(108 days)
The Laurimed Spinal Injection System is intended for use in procedures where injection is required.
The Laurimed Spinal Injection System is indicated for use in spinal epidural injections for administration of anesthetic agents to provide regional anesthesia. Not for use with other needles or catheters.
The Laurimed Spinal Injection System integrates a flexible Catheter with an atraumatic distal tip into a Needle designed for injections/infusion of local anesthetics into the epidural space of the spine.
The Spinal Injection System is supplied as a sterile, single patient use, disposable device.
The given 510(k) notification for the Laurimed Spinal Injection System (K080140) outlines the device's substantial equivalence to predicate devices based on technological characteristics and non-clinical performance data. However, it does not contain the specific information required to answer your questions regarding acceptance criteria and a study that proves the device meets those criteria.
The document is a summary of the 510(k) and focuses on demonstrating substantial equivalence to legally marketed predicate devices, as well as reporting on non-clinical performance to ensure the device functions as intended and meets design specifications. It does not include details about specific acceptance criteria tables, clinical study designs, sample sizes for test or training sets, ground truth establishment, expert qualifications, or MRMC studies.
Therefore, I cannot provide the requested information from the provided text. The document states:
- "Results of the non-clinical performance testing demonstrated that the Spinal Injection System is safe and effective for its intended use."
- "non-clinical testing was conducted to validate the performance of the device and ensure the Spinal Injection System functions as intended and meets design specifications."
These statements confirm that testing was performed, but they lack the granular detail about the acceptance criteria, study design, and results asked for in your prompt. Medical device submissions like this often include detailed test reports as part of the full submission, but only the summary is available here.
§ 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).