Search Results

The SubQKath Catheter and Needle Kit is intended to provide continuous and/or intermittent infusion of local anesthetics and analgesics for subcutaneous infiltration local anesthesia, peripheral plexus anesthesia and pain management during pre-operative, perioperative and post-operative periods associated with surgical procedures.

The HK SubOKath Subcutaneous Catheter is a device intended to provide a means of delivery of local analgesics into the human body via a fenestrated catheter. The device is a single lumen catheter available in a single gauge (16g) size. The distal end of the device allows for flow of analgesia into the surgical wound. The device is supplied sterile and is intended for single use.

This document describes the 510(k) premarket notification for the SubQKath Catheter and Needle Set (K193664). The acceptance criteria and study proving the device meets these criteria are primarily based on non-clinical performance data demonstrating substantial equivalence to predicate devices, rather than a clinical study involving human patients or complex AI algorithm performance.

Therefore, many of the typical questions for AI/ML-based medical devices (like sample size for test/training sets, expert consensus, MRMC studies, or standalone algorithm performance) are not applicable to this submission. This device is a physical medical device, and its safety and effectiveness are established through engineering testing and comparison to existing devices.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly list acceptance criteria in a quantitative table format for each test, but it states that "The subject device met the acceptance criteria of the above tests, and did not raise new questions of safety and effectiveness." The study design is focused on demonstrating physical and material properties, rather than diagnostic accuracy metrics.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not explicitly stated in terms of a "test set" as this is a physical device and testing involves material and functional evaluations, not typically patient data sets. The sample sizes for the various engineering and biocompatibility tests would be dependent on the specific test protocols (e.g., number of catheters tested for flow rate, number of samples for material strength). These details are not provided in this summary.
• Data Provenance: Not applicable in the context of clinical data. The data provenance refers to the results of laboratory-based physical, chemical, and biological performance testing of the device itself. This would be generated from the manufacturer's testing facilities or contract labs.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Number of Experts: Not applicable. Ground truth for a physical device is established through validated testing methodologies and adherence to standards (e.g., ISO, ANSI/AAMI). There's no "ground truth" derived from expert consensus on medical images or clinical outcomes in this type of submission.
• Qualifications of Experts: Not applicable in the context of clinical readers. The "experts" would be engineers, material scientists, and toxicologists conducting the specified tests and interpreting the results according to relevant standards.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. This is not a study requiring reader adjudication of medical data.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• MRMC Study: No. This is not an AI/ML diagnostic device, nor is it a device that would typically undergo a human-reader comparative effectiveness study. It's a physical catheter.
• Effect Size of Human Readers' Improvement: Not applicable.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Standalone Performance: Not applicable. This device does not involve an algorithm.

7. The Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" for this device is based on engineering specifications, material science standards (e.g., ISO 9626, ISO 11607, ISO 10993-1), and functional performance requirements of similar, legally marketed predicate devices. For biocompatibility, it's the biological response measured against established safety thresholds.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This device does not involve AI/ML and therefore does not have a "training set."

9. How the Ground Truth for the Training Set Was Established

• Ground Truth for Training Set Establishment: Not applicable.

Ask a specific question about this device