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510(k) Data Aggregation
(330 days)
Balloon Guiding Catheter
The Balloon Guiding Catheter is intended to assist intravascular catheterization and guidance of an intravascular catheter into a selected vessel in the neuro or peripheral vascular system. The balloon can provide temporary vascular occlusion during angiography.
The proposed device, Balloon Guiding Catheter, is a braid-reinforced, variable stiffness catheter designed for use in facilitating the guidance of an intravascular catheter into a target vessel in the neuro or peripheral vascular system. A radiopaque marker is included on the distal end for angiographic visualization. A compliant balloon is mounted on the distal end to provide temporary vascular occlusion during angiographic procedures. The proposed device is divided into the S and S+ types with different effective lengths, the difference between S type is the size of the catheter.
The provided document is a 510(k) summary for a medical device called a "Balloon Guiding Catheter." It describes the device, its intended use, a comparison to a predicate device, and the non-clinical testing performed to establish substantial equivalence.
Here's an analysis of the acceptance criteria and study information, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria (Implied/Stated) | Reported Device Performance |
|---|---|---|
| Non-Clinical/Performance Testing | ||
| Dimensional Verification | Met specified measurements | Size verification met acceptance criteria. |
| Radiopacity | Visible under X-ray | The radiopaque marker on the catheter tip is visible under X-ray. |
| Torque Testing | Capable of rotation without catheter body damage or bending | The catheter body is not damaged and bent. |
| Balloon Compliance | (Implied: proper expansion with varying liquid volumes) | Compliant. |
| Balloon Expansion/Contraction Time | Met specified times | Balloon expansion and contraction times met acceptance criteria. |
| Balloon Fatigue Test | No balloon leakage or damage after 20 expansions/contractions | The balloon is not leaking or damaged. |
| Balloon Volume Limit | No balloon leakage or damage after 2.5x limit volume injection | The balloon is not leaking or damaged. |
| Peak Tensile Force | Met acceptance criteria | Peak tensile force met acceptance criteria. |
| Catheter Bond Strength | Met acceptance criteria | Catheter bond strength met acceptance criteria. |
| Compatibility Test | Usable as intended with compatible devices in a vascular model | The device can be used as intended. |
| Anti-collapse Test | Compatible devices do not experience increased blocking; catheter does not collapse | Compatible devices do not experience increased blocking during push and retracement, and the catheter did not collapse. |
| Burst Pressure | Met acceptance criteria (greater than manual syringe injection pressures) | Burst pressure met acceptance criteria. |
| Kink Resistance | Met acceptance criteria (per FDA guidance) | Kink resistance met acceptance criteria. |
| Air Leakage | No air leakage (per ISO 10555-1) | No air leakage. |
| Liquid Leakage | No liquid leakage (per ISO 10555-1) | No liquid leakage. |
| Particulate Testing | Number and size of particles similar to comparator device | The number and size of the particles were similar to that of the comparator device. |
| Connector Performance | Met requirements for small bore connectors (per ISO 594-1 & 594-2) | Connector performance met acceptance criteria. |
| Biocompatibility Testing | ||
| Cytotoxicity | Non-cytotoxic (viability > 70% of blank) | Non-cytotoxic. |
| Irritation | No irritation | No irritation. |
| Sensitization | No sensitization | No sensitization. |
| Systemic Toxicity | No abnormal clinical signs indicative of toxicity | No systemic toxicity. |
| Hemolysis | Non-hemolytic (difference from negative control evaluated) | Non-hemolytic. |
| Material Mediated Pyrogenicity | Nonpyrogenic (no temperature rise in study animals) | Nonpyrogenic. |
| In Vivo Thromboresistance | Meet predetermined acceptance criteria (test score is 0, i.e., No thrombosis) | Meet the predetermined acceptance criteria, the test score is 0, i.e., No thrombosis. |
| Complement Activation | No statistical difference from the predicate device | No statistical difference from the predicate device. |
| Partial Thromboplastin Time | No difference from predicate device clotting time | No difference from predicate device. |
| Sterilization & Shelf Life | ||
| Sterility Assurance Level (SAL) | 10-6 (per ISO 11135-1:2014) | SAL of 10-6 achieved. |
| EO and ECH residuals | Below limits specified in ISO 10993-7:2008 | Below the limits specified in ISO 10993-7:2008. |
| Bacterial Endotoxin Levels | Below 2.15 EU/device (per USP ) | Below the level of 2.15 EU/device. |
| Shelf-life | Perform as intended for 2 years | Device will perform as intended to support the proposed 2-year shelf-life. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the exact sample sizes used for each individual non-clinical test. It generally states that "Non-clinical tests were conducted to verify that the proposed device met all design specifications."
- Sample Size: Not explicitly stated for each test.
- Data Provenance: The tests are non-clinical (benchtop and in vitro/in vivo biocompatibility). The document does not specify country of origin for the data; however, the manufacturer is Shanghai Heartcare Medical Technology Co., Ltd. in China, implying testing was likely conducted or commissioned by them. The studies are retrospective in the sense that they are conducted on finished or pilot-production devices to demonstrate performance against specifications.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. This device is a physical medical instrument, not an AI/software device requiring expert consensus for ground truth on a dataset. The "ground truth" for the non-clinical tests is established by objective measurements against established engineering specifications and recognized international standards (e.g., ISO, ASTM, USP).
4. Adjudication Method for the Test Set:
Not applicable. As described above, this is not a study requiring human adjudication of results in the traditional sense of medical image or clinical outcome interpretation.
5. 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:
Not applicable. This is not an AI/software device. No MRMC study was performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI/software device. No standalone algorithm performance study was performed.
7. The Type of Ground Truth Used:
The "ground truth" for this device's acceptance criteria are based on:
- Engineering Specifications: Defined dimensional tolerances, mechanical properties (tensile strength, burst pressure, kink resistance), and functional performance (balloon expansion, torque, anti-collapse).
- International Standards: Adherence to ISO (e.g., ISO 10993 for biocompatibility, ISO 11135 for sterilization, ISO 594 for connectors, ISO 10555-1 for leakage), ASTM (e.g., for seal strength, dye penetration, hemolysis), and USP (for pyrogen and endotoxin testing) standards.
- Benchtop Test Results: Objective measurements and observations from physical testing in controlled laboratory environments.
- Biological Test Results: In vitro and in vivo testing (on study animals, e.g., for systemic toxicity, thromboresistance) according to ISO standards.
8. The Sample Size for the Training Set:
Not applicable. This is not an AI/software device. There is no "training set."
9. How the Ground Truth for the Training Set Was Established:
Not applicable. This is not an AI/software device.
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