CONFLUENT SURGICAL DUAL LIQUID APPLICATOR, MODEL 70-2005093

K042588 · Confluent Surgical,Inc · FMF · Dec 9, 2004 · General Hospital

Device Facts

• Record ID: K042588
• Device Name: CONFLUENT SURGICAL DUAL LIQUID APPLICATOR, MODEL 70-2005093
• Applicant: Confluent Surgical,Inc
• Product Code: FMF · General Hospital
• Decision Date: Dec 9, 2004
• Decision: SESE
• Submission Type: Traditional
• 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 designed for use in a surgical setting. It consists of a Y-connector, three spray tips, and a plunger cap. The device functions by enabling the simultaneous delivery of two separate fluids or solutions to a specific surgical site. It is operated by a clinician during surgical procedures to apply liquids. The device is substantially equivalent to the DuoFlo Dispenser Kit, sharing similar operating principles, component shapes, dimensions, and materials. It provides a mechanical means for fluid application, assisting the surgeon in the controlled delivery of surgical solutions.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Manual piston syringe-based delivery system. Components include Y-connector, spray tips, and plunger cap. Operates via manual mechanical actuation. No software or electronic components.

Indications for Use

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

• DuoFlo™ Dispenser Kit (K872526)

Submission Summary (Full Text)

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K042588
CONFIDENTIAL

DEC - 9 2004

## 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: | September 20, 2004 | |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|
| Sponsor | Confluent Surgical, Inc. | |
| | 101A First Avenue | |
| | Waltham, MA 02451 | |
| Contact | Eric Ankerud | |
| | Phone: | [phone] |
| | Fax: | [phone] |
| | 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) | DuoFlo™ Dispenser Kit (K872526) | |
| | DEVICE DESCRIPTION | |
| Product Description | The Confluent Surgical Dual Liquid Applicator will be configured using the following components: | |
| | | • Y-Connector |
| | | • Three Spray Tips |
| | | • Plunger Cap |
| Indications for Use | The Confluent Surgical Dual Liquid Applicator is indicated<br>for use in the simultaneous delivery of two non-<br>homogenous fluids or solutions onto a surgical site. | |

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K042588

## CONFIDENTIAL

| Safety and Performance | Biocompatibility data and results of bench testing have<br>been provided to support the safety and performance of<br>the Confluent Surgical Dual Liquid Applicator.<br>The data provided support that the Dual Liquid Applicator<br>is substantially equivalent to the currently marketed<br>Duoflo Dispenser Kit. |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is positioned within a circle that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 9 2004

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

Re: K042588

Trade/Device Name: Confluent Surgical Dual Liquid Applicator Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: September 20, 2004 Received: September 22, 2004

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 Federal 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 (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 vour 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/dsma/dsmamain.html

Sincerely yours,

Supar Quora

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

510(k) Number (if known):_K042588

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-homogeneous fluids or solutions onto a surgical site.

X Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Antin Donk

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

510(k) Number:_长442588

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