(59 days)
The B. Braun Omnifix Syringe NRFit is intended for neuraxial use for aspiration/injection of fluids used by healthcare professionals in healthcare facilities.
B. Braun Medical Inc. Omnifix Syringe NRFit configurations are sterile, single use syringes with ISO 80369-6 NRFit compliant fittings. They are available in 1mL, 3mL, 10mL, and 20mL lock and slip configurations. The NRFit tips allow for connections of neuraxial specific applications while reducing the likelihood of misconnections to non-neuraxial devices. The syringe assembly consists of a barrel with a printed graduated scale in milliliters (mL), a stopper and a plunger rod. The plunger rod is yellow to designate a device intended to only connect to ISO 80369-6 compatible devices such as spinal or epidural needles. The plunger rod is pulled back to aspirate fluids or depressed to inject or expel fluids.
The provided text describes a 510(k) premarket notification for a medical device, the Omnifix Syringe NRFit. This document focuses on demonstrating the substantial equivalence of the new device to a predicate device (B. Braun Piston Syringes, K071459) rather than presenting a traditional clinical study with acceptance criteria for an AI/algorithm-driven device.
Therefore, the request for a table of acceptance criteria, sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment for a device meeting acceptance criteria by an AI/algorithm is not applicable to this document.
This FDA clearance is for a physical medical device (a syringe) that has been modified to include a new type of connector (NRFit) for neuraxial use. The "performance" being described in the document relates to mechanical and material properties of the syringe, and its biocompatibility, according to established ISO and ASTM standards, not to the performance of an artificial intelligence algorithm.
Instead, the document details nonclinical performance tests conducted to demonstrate the modified syringe's safety and effectiveness. Here's a breakdown of what is provided and why it doesn't fit the requested AI/algorithm performance criteria:
Summary of Device Performance (as presented in the document):
The document states that the Omnifix Syringe NRFit configurations are "equivalent to that of the predicate B. Braun Medical Inc. Omnifix Syringe in intended use, materials and performance characteristics." The differences primarily relate to the connector type (NRFit vs. Luer) and the
resulting change in indicated use (neuraxial vs. general purpose).
The device's performance is demonstrated through compliance with various international standards, which serve as the "acceptance criteria" for a physical medical device. These are detailed under "Functional Testing Summary of ISO 80369-6 compliant nonclinical tests" and other sections.
1. Table of Acceptance Criteria and Reported Device Performance:
Since this is a physical device and not an AI algorithm, the "acceptance criteria" are the successful demonstration of compliance with the listed ISO and ASTM standards. The document explicitly states "Bench testing performed on the proposed devices supports substantial equivalence." This implies that the device successfully met the requirements of these tests.
| Acceptance Criterion (Standard Compliance) | Reported Device Performance (Implied) |
|---|---|
| ISO 80369-6:2016 for NRFit Connectors | Conforms / Passed |
| - Dimensional Requirements | Conforms / Passed |
| - Fluid leakage requirement | Conforms / Passed |
| - Leakage by pressure decay | Conforms / Passed |
| - Subatmospheric pressure air leakage | Conforms / Passed |
| - Stress cracking | Conforms / Passed |
| - Resistance to separation from axial load | Conforms / Passed |
| - Resistance to separation from unscrewing | Conforms / Passed |
| - Resistance to overriding | Conforms / Passed |
| Biocompatibility per ISO 10993-1:2018 | Conforms / Passed (specific tests listed) |
| - Cytotoxicity | Conforms / Passed |
| - Intracutaneous reactivity | Conforms / Passed |
| - Sensitization | Conforms / Passed |
| - Acute systemic toxicity | Conforms / Passed |
| - Subacute/subchronic systemic toxicity | Conforms / Passed |
| - Genotoxicity | Conforms / Passed |
| - Material-mediated pyrogenicity | Conforms / Passed |
| - Hemolysis | Conforms / Passed |
| Particulate Matter per USP | Conforms / Passed |
| Neurotoxicity assessment | No signs of systemic toxicity or neurological impairment from exposure of leachable compounds from the test article. (Conforms / Passed) |
| Packaging: ASTM F2096:2011 (Bubble Leak) | Conforms / Passed |
| Packaging: ASTM F88/F88M:2015 (Seal Strength) | Conforms / Passed |
| Hypodermic Syringe Functional per ISO 7886-1 | Conforms / Passed |
| Pyrogenicity (Spinal limit 2.15 EU/device) | Conforms / Passed |
2. Sample size used for the test set and the data provenance:
- The document implies that standard test methods prescribed by each ISO/ASTM standard were followed. Therefore, the "sample size" would be the number of devices required by these standards for each respective test (e.g., number of syringes for leakage tests, number of samples for biocompatibility, etc.). These specific numbers are not provided in this high-level summary but would be detailed in the underlying test reports.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). This is internal lab testing of the manufactured product.
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. Ground truth for a physical device's mechanical integrity and biocompatibility is established by adherence to reproducible, standardized test methods, not by expert consensus (like in imaging diagnosis). The "experts" would be qualified laboratory technicians and scientists performing and interpreting these standardized tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This concept applies to human reader studies or algorithmic output interpretation, not to physical device testing against objective standards.
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 is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance is objective compliance with engineering and biocompatibility standards (e.g., specific dimensions, leakage rates, material reactions in biological assays). It is not expert consensus for diagnostic interpretation or patient outcomes data in the sense of a clinical trial for an AI.
8. The sample size for the training set:
- Not applicable. There is no AI algorithm being trained.
9. How the ground truth for the training set was established:
- Not applicable. There is no AI algorithm being trained.
In conclusion, the provided FDA 510(k) clearance letter and its summary are for a modified physical medical device. The "study" proving it meets acceptance criteria refers to a battery of nonclinical, laboratory-based functional and biocompatibility tests against established international standards (ISO, ASTM, USP), not an AI algorithm validation study. Therefore, most of the specific questions posed are not relevant to the content of this document.
§ 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).