Pre-Formed Guidewire

K151244 · Lake Region Medical · DQX · Jun 11, 2015 · Cardiovascular

Device Facts

• Record ID: K151244
• Device Name: Pre-Formed Guidewire
• Applicant: Lake Region Medical
• Product Code: DQX · Cardiovascular
• Decision Date: Jun 11, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

Pre-Formed Guidewires are intended to facilitate the introduction and placement of interventional devices within the chambers of the heart, including those used within transcatheter aortic valve procedures.

Device Story

Pre-Formed Guidewire is a 0.035" diameter, 260-300cm long stainless steel wire used to facilitate placement of interventional devices in heart chambers. Device consists of inner stainless steel core and outer stainless steel coil coated in green PTFE; distal end features double-curve shape. Used by clinicians in interventional cardiology settings. Guidewire acts as a track for delivery of interventional devices, such as those for transcatheter aortic valve procedures. Benefits include improved navigation and placement of interventional tools within cardiac chambers. Device is not for use in coronary or cerebrovascular arteries.

Clinical Evidence

Bench testing and a GLP animal study were performed. Bench testing included dimensional, tensile strength, tip flexibility, catheter compatibility, packaging, tip shape retention, particulate, visual, fracture, flex, corrosion resistance, and linear stiffness tests. A GLP animal study evaluated safety and performance compared to the predicate. No new biocompatibility testing was required as materials remained unchanged. Results demonstrate the device is as safe and effective as the predicate.

Technological Characteristics

Materials: Stainless steel (ASTM A313) core and coil; coil coated in green PTFE. Dimensions: 0.035" diameter, 260-300cm length. Tip: Double-curve shape. Standards: ISO 10993, ISO 11070, ISO 11135, ISO 11138. Non-powered, mechanical device.

Indications for Use

Indicated for facilitating introduction and placement of interventional devices within heart chambers, including transcatheter aortic valve procedures. Contraindicated for use in cerebrovasculature or coronary arteries.

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

• Pre-Formed Guidewires (Lake Region Medical) (K130798)

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 11, 2015

Lake Region Medical Mathew Pexa Sr. Regulatory Specialist 340 Lake Hazeltine Dr. Chaska, Minnesota 55318

Re: K151244

Trade/Device Name: Pre-Formed Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DOX Dated: May 8, 2015 Received: May 11, 2015

Dear Mr. Pexa:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR

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Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

M.A. Hillebrenner

for 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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Image /page/2/Picture/0 description: The image shows the logo for Lake Region Medical. The logo consists of a stylized heart shape in red and gray, followed by the words "Lake Region" in a simple, sans-serif font. Below "Lake Region" is the word "MEDICAL" in a smaller, lighter font.

# INDICATIONS FOR USE STATEMENT

## 510(k) NUMBER (IF KNOWN): K151244

### DEVICE NAME: Pre-Formed Guidewire

### INDICATIONS FOR USE:

The Pre-Formed guidewires are intended to facilitate the introduction and placement of interventional devices within the chambers of the heart including those used within transcatheter aortic valve procedures.

PRESCRIPTION

USE

AND/OR

OVER-THE-COUNTER USE

(Part 21 CFR 801 Subpart D)

×

(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)

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Image /page/3/Picture/0 description: The image shows the logo for Lake Region Medical. The logo consists of a geometric shape on the left, which is a combination of red and gray triangles forming a heart-like shape. To the right of the geometric shape is the text "Lake Region" in a clean, sans-serif font, with the "i" in "Region" having a red square dot. Below "Lake Region" and slightly offset to the right is the word "MEDICAL" in a smaller, lighter font.

# 510(k) SUMMARY

May 8, 2015

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

| 2.1 | MANUFACTURER / REGISTRATION INFORMATION | | | |
|----------------------------------|-----------------------------------------|-----------------|---------------------------|--|
| Lake Region Medical | | Telephone: | 952-448-5111 | |
| 340 Lake Hazeltine Dr. | | Fax: | 952-448-3441 | |
| Chaska, Mn 55318 | | Contact Person: | Mathew Pexa | |
| FDA REGISTRATION NUMBER: 2126666 | | Title: | Sr. Regulatory Specialist | |
| 2.2 | DEVICE TRADE NAME / PROPRIETARY NAME | | | |

Pre-Formed Guidewires

2.3 DEVICE COMMON NAMES / USUAL NAMES / CLASSIFICATION NAMES CATHETER GUIDEWIRE (DQX)

2.4 CLASS OF DEVICE

These devices are commonly known as guides, guidewires, or spring guidewires. The current classification name and product code is Catheter Guidewire (DQX) and is considered a Class II device per 21 CFR Part 870.1330.

| 2.5 | IDENTIFICATION OF PREDICATE DEVICE(s) |
|-----|---------------------------------------|
|-----|---------------------------------------|

Pre-Formed Guidewires (Lake Region Medical) K130798

#### DEVICE DESCRIPTION 2.6

The 0.035" diameter, 260-300cm length guidewire is composed of two primary wire components: a core and a coil. Both components are manufactured from Stainless Steel per ASTM A313. The core wire is a stainless steel wire which forms the inner body of the guidewire. The coil component is the guidewire's outer layer and is a stainless steel wire coated in Green Polytetrafluoroethylene (PTFE), The coil and the core components are welded together on the distal and proximal ends, forming the guidewire. The distal ends are shaped into a double-curve. The following table shows the characteristics of the product family:

| Outside Diameter: | 0.035" |
|-------------------|--------------------------------------|
| Overall Length: | 260cm to 300cm |
| Tip Shape: | Double-Curve |
| Tip Sizes: | Extra Small - Large |
| 2.7 | COMPLIANCE WITH APPLICABLE STANDARDS |

LRM has determined that no mandatory standards, performance standards, or special controls have been established for these devices under Section 514 of the Medical Device Amendments to Federal Food, Drug, and Cosmetic or by any subsequent regulatory action. However, the following standards are referenced within this filing: ISO 10993, ISO 11070, ISO 11135, ISO 11138.

2.8 INTENDED USE STATEMENT

Pre-Formed Guidewires are intended to facilitate the introduction and placement of interventional devices within the chambers of the heart, including those used within transcatheter aortic valve procedures.

NOTE: This modification does not alter its intended use.

2.9 CONTRAINDICATIONS

This wire is not intended for use in the cerebrovasculature or coronary arteries.

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Image /page/4/Picture/0 description: The image shows the logo for Lake Region Medical. The logo consists of a geometric shape on the left, which is a combination of red and gray squares forming a heart-like shape. To the right of the shape, the words "Lake Region" are written in a simple, sans-serif font, with the word "MEDICAL" in smaller letters below.

#### 2.10 TECHNOLOGICAL CHARACTERISTICS

The design specifications are substantially equivalent to the existing Pre-Formed Guidewires

#### QUALITY SYSTEM CONTROL 2.11

### DESIGN CONTROLS

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

### MATERIALS / SUPPLIER / PRODUCT / PROCESS CONTROLS

LRM has formal quality systems in placed to assure that each product manufactured remains equivalent to the predicate products, and that the changes will not have an adverse effect on safety or 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.

#### 2.12 QUALIFICATION TESTING

The conclusions drawn from bench testing and biocompatibility testing demonstrate compliance with the design input summary which shows the device is at least as safe and effective as the current legally marketed device.

### BENCH TESTING

In order to demonstrate equivalence of the guidewire, Lake Region Medical performed bench testing to establish requirements. Test devices were manufactured and inspected according to established requirements for visual/tactile, dimensional and mechanical attributes. The devices were then subjected to the following test methods to show the devices comply with the design input summary:

- Dimensional -
- -FDA Tensile Strength
- -FDA Tip Flexibility
- -FDA Catheter Compatibility
- -Packaging Study
- -Tip Shape Retention
- -Particulate
- ISO Visual "
- -ISO Fracture
- -ISO Flex
- -ISO Corrosion Resistance
- -Linear Stiffness

## BIOCOMPATIBILITY TESTING

There were no changes to materials used in the design or manufacture of the Pre-Formed guidewire family; therefore, no additional biocompatibility tests were completed.

### ANIMAL STUDY

A GLP Animal study was completed to evaluate safety and performance of the guidewire compared to the currently marketed device. The study shows the guidewires are substantially equivalent to the legally marketed device.

#### 2.13 CHANGES FROM PREDICATE DEVICE

- Additional tip shape, Extra Small -
- -Distal core grind diameter minimum made larger

#### 2.14 SUBSTANTIAL EQUIVALENCE DATA

The changes included in this 510(k) for the Pre-Formed guidewire family do not change the indications for use of the Mandrel guidewires and is not a change to the fundamental scientific technology. The information summarized above shows the device will perform as well as the previously marketed device.