Search Results
Found 1 results
510(k) Data Aggregation
(191 days)
The Vas-Cath Soft-Cell dual lumen hemodialysis cutheter is indicated for use in attaining short term or long term vascular access for hemodialysis, hemoperfusion or apheresis therapy via the jugular or subclavian vein.
Soft-Cell Dual Lumen Catheters as currently distributed by BAS are available in straight and precurved configurations, in multiple insertion lengths. Catheters are made of polyurethane containing barium sulfate to provide radiopacity. Colored luer connectors identify the arterial (red) and venous (blue) lumens. Each extension has an atraumatic occlusion clamp, which closes the catheter. A fixed suture wing is located at the bifurcation.
The provided document (K030277) describes a 510(k) submission for a change in the luer connectors of the Soft-Cell Dual Lumen Catheter. This is an Abbreviated 510(k) based on conformance to recognized standards, as the modification is related to the material and design of the luer connectors only, not involving the complete device redesign or new indications for use.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are derived from recognized standards and guidance documents. The reported device performance indicates that all tests met the requirements.
| Acceptance Criteria (Standard/Guidance) | Reported Device Performance |
|---|---|
| ISO 594-1:1986, Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General Requirements | "All test results confirm the modified device to be substantially equivalent to the predicate device." "The test results met the requirements." |
| ISO 594-2:1986, Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock Fittings | "All test results confirm the modified device to be substantially equivalent to the predicate device." "The test results met the requirements." |
| FDA's Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, dated 3/16/95 | "All test results confirm the modified device to be substantially equivalent to the predicate device." "The test results met the requirements." |
| ISO 10555-1:1997, Sterile, single-use intravascular catheters, Part 1. General requirements | "All test results confirm the modified device to be substantially equivalent to the predicate device." |
| ISO 10555-3:1997, Sterile, single-use intravascular catheters, Part 3. Central venous catheters | "All test results confirm the modified device to be substantially equivalent to the predicate device." |
| AAMI/ANSI/ISO-10993-1: 1997, Biological evaluation of medical devices - Part 1: Evaluation and testing, and the FDA Modified ISO 10993 Test Profile | "Biocompatibility testing results met the requirements of ISO-10993... and the FDA Modified ISO 10993 Test Profile." |
| AAMI/ANSI/ISO 11135:1994, Medical devices - Validation and routine control of ethylene oxide sterilization | Not explicitly stated as a separate test, but referenced for evaluation. Implied "All test results confirm the modified device to be substantially equivalent." |
| Specific performance tests for luer connection (Dimensions, Tensile strength of catheter body to hub attachment, Leakage at hub, Catheter burst pressure) | "All test results confirm the modified device to be substantially equivalent to the predicate device." "The test results met the requirements." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes (number of devices) used for each performance test. It only states that "Bench testing was performed according to the above referenced standards and guidance document recommendations." and "All aspects of the modified devices are identical to the predicate devices except for the luer connector hub material and design. All performance testing conducted focused on the qualification of the new connector only."
The data provenance is prospective bench testing conducted in-house by Bard Access Systems, Inc. (the submitter). The country of origin of the data is implicitly the USA, where the submitter is located.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable and therefore not provided in the document. The study involves bench testing of a medical device's physical properties and biocompatibility, not clinical trials or diagnostic accuracy evaluations where expert consensus for ground truth would be required. The "ground truth" for these tests is defined by the objective pass/fail criteria outlined in the referenced international standards (e.g., ISO for Luer fittings, catheter general requirements, and biocompatibility).
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods (like 2+1 or 3+1) are typically used for establishing ground truth in human-reader studies or clinical trials where there's subjectivity. In this bench testing context, results are objectively measured against established scientific and engineering standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating diagnostic imaging devices or other devices where human interpretation is involved. The submission concerns a physical modification to a catheter's luer connector, which is evaluated through bench testing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable as the device is a physical medical device (catheter connector) and not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.
7. The Type of Ground Truth Used
The ground truth used for this study is objective measurement against recognized international and FDA standards and guidance documents. For instance:
- Dimensional accuracy: Ground truth is defined by the dimensional specifications within ISO 594 standards for Luer fittings.
- Tensile strength, leakage, burst pressure: Ground truth is defined by the minimum performance requirements specified in relevant ISO 10555 standards and FDA guidance for intravascular catheters.
- Biocompatibility: Ground truth is defined by meeting the requirements of ISO 10993-1 and the FDA Modified ISO 10993 Test Profile.
8. The Sample Size for the Training Set
This information is not applicable. There is no "training set" in the context of bench testing for a physical medical device. Training sets are used in machine learning for AI/algorithm development.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as #8.
Ask a specific question about this device
Page 1 of 1