MODIFICATION TO: BD DURASAFE PLUS EPIDURAL LOCK CSE NEEDLE SET/KIT by BD

A comparison between the modified BD Durasafe™ Plus! Epidural Lock CSE Needle Set/Kit and existing BD Durasafe™ Variable Extension Combined Spinal Epidural (CSE) Needle Set/Kit is provided in the table below:

| COMPONENT /
CHARACTERISTIC | CSE
(EXISTING DESIGN) | CSE
(MODIFIED DESIGN) |
|-------------------------------|--------------------------|--------------------------|
| Cannula | Stainless Steel | Stainless Steel |
| Needle Hub | Polypropylene | Polypropylene |
| Stylet | Polypropylene | Polypropylene |
| Color Additive | Pink/Gray | Pink/Gray |
| Gasket | None | Isobutyl Rubber |
| Needle Shield | Polyethylene | Polyethylene |
| Locking
Mechanism | Slide/Grip Lock | Pinch Lock |
| Sterilization
Process | ETO | ETO |

AI/ML Overview

This document is a 510(k) premarket notification for a medical device, the BD Durasafe™ Plus! Epidural Lock CSE Needle Set/Kit. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria for device performance. Therefore, much of the requested information regarding acceptance criteria and performance studies is not available in this type of regulatory submission.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

This document does not specify quantitative acceptance criteria for device performance in terms of metrics like sensitivity, specificity, accuracy, or other measurable outcomes typically associated with AI/software performance. The comparison table focuses on physical characteristics and materials.

Component / Characteristic	CSE (Existing Design)	CSE (Modified Design)	Acceptance Criteria (Implied)	Reported Performance
Cannula	Stainless Steel	Stainless Steel	Same material	Same material
Needle Hub	Polypropylene	Polypropylene	Same material	Same material
Stylet	Polypropylene	Polypropylene	Same material	Same material
Color Additive	Pink/Gray	Pink/Gray	Same color scheme	Same color scheme
Gasket	None	Isobutyl Rubber	Appropriate for intended use	Isobutyl Rubber (New)
Needle Shield	Polyethylene	Polyethylene	Same material	Same material
Locking Mechanism	Slide/Grip Lock	Pinch Lock	Secure locking, ease of use	Pinch Lock (New)
Sterilization Process	ETO	ETO	Same process	Same process

The "acceptance criteria" here are implied by the claim of substantial equivalence: the modified design should perform equivalently or better than the predicate device for its intended use, focusing on safety and effectiveness. The "Pinch Lock" and "Isobutyl Rubber" are changes compared to the predicate, implying these new features meet the same safety and effectiveness standards, likely through design verification and validation testing (though not detailed here).

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

Not applicable. This is a submission for a physical medical device, not an AI/software device that typically uses test sets of data. The "test" likely refers to engineering verification and validation testing of the physical device components, not a data-driven model.

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

Not applicable. Ground truth, in the context of expert review, is typically established for diagnostic or screening tests. This document describes a surgical needle set, where effectiveness is measured through its physical function and safety, not by expert interpretation of data.

4. Adjudication Method for the Test Set:

Not applicable, for the reasons mentioned above.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging or similar interpretation tasks where human readers' performance is being evaluated, often with and without AI assistance. This document pertains to a physical medical device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable. This device is a physical medical instrument, not an algorithm.

7. Type of Ground Truth Used:

Not applicable in the typical sense of AI/software performance. For a physical device like this, "ground true" would relate to whether the device functions as intended (e.g., the locking mechanism securely locks, the needle delivers the anesthetic appropriately, materials are biocompatible, sterility is maintained). This would be validated through engineering tests, biocompatibility studies, and sterility assurance, rather than expert consensus on data.

8. Sample Size for the Training Set:

Not applicable. This device is not an AI/ML model that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, for the reasons mentioned above.

Summary of the Study/Evidence Provided in the Document:

The provided document (K0125884) is a 510(k) Premarket Notification to the FDA. The "study" described herein is a comparison and equivalence determination between a modified device (BD Durasafe™ Plus! Epidural Lock CSE Needle Set/Kit) and an existing predicate device (BD Durasafe™ Variable Extension Combined Spinal Epidural (CSE) Needle Set/Kit K945497).

The document argues for substantial equivalence based on:

Same intended use: Both devices are used for combined spinal/epidural (CSE) anesthesia procedure.
Similar confirmation of needle placement.
Same range of needle gauge sizes.
Similar insertion technique.
Same materials: For most components (cannula, needle hub, stylet, needle shield).
Same sterilization process: ETO.

The key modifications are the addition of an Isobutyl Rubber Gasket and a change in the Locking Mechanism from Slide/Grip Lock to Pinch Lock. The submission implies that these changes do not alter the fundamental safety or effectiveness of the device for its intended use, and therefore the modified device is substantially equivalent to the legally marketed predicate. This is a regulatory pathway to demonstrate that a new device is as safe and effective as an already approved device, without requiring extensive new clinical trials specific to the modified device, provided the changes are minor and do not raise new questions of safety or effectiveness.

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).