Who is the manufacturer of WHOLEY GUIDE WIRE SYSTEM?

Covidien, LLC filed the 510(k) submission for WHOLEY GUIDE WIRE SYSTEM (K120863).

What is the FDA product code for WHOLEY GUIDE WIRE SYSTEM?

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

What is the regulatory pathway for WHOLEY GUIDE WIRE SYSTEM?

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

Who can help prepare an FDA 510(k) submission like WHOLEY GUIDE WIRE SYSTEM?

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.

WHOLEY GUIDE WIRE SYSTEM

K120863 · Covidien, LLC · DQX · Apr 19, 2012 · Cardiovascular

Device Facts

Record ID	K120863
Device Name	WHOLEY GUIDE WIRE SYSTEM
Applicant	Covidien, LLC
Product Code	DQX · Cardiovascular
Decision Date	Apr 19, 2012
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1330
Device Class	Class 2
Attributes	3rd-Party Reviewed

Intended Use

The Wholey Guide Wire System is intended to facilitate the placement and exchange of interventional devices during diagnostic or therapeutic interventional procedures. The guide wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side-branches.

Device Story

Wholey Guide Wire System is a 0.035" diameter catheter guide wire used to facilitate placement and exchange of interventional devices during diagnostic or therapeutic procedures. Device features stainless steel core, PTFE-coated coil, and platinum-tungsten marker coil. Distal tip is shapeable and radiopaque; available in various lengths and tip flex configurations. Includes torque device accessory for manual steering within vascular anatomy and optional extension wire for device exchange. Operated by physicians in clinical settings. Device provides mechanical support and navigation path for interventional catheters; torqueability allows navigation through tortuous arteries and avoidance of side-branches. Benefits include improved access to target anatomy and streamlined device exchange.

Clinical Evidence

Bench testing and a GLP animal study were performed. Bench testing included distal pull strength, torque response, tip flexibility, coating durability, lubricity, catheter compatibility, and biocompatibility (ISO 10993). Animal study evaluated safety and performance compared to the predicate. Results demonstrated substantial equivalence.

Technological Characteristics

0.035" diameter guide wire; stainless steel core; PTFE-coated coil; platinum-tungsten marker coil; polycarbonate/brass torque device. Radiopaque distal tip. Sterilized. Complies with ISO 11070:1998 and FDA Coronary and Cerebrovascular Guidewire guidance.

Indications for Use

Indicated for facilitating placement and exchange of interventional devices during diagnostic or therapeutic interventional procedures, including navigation through tortuous arteries and avoiding side-branches.

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

Wholey™ Hi-Torque® Guide Wire (K861765)

Related Devices

K014195 — KAYAK HYDROPHILIC GUIDE WIRES · Boston Scientific Corp · Mar 19, 2002
K970376 — PTCA GUIDEWIRE · Lake Region Mfg., Inc. · Jun 6, 1997
K193571 — Go2Wire Guide Wire · Merit Medical System, Inc. · Apr 8, 2020
K980119 — ACS HI-TORQUE WHOLEY SUPRA CORE GUIDE WIRE · Guidant Corp. · Mar 20, 1998
K161584 — ASAHI® Peripheral Vascular Guide Wire ASAHI Meister®16 · Asahi Intecc Co., Ltd. · Oct 6, 2016

Submission Summary (Full Text)

{0}------------------------------------------------ APR 1 9 2012 Image /page/0/Picture/1 description: The image shows the number K120863 at the top. Below the number is the COVIDIEN logo. The logo is a square with a white shape inside of it, followed by the word COVIDIEN in all caps. # 510(k) Summary ## Wholey™ Guide Wire System | 510(k) Summary | This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 C.F.R § 807.92. | |-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Applicant | Covidien llc, formerly ev3, Inc. | | Submitter | Covidien llc 3300 Campus Drive, Suite N550 Plymouth, MN 55441 Tel: 763-398-7000 Fax: 763-591-3248 | | Contact Person | David Robertson Regulatory Affairs Specialist | | Date Prepared | February 3, 2012 | | Device Trade Name | Wholey™ Guide Wire System | | Device Common Name | Catheter Guide Wire | | Classification Name | Wire, Guide, Catheter (21 CFR 870.1330), Product Code DQX | | Classification Panel | Cardiovascular | | Predicate Devices | Advanced Cardiovascular Systems Inc., Wholey™ Hi-Torque® Guide Wire (K861765) | | Device Description | The Wholey™ Guide Wire System is a 0.035" guide wire available in lengths of 145, 175, 260 and 300cm. The distal tip flex configurations are Standard, Floppy, and Intermediate. Tip shape is Straight or Modified J. The guidewire is composed of a stainless steel core, green PTFE (polytetrafluoroethylene) coated coil, white PTFE sleeve, platinum-tungsten marker coil, and optional extension system connector. The proximal end of the core is covered by a white PTFE sleeve that terminates at 100cm from the distal tip. The distal 100cm of the guidewire is covered with a green PTFE pre-coated coil. The PTFE coated coil and | | | platinum-tungsten coil are welded to the core on the very distal tip. The distal tip is shapeable and radiopaque. | | | A torque device is packaged with the guide wire as an accessory. The polycarbonate/brass torque device is designed to be secured to the proximal portion of a guide wire with a diameter, from 0.020" - 0.040" (0.50mm to 1.01mm) to facilitate steering of the guide wire within the vascular anatomy. | | | A Wholey Extension Wire is an available accessory consisting of a PTFE coated stainless steel guide wire attachment which is 0.035" (0.900 mm) in diameter and 155 cm in length. It is exclusively compatible with 0.035" (0.900 mm) Wholey guide wires which have been modified for the attachment of the Wholey Guide Wire Extension to facilitate device exchange. Refer to the Wholey Guide Wire Extension instructions for use. | | Indication for Use | The Wholey Guide Wire System is intended to facilitate the placement and exchange of interventional devices during diagnostic or therapeutic interventional procedures. The guide wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side-branches. | | Performance data | Bench testing and a GLP animal study were performed to support a determination of substantial equivalence. Results from this testing provide assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. Test methods were developed using FDA Coronary and Cerebrovascular Guidewire guidance and ISO 11070:1998 in order to demonstrate equivalence of the Wholey Guide Wire System to the predicate device. A list of applicable non-clinical tests included performed at baseline and one year aging include: | | | Distal Pull Strength Combined Load Torque Response Tip Flexibility Coating Durability Lubricity and Catheter Compatibility Pouch Peel Dye Penetration Linear Stiffness Dimensional Visual Fracture - ISO Flex - ISO Corrosion Strength of Union – Distal Tip Shape Retention Tip Load Hypotube Flex Jacket Adhesion Body Stiffness (3-Point Bend) Particulate | | | 7 11 | |-------------|-----------------------------------------------| | | be the production of the langue of | | -1 - | C 3-39-1000 | | -44-40 1 | A 400 Acres of any and any and the company of | | | ਮੀ BUNDON, | | | 763-333-7200 | | | COLLE 글 5 이 시 | {1}------------------------------------------------ ﻨﻲ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺮﺍﺟﻊ י · . > ﻬ ﻟﻤﺴﺎﺭ --- | | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | Managements Auto Auto -------- ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | f - Comments of the first of the first of the first of the first of the first the first the first the first the first and the final All Accession of Canadian Career of Canadian Come of Children Comer of Children Comer of Children Comer of Children Comes of Children Comes of Children Comer of Children Come Actually of the | - - - 23-358-7200 A-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4- A Landon and | | | 55441 | | {2}------------------------------------------------ . . . . Radiopacity and Packaging Distribution Thermal Conditioning Wholey™ Guide Wire System 510(k) Summary . Lateral Stiffness | | | acceptance criteria. Cytotoxicity | Biocompatibility testing per ISO 10993 series was performed on the Wholey Guide Wire System and test results met the specified Thrombogenicity | |------------------------------------------|-------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | � � 0 | Kligman Maximization Test Systemic Toxicity Rabbit Pyrogen Hemolysis Complement Activation Assay | Lee and White Coagulation Unactivated Thromboplastin Time Assay USP Physicochemica Test Inhibition and Enhancement | | | criteria. | A GLP animal study was completed to evaluate safety and predicate device for the evaluated safety and performance | performance of the Wholey Guide Wire System compared to the currently marketed predicate device. The study showed the Wholey Guide Wire System is substantially equivalent to the | | Summary of Substantial Equivalence | � ● ● | the predicate devices: Similar basic design and fundamental scientific technology Similar operating principle Similar core wire materials Similar wire diameter Similar wire lengths Similar tip styles | The Wholey Guide Wire System has the following similarities to | | | | | The characteristics that differ from the predicate device are the: | | | ● ● ● | Distal core head Radiopaque marker coil PTFE coated distal 8cm Lack of intermediate joint at 8cm Lack of adhesive between coil and sleeve | | | Carolian | | 3033 Camble Drive | ﺮ ﻣﺮﻳﻜ 753-398-7000 (T) | | | | タンさんなのです。 Nici | 783-398-7200 (E) | 5 ライ 4 7 {3}------------------------------------------------ ﺰ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺮﺍﺟﻊ - White PTFE sleeve . - . Braze extension adapter Based on the similar indications for use, technological Conclusion characteristics, and results from in-vitro and in-vivo testing, Covidien IIc considers the Wholey™ Guide Wire System substantially equivalent to the Wholey™ Hi-Torque® Guide Wire (K861765). | CRITICAL: | 3033 Carters Drive | 763-393-7000 [T] | |-----------|--------------------|------------------| | | Plymouth, MN | 763-393-7200 [F] | | | 55441 | | {4}------------------------------------------------ ### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread. #### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 APR 1 9 2012 Covidien LLC c/o Mark Job Responsible Third Party Official Regulatory Technical Services LLC 1394 25th Street NW Buffalo, MN 55313 Re: K120863 Trade/Device Name: Wholey Guide Wire System Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II (Two) Product Code: DQX Dated: March 21, 2012 Received: March 22, 2012 #### Dear Mr. Job: 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. {5}------------------------------------------------ #### Page 2 - Mr. Mark Job 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. 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. A. Hilleben Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health · Enclosure {6}------------------------------------------------ ### Page 1 of 1 #### Indications for Use Statement . 510(k) Number (if known): K120863 Device Name: Wholey Guide Wire System Indications for Use: The Wholey Guide Wire System is intended to facilitate the placement and exchange of interventional devices during diagnostic or therapeutic interventional procedures. The guide wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches. 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) M. A. Hilliam (Division Sign-Off) (Division Sign-oll) Division of Cardiovascular Devices 510(k) Number K120863