FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The EpiFuse™ Catheter Connector is an alternate catheter connector for inclusion in the SIMS Regional Anesthesia Tray. The EpiFuse™ Catheter Connector consists of two halves joined by a living hinge. The main body contains an elastomeric tube. The catheter is inserted into the input hole at the base of the connector and is retained by the elastomeric tube when the two halves of the connector are folded together. The elastomeric tube also creates a seal to prevent leakage. The design of the modified EpiFuse™ Catheter Connector allows the user to close the device with one hand while holding the catheter with the other. To release the catheter, a Luer slip device is inserted into the release aperture and the two halves of the connector will separate allowing removal of the catheter. The key features and benefits of the EpiFuse™ Catheter connector include a yellow connector body for easy identification as Epidural during clinical use. The EpiFuseTM Catheter Connector is designed for use with 19G, 20G, and 21G epidural catheters. It offers one hand activation for a simplified ease of use and includes a secure locking mechanism to reduce the risk catheter disconnection.

AI/ML Overview

This is a 510(k) premarket notification for a medical device modification, specifically for the EpiFuse™ Catheter Connector within the SIMS Regional Anesthesia Trays. The provided document is a summary and an FDA clearance letter, not a detailed study report. Therefore, much of the requested information regarding a comprehensive clinical study or specific acceptance criteria with detailed performance metrics is not present. This type of submission often relies on a comparison to predicate devices and verification/validation testing rather than extensive clinical trials with human subjects.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a formal table of specific, numeric acceptance criteria. Instead, it broadly states that "Verification/validation testing confirm that the EpiFuse™ Catheter Connector is suitable for use with 19G, 20G, and 21G epidural catheters and is safe and effective for its intended use as a component of the SIMS Regional Anesthesia Tray."

This suggests that the acceptance criteria would have been defined internally by the manufacturer and likely cover aspects such as:

Catheter Compatibility: Successful connection, retention, and release of 19G, 20G, and 21G epidural catheters.
Leakage Prevention: Effective sealing to prevent leakage.
Ease of Use: One-hand activation.
Secure Locking Mechanism: Reduction of disconnection risk.
Biocompatibility: Likely assessed based on material specifications, not explicitly detailed here.
Sterility: Assessed as part of the overall tray.
Dimensional Accuracy: Fit within the tray and with catheters.
Material Strength/Durability: E.g., ability to withstand repeated use/sterilization if applicable (though this is a disposable connector).

Reported Device Performance:

Compatibility: "suitable for use with 19G, 20G, and 21G epidural catheters."
Safety and Effectiveness: "safe and effective for its intended use."
Key Features and Benefits (implying performance):
- Yellow connector body for easy identification as Epidural.
- One-hand activation.
- Secure locking mechanism to reduce risk of catheter disconnection.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not specified in the provided text. The phrase "Verification/validation testing" is broad and does not detail specific sample sizes for tests such as pull strength, leak tests, or functional evaluations.
Data Provenance: Not specified. It's internal manufacturer testing, so it would be laboratory-based and likely conducted at the manufacturer's facility in Keene, NH, USA. It is not a clinical study with patient data, so "retrospective or prospective" is not applicable in the human-subject sense.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided. Given that this is a 510(k) for a device component, the "ground truth" would likely be established through engineering specifications, material standards, and performance testing against industry standards, not by clinical expert consensus on patient data.

4. Adjudication Method for the Test Set

Not applicable/Not provided. Adjudication methods like 2+1 or 3+1 typically refer to the resolution of discrepancies in expert interpretations (e.g., in reading medical images or clinical outcomes). This document describes engineering verification and validation, not a multi-expert review process for clinical data.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done or reported in this document. Such studies are typically for diagnostic imaging devices or software where human readers interpret data with and without AI assistance. This device is a mechanical connector.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

Not applicable. This is a physical medical device component, not an algorithm. Its performance inherently involves human interaction for placement and connection.

7. Type of Ground Truth Used

The "ground truth" for this device would be established through engineering specifications, functional requirements, material standards, and performance against predefined testing protocols (e.g., for catheter retention force, leak integrity, ease of activation). It is not pathology, outcomes data, or expert consensus in the clinical sense. The document states "Verification/validation testing confirm..." which implies objective, measurable criteria were used.

8. Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that requires a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable. As above, no training set is involved for this type of device.

Summary

Regulation Number and Section

§ 868.5140 Anesthesia conduction kit.

(a)
Identification. An anesthesia conduction kit is a device used to administer to a patient conduction, regional, or local anesthesia. The device may contain syringes, needles, and drugs.(b)
Classification. Class II (performance standards).