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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

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.

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when used with a fiberoptic endoscope, this device can be used in the lumbar and sacral spine for observing epidural anatomy, pathology and delivery of drugs approved for epidural indications.

The MYELOTEC VIDEO GUIDED CATHETER (VGC) consists of a flexible double lumen catheter, steering handle and associated ports for access to the lumens. The catheter has a built in steering mechanism that allows for guiding the soft tip through the epidural space and soft tissues for optimal access to the source of distress. Each lumen is one (1) mm in diameter. The design allows the use of a flexible fiber optic endoscope for visual examination of the area and surrounding tissues at the distal end of the catheter. This visual examination then allows the physician to diagnose the potential causes of neural distress and pain.

The port on the second lumen allows the injection of saline to expand the space and expose the source of distress for viewing and treatment. The port also facilitates the connection of syringes to deliver physician selected therapeutic agents as appropriate to their diagnosis.

The provided text is a 510(k) notification summary for the MYELOTEC VIDEO GUIDED CATHETER II. This document primarily focuses on establishing substantial equivalence to a predicate device and does not contain information about acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert qualifications for the device.

Therefore, I cannot provide the requested information from the given text.

The document mainly includes:

• Contact information and submission date
• Device name, classification, and predicate device
• Description and intended uses of the device
• New indications for use
• A comparison table between the MYELOTEC VGC and the RACZ Tun-L-Kath, highlighting differences in attributes like length, lumen diameter, number of lumens, endoscope capability, and steerability.
• An FDA letter confirming the review and substantial equivalence determination.
• An enclosure reiterating the intended use/indications.

Ask a specific question about this device