TITAN GUIDEWIRE

K060454 · Lake Region Mfg., Inc. · DQX · Mar 24, 2006 · Cardiovascular

Device Facts

• Record ID: K060454
• Device Name: TITAN GUIDEWIRE
• Applicant: Lake Region Mfg., Inc.
• Product Code: DQX · Cardiovascular
• Decision Date: Mar 24, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

Titan ™ steerable guidewires are intended for use in angiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature.

Device Story

Titan 100 steerable guidewire (0.014" diameter; 185 cm or 300 cm length) facilitates catheter placement in coronary and peripheral vasculature. Features radiopaque distal tip and embedded magnet for navigation via external navigation system. Distal tip available in straight or angled configurations. Distal portion features hydrophilic coating; proximal portion features PTFE coating. Used by physicians in angiographic procedures. Device provides mechanical support and guidance for interventional tools; magnetic component enables enhanced steerability when used with compatible navigation systems.

Clinical Evidence

Bench testing only. Testing included visual, tactile, dimensional, and mechanical attribute inspections to verify functionality and performance compared to predicate devices. Biocompatibility testing performed on predicate device deemed applicable.

Technological Characteristics

Nominal diameter 0.014"; lengths 185 cm and 300 cm. Materials include radiopaque distal tip, hydrophilic distal coating, and PTFE proximal coating. Features embedded magnet for navigation. Design conforms to 21 CFR 820.30. Sterilization process unchanged from predicate.

Indications for Use

Indicated for use in angiographic procedures to introduce and position catheters and interventional devices within the coronary and 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

• Titan Soft Support (K052347)

Submission Summary (Full Text)

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#### MAR 2 4 2006

## SECTION 2.0 - SUMMARY OF SAFETY AND EFFECTIVENESS

### February 20, 2006

This summary is being included in the Premarket Notification submission in lieu of a statement of availabilitv.

| Company Name, Address, and Telephone Number: |
|----------------------------------------------------------------------------------------------------------------------------------------|
| Lake Region Manufacturing, Inc. (LRM)<br>340 Lake Hazeltine Drive<br>Chaska, MN 55318<br>Telephone: [phone] Fax: [phone] |
| Contact Name: Karen Mortensen<br>Manager, Regulatory Affairs |
| Establishment Registration Number: 2126666 |

Device Trade Name/Proprietary Name: Titan 100 Guidewire (Soft Support, Assert, Super Support)

# Device Common Names/Usual Names and Classification Names:

These devices are commonly known as guides, guidewires, or spring guidewires. The current classification names, and product codes are Angiographic Guidewire (74HAP), Catheter Guidewire (74DQX), and Radiological Catheter Guidewire (74JAJ).

Classification of Devices:

The classification names listed above were originally classified as Class II devices by the Neurology (84HAD), Cardiovascular (74DQX), and Radiology (90JAJ) Review Panels, respectively.

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# SECTION 2.0 - SUMMARY OF SAFETY AND EFFECTIVENESS (continued)

## Applicability of Performance Standards:

LRM has determined that no mandatory performance standards have been established for these devices under Section 514 of the Medical Amendments to Federal Food, Drug, and Cosmetic Act or by any subsequent regulatory action. LRM has also determined that there are no applicable voluntary standards.

### Device Description:

The Titan M steerable quidewires have a nominal diameter of 0.014" and nominal lengths of 185 cm and 300cm. The wire is configured with a radiopaque distal tip and an embedded magnet used with a navigation system to navigate the wire through vasculature. The distal tip can either be straight or angled. A hydrophilic coating covers the distal portion of the wire and a PTFE coating covers the proximal end of the wire.

The quidewires will be packaged in the standard Lake Region single pack packaging configuration (one wire in a dispenser, placed in a pouch, labeled and then placed in individual cartons). There will be no changes to the sterilization process for these guidewires.

## Technological Characteristics:

The design specifications are the same for these Titan ™ iterations as they a e for the Titan™ Soft Support predicate device with the exception of tip flexibility variations.

## Quality System Controls:

Design Control:

LRM is in conformance with the design control procedure requirements as specified in 21 CFR 820.30. Risk analysis was completed by means of a Failure Mode and Effect Analysis (FMEA) and all verification and validation activities resulted in the ability to demonstrate that the predetermined acceptance criteria were met.

Material/Supplier/Product/Process Controls:

LRM has formal quality systems in place to assure that each product manufactured remains equivalent to the predicate products, and that the changes will not have an adverse affect on the safe and effective use of the product. The quality systems include Engineering Change Order Review Material Qualification, Supplier Qualification, Product Qualification, and Process Qualification. These controls are applied to each product size/group.

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### Qualification Testing:

Non-Clinical Tests:

In order to demonstrate equivalence of the Titan™ iterations, LRM and Stereotaxis performed testing to established requirements. Test pieces were tested and inspected according to established specific inspection criteria requirements for visual/tactile, dimensional and mechanical attributes. The results of these tests demonstrated the functionality and performance characteristics of these guidewires are comparable to the currently marketed devices.

Biocompatibility Testing:

Biocompatibility testing has been performed on the predicate device and has been found to be applicable to the modified device.

### Substantial Equivalence Data:

Lake Region believes these Titan™ iterations are substantially equivalent to the Titan'™ Soft Support predicate device cleared under 510(k) K052347. Performance specification changes to the Titan™ iterations are directly related to the varying tip flexibilities of the distal end. All non-clinical test results support the claim of substantial equivalence to the predicate devices.

### Intended Use Statement:

Titan ™ steerable guidewires are intended for use in angiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature.

NOTE: The modification of this device does not alter its intended use.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA".

Public Health Service

MAR 2 4 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Lake Region Manufacturing, Inc. c/o Ms. Karen Mortensen Manager, Regulatory Affairs 340 Lake Hazeltine Drive Chaska, MN 55318

Re: K060454 Titan™ Steerable Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: II Product Code: DQX Dated: February 20, 2006 Received: February 22, 2006

Dear Ms. Mortensen:

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.

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Page 2 – Ms. Karen Mortensen

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease be advised that I Dri 3 issuance or our device complies with other requirements of the Act that I DA has made a determinations administered by other Federal agencies. You must of any I cuttar surates und regaraments, including, but not limited to: registration and listing (21 Comply with an the Not 870 cart 801); good manufacturing practice requirements as set CFN in the quality systems (21 OFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product tastation control pro herems (seting your device as described in your Section 510(k) I mis letter will anow you we connelling of substantial equivalence of your device to a legally prematication: "The PDF intemsg sification 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), please If you desire specific acriver 10- 9 at [phone]. Also, please note the regulation entitled, Connact the Office of Comparket notification" (21CFR Part 807.97). You may obtain Missualling by reference to premaintentibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Donna R. Lachner

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):

K06.454

Steerable Guidewire (Trade Name: Titan TM) Device Name:

ﻧﮯ

Indications For Use:

For use in angiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/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)

sumar R. V. Aunes
Sio-om

(Division Sign-Off) (Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number K060454

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