CONFLUENT SURGICAL EXTENDED TIP APPLICATOR, MODEL 70-2008-008

K072790 · Confluent Surgical,Inc · FMF · Jan 11, 2008 · General Hospital

Device Facts

• Record ID: K072790
• Device Name: CONFLUENT SURGICAL EXTENDED TIP APPLICATOR, MODEL 70-2008-008
• Applicant: Confluent Surgical,Inc
• Product Code: FMF · General Hospital
• Decision Date: Jan 11, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2

Intended Use

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

Device Story

The Confluent Surgical Extended Tip Applicator is a manual surgical accessory designed for the simultaneous delivery of two non-homogenous solutions to a surgical site. The device consists of a Y-connector, a malleable shaft, and three spray tip assemblies. It is intended for use by clinicians in a surgical setting. By allowing the simultaneous application of two solutions, the device facilitates surgical procedures requiring the combination of materials at the site of application.

Clinical Evidence

Bench testing only. Biocompatibility and in vitro bench testing data were provided to support substantial equivalence.

Technological Characteristics

The device comprises a Y-connector, a malleable shaft, and three spray tip assemblies. It functions as a manual piston syringe accessory (21 CFR 880.5860). No energy source or software is utilized.

Indications for Use

Indicated for the simultaneous delivery of two non-homogenous 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 (K061183)

Submission Summary (Full Text)

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## JAN | | 2006

## 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: | September 28, 2007 |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor | Confluent Surgical, Inc.<br>101A First Avenue<br>Waltham, MA 02451 |
| Contact | Virginia Vetter<br>Phone: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] |
| Device Trade/Proprietary Name | Confluent Surgical 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 Dual Liquid Applicator<br>K061183 |
| DEVICE DESCRIPTION | |
| Product Description | The Confluent Surgical Extended Tip Applicator<br>will be configured using a Y-Connector, a Malleable<br>Shaft and three Spray Tip Assemblies. |
| Indications for Use | The Confluent Surgical Extended Tip Applicator is<br>indicated for use in the simultaneous delivery of two<br>non- homogenous solutions onto a surgical site. |
| Safety and Effectiveness | Safety and effectiveness of the Confluent Surgical<br>Extended Tip Applicator have been demonstrated in<br>this submission. The biocompatibility and <i>in vitro</i><br>bench testing data provide support that the Extended<br>Tip Applicator is substantially equivalent to the<br>currently 510(k)-cleared Dual Liquid Applicator. |
| Conclusion | Safety and effectiveness data, same indications for<br>use and same operating principle show the Confluent<br>Surgical Extended Tip Applicator to be substantially<br>equivalent to a predicate device under the Federal<br>Food, Drug and Cosmetic Act |

| Confluent Surgical, Inc. |
|--------------------------|

September 2007

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Image /page/1/Picture/2 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with three wings, representing health, human services, and well-being. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged around the top of the seal in a circular fashion.

JAN 11 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Virginia Vetter Regulatory Affairs Specialist Confluent Surgical, Incorporated 101 A First Avenue Waltham, Massachusett 02451

Rc: K072790

Trade/Device Name: Confluent Surgical Extended Tip Applicator Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: September 28, 2007 Received: November 5, 2007

Dear Ms. Vetter:

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 Eederal Register.

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Page 2 - Ms. Vetter

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/industry/support/index.html.

Sincerely vours,

Clues

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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## CONFIDENTIAL

Section 4: Indications for Use Statement

Page 1_of 1

510(k) Number (if known): Unknown

K072790

Device Name: Confluent Surgical Extended Tip Applicator

Indications for Use:

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

Prescription Use X (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)

Antony D. Moore

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

510(k) Number: __ K Φ72799

| Confluent Surgical, Inc. | Traditional Premarket Notification 510(k) |
|--------------------------------------------|-------------------------------------------|
| | 10 |
| Confluent Surgical Extended Tip Applicator | September 2007 |