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510(k) Data Aggregation
(59 days)
The EMBA Peripheral Embolization Device (PED) is indicated to obstruct or reduce the rate of blood flow in the peripheral vasculature in 6-8mm blood vessels. The device is not indicated for use in blood vessels subject to repetitive motion, such as extremity or pulmonary vessels.
The EMBA™ HOURGLASS™ Peripheral Embolization Device (PED) consists of a covered, implantable, self-expanding structure (Embolic Device) preloaded in a catheter-based Delivery System. The Embolic Device is intended to be deployed to the target site in the vasculature under fluoroscopic guidance. The product is shipped sterile and labeled for single use only.
This document describes the EMBA™ HOURGLASS™ Peripheral Embolization Device (PED). The information provided focuses on the device's substantial equivalence to predicate devices rather than a detailed study proving it meets specific quantitative acceptance criteria for performance metrics in a clinical setting.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a table of quantitative acceptance criteria for performance metrics (e.g., specific thresholds for occlusion rates, migration rates, etc.) that the device was evaluated against in a clinical study. Instead, it lists various comparative performance tests conducted to demonstrate substantial equivalence to predicate devices. These tests focused on design and functional characteristics to show that technological differences do not raise new safety or effectiveness concerns.
| Performance Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Mechanical/Physical | ||
| Kink Radius | Demonstrates performance comparable to predicate devices and does not introduce new safety concerns. | Conducted; passed (implicit in "Comparative performance testing was conducted to demonstrate that the technological differences... do not raise concerns of substantial equivalence"). |
| Trackability | Demonstrates performance comparable to predicate devices and does not introduce new safety concerns. | Conducted; passed (implicit). |
| Partial Deployment & | Demonstrates performance comparable to predicate devices and does not introduce new safety concerns. | Conducted; passed (implicit). |
| Retraction | ||
| Deployment Accuracy | Demonstrates performance comparable to predicate devices and does not introduce new safety concerns. | Conducted; passed (implicit). |
| Chronic Outward Force | Demonstrates performance comparable to predicate devices and does not introduce new safety concerns. | Conducted; passed (implicit). |
| Embolic Device Length & | Within specified design ranges and comparable to predicate devices. | Conducted; passed (implicit). Device dimensions are provided in the DEVICE DESCRIPTION section (e.g., 10mm diameter, 20mm length). |
| Diameter | ||
| Foreshortening | Demonstrates performance comparable to predicate devices and does not introduce new safety concerns. | Conducted; passed (implicit). |
| Contrast Flow | Demonstrates performance comparable to predicate devices and does not introduce new safety concerns (e.g., allows for adequate visualization). | Conducted; passed (implicit). |
| Migration Resistance | Demonstrates performance comparable to predicate devices and does not introduce new safety concerns (e.g., device stays in intended location). | Conducted; passed (implicit). |
| Occlusion Effectiveness | Demonstrates performance comparable to predicate devices and does not introduce new safety concerns (e.g., obstructs blood flow as intended). | Conducted; passed (implicit). The fundamental purpose of the device is to obstruct or reduce blood flow. |
| Corrosion | Demonstrates biocompatibility and structural integrity. | Conducted; passed (implicit). |
| Fatigue Testing | Demonstrates durability and structural integrity over time. | Conducted; passed (implicit). |
| Delivery System Integrity | Demonstrates safe and effective delivery of the device. | Conducted; passed (implicit). |
| Biocompatibility | Biocompatible in accordance with ISO 10993. | "The subject device... passed appropriate ISO 10993 testing to demonstrate biocompatibility." |
| Sterility | Terminally sterilized by ethylene oxide (EtO). | "All of the devices are terminally sterilized by ethylene oxide (EtO)." |
| MR Compatibility | Safe for use in an MR environment. | Conducted; passed (implicit). |
| Shelf Life | Maintains performance and sterility over its stated shelf life. | Conducted; passed (implicit). |
| Clinical Safety & | Demonstrated safety and effectiveness endpoints. | "Human Use Clinical Testing has been conducted on the EMBA™ HOURGLASS™ Peripheral Embolization Device (PED) (n=51) to evaluate safety and effectiveness endpoints." (No specific metrics or results are provided in this summary, just that it was evaluated.) |
| Effectiveness (Human Use) |
2. Sample Size for the Test Set and Data Provenance:
- Sample Size: Human Use Clinical Testing was conducted on n=51.
- Data Provenance: The document does not specify the country of origin. The study appears to be a prospective human use clinical study, although full details are not provided in this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- The document does not mention the number of experts used to establish ground truth for the clinical test set or their specific qualifications. It only states that human use clinical testing was conducted to evaluate "safety and effectiveness endpoints," implying clinical assessment by medical professionals.
4. Adjudication Method for the Test Set:
- The document does not specify the adjudication method used for the clinical test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, this was not an MRMC comparative effectiveness study. The text discusses comparative performance testing against predicate devices, but this refers to bench testing and animal testing, and for the human use study, it was to evaluate safety and effectiveness endpoints of the EMBA device itself, not to compare human readers with and without AI assistance. The device is a physical medical implant, not an AI diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This question is not applicable as the EMBA™ HOURGLASS™ Peripheral Embolization Device is a physical medical device, not a software algorithm. Its "standalone" performance would typically refer to its mechanical and functional performance in in-vitro or animal models, which was indeed performed as "comparative performance testing."
7. The Type of Ground Truth Used:
- For the human use clinical testing, the "ground truth" would implicitly be clinical outcomes data assessed by medical professionals, related to the safety and effectiveness of the device's embolization. For the non-clinical performance tests (Kink Radius, Trackability, Migration Resistance, Occlusion Effectiveness, etc.), the "ground truth" was established by engineering and scientific measurements against predefined specifications or comparison with predicate device performance.
8. The Sample Size for the Training Set:
- This question is not applicable as the device is a physical medical implant, not an AI algorithm that requires a "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set was Established:
- This question is not applicable for the same reason as point 8.
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