(56 days)
An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.
The BD Spinal needle consists of a non-lubricated stainless steel cannula attached to the needle hub using an epoxy adhesive. When appropriate for the procedure, this needle includes a stylet. This stylet consists of non-lubricated stainless steel. The stainless steel stylet is attached to the stylet handle using an epoxy adhesive. The needle assembly is protected with a polypropylene shield. The Spinal needle is packaged appropriately for either sterile or nonsterile, single use, purposes.
This document is a 510(k) summary for the BD Spinal Needle. It asserts substantial equivalence to existing predicate devices rather than presenting a study demonstrating it meets specific acceptance criteria based on novel performance.
Therefore, many of the requested categories are not applicable or cannot be extracted from the provided text, as this type of submission focuses on equivalence to already approved devices rather than a de novo performance study against defined criteria.
Here's a breakdown of the information that can be extracted or inferred:
1. Table of Acceptance Criteria and Reported Device Performance
Not Applicable. This 510(k) submission does not present specific acceptance criteria or performance data for the BD Spinal Needle in the typical sense of a de novo device study. Instead, it claims "identical technological characteristics and perform equivalently" to predicate devices. There are no quantitative measures or thresholds mentioned that the device needed to meet.
2. Sample Size Used for the Test Set and Data Provenance
Not Applicable. No specific test set or data provenance details are provided in this 510(k) summary. The submission relies on establishing substantial equivalence to predicate devices based on design and intended use, not on a new comparative performance study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not Applicable. No test set or ground truth establishment process is described.
4. Adjudication Method for the Test Set
Not Applicable. No test set or adjudication process is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No. A MRMC comparative effectiveness study was not done, as this submission is for a spinal needle, which is a physical medical device, not a diagnostic imaging or AI system typically subject to MRMC studies.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not Applicable. This device is a physical spinal needle; there is no algorithm or AI component to evaluate.
7. The Type of Ground Truth Used
Not Applicable. No ground truth establishment is described for performance evaluation. The "ground truth" for this submission would be the established safety and effectiveness of the predicate devices.
8. The Sample Size for the Training Set
Not Applicable. This is a physical medical device, not a machine learning model, so there is no training set in the context of AI.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. There is no training set mentioned or implied.
Summary of Device's Argument for Meeting "Acceptance Criteria" (Substantial Equivalence):
The "acceptance criteria" for this 510(k) submission is to demonstrate substantial equivalence to legally marketed predicate devices.
- Predicate Devices: BD Spinal Needle, BD Precisionglide Needle, BD Hypoint Needle (all manufactured by Becton, Dickinson and Company).
- Method of Proof: Comparison of device features, materials, intended use, and existing device performance.
- Conclusion: The sponsor states that "The BD Spinal Needle and the predicate device have the same identical technological characteristics and perform equivalently." This assertion is the primary "proof" for this type of submission.
The FDA's letter confirms that they reviewed the submission and determined that the device is substantially equivalent to legally marketed predicate devices for the stated indications for use. This regulatory determination signifies that the device has met the "acceptance criteria" for marketing under a 510(k) pathway, which is substantial equivalence.
§ 868.5150 Anesthesia conduction needle.
(a)
Identification. An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.(b)
Classification. Class II (performance standards).