LUMEND FRONTRUNNER CTO CATHETER AND ACCESSORIES

K033535 · Lumend, Inc. · PDU · Jan 7, 2004 · Cardiovascular

Device Facts

• Record ID: K033535
• Device Name: LUMEND FRONTRUNNER CTO CATHETER AND ACCESSORIES
• Applicant: Lumend, Inc.
• Product Code: PDU · Cardiovascular
• Decision Date: Jan 7, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The LuMend Frontrunner® CTO Catheter and Accessories are intended to facilitate the intraluminal placement of conventional guide wires beyond stenotic lesions (including chronic total occlusions) in the peripheral and coronary vasculature prior to further percutaneous intervention.

Device Story

Sterile, single-use percutaneous catheter; used in coronary/peripheral vasculature. Features handle assembly with rotator, side port for flushing, proximal braided shaft for push/torque control, and flexible distal shaft with bilateral hinged tip pieces. Operator (physician) manually shapes distal shaft and uses handle lever to adjust tip size; handle rotator provides rotational control. Device facilitates 'blunt micro-dissection' to navigate through stenotic lesions. Output is the successful placement of a guide wire beyond the lesion, enabling subsequent percutaneous intervention. Benefits patient by allowing access through chronic total occlusions that might otherwise be impassable.

Clinical Evidence

Bench testing only. Evaluation included in vitro tensile, torque strength, torqueability, tip flexibility, coating adherence/integrity, biocompatibility, and catheter compatibility tests per FDA's Coronary and Cerebrovascular Guidewire Guidance Document (January 1995). All data met internal and external standard requirements.

Technological Characteristics

Percutaneous catheter; features handle assembly with rotator, proximal braided shaft, and distal shaft with bilateral hinged tip pieces. Radiopaque blunt-shaped distal tip. Manual operation for tip size adjustment and rotational control. Biocompatible materials. Sterilized for single use.

Indications for Use

Indicated for patients with stenotic lesions, including chronic total occlusions (CTOs), in the peripheral and coronary vasculature requiring intraluminal placement of conventional guide wires prior to further percutaneous intervention.

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 Frontrunner® CTO Catheter (K031005)

Submission Summary (Full Text)

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# 2. 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: | November 7, 2003 |
|-------------------|------------------------------------------|
| Name: | LuMend, Inc. |
| Address: | 400 Chesapeake Drive |
| | Redwood City, CA 94063 |
| | 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 Percutaneous Catheter |
|----------------------|--------------------------------------------------|
| Trade Name: | LuMend Frontrunner® CTO Catheter and Accessories |
| Common Name: | Percutaneous Catheter |
| Classification Name: | Percutaneous Catheter, 74 DQY / 21 CFR 870.1250 |

# Predicate Devices:

The LuMend Frontrunner® CTO Catheter and Accessories is substantially equivalent in intended use and method of operation to the following predicate device:

LuMend Frontrunner® CTO Catheter K031005

# Device Description:

The LuMend Frontrunner® CTO Catheter is a sterile single-use percutaneous catheter consisting of a handle assembly with an integral rotator und a side port for internal device flushing, a proximal braided shaft for push and torque control, a flexible distal shaft which may be manually shaped, an optional guide wire lumen and a radiopaque blunt-shaped distal variable-size tip assembly in various shapes and sizes. A handle lever provides manual adjustment of the size of the tip assembly, and the handle rotator provides rotational control for the shaft and distal tip assembly. The distal assembly consists of a set of bilateral hinged tip pieces. Guidance and

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tracking of the catheter through the coronary or peripheral vasculature is accomplished by selective manual shaping of the flexible distal shaft, and controlled torquing of the handle rotator and/or the use of a guide wire.

1033535

#### Intended Usc:

The LuMend Frontrunner® CTO Catheter and Accessories are intended to facilitate the intraluminal placement of conventional guide wires beyond stenotic lesions (including chronic total occlusions) in the peripheral and coronary vasculature prior to further percutaneous intervention.

### Comparison to Predicate Device(s):

The LuMend Frontrunner® CTO Catheter and Accessories are substantially equivalent to the previously cleared LuMend Frontrunner® CTO Catheter in terms of embodiment, shape, appearance and function. It has the same indications for use and makes use of the identical mechanism of action: "blunt micro-dissection" to facilitate placement of a guide wire across stenotic vascular lesions including Chronic Total Occlusions (C'l'Os).

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

Design analysis, in virro and in vivo data confirm that basic functional characteristics are substantially equivalent to the predicate device cited. Routine device evaluation consists of testing specified in FDA's Coronary and Cerebrovascular Guidewire Guidance Dovument (January 1995) and inoluded in vitro tensile, torque strength, torqueability, tip flexibility, coating adherence/integrity, biocompatibility and catheter compatibility tests. All data continued to fall well within internal specification requirements, as well as external standard requirements and predicate performance expectations.

#### Summarv:

Based upon the product technical information, intended use, performance and biocompatibility information provided in this pre-market notification, the LuMend Frontrunner® CTO Catheter has been shown to be substantially equivalent to a currently marketed predicate device.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

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

SEP 1 8 2013

Re: K033535

Trade/Device Name: LuMend Frontrunner CTO Catheter and Accessories Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: PDU, DQY Dated: December 10, 2003 Received: December 11, 2003

Dear Mr. Daniel:

This letter corrects our substantially equivalent letter of January 7, 2004.

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical

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device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act 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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Z.n.Z.

Image /page/3/Picture/8 description: The image contains a handwritten word, "for", in cursive script. The letters are connected, with the "f" having a loop extending above the main body of the letter and a stroke extending below the line. The "o" and "r" are joined together, forming a continuous shape. The writing appears to be done with a pen or marker, and the lines are smooth and flowing.

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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# 4. INDICATIONS FOR USE FORM

.

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

LuMend Frontrunner® CTO Catheter and Accessories Device Name:

Indications For Use:

The LuMend Frontrunner® CTO Catheter and Accessories are intended to facilitate the intraluminal placement of conventional guide wires beyond stenotic lesions (including chronic total occlusions) in the peripheral and coronary vasculature prior to further percutaneous intervention.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Stealte

Division Shipment)
Division of Cardiovascular Devices

510(K) Number K03352 (SM. IQ

Prescription Use (Per 21 CFR 801.109)

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Over-The-Counter Use

(Optional Format 1-2-96)