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.

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.

AI/ML Overview

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."

Summary

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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.

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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

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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:

Stretch Extension Wire:

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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510(k) Summary

per 21 CFR §807.92

Sponsor:	Boston Scientific Corporation300 Boston Scientific WayMarlborough, Massachusetts 01752USA
Contact Name andInformation	Nikki M WahlbergOne Scimed PlaceMaple Grove, MN 55311-1566Phone: 763-494-2381Fax: 763-494-2981e-mail: Nikki.Wahlberg@bsci.com
Prepared	01 July 2015
Proprietary Name	Fighter™ GuidewireMarvel™ GuidewireSamurai™ GuidewireSamurai™ RC GuidewireStretch Extension Wire
Common Name	Catheter Guide Wire
Product Code	DQX
Classification	Class II, 21 CFR Part 870.1330
Primary PredicateDevice	CholCE™ Guidewire	K143587	15 Jan 2015
	AddWire™ Extension Wire	K030617	21 May 2003
ReferenceDevice(s)	ASAHI SION blue Guide Wire	K122468	08 Mar 2013
	ASAHI X-TREME Guide Wire	K072431	26 Sep 2007

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Device Description

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).

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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 CarrierTube
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 andSC5b-9

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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).

Regulation Number and Section

§ 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.