LAKE REGION HYDROPHILIC GUIDEWIRE

K040825 · Lake Region Mfg., Inc. · DQX · May 17, 2004 · Cardiovascular

Device Facts

• Record ID: K040825
• Device Name: LAKE REGION HYDROPHILIC GUIDEWIRE
• Applicant: Lake Region Mfg., Inc.
• Product Code: DQX · Cardiovascular
• Decision Date: May 17, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The Lake Region Hydrophilic Guidewire is indicated for general intravascular use to aid in the selective placement of catheters in the coronary, peripheral, visceral and cerebral vasculature.

Device Story

The Lake Region Hydrophilic Guidewire is a flexible, tapered core wire designed to facilitate catheter placement within the coronary, peripheral, visceral, and cerebral vasculature. The device features a hydrophilic coating to reduce friction during navigation and a radiopaque distal coil to assist in fluoroscopic visualization. It is available in 0.010" or 0.014" outer diameters and 180cm lengths. The guidewire is used by clinicians in a clinical setting to navigate the vascular system; the radiopaque tip allows the physician to track the wire's position via fluoroscopy. By providing a trackable path, the device enables the precise placement of diagnostic or therapeutic catheters, potentially improving procedural outcomes and patient safety during vascular interventions.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on identical design, materials, and manufacturing processes to the predicate device (K003084). Bench testing and design validation were previously established under the predicate submission.

Technological Characteristics

Flexible tapered core wire with hydrophilic coating and radiopaque distal coil. Available in 0.010" or 0.014" OD, 180cm length. Mechanical device; no energy source or software. Sterilization process is consistent with predicate device specifications.

Indications for Use

Indicated for general intravascular use to aid in the selective placement of catheters in the coronary, peripheral, visceral, and cerebral vasculature for patients requiring such procedures.

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

• Concentric Medical Hydrophilic Guidewire (K003084)

Submission Summary (Full Text)

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## SECTION 2.0 - SUMMARY OF SAFETY AND EFFECTIVENESS

## March 26, 2004

#### General Information 2.1

- Company Name, Address, and Telephone Number 2.1.1
Lake Region Manufacturing, Inc. (LRM) 340 Lake Hazeltine Drive Chaska, MN 55318 Telephone: [phone] Fax: [phone]

Contact Name: Karen Mortensen Senior Regulatory Compliance Specialist

- Device Trade Namc/Proprietary Name 2.1.2
LRM produces guidewires on an OEM basis for other manufacturers, kit assemblers, and distributors. Consequently there are a large number of trade and proprietary names not including or associated with LRM. LRM has no proprietary names of its own to be included with this submission.

- 2.1.3 Device Common Names/Usual Names and Classification Names
These devices are commonly known as coronary and peripheral catheter guidewires. The current classification names and product codes are Wire, Guide, Catheter (74DQX).

- 2.1.4 Establishment Registration Number: 2126666
- Classification of Devices 2.1.5

Catheter guidewires have been classified as Class II devices by the Circulatory Systems Devices Panel (reference 21 CFR 870.1330).

- 2.1.6 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.

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#### Labels, Labeling, and Advertising 2.2

LRM produces cardiovascular and vascular guidewires on an OEM basis for other manufacturers, kit assemblers, and distributors. There is no direct distribution by LRM. Changes to the customer controlled labels, labeling, or promotional material are at their discretion, including the resolution of any resulting regulatory obligations. A fraction of the total production bears LRM controlled labels and labeling.

#### 2.3 Statement of Availability

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

#### Device Description 2-4

- The Lake Region Hydrophilic Guidewire consists of a flexible, 2.4.1 tapered core wire that decreases in outer diameter from the The hydrophilic coating reduces proximal to the distal end. The radiopaque distal coil facilitates friction during use. The Lake Region Hydrophilic fluoroscopic visualization. Guidewire will be available in two configuration, with either an outer diameter of 0.010" or 0.014" and 180cm long.
The guidewire dimensions are as follows:

| Product Description | Shaft OD<br>(nominal) | Shaft Length<br>(nominal) | Coil Length<br>(nominal) |
|---------------------|-----------------------|---------------------------|--------------------------|
| 0.010" Guidewire | .010" | 180 cm | 10 cm |
| 0.014" Guidewire | .014" | 180 cm | 10 cm |

#### Engineering Specifications 2.4.2

The design specifications are the same for the proposed device as they are for the predicate device (K003084). The finished devices must meet the same basic design criteria.

#### 2.5 Substantial Equivalence Data

#### 2.5.1 Background Information

The proposed device is the same device as the predicate device. Lake Region manufactured the predicate device for Concentric Medical and Concentric Medical contracted with Lake Region to do the design validation testing. Therefore, the majority of the information supplied in the Concentric Medical 510(k) submission originated with Lake Region Manufacturing.

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| Item | Proposed Device Differences from Predicate cleared<br>under 510(k) K003084 |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Raw Materials | No change |
| Assembly Process | No change |
| Physical Characteristics | No change |
| Labeling/IFU | The only change to the IFU will be to the manufacturer<br>information and the omission of the optional introducer<br>information. |
| Intended Use | No change |
| Anatomical Sites | No change |
| Target Population | No change |
| Performance Testing | No change |
| Safety Characteristics | No change |
| Biocompatibility | No change |
| Risk Analysis | No change |

# 2.5.2 Comparison table of predicate to proposed device

#### Design Control and Validation Activities 2.6

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 critcria could be met.

As there were no changes to the device itself and Lake Region conducted the original design verification testing used to establish safety and effectiveness under Concentric Medical Hydrophilic Guidewire K003084, no further testing has been required.

#### Material/Product/Process Qualification 2.7

LRM has formal quality systems in place to assure that the proposed product will remain equivalent to the predicate product. The quality include Engineering Change Order Review, Material systems Qualification, Product Qualification, and Process Qualification. These controls are applied to each product size/group.

#### 2.8 Biocompatibility Testing

The materials for the proposed device are identical to the predicate device cleared under K003084 and are identically processed and sterilized. Therefore, biocompatibility testing for the proposed device is not required.

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#### Packaging and Sterilization Information 2.9

LRM produces guidewires on an OEM basis for other manufacturers, kit assemblers, and distributors. There is no direct distribution by LRM. A portion of the production is private label, sterile packaged to customer specifications, a fraction of that product is provided sterile to the customer.

The single packaged guidewire is placed in a dispenser and then into a Tyvek®/poly pouch. The packaged product may be packaged singlely or in five or ten pouchs to a shelf carton, which are typical packaging configurations.

There will be no changes to the sterilization process for the portion of packaged product shipped sterile to the customer. For the product that is shipped bulk, the packaging design and sterilization process parameters are the customer's responsibility. LRM will not recommend that its customers modify their packaging or sterilization procedures as a result of this submission.

#### 2.10 Intended Use Statement

The intended use statement is the same as the intended use statement for the predicate device cleared under K003084, specifically:

The Lake Region Hydrophilic Guidewire is indicated for general intravascular use to aid in the selective placement of catheters in the coronary, peripheral, visceral and cerebral vasculature.

#### Conclusion 2.11

The Lake Region Hydrophilic Guidewire is substantially equivalent to the predicate guidcwire cleared under 510(k) K003084. There have been no significant changes to the guidewire design as previously manufactured by Lake Region Manufacturing for Concentric Medical.

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Public Health Service

Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with three wavy lines representing the body, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the figure. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 17 2004

Lake Region Manufacturing, Inc. c/o Karen Mortensen Senior Regulatory Compliance Specialist 340 Lake Hazeltine Drive Chaska, MN 55318-1029

K040825 Re:

Lake Region Hydrophilic Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II Product Code: DQX Dated: March 26, 2004 Received: March 30, 2004

Dear Ms. Mortensen:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave tevenced your boother of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 use stated in the enorosaly to regary the enactment date of the Medical Device Amendments, or to commerce provision in May 20, 1978, accordance with the provisions of the Federal Food, Drug, de necs that have boon require approval of a premarket approval application (PMA). and Cosmetic (110) therefore, subject to the general controls provisions of the Act. The I ou may, merelove, mains of the Act include requirements for annual registration, listing of general controll provincitive, 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 If your device to such additional controls. Existing major regulations affecting your device can he 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 Please be advised that FDA's issuance of a substitution with other requirements of the Act
that FDA has made a determination that your device Edger League of Soumust that FDA has made a determination and your creases by other Federal agencies. You must
or any Federal statutes and regulations administered by other to: registration and li or any Federal statutes and regulations and limited to: registration and listing (21)
comply with all the Act's requirements, including, but not itements as set comply with all the Act s requirements, mename, surving practice requirements as set
CFR Part 807); labeling (21 CFR Part 801); gractice requirements as set CFR Part 807); labeling (2) CFR Patl 801); good manufacturing platf.applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and 1f applicab forth in the quality systems (QS) regulation (21-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Action S product radiation control provisions (Scctions 95 described in your Section 510(k)
This letter will allow you to begin marketing your device of your device to a legal This letter will allow you to begin makemig your as walnece of your device to a legally
premarket notification. The FDA finding of substantial equivalend thus, permits vour premarket notification. The FDA imalig of substantal equivalies by the subsitive of the to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
rs (11) 11 (11) (11) (11) (11) (11) - Alles mlesse note the requilation en If you desire specific advice for your uevice on on on nasmile (1) = 1 = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = contact the Office of Compliatice at (301) 574 10 107 (21CFR Part 807.97). You may obtain
"Misbranding by reference to premarket notification of Small "Misbranding by reference to premarket nontiedation of Set from the Division of Small
other general information on your responsibilities under the Act from worker (900) 638-2 other general information on your responsibilities and con-free number [phone] or [phone] or at its Internet address

[phone] or at its mtornol as a smamain. html

Sincerely yours,

Dana R. Vochner

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

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# Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The Lake Region Hydrophilic Guidewire is indicated for general intravascular use to aid in the selective placement of catheters in the coronary, peripheral, visceral and cerebral 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)

Donna R. Vochner

(Division Sign-Off)
Division of Cardiovascular Devices

:0(k) Number Ko40825

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