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.

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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with healthcare, featuring a staff with a serpent entwined around it.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 12, 2016

Boston Scientific Corporation Nikki Wahlberg Sr. Regulatory Affairs Specialist One Scimed Place Maple Grove, Minnesota 55311

Re: K152231

Trade/Device Name: Hornet Guidewire, Hornet 10 Guidewire, Hornet 14 Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: August 6, 2015 Received: August 7, 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 devicerelated 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" (21 CFR 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
	Form Approved: OMB No. 0910-0120
	Expiration Date: January 31, 2017
	See PRA Statement below.
510(k) Number ( if known )	K152231
Device Name	Hornet™ Guidewire, Hornet™ 10 Guidewire, and Hornet™ 14 Guidewire
Indications for Use ( Describe )	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.
Type of Use ( Select one or both, as applicable )
	☑ 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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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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FORM FDA 3881 (8/14) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF

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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	07 August 2015
Proprietary Name	HornetTM GuidewireHornetTM 10 GuidewireHornetTM 14 Guidewire
Common Name	Catheter Guide Wire
Product Code	DQX
Classification	Class II, 21 CFR Part 870.1330
Primary PredicateDevice	CholCETM Guidewire	K143587	15 Jan 2015
ReferenceDevice(s)	ASAHI Confianza Pro	K041531	08 Mar 2013

Device Description

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Indications for Use / Intended Use

Comparison of Technological Characteristics

The Hornet, Hornet 10, and Hornet 14 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).

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 ISO 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

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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

Clinical Testing

Clinical evaluation was not required for this device.

Conclusion

Based on the indications for use, technological characteristics, safety and performance testing, the Hornet, Hornet 10, and Hornet 14 Guide Wires are appropriate for the stated intended uses and are considered to be substantially equivalent to the ChoICE Guide Wire (K143587).

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.