EVICEL APPLICATION DEVICE

K130900 · Ethicon Inc (On Behalf of Omrix Biopharaceuticals · FMF · Aug 13, 2013 · General Hospital

Device Facts

• Record ID: K130900
• Device Name: EVICEL APPLICATION DEVICE
• Applicant: Ethicon Inc (On Behalf of Omrix Biopharaceuticals
• Product Code: FMF · General Hospital
• Decision Date: Aug 13, 2013
• 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 (CO2 pressure only, utilizing the pressure regulator unit) onto the surface.

Device Story

EVICEL Application Device is a sterile, single-use delivery system for EVICEL Fibrin Sealant. Device enables simultaneous application of two biological components; functions via dripping (no air pressure) or spraying (using CO2 pressure regulator). Accessory tips provided for clinical versatility. Used by clinicians in surgical settings to apply sealant to tissue surfaces. Device design, principle of operation, and technology are identical to the predicate; submission reflects updated indications and contraindications.

Clinical Evidence

Bench testing only; no clinical data provided. Equivalence established through design and technological comparison to the predicate device.

Technological Characteristics

Sterile, single-use mechanical application device. Includes accessory tips and a CO2 pressure regulator (Class I, exempt). Operates via manual dripping or gas-assisted spraying. No software or electronic components.

Indications for Use

Indicated for simultaneous topical application of two biological components of EVICEL Fibrin Sealant via dripping or spraying onto a surface.

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.

Predicate Devices

• EVICEL Application Device (K090162)

Submission Summary (Full Text)

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Applicant:

Classification:

Common Device Name:

Date:

Predicate Devices: EVICEL Application Device (K090162)

Piston Syringe

Class II, FMF

Manufacturer: Omrix biopharmaceuticals Ltd.

# Description of the Device Subject to Premarket Notification:

The EVICEL Application device is a sterile single used to apply the two biological components of the EVICEL® Fibrin Sealant (Human). Accessory tips are also provided separately to help provide the user different options for various clinical uses. The pressure regulator (Class I, Exempt) may also be provided as an accessory to help reduce the pressure of the gas obtained from a CO2 source to within the recommended range for use.

### Indications for Use:

The EVICELTM 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 (CO2 pressure only, utilizing the pressure regulator unit) onto the surface.

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# Summary of Technological Characteristics of New Device to Predicate Devices:

There are no changes to the principle of operation and fundamental scientific technology of the proposed device is equivalent to the predicate device; the device is exactly the same as the current EVICEL Application device. The only change to the new device is a modified Indications for Use Statement and an addition of a contraindication.

# Conclusion:

Since there are no changes to the device design, principles of operation and fundamental scientific technology, we conclude that the proposed device is substantially equivalent to the predicate device under the Federal Food, Drug, and Cosmetic Act.

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

August 13, 2013

Ethicon Incorporated on behalf of Omrix Biopharmaceuticals Limited Ms. Shikha Gola Manager, Regulatory Affairs Route 22 West SOMERVILLE NJ 08876

Re: K130900

Trade/Device Name: EVICEL™ Application Device Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: June 28, 2013 Received: July 1, 2013

Dear Ms. Gola:

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

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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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

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Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### 5 INDICATIONS FOR USE STATEMENT

510(k) No (if known): K13 0900

Device Name: EVICEL™ Application Device

#### Indications for 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 (CO2 pressure only, utilizing the pressure regulator unit) onto the surface.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ V (Part 21 CFR 801 Subpart D)

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AND/OR

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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Richard C. Chapman 2013.08.13 10:04:21 -04'00'

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K130900