LUMEND PERCUTANEOUS CATHETER

K011562 · Lumend, Inc. · DQY · Jan 16, 2002 · Cardiovascular

Device Facts

• Record ID: K011562
• Device Name: LUMEND PERCUTANEOUS CATHETER
• Applicant: Lumend, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Jan 16, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The LuMend Percutaneous Catheter is intended to be used in conjunction with a steerable guide wire in order to access discrete regions of the coronary vasculature. It may be used to facilitate placement of guide wires and other interventional devices.

Device Story

Sterile, single-use percutaneous coronary catheter; consists of guide wire lead, handle assembly, proximal/distal shaft, and variably curved distal tip. Used in conjunction with steerable guide wire to navigate coronary vasculature; facilitates placement of guide wires and interventional devices. Operated by physicians in clinical settings. Provides support and guidance for interventional procedures; allows exchange of devices such as balloon dilatation catheters. Benefits patient by enabling access to discrete vascular regions for subsequent therapeutic intervention.

Clinical Evidence

Bench testing only. Evaluation included testing for tensile strength, torqueability, tip flexibility, and coating adherence/integrity in accordance with FDA's 'Guidewire Guidance' (January 1995). Data confirmed performance within internal specifications and predicate expectations.

Technological Characteristics

Sterile, single-use percutaneous coronary catheter. Features steerable guide wire compatibility, variable distal tip curvature, and handle assembly. Materials and construction are similar to predicate guiding catheters. No electronic components or software.

Indications for Use

Indicated for use in the coronary vasculature to facilitate the placement of steerable guide wires and other interventional devices.

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

• ILTTM 0.014" Catheter (K001992)
• Medtronic Zuma™ Guiding Catheters (K000677)
• Guidant Viking Optima™ Guiding Catheter (K001435)

Submission Summary (Full Text)

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# JAN 1 6 2002

## 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. KU11562

> TBD 510(k) Number:

### Applicant Information:

May 18, 2000 Date Prepared:

| Name: | LuMend, Inc. |
|----------|----------------------------------------------------------------|
| Address: | 400 Chesapeake Drive<br>Redwood City, CA 94063<br>650-364-1400 |

| Contact Person: | Michael A. Daniel |
|-------------------|-------------------|
| Phone Number: | [phone] |
| Facsimile Number: | [phone] |

#### Device Information:

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

### Predicate Devices:

The LuMend Percutaneous Catheter is substantially equivalent in intended use and/or method of operation design and materials to a combination of the following predicate devices:

- ILTTM 0.014" Catheter (K001992), 1.
- Medtronic Zuma™ Guiding Catheters (K000677) and 2.
- Guidant Viking Optima™ Guiding Catheter (K001435) 3.

### Device Description:

The LuMend Percutaneous Catheter is a sterile single-use percutaneous coronary catheter consisting of a guide wire lead and handle assembly, proximal and distal shaft and variably curved distal tip. Guidance and tracking of the catheter through the coronary vasculature is accomplished in conjunction with a steerable guide wire.

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## (Continued)

## Intended Use:

The LuMend Percutaneous Catheter is intended to be used in conjunction with a steerable guide I he Lunelia Perculancous Catholor is interest to see a very vasculature. It may be used to facilitate placement of guide wires and other interventional devices.

# Comparison to Predicate Device(s):

The LuMend Percutaneous Catheter is substantially equivalent to a combination of the ILTTM
Collection of Cathere is not The The Catalian Catheters (K000677) and the The Luvicin's Cromanoous Cat.Mediconic Zuma™ Guiding Catheters (K000677) and the Guidant Viking Optima™ Guiding Catheter (K001435).

The LuMend Percutaneous Catheter is essentially identical to the ILTM 0.014" Catheter (K001992), in terms of intended use. Both devices are primarily intended to be used in (KU01392), in tenns of intended ass. "Dot access discreet regions of the vasculature prior confidition with a steeraore gates wire in other as been navigated and any lession to angloplasty and stemmy. "In oour cases only be exchanged and a balloon dilatation catheter may be immediately introduced.

The LuMend Percutaneous Catheter is similar in terms of shape, size, materials and construction The Luvicha i croutuneous Calleters used to provide guide wire and other catheter support and to common coronal y satiletels about is point the Medtronic Zuma™ Guiding Catheters guidance. Examples of the Guiding Catheter (K001435) in terms of size ranges, design, materials used, form and function.

# In Vitro, In Situ and In Vivo Test Data:

Design analysis and in vitro data confirm that basic functional characteristics are substantially Dosign and in the predicate devices cited. Device evaluation consisted of testing specified in equivalent to the production Guidewire Guidance" Document – January 1995 and I'DA 3 Coronal J and Cercer strength, torqueability, tip flexibility, coating adherence/integrity, Included in viro tensity, corque bacagaility. All data fell well within, both, internal specification blocompanisms, as well as external standard requirements and predicate performance expectations.

## Summary:

Based upon the product technical information, intended use, and performance information Dason apon this pre-market notification, the LuMend Percutaneous Catheter has been shown to be substantially equivalent to currently marketed predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 6 2002

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

K011562 Re:

> LeMend Percuataneous Catheter Regulation Number: 870.1250 Regulation Name: Percutaneous catheter. Regulatory Class: Class II Product Code: DQY Dated: October 18, 2001 Received: October 18, 2001

Dear Mr. Daniel:

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.

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 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 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 forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Michael A. Daniel

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter with and in you to ough finding of substantial equivalence of your device to a legally prematics notification. "The Pressification 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 and If you desire specific ad 1.0 for in vitro diagnostic devices), please contact the Office of additionally 21 OF CF C F C F . F ar - 586. Additionally, for questions on the promotion and advertising of Compliance at [phone]. Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrh/dsma/dsmamain.html

Sincerely yours,

Ans. Daniel Miller, M.D.

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

Enclosure

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#### 4802 K011562 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

LuMend Percutaneous Catheter Device Name:

Indications For Use:

The LuMend Percutaneous Catheter is intended to be used in conjunction with a steerable The Luvielia Ferculancous Cathecer is antone of the coronary vasculature. It may be used guide wire in order to access assires and other interventional devices.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Oak Th

Division of Cardiovascular & Respiratory Devicze
510(k) Number K011362

ﺳ Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)