KAYAK HYDROPHILIC GUIDE WIRES

K014195 · Boston Scientific Corp · DOX · Mar 19, 2002 · Clinical Toxicology

Device Facts

• Record ID: K014195
• Device Name: KAYAK HYDROPHILIC GUIDE WIRES
• Applicant: Boston Scientific Corp
• Product Code: DOX · Clinical Toxicology
• Decision Date: Mar 19, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3550
• Device Class: Class 2

Intended Use

The Boston Scientific Corporation (BSC) Kayak™ Hydrophilic Guide Wires are intended to facilitate the placement of a catheter during diagnostic or interventional procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches. This device is not intended for use in the coronary arteries or the neurovasculature.

Device Story

Steerable guide wire used to facilitate catheter placement during diagnostic or interventional procedures. Device consists of nickel titanium core, polyurethane jacket containing tungsten, and hydrophilic coating for lubricity. Available in 0.035 and 0.038 inch diameters; 80, 150, and 180 cm lengths; various tip flexibilities (standard, stiff, long taper) and designs (straight, angled). Operated by physicians in clinical settings to navigate tortuous arteries and avoid side branches. Manual torque applied by operator to steer wire. Benefits include improved navigation through complex vascular anatomy.

Clinical Evidence

Bench testing only. Evaluation included tensile strength, torque strength, cantilever stiffness, tip prolapse, peel test, lubricity, durability, biocompatibility, and shelf life. Results met all acceptance criteria.

Technological Characteristics

Nickel titanium core; polyurethane jacket with tungsten; hydrophilic coating. Diameters: 0.035, 0.038 inches. Lengths: 80, 150, 180 cm. Tip designs: straight, angled; flexibilities: standard, stiff, long taper. Manual operation. No software or energy source.

Indications for Use

Indicated for patients undergoing diagnostic or interventional procedures requiring catheter placement. Contraindicated for use in coronary arteries or neurovasculature.

Regulatory Classification

Identification

A lead test system is a device intended to measure lead, a heavy metal, in blood and urine. Measurements obtained by this device are used in the diagnosis and treatment of lead poisoning.

Predicate Devices

• Terumo Radifocus Glidewire (K961445)
• Cordis Hydronol Steerable Guidewire (K973845)

Reference Devices

• Renegade Braided Microcather (K973645)

Submission Summary (Full Text)

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## MAR 1 9 2002

K014195

## Summary of Safety and Effectiveness

## Section 6

Submitter's Information

Name and Address Boston Scientific Scimed, Inc. One Scimed Place Maple Grove, Minnesota 55311

Contact Person Mark Murphy 763-494-2377

Date December 20, 2001

Device Name

Proprietary Name Boston Scientific Corporation Kayak™ Hydrophilic Guide Wires

Common or Usual Name Kayak™ Guide Wires

Classification Name Catheter Guide Wire

Predicate Devices:

The following predicate devices are currently marketed.

| Product | 510(k) | Clearance Date |
|----------------------------------------|---------|----------------|
| Terumo Radifocus Glidewire | K961445 | 07/09/1996 |
| Cordis Hydronol Steerable<br>Guidewire | K973845 | 01/05/1998 |

6-1

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# Summary of Safety and Effectiveness, Continued

| Models<br>Available | The Kayak™ Hydrophilic Guide Wires are steerable guide wires<br>available in a nominal diameter of 0.035 and 0.038 inches and nominal<br>lengths of 80, 150 and 180 centimeters. The available tip flexibilities<br>will be<br>• Standard,<br>• Stiff<br>• Long Taper.<br><br>The distal three centimeters of all models are available in straight and<br>pre-formed angled tip design. |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>Components | The Kayak™ Hydrophilic Guide Wire consists of the following three<br>components:<br>• nickel titanium core<br>• polyurethane jacket<br>• hydrophilic coating |
| Polyurethane<br>Jacket | The full length of the guide wire has a polyurethane jacket containing<br>tungsten encasing the core wire. |
| Hydrophilic<br>Coating | The full length of the guide wire has a hydrophilic coating for lubricity. |

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## Summary of Safety and Effectiveness, Continued

The Boston Scientific Corporation (BSC) Kayak™ Hydrophilic Guide Intended Use Fires are intended to facilitate the placement of a catheter during diagnostic or interventional procedures. The wire can be torqued to diaghoods or ination through tortuous arteries and/or avoid unwanted side branches. This device is not intended for use in the coronary arteries or the neurovasculature.

Summary of Technological Characteristics The Kayak™ Hydrophilic Guide Wires are manufactured in a similar manner to legally marketed BSC hydrophilic guide wires and manner to 10gaily including the Renegade Braided Microcather (K973645) and the predicate device -- Terumo Radifocus Glidewire (K961445).

Non-Clinical Test Summary Testing and evaluation of the guide wires included:

- · tensile strength
- · torque strength
- · cantilever stiffness
- · tip prolapse
- peel test
- · lubricity and durability
- · biocompatibility
- · product shelf life

#### Results

Test results demonstrate that the Kayak™ Hydrophilic Guide Wires met all evaluation acceptance criteria and are adequate for their intended use.

#### Summary

The Kayak™ Hydrophilic Guide Wires are considered to be substantially equivalent to guide wires currently marketed by BSC and for Terumo Corporation based on a comparison of intended use, design and the results of in vitro testing and evaluation.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 9 2002

Mr. Mark Murphy Regulatory Affairs Specialist Boston Scientific Scimed, Inc. One Scimed Place Maple Grove MN 55311

Re: K014195

> Trade/Device Name: Kayak™ Hydrophilic Guide Wires Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire. Regulatory Class: Class II Product Code: DOX Dated: December 20, 2001 Received: December 21, 2001

Dear Mr. Murphy:

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 such 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. 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); good manufacturing practice requirements as set

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#### Page 2 - Mr. Mark Murphy

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quarty by systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter wification. The FDA finding of substantial equivalence of your device to a legally premarket notification. The PDF micing of casion for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and If you desire specific acrise for for invitro diagnostic devices), please contact the Office of additionally 21 CH Far 8071 or additionally, for questions on the promotion and advertising of Compliance at [phone]. Timber of Compliance at [phone]. Also, please note the your do roo, product of market notification" (21CFR Part 807.97). If guilation chittived, "Nisoftananing of responsibilities under the Act may be obtained from the Other general mionmation on your neernational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Dork Teen

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

Enclosure

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510(k) Notification BSC Kayak Guide Wires

.

## Indications for Use

Section 2

| 510(k) Number | K014195 |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Kayak™ Hydrophilic Guide Wires |
| Indications for<br>Use: | The Boston Scientific Corporation (BSC) Kayak™ Hydrophilic Guide Wires are intended to facilitate the placement of a catheter during diagnostic or interventional procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches. This device is not intended for use in the coronary arteries or the neurovasculature. |

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## Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109) ✓

OR

Over The Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Division of Cardiovascular & Respiratory Devices
510(k) Number K014195