(26 days)
The BOSS 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 Balloon Guide Catheter system is a sterile, single-use intravascular catheter. The BOSS Balloon Guide Catheter is a 90 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 Balloon Guide Catheter uses a distal hydrophilic coating to provide lubricity and reduce friction between the catheter shaft and the vessel wall. The BOSS 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 is a 510(k) Summary for the BOSS™ Balloon Guide Catheter, a medical device. It describes the non-clinical performance testing conducted to demonstrate substantial equivalence to legally marketed predicate devices, which means no clinical studies were required. Therefore, the information typically associated with AI/ML device studies (e.g., training set, test set, expert adjudication, MRMC studies, standalone performance) is not applicable here as this is a medical device, not an AI/ML diagnostic tool.
The "acceptance criteria" for this device are the pre-determined thresholds for various physical, functional, and biocompatibility tests, as detailed in the "NONCLINICAL PERFORMANCE TESTING SUMMARY" and "Biocompatibility Testing Summary" sections. The "study that proves the device meets the acceptance criteria" refers to the successful completion of all these non-clinical (bench and animal) tests.
Here's a breakdown of the requested information based on the provided text, reinterpreting "acceptance criteria" and "study" in the context of a medical device 510(k) submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Study Name | Description | Reference Standard | Acceptance Criteria (Implied / Stated) | Reported Device Performance |
|---|---|---|---|---|
| Visual Inspection and Dimensional Verification | To demonstrate that the product meets the dimensional specifications | ISO 10555-1:2013 Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements | Meeting pre-determined specifications | Pass: All samples met the pre-determined acceptance criteria |
| Surface Inspection | To demonstrate the product satisfies the visual surface requirements | ISO 10555-1:2013 Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements | Meeting pre-determined requirements | 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 | 360 degrees rotation without failure, meeting pre-determined criteria | 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 | Meeting tensile strength requirements | 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 | Acceptable kink resistance, meeting pre-determined criteria | Pass: All samples met the pre-determined acceptance criteria |
| Catheter Lubricity | Pad friction test to compare coated to uncoated samples | Characterization only | Characterization: Implied reduction in friction desired | 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 Evaluation of particulates associated with vascular medical devices, USP Particulate Matter in Injections | Meeting pre-determined acceptance criteria for particulate quantity and size | Pass: All samples met the pre-determined acceptance criteria |
| Radiopacity | To determine the radiopaque characteristics of the device. | ISO 10555-1:2013 Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements | Meeting pre-determined acceptable radiopaque characteristics | Pass: All samples met the pre-determined acceptance criteria |
| Push/Track, 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 Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements | Deliverability, proper inflation/deflation, compatibility, removal without damage, meeting pre-determined criteria | 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 Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements | Meeting liquid leakage requirements | 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 Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements | Meeting hub aspiration air leakage requirements | 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 (Comparative, not a standard test) | Stiffness similar to other marketed devices, meeting pre-determined criteria | Pass: All samples met the pre-determined acceptance criteria |
| Corrosion Resistance | To demonstrate the product satisfies the corrosion resistance requirements | ISO 10555-1:2013 Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements | Meeting corrosion resistance requirements | 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 300 psi of internal pressure. | ISO 10555-1:2013 Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements | No leak or rupture at up to 300 psi | 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 Intravascular Catheters - Sterile and Single-Use Catheters - Part 4: Balloon Dilatation Catheters | Meeting inflation and deflation time specifications | 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 Intravascular Catheters - Sterile and Single-Use Catheters - Part 4: Balloon Dilatation Catheters | No degradation after 10 inflation cycles | 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 Intravascular Catheters - Sterile and Single-Use Catheters - Part 4: Balloon Dilatation Catheters | Meeting inflation volume vs. balloon diameter specifications | 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 of 1.5 ml. | ISO 10555-4:2013 Intravascular Catheters - Sterile and Single-Use Catheters - Part 4: Balloon Dilatation Catheters | Withstanding 1.5 ml injection volume | 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 Small-bore connectors for liquids and gases in healthcare applications - Part 7, Connectors for intravascular or hypodermic applications. | Meeting requirements for small bore connectors | 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 | Meeting user needs under simulated use conditions | 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 12-month shelf life equivalent (T=12) | Evaluation of device following accelerated aging to a 12-month shelf life equivalent; ISTA procedure 3A (2018), ASTM D4169-16, ASTM F1980-16, ASTM F88-15, ASTM F2096-11 (for packaging) | Meeting all specifications at T=0 and T=12-month AA equivalent | 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 | Meeting visual and adherence requirements for packaging and labeling | Pass: All samples met the pre-determined acceptance criteria |
| Biocompatibility Testing | ||||
| Cytotoxicity | To demonstrate non-cytotoxicity | ISO 10993-5:2009 | Non-cytotoxic | Pass: Noncytotoxic according to the predetermined acceptance criteria |
| Intracutaneous Irritation | To demonstrate acceptable intracutaneous reactivity | ISO 10993-10:2010 | Meeting test requirements for intracutaneous reactivity | Pass: Test requirements for intracutaneous reactivity were met according to the predetermined acceptance criteria |
| Sensitization | To demonstrate no sensitization response | ISO 10993-10:2010, Kligman Maximization Test | No sensitization response | Pass: Did not elicit a sensitization response according to the predetermined acceptance criteria |
| Systemic Toxicity | To demonstrate acceptable systemic toxicity | ISO 10993-11:2017 | Meeting test requirements for systemic toxicity | Pass: Test requirements for systemic toxicity were met according to the predetermined acceptance criteria |
| Material Mediated Pyrogenicity | To demonstrate non-pyrogenicity | ISO 10993-11:2017, USP 40 Pyrogen Test | Non-pyrogenic | Pass: Nonpyrogenic, met the predetermined acceptance criteria |
| Hemolysis | To demonstrate non-hemolytic properties | ASTM F756-17, ISO 10993-4 | Non-hemolytic | Pass: Non-hemolytic, met the predetermined acceptance criteria |
| Complement Activation | To demonstrate similar complement activation characteristics as control device | ISO 10993-4:2017, SC5b-9 Complement Activation | Similar complement activation characteristics to control device | Pass: Demonstrates similar complement activation characteristics as the control device, met the predetermined acceptance criteria |
| In vivo Thromboresistance | To demonstrate similar thromboresistance characteristics as control device | ISO 10993-4:2017 | Similar thromboresistance characteristics to control device | Pass: Demonstrates similar thromboresistance characteristics as the control device, met the predetermined acceptance criteria |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: The document repeatedly states "All samples met the pre-determined acceptance criteria" or similar for the non-clinical bench tests. While the exact numerical sample size for each test is not explicitly listed, it implies that a sufficient number of devices were tested to meet the requirements of the referenced standards (e.g., ISO 10555-1, FDA guidances). For the animal study, the sample size is not specified but it states "an acute porcine model."
- Data Provenance:
- Country of Origin: Not specified for the bench tests. The animal study used an "acute porcine model."
- Retrospective or Prospective: All testing was prospective, designed specifically to evaluate the device against established standards and criteria for regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable. The "ground truth" for this medical device 510(k) submission is established by the performance standards (e.g., ISO, ASTM, FDA guidances) and the physical properties of the device itself (e.g., dimensions, strength, material characteristics). Experts were involved in setting these standards and conducting the tests, but not in the "ground truth" establishment in the sense of labeling data for an AI/ML model for diagnostic purposes.
4. Adjudication Method for the Test Set
Not applicable. This is not a study requiring human adjudication of results in the context of an AI/ML model. The "adjudication" is inherent in whether the device "passes" or "fails" the pre-defined engineering and performance criteria.
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 medical device (catheter) and the submission is based on non-clinical performance and substantial equivalence to predicate devices, not an AI/ML diagnostic tool requiring MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" in this context is based on:
- Established international and national standards for medical devices (e.g., ISO 10555 series, ISO 10993 series, AAMI, ASTM).
- FDA guidance documents for specific device types (e.g., PTCA Catheters).
- Pre-determined engineering specifications and performance criteria for the device.
- Results from a non-GLP (Good Laboratory Practice) animal study.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. There is no training set for this 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).