APPROACH HYDRO ST WIRE GUIDE, MODEL HMW

K091385 · Cook, Inc. · DQX · Aug 7, 2009 · Cardiovascular

Device Facts

• Record ID: K091385
• Device Name: APPROACH HYDRO ST WIRE GUIDE, MODEL HMW
• Applicant: Cook, Inc.
• Product Code: DQX · Cardiovascular
• Decision Date: Aug 7, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

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

Device Story

Approach Hydro ST Wire Guide is a peripheral vascular guide wire used to facilitate percutaneous catheter delivery. Device consists of stainless steel wire core, PTFE coating, and stainless steel/platinum distal tip; features hydrophilic coating for lubricity. Available in 0.0142-inch diameter and 135, 190, 300 cm lengths. Supplied sterile for single-use. Operated by clinicians in clinical settings to navigate vasculature for catheter placement.

Clinical Evidence

Bench testing only. Tests included tensile, tip stiffness, fracture, flexing, torque strength, torque response, lubricity, corrosion resistance, biocompatibility, bioburden, endotoxin, and EtO residual testing.

Technological Characteristics

Stainless steel wire core; PTFE coating; stainless steel and platinum distal tip; hydrophilic coating. Diameter: 0.0142 inches. Lengths: 135, 190, 300 cm. Sterilized via EtO. Mechanical guide wire.

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.

Submission Summary (Full Text)

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# 510(k) Summary

## Submitted By:

Karen Bradburn, RAC Senior Regulatory Affairs Specialist Cook Incorporated 750 Daniels Way, PO Box 489 Bloomington, IN 47402

AUG 0 7 2009

#### Device:

Trade Name: · Proposed Classification:

Approach Hydro ST Wire Guide Wire, Guide, Catheter 21 CFR §870.1330

#### Indications for Use:

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

### Predicate Devices:

The Approach Hydro ST Wire Guide is identical in terms of intended use and similar in terms of materials of construction and technological characteristics to predicate devices reviewed as devices for facilitating delivery of percutaneous catheters into the peripheral vasculature.

## Device Description:

The Approach Hydro ST Wire Guide is manufactured using a stainless steel wire with a PTFE coating and a stainless steel and platinum distal tip. The wire guide has a hydrophilic coating. The maximum outside diameter is 0.0142 inches and will be available in 135, 190 and 300 centimeter lengths. It will be supplied sterile, intended for one-time use.

#### Substantial Equivalence:

The Approach Hydro ST Wire Guide is similar to many devices in commercial p distribution for facilitating delivery of percutaneous catheters into the peripheral vasculature. The identical indications for use, principles of operations, similar materials of construction and technological characteristics of the wire guide support a determination of substantial equivalence.

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# Test Data:

The Approach Hydro ST Wire Guide was subjected to the following tests to assure reliable design and performance under the specified testing parameters. These tests were comprised of:

- Tensile Test 1.
- Tip Stiffness 2.
- Fracture Test 3.
- 4. Flexing Test
- న. Torque Strength Test
- Torque Response Test 6.
- 7. Lubricity Test
- 8. Corrosion Resistance Test
- Biocompatibility Testing 9.
- 10. Bioburden Testing
- Endotoxin Testing 11.
- 12. 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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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 with three stripes forming its wing and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-0609 Silver Spring, MD 20993-0002

AUG 0 7 2009

Cook Incorporated % Ms. Karen Bradburn, RAC Senior Regulatory Affairs Specialist 750 Daniels Way P.O. Box 489 Bloomington, Indiana 47402-0489

Re: K091385

Trade/Device Name: Approach Hydro ST Wire Guide Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: II Product Code: DQX Dated: July 7, 2009 Received: July 8, 2009

Dear Ms. Bradburn:

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 or any Federal statutes and regulations administered by other Federal agencies.

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Page 2-Ms. Karen Bradburn

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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

uma R. bichner

Image /page/3/Picture/9 description: The image shows a black and white drawing of a symbol. The symbol appears to be a stylized letter, possibly a cursive 'S' or a similar character. The lines are thick and somewhat uneven, giving the symbol a hand-drawn appearance.

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

Enclosure

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Ko91385 510(k) Number (if known):

Device Name: Approach Hydro ST Wire Guide

Indications for Use:

Indicated for use in facilitating delivery of percutaneous catheters into the peripheral vasculature.

Prescription Use X (Per 21 CFR 801 Subpart D) OR

Over-the-Counter Use (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) Druma R. Jo Mars ﻟﻠ (Division Sign-Off)

Division of Cardiovascular Devices

510(k) Number Ko 9138