(163 days)
Fighter™, Marvel™, Samurai™, and Samurai™ RC Guidewires:
Boston Scientific Fighter™, Marvel™, and Samurai™ RC 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.
Stretch Extension Wire:
Attachment of the Stretch Extension Wire to a Boston Scientific extendable guidewire creates an extended guide wire that can be used to exchange out a percutaneous transluminal coronary angioplasty (PTCA) or percutaneous transluminal angioplasty (PTA) catheter without removing the original guide wire from the exchange is complete, the Stretch Extension Wire can be detached and the original guide wire can be used in a conventional manner.
The Fighter™, Marvel™, Samurai™, and Samurai™ RC 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 quide wires are compatible exclusively with the Stretch Extension Wire which can extend the quide 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 quide 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. The Marvel and Samurai wires are available in an additional J-tip configuration.
The Stretch Extension Wire is composed of a stainless steel core wire coated with PTFE and contains a hypotube that is compatible with the 190 cm Fighter, Marvel, Samurai, and Samurai RC Guidewires.
The provided document is a 510(k) premarket notification for guidewires and an extension wire. It describes the design verification and biocompatibility testing performed to demonstrate substantial equivalence to predicate devices, rather than a study proving a device meets specific acceptance criteria with reported performance metrics. Therefore, most of the requested information regarding acceptance criteria and study particulars cannot be extracted directly from this document in the manner typically associated with clinical performance studies for AI/medical imaging devices.
However, I can extract information about the types of tests performed and the overall conclusion of substantial equivalence.
Here's a breakdown of the information that can and cannot be found in the provided text:
1. A table of acceptance criteria and the reported device performance
This document does not provide a table of acceptance criteria or specific reported device performance metrics in the format requested. It lists various tests performed (e.g., Dimensional Evaluation, Coating Durability, Tensile) but does not provide quantitative acceptance criteria or results. The conclusion states that the tests provide "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."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. The document describes design verification and biocompatibility testing, not clinical studies with patients. Therefore, terms like "test set" in the context of clinical data are not applicable here.
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 information is not applicable. No ground truth establishment by experts is mentioned, as this is a materials/engineering performance evaluation, not expert-based assessment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. No adjudication method is mentioned as this is a materials/engineering performance evaluation.
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
This information is not applicable. This document is for medical devices (guidewires and extension wires), not an AI/imaging device. No MRMC study or AI assistance is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. This document is for medical devices (guidewires and extension wires), not an AI/imaging device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
This information is not applicable. The "ground truth" in this context would be the pass/fail criteria for the engineering and biocompatibility tests performed.
8. The sample size for the training set
This information is not applicable. No training set is mentioned as this is a medical device performance evaluation, not a machine learning model.
9. How the ground truth for the training set was established
This information is not applicable. No training set is mentioned.
Summary of what is available from the document:
This submission details the design verification and biocompatibility testing for Fighter™, Marvel™, Samurai™, Samurai™ RC Guidewires, and the Stretch™ Extension Wire. The purpose of these tests was to demonstrate substantial equivalence to legally marketed predicate devices.
Tests Performed:
The following performance tests were completed:
- Dimensional Evaluation
- Tip Flexibility
- Tensile
- Device Compatibility
- Coating Lubricity
- Master Shipping Carton/Condition
- Label Adhesion and Print Quality
- Sterile Barrier Integrity
- Coating Durability
- Wire Flex
- Combined Load
- Torque Response
- Wire Fracture
- Pouch Seal Strength
- Shelf Carton Condition
- Visual Sterile Barrier Integrity
- Radiodetectability
- Particulate Evaluation
- Corrosion Testing
- Exchange Connect
- Exchange Tensile
- Carrier Tube Assembly
- Withdrawal from Carrier Tube
The following biocompatibility tests were completed:
- Cytotoxicity
- Sensitization
- Intracutaneous Reactivity
- Acute Systemic Injection
- Natural Rubber Latex
- Ames Mutagenicity
- Mouse Lymphoma
- Hemolysis Direct Contact
- Hemolysis Extract Method
- Partial Thromboplastin Time
- In vitro Hemocompatibility
- Materials Mediated Pyrogen
- In Vivo Thrombogenicity
- USP Physicochemical
- Complement Activation C3a and SC5b-9
Conclusion of the Study:
"Based on the indications for use, technological characteristics, safety and performance testing, the Fighter, Marvel, Samurai, and Samurai RC Guide Wires are appropriate for the stated intended uses and are considered to be substantially equivalent to the ChoICE Guide Wire (K143587) and the Stretch Extension Wire is considered to be substantially equivalent to the AddWire Extension Wire (K030617)."
Clinical Testing:
- "Clinical evaluation was not required for this device."
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.