MODIFICATION TO OUTBACK CATHETER

K040771 · Lumend, Inc. · DQY · Apr 23, 2004 · Cardiovascular

Device Facts

• Record ID: K040771
• Device Name: MODIFICATION TO OUTBACK CATHETER
• Applicant: Lumend, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Apr 23, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The Outback® Catheter is intended to facilitate placement and positioning of guidewires/catheters within the peripheral vasculature. The Outback® Catheter is not intended for use in the coronary or cerebral vasculature.

Device Story

Outback® Catheter is a sterile, single-use percutaneous catheter used to facilitate guidewire/catheter placement in peripheral vasculature. Device consists of a guide tip, deployment shaft, catheter shaft, and deployment handle with control knob. Operation: proximal retraction of control knob positions curved guide tip coaxially within nosecone for tracking over guidewire to vascular site; guidewire retraction allows curved tip advancement from nosecone port. Radiopaque nosecone and guide tip enable fluoroscopic visualization for precise placement. Once positioned, guidewire is advanced through guide to desired location; guide tip is retracted into nosecone, and catheter is removed, leaving guidewire in place. Used by physicians in clinical settings under fluoroscopic guidance. Benefits include improved navigation and positioning of interventional tools within peripheral vessels.

Clinical Evidence

Bench testing only.

Technological Characteristics

Sterile, single-use percutaneous catheter. Components: guide tip, deployment shaft, catheter shaft, deployment handle. Features radiopaque nosecone for fluoroscopic visualization. Materials: additional material options added compared to predicate. Mechanical operation via manual control knob for tip deflection. No software or electronic components.

Indications for Use

Indicated for facilitating placement and positioning of guidewires and catheters within the peripheral vasculature. Contraindicated for use in coronary or cerebral vasculature.

Regulatory Classification

Identification

A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

Predicate Devices

• LuMend Outback® Catheter (K032298)

Submission Summary (Full Text)

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# 3. 510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

510(k) Number: TBD

#### Applicant Information:

| Date Prepared: | March 24, 2004 |
|----------------|--------------------------------------------------------------------|
| Name: | LuMend, Inc. |
| Address: | 400 Chesapeake Drive<br>Redwood, CA. 94063<br>Office: 650-364-1400 |

| Contact Person: | Michael A. Daniel |
|-------------------|------------------------------------------|
| Phone Number: | Office: 925-254-5228 / Cell 415-407-0223 |
| Facsimile Number: | [phone] |

#### Device Information:

| Classification: | Class II |
|----------------------|-------------------------------------------------|
| Trade Name: | Outback® Catheter |
| Common Name: | Percutaneous Catheter |
| Classification Name: | Percutaneous Catheter, 74 DQY / 21 CFR 870.1250 |

#### Predicate Devices:

The Outback® Catheter is substantially equivalent in intended use and method of operation to the following predicate devices:

LuMend Outback® Catheter cleared via 510(k) K032298 on 8/26/04

#### Device Description:

The Outback® catheter is a sterile, single use device comprised of three primary elements. 1) guide tip, [deployment shaft], 2) catheter shaft and 3) deployment handle with a control knob. Upon proximal retraction of the guide via the control knob, the guide's curved tip is positioned coaxially within the noscone. In this configuration the catheter may be tracked over a guide wire to the selected vascular site. The guidewire is then retracted into the guide, allowing the curved guide tip to be advanced from the nosecone end port. The radiopaque nosecone and guide tip facilitate placement into the selected region of the vascular site, with fluoroscopic guidance. Upon proper placement of the guide tip, the guide wire may be advanced through the guide and

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into the desired location. The guide tip is then retraced into the nosecone, and the catheter is proximally retraced leaving the guide wire in place in the vasculature.

### Intended Use:

The Outback® Catheter is intended to facilitate placement and positioning of guidewires/catheters within the peripheral vasculature. The Outback® Catheter is not intended for use in the coronary or cerebral vasculature.

## Comparison to Predicate Device(s):

The LuMend Outback® Catheter is very similar to the previously cleared LuMend Outback® Catheter cleared via 510(k) K032298. A few minor changes have been made (see detailed device description), however, the principle of operation, intended use, fundamental design, and function of the product remains basically the same. Additional material options have been added. This version of the Outback® Catheter is clearly substantially equivalent to the previously cleared Outback device.

#### Summary:

Based upon the indication for use and the design and engineering data provided in this premarket notification, the Outback® Catheter has been shown to be substantially equivalent to a currently marketed predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

APR 2 3 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

LuMend, Inc. c/o Mr. Michael A. Daniel Regulatory and Clinical Affairs 400 Chesapeake Drive Redwood City, CA 94063

Re: K040771

Trade Name: Outback® Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: DQY Dated: March 24, 2004 Received: March 25, 2004

Dear Mr. Daniel:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your beceion of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enatiment date of the enactment date of the Medical Device Amendments, or to commerce phor to may 20, 1978, inc the encordance with the provisions of the Federal Food, Drug, devices that have been require approval of a premarket approval application (PMA). and Cosmotion (110. (110.) that the device, subject to the general controls provisions of the Act. The I ou may, therefore, mains of the Act include requirements for annual registration, listing of general controls provision 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 If your device is olassinod (000 as 870) cls. Existing major regulations affecting your device can may be subject to suen additional com. Citie 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 -- Mr. Michael A. Daniel

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualice of a subsidiation of the requirements of the Act
that FDA has made a determination that your device of a complies. You must that FDA has made a decidination administered by other Federal agencies. You must of any rederal statutes and regulations continues but not limited to: registration and listing (21
comply with all the Act's requirements, including, but not limited to set comply with all the Act s requirements, monality, career and security of can't settle CFR Part 807), labeling (21 CFR Part 800), good if applicable, the electronic forth in the quality systems (QD) regulations (Sections 531-542 of the Act); 21 CFR 1000-1050.
Product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000 product radiation control provisions (Doctors of C vice as described in your Section 510(k)
This letter will allow you to begin marketing your device of world from douice to I his letter will anow you to oegin manketing your antial equivalence of your device to a legally premarket notification. THE PDA mumg of succeantal request 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 If you desire specific advice for your device on one as note the regulation entitled, Comact the Office of Computise at (501) stiffication" (21CFR Part 807.97). You may obtain " Misbranding by reference to premantee to tilteast on the Act from the Division of Small other general information on your responses.com its toll-free number [phone] or
Manufacturers, International and Consumer Assistance at its to the comming them Manufacturers, Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Dina R. Vochner

GA 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): K040771

Device Name: Outback® Catheter

Indications For Use:

The Outback® Catheter is intended to facilitate placement and positioning of The Outback "Outhers within the peripheral vasculature. The Outback Catheter is not intended for use in the coronary or cerebral vasculature.

Prescription Use_ × (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)

Daring R-bechner
Sign-off

**Cardiovascular**

10(k) number K040771