MANDREL GUIDEWIRE

K140485 · Lake Region Medical · DQX · Mar 27, 2014 · Cardiovascular

Device Facts

• Record ID: K140485
• Device Name: MANDREL GUIDEWIRE
• Applicant: Lake Region Medical
• Product Code: DQX · Cardiovascular
• Decision Date: Mar 27, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

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

Device Story

Mandrel guidewires consist of Nitinol or stainless steel core wire, tapered at distal tip, with secured distal coil. Coil materials include stainless steel, palladium, platinum, or tungsten. Guidewires may feature PTFE or silicone coating and proximal core markers. Used in angiographic procedures by physicians to introduce and position catheters and interventional devices within coronary and peripheral vasculature. Device provides mechanical guidance for interventional tools. Benefits include facilitating navigation through vasculature during diagnostic or therapeutic procedures.

Clinical Evidence

Bench testing only. Testing included visual/tactile inspection, dimensional/mechanical attributes, radiopacity, lubricity, J-memory, stiffness, adhesion/durability, pull test, torque strength/control, particulate testing, and ISO-standard tests (strength of union, flex, corrosion, fracture, hydrodurability). Biocompatibility testing (cytotoxicity, hemolysis) confirmed safety of tungsten addition.

Technological Characteristics

Core: Nitinol or stainless steel. Coil: Stainless steel, palladium, platinum, or tungsten. Coating: PTFE or silicone. Dimensions: 20cm-500cm length, 0.014"-0.35" diameter. Sensing/Actuation: Mechanical guidance. Standards: ISO 10993 (biocompatibility), ISO 11070 (introducer needles/catheters/guidewires), ISO 11135 (sterilization).

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 age or gender restrictions; no contraindications listed.

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

• Mandrel Guidewires (Lake Region Medical) (K011084)
• Mandrel Guidewires (Lake Region Medical) (K022759)
• Mandrel Guidewires (Lake Region Medical) (K033758)
• Mandrel Guidewires (Lake Region Medical) (K080144)

Submission Summary (Full Text)

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Lake Region

# SECTION 2.0 - 510(k) SUMMARY

September 24, 2014

This summary is being included in the Premarket Notification 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: | Regulatory Specialist II |

2.2 DEVICE TRADE NAME / PROPRIETARY NAME

Mandrel Guidewires or M-Wires

DEVICE COMMON NAMES / USUAL NAMES / CLASSIFICATION NAMES 2.3

- 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.

- IDENTIFICATION OF PREDICATE DEVICE(s) 2.5

| K011084 | Mandrel Guidewires (Lake Region Medical) |
|---------|------------------------------------------|
| K022759 | Mandrel Guidewires (Lake Region Medical) |

- Mandrel Guidewires (Lake Region Medical) K033758
- K080144 Mandrel Guidewires (Lake Region Medical)

### DEVICE DESCRIPTION 2.6

The Mandrel wire family is made of a coated (PTFE or Silicone) or uncoated Nitinol or Stainless Steel core wire that is tapered at the distal tip where a coil is secured to the distal end. The distal coil can be anywhere from 2cm to 30cm depending on specific design and can consist of Stainless Steel, Palladium, Platinum, or the proposed Tungsten materials. The guidewire may contain proximal core markers. The Mandrel guidewire family is bound by the following parameters:

| Lengths: | 20cm to 500cm |
|-------------------|-----------------------------------------------|
| Outside Diameter: | 0.014" To 0.35" |
| Tips: | Straight or shaped with various flexibilities |
| Coil Length: | 2cm to 30cm |

### 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.

### INTENDED USE STATEMENT 2.8

Mandrel guidewires are intended for use in angiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature. NOTE: This modification does not alter its intended use.

### 2.9 CONTRAINDICATIONS

There are no contraindications listed.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Lake Region Medical Mathew Pexa Regulatory Specialist II 340 Lake Hazeltine Dr. Chaska, MN 55318

Re: K140485

Trade/Device Name: Mandrel Guidewire with Tungsten Regulation Number: 21 CFR 870.1330 Regulation Name: Guidewire Regulatory Class: Class II Product Code: DQX Dated: February 11, 2014 Received: February 26, 2014

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 four d 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 or any with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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### Page 2 - Mathew Pexa

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

## Kenneth J. Cavanaugh -S

- 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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PRODUCT: MANDREL GUIDEWIRE FAMILY w/ TUNGSTEN - Vascular Use SUBMISSION DATE: February 11, 2014 SUBMISSION TYPE: SPECIAL 510(k)

## INDICATIONS FOR USE STATEMENT

510(k) NUMBER (IF KNOWN):

DEVICE NAME: Mandrel Guidewire

INDICATIONS FOR USE:

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

| PRESCRIPTION | X | AND/OR | OVER-THE-COUNTER |
|-----------------------------|---|------------------------|------------------|
| USE | | | 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)

> Bram D. Zuckerman -S 2014.03.27 16:48:58 -04'00'

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Image /page/4/Picture/0 description: The image shows the logo for Lake Region Healthcare. The logo consists of a red circular design on the left, followed by the words "Lake Region" in a bold, serif font. Below "Region" is the word "Medical" in a smaller font size. The logo is clean and professional, suggesting a healthcare organization.

### TECHNOLOGICAL CHARACTERISTICS 2.10

The design specifications are substantially equivalent to the existing Mandrel Guidewires. Material used for the coil of the guidewire will include the addition material option of Tungsten.

### 2.11 QUALITY SYSTEM CONTROL

## DESIGN CONTROLS

LRM is in conformance with the design control procedure requirements as specified in 21 CFR Part 820.33. 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:

- Visual
- Radiopacity
- Lubricity
- J-Memory Test
- Body Stiffness
- Adhesion / Durability
- Guidewire Pull test
- · Torque Strength • Torque Control
- Dimensional • Linear Stiffness
- Lateral Stiffness
- Particulate Test
- ISO Strength of Union
- ISO Flex Test
- ISO Corrosion Resistance Test
- · ISO Fracture Test
- · Hydrodurability
- BIOCOMPATIBILITY TESTING

Biocompatibility testing per the design input summary requirements show the addition of Tungsten to the device does not affect the biocompatibility of the device is still in compliance with pre-defined acceptance criteria outlined in the product Design Input Summary. A biocompatibility risk assessment determined the following biocompatibility tests are required:

- · Cytotoxicity · Hemolysis
### 2.13 SUBSTANTIAL EQUIVALENCE DATA

The addition of Tungsten to the Mandrel guidewire family does 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.