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510(k) Data Aggregation
(196 days)
MEDCOMP SC4
THE MEDCOMP SC4 HEMODIALYSIS CATHETER IS INDICATED FOR USE IN ATTAINING LONG-TERM VASCULAR ACCESS FOR HEMODIALYSIS AND APHERESIS. IT MAY BE INSERTED PERCUTANEOUSLY AND IS PRIMARILY PLACED IN THE INTERNAL JUGULAR VEIN. ALTERNATE INSERTION SITES INCLUDE THE SUBCLAVIAN VEIN. CATHETERS GREATER THAN 40CM ARE INTENDED FOR FEMORAL VEIN INSERTION. THE SC4 EXTENSION SET IS INTENDED TO REPAIR THE SC4 HEMODIALYSIS CATHETER.
The Medcomp SC4 is a 16F polyurethane, double lumen catheter used to remove and return blood through two-secregated lumen passages. Both lumens are "D" shaped, tapered at the distal tip, each with a series of side holes. The distal venous lumen extends beyond the arterial lumen to reduce recirculation. The fixed polyester cuff allows for tissue ingrowth for long term placement. A removable suture wing hub is provided for securing the catheter after initial placement. The arterial and venous lumens are designed to be split, or peeled apart, prior to insertion to provide two free-floating lumens within the vessel. After the catheter has been positioned the catheter lumens can be trimmed and an extension set is assembled on the proximal end of the catheter. Red and blue luer connectors and clamps identify the arterial and venous extensions set. Priming volume information is printed on the catheter lumen.
Here's an analysis of the provided text regarding the Medcomp SC4 device, focusing on acceptance criteria and study details:
Summary of Acceptance Criteria and Device Performance for Medcomp SC4 Hemodialysis Catheter (K022678)
Based on the provided 510(k) summary, the Medcomp SC4 Hemodialysis Catheter's performance was evaluated through in-vitro testing to demonstrate substantial equivalence to predicate devices. There was no clinical data deemed necessary.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Performance Parameter | Reported Device Performance | Study Type |
|---|---|---|---|
| Mechanical Properties | Tensile Strength | Demonstrated substantial equivalence to predicate devices | In-vitro |
| Mechanical Properties | Joint Strength | Demonstrated substantial equivalence to predicate devices | In-vitro |
| Integrity | Leakage | Demonstrated substantial equivalence to predicate devices | In-vitro |
| Hemodynamic Performance | Recirculation | Demonstrated substantial equivalence to predicate devices | In-vitro |
| Hemodynamic Performance | Flow Performance | Demonstrated substantial equivalence to predicate devices | In-vitro |
| Material Properties | Lumen Peel | Demonstrated substantial equivalence to predicate devices | In-vitro |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: The document does not specify the exact sample sizes (number of catheters or test specimens) used for each in-vitro test.
- Data Provenance: The data is described as "In-vitro performance data," indicating it was generated in a controlled laboratory setting. There is no information regarding country of origin, nor is it retrospective or prospective clinical data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable. The ground truth for this device was established via validated in-vitro testing methods against established performance benchmarks or comparisons to predicate devices, not through expert human evaluation of a dataset.
4. Adjudication Method for the Test Set:
- Not applicable. As noted above, the evaluation was based on in-vitro test results and comparison to predicate devices, not on human adjudication of a clinical dataset.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No. An MRMC comparative effectiveness study was not performed. The submission explicitly states: "Clinical data was not deemed necessary since substantial equivalence is addressed by way of comparison to a legally marketed device."
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
- Not applicable. This device is a physical medical device (hemodialysis catheter), not an algorithm or AI system.
7. The Type of Ground Truth Used:
- The "ground truth" for this submission was based on:
- Validated In-vitro Testing Methods: Standard engineering and material science tests to assess the physical and functional characteristics of the catheter.
- Performance of Legally Marketed Predicate Devices: The results of the in-vitro tests were compared against the known performance characteristics of the Medcomp Ash Split-Cath™ II (K020465) and Medcomp Bio-Flex™ CS (K971925) to demonstrate "substantial equivalence."
8. The Sample Size for the Training Set:
- Not applicable. There was no "training set" as this is not an AI/ML device. The device's design and manufacturing likely involved internal R&D and testing, but these are not referred to as a "training set" in the context of this 510(k) summary.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable, as there was no training set for an algorithm. The design and validation of the catheter were based on engineering principles and regulatory requirements for medical devices.
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