Who is the manufacturer of V-14 CONTROL WIRE GUIDEWIRE?

Boston Scientific Corporation filed the 510(k) submission for V-14 CONTROL WIRE GUIDEWIRE (K112745).

What is the FDA product code for V-14 CONTROL WIRE GUIDEWIRE?

DQX. It is classified under 21 CFR 870.1330 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for V-14 CONTROL WIRE GUIDEWIRE?

510(k) clearance (submission type: Special).

Who can help prepare an FDA 510(k) submission like V-14 CONTROL WIRE GUIDEWIRE?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

V-14 CONTROL WIRE GUIDEWIRE

K112745 · Boston Scientific Corporation · DQX · Oct 18, 2011 · Cardiovascular

Device Facts

Record ID	K112745
Device Name	V-14 CONTROL WIRE GUIDEWIRE
Applicant	Boston Scientific Corporation
Product Code	DQX · Cardiovascular
Decision Date	Oct 18, 2011
Decision	SESE
Submission Type	Special
Regulation	21 CFR 870.1330
Device Class	Class 2

Intended Use

The V-14 ControlWire Guidewires are intended to facilitate the placement and exchange of balloon dilatation catheters or other therapeutic devices during Percutaneous Transluminal Angioplasty (PTA) or other intravascular interventional procedures. The V-14 ControlWire Guidewires are not intended for use in the cerebral vasculature. The devices are provided non-pyrogenic, sterile, and intended for one procedure only.

Device Story

V-14 ControlWire Guidewire is a hydrophilic-coated, polymer-tipped guidewire used to facilitate placement and exchange of balloon dilatation catheters or other therapeutic devices during peripheral vascular procedures. Core wire is 304V stainless steel; distal portion is tapered for flexibility and covered by a two-part polymer sleeve with hydrophilic coating for lubricity; proximal portion is PTFE-coated. Available in 182 cm and 300 cm lengths, straight or angled tips, and short or long tapers. Used by physicians in clinical settings during intravascular interventions. Device provides a track for therapeutic catheters; aids in navigating vascular anatomy. Single-use, sterile, non-pyrogenic.

Clinical Evidence

No clinical data. Substantial equivalence is supported by non-clinical performance testing, including biocompatibility (cytotoxicity, sensitization, reactivity, systemic toxicity, pyrogenicity, hemolysis, hemocompatibility), mechanical testing (torqueability, tensile strength, tip flexibility, coating durability, kink resistance, fatigue), and sterility/packaging validation.

Technological Characteristics

304V stainless steel core wire; two-part polymer sleeve; hydrophilic coating; PTFE proximal coating. Dimensions: 182 cm or 300 cm lengths; straight/angled tips; short/long tapers. Mechanical sensing/actuation via manual manipulation. Sterilization: sterile, non-pyrogenic. No software or electronic components.

Indications for Use

Indicated for patients undergoing Percutaneous Transluminal Angioplasty (PTA) or other intravascular interventional procedures requiring placement/exchange of balloon dilatation catheters or therapeutic devices. Contraindicated for use in cerebral vasculature.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

PT Graphix Guidewire (K962572)

Related Devices

K033742 — BOSTON SCIENTIFIC V-18 CONTROL WIRE · Boston Scientific Corp · Jan 12, 2004
K091385 — APPROACH HYDRO ST WIRE GUIDE, MODEL HMW · Cook, Inc. · Aug 7, 2009
K032183 — IQ HYDROPHILIC GUIDE WIRE · Boston Scientific Corp · Aug 1, 2003
K020340 — MODIFICATION TO HI-TORQUE WHISPER LS AND MS GUIDE WIRES WITH HYDROCOAT HYDROPHILIC COATING · Guidant Corp. · Mar 1, 2002
K071721 — ASAHI ASTATO 30 PERIPHERAL GUIDE WIRE, MODELS - PAGH18M071, PAGH18M371 · Asahi Intecc Co., Ltd. · Jul 13, 2007

Submission Summary (Full Text)

{0}------------------------------------------------ Special 510(k) Notification Pri: V-14 ControlWire Guidewire Guidewire K112745 OCT 1 8 2011 . ## 510(k) Summary per 21 CFR §807.92 (c) | Submitter's Name and Address | Boston Scientific Corporation One Scimed Place Maple Grove, MN 55311 | | | |---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|-----------------| | Contact Name and Information | Shannon Pettit Senior Regulatory Affairs Specialist Tel: 763-494-2833 Fax: 763-494-2222 E-mail: Shannon.Pettit@bsci.com | | | | Date Prepared | 20 September 2011 | | | | Trade Name | V-14TM ControlWire® Guidewire | | | | Common Name | Wire, Guide, Catheter | | | | Classification | Class II | | | | Product Code | DQX (21 CFR 870.1330) | | | | Predicate Device | Boston Scientific PT Graphix Guidewire (Formerly SCIMED CholCE PT Vision) | K962572 | SE: 17 Dec 1996 | | Reason for Submission | To gain clearance for the V-14 ControlWire Guidewire based on a narrowed intended use of the currently marketed PT Graphix Guidewire cleared under K962572. | | | | Device Description | The V-14 ControlWire Guidewire is a hydrophilic coated polymer tipped guide wire intended to facilitate the placement of balloon dilatation catheters, and/or other therapeutic devices during peripheral vascular procedures. V-14 ControlWire core wire is constructed using 304V stainless steel wire. The distal portion of the core wire is tapered in diameter to provide added flexibility. The distal portion of the core wire is covered by a two part polymer sleeve. The polymer sleeve is coated with a hydrophilic coating to create a lubricious surface and improve wire handling. The proximal portion of the core wire is coated with polytretraflouroethylene (PTFE). The V-14 ControlWire comes in two length configurations (182 cm and 300 cm), two distal tip configurations (Straight and Angled) and two taper lengths (Short Taper and Long Taper). | | | {1}------------------------------------------------ K112745 P.2 of 3 Special 510(k) Notification V-14 ControlWire Guidewire | Indications for Use | The V-14 ControlWire Guidewires are intended to facilitate the placement and exchange of balloon dilatation catheters or other therapeutic devices during Percutaneous Transluminal Angioplasty (PTA) or other intravascular interventional procedures. The V-14 ControlWire Guidewires are not intended for use in the cerebral vasculature. The devices are provided non-pyrogenic, sterile, and intended for one procedure only. | |---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Comparison of Technological Characteristics | The narrowed intended use of the V-14 ControlWire Guidewire as compared to PT Graphix Guidewire does not affect or alter the fundamental scientific technology of the cleared components. The design, operating principles, shelf-life, materials, construction, accessories, performance, sterilization method, and manufacturing of the devices will remain unchanged. | ﺪ {2}------------------------------------------------ | Non-Clinical Performance Data | Determination of substantial equivalence is based on an assessment of non-clinical performance data. Non-clinical performance data submitted in support of the overall safety and efficacy of the device is based on the Failure Modes/Effects Analysis (FMEA) risk analysis method completed for the V-14 ControlWire to demonstrate that the proposed devices are suitable for their intended use. All testing performed and data demonstrate passing results according to executed verification protocols. Therefore, results of non-clinical performance data, including biocompatibility, sterility, and packaging testing, supports the safety and efficacy of the V-14 ControlWire | | | |----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | | Guidewires. The following performance tests were performed: Torqueability Radiopacity Polymer sleeve lubricity / wire movement Magnetic segment resiliency Magnetic performance Distal tip tensile Proximal tensile Surface Inspection Bends Corrosion resistance Flexing test Biocompatibility: Cytotoxicity Sensitization Intracutaneous Reactivity Acute Systemic Toxicity Materials Mediated Rabbit Pyrogen Hemolysis Direct Partial Thromboplastin Time In Vitro Hemocompatibility Assay Complement Activation USP Physicochemical Latex | Tip flexibility Coating adherence Coating durability - distal Magnetic section kink resistance Magnetic section joint kink resistance / fatigue J-tip / angled tip retention Torque strength Polymer sleeve shear Overall length Fracture test | | | Clinical Performance Data | Clinical Evaluation was not required for these devices. | | | | Conclusion | Based on the Indications for Use, unaltered technological characteristics, and submitted non-clinical performance data, the Boston Scientific V-14 ControlWire Guidewire is shown to be appropriate for its intended use and is considered to be substantially equivalent to the PT Graphix Guidewire (K962572). | | | · {3}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized eagle or bird in flight, composed of three curved lines. ## Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Boston Scientific Corporation % Ms. Shannon Pettit One Scimed Place Maple Grove, MN 55311-1566 OCT 1 8 2011 Re: K112745 Trade/Device Name: V-14 ControlWire Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: September 20, 2011 Received: September 21, 2011 Dear Ms. Pettit: 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 contractly and i 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 (111) e 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 {4}------------------------------------------------ Page 2 - Ms. Shannon Pettit device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours, Bram D. Zuckerman, M.D. Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ ## Indications for Use 510(k) Number (if known): KU2745 Device Name: V-14™ ControlWire® Guidewire Indications for Use: The V-14 ControlWire Guidewires are intended to facilitate the placement and exchange of balloon dilatation catheters or other therapeutic devices during Percutaneous Transluminal Angioplasty (PTA) or other intravascular interventional procedures. The V-14 ControlWire Guidewires are not intended for use in the cerebral vasculature. The devices are provided non-pyrogenic, sterile, and intended for one procedure only. Prescription Use X· (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use _ (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Signature Division Sign-Off) Pasion for Cardiovasculc.ices 5!ük Number #1121945. Page 1 of _ 1