HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL

K101011 · Abbott Vascular, Inc. · DQX · May 24, 2010 · Cardiovascular

Device Facts

• Record ID: K101011
• Device Name: HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL
• Applicant: Abbott Vascular, Inc.
• Product Code: DQX · Cardiovascular
• Decision Date: May 24, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

To facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The wire is also intended to facilitate the placement of compatible stent devices during therapeutic intravascular procedures.

Device Story

Steerable guide wire used to facilitate placement of balloon dilatation catheters and compatible stents during PTCA, PTA, and therapeutic intravascular procedures. Device features 0.0137" maximum diameter, 190 cm or 300 cm lengths, and distal tip in straight shapeable or pre-shaped J configurations. Distal segment features hydrophilic coating; proximal core features PTFE coating to reduce friction. DOC extendable in 190 cm lengths. Operated by physicians in clinical settings to navigate vasculature; provides mechanical support and guidance for interventional devices. Benefits include improved maneuverability and reduced friction during catheter delivery.

Clinical Evidence

Bench testing only. In vitro testing included tensile strength, torque strength, torqueability, coating adherence/integrity, and friction testing. Biocompatibility testing included cytotoxicity, hemolysis, acute systemic toxicity, complement activation, coagulation, intracutaneous reactivity, USP systemic injection, sensitization, rabbit pyrogen, LAL pyrogen, bacterial endotoxins, and in vivo thrombogenicity. All tests met acceptance criteria.

Technological Characteristics

Steerable guide wire; 0.0137" max diameter; 190/300 cm lengths. Materials: core wire, tip coils, solders. Coatings: hydrophilic (distal), PTFE (proximal). DOC extendable. Class II device (DQX).

Indications for Use

Indicated for patients undergoing percutaneous transluminal coronary angioplasty (PTCA), percutaneous transluminal angioplasty (PTA), or therapeutic intravascular procedures requiring placement of balloon dilatation catheters or compatible stent devices.

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

• HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL Guide Wire (K013833)
• HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II Guide Wire (K072460)

Reference Devices

• HT PROGRESS Guide Wire (K091825)

Submission Summary (Full Text)

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K101011

# MAY 2 4 2010

#### 510(k) Summary

The 510(k) Summary is submitted in accordance with 21 CFR §807.92 and the requirements of the Safe Medical Device Act (SMDA) of 1990.

| 1. | Submitter's Name | Abbott Vascular Inc. |
|-----|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. | Submitter's Address | 26531 Ynez Road, Temecula, CA 92591 |
| 3. | Telephone | [phone] |
| 4. | Fax | [phone] |
| 5. | Contact Person | Kay Setzer |
| 6. | Date Prepared | April 5, 2010 |
| 7. | Device Trade Name | HI-TORQUE BALANCE MIDDLEWEIGHT<br>UNIVERSAL Guide Wire Family |
| 8. | Device Common Name | Guide Wire |
| 9. | Device Classification Name | Catheter Guide Wire (DQX) |
| 10. | Predicate Device Name | HI-TORQUE BALANCE MIDDLEWEIGHT<br>UNIVERSAL Guide Wire (K013833, cleared<br>January 16, 2002), HI-TORQUE BALANCE<br>MIDDLEWEIGHT UNIVERSAL II Guide Wire<br>(K072460, cleared April 11, 2008) |

#### 11. Device Description

The HI-TORQUE BALANCE MIDDLEWEIGHT™ UNIVERSAL Guide Wire is a steerable guide wire available in a maximum diameter of 0.0137" and in lengths of 190 cm and 300 cm. The distal segment of the guide wire, up to the hypotube, is coated with hydrophilic coating to reduce friction for improved guide wire movement within the catheter. The distal tip is offered in a straight shapeable configuration and a pre-shaped "J" configuration. The proximal core has a maximum diameter of 0.0137". The proximal end of the guide wire is coated with PTFE, which reduces friction of the wire within a catheter. The BMW™ Universal Guide Wire is DOC® extendable in the 190 cm lengths.

Sept. 25, 2009)

HT PROGRESS Guide Wire (K091825, cleared

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#### 12. Indication for Use

To facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The wire is also intended to facilitate the placement of compatible stent devices during therapeutic intravascular procedures.

#### 13. Technological Characteristics

Comparisons of the new and predicate devices show that the technological characteristics such as product performance, design and intended use are substantially equivalent to the current marketed predicate devices. The proposed device is similar in design and materials to the currently marketed product in that its core wire, tip coils, and solders remain the same. The hydrophilic coating has been changed but is similar to previously marketed devices.

#### 14. Performance Data

In vitro bench testing, including tensile strength, torque strength, torqueability, coating adherence and integrity (particulate testing), and friction testing were conducted on the subject device. Biocompatibility testing was leveraged from predicate devices with similar materials. Biocompatibility tests included cytotoxicity, hemolysis, acute systemic toxicity, complement activation, coagulation, intracutaneous (intradermal) reactivity test. USP systemic injection test, sensitization, rabbit pyrogen test, LAL pyrogen, bacterial endotoxins, and in vivo thrombogenicity tests. The in vitro bench tests and the biocompatibility tests demonstrated that the HI-TORQUE BALANCE MIDDLEWEIGHT™ UNIVERSAL Guide Wire met all acceptance criteria and performed similarly to the predicate devices. No new safety or effectiveness issues were raised during the testing program and therefore, the HI-TORQUE BALANCE MIDDLEWEIGHT™ UNIVERSAL Guide Wire may be considered substantially equivalent to the predicate devices.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of the department's name, "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA," arranged in a circular fashion around a stylized symbol. The symbol is a depiction of a human figure embracing an eagle, representing the department's mission to protect the health of all Americans and provide essential human services.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Abbott Vascular Inc. c/o Ms. Kay Setzer Senior Regulatory Affairs Associate 26531 Ynez Road Temecula, CA 92590

MAY 2 4 2010

Re: K101011

Trade Name: HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL Guide Wire Family Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II Product Code: DQX Dated: May 7, 2010 Received: May 10, 2010

Dear Ms. Setzer:

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.

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Page 3 - Ms. Kay Setzer

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/ReportalProblem/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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Duna R. Vachner

Image /page/3/Picture/7 description: The image shows what appears to be a signature. The signature is composed of curved lines and a horizontal line. The signature is in black ink and is on a white background.

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):

Device Name: HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL Guide Wire Family

Indications for Use:

To facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The wire is also intended to facilitate the placement of compatible stent devices during therapeutic intravascular procedures.

Prescription Use (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duana D. kliner

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_KTO 10 (1