(46 days)
The CELLO II Balloon Guide Catheter is indicated for use in facilitating the insertion and guidance of intravasular 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 II Balloon Guide Catheter is a coaxial-lumen, braid-reinforced, variable stiffness catheter with one radiopaque ring marker on the distal end of the balloon and a bifurcated Luer hub on the proximal end. A compliant urethane balloon is mounted on the distal end. Balloon Guide Catheter dimensions and recommended balloon volumes are indicated on the product label. Each catheter is supplied with inserters, a Y-Connector, 3-way stopcocks and syringes.
The CELLO II Balloon Guide Catheters are intended for use in hospitals or other health care facilities which are equipped with trained personnel and specialized equipment to perform peripheral and neurovascular procedures.
The CELLO II Balloon Guide Catheter is intended for facilitating the insertion and guidance of intravascular catheters into selected blood vessels in the peripheral and neuro vasculature systems. The tip of the catheter features a balloon of urethane rubber. Radiopaque ring marker identifies the distal end of the balloon. The shaft is a dual lumen type with coaxial structure featuring a built-in braided stainless steel coil.
The materials of construction are similar to those used in many other similar catheters. The shaft is made of polyurethane, polyamide, stainless steel, and fluorine resin; the balloon is made of urethane. Patient contact is of limited duration, less than 24 hours.
Here's a breakdown of the acceptance criteria and study information for the CELLO II Balloon Guide Catheter, based on the provided document:
This document describes a medical device, a catheter, and the tests performed to demonstrate its safety and effectiveness. It is not an AI/ML device, so many of the requested fields regarding AI performance, expert review, training sets, and comparative effectiveness studies are not applicable.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Nonclinical Tests: CELLO II Balloon Guide Catheter | ||
| Surface | Free from extraneous matter, process and surface defects. | Pass |
| Force at Break | Tip and all joints meet reliability/confidence requirements in statistical confidence limits test. | Pass |
| Freedom from Leakage | Shall not leak liquid when pressurized per methods in ISO 10555-1, Annex C. Shall not leak air when aspirated per methods in ISO 10555-1, Annex D. | Pass |
| Tip Configuration | Distal tip smooth, rounded, tapered or similarly finished. | Pass |
| Hubs | Comply with ISO 80369-7. | Pass |
| Freedom from Leakage and Damage upon Inflation | No leakage or evidence of damage, such as herniation or bursting of the shaft or balloon. | Pass |
| Dimensional Verification | All dimensions meet reliability/confidence requirements in statistical confidence limits test. | Pass |
| Balloon Preparation, Deployment and Retraction | Catheters can be advanced to intended sites within a tortuous 3D vessel model where other devices can be deployed distally and retracted; all devices could be retracted without damage. | Pass |
| Balloon Rated Burst Volume | All balloons met reliability/confidence requirements in statistical confidence limits test. | Pass |
| Balloon Fatigue | All balloons withstand 20 cycles of inflation. | Pass |
| Balloon Compliance | All balloons have predictable change in size with volume of contrast solution. | FIO (For Information Only) |
| Balloon Inflation-Deflation Time | All balloons inflate and deflate predictably. | FIO (For Information Only) |
| Flexibility and Kink | All catheters meet reliability/confidence requirements in statistical confidence limits test. | Pass |
| Torque Strength | All models can be torqued at least 135° when the distal tip is fixed in a tortuous 3D vessel model. | FIO (For Information Only) |
| Radiopacity | Radiopaque markers are visible during angiography under a variety of conditions. | FIO (For Information Only) |
| Particulate testing | All catheters meet the particle generation criteria and exhibit similar size and quantity of particulates in comparison to the predicate device. | Pass |
| Tip Flexibility | The tips of catheters meet the tip flexibility criteria. | Pass |
| Contrast Agent Durability | There was no damage after application of pressure of 300 PSI. | Pass |
| Biocompatibility: CELLO II Balloon Guide Catheters | ||
| Cytotoxicity | Non-Cytotoxic based on ISO 10993-5:2009 L929 MEM Elution Test. | Non-Cytotoxic (Pass) |
| Sensitization | Non-Sensitizing based on ISO10993-10:2010 Guinea Pig Maximization Test. | Non-Sensitizing (Pass) |
| Irritation/Intracutaneous Reactivity | Non-Irritant based on ISO10993-10:2010 Intracutaneous Injection Test. | Non-Irritant (Pass) |
| Acute Systemic Toxicity | No Acute Toxicity based on ISO10993-11:2017 Systemic Injection Test. | No Acute Toxicity (Pass) |
| Material-Mediated Pyrogenicity | Non-Pyrogenic based on ISO10993-11:2017 Rabbit Pyrogen Test. | Non-Pyrogenic (Pass) |
| Hemocompatibility (Hemolysis) | Non-Hemolytic based on ASTM F756-17 Hemolysis-Rabbit Blood (Direct and Indirect contact). | Non-Hemolytic (Pass) |
| Hemocompatibility (PTT) | Hemocompatible based on ASTM F2382-18 Partial Thromboplastin Time Test (Direct contact). | Hemocompatible (Pass) |
| Hemocompatibility (Platelet & Leukocyte Binding) | Hemocompatible based on ISO10993-4:2017 Platelet and leukocyte Binding- (Direct contact). | Hemocompatible (Pass) |
| Hemocompatibility (Complement Activation) | Non-Complement Activation based on ISO10993-4:2017 Complement Activation Assay (Direct contact). | Non-Complement Activation (Pass) |
| Hemocompatibility (Thrombogenicity) | Non-Thrombogenic based on ISO10993-4:2017 Thrombogenicity Study in Dog. | Non-Thrombogenic (Pass) |
| Biocompatibility: Y-Connector | ||
| Cytotoxicity | Non-Cytotoxic based on ISO 10993-5:2009 L929 MEM Elution Test. | Non-Cytotoxic (Pass) |
| Sensitization | Non-Sensitizing based on ISO10993-10:2010 Guinea Pig Maximization Test. | Non-Sensitizing (Pass) |
| Irritation/Intracutaneous Reactivity | Non-Irritant based on ISO10993-10:2010 Intracutaneous Injection Test. | Non-Irritant (Pass) |
| Acute Systemic Toxicity | No Acute Toxicity based on ISO10993-11:2017 Systemic Injection Test. | No Acute Toxicity (Pass) |
| Material-Mediated Pyrogenicity | Non-Pyrogenic based on ISO10993-11:2017 Rabbit Pyrogen Test. | Non-Pyrogenic (Pass) |
| Hemocompatibility (Hemolysis) | Non-Hemolytic based on ASTM F756-17 Hemolysis-Rabbit Blood (Direct and Indirect contact). | Non-Hemolytic (Pass) |
2. Sample size used for the test set and the data provenance
The document does not explicitly state a sample size for each individual non-clinical or biocompatibility test. These tests are typically performed on a statistically significant number of manufactured units or material samples to ensure representativeness and reliability of the results. The provenance is likely from the manufacturer's internal testing facilities, as these are in vitro and in vivo (animal studies for biocompatibility) tests, not human data. The document implies these tests were conducted as part of the regulatory submission (premarket notification).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a medical device (catheter) and not an AI/ML device that requires expert ground truth for image interpretation or diagnosis. The "ground truth" for these tests comes from established scientific methods, standards (e.g., ISO, ASTM), and laboratory measurements.
4. Adjudication method for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or AI/ML evaluations where multiple human readers assess cases and a consensus or tie-breaker is needed. These are laboratory and material tests.
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 a physical medical device, not an AI/ML diagnostic or assistive tool. No MRMC studies were performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. No AI algorithm is involved.
7. The type of ground truth used
The ground truth for the nonclinical and biocompatibility tests is based on:
- Established industry standards: Such as ISO 10555-1, ISO 80369-7, ISO 10993 series, and ASTM F756-17, ASTM F2382-18.
- Quantitative measurements: Measuring physical properties (e.g., force, dimensions, burst volume, inflation/deflation time, torque, particle count).
- Qualitative observations: Visual inspection (e.g., surface, damage, tip configuration, radiopacity).
- Biological assays/animal studies: For biocompatibility endpoints (e.g., cytotoxicity, sensitization, irritation, systemic toxicity, hemocompatibility experiments using rabbit blood and in vivo thrombogenicity study in dogs).
8. The sample size for the training set
Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML 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).