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510(k) Data Aggregation
(332 days)
TRANSSEPTAL NEEDLE/TROCAR
Used to create the primary puncture in the interatrial septum when passing an introducer and/or catheter through the septum from the right side of the heart to the left side.
The Thomas Medical Transseptal Needle consists of a specifically curved distal portion to accommodate positioning in the cardiac anatomy when used in conjunction with a transseptal introducer. A stopcock is attached to the proximal end of the needle for air aspiration, fluid infusion, blood sampling and pressure monitoring. A pointer is included on the needle shield to show orientation of the curve.
Here's the analysis of the provided text regarding the acceptance criteria and study for the Transseptal Needle:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Mechanical Integrity | Hub pull test | Passed protocol requirements | All samples passed |
| Mechanical Integrity | Hub to Stopcock pull test | Passed protocol requirements | All samples passed |
| Mechanical Integrity | Wire to Handle pull test (assuming "Wire" refers to needle) | Passed protocol requirements | All samples passed |
| Mechanical Integrity | Needle to Hub torque force | Passed protocol requirements | All samples passed |
| Intended Use | Create primary puncture in interatrial septum | Functionally equivalent to predicate devices | Substantially equivalent to predicate devices |
2. Sample Size Used for the Test Set and Data Provenance
The provided text states, "All samples passed the protocol qualification testing requirements." It does not specify an explicit sample size for each test. It also does not provide any information about the data provenance (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The text describes mechanical qualification testing, not a study involving expert assessment of a medical condition or images.
4. Adjudication Method for the Test Set
This information is not applicable as the tests conducted were mechanical qualification tests and did not involve expert adjudication of results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not performed. The submission is for a medical device (a needle) and not an AI or diagnostic imaging device that would typically undergo such a study. The “study” described is qualification testing to ensure the device’s mechanical integrity.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, a standalone performance study was not done. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the qualification testing was the pre-defined protocol qualification testing requirements. These requirements would have defined acceptable ranges or thresholds for the mechanical properties being tested (e.g., minimum pull force, maximum torque). For the overall device, the "ground truth" for its regulatory approval was its substantial equivalence to predicate devices in terms of intended use and technological characteristics.
8. The Sample Size for the Training Set
This information is not applicable. This submission is for a physical medical device, not a machine learning model, so there is no concept of a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as #8.
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