EVICEL APPLICATION DEVICE

K070575 · Omrix Biopharmaceuticals , Ltd. · FMF · May 29, 2007 · General Hospital

Device Facts

• Record ID: K070575
• Device Name: EVICEL APPLICATION DEVICE
• Applicant: Omrix Biopharmaceuticals , Ltd.
• Product Code: FMF · General Hospital
• Decision Date: May 29, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The EVICEL™ Application Device is intended for the simultaneous topical application of the two biological components of EVICEL™ fibrin sealant via dripping (no air Pressure) or via spraying (with air or CO2 pressure utilizing the pressure regulator unit) onto the surface.

Device Story

EVICEL™ Application Device facilitates simultaneous topical delivery of two-component fibrin sealant. System enables two application modes: dripping (gravity/manual) or spraying (using external air or CO2 pressure via integrated regulator unit). Device used in surgical settings by clinicians to apply sealant to tissue surfaces. Output is controlled, simultaneous delivery of biological components to aid in surgical site management. Benefits include precise, uniform application of fibrin sealant during procedures.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Piston syringe-based application system. Supports dual-component delivery via dripping or gas-assisted (air/CO2) spraying. Includes pressure regulator unit for spray functionality. Class II device (21 CFR 880.5860).

Indications for Use

Indicated for the simultaneous topical application of two-component fibrin sealant via dripping or spraying onto surgical surfaces.

Regulatory Classification

Identification

A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 9 2007

Dr. David Nakar Manager Regulatory Affairs Omrix Biopharmaceuticals, Limited MDA Blood Bank, Sheba Hospital 52621 Ramat Gan ISRAEL

Re: K070575

Trade/Device Name: EVICEL™ Application Device Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: February 26, 2007 Received: February 28, 2007

Dear Dr. Nakar:

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 Eederal Register.

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## Page 2 - Dr. Nakar

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 and insments 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 Scction 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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to promarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities undcr 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,

Cars

Chiu Lin. Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

## Enclosure

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K 070575

## INDICATIONS FOR USE STATEMENT

:

| 510(k) Number | K070575 |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | EVICEL ^TM Application Device |
| Indications for Use | The EVICEL ^TM Application Device is intended for the simultaneous topical application of the two biological components of EVICEL ^TM fibrin sealant via dripping (no air Pressure) or via spraying (with air or CO ₂ pressure utilizing the pressure regulator unit) onto the surface. |

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF
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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | OR Over-The-Counter Use__________ |
|-----------------------|-----------------------------------|
| (Per 21 CFR 801. 109) | |

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