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510(k) Data Aggregation
(127 days)
Günther Tulip**®** Vena Cava Filter Retrieval Set
The product has been designed for retrieval of implanted Günther Tulip and Cook Celect Vena Cava Filters in patients who no longer require a filter. Retrieval of the filter can be performed only by jugular approach.
The Günther Tulip Vena Cava Filter Retrieval Set consists of a retrieval loop system with a braided platinum wire loop, a coaxial retrieval sheath system, an entry needle, a wire guide, and a dilator. The outer sheath is provided with a radiopaque band on the distal tip to assist in positioning of the sheath.
The Günther Tulip Vena Cava Filter Retrieval Set is supplied sterile in a peel-open package.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Günther Tulip Vena Cava Filter Retrieval Set:
Based on the provided text, this submission (K181757) is for minor changes to an already cleared device, not an entirely new device requiring extensive clinical trials to prove effectiveness/safety. Therefore, the "acceptance criteria" and "device performance" are primarily focused on demonstrating that the modified device remains substantially equivalent to its predicate device (K073374) despite the changes. There isn't a table of specific clinical acceptance criteria (like sensitivity/specificity for an AI device) because this is a mechanical device update, not a diagnostic algorithm.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (for substantial equivalence) | Reported Device Performance |
|---|---|
| Mechanical/Physical Integrity & Functionality: Device maintains intended design and operational characteristics despite dimensional/material changes to core wire. | Performance testing (dimensional, functionality, and tensile testing): Demonstrated that the Günther Tulip Vena Cava Filter Retrieval Set met applicable design and performance requirements. The material change to the core wire was associated with a long history of clinical use in vascular applications and is non-patient contacting; no additional performance testing beyond the generic tests was deemed necessary as no changes to overall design, manufacturing, sterilization, or principles of operation were introduced. |
| Packaging Integrity: Outer packaging material change does not compromise sterility or device integrity. | Distribution testing: Confirmed packaging effectiveness. Package integrity and seal strength testing: Performed on 3-year accelerated aged devices, demonstrating suitable integrity. |
| Shelf Life Extension: Device maintains performance and sterility over an extended shelf life of 3 years. | Performance testing (dimensional, functionality, and tensile testing) and package integrity and seal strength testing on 3-year accelerated aged devices: These tests demonstrated the device maintained its required performance and sterility over the extended shelf life. Simulated use testing on 3-year accelerated aged devices: Further supported the extended shelf life by showing the device functioned as intended after accelerated aging. |
| Labeling Adequacy: Updated labeling reflects current safety/performance information and regulatory standards. | Summary of Device Labeling Changes: Device labeling changes were made to reflect added or changed safety information based on post-market surveillance, clinical study data, and information published in regulatory communications and the international test standard on vena cava filters (ISO 25539:2011). Impacted sections include Device Description, Warnings, Precautions, Potential Adverse Events, Clinical Studies, step-by-step Instructions for Use, and References. This indicates that the labeling was updated to meet current standards and reflect available data. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for the Test Set: Not applicable in the context of human data. The "test set" here refers to the physical devices undergoing various engineering and accelerated aging tests. The text does not specify the exact number of devices tested for each performance test (dimensional, functionality, tensile, distribution, package integrity, simulated use).
- Data Provenance: Not applicable in the context of human data. The tests described are laboratory/benchtop performance tests on the physical device. The material change to the core wire is noted to have a "long history of clinical use in vascular applications," which refers to general material knowledge rather than specific data provenance for this device modification study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Number of Experts: Not applicable. This study focuses on engineering and benchtop performance of a physical medical device, not on interpreting images or patient data to establish a ground truth that would require medical experts.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. This study involves objective performance testing of a physical device. There is no subjective interpretation requiring an adjudication process.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: No, an MRMC study was not done. The device is a physical medical instrument (vena cava filter retrieval set), not an AI algorithm or a diagnostic tool that would involve human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Study: No, this is not an AI algorithm.
7. The Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" for this submission is based on accepted engineering standards, predetermined design specifications, and performance requirements for medical devices. For example, the ground truth for tensile strength would be a minimum force it must withstand, or for package integrity, it would be a "pass/fail" based on established testing protocols. The "long history of clinical use" for the core wire material serves as a form of "ground truth" regarding its safety and suitability for vascular applications.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This is not an AI device or a study involving a "training set" in the machine learning sense. The device is a physical instrument.
9. How the Ground Truth for the Training Set was Established
- Ground Truth for Training Set: Not applicable. There is no training set mentioned or implied in this submission, as it is not an AI/machine learning device.
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