(78 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 iniections for the administration of contrast media, anesthetic agents to provide regional anesthesia, and anti-inflammatory medications. 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/infusions of contrast media, anesthetics, and anti-inflammatory medications into the epidural space of the spine.
The Spinal Injection System is supplied as a sterile, single patient use, disposable device.
The provided text describes a 510(k) summary for the Laurimed Spinal Injection System. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed acceptance criteria and a study to prove performance.
Therefore, most of the requested information regarding detailed acceptance criteria, specific performance metrics, sample sizes, expert qualifications, and study design for proving the device meets acceptance criteria is not present in the provided document.
Here's a breakdown of what can be extracted and what is missing:
Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Specified | "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." (General statement, no specific metrics) |
Missing Information Summary
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not specified.
- 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): Not applicable, as no clinical study with ground truth establishment is described.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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. The device is a medical instrument, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a medical instrument, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no clinical study requiring ground truth is described. The document refers to "non-clinical testing" and "design specifications."
- The sample size for the training set: Not applicable, as the device is not an AI/ML product requiring a training set.
- How the ground truth for the training set was established: Not applicable.
Information Present (Regarding Acceptance Criteria & Study)
- Acceptance Criteria: Not explicitly stated as specific, quantifiable criteria in the document. The general statement made is that "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." This suggests an internal set of design specifications served as the acceptance criteria, but their details are not provided.
- Study Proving Acceptance: The document refers to "non-clinical testing" that demonstrated the device is "safe and effective for its intended use" and "functions as intended and meets design specifications." This implies engineering and performance tests were conducted. However, no details about the methodology, specific tests, results, or comparison data are included in this 510(k) summary. The primary study mentioned is a "Technological Comparison" to a predicate device (Laurimed Spinal Injection System K080140) to establish "substantial equivalence."
In summary, the provided 510(k) document is a high-level summary focused on demonstrating substantial equivalence through non-clinical testing and comparison to a predicate device rather than detailing specific acceptance criteria and the comprehensive study data that proved those criteria were met.
§ 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).