(282 days)
For administration of anesthetic agents into the epidural space to provide epidural or caudal anesthesia.
EPINAUT Spring Guide Epidural Catheter is constructed of a stainless steel continuous spring. EPINUAT Spring Guide Epidural Catheter offers two types of catheter. The catheter types, L330 & L600 have an uncoated distal tip which is flexible, smooth and rounded with coils slightly spread for maximum flexibility and lateral distribution of injectant. The other catheter types, C310 & C600 have a distal end which is entirely coated by tube for maximum smoothness. There are 16 models in EPINAUT: L33011320, L33013820, L33011315, L33013815, L60011320, L60013820, L60011315, L60013815, C31011320, C31013820, C31011315, C31013815, C60011320, C60013820, C60011315 and C60013815. Each model is characterized by different length of catheter, length and outer diameter of wire, inner diameter of adapter, length and diameter of introducer needle and needle cap.
EPINUAT Spring Guided Epidural Catheter have enhanced tensile/ break strength and restrict longitudinal catheter stretch, while the spring coils make the catheter resistant to kinking and collapsing. Wire is also provided with the device which consists of a stainless steel and a molded plastic hub.
The introducer needle is inserted into the epidural space through the sacral hiatus under intermittent fluoroscopy. After appropriate determination of the epidurogram and target area, the catheter with the wire in it is advanced through the introducer needle to the concerned area as determined by MRI or symptomatology. When the catheter is approached to target site, the wire is removed from the catheter and then the medication can be injected by attaching the adapter to a syringe.
The medical device in question, EPINAUT, is an Anesthesia Conduction Catheter. The provided context does not include information about clinical studies involving human patients or AI-based performance metrics. The information focuses on non-clinical testing to establish substantial equivalence to a predicate device.
Here's an analysis of the provided text in relation to the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes various non-clinical tests performed to evaluate the performance of EPINAUT and to demonstrate substantial equivalence to the predicate device, the Racz Epidural Catheter. The acceptance criteria are implicitly met if the test results "met the pre-set criteria" or "supported that the subject device is substantially equivalent." Specific numerical acceptance criteria are not explicitly stated for all tests; rather, the successful completion of the test according to a standard often serves as the acceptance.
| No. | Test | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|---|
| 1 | Visual Inspection (Appearance) | Device appears as intended, free from defects. | Test performed, results met pre-set criteria. |
| 2 | Size Measurement | Dimensions conform to specifications. | Test performed, results met pre-set criteria. |
| 3 | Leakage Test (Catheter) | No leakage. | Test performed, results met pre-set criteria. |
| 4 | Tensile strength (Catheter) | Meets specified tensile strength (e.g., ISO 10555-1 Annex B for catheter, BS 6196:1989 Appendix D for catheter-hub/Stylet/Needle Stylet). | Test performed, results met pre-set criteria. (Also see side-by-side testing results below). |
| 5 | Assemble compatibility (Catheter) | Components fit together correctly. | Test performed, results met pre-set criteria. |
| 6 | Radiopacity test | Device is visible under fluoroscopy. | Test performed, results met pre-set criteria. |
| 7 | Corrosion resistance test | No significant corrosion. | Test performed, results met pre-set criteria. |
| 8 | Flexural Rigidity (Catheter introducer and needle) | Meets specified flexibility requirements. | Test performed, results met pre-set criteria. |
| 9 | Pulling (Drawing) Test (Catheter introducer and needle) | Meets specified pulling force requirements. | Test performed, results met pre-set criteria. |
| 10 | Flexural Rigidity (Wire) | Meets specified flexibility requirements. | Test performed, results met pre-set criteria. |
| 11 | EO Gas residue | Residue levels below accepted limits. | Test performed, results met pre-set criteria. |
| 12 | Sterility Test | Sterility Assurance Level (SAL) of 10^-6 (in accordance with ISO 11135 and ISO 11737-1, 2). | Test performed, results met pre-set criteria. |
| 13 | Endotoxin Test | Endotoxin levels below specified limits. | Test performed, results met pre-set criteria. |
| 14 | Particulate Matter Test | Particulate matter levels below specified limits. | Test performed, results met pre-set criteria. |
| Side-by-Side Comparative Tests with Predicate Device: | |||
| 1 | Tensile strength (Catheter, Catheter-Hub, Stylet, Needle Stylet) | Performance comparable to predicate device, meeting relevant standards (ISO 10555-1 Annex B, BS 6196:1989 Appendix D for various components, BS 6196:1989 Appendix F for Needle Stylet). | "The test results supported that the subject device is substantially equivalent to the predicate devices." Implies comparable or better performance. |
| 2 | Dullness test | Performance comparable to predicate device, meeting BS 6196:1989 Appendix G. | "The test results supported that the subject device is substantially equivalent to the predicate devices." Implies comparable or better performance. |
| 3 | Fluid pressure of the catheter/adapter connection | Performance comparable to predicate device, meeting ISO 10555-1 Annex G. | "The test results supported that the subject device is substantially equivalent to the predicate devices." Implies comparable or better performance. |
| 4 | Flow rate | Performance comparable to predicate device, meeting ISO 10555-1 Annex E. | "The test results supported that the subject device is substantially equivalent to the predicate devices." Implies comparable or better performance. |
| 5 | Luminal integrity | Performance comparable to predicate device, meeting ISO 10555-1 Annex C. | "The test results supported that the subject device is substantially equivalent to the predicate devices." Implies comparable or better performance. |
| Biocompatibility: | Biocompatible as per ISO 10993-4, 5, 10, 11 and USP 39 for External communicating device (tissue/bone/dentin communicating), Limited exposure ( |
§ 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).