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510(k) Data Aggregation
(360 days)
The Medcomp® Split-Cath® II is indicated for use in attaining chronic (longthe wousehip access for hemodialysis and apheresis. It may be inserted tonni/ vaceusly and is ideally placed in the internal jugular vein of an adult patient. Alternate insertion site includes the subclavian vein as required.
The Medcomp Split-Cath II is a polycarbonate/polyurethane, double lumen catheter used to remove and return blood through two-segregated lumen passages. Both lumens are "D" shaped, tapered at the distal tip, with eight 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.
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. The side holes are orientated to allow 360-degree arterial uptake and venous return. The lumens are connected to the extensions via a soft pliable hub with suture wing. Red and blue luer connectors and clamps identify the arterial and venous extensions. Priming volume information is printed an identification ring housed within the extension line clamp.
The provided document is a 510(k) premarket notification for the Medcomp® Split-Cath® II Hemodialysis Catheter. It seeks to demonstrate substantial equivalence to predicate devices, rather than establishing de novo safety and effectiveness. Therefore, the information typically found in a study proving a device meets acceptance criteria for new devices (like detailed performance metrics against specific acceptance criteria, sample sizes for test and training sets, expert qualifications for ground truth, MRMC studies, or standalone algorithm performance) is largely absent.
However, based on the provided text, here's an attempt to answer the questions within the context of a substantial equivalence submission:
Acceptance Criteria and Study to Prove Device Meets Criteria for Medcomp® Split-Cath® II Hemodialysis Catheter
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel performance metrics against pre-defined acceptance criteria for a new device. The "acceptance criteria" here are implicitly tied to the performance of the predicate device and the general safety/effectiveness standards for such devices.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| I. Substantial Equivalence to Predicate Devices: | Met: The technological characteristics of the Split-Cath II are stated to be substantially equivalent to the predicate devices (Medcomp Ash Split-Cath II, Medcomp Bio-Flex CS Cath, and Medcomp Split-Stream SC4) in terms of: - Intended use - Insertion method - Anatomical location - Design - Performance - Labeling - Manufacturing process - Method of sterilization |
| II. Physical and Functional Performance (In Vitro): | Met: In Vitro performance data for the Medcomp Split Cath II demonstrated substantial equivalence to the legally marketed Ash Split-Cath II catheter for: - Tensile strength - Joint strength - Leakage - Recirculation - Flow performance - Flexural - Lumen peel |
| III. Biocompatibility: | Met: Biocompatibility testing on the Split-Cath II demonstrates the lumen materials meet the requirements of USP XXII for a permanent contact device. Substantial equivalence for lumen material formulation to the predicate device (polyurethane) is also noted, with the only difference being a second vendor for the material. |
| IV. Regulatory Compliance (e.g., GMP, Labeling, Sterilization): | Met (Implied): The FDA letter instructs the submitter to comply with all Act's requirements, including annual registration, listing of devices, good manufacturing practice (QSR), and labeling, implying these are expected for market entry. The submission likely contained documentation to support compliance with manufacturing and sterilization processes, as these were mentioned in the substantial equivalence comparison. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a "test set" sample size in the traditional sense of a clinical trial. The performance data provided is in vitro, focusing on engineering characteristics. The "test set" for demonstrating substantial equivalence primarily refers to the Medcomp Split Cath II samples used in the specified in vitro tests. The document does not specify the number of devices or components tested for each in vitro performance measure.
Data Provenance: The in vitro data was generated specifically for this 510(k) submission, likely at Medcomp's facilities or an accredited testing lab. No country of origin for the data is specified, but the submitter is based in Harleysville, PA, USA. The data is prospective in the sense that it was generated for the purpose of this submission and to evaluate the new device against the predicate.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable and not provided in the document. For a 510(k) submission based on substantial equivalence and in vitro testing, there isn't typically a ground truth established by medical experts in the same way there would be for a diagnostic or AI device that requires expert adjudication. The "ground truth" for in vitro performance tests would be the established engineering and materials science principles and the performance of the legally marketed predicate device.
4. Adjudication Method for the Test Set
Not applicable and not provided. As the primary performance data discussed is in vitro and focused on mechanical and material characteristics, there is no expert adjudication method like "2+1" typically used for clinical endpoints or image interpretation.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Clinical data was not deemed necessary since substantial equivalence is addressed by way of comparison to a legally marketed device." Therefore, there is no information on human reader improvement with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done
Not applicable. This device is a medical catheter, not an AI algorithm or an imaging device.
7. The Type of Ground Truth Used
The "ground truth" for this submission is:
- Predicate Device Performance: The established performance characteristics of the legally marketed predicate device(s), particularly the Ash Split-Cath II catheter, as demonstrated through in vitro testing.
- Industry Standards/Regulations: Compliance with relevant standards like USP XXII for biocompatibility.
- Design Specifications: The documented design specifications of the proposed device being identical to the predicate (Ash Split-Cath II) except for the lumen material vendor.
8. The Sample Size for the Training Set
Not applicable. This submission is for a physical medical device (catheter) and does not involve AI algorithms that require training sets in the typical sense.
9. How the Ground Truth for the Training Set was Established
Not applicable. As above, no training set for an AI algorithm is involved.
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