(329 days)
For administration of anesthetic agents into the epidural space to provide continuous epidural or caudal anesthesia for up to 72 hours.
The Versa-Kath Epidural Catheter consists of a stainless steel spring lumen with a dual coating. The inner coating is Polyester tube and the outer coating is Fluorinated Ethylene Polypropylene tube. A stylet is also provided with the device which consists of a stainless steel wire and a molded plastic hub. The Versa-Kath will be provided as a sterile, single use, disposable device. The Versa-Kath will be a 21 gauge catheter available in various lengths.
Here's an analysis of the provided document regarding the acceptance criteria and study for the Versa-Kath Epidural Catheter:
The document does not describe an AI/ML medical device. It pertains to a physical medical device, the Versa-Kath Epidural Catheter, which is anesthesia conduction catheter. Therefore, many of the typical questions for AI/ML device studies (like sample sizes for test/training sets, ground truth establishment methods, expert qualifications, adjudication, MRMC studies, standalone performance, etc.) are not applicable in this context.
Instead, the submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical (bench) testing.
Here's the information that can be extracted relevant to acceptance criteria and the study, as far as it applies to a non-AI/ML device:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Tensile Strength | Similar to predicate device (Racz Epidural Catheter K954584) | Confirmed similar to predicate device |
| Flow | Similar to predicate device (Racz Epidural Catheter K954584) | Confirmed similar to predicate device |
| Deflection (Stiffness) | Conformance to BS 6196 | Confirmed conformance to BS 6196 and similar to predicate device |
| Fluid Pressure (Catheter/Adapter Connection) | Similar to predicate device (Racz Epidural Catheter K954584) | Confirmed similar to predicate device |
| Luminal Integrity | Similar to predicate device (Racz Epidural Catheter K954584) | Confirmed similar to predicate device |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for the bench testing. It refers to "Bench Testing performed," implying that a sufficient number of samples were tested to support the conclusions. As this is bench testing of a physical device, data provenance (country of origin, retrospective/prospective) is not relevant in the same way it would be for clinical data or AI data. The tests were performed in a lab setting by the manufacturer, Epimed International, Inc.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
N/A. This is a physical device. "Ground truth" in this context would be objective physical measurements from testing, not expert consensus on medical images or clinical data.
4. Adjudication Method for the Test Set
N/A. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert labeling or diagnoses, which is not applicable here.
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
N/A. This is not an AI device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A. This is not an AI device.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established through objective engineering measurements and adherence to recognized standards (like BS 6196) during bench testing, and comparison to the characteristics of a legally marketed predicate device.
8. The Sample Size for the Training Set
N/A. This is not an AI device. There is no concept of a "training set" for this type of device.
9. How the Ground Truth for the Training Set was Established
N/A. This is not an AI device.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The study was a non-clinical bench testing evaluation designed to demonstrate that the Versa-Kath Epidural Catheter has substantially equivalent physical and technical characteristics and performance to its identified predicate device, the Racz Epidural Catheter (K954584).
Key aspects of the study:
- Type of Study: Bench testing (non-clinical).
- Tests Performed:
- Tensile strength
- Flow
- Deflection (stiffness)
- Fluid Pressure of the catheter/adapter connection
- Luminal integrity
- Methodology: The Versa-Kath Epidural Catheter was tested and its performance characteristics were directly compared to those of the predicate device. For deflection (stiffness), conformance to standard BS 6196 was also evaluated.
- Conclusion: The manufacturer concluded that the testing confirmed the Versa-Kath's performance is "similar to that of the device [predicate]" and demonstrated substantial equivalence, leading to its determination as "safe and effective."
The FDA's decision to clear the device (K023140) signifies their concurrence with the manufacturer's conclusion that the non-clinical data supported the substantial equivalence claim.
§ 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).