CONFLUENT SURGICAL DUAL LIQUID APPLICATOR, MODEL 70-2005-093

K061183 · Confluent Surgical,Inc · FMF · Jun 1, 2006 · General Hospital

Device Facts

• Record ID: K061183
• Device Name: CONFLUENT SURGICAL DUAL LIQUID APPLICATOR, MODEL 70-2005-093
• Applicant: Confluent Surgical,Inc
• Product Code: FMF · General Hospital
• Decision Date: Jun 1, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5860
• Device Class: Class 2

Intended Use

The Confluent Surgical Dual Liquid Applicator is indicated for use in the simultaneous delivery of two non-homogenous fluids or solutions onto a surgical site.

Device Story

The Confluent Surgical Dual Liquid Applicator is a manual delivery system used in surgical settings to simultaneously apply two separate fluids or solutions to a surgical site. The device consists of a Y-connector, a plunger cap, and one of three spray tips. The spray tips are constructed from polycarbonate with a polycarbonate or nylon orifice cup. The device functions as a piston syringe to facilitate the controlled, simultaneous delivery of the two fluids. It is intended for use by healthcare professionals during surgical procedures.

Clinical Evidence

Bench testing only.

Technological Characteristics

Manual piston syringe system. Components include a Y-connector, plunger cap, and spray tips. Materials: polycarbonate (spray tip, orifice cup) and nylon (orifice cup). No electronic components or software.

Indications for Use

Indicated for the simultaneous delivery of two non-homogenous fluids or solutions onto a surgical site.

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 Dual Liquid applicator (K042588)

Submission Summary (Full Text)

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K061183

## 510(k) Summary

JUN - 1 2006

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 14, 2006 | |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Sponsor | Confluent Surgical, Inc. | |
| | 101A First Avenue | |
| | Waltham, MA 02451 | |
| Contact | Eric Ankerud | |
| | [phone]<br>Phone: | |
| | [phone]<br>Fax: | |
| | E-mail: [e-mail] | |
| Device Trade/Proprietary Name | Confluent Surgical Dual Liquid Applicator | |
| Classification Name | Piston Syringe (21 CFR 880.5860) | |
| | Class II | |
| | Product Code: FMF | |
| | | |
| Common Name | Confluent Surgical Dual Liquid Applicator | |
| | | |
| Predicate Device(s) | Confluent Surgical Dual Liquid applicator (K042588) | |
| DEVICE DESCRIPTION | | |
| Product Description | The Confluent Surgical Dual Liquid Applicator will be | |
| | configured using the following components: | |
| | Y-Connector | |
| | Three Spray Tips; the Spray Tip consists of a | |
| | polycarbonate Spray Tip, and a polycarbonate or<br>nylon orifice cup. | |
| | Plunger Cap | |
| | | |
| Indications for Use | The Confluent Surgical Dual Liquid Applicator is indicated | |
| | for use in the simultaneous delivery of two non- | |
| | homogenous fluids or solutions onto a surgical site. | |
| Technological Characteristics: | The proposed device incorporating the modification | |
| | discussed in this submission has similar technological | |
| | characteristics compared to the predicate device | |
| Safety and Performance | Testing conducted to characterize performance of the<br>proposed device incorporating the modification discussed<br>in this submission has demonstrated that it is substantially<br>equivalent to the predicate device and that it is suitable for<br>the intended use specified. | |
| Conclusion | Based on 1) safety and performance data, and 2)<br>similarities in indication for use, operating principle,<br>component shape and dimensions, materials and<br>manufacturing processes, the Confluent Surgical Dual<br>Liquid Applicator has been shown to be substantially<br>equivalent to a predicate device under the Federal Food,<br>Drug and Cosmetic Act. | |

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 1 2006

Mr. Eric P. Ankerud Vice President, Clinical, Regulatory & Quality Confluent Surgical, Incorporated 101A First Avenue Waltham, Massachusetts 02451

Re: K061183

Trade/Device Name: Confluent Surgical Dual Liquid Applicator Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: April 27, 2006 Received: May 2, 2006

Dear Mr. Ankerud:

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 Lederal Register.

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## Page 2 -Mr. Ankerud

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): 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 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). please contact 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 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 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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## Indications for Use Statement

Page 1_of 1

| 510(k) Number (if known): | KC61183 |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Confluent Surgical Dual Liquid Applicator |
| Indications for Use: | The Confluent Surgical Dual Liquid Applicator is indicated for use in the simultaneous delivery of two non-homogenous fluids or solutions onto a surgical site. |

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-the -Counter Use (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)

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