(28 days)
The BOSS™ 8F Balloon Guide Catheter is indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neurovascular systems. The balloon provides temporary vascular occlusion during these procedures. The balloon guide catheter is also indicated for use as a conduit for retrieval devices.
The BOSS 8F Balloon Guide Catheter system is a sterile, single-use intravascular catheter. The BOSS 8F Balloon Guide Catheter is an 85 and 95 cm long, variable stiffness catheter utilizing a bifurcated dual port luer hub on the proximal end and a radiopaque marker band at the tip distal to the balloon. The catheter shaft has an annular inflation lumen and a coaxial central lumen with stainless steel coil and is braid reinforced. The hub central port leads to the central lumen to facilitate introduction of interventional devices through the central lumen. The inflation port is positioned at an angle to the central port, connecting to the annular inflation lumen, and is used to facilitate inflating and deflating the balloon with a syringe. The BOSS 8F Balloon Guide Catheter uses a distal hydrophilic coating to provide lubricity and reduce friction between the catheter shaft and the vessel wall. The BOSS 8F Balloon Guide Catheter is packaged with the 6F dilator to facilitate the option of direct access into the blood vessel without the use of an introducer sheath.
This document describes the non-clinical performance testing for the BOSS 8F Balloon Guide Catheter, a medical device. There is no information regarding a study of an AI device. As such, I cannot provide details on factors like sample size, ground truth, expert qualifications, or comparative effectiveness studies related to AI.
However, I can provide the acceptance criteria and reported device performance based on the non-clinical bench testing for the BOSS 8F Balloon Guide Catheter.
1. Table of Acceptance Criteria and Reported Device Performance
The device performance is uniformly reported as "Pass" for all tests, indicating that "All samples met the pre-determined acceptance criteria" or similar outcomes for biocompatibility (e.g., "Noncytotoxic," "Non-hemolytic"). The reference standards listed for each test effectively serve as the basis for the acceptance criteria.
| Study Name | Description | Reference Standard (Basis for Acceptance Criteria) | Reported Device Performance |
|---|---|---|---|
| Performance Bench Testing Summary | |||
| Visual Inspection and Dimensional Verification | To demonstrate that the product meets the dimensional specifications | ISO 10555-1:2013 | Pass (All samples met the pre-determined acceptance criteria) |
| Surface Inspection | To demonstrate the product satisfies the visual surface requirements | ISO 10555-1:2013 | Pass (All samples met the pre-determined acceptance criteria) |
| Torque Testing | To demonstrate that the product is capable of 360 degrees of rotation about the central lumen axis without failure. | FDA guidance PTCA Catheters:2010 §VIII.A.10 | Pass (All samples met the pre-determined acceptance criteria) |
| Tensile | To demonstrate the product satisfies the tensile strength requirements for bonds and tip pull test | ISO 10555-1:2013, FDA guidance PTCA Catheters:2010 §VIII.A.7, 8 | Pass (All samples met the pre-determined acceptance criteria) |
| Kink Resistance | To demonstrate that the product has acceptable kink resistance | FDA Guidance PTCA:2010 §VIII.A.9 Kink Test | Pass (All samples met the pre-determined acceptance criteria) |
| Catheter Lubricity | Pad friction test to compare coated to uncoated samples | Characterization only | Pass (Results show a 97% reduction in friction compared to uncoated samples) |
| Particulates, Coating Integrity | This study was conducted to determine the quantity and size of particles generated during simulated use | AAMI TIR42:10, USP | Pass (All samples met the pre-determined acceptance criteria) |
| Radiopacity | To determine the radiopaque characteristics of the device. | ISO 10555-1:2013 | Pass (All samples met the pre-determined acceptance criteria) |
| Push/Track, Simulated Use, Device Compatibility | To demonstrate that the device is deliverable through tortuous path model without kinking or buckling, is able inflate, deflate balloon at target, is compatible with treatment devices and removed without damage. | ISO 10555-1:2013 | Pass (All samples met the pre-determined acceptance criteria) |
| System Leak - Liquid Leak | To demonstrate that the product meets the liquid leakage under pressure requirements | ISO 10555-1:2013 | Pass (All samples met the pre-determined acceptance criteria) |
| System Leak - Aspiration | To demonstrate that the product meets the hub aspiration air leakage requirements | ISO 10555-1:2013 | Pass (All samples met the pre-determined acceptance criteria) |
| Tip Stiffness | To demonstrate that the stiffness of the distal end of the product is similar to other marketed devices. | N/A | Pass (All samples met the pre-determined acceptance criteria) |
| Corrosion Resistance | To demonstrate the product satisfies the corrosion resistance requirements | ISO 10555-1:2013 | Pass (All samples met the pre-determined acceptance criteria) |
| Catheter Burst Pressure Under Static Conditions | To demonstrate the catheter does not leak or rupture up to rated internal pressure. | ISO 10555-1:2013 | Pass (All samples met the pre-determined acceptance criteria) |
| Balloon Inflation / Deflation | To demonstrate balloon meets the inflation and deflation time specifications | ISO 10555-4:2013 | Pass (All samples met the pre-determined acceptance criteria) |
| Balloon Fatigue | To demonstrate that there is no degradation of the balloon after 10 inflation cycles. | ISO 10555-4:2013 | Pass (All samples met the pre-determined acceptance criteria) |
| Balloon Diameter / Volume | To demonstrate that the product meets the inflation volume vs balloon diameter specifications | ISO 10555-4:2013 | Pass (All samples met the pre-determined acceptance criteria) |
| Balloon Rated Burst Volume | To demonstrate that the balloon is capable of withstanding an injection volume to the rated burst volume | ISO 10555-4:2013 | Pass (All samples met the pre-determined acceptance criteria) |
| Small Bore Connector Compliance with Standard | To demonstrate that the product meets the requirements for small bore connectors | ISO 80369-7: 2016 | Pass (All samples met the pre-determined acceptance criteria) |
| Usability Study / Simulated Use | Evaluation of device performance to meet the user needs under simulated use conditions with accessories and treatment devices | FDA Guidance Human Factors and Usability Engineering 2016, IEC 62366:2015 | Pass (All samples met the pre-determined acceptance criteria) |
| Conditioning, Distribution, and Shelf-life Aging | To demonstrate the device met all specifications at both baseline (T=0) and following accelerated aging to a 6-month shelf life equivalent (T=6) | Evaluation of device following accelerated aging to a 6-month shelf life equivalent | Pass (All samples met the pre-determined acceptance criteria) |
| Package Testing: Conditioning, Distribution, Shelf-Life | Evaluation of packaging strength and integrity at both baseline (T=0) and following accelerated aging to a 6-month shelf life equivalent (T=6) | ISTA procedure 3A (2018), ASTM D4169-16, ASTM F1980-16, ASTM F88-15, ASTM F2096-11, ASTM 1929-15 | Pass (All samples met the pre-determined acceptance criteria) |
| Visual Inspection Packaging and Labeling | To demonstrate that the product meets the packaging and labeling visual and adherence requirements | N/A | Pass (All samples met the pre-determined acceptance criteria) |
| Biocompatibility Testing Summary | |||
| Cytotoxicity | Tested in accordance with ISO 10993-5:2009, Neutral Red Uptake Method | ISO 10993-5:2009 (noncytotoxic according to predetermined acceptance criteria) | Pass (Noncytotoxic according to the predetermined acceptance criteria) |
| Intracutaneous Irritation | Tested in accordance with ISO 10993-10:2010 | ISO 10993-10:2010 (test requirements for intracutaneous reactivity met) | Pass (Test requirements for intracutaneous reactivity were met according to the predetermined acceptance criteria) |
| Sensitization | Tested in accordance with ISO 10993-10, Kligman Maximization Test | ISO 10993-10 (did not elicit a sensitization response) | Pass (Did not elicit a sensitization response according to the predetermined acceptance criteria) |
| Systemic Toxicity | Tested in accordance with ISO 10993-11:2017 | ISO 10993-11:2017 (test requirements for systemic toxicity met) | Pass (Test requirements for systemic toxicity were met according to the predetermined acceptance criteria) |
| Material Mediated Pyrogenicity | Tested in accordance with ISO 10993-11:2017 and USP 40 Pyrogen Test | ISO 10993-11:2017, USP 40 (nonpyrogenic, met predetermined acceptance criteria) | Pass (Nonpyrogenic, met the predetermined acceptance criteria) |
| Hemolysis | Tested in accordance with ASTM F756-17 and ISO 10993-4 (Direct and Indirect Methods) | ASTM F756-17, ISO 10993-4 (non-hemolytic, met predetermined acceptance criteria) | Pass (Non-hemolytic, met the predetermined acceptance criteria) |
| Complement Activation | Tested in accordance with ISO 10993-4:2017 (SC5b-9 Complement Activation) | ISO 10993-4:2017 (demonstrates similar complement activation characteristics as the control device, met predetermined acceptance criteria) | Pass (Demonstrates similar complement activation characteristics as the control device, met the predetermined acceptance criteria) |
| In vivo Thromboresistance | Tested in accordance with ISO 10993-4:2017 | ISO 10993-4:2017 (demonstrates similar thromboresistance characteristics as the control device, met predetermined acceptance criteria) | Pass (Demonstrates similar thromboresistance characteristics as the control device, met the predetermined acceptance criteria) |
The following information is Not Applicable (N/A) as the provided document describes non-clinical performance testing for a physical medical device (catheter), not an AI/Software as a Medical Device (SaMD).
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as this is bench testing of a physical device.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. "Ground truth" in this context would refer to objective material properties or performance under specified conditions, measured by instrumentation.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this device's testing is implicitly defined by the quantifiable limits and observable characteristics specified in the referenced ISO and FDA standards.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
§ 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).