CORONARY PERIPHERAL AND RENAL STEERABLE GUIDEWIRE

K042338 · Lake Region Mfg., Inc. · DQX · Sep 16, 2004 · Cardiovascular

Device Facts

• Record ID: K042338
• Device Name: CORONARY PERIPHERAL AND RENAL STEERABLE GUIDEWIRE
• Applicant: Lake Region Mfg., Inc.
• Product Code: DQX · Cardiovascular
• Decision Date: Sep 16, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Indications for 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, including the renal vasculature. The steerability feature allows the guidewire to be torqued to facilitate navigation through the vasculature.

Device Story

The device is a steerable guidewire consisting of a PTFE-coated stainless steel core ground at the distal end for flexibility. It features a distal tip coil soldered to the core and additional radiopaque marker coils. The device is used by physicians in clinical settings to navigate coronary, peripheral, and renal vasculature. The guidewire is torqued by the operator to facilitate navigation, allowing for the introduction and positioning of catheters and interventional devices. It is offered in various lengths (130cm-300cm), diameters (.014"-.018"), and tip configurations (straight or shaped). The device is provided to OEM manufacturers, kit assemblers, and distributors, and may be supplied sterile or bulk.

Clinical Evidence

No clinical data. Equivalence was established through bench testing, including visual, tactile, dimensional, and mechanical attribute inspections. Biocompatibility was established based on the use of materials identical to the predicate device and a history of proven biocompatibility.

Technological Characteristics

Materials: PTFE-coated stainless steel core, soldered distal tip coil, radiopaque marker coils. Dimensions: .014"-.018" diameter, 130cm-300cm length. Features: Shapeable straight or preshaped tip, optional MDX (silicone) coating. Connectivity: None. Sterilization: Ethylene oxide (for sterile-packaged units).

Indications for Use

Indicated for use in angiographic procedures to introduce and position catheters and interventional devices within the coronary, peripheral, and renal vasculature in patients requiring vascular navigation.

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

• LRM predicate device (K022813)
• LRM predicate device (K011968)

Submission Summary (Full Text)

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K042338

## SEP 1 6 2004

## SECTION 2.0 – SUMMARY OF SAFETY AND EFFECTIVENESS

### August 25, 2004

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)<br>340 Lake Hazeltine Drive<br>Chaska, MN 55318<br>Telephone: [phone] Fax: [phone] |
| Contact Name: Karen Mortensen<br>Senior Regulatory Compliance Specialist |

Establishment Registration Number: 2126666

## Device Trade Name/Proprietary Name:

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.

## 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 quidewires. Angiographic Guidewire (74HAP), Catheter Guidewire (74DQX), and Radiological Catheter Guidewire (74JAJ).

Classification of Devices:

Olassification of Donoos 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:

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:

LRM produces cardiovascular and vascular guidewires on an OEM basis for ether manufacturers kit assemblers and distributors. There is no direct other manafacturer int ages to the customer controlled labels labeling or diotion by Erinals are at their discretion including the resolution of any promotion regulatory obligations. A fraction of the total production bears LRM controlled labels and labeling.

### Device Description:

This device is a guidewire with a PTFE coated stainless steel core that has been ground at the distal end to provide the appropriate tip flexibility. boon ground for the coils are joined to the core at the ground end and a distal tip coil is soldered to the core. The proximal PTFE coated portion of the core has two sections of the PTFE removed to aid in estimating guidewire positioning.

The product is offered with a shapeable straight tip or in a preshaped configuration. The guidewires are optionally coated with MDX (silicone). The guidewires are bound by the following parameters:

| Outside Diameter: | .014" - .018" |
|-------------------|---------------------------------------------------|
| Lengths: | 130cm - 300cm |
| Tips: | Straight or shaped with various tip flexibilities |

## Engineering Specifications:

The design specifications are the same for the proposed device as they are for the LRM predicate device [reference 510(k)s K022813 and K011968] with the exception of the smaller outer diameter and the additional radiopaque marker coils soldered to the core proximal to the existing radiopaque coil. The finished device must meet the same basic design criteria as the predicate device.

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# SECTION 2.0 – SUMMARY OF SAFETY AND EFFECTIVENESS (continued)

## Substantial Equivalence Data:

Lake Region believes this device is substantially equivalent to the predicate device. Eake Region belioved this active to between the predicate device and the proposed below lists the differences bettre the changes to the device met the device. predetermined acceptance criteria.

| Item | Proposed Device Differences from LRM Predicate<br>cleared under 510(k) K022813 |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| Raw Materials | Core:<br>No change to raw material<br><br>Coils:<br>No change to raw material |
| Assembly Process | No change to assembly processes with the exception<br>of the additional solder step to join the additional<br>radiopaque marker coils to the core. |
| Physical<br>Characteristics | No change except to offer a .014" along with the<br>.018" diameter. |
| Labeling/IFU | No change to the labeling/IFU except to change the<br>description to add the smaller diameter. |
| Intended Use | No change to intended use |
| Anatomical Sites | No change |
| Target Population | No change |
| Performance | No change |
| Testing | No change |
| Safety<br>Characteristics | No change |
| Biocompatibility | No change |
| Risk Analysis | No change |

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

## Quality System Controls:

Design Control:

Design oonformance with the design control procedure requirements as ERM 10 11 0011 CFR 820.30. Risk analysis was completed by means of a Specifically 21 OFF ecolor sis (FMEA) and all verification and validation rativities resulted in the ability to demonstrate that the predetermined acceptance criteria were met.

### Material/Product/Process Controls:

Matchain Todoon Tooob Donline in place to assure that each product manufactured remains equivalent to the predicate products, and that the mandidotarou Tomans o adverse affect on the safe and effective use of the The quality systems include Engineering Change Order Review, product. product. - The Qualification, Product Qualification, and Process Qualification. These controls are applied to each product size/group.

### Qualification Testing:

Non-Clinical Tests:

In order to demonstrate equivalence of the proposed device, LRM performed testing to established requirements. Test pieces were tested and inspected tooling to established specific inspection criteria requirements for visual/tactile, dimensional and mechanical attributes. The results of these viouslikability, umonitionality and performance characteristics of these guidewires are comparable to the currently marketed devices.

### Biocompatibility Testing:

There are no new materials used in the modification of this device. Biocompatibility testing has been performed on the predicate product and has been found to be applicable to the modified device. This testing, along with a market history of proven biocompatibility, establishes acceptable biocompatibility for this device.

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

## Packaging and Sterilization Information:

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, some 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 as five or ten pouches in 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.

### Intended Use Statement:

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, including the renal vasculature. The steerability feature allows the guidewire to be torqued to facilitate navigation through the vasculature.

NOTE: The modification of this device does not alter its intended use.

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is positioned within a circle that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 6 2004

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

Re: K042338

K042530
Trade/Device Name: Coronary, Peripheral and Renal Steerable Hydrophilic Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guidewire Regulatory Class: Class II Product Code: DQX Dated: August 27, 2004 Received: August 30, 2004

Dear Ms. Mortensen:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaused 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 conninered pror to May 20, 1978, in accordance with the provisions of the Federal Food, Drug, de vices that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, therefore, mains 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 i lease of a recommation 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

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Page 2 – Ms. Karen Mortensen

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic (21 CFR 1000-1050 forth in the quality systems (QD) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Action Section S product radiation control provisions (Sections 35 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 manxemily of substantial equivalence of your device to a legally premarket notification. The FDA iniding of substantial equive 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
s and the may be and 1648 - the same of the same and the requires an the re If you desire specific advice for your de rice of east. Also, please note the regulation entitled, contact the Office of Comphalled at [phone] (21CFR Part 807.97). You may obtain " Misoranding by reference to premance notificals as the Act from the Division of Small other general information on your responsible.com and and the mumber [phone] or [phone] or at its Internet address

[phone] of at its internetadios
http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Dvina R. Vochner

A 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): Ko42338

Device Name:___Coronary Periperal and Renal Steerable Hydrophilic Guidewire

Indications For Use:

Lake Region's steerable guidewires are intended for use in angiographic Lake Negron's Stocrable galability catheters and interventional devices procedures to introduce and peripheral vasculature, including the renal within the obronary and facilitate navigation through the vasculature.

Prescription Use X ___________________________________________________________________________________________________________________________________________________________

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)

Muna D. Salmer

(Division Sian-Off) Division of Cardiovascular Devices

510(k) Number K042338

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