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510(k) Data Aggregation
(309 days)
K/DEN number and list them here in a comma separated list exactly as they appear in the text:
K020089
THE MEDCOMP® T-3 CATHETER IS INDICATED FOR USE IN ATTAINING SHORT-TERM VASCULAR ACCESS FOR HEMODIALYSIS, APHERESIS AND INFUSION. IT MAY BE INSERTED PERCUTANEOUSLY AND IS PRIMARILY PLACED IN THE INTERNAL JUGULAR VEIN OF AN ADULT PATIENT. ALTERNATE INSERTION SITES INCLUDE THE SUBCLAVIAN VEIN. THE MEDCOMP® T-3 CATHETER IS INDICATED FOR A DURATION LESS THAN (30) DAYS.
The Medcomp® T-3 catheter is a 15.5 polyurethane, triple lumen catheter used to remove and return blood with a third internal lumen for infusion. The Medcomp® T-3 catheter is comprised of a soft thermosensitive, radiopaque polyurethane material that is rigid upon insertion and once it reaches body temperature becomes soft to reduce vessel trauma. The lumens are connected to the extensions via a soft pliable hub with a suture wing for secure placement. Clamps are provided on the extension tubes to prevent air/fluid communication. The luers and clamps are color coded, red for arterial, blue for venous and a clear luer for infusion of drugs, TPN or fluid administration. The catheters are available in 15.5F. The catheter is offered in 28 and 32cm. The Medcomp® T-3 catheter is packaged with the necessary accessories to facilitate catheter insertion.
The provided text describes a 510(k) premarket notification for the Medcomp® T-3 hemodialysis catheter, focusing on its substantial equivalence to predicate devices rather than a detailed study proving its acceptance criteria with specific performance metrics. Therefore, many of the requested details about a study and acceptance criteria are not explicitly present in the provided document.
However, I can extract the available information and indicate where data is missing.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria with pass/fail thresholds. Instead, it refers to demonstrating "substantial equivalence" to predicate devices. The performance data is summarized qualitatively.
| Criterion Category | Acceptance Metric (Implicit) | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Substantially equivalent to predicate devices, in accordance with ISO 10555-1 and 10555-3. | - Force at Break: Demonstrated substantial equivalence. |
| - Air and Liquid Leakage: Demonstrated substantial equivalence. | ||
| - Recirculation: Demonstrated substantial equivalence. | ||
| - Flow Performance: Demonstrated substantial equivalence. | ||
| Biocompatibility | Meets ISO 10993 requirements for a permanent contact device. | - Biocompatibility testing on the Medcomp® T-3 catheter demonstrates that the materials used meet the requirements of ISO 10993 for a permanent contact device. |
| Clinical Safety & Effectiveness | (Not explicitly stated, generally inferred from predicate device's established safety and effectiveness) | Addressed in predicate device 510(K) K020089. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a sample size for the in-vitro test set.
The data provenance is for in-vitro testing, meaning it was laboratory-based testing, not human data. Therefore, country of origin is not relevant in the context of patient data, and it is by nature "retrospective" as the device was tested after its design.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document, as the performance data described is in-vitro (laboratory) testing, not clinical data requiring expert human assessment for ground truth.
4. Adjudication Method
This information is not provided in the document. This is typically relevant for clinical studies or studies involving human assessment of data, which is not the primary focus of the performance data described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not performed or described in this document. The submission focuses on in-vitro performance and substantial equivalence to existing devices.
6. Standalone Performance Study
Yes, a standalone study was performed in the sense that the Medcomp® T-3 catheter underwent in-vitro performance testing (force at break, air/liquid leakage, recirculation, flow performance) without human intervention in the loop of the test itself. The results of these tests demonstrated substantial equivalence to predicate devices. However, this is not "standalone algorithm performance" as would be relevant for an AI/software device.
7. Type of Ground Truth Used
For the in-vitro performance tests, the "ground truth" would be established by engineering specifications, industry standards (ISO 10555-1 and 10555-3), and benchmarks set by the predicate devices. For biocompatibility, the ground truth is established by the requirements of ISO 10993.
8. Sample Size for the Training Set
This information is not applicable and not provided. This device is a medical device (catheter), not an AI/machine learning algorithm, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided, as there is no "training set" for this type of medical device.
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