(203 days)
Regional Anesthesia: To provide a device to accomplish the Combined Spinal (CSE) Epidural Technique
The only change described in this 510(k) is replacing the epidural catheter with the Stella-Cath™ Epidural Catheter, a nylon epidural catheter with star shape interna profile.
This document describes a 510(k) submission for the BD DURASAFE™ CSE TRAY WITH STELLA-CATH™, which is a modified version of an existing device. The core of the submission is to demonstrate the substantial equivalence of the new device to the predicate device (BD Durasafe™ Combined Spinal Epidural Anesthesia Needle Set/Kit).
This is a medical device submission and does not describe an AI/ML algorithm or a study involving human readers or experts to establish ground truth in the context of an AI/ML system. Therefore, many of the requested fields cannot be directly answered.
The "acceptance criteria" here refer to performance specifications for the new device that demonstrate it is as safe and effective as the predicate device. The "study" refers to mechanical testing that verified these specifications.
Here's the information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion (Specification Requirement) | Reported Device Performance |
|---|---|
| BD Stella-Cath™ Catheter Performance | Meets all specification requirements; not inferior to current product. |
| All Components Conformance | Conform to physical, mechanical, and biological specifications. |
| ISO 594 (Conical Fittings) | Conforms to standard. |
| ISO 7864 (Sterile Disposable Needles) | Conforms to standard. |
| ISO 7886-1 (Sterile Disposable Syringes) | Conforms to standard. |
| ISO 10993-1 (Biological Evaluation of Medical Devices) | Conforms to standard. |
| Cannula Strength | Same as predicate device (Federal Stiffness Test). |
| Needle Bond Strength | Same as predicate device (8 lb. minimum). |
| Biocompatibility | Same as predicate device (ISO standards met). |
| Materials | Same as predicate device (Approved materials). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated. The document mentions "mechanical testing results," implying tests were conducted, but the number of units tested is not provided.
- Data Provenance: Not specified, but likely refers to internal testing conducted by Becton Dickinson and Company.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This is not applicable as the study involves mechanical and physical testing of a medical device, not an AI/ML system or a clinical study requiring expert ground truth for interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This is not applicable. The device performance is assessed against predefined engineering specifications and ISO standards, not through human adjudication of diagnostic interpretations.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This study is for a medical device's physical and mechanical properties, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This is not applicable as no algorithm is being evaluated. The "standalone" performance refers to the device's inherent mechanical and biological characteristics.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" here is defined by industry standards (ISO), pre-defined engineering specifications, and the established performance characteristics of the predicate device. For example, "Needle Bond Strength - 8 lb. minimum" is a ground truth specification.
8. The sample size for the training set
- This is not applicable as there is no AI/ML algorithm being developed or trained.
9. How the ground truth for the training set was established
- This is not applicable as there is no AI/ML algorithm being developed or trained.
§ 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).