(147 days)
The CELLO Balloon Guide Catheter is indicated for use in facilitating the insertion and guidance of intravascular catheters into a selected blood vessel in the peripheral and neuro vasculature systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures.
The CELLO Balloon Guide Catheter is a coaxial-lumen, braid-reinforced, variable stiffness catheter with two radiopaque markers on both the distal and proximal ends of the balloon and a bifurcated luer hub on the proximal end. A compliant silicone balloon is mounted on the distal end. Balloon Guide Catheter dimensions and recommended inflation volumes are indicated on the product label. Each catheter is supplied with an appropriately-size Dilator.
Here's an analysis of the provided 510(k) Summary, focusing on acceptance criteria and the study proving the device meets them:
Acceptance Criteria and Device Performance for CELLO Balloon Guide Catheter (K120781)
1. Table of Acceptance Criteria and Reported Device Performance
The device under review is primarily mechanical, and the "acceptance criteria" are embodied in the results of the non-clinical and biocompatibility tests conducted. The reported device performance is indicated by whether each test passed, failed, or was for informational purposes only.
| Test Category | Specific Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Nonclinical Tests (CELLO Balloon Guide Catheters) | |||
| Surface | Free from extraneous matter, process and surface defects. | Acceptable surface finish, no defects. | Pass |
| Force at Break | All joints meet reliability/confidence requirements in statistical confidence limits test | Joints must withstand specific force without breaking, within statistical limits. | Pass |
| Freedom from Leakage | Shall not leak liquid when inflated. Air shall not leak into the hub during aspiration. | No leakage of liquid when inflated, no air leakage into hub during aspiration. | Pass |
| Tip Configuration | Distal tip smooth, rounded, tapered or similarly finished. | Distal tip must be atraumatic. | Pass |
| Hubs | Comply with ISO 594-1 and ISO 594-2 | Hubs must conform to specified ISO standards. | Pass |
| Freedom from Leakage and Damage on Inflation | No leakage or evidence of damage, such as herniation or bursting of the shaft or balloon. | No leakage or damage (herniation, bursting) during inflation. | Pass |
| Dimensional Verification | All dimensions meet reliability/confidence requirements in statistical confidence limits test | All dimensions must be within specified tolerances, within statistical limits. | Pass |
| Balloon Preparation, Deployment and Retraction | Catheters can be advanced to intended sites within a realistic tortuous path model where other devices can be deployed distally and retracted; all devices could be retracted without damage. | Successful navigation through tortuous path, deployment and retraction of other devices, and full device retraction without damage. | Pass |
| Balloon Rated Burst Pressure (RBP) | All balloons meet reliability/confidence requirements in statistical confidence limits test | Balloons must withstand RBP without bursting, within statistical limits. | Pass |
| Balloon Fatigue | All balloons withstand 20 cycles of inflation | Balloons must withstand 20 inflation cycles without failure. | Pass |
| Balloon Compliance | All balloons have predictable change in size with pressure | Balloons should exhibit consistent and predictable size changes with pressure application. | FIO* |
| Balloon Inflation-Deflation Time | All balloons inflate and deflate predictably | Balloons should inflate and deflate within acceptable, predictable timeframes. | FIO* |
| Flexibility and Kink | All catheters meet reliability/confidence requirements in statistical confidence limits test | Catheters must maintain integrity and function without kinking, within statistical limits. | Pass |
| Torque Strength | All models can be torqued at least 180° when the distal tip is fixed in a tortuous path model | Catheters must transmit torque effectively in a tortuous path without failure. | FIO* |
| Radiopacity | Radiopaque markers are visible during angiography under a variety of conditions | Radiopaque markers must be clearly visible during angiography in various conditions. | FIO* |
| Nonclinical Tests (Dilator) | |||
| Surface | Free from extraneous matter, process and surface defects. | Acceptable surface finish, no defects. | Pass |
| Force at Break | All joints meet reliability/confidence requirements in statistical confidence limits test | Joints must withstand specific force without breaking, within statistical limits. | Pass |
| Freedom from Leakage | Shall not leak liquid when inflated. Air shall not leak into the hub during aspiration. | No leakage of liquid when inflated, no air leakage into hub during aspiration. (Likely refers to the dilator's hub functionality, if applicable to aspiration) | Pass |
| Tip Configuration | Distal tip smooth, rounded, tapered or similarly finished. | Distal tip must be atraumatic. | Pass |
| Hubs | Comply with ISO 594-1 and ISO 594-2 | Hubs must conform to specified ISO standards. | Pass |
| Freedom from Leakage and Damage on Inflation | No leakage or evidence of damage, such as herniation or bursting of the shaft or balloon. | No leakage or damage (herniation, bursting) during inflation. (Likely refers to any balloon on the dilator, if applicable, or general structural integrity) | Pass |
| Biocompatibility (CELLO Balloon Guide Catheters & Dilator) | |||
| L29 MEM Elution Test-ISO | Non-Cytotoxic | No evidence of cytotoxicity. | Pass |
| Kligman Maximization Test | No Sensitization | No evidence of sensitization. | Pass |
| Intracutaneous Injection Test | Non-Irritant | No evidence of irritation. | Pass |
| Systemic Injection Test-ISO | No acute toxicity | No evidence of acute toxicity. | Pass |
| Rabbit Pyrogen Test (Material Mediated) - ISO | Non-pyrogenic | No evidence of pyrogenicity. | Pass |
| Hemolysis- Direct Contact | Non-hemolytic | No evidence of hemolysis (direct contact). | Pass |
| Hemolysis-Rabbit Blood-ASTM Indirect Contact | Non-hemolytic | No evidence of hemolysis (indirect contact). | Pass |
| Complement Activation-Direct Contact | Non-Complement Activation | No evidence of complement activation (direct). | Pass |
| Complement Activation Assay-ISO Indirect Contact | Non-Complement Activation | No evidence of complement activation (indirect). | Pass |
| In-vivo Thrombogenicity (Catheter) | Patent vessels, No thrombus | Better thrombo-resistance than control. | Pass (Better than control) |
| In-vivo Thrombogenicity (Dilator) | Less thrombus than control | Better thrombo-resistance than control. | Pass (Better than control) |
*FIO: For Information Only - These tests were performed, but the results were provided for informational purposes and not necessarily as pass/fail acceptance criteria in the same way as the others. However, the presence of these results implies an expected functional characteristic.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the exact sample sizes used for each nonclinical or biocompatibility test. It mentions "All joints," "All dimensions," and "All balloons" meeting reliability/confidence requirements in "statistical confidence limits test," which implies that a statistically significant number of samples were tested. However, the specific number of units tested for each criterion is not provided.
- Data Provenance: The studies are nonclinical (benchtop and in vitro/in vivo biocompatibility) and were conducted by the manufacturer, Fuji Systems Corporation, or their designated testing laboratories. The country of origin for the data is not explicitly stated, but the manufacturer is based in Japan. These are retrospective data collected as part of the device development and regulatory submission process.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This submission pertains to a mechanical medical device (catheter) and focuses on engineering performance and biocompatibility. There is no "ground truth" established by human experts in the context of diagnostic accuracy found in AI/imaging device submissions. The "ground truth" for these tests is defined by the objective measurement criteria and standards outlined in the test protocols (e.g., ISO standards, ASTM standards, internal reliability requirements).
4. Adjudication Method for the Test Set
Not applicable. This is a nonclinical study involving objective measurements and standardized tests, not subjective interpretations requiring adjudication by multiple readers/experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. This is a submission for a mechanical medical device, not a diagnostic imaging or AI-assisted device. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for the nonclinical tests is based on:
- Objective Measurement: Adherence to specified dimensions, force limits, inflation pressures, deployment characteristics, and physical properties.
- Standardized Protocols: Compliance with international standards (e.g., ISO 594-1, ISO 594-2, ISO biocompatibility tests, ASTM methods).
- Pre-defined Pass/Fail Criteria: Each test had distinct criteria that determined a "Pass" or "Fail" outcome (or "For Information Only").
8. The Sample Size for the Training Set
Not applicable. This is a hardware medical device; it does not involve machine learning algorithms requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
§ 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).