BAXTER DUPLOSPRAY MIS APPLICATOR

K061092 · Micromedics, Inc. · FMF · Sep 13, 2006 · General Hospital

Device Facts

• Record ID: K061092
• Device Name: BAXTER DUPLOSPRAY MIS APPLICATOR
• Applicant: Micromedics, Inc.
• Product Code: FMF · General Hospital
• Decision Date: Sep 13, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This device is for the application of Tisseel® Fibrin Sealant.

Device Story

Baxter DuploSpray MIS Applicator is a manual delivery system designed for the application of Tisseel® Fibrin Sealant during minimally invasive surgery. The device functions as a piston syringe mechanism to deliver the sealant components to the surgical site. It is intended for use by surgeons in an operating room environment. The device facilitates precise application of the fibrin sealant, aiding in hemostasis and tissue sealing, which can improve surgical outcomes and reduce bleeding complications.

Clinical Evidence

Bench testing only.

Technological Characteristics

Manual piston syringe applicator system. Designed for delivery of Tisseel® Fibrin Sealant. Non-powered, mechanical device.

Indications for Use

Indicated for the application of Tisseel® Fibrin Sealant in patients requiring surgical hemostasis or tissue sealing. 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

• K961421

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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## SEP 1 3 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Thomas Lopac Manager of Quality Assurance and Regulatory Affairs Micromedics, Incorporated 1270 Eagan Industrial Road, Suite #120 St. Paul, Minnesota 55121-1385

Re: K061092

Trade/Device Name: Baxter DuploSpray MIS Applicator Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: August 9, 2006 Received: August 10, 2006

Dear Mr. Lopac:

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 (1 will) it has 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.

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## Page 2 - Mr. Lopac

Please be advised that FDA's issuance of a substantial equivalence determination does not I loase oe act rised that 122 retermination that your device complies with other requirements modi that I Dr I has made statutes and regulations administered by other Federal agencies. or the Act of any 1 ederal base as a requirements, including, but not limited to: registration r ou listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and ifsing (21 ce read of the quality systems (QS) regulation (21 CFR Part 820); and if requirements as bettronic 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) Fins feter wifification. The FDA finding of substantial equivalence of your device to a premarket notified bevice 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), r you dontact the Office of Compliance 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 vours.

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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## STATEMENT OF INDICATIONS FOR USE

K061092 510(k) Number (if known):

Device Name: Baxter DuploSpray MIS Applicator

Indications for Use:

This device is for the application of Tisseel® Fibrin Sealant.

X OR Prescription Use: (Per 21 CFT 801.109)

Over-The-Counter

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Auten D. W.

11 3:50-Off) on of Anesthesiology, General Hospital, :on Control, Dental Devices

Number: K96/42