(23 days)
EpiFaith Syringe is intended for use with an epidural needle for detecting a loss of resistance, which aids a clinician in verifying needle tip placement in the epidural space.
The EpiFaith is a loss of resistance syringe with spring loaded piston, which can provide a means for detecting entry into the epidural space. Based on the principle of LOR technique, the piston will simultaneously move forward when the pressure drop occurs due to the spring force. The moving of the piston can provide a visual signal to indicate the LOR as well as verify the needle tip placement in the epidural space. The EpiFaith syringe is compatible to a 16-18 gauge epidural needle with Luer or NRFit connector. The user can push the plunger to increase the pressure after the syringe is connected to an inserted needle. Then, the user can advance the needle until the visual signal occurring. Because the piston is spring loaded, the automatic ejection of the syringe will happen when the LOR occurring, resulting in the movement of the piston. There are two different models of EpiFaith Syringe. The proposed models are listed below. The only difference between two models is the type of the connector.
This document, K192421, is a 510(k) summary for the EpiFaith Syringe. It describes the device, its intended use, and a comparison to a predicate device (K182268) to demonstrate substantial equivalence.
It's important to note that this 510(k) submission is for a medical device (a syringe), not an AI/ML-enabled medical device. Therefore, the questions related to AI/ML performance, ground truth, human readers, and training/test sets are not directly applicable to this document. The "Performance Data" section discusses traditional non-clinical tests for a medical syringe.
However, I will extract the available information as best as possible, interpreting "acceptance criteria" and "device performance" in the context of a non-AI/ML medical device.
1. Table of Acceptance Criteria and Reported Device Performance
For this medical device, acceptance criteria relate to its physical properties and functional performance as a syringe, not diagnostic or predictive accuracy. The performance data is based on non-clinical tests.
| Acceptance Criterion (Type of Test) | Reported Device Performance (Summary from document) |
|---|---|
| Risk assessment (ISO 14971: 2007) | Conducted, suggesting risks are assessed and managed. |
| Friction forces test (ISO 7886-1: 2017) | Conducted, implying the device meets the standard for plunger movement. |
| Liquid leakage test (ISO 7886-1: 2017) | Conducted, implying the device meets the standard for fluid containment. |
| Biocompatibility Assessment (ISO 10993: In vitro cytotoxicity, Skin sensitization, Intracutaneous irritation, Acute systemic toxicity, Pyrogen test, Limulus amebocyte lysate endotoxin) | Meets guidelines, indicating the materials are safe for biological contact. |
| Sterility (Sterile assurance level) | 10^-6 (E.O gas sterilization), indicating a very low probability of non-sterile product. |
| Packaging Integrity | "Tyvek and PET", implying standard medical packaging. |
| Compliance with ISO 80369-6 (NRFit) | Yes (for NRFit model) - indicates connector compatibility. |
| Compliance with ISO 80369-7 (Luer slip) | Yes (for Luer slip model) - indicates connector compatibility. |
The document states: "Design Verification activities were performed on subject device and all necessary tests were verified to meet the required acceptance criteria." and "the material change of syringe piston meets the requirements that are considered essential for its intended use".
2. Sample size used for the test set and the data provenance
This document does not specify exact sample sizes for the non-clinical tests (e.g., how many syringes were tested for friction or leakage). The tests are typically performed on a statistically relevant sample size according to the respective ISO standards. The data provenance is from Flat Medical Co., Ltd., Taipei City, Taiwan, the device manufacturer. The tests are non-clinical (bench testing), not retrospective or prospective human subject data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as the validation is for a physical medical device (syringe) performing mechanical and biocompatibility functions, not an AI/ML model requiring expert review for diagnostic ground truth. The "ground truth" for these tests are objective measurements (e.g., force, leakage presence/absence, biochemical reactions).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication typically refers to expert consensus in diagnostic studies, which is not relevant here. The tests are based on objective, measurable criteria defined by international 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/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is based on objective measurements and adherence to established international standards (e.g., ISO 7886-1 for syringes, ISO 10993 for biocompatibility). For example, a "friction force" reading compared against a defined maximum in the standard, or absence of leakage as per the standard.
8. The sample size for the training set
Not applicable. This is a manufactured physical device, not an AI/ML model that undergoes a "training" phase.
9. How the ground truth for the training set was established
Not applicable. See point 8.
§ 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).