HI-TORQUE BALANCE MIDDLEWEIGHT ELITE

K103101 · Abbott Vascular-Cardiac Therapies · DQX · Feb 10, 2011 · Cardiovascular

Device Facts

• Record ID: K103101
• Device Name: HI-TORQUE BALANCE MIDDLEWEIGHT ELITE
• Applicant: Abbott Vascular-Cardiac Therapies
• Product Code: DQX · Cardiovascular
• Decision Date: Feb 10, 2011
• Decision: SESE
• Submission Type: Traditional
• 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 guide wire may also be used with compatible stent devices during therapeutic procedures.

Device Story

Steerable guide wire; 0.0145" max diameter; 190 cm or 300 cm lengths. Distal segment features hydrophilic coating; proximal core features hydrophobic coating to reduce friction. Distal tip available in straight shapeable or pre-shaped 'J' configurations. DOC® extendable in 190 cm lengths; includes Wire Identifier for distinguishing wires. Used by physicians in clinical settings to facilitate placement of balloon dilatation catheters and compatible stents during PTCA/PTA procedures. Device provides mechanical support and navigation for interventional tools within vasculature.

Clinical Evidence

Bench testing only. Testing included catheter compatibility, tensile strength, torque strength, torqueability, coating adherence/integrity (particulate testing), and friction testing. Biocompatibility testing included cytotoxicity, hemolysis, acute systemic toxicity, complement activation, intracutaneous toxicity, sensitization, pyrogen, and in vivo thrombogenicity. All tests met acceptance criteria.

Technological Characteristics

Steerable guide wire; 0.0145" diameter; hydrophilic distal coating; hydrophobic proximal coating. Materials include metallic core. Available in 190 cm and 300 cm lengths. Straight or 'J' tip configurations. DOC® extension system. No software or electronic components.

Indications for Use

Indicated for patients undergoing percutaneous transluminal coronary angioplasty (PTCA) or percutaneous transluminal angioplasty (PTA) requiring the 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

• BALANCE MIDDLEWEIGHT (BMW) Guide Wire (K971815, K973494)
• HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II Guide Wire (K072460)
• Terumo Runthrough (K063695)

Submission Summary (Full Text)

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# 10310

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## 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 | September 22, 2010 |
| 7. Device Trade Name | HI-TORQUE BALANCE MIDDLEWEIGHT ^TM<br>ELITE Guide Wire Family |
| 8. Device Common Name | Guide Wire |
| 9. Device Classification Name | Catheter Guide Wire (DQX) |
| 10. Predicate Device Name | BALANCE MIDDLEWEIGHT (BMW) Guide<br>Wire (K971815, cleared July 9, 1997 and<br>K973494, cleared December 12, 1997), HI-<br>TORQUE BALANCE MIDDLEWEIGHT<br>UNIVERSAL II Guide Wire (K072460, cleared<br>April 11, 2008), and the Terumo Runthrough<br>(K063695, cleared April 4, 2007) |

#### 11. Device Description

The HI-TORQUE BALANCE MIDDLEWEIGHT™ ELITE Guide Wire is a steerable guide wire available in a maximum diameter of 0.0145" and in lengths of 190 cm and 300 cm. The distal segment of the guide wire 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 0.0145". The proximal end of the guide wire is coated with hydrophobic coating, which reduces friction of the wire within a catheter. The ELITE Guide Wire is DOC® extendable in the 190 cm lengths. Over the coin DOC is a Wire Identifier to aid in distinguishing between two wires during use.

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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 angioplass (PTA). The guide wire may also be used with compatible stent devices during therapeutic 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.

#### 14. Performance Data

In vitro bench testing, including catheter compatibility, tensile strength, torque strength, torqueability, coating adherence and integrity (particulate testing), and friction testing were conducted on the subject device. Biocompatibility testing included cytotoxicity, hemolysis (direct and indirect), acute systemic toxicity, complement activation, intracutaneous toxicity, acute systemic toxicity, sensitization, pyrogen, and in vivo thrombogenicity tests. The in vitro bench tests and the biocompatibility tests demonstrated that the HI-TORQUE BALANCE MIDDLEWEIGHT™ ELITE 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-TOROUE BALANCE MIDDLEWEIGHTTM ELITE Guide Wire Family maybe 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 U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol on the right side. On the left side, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.

#### Public Health Service

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

Abbott Vascular, Inc c/o Ms. Kay Setzer Senior Regulatory Affairs Associates 26531 Ynez Road Temecula, CA 92591

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Re: K103101

Trade/Device Name: HI-TORQUE Balance Middleweight™ Elite Guide Wire Family Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II (two) Product Code: DQX Dated: January 25, 2011 Received: January 26, 2011

Dear Ms. Setzer:

and the country of the county

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.

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

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Page 2 – Ms. Suzanne Redman

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.html 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Duran R. Vimer

Image /page/3/Picture/9 description: The image shows a black and white drawing of a stylized letter 'W'. The 'W' is formed by a curved line that starts at the bottom left, rises to a peak, dips down to form a valley, rises again to another peak, and then curves down to the right. A straight line extends from the bottom left of the 'W' towards the bottom right, adding a slight diagonal element to the overall design. The drawing appears to be a simple, abstract representation of the letter.

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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### INDICATION FOR USE

KI03101 510(k) Number (if known):

HI-TORQUE BALANCE MIDDLEWEIGHT ELITE Guide Wire Device Names: Family

Indications for Use:

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This Guide Wire is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). This guide wire may also be used with compatible stent devices during therapeutic procedures.

Prescription Use_ X (Per 21 CFR 801.109)

Over-The-Counter (Optional Format 1-1-96) .

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

iv

Dianne R. Mc James

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_K10 310 1

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