(18 days)
Mach1 Guide Catheters are intended for use in general intravascular and coronary applications. They provide a pathway through which medical instruments, such as balloon dilatation catheters, guide wires or other therapeutic devices may be introduced. These devices are not intended for use in the cerebral vasculature.
The Boston Scientific 5F, 7F, and 8F Mach1 catheters are similar to the currently marketed 6F Mach1 Guide Catheter, with the addition of three French sizes to the catheter line.
The Boston Scientific Mach1 catheters are designed to provide a pathway through which medical instruments, such as balloon dilatation catheters, guide wires or other diagnostic or therapeutic devices, may be introduced. These devices are not intended for use in the cerebral vasculature. The Mach1 catheters will be offered in 5F, 6F, 7F, and 8F sizes and are available in lengths ranging from 40-125 cm, with optional side holes. The devices are provided sterile and intended for one procedure use only.
The Mach1 catheters are manufactured using similar construction techniques as other currently marketed Boston Scientific guide catheters. The catheter shaft consists of three layers: the inner, middle and outer layers. The outer layer is composed of four segments,(5F has three segments) inclusive of the proximal shaft segment, but not including the distal tip. The outer layer segments are composed of the same material, (Arnitel) but use varying durometers of the Arnitel (polyether-ester) shaft materials providing specific flexibility zones over the length of the catheter. The tip consists of a reinforced tip portion and a non-reinforced tip portion. The 6F, 7F and 8F tip is made of Hytrel, while the 5F has an Arnitel tip.
The provided text describes a 510(k) premarket notification for Boston Scientific's 5F, 7F, and 8F Mach1 Guide Catheters. This document focuses on demonstrating substantial equivalence to a legally marketed predicate device (the 6F Mach1 Guide Catheter), rather than establishing performance against specific acceptance criteria for a novel device through clinical trials involving AI or diagnostic performance.
Therefore, many of the requested categories are not applicable or not present in the provided text, as this type of submission relies on non-clinical (in-vitro) testing and comparison to an existing device rather than a comprehensive clinical study with human readers, AI assistance, or complex ground truth establishment for diagnostic accuracy.
Here's a breakdown based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly quantifiable metrics like sensitivity or specificity. Instead, they are related to the functional performance and physical characteristics of the guide catheters, ensuring they are safe and perform as intended and are similar to the predicate device. The performance is reported as meeting these criteria.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Material & Design Equivalence | Similar construction techniques and materials (Arnitel, Hytrel) as currently marketed 6F Mach1, with variations in durometers and tip materials for different sizes (5F, 7F, 8F). Design for providing a pathway for medical instruments. |
| Functional Testing | Test results verified that the 5F, 7F and 8F Mach1 catheters are adequate for the intended use in all areas listed below. |
| - Shaft and Distal Segment Tensile and Elongation | Adequate |
| - Tip Tensile | Adequate |
| - Tip Deflection | Adequate |
| - Hub to Shaft Tensile | Adequate |
| - Pressure Shaft Burst and Leak | Adequate |
| - Torque Response | Adequate |
| - Lumen Integrity | Adequate |
| - Radiopacity | Adequate |
| Biocompatibility | Conducted and adequate |
| Package Pouch Burst | Conducted and adequate |
| Product Shelf Life | Conducted and adequate |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated as "sample size" in the context of diagnostic or AI performance evaluation. The "test set" consisted of the manufactured 5F, 7F, and 8F Mach1 catheters on which the functional, biocompatibility, packaging, and shelf-life tests were performed. The exact number of units tested for each specific test is not detailed, but it would have been a representative sample from production batches.
- Data Provenance: The tests were non-clinical (in-vitro) conducted by Boston Scientific Scimed, Inc. within their facilities. This is not human-patient data from a specific country, but rather laboratory and engineering test data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. For this type of submission, "ground truth" refers to established engineering standards, material specifications, and functional requirements for medical devices, not diagnostic interpretations by human experts. The assessment of whether the functional tests met the requirements would be done by product engineers and quality assurance personnel.
- Qualifications of Experts: Not applicable in the context of diagnostic interpretation. The experts involved would be engineers, material scientists, and quality control professionals.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There was no "adjudication" in the sense of reconciling differing expert opinions on diagnostic findings, as this was a non-clinical evaluation. Test results would be compared against predefined internal specifications and industry standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This submission does not involve human readers or AI assistance.
- Effect Size of AI Improvement: Not applicable.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Standalone Study: No, a standalone algorithm performance study was not done. This device is a physical medical instrument, not an AI algorithm.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth for this submission consists of:
- Engineering Specifications: Predefined performance metrics, material properties, and design tolerances.
- Industry Standards: Relevant ISO or ASTM standards for catheter performance and safety.
- Predicate Device Performance: The established, safe, and effective performance of the 6F Mach1 Guide Catheter (K010874) against which the new sizes were compared for substantial equivalence.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. There is no "training set" in the context of AI or machine learning for this device submission. The design and manufacturing processes are based on established engineering principles and prior experience with similar devices.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable, as there is no training set mentioned for this type of device submission.
§ 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).