EASYSPRAY AND SPRAY SET FOR TISSEEL (FIBER SEALANT)

K050495 · Baxter Healthcare Corp., Bioscience · FMF · May 2, 2005 · General Hospital

Device Facts

• Record ID: K050495
• Device Name: EASYSPRAY AND SPRAY SET FOR TISSEEL (FIBER SEALANT)
• Applicant: Baxter Healthcare Corp., Bioscience
• Product Code: FMF · General Hospital
• Decision Date: May 2, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The EasySpray and Spray Set are intended for use in the simultaneous application of TISSEEL Two-Component Fibrin Sealant using the DUPLOJECT System

Device Story

EasySpray and Spray Set are accessories for the DUPLOJECT system used to apply TISSEEL Two-Component Fibrin Sealant. The system functions as a pneumatic delivery mechanism for the sealant. The device features a clip that attaches to the back end of the DUPLOJECT, which serves as the gas on/off control, replacing the foot pedal mechanism found in the predicate TISSOMAT system. The device is operated by a clinician to facilitate the simultaneous application of the sealant components. It does not alter the fundamental scientific technology of the sealant application process.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Piston syringe accessory; pneumatic gas flow control system; clip-on interface for DUPLOJECT; manual operation; non-electronic; non-software.

Indications for Use

Indicated for the simultaneous application of TISSEEL Two-Component Fibrin Sealant using the DUPLOJECT System. Prescription use only.

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

• TISSOMAT and Spray Set (K981089)

Submission Summary (Full Text)

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510(k) # K050495

## 510(k) SUMMARY EasySpray and Spray Set for TISSEEL (Fibrin Sealant)

| Date Prepared | February 25, 2005 |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter | Baxter Healthcare<br>Baxter BioScience<br>One Baxter Way<br>Westlake Village, CA 91362 |
| Contact | Ron Lagerquist<br>Senior Manager, Regulatory Affairs |
| Device Name | Piston Syringe Accessories |
| Common/Usual/<br>Classification Name | Piston Syringe Accessories<br>80 FMF |
| Device Description | The EasySpray and Spray Set system represents minor design modifications to the TISSOMAT and Spray Set, 510(k) K981089. The purpose of the design modifications is to accommodate a change in the location of the gas on/off function of the system. The original TISSOMAT and Spray Set design includes a foot pedal to turn the gas flow on and off. The EasySpray and Spray Set system moves the control from a foot pedal, to a clip that attaches to the back end of the DUPLOJECT. |
| Intended Use | The EasySpray and Spray Set are intended for use in the simultaneous application of TISSEEL Two-Component Fibrin Sealant using the DUPLOJECT System |
| Predicate Device | TISSOMAT and Spray Set K981089 |
| Substantial Equivalence | The EasySpray and Spray Set represent minor design modifications to the TISSOMAT and Spray Set. The design modifications do not affect the intended use of the device or alter the fundamental scientific technology of the system. In addition, there have been no changes to TISSEEL Fibrin Sealant as a result of the device modifications described in this Pre-Market Notification. |

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Image /page/1/Picture/1 description: The image is a circular seal or logo. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the seal is a stylized image of an eagle or bird-like figure with three distinct wing or feather segments.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 2 2005

Mr. Ronald F. Lagerquist, RAC Senior Manager, Regulatory Affairs Baxter Healthcare Corporation One Baxter Way Westlake Village, California 91362-3811

Re: K050495

Trade/Device Name: EasySpray and Spray Set Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: February 25, 2005 Received: April 6, 2005

Dear Mr. Lagerquist:

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 received a or 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 the Fouch a plication (PMA). You may, therefore, market the device, subject to the general approvisions 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 (1 writ), it hay ob of Federal Regulations, Title 21, Parts 800 to 898. In your device A may publish further announcements concerning your device in the Federal Register.

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## Page 2 - Mr. Lagerquist

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advisod that 1 DT 3 lestained on that your device complies with other requirements modi that I Drima made statutes and regulations administered by other Federal agencies. of the Act of ally I ederal statuse and squirements, including, but not limited to: registration r ou must comply war a 807); labeling (21 CFR Part 801); good manufacturing practice allo listing (21 CF RT art 007), labality systems (QS) regulation (21 CFR Part 820); and if requirements as set form in the quality ijon 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) This letter will and in Jourse FDA finding of substantial equivalence of your device to a premarket notification. - The PDF minuts 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), II you desire specificatives for your de at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may overn 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,

Quetic f. Michael Dmd.

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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K050495
page 1 of 1

Indications for Use

171 510(k) Number (if known):

Device Name: EasySpray and Spray Set

Indications for Use:

The EasySpray and Spray Set are intended for use in the simultaneous application of TISSEEL Two-Component Fibrin Sealant using the DUPLOJECT System.

X Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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## Concurrence of CDRH, Office of Device Evaluation (ODE)

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Susan Rummo

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10(k) Number