FIBERNET EMBOLIC PROTECTION SYSTEM

K082348 · Lumen Biomedical, Inc. · NTE · Nov 18, 2008 · Cardiovascular

Device Facts

• Record ID: K082348
• Device Name: FIBERNET EMBOLIC PROTECTION SYSTEM
• Applicant: Lumen Biomedical, Inc.
• Product Code: NTE · Cardiovascular
• Decision Date: Nov 18, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The FiberNet® Embolic Protection System is indicated for use as a guidewire and emboli protection system to capture and remove embolic material (thrombus/debris) produced while performing percutaneous transluminal interventional procedures in carotid arteries in high surgical risk patients with reference vessel diameters of 3.5 to 7.0mm.

Device Story

FiberNet Embolic Protection System functions as a guidewire and embolic capture device during carotid artery interventions. System comprises a fiber filter mounted on a 0.014" guidewire, an attachable actuator tool (capture wire), and a 0.014" guidewire-compatible aspiration catheter (Xtract). Accessories include syringes, introducer, actuation template, and cell strainer. Used by physicians in clinical settings during percutaneous procedures. The fiber filter captures embolic debris generated during stenting; the aspiration catheter facilitates removal of captured material. Benefits include reduction of embolic events during carotid procedures. Performance verified via bench and animal testing; clinical safety and efficacy supported by the EPIC Trial.

Clinical Evidence

EPIC Trial: non-randomized, multi-center study in high surgical risk patients undergoing carotid stenting. Primary endpoint: device safety and performance. Results showed FiberNet EPS met performance goals based on ARCHeR3 trial data. Serious adverse event frequency and type were comparable to other studies.

Technological Characteristics

System includes fiber filter on 0.014" guidewire, capture wire, and aspiration catheter. Accessories: 30 ml syringes, peel-away introducer, actuation template, 40µm cell strainer. Mechanical capture mechanism. Sterilization and biocompatibility verified per standard requirements.

Indications for Use

Indicated for high surgical risk patients undergoing percutaneous transluminal interventional procedures in carotid arteries (vessel diameters 3.5-7.0mm) to capture and remove embolic material.

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

• FilterWire EZ™ Embolic Protection System (K032884)
• SpideRX™ Embolic Protection System (K052659)
• Guardwire System (K072990)
• Xtract™ Aspiration Catheter (K071529)

Submission Summary (Full Text)

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K612348

NOV 1 8 2008

Lumen Biomedical, Inc.

14505 21* Avenue North, Suite 212 Plymouth, MN 55447
[phone] Business
[phone] Fax

| Contact Person: | Maria Brittle<br>Director Regulatory Affairs |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Summary Date: | August 14, 2008 |
| Product Trade Name: | FiberNet® Embolic Protection System |
| Common Name: | Embolic Protection Device |
| Classification Name: | Catheter, Percutaneous |
| Predicate(s): | K032884 FilterWire EZ™ Embolic Protection System<br>K052659 SpideRX™ Embolic Protection System<br>K072990 Guardwire System<br>K071529 Xtract™ Aspiration Catheter |
| Intended Use: | The FiberNet® Embolic Protection System is indicated for use as a<br>guidewire and emboli protection system to capture and remove embolic<br>material (thrombus/debris) produced while performing percutaneous<br>transluminal interventional procedures in carotid arteries in high surgical<br>risk patients with reference vessel diameters of 3.5 to 7.0mm. |
| Device Description: | The system consists of a fiber filter on a 0.014" guidewire with<br>attachable actuator tool (capture wire) and a 0.014" guidewire<br>compatible aspiration catheter with attachable stopcock assembly (Xtract<br>catheter, K071529). System accessories included in the package consist<br>of two 30 ml syringes, a peel-away introducer, an actuation template,<br>and a 40µm cell strainer cup. |
| Safety & Performance: | Non-Clinical: <i>In vitro</i> testing consisted of biocompatibility, sterilization,<br>packaging, and product shelf life, and performance testing on the bench<br>and in animals. Test results verified the device is adequate for its<br>intended use and is equivalent to the predicate devices.<br><br>Clinical: The EPIC Trial was a non-randomized multi-center study<br>assessing device safety and performance when used with commercially<br>available carotid stent systems in high surgical risk patients. Statistical<br>analysis confirmed the FiberNet EPS rate met the performance goal<br>based on ARCHeR3, demonstrating acceptable performance. Serious<br>adverse events were similar in frequency and type to other studies. |
| Conclusion: | The FiberNet Embolic Protection System is substantially equivalent to<br>the predicate embolic protection systems in technological characteristics<br>and performance |

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Public Health Service

Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 8 2008

Lumen Biomedical, Inc. c/o Maria E. Brittle, PhD, RAC Director, Regulatory Affairs 14505 21st Avenue North, Suite 212 Plymouth, MN 55447

Re: K082348

Trade/Device Name: FiberNet Embolic Protection System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NTE Dated: November 13, 2008 Received: November 14, 2008

Dear Dr. Brittle:

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);

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Page 2 - Dr. Maria E. Brittle

labeling (21 CFR Part 801); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.

Sincerely yours.

Donna R. Kirchner

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): K082348

FiberNet® Embolic Protection System · Device Name:

Indications for Use:

The FiberNet® Embolic Protection System is indicated for use as a guidewire and emboli protection system to capture and remove embolic material (thrombuseded is) produced while performing percutaneous transluminal interventional procedures in carotid arteries in high surgical risk patients with reference vessel diameters of 3.5 to 7.0 mm.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

vina D. balmer

(Division Sir ... - Off) Division on Cardiovascular Devices

510(k) Number_K082348

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