(202 days)
RC-15 Model: The Recovery Cone Removal System is intended for use to percutaneously remove the Recovery Filter, Recovery G2 Filter and G2 X Filter from the vena cava.
FBRC Model: The Recovery Cone Removal System is intended for use to percutaneously remove the G2 X Filter, G2 Express Filter, G2 Filter and the Recovery Filter from the vena cava, or facilitate the retrieval of foreign objects from the peripheral vascular system.
The Recovery Cone® Removal System is intended to percutaneously remove the G2® X Filter, G2® Express™ Filter, G2® Filter or Recovery® Filter from the vena cava or facilitate the retrieval of foreign objects from the peripheral vascular system. The device is provided sterile and is single use only. The Recovery Cone® Removal System consists of the Removal Cone and Introducer Catheter. The cone consists of a reinforced urethane cone. 15-mm in diameter. The cone is connected to a plastic (Pebax) shaft and handle. The shaft has a central lumen that accommodates a 0.035" guidewire. A Touhy-Borst Y-adapter is used to connect the cone to the Introducer Catheter and to a saline flush or drip. The Introducer Catheter consists of a 10 French I.D. introducer sheath and dilator. The introducer sheath has a radiopaque marker for enhanced fluoroscopic visualization.
The provided document is a 510(k) summary for the Recovery Cone® Removal System, a medical device intended for percutaneous removal of vena cava filters or retrieval of foreign objects from the peripheral vascular system.
Based on the provided text, here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document lists performance tests conducted, but it does not explicitly state quantitative acceptance criteria or reported device performance values for most tests. It primarily states that tests were performed and conclude the device is substantially equivalent to the predicate.
However, based on the testing categories, the general implied acceptance criteria would be successful completion of the test without failure, comparable performance to the predicate device where applicable, and demonstration of safety and efficacy for its intended use.
| Acceptance Criteria Category (Implied) | Reported Device Performance (Implied) |
|---|---|
| In-Vitro Filter Performance | Successfully tested. |
| Filter Retrieval | Successfully demonstrated in-vitro, in-vivo, and through clinical references. |
| Foreign Body Retrieval | Successfully demonstrated in-vitro, in-vivo, and through clinical references. |
| Sheath and Dilator Integrity (Tensile, Torque, Leak) | Successfully met integrity requirements. |
| Catheter Simulated Use Test | Successfully passed simulated use. |
| Marker Band Integrity | Maintained integrity. |
| Filter Removal Force | Successfully demonstrated appropriate removal force. |
| Biocompatibility (Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Pyrogenicity, Hemocompatibility, Thromboresistance, Coagulation) | Successfully met ISO 10993 standards and demonstrated biocompatibility. |
| Substantial Equivalence Determination | Device is substantially equivalent to the predicate device based on all tests. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify exact sample sizes (e.g., number of devices, number of animals, number of clinical cases) for any of the in-vitro, in-vivo, or clinical reference testing.
- Data Provenance:
- Country of Origin: Not specified.
- Retrospective or Prospective: Not explicitly stated for either in-vivo animal testing or clinical references. The mention of "clinical references" suggests a review of existing data rather than a new prospective clinical trial for this submission.
3. Number of Experts and Qualifications for Ground Truth of Test Set
- This information is not provided in the document. The document refers to "in-vivo animal testing and within clinical references" for evaluating filter capture and retrieval, but it does not detail how ground truth was established by experts for these.
4. Adjudication Method for the Test Set
- This information is not provided in the document. There is no mention of expert adjudication for any test results.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study is not mentioned in the document. This is a device for percutaneous retrieval, not an imaging or diagnostic device typically evaluated with such studies.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)
- This question is not applicable as the Recovery Cone® Removal System is a physical medical device. It does not involve an algorithm or AI component in the way this question implies.
7. Type of Ground Truth Used
- For the performance testing, the ground truth appears to be based on:
- Successful mechanical operation: Demonstrating that the device can successfully capture and retrieve filters/foreign objects.
- Compliance with engineering standards: Meeting specifications for tensile strength, torque, leak integrity, etc.
- Compliance with biocompatibility standards: Meeting ISO 10993 requirements.
- Successful clinical outcomes: Implied from "clinical references" demonstrating its ability to be used for its intended purpose.
8. Sample Size for the Training Set
- This question is not applicable as the Recovery Cone® Removal System does not involve machine learning or AI that would require a "training set." Performance testing typically involves a "test set" to validate the device's design.
9. How Ground Truth for the Training Set Was Established
- This question is not applicable for the same reason as point 8.
§ 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).