(199 days)
The RK Epidural Needle is indicated for either single injection of drug or placement of an Epimed Spring Guided Catheter or traditional epidural catheter.
The RK Epidural Needle consists of a stainless steel cannula with a ground beveled distal tip. A plastic hub is molded onto the proximal end of the cannula. A stainless steel stylet with a molded plastic hub is also provided with the device. The RK Epidural Needle will be provided as a sterile, single use, disposable device. The RK Epidural Needle will be available in a variety of lengths and gauges.
This 510(k) summary for the RK Epidural Needle (K072005) does not contain the information requested about acceptance criteria or a study proving the device meets said criteria.
The document is a traditional 510(k) submission, which focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific performance acceptance criteria through a dedicated study.
Here's why the requested information is absent:
- Substantial Equivalence: The primary method for clearance in this type of 510(k) is to show that the new device has "similar physical and technical characteristics" and the same "intended use" as legally marketed predicate devices. This approach argues that if the predicate devices are considered safe and effective, and the new device is substantially equivalent, then the new device is also safe and effective. It does not require a new clinical trial or performance study proving specific acceptance criteria are met in the same way a novel device or a device requiring a PMA would.
- Device Type: This is a Class II device (Anesthesia Conduction Needle). For such devices, often bench testing, material safety, and performance data comparing it to predicates (e.g., tip design, material strength, flow rates if applicable) are used to demonstrate equivalence, but not necessarily a formal clinical study with acceptance criteria in the sense of accuracy, sensitivity, or specificity.
- Content of the Summary: The provided text is a summary of the 510(k) application. It lists:
- Company information
- Date prepared
- Trade and common name
- Product class and classification
- Predicate device(s)
- Description of the device
- Intended Use
- Comparison to Predicate
- Conclusion affirming substantial equivalence.
Therefore, I cannot provide the requested table, sample sizes, expert details, adjudication methods, MRMC study information, standalone performance, or ground truth details from this document because it is not present. The document states that the comparison to predicate devices demonstrates that the RK Epidural Needle is safe and effective, implying that the safety and effectiveness are inferred from its similarity to already cleared devices, not from a new study designed to meet specific acceptance criteria.
§ 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).