(27 days)
The EN Snare® Endovascular Snare System is intended for use in the coronary and peripheral vascular system or hollow viscous to retrieve and manipulate foreign objects. Retrieval and manipulation procedures include, indwelling venous catheter repositioning, indwelling venous catheter fibrin sheath stripping, and central venous access veupuncture procedure assistance.
The EN Snare Endovascular Snare System consists of four individual components: snare: catheter: insertion tool and torque device. Systems are available in various sizes and lengths. The snare is comprised of 3 interlaced stranded cables of platinum and super-elastic nitinol that form 3 loops and are mechanically secured with a crimp collar to a nitinol shaft wire. The superelastic nitinol construction enables the loops of the snare to be introduced through a catheter without the risk of deformation. The catheter is manufactured with a Pebax outer layer and a PTFE inner layer with an embedded iridium/platinum markerband at the distal end, a Pebax hub and a polycarbonate luer. A snare insertion tool is also included for optional back-end loading of the snare into a preplaced catheter. The snare insertion tool is manufactured from polypropylene. The snare is inserted into an intravascular catheter and manipulated by use of an external torque device. The snare is offered in sizes ranging from 2mm to 45mm, with catheter sizes of 3.2F, 6F, and 7F.
The provided document is a 510(k) Premarket Notification from the FDA for a medical device called the "EN Snare Endovascular Snare System." It focuses on demonstrating substantial equivalence to a predicate device through various performance and safety tests.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that a "battery of testing was conducted in accordance with protocols based on requirements outlined in guidance's and industry standards and these were shown to meet the acceptance criteria that were determined to demonstrate substantial equivalence." However, it does not explicitly list specific numerical acceptance criteria for each test. Instead, it lists the types of tests performed and concludes that the device "met the acceptance criteria applicable to the safety and effectiveness of the device."
Therefore, a table cannot be constructed with specific numerical acceptance criteria. The performance is reported as meeting these (unspecified in detail) criteria.
Note: For medical devices, acceptance criteria are typically well-defined in the test protocols, but these are often considered proprietary and not included in publicly available 510(k) summaries beyond broad statements of compliance.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Material & Design | |
| Corrosion Testing | Met acceptance criteria |
| Luer Testing | Met acceptance criteria |
| Packaging Testing | Met acceptance criteria |
| Catheter and Insertion Tool | |
| Surface (external) | Met acceptance criteria |
| Radiodetectability | Met acceptance criteria |
| Dimensions (Markerband) | Met acceptance criteria |
| Surface (PTFE Liner) | Met acceptance criteria |
| Dimensions (Tip Angle/Length) | Met acceptance criteria |
| Dimensions (Length, Diameter) | Met acceptance criteria |
| Atraumatic Catheter Tip | Met acceptance criteria |
| Markerband retention | Met acceptance criteria |
| Torque Strength | Met acceptance criteria |
| Kink resistance | Met acceptance criteria |
| Buckling resistance | Met acceptance criteria |
| Freedom from Liquid Leakage | Met acceptance criteria |
| Freedom from Air Leakage | Met acceptance criteria |
| Force at break (Hub-Tube) | Met acceptance criteria |
| System | |
| Snare Loop Resistance | Met acceptance criteria |
| Guiding Catheter Resistance | Met acceptance criteria |
| Snare insertion tool fitment | Met acceptance criteria |
| Snare insertion | Met acceptance criteria |
| Insertion Tool tear away force from the snare | Met acceptance criteria |
| Snare inspection after insertion tool removal | Met acceptance criteria |
| Snare loop protrusion | Met acceptance criteria |
| Force at break (Insertion Tool Hub-Tube) | Met acceptance criteria |
| Catheter hub with female luer | Met acceptance criteria |
| Corrosion resistance | Met acceptance criteria |
| Biocompatibility | |
| Cytotoxicity | Met acceptance criteria |
| Sensitization | Met acceptance criteria |
| Irritation | Met acceptance criteria |
| Acute Systemic Toxicity | Met acceptance criteria |
| Pyrogenicity | Met acceptance criteria |
| Genotoxicity | Met acceptance criteria |
| Hemolysis | Met acceptance criteria |
| Thrombogenicity | Met acceptance criteria |
| Complement Activation | Met acceptance criteria |
| Chemical Tests | Met acceptance criteria |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each specific test (e.g., number of devices tested for kink resistance). It reports a "battery of testing" was conducted.
Moreso, this is a premarket notification for a medical device (EN Snare Endovascular Snare System), and the studies described are engineering and bench testing rather than clinical trials with human subject data. Therefore, concepts like "country of origin of the data" (for human subjects) or "retrospective or prospective" do not directly apply in the typical sense. The data provenance would be from laboratory and bench testing environments, likely performed at the manufacturer's (Merit Medical Systems, Inc.) facilities or certified testing labs.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable to the type of studies described. The "ground truth" for these engineering and biocompatibility tests is established by objective measurements against predefined engineering specifications, international standards (e.g., ISO, ASTM), and regulatory guidance documents, not by expert human consensus (like in diagnostic AI studies). The "experts" involved would be engineers, material scientists, and microbiologists who design and execute the tests and interpret the results against those standards.
4. Adjudication Method for the Test Set
This is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where human readers are making subjective diagnoses or assessments which then need to be reconciled. For device performance testing, the results are objective measurements from instruments or standardized observations which either meet or fail the specified acceptance criteria.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of diagnostic algorithms, often in comparison to human readers, and involves multiple human readers assessing medical cases.
The document describes pre-market testing for a physical medical device (an endovascular snare system), focusing on its mechanical, material, and biological safety characteristics, not its diagnostic or interpretative capabilities.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device described, the "EN Snare Endovascular Snare System," is a physical medical instrument used for retrieving foreign objects and manipulating catheters. It is not an algorithm, software, or AI system requiring standalone performance evaluation in that context.
7. The Type of Ground Truth Used
The "ground truth" for the tests performed on the EN Snare Endovascular Snare System is constituted by:
- Engineering Specifications: Explicit design requirements and performance parameters set by the manufacturer.
- International Standards: Compliance with relevant ISO (e.g., ISO 10555-1, ISO 594-1/2, ISO 11135, ISO 10993-1, ISO 2233) and ASTM (e.g., ASTM F1980-07) standards.
- FDA Guidance: Adherence to FDA guidance documents (e.g., Coronary and Cerebrovascular Guide Wire Guidance, FDA Modified ISO 10993 Test Profile FDA Memo G95-1).
The tests confirm that the device physically functions as intended, is safe in terms of materials and interactions with the body, and meets required structural integrity, rather than confirming a medical diagnosis.
8. The Sample Size for the Training Set
This question is not applicable. The studies described are physical performance, material, and biocompatibility tests for a medical device. There is no "training set" in the context of machine learning or AI algorithms. The device's design and manufacturing processes are informed by engineering principles, material science, and regulatory requirements, not by training data in the AI sense.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable, as there is no "training set" for physical device testing in the context of AI. The "ground truth" for the device's design and manufacturing relies on established scientific and engineering principles, verified material properties, and adherence to quality control standards, rather than a labeled dataset.
§ 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).