-20:2015. |
| General Performance & Functional Testing (Internal Specifications) | Device performs as intended via internal functional tests. | "Performance and functional testing to internal specifications" was successfully completed. |
Explanation of Non-Applicable AI/ML Study Information:
The following points are not applicable to this 510(k) submission because it is for a physical medical device (syringe), not an AI/ML product:
- Sample size used for the test set and the data provenance: Not relevant for a syringe. Bench testing is performed on manufactured units, not a "test set" of patient data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a syringe's performance is determined by physical measurements against engineering specifications and ISO standards, not expert medical interpretation.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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 is a syringe, not an AI diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for a syringe's performance is compliance with ISO standards and engineering specifications through bench testing, demonstrating its physical and material properties are safe and effective. It's not based on clinical "outcomes data" in the diagnostic sense or expert interpretation of medical images.
- The sample size for the training set: Not applicable. There is no AI model to train.
- How the ground truth for the training set was established: Not applicable.
In summary, this FDA clearance demonstrates that the Omnifix® Low Dead Space Luer Lock Syringe is substantially equivalent to a predicate device. This is achieved through rigorous nonclinical (bench) testing that confirms the syringe meets established ISO standards for performance, materials, and safety, and that its design and intended use are consistent with previously cleared devices.
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