APPROACH PRO ST WIRE GUIDE

K110163 · Cook Incorporated · DQX · Feb 25, 2011 · Cardiovascular

Device Facts

• Record ID: K110163
• Device Name: APPROACH PRO ST WIRE GUIDE
• Applicant: Cook Incorporated
• Product Code: DQX · Cardiovascular
• Decision Date: Feb 25, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The Approach Pro ST Wire Guide is indicated for use in facilitating delivery of percutaneous catheters into the peripheral vasculature.

Device Story

The Approach Pro ST Wire Guide is a manual guide wire used to facilitate the delivery of percutaneous catheters into the peripheral vasculature. It consists of a stainless steel core wire coated with PTFE. The device is operated by a clinician during vascular procedures. It functions as a mechanical aid for catheter placement. The device is supplied sterile for one-time use.

Clinical Evidence

Bench testing only. Tests included three-point bend, corrosion resistance, radiopacity, torque response/strength, tensile evaluation of distal tip, deflection load characterization, fracture resistance, resistance to damage by flexing (pre- and post-accelerated aging), biocompatibility, pyrogen, bioburden, endotoxin, and EtO residual testing.

Technological Characteristics

Stainless steel core wire with PTFE coating. Outside diameter 0.014 inches; available in 135 cm, 190 cm, and 300 cm lengths. Sterile, single-use, manual mechanical device.

Indications for Use

Indicated for facilitating delivery of percutaneous catheters into the peripheral 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

• Approach Pro LT Wire Guide (K070410)

Submission Summary (Full Text)

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Special 510(K) Premarket Notification Approach Pro ST Wire Guide COOK INCORPORATED January 18, 2011

#### 510(k) Summary

## Submitted By:

Aaron Santner, PhD Regulatory Science Associate Cook Incorporated 750 Daniels Way, PO Box 489 Bloomington, IN 47402

#### Device:

Trade Name: Proposed Classification: Approach Pro ST Wire Guide Wire, Guide, Catheter 21 CFR §870.1330

## Indications for Use:

The Approach Pro ST Wire Guide is indicated for use in facilitating delivery of percutaneous catheters into the peripheral vasculature.

#### Predicate Devices:

The Approach Pro ST Wire Guide is a modification of the Approach Pro LT Wire Guide, D.C. #K070410, which was cleared for commercial distribution on April 27, 2007.

### Device Description:

The Approach Pro ST Wire Guide consists of a stainless steel core wire coated with polytetrafluoroethylene (PTFE). The outside diameter of the Approach Pro ST Wire Guide is 0.014 inches and the device will be available in 135 cm, 190 cm, and 300 cm lengths. It will be supplied sterile and intended for one-time use.

ર્ડ 4

K110163

# FEB 2 5 2011

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## Substantial Equivalence:

The Approach Pro ST Wire Guide is similar to many devices in commercial distribution for facilitating delivery of percutaneous catheters into the peripheral vascular system. The Approach Pro ST Wire Guide is a modification of the Approach Pro LT Wire Guide, D.C. #K070410, which was cleared for commercial distribution on April 27, 2007. The Approach Pro LT and Approach Pro ST Wire guides share identical indications for use, principles of operation, technological characteristics, and similar materials of construction, supporting a determination of substantial equivalence.

# Test Data:

The Approach Pro ST Wire Guide was subjected to the following tests to assure reliable design and performance under the specified testing parameters. These tests included:

- Three Point Bend Test 1.
- 2. Corrosion Resistance Test
- 3. Radiopacity Evaluation
- 4. Evaluation of Torque Response and Torque Strength
- 5. Tensile Evaluation of the Distal Tip
- Q. Characterization of Loads Required to Deflect the Distal Tip
- 7. Evaluation of Resistance to Fracture
- 8. Evaluation of Resistance to Fracture after 3-Year Accelerated Aging
- Evaluation of Resistance to Damage by Flexing 9.
- Evaluation of Resistance to Damage by Flexing after 3-Year Accelerated Aging 10.
- 11. Biocompatibility Testing
- 12. Pyrogen Testing
- Bioburden Testing 13.
- 14. Endotoxin Testing
- 15. EtO Residual Testing

The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a wire guide.

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

Cook Incorporated c/o Aaron Santner, PhD Regulatory Science Associate 750 Daniels Way, PO Box 489 Bloomington, IN 47402

FEB 2 5 2011

Re: K110163

Trade/Device Name: Approach Pro ST Wire Guide Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II (two) Product Code: DQX Dated: January 18, 2011 Received: January 27, 2011

Dear Dr. Santner:

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.

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Page 2 - Aaron Santner, PhD

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

Sincerely yours,

D. Zuckerman, M.D. Bra Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Special 510(K) Premarket Notification Approach Pro ST Wire Guide
COOK INCORPORATED January 18, 2011

..

510(k) Number (if known): D.C. #K110163

Device Name: Approach Pro ST Wire Guide

Prescription Use __ X

Indications for Use: For use in facilitating delivery of percutaneous catheters into the peripheral vasculature.

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(Per 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|----------|
| (Division Sign-Off) | |
| Division of Cardiovascular Devices | |
| 510(k) Number: | K110 163 |

OR

Over–the-Counter Use

(21 CFR 807 Subpart C)