(185 days)
The Combined Spinal/Epidural Anesthesia System is indicated for the injections of local anesthetics into the spinal and epidural spaces of a patient to provide regional anesthesia. The adminsistration of the spinal anesthesia allows rapid anesthesia onset and the placement of an epidural catheter allows for bolus injections or continuous infusion of local anesthetics or other drugs into the epidural space.
The combined spinal epidural needle kit is intended for injection of local anesthetics into the intrathecal space via a spinal needle introduced through the epidural needle, and injection of local anesthetics into the epidural space via the epidural needle, or via an epidural catheter passed through the epidural needle.
Combined Spinal/Epidural Anesthesia Needles are instruments used for a spinal (subarachnoid) injection of anesthetics, followed by the placement of an epidural catheter to allow modification of the spinal analgesia if necessary, or bolus injections or continuous infusion of local anesthetics or other drugs into the epidural space for subsequent pain relief if required. The spinal needle consists of a luer hub, a stainless steel cannula with a pencil point tip, a stainless steel stylete, and a locking colar. The tuohy epidural needle consists of a luer hub, a stainless steel cannula with a Weiss tip, and a matching flange to accept the spinal needles locking colar. The needles are a matched set. The needles are provided as sterile, single use, disposable devices. They may be packaged as a set or included as a set in our regional anesthesia trays. The sizes are tabulated below:
| Spinal Needle | ||
|---|---|---|
| 26g 5 3/16" | ||
| (132 mm) | 27g 5 3/16" | |
| (132 mm) | ||
| Epidural Needle | ||
| 17g 3.5" (90 mm) | X | X |
| 18g 3.5" (90 mm) | X |
The Tuohy needle and the spinal needle have interlocking collars that enable the spinal needle to be locked into position once the dura has been pierced so that it is secured to the Tuohy needle to prevent acceidental displacement. The numbers on the Tuohy needle hub indicate the distance in millimeters that the spinal needle protrudes from the epidural Tuohy needle.
This document is a 510(k) Pre-Market Notification submission for the CSEcure™ Combined Spinal/Epidural Anesthesia System with Lock. It focuses on demonstrating substantial equivalence to a predicate device rather than providing specific acceptance criteria and a detailed study report with quantitative performance metrics against those criteria.
Therefore, many of the requested details such as specific acceptance criteria for a device's performance, statistical sample sizes for test and training sets, expert qualifications, and adjudication methods are not present in this type of regulatory document.
However, I can extract the information that is available:
1. A table of acceptance criteria and the reported device performance:
This document does not provide a specific table of quantitative acceptance criteria for device performance. Instead, it relies on demonstrating equivalence to a predicate device through "comparison testing." The reported device performance is described qualitatively as:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Similar Technical Characteristics | "The device has the same technical characteristics as the predicate device marketed by Becton-Dickinson." |
| Comparable Performance | "Comparison testing between the proposed device and the predicate device... compared well." |
| Safety & Effectiveness | "There were no differences seen in performance accept for an increased flow rate of 28.6% in the 27g spinal needle. The differences in these needles are not significant and substantiate that the needles are safe and effective. The testing substantiates this claim." |
| Substantial Equivalence | "The testing performed and comparison to the predicate device demonstrate that the proposed device is safe and effective and is substantially equivalent to the predicate device." |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified. The document only mentions "comparison testing."
- Data Provenance: Not specified, but likely internal testing performed by SIMS Portex Inc. (the manufacturer). Retrospective or prospective is not indicated.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is a non-clinical study involving physical device testing (e.g., flow rate, technical characteristics), not clinical data requiring expert review for ground truth. Therefore, this information is not applicable and not present.
4. Adjudication method for the test set:
Not applicable, as this was non-clinical testing.
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:
No. This is a medical device in the field of anesthesia, not an AI/imaging device that would involve human readers for interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No. This is a physical medical device, not an algorithm.
7. The type of ground truth used:
The "ground truth" for this non-clinical study relied on direct measurement and comparison of technical characteristics and physical performance (e.g., flow rate) against the established characteristics and performance of the legally marketed predicate device.
8. The sample size for the training set:
Not applicable. This is a non-clinical study for a physical device, not an AI or machine learning model that requires a training set.
9. How the ground truth for the training set was established:
Not applicable (as per point 8).
§ 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).