(189 days)
No
The description focuses on the physical characteristics and materials of a guidewire, with no mention of AI or ML capabilities.
No
The device is a guidewire, intended to facilitate the placement of other therapeutic devices, not to provide therapy itself.
No
The device is a guidewire used to facilitate the placement of other therapeutic or diagnostic devices, not a diagnostic device itself.
No
The device description clearly details physical components such as a stainless steel core wire, coils, and coatings, indicating it is a hardware medical device.
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 used 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 purpose.
- Device Description: The description details the physical components of the guidewire (stainless steel core, coils, coatings) and its function in guiding other devices within the vasculature. This is consistent with an invasive medical device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information about a physiological state, health, or disease. IVDs typically involve analyzing blood, urine, tissue, or other biological samples.
Therefore, the Boston Scientific Hornet, Hornet 10, and Hornet 14 Guidewires are considered invasive medical devices used for interventional procedures, not IVDs.
N/A
Intended Use / Indications for Use
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.
Product codes
DQX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Coronary artery, intravascular (excluding cerebral vasculature)
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
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. Performance tests completed include: 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 completed include: Cytotoxicity, Ames Mutagenicity, In vitro Hemocompatibility, Sensitization, Mouse Lymphoma, Materials Mediated Pyrogen, Intracutaneous Reactivity, Hemolysis Direct Contact, In Vivo Thrombogenicity, 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
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 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.
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" (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
2
| 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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
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:
Department of Health and Human Services
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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."
FORM FDA 3881 (8/14) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
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 | 07 August 2015 | | |
| Proprietary Name | HornetTM Guidewire
HornetTM 10 Guidewire
HornetTM 14 Guidewire | | |
| Common Name | Catheter Guide Wire | | |
| Product Code | DQX | | |
| Classification | Class II, 21 CFR Part 870.1330 | | |
| Primary Predicate
Device | CholCETM Guidewire | K143587 | 15 Jan 2015 |
| Reference
Device(s) | ASAHI Confianza Pro | K041531 | 08 Mar 2013 |
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.
4
Indications for Use / Intended Use
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.
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 Carrier |
| Tube | ||
| Sterile Barrier Integrity | Visual Sterile Barrier Integrity |
5
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 |
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).