(354 days)
The Branchor Balloon Guide Catheter is indicated for use to facilitate the insertion and guidance of an intravascular catheter into a selected blood vessel in the neuro vasculature, and injection of contrast media.
The balloon provides temporary vascular occlusion during these procedures.
The Branchor Balloon Guide Catheter can also be used as a conduit for retrieval devices.
This balloon guide catheter is a variable stiffness catheter that has a radio-opaque marker at the distal end of the balloon and a branched connector at the proximal end, and is equipped with a braid reinforced coaxial lumen. A balloon is attached to the distal end, and the dimensions of this balloon guide catheter and the recommended balloon injection volume are indicated on the product label. The balloon guide catheter is provided sterile, using ethylene oxide, and is intended for single use only by physicians who have been adequately trained in neurointerventional procedures.
The outer surface of this balloon guide catheter is coated with a hydrophilic coating in order to enhance lubricity when the surface is wet. The shaft lumen is provided with PTFE coating, except the connector part, to facilitate the passage of the guidewire and other devices through the section.
Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on what is present and noting what is not mentioned:
It's important to note that this document is a 510(k) premarket notification, which demonstrates substantial equivalence to existing devices, usually through non-clinical bench testing. It is not typically a clinical study involving human patients or complex AI performance metrics like those for image analysis.
Acceptance Criteria and Device Performance
This submission is for a medical device (Balloon Guide Catheter), not an AI/ML imaging device. As such, the "reported device performance" refers to the results of non-clinical bench testing, which are primarily pass/fail against engineering and design specifications.
| Acceptance Criteria (Test) | Reported Device Performance |
|---|---|
| Air Leakage Into Hub Assembly During Aspiration | Pass |
| Balloon Diameter to Inflation Pressure | Pass |
| Balloon Inflation and Deflation Times | Pass |
| Balloon Maximum Diameter | Pass |
| Burst Pressure | Pass |
| Coating Integrity/Particulate Evaluation | (Characterization Only) |
| Design Verification – Simulated Use | Pass |
| Dimensional Analysis | Pass |
| Freedom from Leakage and Damage on Inflation | Pass |
| Kink Resistance Test | Pass |
| Liquid Leakage Under Pressure | Pass |
| Lumen Collapse Under Maximum Aspiration | Pass |
| Luer Hub Testing | Pass |
| Peak Tensile Strength - Tip | Pass |
| Peak Tensile Strength - Tube Junction | Pass |
| Radio-detectability | Pass |
| Tip Flexibility | Pass |
| Torque Strength | Pass |
| Visual Inspection - Distal Tip | Pass |
| Visual Inspection - Surface | Pass |
Biocompatibility Testing
| Acceptance Criteria (Test summary for "Conclusion") | Reported Device Performance (Conclusion) |
|---|---|
| Systemic Toxicity - Rabbit Pyrogen Test | Non-pyrogenic |
| Systemic Toxicity - Systemic Injection | No acute systemic toxicity |
| Cytotoxicity - L929 cells/MEM Elution Test | Non-cytotoxic |
| Sensitization - Guinea Pig Maximization Test | Non-sensitizing |
| Irritation - Intracutaneous Injection Test | Non-irritant |
| Hemocompatibility - Hemolysis | Non-hemolytic |
| Hemocompatibility - Partial Thromboplastin Time Assay (PTT) | Minimal Activator |
| Hemocompatibility - Complement Activation Assay (SC5b-9) | Non-Potential Activator |
| Hemocompatibility – Thrombogenicity | No Thrombosis |
Study Details (Applicable to Non-Clinical Bench Testing)
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Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not explicitly stated for each test, but standard engineering testing involves sufficient samples to achieve statistical confidence for each specific test (e.g., multiple units for burst pressure, tensile strength, etc.).
- Data Provenance: The submission is from "ASAHI INTECC CO., LTD" in "Aichi 489-0071, Japan". This indicates the testing was conducted by or on behalf of the manufacturer, likely in Japan or a contracted laboratory. The nature of these tests (bench tests) means they are not "retrospective or prospective" in the sense of patient data.
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Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- This is a non-clinical device performance study (bench testing), not a study assessing AI performance or diagnostic accuracy. Therefore, "experts" in the context of establishing ground truth for data interpretation (like radiologists for image analysis) are not applicable. The "ground truth" for these tests is defined by engineering specifications and standards (e.g., how much pressure a balloon should withstand).
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Adjudication Method for the Test Set:
- Not applicable. Adjudication methods (like 2+1 voting) are used in clinical studies or studies where human interpretation of complex data (like medical images) is involved. Bench tests have objective pass/fail criteria based on measured physical properties.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is not an AI/ML imaging device and thus no MRMC study was conducted.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This is not an AI/ML device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the non-clinical tests, the "ground truth" is based on engineering specifications, recognized industry standards (e.g., ISO), and physical measurements designed to ensure the device meets its intended performance characteristics and safety profile.
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The sample size for the training set:
- Not applicable. This is not an AI/ML device, so there is no "training set."
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How the ground truth for the training set was established:
- Not applicable. There is no training set for this type of device submission.
§ 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).