(353 days)
The Medline Epidural Catheter is indicated for the injection of local anesthetics into the epidural space for patients over 22 lbs. (10kgs.), for a duration of use of up to 72 hours.
The Medline Epidural Catheter is a single use device made of flexible, nylon tubing which is sold as sterile individually packaged and sterile packaged inside a kit/procedure tray. The epidural catheter is designed as a closed tip device with 3 eyes for distribution of anesthetic agents. The catheters have a black radiopaque stripe. The catheter is available in 19G and is 800 millimeters long. The catheter has a marked tip, with 1cm increments up to 25cm. The 10cm mark is indicated by two marks, 15cm by three marks, 20cm by four marks and 25cm by five marks. As an added safety feature, the solid wide warning mark indicates exit of catheter from needle when using a Medline Epidural Needle. This device is intended to be used in conjunction with an epidural catheter connector cleared under K051171.
The provided text describes the 510(k) premarket notification for the Medline Epidural Catheter, seeking to demonstrate its substantial equivalence to a predicate device. This document does not pertain to an AI/ML device, and therefore, many of the requested criteria related to AI/ML device evaluation are not applicable.
Here's an analysis based on the provided text, focusing on the available information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present "acceptance criteria" in the typical sense for an AI/ML device where specific metrics like sensitivity, specificity, or AUC are outlined. Instead, it relies on demonstrating substantial equivalence to a predicate device through non-clinical performance testing. The "acceptance criteria" here are implicitly that the device performs comparably to the predicate or within established safety and performance standards for its type, as indicated by the "Pass" results for each test.
| Standard or Reference | Test Method | Data Generated | Reported Device Performance (Result) |
|---|---|---|---|
| ISO 10993-5 | Cytotoxicity | Cytotoxicity | Pass |
| ISO 10993-10 | Intracutaneous reactivity | Dermal irritation | Pass |
| ISO 10993-10 | Maximization sensitization | Dermal sensitization | Pass |
| ISO 10993-11 | Subacute toxicity | Subacute toxicity | Pass |
| ISO 10993-11 | Systemic injection | Systemic injection | Pass |
| ASTM F 756-13 | Hemolysis assay | Hemolytic potential | Pass |
| USP Pyrogen Test Procedure, Section (USP37) | Pyrogen | Non-pyrogenic | Pass |
| ASTM F 623 | Flow rate | Flow rate | Pass |
| Not specified | Extractables analysis | Extractables analysis | No toxicological risk |
| Not specified | Appearance / ink / x-ray detection | Visual appearance / ink tenacity / x-ray detection | Pass |
| Not specified | Tensile strength | Tensile properties | Pass |
| Not specified | Particulate matter | Particulate size | Pass |
| Not specified | Kink / dimensional analysis testing | Flow rate / marking accuracy | Pass |
2. Sample size used for the test set and the data provenance
The document provides a summary of non-clinical testing. It does not specify sample sizes for each test listed. The tests are laboratory-based and material-based, not involving patient data or clinical samples in the way an AI/ML device would. Data provenance is not applicable in the context of clinical populations for these types of tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a non-clinical evaluation of a physical medical device. Ground truth is established by standardized laboratory methods and measurements, not by expert interpretation of data.
4. Adjudication method for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus in interpreting images or clinical cases, which is not relevant to the non-clinical testing of this device.
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
Not applicable. This device is not an AI-assisted diagnostic or therapeutic tool. No human reader studies (MRMC) were performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm.
7. The type of ground truth used
The ground truth for the non-clinical tests is based on established scientific and engineering standards and measurements (e.g., ISO, ASTM, USP standards) for material properties (cytotoxicity, dermal irritation, etc.), physical performance (flow rate, tensile strength), and safety (pyrogenicity, extractables).
8. The sample size for the training set
Not applicable. This device does not involve training data as it is not an AI/ML model.
9. How the ground truth for the training set was established
Not applicable. This device does not involve training data.
§ 868.5120 Anesthesia conduction catheter.
(a)
Identification. An anesthesia conduction catheter is a flexible tubular device used to inject local anesthetics into a patient and to provide continuous regional anesthesia.(b)
Classification. Class II (performance standards).