Search Results

The Super C™ Hemodialysis/Apheresis Chronic Catheter is indicated for use in attaining short and long term vascular access for hemodialysis. hemoperfusion or apheresis therapy via the jugular or subclavian vein. The catheter is intended for implantation dwell time of greater than 30 days.

The Super C™ Hemodialysis/Apheresis Chronic Catheter is composed of a radiopague polyurethane catheter shaft with two lumens (arterial and venous) in a Crescent (Circle "C") configuration. The lumens are distinguishable by color-coded clamps on clear silicone extensions. The fixed retention cuff on the shaft provides an anchoring site for tissue ingrowth during long-term placement. The Super C™ Hemodialysis/Apheresis Chronic Catheter offered in straight versions are available in 19 cm, 23 cm, and 28 cm cuff to tip insertion lengths. Additionally, the Super C™ Hemodialysis/Apheresis Chronic Catheter is available with a J-Cannula version in 19 cm and 23 cm cuff to tip insertion lengths.

The provided text describes a 510(k) premarket notification for the Super C™ Hemodialysis/Apheresis Chronic Catheter. This type of submission is a regulatory pathway for medical devices that are substantially equivalent to legally marketed predicate devices, not a study designed to prove the device meets specific performance criteria through clinical trials or detailed algorithm performance evaluation.

Therefore, many of the requested categories for device acceptance criteria and studies are not applicable to this submission as it focuses on demonstrating substantial equivalence through comparison of technological characteristics and performance testing data rather than a detailed clinical study with established ground truth, expert adjudication, or MRMC studies.

Here's a breakdown of what can be extracted from the provided text, and where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

The text does not specify quantitative acceptance criteria. Instead, it states that "Performance testing was conducted data for Super C™ Hemodialysis/Apheresis Chronic Catheter and compared to the predicate devices identified in this 510(k). Test results demonstrated that the Super C™ Hemodialysis/Apheresis Chronic Catheter is substantially equivalent to these predicate devices commercially in distribution for the same intended use."

This implies the acceptance criterion was "substantial equivalence" to the specified predicate devices, meaning its performance characteristics (material type, intended use, operating principle, number of lumens) were similar enough and its performance test results did not raise new questions of safety or effectiveness.

2. Sample size used for the test set and the data provenance

• Sample Size: Not specified. The document states "Performance testing was conducted data," indicating in-vitro or bench testing, but does not specify the number of units or tests performed.
• Data Provenance: The nature of 510(k) submissions generally means this would be internal company testing (Horizon Medical Products, Inc.). The data would be prospective in the sense that the company specifically conducted tests for this submission, but it's not a clinical study involving patients or patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable. This device is a physical medical device (catheter), not one that generates diagnostic output requiring expert interpretation for ground truth. The "ground truth" for its performance would be established by direct physical measurements, material properties testing, and functional assessments, not expert consensus on interpretations.

4. Adjudication method for the test set

• Not Applicable. As no expert interpretation or diagnostic output is involved, there is no need for an adjudication method.

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

• Not Applicable. This is a physical medical device (catheter), not an AI-powered diagnostic tool. Therefore, MRMC studies and assessment of human reader improvement with AI assistance are irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable. This is a physical medical device, not an algorithm or software.

7. The type of ground truth used

• Not Applicable in the sense of a diagnostic outcome. The "ground truth" for a physical device like this is its physical and functional performance, verified through engineering tests, material science analysis, and potentially some animal or cadaver studies (though not explicitly mentioned here, implied by performance testing). For example, tensile strength would be measured directly, or flow rates assessed under simulated conditions.

8. The sample size for the training set

• Not Applicable. This is a physical medical device, not a machine learning algorithm that requires a training set.

9. How the ground truth for the training set was established

• Not Applicable. (See point 8)

Ask a specific question about this device