(142 days)
EMBOGUARD Balloon Guide Catheters are indicated for use in facilitating the insertion and guidance of an intravasular catheter into a selected blood vessel in the neurovascular system. The balloon provides temporary vascular occlusion during angiographic procedures. The Balloon Guide Catheter is also indicated for use as a conduit for Retrieval Devices.
EMBOGUARD Balloon Guide Catheter is a dual lumen, braid-reinforced, variable stiffness catheter with an eccentric inflation lumen, a radiopaque marker on the distal end and a bifurcated luer hub on the proximal end. A compliant balloon is mounted on the distal end. The distal end of the device shaft has a hydrophilic coating. Balloon Guide Catheter dimensions are indicated on the product label.
This document describes the regulatory submission for the EMBOGUARD™ Balloon Guide Catheter (K212340). As such, the "acceptance criteria" and "device performance" refer to the results of bench and animal testing demonstrating substantial equivalence to a predicate device, rather than performance metrics for an AI algorithm. Therefore, many of the requested fields are not applicable in this context.
Here's a breakdown of the provided information, addressing your points where relevant:
1. Table of Acceptance Criteria and Reported Device Performance
The submission details numerous performance tests to demonstrate substantial equivalence to a predicate device. The general acceptance criterion for all of these tests is "Pass," meaning the device met the pre-determined specifications or demonstrated comparable performance to the predicate. The reported device performance for all listed tests is "Pass," indicating that all samples met the pre-determined acceptance criteria.
| Study Name | Acceptance Criteria | Reported Device Performance (all samples) |
|---|---|---|
| Visual Inspection and Dimensional Verification | Met visual & dimensional specifications | Pass |
| Visual Surface Inspection | Met visual surface requirements | Pass |
| Torque Durability | Capable of 360 degrees hub rotation | Pass |
| Torque to Failure | Met pre-determined acceptance criteria | Pass (characterized only) |
| Torque Transmission | Torque transmission characterized | Pass (characterized successfully after min 720° hub rotation) |
| Tensile Strength | Met tensile strength requirements | Pass |
| Flexibility and Kink Resistance | Acceptable flexibility & kink resistance | Pass |
| Kink to Failure | Determined bend radius at which kink occurs | Pass (characterized at different sections down to 2.5mm mandrel) |
| Catheter Lubricity and Durability | Met coating lubricity & durability specifications | Pass |
| Coating Length and Location | Met coating length & location specifications | Pass |
| Particulates | Particulates comparable to cleared controls | Pass (characterized only) |
| Coating Integrity | Coating characterized pre- & post-simulated use | Pass (characterized only) |
| Radiopacity | Met radiopaque characteristics requirements | Pass |
| Simulated Use | Demonstrated device performance in simulated anatomy | Pass |
| Simulated Clot Retrieval Testing | Demonstrated device performance (incl. clot retrieval) | Pass |
| User Evaluation | Demonstrated device performance in simulated anatomy | Pass |
| Catheter Deliverability and Withdrawal Force | Met required tracking force specification | Pass |
| Catheter Luer Hub Dimensional and Performance Testing | Met requirements for small bore connectors | Pass |
| Inner Lumen Integrity - Pressure | Met pressure requirements | Pass |
| Inner Lumen Integrity - Aspiration | Met aspiration air leakage requirements | Pass |
| Hub Shaft Pressure Integrity | Met minimum inner diameter specification | Pass |
| Introducer Sheath Compatibility (Insertion and Withdrawal) | Met required insertion & withdrawal force | Pass |
| Introducer Sheath Compatibility (Re-insertion and Re-withdrawal) | Device integrity maintained post re-insertion & re-withdrawal | Pass |
| Tip Stiffness | Similar to predicate device | Pass |
| Balloon Location | Met balloon location specification | Pass |
| Balloon Inflation / Deflation | Met inflation & deflation time specifications | Pass |
| Balloon Fatigue | No degradation after 20 inflation cycles | Pass |
| Balloon OD and Compliance | Met max recommended inflation volume vs. balloon diameter specifications | Pass |
| Balloon Concentricity | Met balloon diameter specifications on each side | Pass |
| Balloon Burst | Capable of withstanding 2x and 2.5x recommended inflation volume | Pass |
| Conditioning, Distribution, and Shelf Life Aging - Device | Met all specifications at baseline & after 1-year aging | Pass |
| Conditioning, Distribution, and Shelf Life Aging - Packaging | Maintained packaging strength & integrity | Pass |
| Visual Inspection Packaging and Labeling | Met packaging & labeling visual & adherence requirements | Pass |
| System Visual Inspection (Dilator) | Met visual & dimensional specifications | Pass |
| Effective Length, Outer Diameter, Inner Diameter, Taper Diameter (Dilator) | Met visual & dimensional specifications | Pass |
| Tensile Strength (Dilator) | Withstood peak tensile strength | Pass |
| Kink Resistance (Dilator) | No kinks, defects, or damage | Pass |
| Luer Dimensional (Dilator Hub) | Met dimensional specifications | Pass |
| Fluid Leakage by Pressure Decay (Dilator Hub) | No leakage under pressure | Pass |
| Sub-atmospheric Pressure Air Leakage (Dilator Hub) | No air leakage | Pass |
| Stress Cracking (Dilator Hub) | No cracking under axial force & torque | Pass |
| Resistance to Separation from Axial Load (Dilator Hub) | No separation from reference connector | Pass |
| Resistance to Separation from Unscrewing (Dilator Hub) | No overriding of threads | Pass |
| Resistance to Overriding (Dilator Hub) | No overriding of threads | Pass |
| Torque Durability (Dilator Hub) | No separation/embolization after 1 rotation | Pass |
| Visual Inspection (Luer Activated Valve) | Met visual specifications | Pass |
| Leak Test (Luer Activated Valve) | No leakage during inflation/deflation | Pass |
| Activation (Luer Activated Valve) | Allowed flow, no leakage when activated, prevented flow when syringe removed | Pass |
| LAV Male & Female Luer Dimensional (Luer Activated Valve) | Met dimensional specifications | Pass |
| Fluid Leakage by Pressure Decay, Sub-atmospheric Pressure Air Leakage (LAV) | No leakage under pressure | Pass |
| Stress Cracking (LAV) | No cracking under axial force & torque | Pass |
| Resistance to Separation from Axial Load (LAV) | No separation from reference connector | Pass |
| Resistance to Separation from Unscrewing (LAV) | No separation from reference connector | Pass |
| Resistance to Overriding (LAV) | No overriding of threads | Pass |
| Visual Inspection (Rotating Hemostasis Valve) | Met visual specifications | Pass |
| ID (Male Luer) (Rotating Hemostasis Valve) | Met ID specification | Pass |
| ID (Compression Seal) (Rotating Hemostasis Valve) | Met ID specification | Pass |
| ID (Side Port) (Rotating Hemostasis Valve) | Met ID specification | Pass |
| Seal Integrity (Pressure) (Rotating Hemostasis Valve) | No leakage or collapse under pressure | Pass |
| Seal Integrity (Aspiration) (Rotating Hemostasis Valve) | No leakage or collapse under aspiration | Pass |
| Gauging (RHV Hub Luer) | Met conical part of lock fitting | Pass |
| Liquid Leakage (RHV Hub Luer) | No leakage sufficient to form a falling drop | Pass |
| Air Leakage (RHV Hub Luer) | No continued formation of air bubbles | Pass |
| Separation Force / Unscrewing Torque (RHV Hub Luer) | Fitting remained attached to reference fitting | Pass |
| Ease of Assembly (RHV Hub Luer) | Met requirements for small bore connectors | Pass |
| Resistance to Overriding (RHV Hub Luer) | No overriding of threads or lugs | Pass |
| Stress Cracking (RHV Hub Luer) | Withstood stress cracking | Pass |
2. Sample Size Used for the Test Set and Data Provenance
- Bench Testing: The specific sample sizes for each bench test are not explicitly stated in the document. However, the results consistently state "All samples met the pre-determined acceptance criteria," implying that a sufficient number of samples were tested to gain confidence in the results according to the referenced standards. The data provenance is from internal testing conducted by Neuravi Ltd.
- Animal Studies: The document mentions "Acute animal study has been performed." The specific number of animals is not provided. The model used was a swine model. This is prospective data from animal testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable. The device is a medical catheter, and its performance is evaluated through physical and biological testing, not by expert interpretation of images or other data that would require "ground truth" to be established by experts in the context of an AI study.
4. Adjudication Method for the Test Set
This information is not applicable. The device is a medical catheter, and its performance is evaluated through physical and biological testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was conducted. This device is a physical medical device, not an AI algorithm requiring human reader performance evaluation.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This information is not applicable. The device is a physical medical device, not an AI algorithm.
7. Type of Ground Truth Used
The "ground truth" for this device's performance is established through adherence to recognized international standards, internal specifications, and comparison to a predicate device. For example:
- Biocompatibility: Based on established biological response criteria defined in ISO 10993 series standards (e.g., non-cytotoxic, non-sensitizing, non-pyrogenic).
- Bench Testing: Based on pre-determined product performance specifications derived from relevant ISO standards (e.g., ISO 10555, ISO 11070) and FDA guidance documents.
- Animal Studies: Based on evaluation of usability, effectiveness, safety (histological evaluation), and comparison to the predicate device in a swine model.
There is no "expert consensus," "pathology," or "outcomes data" in the sense of a medical diagnostic ground truth for an AI algorithm.
8. Sample Size for the Training Set
This information is not applicable. The device is a physical medical device, not an AI algorithm.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. The device is a physical medical device, not an AI algorithm.
Summary for this specific device:
The K212340 submission for the EMBOGUARD™ Balloon Guide Catheter focuses on demonstrating substantial equivalence to an existing predicate device (8F FlowGate Balloon Guide Catheter, K153729) through extensive non-clinical testing.
- Acceptance Criteria: For all tests, the acceptance criteria were pre-determined specifications, often derived from international standards (e.g., ISO 10993, ISO 10555, ISO 11070, ISO 80369) and FDA guidance documents. For comparison studies, the criterion was similarity or equivalence to the predicate device.
- Device Performance: The device "Passed" all listed biocompatibility, sterilization/shelf-life, and bench tests, indicating it met the pre-determined acceptance criteria for each.
- Study Types: The studies included:
- Biocompatibility Testing: Covering cytotoxicity, sensitization, intracutaneous irritation, systemic toxicity, hemocompatibility (hemolysis, complement activation, thrombogenicity), and genotoxicity.
- Sterilization and Shelf Life Studies: Validation of EtO sterilization and 1-year shelf life.
- Bench Testing: A comprehensive suite of physical and mechanical tests covering visual inspection, dimensions, torque, tensile strength, flexibility, kink resistance, lubricity, coating, particulates, radiopacity, simulated use (including clot retrieval), user evaluation, compatibility with ancillary devices, lumen integrity, and balloon performance. All these were direct physical tests of the device.
- Animal Studies: An acute animal study in a swine model to assess usability, effectiveness, safety, and histological response compared to the predicate device.
- No clinical studies were performed.
- The document does not detail any AI component, and thus questions related to AI-specific metrics (sample sizes for training/test sets, expert ground truth, MRMC studies) are not relevant to this submission. The "ground truth" here refers to the validated physical and biological properties of the device as measured against established scientific and regulatory standards.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).