Search Results

Boston Scientific Hornet, Hornet 10, and Hornet 14 Guidewires are intended to facilitate the placement of balloon dilatation catheters or other interventional therapeutic devices during percutaneous transluminal coronary angioplasty (PTCA) or other intravascular interventional procedures. These guidewires are not intended for use in the cerebral vasculature.

Device Description

The Hornet, Hornet 10, and Hornet 14 Guidewires are designed to facilitate the placement of interventional coronary devices such as dilating balloon catheters, stent delivery systems and other coronary artery diagnostic or therapeutic devices. The guide wires are available in a nominal diameter of 0.014 inches and nominal lengths of 190 cm and 300 cm. The 190 cm guide wires are compatible exclusively with the Stretch Extension Wire which can extend the guide wire length allowing for exchange of Over-The-Wire systems. The guide wires are composed of a stainless steel core wire which tapers at the distal end. The tapered distal end of the guide wire is covered with a proximal stainless steel coil and a distal platinum/nickel radiopaque coil that allows for visualization while using fluoroscopy. The proximal end of the guide wire contains a polytetrafluoroethylene (PTFE) coating and the distal portion of the wire is coated with a hydrophilic coating. All wires are available in a straight tip configuration.

AI/ML Overview

This document describes the Hornet Guidewire, Hornet 10 Guidewire, and Hornet 14 Guidewire, intended to facilitate the placement of balloon dilatation catheters or other interventional therapeutic devices during percutaneous transluminal coronary angioplasty (PTCA) or other intravascular interventional procedures. The submission is for a 510(k) premarket notification (K152231), indicating it's a medical device.

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists various performance tests conducted for the device. However, it does not explicitly state specific quantitative acceptance criteria or detailed results for each test. It broadly states that "The result of the test provides reasonable assurance that the proposed devices have been designed and tested to assure conformance to the requirements for its intended use" and "No new safety or performance issues were raised during the testing."

Here's a table based on the listed performance tests, acknowledging the lack of specific numerical acceptance criteria and performance data in the provided text:

Acceptance Criteria (Inferred from Test Name)	Reported Device Performance
Mechanical Performance
Dimensional Evaluation (e.g., diameter, length)	Implied acceptable.
Tip Flexibility	Implied acceptable.
Tensile Strength	Implied acceptable.
Combined Load	Implied acceptable.
Torque Response	Implied acceptable.
Wire Flex Endurance	Implied acceptable.
Wire Fracture Resistance	Implied acceptable.
Exchange Tensile Strength	Implied acceptable.
Coating Performance
Coating Durability	Implied acceptable.
Coating Lubricity	Implied acceptable.
Visibility
Radiodetectability	Implied acceptable.
Material/Biocompatibility
Particulate Evaluation	Implied acceptable.
Corrosion Testing	Implied acceptable.
Cytotoxicity	Implied acceptable.
Sensitization	Implied acceptable.
Intracutaneous Reactivity	Implied acceptable.
Acute Systemic Injection	Implied acceptable.
Natural Rubber Latex Content	Implied acceptable.
Ames Mutagenicity	Implied acceptable.
Mouse Lymphoma Mutagenicity	Implied acceptable.
Hemolysis Direct Contact	Implied acceptable.
Hemolysis Extract Method	Implied acceptable.
Partial Thromboplastin Time	Implied acceptable.
In vitro Hemocompatibility	Implied acceptable.
Materials Mediated Pyrogenicity	Implied acceptable.
In Vivo Thrombogenicity	Implied acceptable.
USP Physicochemical	Implied acceptable.
Complement Activation C3a and SC5b-9	Implied acceptable.
Packaging/Sterilization
Device Compatibility	Implied acceptable.
Exchange Connect Integrity	Implied acceptable.
Master Shipping Carton/Condition	Implied acceptable.
Pouch Seal Strength	Implied acceptable.
Carrier Tube Assembly Integrity	Implied acceptable.
Label Adhesion and Print Quality	Implied acceptable.
Shelf Carton Condition	Implied acceptable.
Withdrawal from Carrier Tube ease	Implied acceptable.
Sterile Barrier Integrity	Implied acceptable.
Visual Sterile Barrier Integrity	Implied acceptable.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

The document lists various "Design verification testing" and "biocompatibility tests" that were performed. However, the specific sample sizes used for these tests are not provided in the document. The data provenance (e.g., country of origin, retrospective or prospective) is also not mentioned.

3. 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):

This device appears to be a physical medical instrument (guidewire) and the testing described is primarily benchtop and biocompatibility testing, not diagnostic AI or image analysis. Therefore, the concept of "ground truth established by experts" as typically seen in AI/diagnostic studies is not applicable in this context. The evaluation relies on standardized engineering and biocompatibility test methods and their predetermined acceptance criteria.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

As mentioned above, since this is mechanical and biocompatibility testing of a physical device, not an interpretive diagnostic study, the concept of an "adjudication method" involving multiple human readers is not applicable. The results are determined by the outcome of the physical tests against established specifications.

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:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of images or data, often assisted by AI. The Hornet Guidewire is a physical interventional device, and its evaluation focuses on its mechanical properties and biocompatibility.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

No, a standalone (algorithm only) performance study was not done. This type of study is specifically for evaluating artificial intelligence algorithms. The Hornet Guidewire is a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

For this medical device, the "ground truth" for proving its safety and effectiveness is established through adherence to predetermined engineering specifications, validated test methods (aligned with standards like EN ISO 11070 and relevant guidance documents like Coronary & Cerebrovascular Guide Wire Guidance January 1995), and generally accepted biocompatibility endpoints. The results of these tests against established limits and benchmarks serve as the "ground truth."

8. The sample size for the training set:

Not applicable. The Hornet Guidewire is a physical medical device, not an AI algorithm. Therefore, there is no "training set" in the context of machine learning. The device design and manufacturing processes are developed through traditional engineering methods.

9. How the ground truth for the training set was established:

Not applicable. As stated above, this is a physical medical device, not an AI algorithm, so there is no training set or ground truth for training in this context.

Ask a Question

Ask a specific question about this device

Page 1 of 1