(71 days)
The SeQure™ Snare System is intended for use in the cardiovascular system as a tool to retrieve and manipulate foreign objects.
The SeQure™ Snare System consists of a snare, a catheter, a loader and a torquer. The snare is constructed of a nitinol shaft and a loop with the plane of the loop perpendicular to the nitinol shaft. The nitinol loop is covered with a tungsten coil which is coated by laminated titanium and its nitride to enhance radiopaque. The pre-formed snare loop can be introduced through catheter without risk of permanent deformation because of super-elasticity of nitinol material. The catheter connector and PE tubing with a radiopaque markband at its distal tip to enhance the visibility during the operation. The snare is pre-assembled with the loader and the torque, and then packaged together with corresponding catheter.
The provided documentation describes the SeQure™ Snare System (K102484), a medical device intended for retrieving and manipulating foreign objects in the cardiovascular system.
Here's an analysis of the acceptance criteria and the study data, based only on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission is a 510(k) Pre-Market Notification, which primarily focuses on demonstrating substantial equivalence to a predicate device rather than setting and meeting specific, quantitative acceptance criteria for de novo performance. Therefore, the "acceptance criteria" here are implicitly the design specifications and performance benchmarks of the predicate device (ev3 Amplatz "Goose Neck" Snare Device, K972511).
| Acceptance Criteria (Implicit - Substantial Equivalence to Predicate) | Reported Device Performance |
|---|---|
| Device design, dimension, components, structure, and fundamental technology are identical to the predicate device. | "The design, dimension, components, structure and fundamental technology of SeQure™ Snare System are all identical with predicate device ev3 Amplatz 'Goose Neck' Snare". |
| Performance in specific areas: | Validated and verified through testing. |
| - Dimension | Tested and met design specifications. |
| - Delivery and Retrieving | Tested and met design specifications. |
| - Torque Strength | Tested and met design specifications. |
| - Tensile Strength | Tested and met design specifications. |
| - Biocompatibility | Tested and met design specifications. |
| - Package | Tested and met design specifications. |
| Overall Conclusion: Safe and effective as the predicate device. | "The SeQure™ Snare System is safe and effective as Predicate Device ev3 Amplatz 'Goose Neck' Snare Device based on performance testing." |
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not specify the sample size for any of the performance tests (Dimension, Delivery and Retrieving, Torque Strength, Tensile Strength, Biocompatibility, Package).
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given that it's a pre-market notification, the performance testing would typically be prospective, conducted by the manufacturer (Lifetech Scientific (Shenzhen) Co., Ltd in China).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not provide any information about experts, their number, or qualifications for establishing ground truth. The performance data mentioned refers to engineering and biocompatibility tests, not clinical evaluations that typically involve expert interpretation.
4. Adjudication method for the test set
The document does not mention any adjudication method. This type of information is typically relevant for clinical studies involving multiple reviewers/readers, which is not described here.
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, there is no mention of an MRMC comparative effectiveness study.
- AI Improvement: The device described is a physical medical device (Snare System), not an AI-powered diagnostic or assistive technology. Therefore, the concept of "human readers improve with AI" is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is a physical snare system. The concept of "standalone algorithm performance" is not applicable. The performance tests are for the physical properties and function of the device itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the performance tests (Dimension, Delivery and Retrieving, Torque Strength, Tensile Strength, Biocompatibility, Package) would be against engineering design specifications, industry standards, and regulatory requirements (e.g., ISO standards for biocompatibility, mechanical testing standards for strength). There is no mention of clinical ground truth like pathology or outcomes data in this summary.
8. The sample size for the training set
The device is a physical medical device, not a machine learning or AI algorithm. Therefore, there is no "training set" in the context of AI/ML. The manufacturing processes and material specifications are developed through engineering and R&D, not algorithmic training.
9. How the ground truth for the training set was established
As there is no "training set" in the AI/ML sense, this question is not applicable.
§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).