FUNNEL GUIDE CATHETER MODEL G1020608

K102439 · Lazarus Effect, Inc. · DQY · Jan 12, 2012 · Cardiovascular

Device Facts

• Record ID: K102439
• Device Name: FUNNEL GUIDE CATHETER MODEL G1020608
• Applicant: Lazarus Effect, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Jan 12, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The Funnel Guide Catheter™ is indicated for use in the peripheral and coronary vasculature for the introduction of interventional and/or diagnostic devices.

Device Story

Funnel Guide Catheter is a single-lumen, variable-stiffness catheter featuring an atraumatic nitinol wire-braided funnel distal tip. Designed to facilitate passage of interventional/diagnostic devices into peripheral and coronary vasculature. Operated by clinicians in interventional radiological settings. Device provides a conduit for secondary devices; compatible with 6F or greater introducer sheaths/guide catheters. Performance relies on mechanical navigation through vasculature; fluoroscopic visibility aids placement. Benefits include improved device delivery and navigation during interventional procedures.

Clinical Evidence

No human clinical data. Evidence consists of bench testing (dimensional, kink resistance, torque, navigation/insertion force, burst pressure, etc.), biocompatibility testing (cytotoxicity, sensitization, reactivity, pyrogen, systemic toxicity, hemolysis, thromboresistance, complement activation), and in vivo porcine model testing (histology and fluoroscopic visibility).

Technological Characteristics

Single-lumen catheter; variable stiffness shaft; nitinol wire-braided funnel distal tip. Materials: PTFE, stainless steel, platinum, Pebax, nitinol. Dimensions: 6 French OD, 102cm length. Compatible with 0.035in/0.038in guidewires. Non-powered, mechanical device.

Indications for Use

Indicated for use in peripheral and coronary vasculature for introduction of interventional and/or diagnostic devices in patients requiring such procedures.

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

• Neuron Intracranial Access System (Penumbra, Inc.)
• Envoy Guiding Catheter (Cordis Corporation)

Submission Summary (Full Text)

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# JAN 1 2 2012

#### 5. 510(K) SUMMARY

| Date Prepared: | August 25, 2010 | |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------|--|
| Trade Name: | Funnel Guide Catheter™ | |
| Common Name: | Percutaneous Catheter | |
| Classification: | Class II, 21 CFR 870.1250, Product Code DQY | |
| Applicant: | Lazarus Effect, Inc.<br>560 Division Street<br>Campbell, CA 95008<br>USA<br>Telephone: [phone]<br>Fax: [phone] | |
| Contact Person: | Carrie Neuberger<br>Vice-President, Regulatory and Clinical Affairs<br>and Quality Assurance | |
| Predicate Devices: | Neuron Intracranial Access System, manufactured<br>by Penumbra, Inc.<br><br>Envoy Guiding Catheter, manufactured by Cordis<br>Corporation | |

#### Device Description:

The Lazarus Effect Funnel Guide Catheter" (Funnel Guide Catheter") is a single-lumen, variable-stiffness catheter with an atraumatic nitinol wire braided funnel distal tip to facilitate the passage of other interventional and/or diagnostic devices. Device dimensions and configuration are shown on the product label. The Funnel Guide Catheter" is compatible with introducer sheaths and guide catheters having an inner diameter of 6F or greater. A rotating hemostasis valve with side-arm adapter and a compatible guidewire may be used, but are not provided with the Funnel Guide Catheter™.

### Intended Use:

The Funnel Guide Catheter™ is indicated for use in the peripheral and coronary vasculature for the introduction of interventional and/or diagnostic devices. The indicated use is substantially equivalent to that of the legally marketed predicate devices.

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## Technological Characteristics of the Device Compared to the Predicate Devices:

The Funnel Guide Catheter" is intended for use in interventional radiological procedures. It is substantially equivalent to other interventional radiological devices currently on the market. The Funnel Guide Catheter" is substantially equivalent to the identified predicate devices with regard to device design, materials, patient population and anatomical site. The intended use for the Funnel Guide Catheter has been revised and is a subset of the intended use for the predicate devices. This change, and any differences due to the technological characteristics of the Funnel Guide Catheter" compared to its predicate devices do not raise new issues of safety or effectiveness.

| Device | Lazarus Effect Funnel<br>Guide CatheterTM<br>(Subject Device) | Penumbra Inc.,<br>Neuron Intracranial<br>Access System | Cordis Endovascular<br>Systems ENVOY<br>Guiding Catheter |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Funnel Guide<br>CatheterTM is indicated<br>for use in the peripheral<br>and coronary<br>vasculature for the<br>introduction of<br>interventional and/or<br>diagnostic devices. | The Neuron<br>Intracranial Access<br>System is indicated for<br>the introduction of<br>interventional devices<br>into the peripheral,<br>coronary, and neuro<br>vasculature. | The Envoy Guiding<br>Catheter is intended for<br>use in the peripheral,<br>coronary, and<br>neurovasculature for<br>the introduction of<br>interventional /<br>diagnostic devices. |
| Design: | | | |
| Outer Diameter<br>(OD) | 6 French | 6 French | 6 French |
| Inside Diameter<br>(ID) | 0.062in | 0.070in and 0.053in | 0.070in |
| Working Length | 102cm | 95-115cm | 90-100cm |
| Catheter shaft | Transition in stiffness<br>from hub to tip | Transition in stiffness<br>from hub to tip | Transition in stiffness<br>from hub to tip |
| Wire Compatibility | 0.035in/.038in | 0.035in/.038in | 0.035in/.038in |
| Materials | Predominantly PTFE,<br>Stainless Steel,<br>platinum, Pebax, Nitinol | Stainless Steel,<br>platinum, hydrophilic<br>coating | Predominantly PTFE,<br>Stainless Steel,<br>Nylon/polyurethane |

#### Materials in the predicate devices are not known with certainty. Material Note: equivalence is demonstrated by performance tests and biocompatibility tests.

### Summary of Studies:

Bench testing, biocompatibility testing and in vivo testing in the animal model were performed on the device materials and on finished devices. These tests included:

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#### Bench Testing:

- Dimensional measurement .
- Visual examination .
- . Fluoroscopic evaluation
- Kink resistance ●
- Simulated use
- . Torque transmission
- . Repeated use
- Navigation and insertion force
- . Air and fluid leak
- . Corrosion resistance
- . Tensile testing (force at break)
- . Fluid flow rate
- Burst pressure ●
- Product and packaging stability (shelf-life) .
- Packaging integrity (seal strength and puncture resistance) .

### Biocompatibility Testing:

- Cytotoxicity .
- . Sensitization assay
- Intracutaneous reactivity .
- . Pyrogen
- Systemic toxicity .
- . Hemolysis
- Thromboresistance .
- Complement Activation ●
- Sterilization .

### In-vivo Testing:

- Simulated use porcine model (including histology and fluoroscopic visibility) .
The results of the performance, biocompatibility, and in-vivo tests verified that the Funnel Guide Catheter™ performs as designed and is suitable for its intended use.

### Conclusion:

The data contained in this submission demonstrate that the Lazarus Effect Funnel Guide Catheter" is substantially equivalent to the identified predicate devices in regards to device design, materials, patient population, anatomical site, and intended use :

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

JAN 1 2 2012

Lazarus Effect, Inc. c/o Ms. Carrie Neuberger Vice President, Regulatory and Clinical Affairs and Quality Assurance 560 Division Street Campbell, CA 95008

Re: K102439

Trade/Device Name: Funnel Guide Catheter™ Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DOY Dated: November 29, 2011 Received: November 30, 2011

Dear Ms. Neuberger:

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 misoranding and adulteration.

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 of 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

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Page 2 - Ms. Carrie Neuberger

(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/Resourcesfor You/Industry/default.htm.

Sincerely yours, .

M.A. Killebrew

Gram 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 STATEMENT 4.

510(K) Number (if known): K102439

Device Name: Lazarus Effect - Funnel Guide Catheter™

Indications for Use:

The Funnel Guide Catheter" is indicated for use in the peripheral and coronary vasculature for the introduction of interventional and/or diagnostic devices.

AND/OR

Prescription Use _____________________________________________________________________________________________________________________________________________________________

Over-the-Counter Use

(21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

M. A. Hillhouse

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_K102439