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510(k) Data Aggregation
(227 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 a spring-loaded piston, which can provide a means for detecting entry into the epidural space. Based on the principle of the 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 assist in verifying 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 occurs. Because the piston is spring loaded, the automatic ejection of the content of the syringe will happen when the LOR occurs, resulting in the movement of the piston. There are two different models of EpiFaith Syringe. The proposed models are listed in Table 4.1. The only differences between two models are the type of the connector and color.
The provided text describes a 510(k) submission for the EpiFaith Syringe, a loss-of-resistance syringe used for detecting entry into the epidural space. This document is a summary and primarily focuses on demonstrating substantial equivalence to a predicate device (AutoDetect Syringe K041590) through characterization and non-clinical performance testing.
The document does not include information on a clinical study (MRMC, standalone, or otherwise) involving human readers or expert consensus for establishing ground truth from clinical images. The performance data described are exclusively non-clinical bench tests and compliance with recognized standards.
Therefore, many of the requested items related to clinical study design, sample sizes for test/training sets, expert consensus, and human reader performance are not applicable or not present in this 510(k) summary.
Here's a breakdown of the information that is available based on the provided text:
Acceptance Criteria and Device Performance (Non-Clinical)
The performance data for the EpiFaith Syringe are entirely based on non-clinical bench testing and adherence to recognized standards. The acceptance criteria are implicitly defined by compliance with these standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Defined by adherence to standards) | Reported Device Performance |
|---|---|
| ISO 7886-1:2017 (Sterile hypodermic syringes for single use – Part 1: Syringes for manual use) | "The EpiFaith Syringe complies with the FDA recognized consensus standards: ISO 7886-1:2017... Results of the testing demonstrate that the subject device met the acceptance criteria sufficient for its intended use." (Implies successful performance across all relevant parameters of the standard, e.g., dimensions, capacity, sterility, luer connection, plunger operation). |
| ISO 80369-6:2016 (Small-bore connectors for liquids and gases in healthcare applications – Part 6: Connectors for neuraxial applications) | "The EpiFaith Syringe complies with the FDA recognized consensus standards: ... ISO 80369-6:2016... Results of the testing demonstrate that the subject device met the acceptance criteria sufficient for its intended use." (Implies successful performance related to the NRFit connector specifications). |
| ISO 80369-7:2016 (Small-bore connectors for liquids and gases in healthcare applications – Part 7: Connectors for intravascular or hypodermic applications) | "The EpiFaith Syringe complies with the FDA recognized consensus standards: ... ISO 80369-7:2016, as outlined within this submission. Results of the testing demonstrate that the subject device met the acceptance criteria sufficient for its intended use." (Implies successful performance related to the Luer slip connector specifications). |
| ISO 80369-20:2015 (Small-bore connectors for liquids and gases in healthcare applications – Part 20: Common test methods) | "Conformity to these standards demonstrates that the proposed EpiFaith Syringe met the standards' established acceptance criteria for the device." (Indicates application of common test methods and successful results.) |
| ISO 10993-1, -4, -5, -7, -10, -11 (Biological Evaluation of Medical Devices – various parts) | "The biocompatibility evaluation for the EpiFaith Syringe was conducted in accordance with the FDA Guidance Document... and International Standard ISO 10993-1... Testing included the following: Hemolysis, In vitro cytotoxicity, Skin sensitization, Intracutaneous irritation, Acute systemic toxicity, Material-Mediated Pyrogens, Limulus amoebocyte lysate endotoxin." (Implies all these tests passed per the ISO 10993 standards). |
| **ASTM F1980-16, ISO 11135, ASTM F1140, ASTM F1608-00, ISO 15223-1, ASTM F756-17, USP , USP , USP , ISO 28590, ASTM F88, ASTM F1886, ASTM F1929, ISO 11737-2, ISO 14971, USP ** (Sterilization, Packaging, Labeling, Pyrogenicity, Quality Mgmt, Particulate Matter, etc.) | "A battery of tests was performed based on the requirements of the below recognized consensus standards and guidance, as well as biocompatibility, sterilization, and packaging standards and guidance. Conformity to these standards demonstrates that the proposed EpiFaith Syringe met the standards' established acceptance criteria for the device." (Implies successful performance across all listed standards). |
| Performance Bench Testing: Visual indicator response time, Needle protruding length and visual indicator activation on an epidural simulator, Resistance of the O-ring, Human Factors and Usability Testing on an epidural simulator | "Results of the testing demonstrate that the subject device met the acceptance criteria sufficient for its intended use." (Implies these specific bench tests were successfully completed and met internal acceptance criteria to support intended use). |
Information Not Present in the Provided Document:
The following requested items are typically associated with clinical studies, especially those involving AI/imaging devices, and are not found in this 510(k) summary as it pertains to a mechanical medical device (syringe):
- Sample sizes used for the test set and the data provenance: Not applicable; no clinical test set data presented.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable; no clinical ground truth established from expert readings.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable; no clinical test set.
- 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: No MRMC study was done, as this is a mechanical syringe, not an AI/imaging device.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No standalone algorithm performance provided, as this is a mechanical syringe.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for clinical ground truth. The "ground truth" for this device would be defined by the physical and material properties meeting the specifications of the listed international standards.
- The sample size for the training set: Not applicable; no training set data relevant to AI/machine learning.
- How the ground truth for the training set was established: Not applicable; no training set ground truth relevant to AI/machine learning.
Summary of the Study Proving Device Meets Acceptance Criteria:
The study proving the EpiFaith Syringe meets its acceptance criteria is a series of non-clinical bench tests and evaluations demonstrating compliance with a comprehensive list of international and consensus standards for piston syringes, biocompatibility, sterilization, packaging, and specific functional performance metrics (e.g., visual indicator response, O-ring resistance, human factors on a simulator). The document states that "Conformity to these standards demonstrates that the proposed EpiFaith Syringe met the standards' established acceptance criteria for the device." The rationale for substantial equivalence relies on these non-clinical tests showing the device performs comparably to the predicate and meets its intended use. No clinical trials or studies involving human patients or complex data interpretation (like AI in imaging) were conducted or are required for this type of device and submission.
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