(88 days)
The SIMS Portex Epidural Catheter is indicated for the injection of local anesthetics into the epidural space.
The SIMS Portex Epidural Catheter is made of flexible, nylon tubing. The catheter may be closed-ended with lateral eyes or an open-ended catheter with finished tip. The tip of the catheter is marked. The catheter has a single mark at 5 cm from the tip with 1 cm increments, up to 20 cm. The 10 cm mark is indicated by two marks, 15 cm by three marks, and 20 cm by four marks. The catheter is available in 20g (O.D. .042"/I.D. .023") or 21g (O.D. .033"/I.D. . 019") sizes. The catheters have a nominal length of 38 inches. The catheters may include a stylete. The catheters are provided with a catheter connector (K965017) to provide a means of administration of anesthetics and/or analgesics. They are provided sterile in individual packages or as a component of a continuous epidural procedure tray (K965017).
The provided 510(k) summary for the SIMS Portex Epidural Catheter indicates that no clinical data was submitted to demonstrate the device meets acceptance criteria. Instead, the submission relies on non-clinical data to establish substantial equivalence to a predicate device.
Therefore, many of the requested sections regarding clinical study design, ground truth, expert adjudication, and MRMC studies are not applicable or cannot be extracted from this document.
Here's the information that can be extracted and a clear indication where information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Dimensional Characteristics | Performs equivalently to predicate device |
| Flow Rate | Performs equivalently to predicate device |
| Compression Resistance | Performs equivalently to predicate device |
| Hub/Catheter Detachment | Performs equivalently to predicate device |
| Deflection Resistance | Performs equivalently to predicate device |
| Modulus of Elasticity | Performs equivalently to predicate device (with an increase in percent elongation compared to predicate due to material change, but this has "no affect on performance criteria"). |
| Tensile Strength | Performs equivalently to predicate device |
| Elongation | Performs equivalently to predicate device (with an increase in percent elongation compared to predicate due to material change, but this has "no affect on performance criteria"). |
| ETO Residuals | Data submitted (implies acceptable levels) |
| Biological Safety (per ISO 10993) | Data submitted (implies acceptable levels based on ISO 10993 standards) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable. No clinical test set. Non-clinical data was used.
- Data Provenance: Not applicable. Non-clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Not applicable. No clinical test set requiring expert ground truth.
4. Adjudication Method for the Test Set
- Not applicable. No clinical test set requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No.
- Effect Size of Human Readers with/without AI assistance: Not applicable, as this is neither an AI device nor was an MRMC study performed.
6. Standalone (Algorithm Only) Performance Study
- Was a standalone study done? Not applicable. This is not an AI algorithm. The device is a physical epidural catheter.
7. Type of Ground Truth Used
- For Non-Clinical Data: Engineering specifications, material science standards (e.g., ISO 10993 for biological safety), and comparative measurements against the predicate device.
8. Sample Size for the Training Set
- Not applicable. This is not an AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. This is not an AI algorithm requiring a training set or ground truth establishment for training.
§ 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).