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510(k) Data Aggregation
(90 days)
MEDCOMP REPAIR KIT, MODEL ASPCRPK
THE MEDCOMP REPAIR KIT IS INDICATED FOR USE IN REPLACING DAMAGED FEMALE LUER CONNECTORS, CLAMPS, OR REPAIRING EXTENSIONS WHERE THERE IS A MINIMUM OF 4.5cm VIABLE EXTENSION TUBING.
REPAIRS MEDCOMP CATHETERS: 10F Ash Split Cath® XL, 10F Ash Split Cath® II, 14F Ash Split Cath®, 14F Ash Split Cath® XL, 14F Ash Split Cath® II, 16F Ash Split Cath® II
The Medcomp Repair Kit is two-piece replacement luer adaptor and cap used to repair damaged female luer connectors on Medcomp Hemodialysis Catheters. The Medcomp Repair Kit also consists of replacement arterial and venous clamps.
Acceptance Criteria and Device Performance Study for Medcomp Repair Kit (K022570)
The Medcomp Repair Kit is a two-piece replacement luer adaptor and cap intended for repairing damaged female luer connectors on Medcomp Hemodialysis Catheters. It also includes replacement arterial and venous clamps. The device is designed to repair extensions where there is a minimum of 4.5cm viable extension tubing on specific Medcomp Catheter models.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Simulated Use Performance | Demonstrated substantial equivalence to predicate device |
| Tensile Strength | Demonstrated substantial equivalence to predicate device |
| Leakage | Demonstrated substantial equivalence to predicate device |
| (General): Safety and Effectiveness | Sufficiently demonstrated through in-vitro testing |
| (General): Substantial Equivalence to Predicate Device | In-vitro performance data supports substantial equivalence |
2. Sample Size for Test Set and Data Provenance
No specific test set sample size is explicitly stated in the provided document. The performance data relied on in-vitro testing only. Therefore, there is no information regarding the country of origin or whether the data was retrospective or prospective, as these aspects are typically relevant for clinical studies.
3. Number of Experts and Qualifications for Ground Truth Establishment
Not applicable. The study involved in-vitro testing, not clinical evaluation requiring expert consensus for ground truth establishment.
4. Adjudication Method for Test Set
Not applicable. As the study was an in-vitro performance evaluation, there was no human adjudication process involved.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. The submission explicitly states that "Clinical studies were not deemed necessary."
6. Standalone (Algorithm Only) Performance Study
Not applicable. The Medcomp Repair Kit is a physical medical device, not an algorithm or AI-driven system. Therefore, a standalone (algorithm only) performance study is not relevant.
7. Type of Ground Truth Used
The ground truth for this device's performance was established through in-vitro testing against the performance characteristics of a legally marketed predicate device (K011015 Bard Catheter Repair Kit). This implies that the 'ground truth' was defined by the established performance benchmarks and regulatory compliance of the predicate device.
8. Sample Size for the Training Set
Not applicable. There was no "training set" as this device is not an AI/ML algorithm requiring training data. The assessment was based on comparing the repair kit's physical and functional performance to a predicate device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there was no training set, there was no ground truth established for one. The evaluation focused on demonstrating that the performance of the Medcomp Repair Kit was substantially equivalent to the predicate device through in-vitro testing.
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