COVIDIEN EXTENDED TIP APPLICATOR

K091315 · Confluent Surgical,Inc · FMF · Jun 5, 2009 · General Hospital

Device Facts

• Record ID: K091315
• Device Name: COVIDIEN EXTENDED TIP APPLICATOR
• Applicant: Confluent Surgical,Inc
• Product Code: FMF · General Hospital
• Decision Date: Jun 5, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5860
• Device Class: Class 2

Intended Use

The COVIDIEN Extended Tip Applicator is indicated for use in the simultaneous delivery of two non-homogenous solutions onto a surgical site.

Device Story

Single-use, disposable applicator; connects to two standard syringes via female luer fittings; features shaft with two separate, independent lumens to prevent premature mixing of non-homogenous solutions; shaft bendable up to 60 degrees for access to confined surgical spaces. Used by clinicians in surgical settings to deliver solutions simultaneously to a surgical site. Benefits include precise, simultaneous application of separate components while maintaining separation until delivery.

Clinical Evidence

No clinical data. Safety and effectiveness demonstrated via biocompatibility and performance bench testing.

Technological Characteristics

Single-use, disposable applicator; two female luer fittings; dual-lumen shaft; bendable up to 60 degrees. Materials are biocompatible. No electronic components or software.

Indications for Use

Indicated for the simultaneous delivery of two non-homogenous solutions onto a surgical site. No specific patient population, age, or gender restrictions provided.

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

• Confluent Surgical Extended Tip Applicator (K072790)

Submission Summary (Full Text)

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# JUN - 5 2009

## Section 5: 510(k) Summary

This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990. The contents of the 510(k) summary have been provided in conformance with 21 CFR §807.98.

| Date Prepared: | April 21, 2009 |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor | Covidien (formerly Confluent Surgical, Inc.)<br>101A First Avenue<br>Waltham, MA 02451 |
| Contact | Sean Reynolds<br>Phone: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] |
| Device Trade/Proprietary<br>Name | COVIDIEN Extended Tip Applicator |
| Classification Name | Piston Syringe (21 CFR 880.5860)<br>Class II<br>Product Code: FMF |
| Common Name | Extended Tip Applicator |
| Predicate Device(s) | Confluent Surgical Extended Tip Applicator - K072790 |
| DEVICE DESCRIPTION | |
| Product Description | The COVIDIEN Extended Tip Applicator is a single-use,<br>disposable applicator intended for the simultaneous delivery of two<br>non-homogenous solutions onto a surgical site. The COVIDIEN<br>Extended Tip Applicator provides two (2) female luer fittings for<br>connection to standard syringes containing two non-homogenous<br>solutions. The shaft of the Extended Tip Applicator maintains two<br>separate and independent lumens, which keep the two solutions<br>separate and prevent premature mixing. The Extended Tip<br>Applicator shaft is bendable up to 60 degrees to facilitate access to<br>confined spaces at the surgical site. |
| Indications for Use | The COVIDIEN Extended Tip Applicator is indicated for use in<br>the simultaneous delivery of two non-homogenous solutions onto a<br>surgical site. |
| Safety and Effectiveness | Safety and effectiveness of the Extended Tip Applicator have been<br>demonstrated in this submission. Biocompatibility testing assures<br>the device complies with applicable sections of industry and safety<br>standards. Performance testing ensures that the Extended Tip<br>Applicator meets all of its functional requirements and performs as<br>intended. |
| Conclusion | Performance data, identical indications for use and identical<br>operating principle demonstrate the Covidien Extended Tip<br>Applicator to be substantially equivalent to a predicate device<br>under the Federal Food, Drug and Cosmetic Act. |

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with outstretched wings.

Public Health Service

od and Drug Administration 200 Corporate Boulevard Rockville MD 20850

Mr. Sean Reynolds Senior Associate, Regulatory Affairs Confluent Surgical, Incorporated 101A First Avenue Waltham, Massachusetts 02451

JUN - 5 2009

Re: K091315

Trade/Device Name: Covidien Extended Tip Applicator Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: May 1, 2009 Received: May 4, 2009

Dear Mr. Reynolds:

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 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.

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### Page 2 - Mr. Reynolds

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/cdrh/comp/ 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/cdrh/mdr/ 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/cdrh/industry/support/index.html.

Sincerely yours,

Anthony D. m

Susan Runner, D.D.S., MA Acting Division 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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#### 125 Indications for Use Statement

K091316 510(k) Number (if known):

Device Name: Extended Tip Applicator

Indications for Use: The Extended Tip Applicator is indicated for use in the simultaneous delivery of two non-homogenous solutions onto a surgical site.

Prescription Use _ X AND/OR

Over-the -Counter Use

(21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

LCDR. Collum Second

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

KO91315 510(k) Number:

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