(163 days)
No
The device description and performance studies focus on the physical properties and mechanical performance of guidewires and an extension wire, with no mention of AI or ML capabilities.
No
Explanation: The device is described as facilitating the placement of other therapeutic devices, rather than being a therapeutic device itself.
No
The device is described as a guidewire intended to facilitate the placement of therapeutic devices. While it assists in placing devices that might be used for diagnostic purposes, the guidewire itself does not perform a diagnostic function.
No
The device description clearly details physical components made of stainless steel, platinum/nickel, and PTFE, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the 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." This describes a device used within the body for a therapeutic or interventional procedure, not a device used outside the body to examine specimens from the body for diagnostic purposes.
- Device Description: The description details the physical components and function of a guidewire used to navigate within blood vessels. This aligns with an interventional device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
Therefore, the device described is an interventional medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
DQX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopy
Anatomical Site
Coronary artery, intravascular
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Design verification testing was performed to support a determination of substantial equivalence according to Coronary & Cerebrovascular Guide Wire Guidance January 1995 and EN INO 11070. 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. No new safety or performance issues were raised during the testing. Performance tests included: Dimensional Evaluation, Coating Durability, Radiodetectability, Tip Flexibility, Wire Flex, Particulate Evaluation, Tensile, Combined Load, Corrosion Testing, Device Compatibility, Torque Response, Exchange Connect, Coating Lubricity, Wire Fracture, Exchange Tensile, Master Shipping Carton/Condition, Pouch Seal Strength, Carrier Tube Assembly, Label Adhesion and Print Quality, Shelf Carton Condition, Withdrawal from Carrier Tube, Sterile Barrier Integrity, Visual Sterile Barrier Integrity. Biocompatibility tests included: Cytotoxicity, Ames Mutagenicity, In vitro Hemocompatibility, Sensitization, Mouse Lymphoma, Materials Mediated Pyrogen, Intracutaneous Reactivity, Hemolysis Direct Contact, In Vivo Thrombogencity, Acute Systemic Injection, Hemolysis Extract Method, USP Physicochemical, Natural Rubber Latex, Partial Thromboplastin Time, Complement Activation C3a and SC5b-9. Clinical evaluation was not required for this device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of three human profiles facing right, arranged in a cascading manner. The profiles are rendered in black and have a flowing, abstract design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the left side of the logo.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 16, 2015
Boston Scientific Corporation Nikki M. Wahlberg Senior Regulatory Affairs Specialist One Scimed Place Maple Grove, MN 55311-1566
Re: K151840
Trade/Device Name: Fighter™ Guidewire, Marvel™ Guidewire, Samurai™ Guidewire, Samurai™ RC Guidewire, Stretch™ Extension Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: II Product Code: DQX Dated: November 13, 2015 Received: November 16, 2015
Dear Nikki Wahlberg:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kenneth J. Cavanaugh -S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K151840
Device Name
Fighter™ Guidewire, Marvel™ Guidewire, Samurai™ Guidewire, and Samurai™ RC Guidewire Stretch Extension Wire
Indications for Use (Describe)
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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☒ | |
| ☐ |
X | Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
per 21 CFR §807.92
| Sponsor: | Boston Scientific Corporation
300 Boston Scientific Way
Marlborough, Massachusetts 01752
USA | | |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|---------|-------------|
| Contact Name and
Information | Nikki M Wahlberg
One Scimed Place
Maple Grove, MN 55311-1566
Phone: 763-494-2381
Fax: 763-494-2981
e-mail: Nikki.Wahlberg@bsci.com | | |
| Prepared | 01 July 2015 | | |
| Proprietary Name | Fighter™ Guidewire
Marvel™ Guidewire
Samurai™ Guidewire
Samurai™ RC Guidewire
Stretch Extension Wire | | |
| Common Name | Catheter Guide Wire | | |
| Product Code | DQX | | |
| Classification | Class II, 21 CFR Part 870.1330 | | |
| Primary Predicate
Device | CholCE™ Guidewire | K143587 | 15 Jan 2015 |
| | AddWire™ Extension Wire | K030617 | 21 May 2003 |
| Reference
Device(s) | ASAHI SION blue Guide Wire | K122468 | 08 Mar 2013 |
| | ASAHI X-TREME Guide Wire | K072431 | 26 Sep 2007 |
4
Device Description
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.
Indications for Use / Intended Use Guide Wire
Boston Scientific Fighter™, Marvel™, Samurai™, 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 quidewires are not intended for use in the cerebral vasculature.
Indications for Use / Intended Use Extension Wire
Attachment of the Stretch Extension Wire to a Boston Scientific extendable quidewire 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 artery. When the exchange is complete, the Stretch Extension Wire can be detached and the original guide wire can be used in a conventional manner
Comparison of Technological Characteristics
The Fighter™, Marvel™, Samurai™, and Samurai™ RC Guidewires incorporate substantially equivalent device materials and design, packaging materials and design, fundamental technology, manufacturing processes, sterilization process and intended use as the ChoICE™ Guidewire (K143587).
The Stretch Extension Wire incorporates substantially equivalent device materials and design, packaging materials and design, fundamental technology, manufacturing processes, sterilization process and intended use as the AddWire™ Extension Wire (K030617).
5
Performance Data
Design verification testing was performed to support a determination of substantial equivalence according to Coronary & Cerebrovascular Guide Wire Guidance January 1995 and EN INO 11070. 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. No new safety or performance issues were raised during the testing.
The following performance tests were completed:
| Dimensional Evaluation | Coating Durability | Radiodetectability |
|---|---|---|
| Tip Flexibility | Wire Flex | Particulate Evaluation |
| Tensile | Combined Load | Corrosion Testing |
| Device Compatibility | Torque Response | Exchange Connect |
| Coating Lubricity | Wire Fracture | Exchange Tensile |
| Master Shipping Carton/Condition | Pouch Seal Strength | Carrier Tube Assembly |
| Label Adhesion and Print Quality | Shelf Carton Condition | Withdrawal from Carrier |
| Tube | ||
| Sterile Barrier Integrity | Visual Sterile Barrier Integrity |
The following biocompatibility tests were completed:
| Cytotoxicity | Ames Mutagenicity | In vitro Hemocompatibility |
|---|---|---|
| Sensitization | Mouse Lymphoma | Materials Mediated Pyrogen |
| Intracutaneous Reactivity | Hemolysis Direct Contact | In Vivo Thrombogencity |
| Acute Systemic Injection | Hemolysis Extract Method | USP Physicochemical |
| Natural Rubber Latex | Partial Thromboplastin Time | Complement Activation C3a and |
| SC5b-9 |
6
Clinical Testing
Clinical evaluation was not required for this device.
Conclusion
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).