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510(k) Data Aggregation
(110 days)
EMBO PLUS EMBOLECTOMY CATHETER
The EMBO-Plus Embolectomy Catheter is indicated for use within vessels in the arterial system and synthetic arteriovenous dialysis fistulae for the removal of fresh, soft emboli and thrombi.
The proposed EMBO-Plus Embolectomy Catheter is designed for the removal of fresh, soft emboli and thrombi from within vessels in the arterial system and synthetic arteriovenous dialysis fistulae. The EMBO-Plus Embolectomy Catheter is an .035" guide-wire compatible, compliant embolectomy balloon system with a proprietary valve system which allows injection of physician specified agents without the need to remove the guidewire. By providing two functions within the catheter the operator is able to remove fresh, soft emboli and thrombi from within the arterial system and synthetic arteriovenous dialysis fistulae without having to lose guidewire position.
The provided text describes a 510(k) premarket notification for the EMBO-Plus Embolectomy Catheter, a medical device. This document focuses on the device itself and its comparison to a predicate device, not on an AI system or software with acceptance criteria in the typical sense of a diagnostic or predictive model.
Therefore, the requested information regarding acceptance criteria for an AI device, sample sizes for test/training sets, expert consensus, MRMC studies, and ground truth establishment cannot be provided from the given text.
The text details the following for the physical device:
- Device Description: The EMBO-Plus Embolectomy Catheter is designed for the removal of fresh, soft emboli and thrombi from within vessels in the arterial system and synthetic arteriovenous dialysis fistulae. It is an .035" guide-wire compatible, compliant embolectomy balloon system with a proprietary valve system allowing injection of agents without guidewire removal.
- Intended Use: Removal of fresh, soft emboli and thrombi from vessels in the arterial system and synthetic arteriovenous dialysis fistulae.
- Performance Data (for the device):
- Biocompatibility testing: Conducted according to ISO/ASTM standards (e.g., ISO MEM Elution Assay, ASTM Hemolysis Assay, Complement Activation C3a and SC5b-9 Assay, Partial Thromboplastin Time, Thromboresistance Evaluation, Rabbit Pyrogen, Guinea Pig Maximization Sensitization, Acute Systemic Injection Test, Intracutaneous Reactivity Test, Pyrogen (LAL) Chromogenic).
- In-vitro performance bench tests: Included Balloon Crossing Profile, Catheter Shaft Diameter, Guidewire Lumen Diameter, Catheter Shaft Markings, Balloon Working Diameter, Balloon Inflation/Deflation Time, Balloon Fatigue, Catheter Body Burst Strength, Catheter Bond and Tip Pull Strength, Catheter Torque Strength, Contrast Media Flow Rate, Adherent Clot Removal, Simulated Use/Flexibility/Kink, Radiopacity.
- In-vivo animal model testing: Performed in accordance with 21 CFR Part 58 "Good Laboratory Practices for Nonclinical Laboratory Studies." Synthetic arteriovenous access grafts were surgically placed in ovine specimens, allowed to mature, and then a simulated procedure was performed on test and control comparator groups. Post-procedure animals were observed, and vessel and organ histology was completed to compare responses.
Acceptance Criteria and Device Performance (Based on Device Testing, Not AI Algorithm):
| Acceptance Criteria Category (Device) | Reported Device Performance and Study |
|---|---|
| Biocompatibility | All tests completed (e.g., ISO MEM Elution, ASTM Hemolysis, Complement Activation, Partial Thromboplastin Time, Thromboresistance, Rabbit Pyrogen, Guinea Pig Sensitization, Acute Systemic Injection, Intracutaneous Reactivity, LAL Pyrogen). Results showed materials are non-toxic and non-sensitizing. |
| In-vitro Performance Bench Testing | All tests completed (e.g., Balloon Crossing Profile, Catheter Shaft Diameter, Guidewire Lumen Diameter, Catheter Shaft Markings, Balloon Working Diameter, Balloon Inflation/Deflation Time, Balloon Fatigue, Catheter Body Burst Strength, Catheter Bond and Tip Pull Strength, Catheter Torque Strength, Contrast Media Flow Rate, Adherent Clot Removal, Simulated Use/Flexibility/Kink, Radiopacity). |
| In-vivo Animal Model Testing | Completed in ovine specimens with surgically placed synthetic arteriovenous access grafts. Simulated procedures performed, animals survived and observed, followed by vessel and organ histology. Conducted in accordance with 21 CFR Part 58 "Good Laboratory Practices." |
| Overall Conclusion | "All test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the EMBO-Plus Embolectomy Catheter met the established specifications necessary for consistent performance during its intended use." |
Information Not Applicable or Not Provided in the Text (Related to AI/Software):
- Sample size for the test set and data provenance: Not applicable as this is a physical medical device, not an AI algorithm.
- Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable. Device ground truth is established through physical and biological testing.
- Adjudication method for the test set: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
- Standalone (algorithm only) performance: Not applicable.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the device, ground truth is established through validated physical (bench) and biological (biocompatibility, in-vivo animal model) test methods, comparing performance against established specifications and a predicate device.
- Sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
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