DUPLOREACH

K014088 · Baxter Healthcare Corp · FMF · Jun 7, 2002 · General Hospital

Device Facts

• Record ID: K014088
• Device Name: DUPLOREACH
• Applicant: Baxter Healthcare Corp
• Product Code: FMF · General Hospital
• Decision Date: Jun 7, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The DUPLOREACH Extended Applicator, in conjunction with the DUPLOJECT Double-Barreled Syringe Applicator Device, is intended for the mixing and delivery of TISSEEL VH Fibrin Sealant.

Device Story

The DUPLOREACH Extended Applicator is a stainless steel encased dual-lumen cannula designed to attach to the DUPLOJECT Double-Barreled Syringe Applicator via screw-on luer connectors. It facilitates the delivery of TISSEEL VH Fibrin Sealant to hard-to-reach surgical sites. The device features a replaceable tip secured by a sliding lock mechanism, controlled by a trigger on the device body; a visual window confirms the tip is fully locked. Two replacement spray tips are included. The device is operated by clinicians to mix and apply fibrin sealant during procedures. It extends the dual-lumen cannula reach before the mixing chamber, allowing for precise application in confined anatomical spaces.

Clinical Evidence

Bench testing only. In vitro testing confirmed that the mixing performance of TISSEEL Fibrin Sealant using the DUPLOREACH Extended Applicator is equivalent to the predicate device.

Technological Characteristics

Stainless steel encased dual-lumen cannula; screw-on luer style connectors; sliding lock mechanism for replaceable tips; trigger-actuated locking system with visual indicator. Mechanical device; no energy source or software.

Indications for Use

Indicated for the mixing and delivery of TISSEEL VH Fibrin Sealant when used with the DUPLOJECT Double-Barreled Syringe Applicator. Intended for use in hard-to-reach locations.

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

• SEALOUETTE Fibrin Sealant Applicator (K992351)

Submission Summary (Full Text)

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K014088

| Date Prepared | 30 November 2001 |
|-----------------------------------|------------------------------------------------------------------------|
| 510(k) No. | |
| Submitter | Baxter Healthcare Corporation |
| | Baxter BioScience |
| | 550 North Brand Boulevard |
| | Glendale, CA 91203 |
| Contact | Arlene Vidor |
| | Vice President, Regulatory Affairs, North America |
| Device Name | DUPLOREACH Extended Applicator |
| Common/Usual/ Classification Name | Syringe, Piston |
| Predicate Device | SEALOUETTE Fibrin Sealant Applicator |
| | 510(k) No. K992351 |
| | Baxter Healthcare Corporation, Baxter BioScience |
| Device Description | The DUPLOREACH Extended Applicator, which consists of a |
| | stainless steel encased dual-lumen cannula that attaches to the |
| | DUPLOJECT Double-Barreled Syringe Applicator device via two |
| | screw-on leur style connectors, is used for the delivery of TISSEEL |
| | Fibrin Sealant in hard to reach locations. The Extended Applicator |
| | is equipped with a replaceable tip that is attached via a sliding lock |
| | mechanism, ensuring the tip does not detach during use. A trigger |
| | mechanism on the body of the device locks and unlocks the tip. |
| | A window above the trigger provides the user with a clear |
| | indication when the tip is in the fully locked position. Two |
| | replacement spray tips are supplied with each Extended Applicator |
| | device. |
| | The primary changes from the predicate device are the adaptations |
| | necessary to allow the DUPLOREACH Extended Applicator to be |
| | used with the DUPLOJECT applicator device and the extension of |
| | the dual-lumen cannula before the mixing chamber. Other minor |
| | modifications were made to either support these primary changes or |
| | to enhance the functionality of the device. No modifications were |
| | made to the DUPLOJECT device to accommodate the |
| | DUPLOREACH Extended Applicator. |
| | |
| | The modified device has been shown to be substantially equivalent |
| | to the predicate device through in vitro testing, in which the mixing |
| | of TISSEEL Fibrin Sealant was shown to be equivalent in both the |
| | cleared and modified devices. |
| | The DUPLOREACH Extended Applicator, in conjunction with the |
| Intended Use | DUPLOJECT Double-Barreled Syringe Applicator Device, is |
| | intended for the mixing and delivery of TISSEEL VH Fibrin |
| | Sealant. |

TISSEEL and DUPLOJECT are trademarks of Baxter AG, Vienna Austria.

BAXTER, DUPLOREACH and SEALOUETTE are trademarks of Baxter International, Inc.

BAXTER, DUPLOJECT and TISSEEL are registered in the US Patent and Trademark Office.

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular emblem with the department's name encircling an inner graphic. The graphic features a stylized representation of three human profiles facing right, stacked one behind the other, suggesting a sense of community and support.

7 2002 JUN

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Arlene Vidor Vice President. Regulatory Affairs Baxter Healthcare Corporation Baxter Bioscience Division 550 North Brand Boulevard Glendale. California 91203-1900

Re: K014088

Trade/Device Name: DUPLOREACH Extended Applicator Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: April 25, 2002 Received: April 26, 2002

Dear Ms. Vidor:

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

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## Page 2 — Ms. Vidor

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 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone] . Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Susan Runros

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE STATEMENT

| 510(k) Number | K014088 |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | DUPLOREACH Extended Applicator |
| Indications for Use | The DUPLOREACH Extended Applicator, in conjunction with<br>the DUPLOJECT Double-Barreled Syringe Applicator Device,<br>is intended for the mixing and delivery of TISSEEL VH Fibrin<br>Sealant. |

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)

OR

Over-the-Counter Use__________________________________________________________________________________________________________________________________________________________

Patricia Cuscenite

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices and General Hospital Beviegs
510(k) Number ___________________________________________________________________________________________________________________________________