MODIFICATION TO OUTBACK CATHETER

K043534 · Lumend, Inc. · DQY · Jan 21, 2005 · Cardiovascular

Device Facts

• Record ID: K043534
• Device Name: MODIFICATION TO OUTBACK CATHETER
• Applicant: Lumend, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Jan 21, 2005
• 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 guide wires / 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 device for peripheral vascular procedures. Components include guide tip, deployment shaft, catheter shaft, and deployment handle with control knob. Operation: proximal retraction of guide via control knob positions curved tip coaxially within nosecone for tracking over guidewire to vascular site; guidewire retraction allows curved tip advancement from nosecone end port. Radiopaque nosecone and guide tip facilitate fluoroscopic-guided placement. Once positioned, guidewire is advanced through guide to target location; guide tip is retracted into nosecone, and catheter is removed, leaving guidewire in place. Used by physicians in clinical settings to assist in complex vascular access; improves precision of guidewire placement in peripheral vessels.

Clinical Evidence

Bench testing only.

Technological Characteristics

Sterile, single-use percutaneous catheter. Components: guide tip, deployment shaft, catheter shaft, deployment handle with control knob. Features radiopaque nosecone and guide tip for fluoroscopic visualization. Materials include additional options compared to predicate. No electronic components or software.

Indications for Use

Indicated for facilitating placement and positioning of guide wires 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 (K040771)
• 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 k043534 |
|----------------|-------------|
|----------------|-------------|

#### Applicant Information:

- Date Prepared: December 20, 2004
Name: LuMend, Inc. Address: 400 Chesapeake Drive Redwood, CA. 94063 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) K040771 on 4/23/04 and K032298 on 8/26/03

#### 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 ip is positioned coaxially within the nosecone. In this configuration the catherer may be tracked over a guide wire to the sclected 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.

LuMend, Inc. Outback Catheter 510(k) Submission. December 20, 2004

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Upon proper placement of the guide tip, the guide wire may be advanced through the guide and 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 guide wires / 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) K0407771. 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/2 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around the perimeter. In the center of the circle is a stylized image of an eagle or bird-like figure, with its wings spread and head turned to the side.

JAN 2 1 2005

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: K043534

Trade Name: Outback® Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: DQY Dated: December 20, 2004 Received: December 22, 2004

Dear Mr. Daniel:

We have reviewed your Section 510(k) premarket notification of intent to market the device to We have reviewed your Section 910(x) premantee nearly equivalent (for the indications referenced above and nave uctchined the acresed predicate devices marketed in interstate for use stated in the encrosure) to regary manatism of the Medical Device Amendments, or to commerce prior to May 28, 1776, the enactified in accordance with the Federal Food. Drug.
devices that have been reclassified in accordance with the provisions of the United devices that have been recured in accordance while approval approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval or of the and Cosment Act (Act) that do not require appro the seneral controls provisions of the Act. The You may, therefore, market the devreet, books requirements for annual registration, listing of general controls provisions of the 110 labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), in If your device is classified (Sec above) into ettier on a or regulations affecting your device can be may be subject to such additional controls. Extrong may on 898. In addition, FDA may be found in the Oous acements 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 3 issualled of a babevice complies with other requirements of the Act that FDA has made a determination that your stered by other Federal agencies. You must of any rederal statutes and regalations and admited to: registration and listing (21 comply with an the Act 3 requirements, moraling, were and acturing practice requirements as set a CFK Part 807), adomig (21 CFR Part 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, 1050 forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (sveting your device as described in your Section 510(k) This letter with anow you to begin maxical equivalence of your device to a legally premaired notineadon. The PDF mailing sification for your device 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 davice 10. Jour as 1) 594-4646. Also, please note the regulation entitled, connact the Office of Comphanes as (set notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Diana R. Vachner

Image /page/3/Picture/5 description: The image contains a handwritten symbol or character. It appears to be a stylized or cursive form, possibly resembling a combination of letters or a unique design. The character is drawn with curved lines and has a flowing, interconnected structure.

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): K043534

Qutback® Catheter Device Name:

## Indications For Use:

The Outback® Catheter is intended to facilitate placement and positioning of guide wires/ The Outback "Catherer is Inchieva to laciniano provinces "Catheter is not intended for use in the coronary or cerebral vasculature.

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)

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)

Dma D. bachner

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number_K04 3534

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