FREEWAY AND RAILRUNNER GUIDEWIRES

K082922 · Lake Region Mfg., Inc. · DQX · Dec 9, 2008 · Cardiovascular

Device Facts

• Record ID: K082922
• Device Name: FREEWAY AND RAILRUNNER GUIDEWIRES
• Applicant: Lake Region Mfg., Inc.
• Product Code: DQX · Cardiovascular
• Decision Date: Dec 9, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

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

Device Story

Freeway™ and Railrunner™ are steerable guidewires used in angiographic procedures to navigate catheters and interventional devices through coronary and peripheral vasculature. The device consists of a PTFE-coated stainless steel core body and a radiopaque platinum alloy distal coil, secured by solder. Available in straight or pre-shaped configurations, the guidewires may feature MDX (silicone) or hydrophilic coatings on the distal tip. The device is operated by a physician in a clinical setting. It functions as a mechanical guide to facilitate the placement of interventional tools, aiding in diagnostic or therapeutic vascular procedures.

Clinical Evidence

No clinical data. Substantial equivalence is supported by non-clinical bench testing, including dimensional, mechanical, and tactile attribute inspections, and biocompatibility testing per ISO 10993 series.

Technological Characteristics

PTFE-coated stainless steel core; radiopaque platinum alloy distal coil; solder joints. Dimensions: 0.014" OD, 175-300 cm length. Coatings: MDX (silicone) or hydrophilic. Flexibility: 3-6 gm (Freeway) and 9-12 gm (Railrunner) distal loads. Mechanical device; no energy source or software.

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

• K970376
• K041624
• Asahi PTCA Guide Wire Confianza Pro Guidewire (K041531)

Submission Summary (Full Text)

{0}------------------------------------------------

H082922

## SECTION 2.0 - SUMMARY OF SAFETY AND EFFECTIVENESS

## September 29, 2008 (revised October 31, 2008)

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 Medical 340 Lake Hazeltine Drive Chaska, MN 55318

[phone], Extension 6381 Telephone: [phone] Fax: Contact Person: Deep Pal

Regulatory Affairs Specialist Title:

# ESTABLISHMENT REGISTRATION NUMBER

2126666

#### DEVICE TRADE NAME/PROPRIETARY NAME

FREEWAY™ and RAILRUNNER™ Guidewires

#### DEVICE COMMON NAMES/USUAL NAMES/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 CALL & C

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

#### APPLICABILITY OF PERFORMANCE STANDARDS

ILRM 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

These Freeway™ and Railrunner™ Guidewires are composed of two primary components: A PTFE coated stainless steel steerable core body, and a radiopaque platinum alloy distal coil. The coil is secured in its location by solder, which is attached to the core. The coil is attached to the core at the distal end, proximal end of the coil, and at a midpoint section (intermediate ioint). The product is offered with a shapeable straight tip or in a pre-shaped configuration. The Guidewires are optionally coated with MDX (silicone) over the distal tip and hydrophilic coating over portions of the distal tip of the Guidewire. The Guidewires are bound by the following parameters:

| Outside Diameter: | .014" |
|-------------------|----------------------------------------------------------------|
| Lengths: | 175cm - 300 cm |
| Tips: | Straight or shaped |
| Flexibility: | FREEWAY - 3 and 6 gm and RAILRUNNER - 9 and 12 gm distal loads |

Page 2-1

{1}------------------------------------------------

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

#### TECHNOLOGICAL CHARACTERSTICS

TECHNOLOGICAL CHARACTERSTICS The design specifications are substantially onlines designs include stiffer tip Cleared under 5 ro(R) Ror of and Asahi Wire Asahi PTCA Guide Wire Confianza Pro Guidewire cleared under 510(k) K041531.

#### QUALITY SYSTEM CONTROLS

#### DESIGN CONTROL

LRM is in conformance with the design control procedure requirements as specified ENM is in conformance with the access completed by means of a Failure Mode and In 21 OF C 020.00. This and ill 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 ENN has formal quality oyetems in 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 Indialo - Engineering Qualification, and Process Qualification. These controls are applied to each product size/group.

#### QUALIFICATION TESTING

# NON-CLINICAL TESTS - Children - But

In order to demonstrate equivalence of the Freeway™ and Railrunner™ Guidewire iterations, LRM performed testing to established requirements. Test pieces were tested and inspected according to established specific inspection criteria toolou - and - inspiretalitactile, 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 per ISO 10993 series has been performed on the Freeway™ and Railrunner™ devices and has been found to be acceptable.

#### SUBSTANTIAL EQUIVALENCE DATA

Lake Region believes the Freeway™ and Railrunner™ Guidewire iterations are substantially equivalent to the predicate devices cleared under 510(k) K970376, K041624 and K041531. All non-clinical test results support the claim of substantial equivalence to the predicate devices.

#### INTENDED USE STATEMENT

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.

{2}------------------------------------------------

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird. The logo is black and white.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 9 ...

Lake Region Medical c/o Mr. Deep Pal Regulatory Affairs Specialist 340 Lake Hazeltine Drive Chaska, MN 55318-1029

K082922 Re:

> Trade/Device Name: FREEWAY and RAILRUNNER Guidewires Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guidewire Regulatory Class: Class II Product Code: DQX Dated: November 3, 2008 Received: December 4, 2008

Dear Mr. Pal:

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 forth in the quality

{3}------------------------------------------------

Page 2 - Mr. Deep Pal

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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.

Sincerely yours,

K/h

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

Enclosure

{4}------------------------------------------------

#### INDICATIONS FOR USE

510(k) Number (if known): KO82922

Device Name:_____FREEWAY™ and RAILRUNNER™ Guidewires

Indications for Use:

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

Prescription Use X (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)

(Division Sign-Off) of Cardiovascular Devices 07 192

Page 1 of

PAGE 9-1