(148 days)
The Spring-Wound Epidiral Catheter is intended for administration of local anesthetic agents into the epidural space to provide continuous epidural or caudal anesthesia. Micor recommends that the catheter be removed or replaced every 72 hours.
This catheter exhibits the same design and performance as the cited predicates. Its external sheath (patient-contact) material is identical to that used in the Preferred Medical predicate.
The provided text is a 510(k) summary for a medical device: the Micor® Spring-Wound Epidural Catheter. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through a clinical trial with specific performance metrics and acceptance criteria as might be expected for novel devices.
Therefore, many of the typical elements requested in your prompt (like specific acceptance criteria based on numerical performance, sample sizes for test sets, expert ground truth, MRMC studies, or standalone algorithm performance) are not applicable or not present in this type of regulatory document.
However, I can extract information related to the demonstration of equivalence, which functions as the "study" for this type of submission.
Here's a breakdown of the information based on your request, explaining why certain sections are not applicable:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: For a 510(k) submission, the "acceptance criteria" are demonstrating substantial equivalence to a predicate device. This is primarily established by showing that the subject device has the same intended use, similar technological characteristics, and similar materials to legally marketed predicate devices, and that no new issues of safety or effectiveness are raised. There are no explicit numerical performance criteria (e.g., sensitivity, specificity, accuracy) defined or measured for this type of device in this document.
- Reported Device Performance: The document states:
- "This catheter exhibits the same design and performance characteristics as the legally marketed predicates."
- "The subject device will function the same as the predicate devices."
- "The technological characteristics of Micor's Spring-Wound Epidural Catheter, as compared to those of the Arrow and Epimed predicates, are essentially the same."
- "The materials incorporated in the subject device are identical to ones contained in the legally-marketed predicates..."
- "The intended use of the subject device is equivalent to that of all three predicate devices."
- "Conclusion No new issues of safety or effectiveness are raised by the design of this device. Micor's Spring-Wound Epidural Catheter is equivalent to the cited predicate devices in its material, technology, and intended use."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This submission is based on a comparison of design, materials, and intended use to existing predicate devices, not on a clinical "test set" of patient data. There are no test sets or data provenance mentioned.
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)
- Not Applicable. As there is no test set in the clinical sense, there is no expert ground truth established for patient data. The "ground truth" here is the established safety and effectiveness of the predicate devices based on their long-term use and regulatory clearance. The FDA's review committee (Division of Cardiovascular, Respiratory, and Neurological Devices) acts as the expert body reviewing the comparison.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No test set, no adjudication method.
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 is not an AI/Software as a Medical Device (SaMD) and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a hardware medical device (catheter), not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this 510(k) submission is the established safety and effectiveness profile of the predicate devices (Arrow International, Inc. FlexTip Plus® Epidural Catheter, Epimed International, Inc. Feth-R-Kath® Epidural Catheters (K981329), and Preferred Medical Products Epidural Catheter (K885278)). The substantial equivalence argument relies on the premise that if the new device is sufficiently similar to these legally marketed devices, it can be considered safe and effective for its intended use.
8. The sample size for the training set
- Not Applicable. There is no "training set" in the context of device development for a 510(k) submission like this.
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
§ 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).