TITAN STEERABLE (PTCA) GUIDEWIRE

K052347 · Lake Region Mfg., Inc. · DQX · Feb 17, 2006 · Cardiovascular

Device Facts

• Record ID: K052347
• Device Name: TITAN STEERABLE (PTCA) GUIDEWIRE
• Applicant: Lake Region Mfg., Inc.
• Product Code: DQX · Cardiovascular
• Decision Date: Feb 17, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

Lake Region's 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™ Guidewire is a steerable guidewire (0.014" diameter) used to navigate catheters and interventional devices through coronary and peripheral vasculature. Device features a distal radiopaque tip (straight or angled) and an embedded magnet within a gold cup at the distal end. Magnet enables magnetic actuation and control when used with a compatible navigation system. Proximal end features PTFE coating. Used by physicians in clinical settings (e.g., cath lab) to facilitate precise placement of interventional tools. Magnetic navigation allows for enhanced steerability compared to standard manual guidewires, potentially improving procedural efficiency and patient outcomes during vascular interventions.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by non-clinical bench testing, including visual, tactile, dimensional, and mechanical performance evaluations compared to predicate devices. Biocompatibility is established via testing on predicate devices.

Technological Characteristics

Steerable guidewire, 0.014" nominal diameter. Features: distal radiopaque tip, embedded magnet in gold cup for magnetic actuation, PTFE coating on proximal end. Materials and design are consistent with predicate devices, modified only by the addition of the magnetic component. Sterilization process remains unchanged.

Indications for Use

Indicated for use in angiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature. No specific patient population age or gender restrictions provided.

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

• Lake Region Guidewire (K041624)
• Lake Region Guidewire (K042854)

Submission Summary (Full Text)

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K052-347

alle Region Manufacturing, Inc. 340 Lake Hazeltine Drive Chuska, MN 55318-1029 USA TEL: [phone] FAX: [phone]

Image /page/0/Picture/2 description: The image shows a logo for "Lake Region". The logo consists of a stylized square with the letters "L" and "R" intertwined within it. Below the symbol, the words "Lake Region" are written in a simple, bold font. The entire logo is in black and white.

# FEB 1 7 2006

# SECTION 2.0 - SUMMARY OF SAFETY AND EFFECTIVENESS

August 25, 2005

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

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

### Device Trade Name/Proprietary Name:

Titan™ Guidewire

# Device Common Names/Usual Names and Classification Names:

These devices are commonly known as guides, guidewires, or spring The current classification names, and product codes are guidewires. 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 Erin has determinou that is under Section 514 of the Medical Amendments established for those of the or by any subsequent regulatory to i ederal i ood, Brag, and conned that there are no applicable voluntary standards.

### Device Description:

These steerable guidewires have a nominal diameter of 0.014" and nominal These stoorable galability on. The wire is configured with a radiopaque longthe of Tree on embedded magnet used with a navigation system to navigate the wire through vasculature. The distal tip can either be straight or angled. A the wire through raccurers the distal portion of the wire and a PTFE coating covers the proximal end of the wire.

The guidewires will be packaged in the standard Lake Region single pack rno gaias mobility (one wire in a dispenser, placed in a pouch, labeled packaging conngarations). There will be no changes to the sterilization process for these guidewires.

## Technological Characteristics:

The design specifications are the same for the proposed device as they are from the LRM predicate device with the exception of the additional magnet inside the gold cup at the distal end of the guidewire which will accommodate magnetic actuation and control.

## 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 raniate 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:

Nort-Clinical rests.
In order to demonstrate equivalence of the proposed device, LRM and In "order" to "demondtate" oquirements. TTest pieces were Stereotaxis performed tooling to established specific inspection criterial requirements for visual/tactile, dimensional and mechanical attributes. The requirements for visuallacile, antionality and performality and performance results of these guidewires are comparable to the currently marketed devices.

#### Biocompatibility Testing:

Biocompatibility testing has been performed on the predicate products and has been found to be applicable to the modified device. This testing, along has been found to be applicable biocompatibility, establishes acceptable biocompatibility for this device.

#### Substantial Equivalence Data:

Substantial Equirant this device is substantially equivalent to the predicate Eake Region believes and device, cleared under 510(K) K041624, is the device. - The Eake Rogion as not and started under K042854 is the primary predicate to show that material additions (gold cup/spacer and secondary prodioute to chex end in a previously cleared predicate device in magnet at the distance intended use. Performance specification the same classimoution for the can directly related to the addition of the changes to the proposed action are are arrestation system. All non-clinical test embedded magnet being assemmal equivalence to the predicate devices.

#### Intended Use Statement:

.

Lake Region's steerable guidewires are intended for use in angiographic Eake rogier o etoduce and position catheters and interventional devices i 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/2 description: The image shows the address for the Food and Drug Administration. The address is 9200 Corporate Boulevard, Rockville MD 20850. The text is in a simple, sans-serif font and is left-aligned.

FEB 1 7 2006

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

Re: K052347 Titan Steerable (PTCA) Guidewire Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter introducer Regulatory Class: II Product Code: DOX Dated: January 25, 2006 Received: January 26, 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 Prease or advised that I DA issuanted or our device complies with other requirements of the Act that IDA has made a determinations administered by other Federal agencies. You must of ally I cuchal statutes and regulations ancluding, but not limited to: registration and listing (21 Comply with an the Act 3 requirements, not 801); good manufacturing practice requirements as set CFK Fart 807), adomig (21 CFR Part 820); and if applicable, the electronic (2004) 1050 forth in the quality byteening (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provinces. (Seeing your device as described in your Section 510(k) I ins icticle will anow you to organization of substantial equivalence of your device to a legally prematics notification: "The PDF First on 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 darroliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general International 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,

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):

Device Name:___Steerable (PTCA) Guidewire_(Trade Name: Titan™)

Indications For Use:

For use in angiographic procedures to introduce and position catheters and i or use in anglographic proche prochary 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)

signature

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K052347

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