(87 days)
An Epidural Needle is indicated for the injection of anesthetic agents into the epidural space or to facilitate the placement of an epidural catheter.
Epidural needles are instruments used for the injection of anesthetic agents into the epidural space or to facilitate the placement of an epidural catheter into the epidural space for continuous infusion of anesthetic agents into the epidural space for subsequent pain relief if required.
The needle consists of a plastic Luer hub, a stainless steel cannula, a plastic stylet and removable wings. The needle cannula has 10cm depth markings on it to assist in the needle placement.
The needles are provided as sterile, single use, disposable devices. They may be packaged individually or included in our regional anesthesia trays. The needles are provided with a Tuohy point in both 17g and 18g sizes.
This document describes the FDA 510(k) submission for Epidural Anesthesia Needles, focusing on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and detailed device performance metrics. Therefore, many of the requested elements for an AI/device performance study are not applicable or explicitly stated in this type of submission.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (from standards) | Reported Device Performance (as stated in submission) |
|---|---|---|
| Stainless Steel Components | ISO 9626 (likely for dimensions, mechanical properties, surface finish, etc.) | "meets performance standards where applicable" |
| Luer Hub | ISO 594-1 and ISO 594-2 (likely for dimensions, gauge size, freedom from leakage, etc.) | "meets performance standards where applicable" |
| Hub to Needle Bond Strength | ISO 7864 (likely for testing the integrity of the bond) | "meets performance standards where applicable" |
| Visual Characteristics | Not explicitly stated (likely absence of defects, proper assembly) | "performs equivalently to the predicate device" |
| Dimensional Characteristics | Not explicitly stated (likely within manufacturing tolerances) | "performs equivalently to the predicate device" |
| Overall Performance | Not explicitly stated (likely functional use parameters) | "performs equivalently to the predicate device" |
Important Note: The document states that the new device has "the same technological characteristics as the predicate devices" and "meets performance standards where applicable for: ISO 9626, ISO 594-1 and ISO 594-2, ISO 7864." The performance is reported as performing "equivalently to the predicate device" and that "data submitted demonstrates that the epidural needle performs equivalently to the predicate device" across visual, performance, and dimensional characteristics. Specific numerical performance results against these ISO standards are not provided in this summary.
Regarding the Absence of an AI/Device Performance Study:
The provided text is a 510(k) summary for a medical device (Epidural Anesthesia Needles) seeking substantial equivalence to a predicate device. It is not an AI/ML medical device submission, nor does it describe a study establishing clinical performance of a diagnostic or therapeutic AI product. Therefore, the following points are not applicable to this document as it does not describe such a study:
- 2. Sample size used for the test set and the data provenance: Not applicable. This is a physical medical device; no test set of data is described.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth for data is established.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set for adjudication.
- 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 device.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI device.
- 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. No ground truth for data is established.
- 8. The sample size for the training set: Not applicable. No training set for an algorithm.
- 9. How the ground truth for the training set was established: Not applicable. No ground truth for an algorithm.
Summary of the Study (as described in the 510(k) summary):
The "study" described is a non-clinical data submission aimed at demonstrating substantial equivalence to a predicate device (K000495, Ballard Medical Products Epidural and Spinal Needles).
- Study Type: Non-clinical (bench testing, materials verification).
- Objective: To show that the Epidural Anesthesia Needles have the same technological characteristics and perform equivalently to the predicate device.
- Data Provenance: Not specified, but generally refers to internal company testing and adherence to international standards (ISO 9626, 594-1, 594-2, 7864).
- Ground Truth: The "ground truth" in this context is the established performance and safety of the predicate device and compliance with relevant ISO standards. Equivalence is the metric.
- Clinical Data: Explicitly stated as "Not required," indicating that the non-clinical data was sufficient for the substantial equivalence determination for this device type.
§ 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).