MODIFICATION TO CONFLUENT SURGICAL MICROMYST APPLICATOR AND AIR PUMP

K070814 · Confluent Surgical,Inc · FMF · May 30, 2007 · General Hospital

Device Facts

• Record ID: K070814
• Device Name: MODIFICATION TO CONFLUENT SURGICAL MICROMYST APPLICATOR AND AIR PUMP
• Applicant: Confluent Surgical,Inc
• Product Code: FMF · General Hospital
• Decision Date: May 30, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Confluent Surgical MicroMyst Applicator and Air Pump are indicated for use in the simultaneous delivery of two non-homogenous fluids or solutions onto a surgical site.

Device Story

The Confluent Surgical MicroMyst Applicator and Air Pump system delivers two non-homogenous fluids or solutions simultaneously to a surgical site. The system consists of an applicator, an air line with a filter, and an air source (pump). It is intended for use in a surgical setting to facilitate the application of surgical fluids. The device functions by using the air pump to provide the necessary pressure for fluid delivery through the applicator. The healthcare provider operates the device to apply the fluids, which may assist in surgical procedures. The device is a modification of a previously cleared system.

Clinical Evidence

Bench testing only.

Technological Characteristics

System includes an applicator, air line with filter, and air pump. Operates via pneumatic delivery of two non-homogenous fluids. No software or electronic control algorithms described.

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 MicroMyst Applicator and Air Pump (K050998)

Submission Summary (Full Text)

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CONFIDENTIAL

MAY 3 0 2007

## 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.

| Sponsor: | Confluent Surgical, Inc.<br>101A First Avenue<br>Waltham, MA 02451 | |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|
| Contact: | Kristine Burke | |
| | Phone: | [phone] |
| | Fax: | [phone] |
| | E-mail: | [e-mail] |
| Device Trade/Proprietary Name(s) | Confluent Surgical MicroMyst Applicator<br>Confluent Surgical Air Pump | |
| Classification Name: | Piston Syringe (21 CFR 880.5860)<br>Class II<br>Product Code: FMF | |
| Common Name: | Confluent Surgical MicroMyst Applicator and Confluent<br>Surgical Air Pump | |
| Predicate Device(s): | Confluent Surgical MicroMyst Applicator and Air Pump<br>(K050998) | |
| DEVICE DESCRIPTION | | |
| Product Description: | The Confluent Surgical MicroMyst Applicator will be<br>configured using the following components:<br>ApplicatorAir line with FilterAir Source | |
| Indications for Use: | The Confluent Surgical MicroMyst Applicator and Air<br>Pump are indicated for use in the simultaneous delivery of<br>two non-homogenous fluids or solutions onto a surgical<br>site. | |
| Technological Characteristics: | The proposed device incorporating the modification<br>discussed in this submission has similar technological<br>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>design, materials, and manufacturing processes, the<br>Confluent Surgical MicroMyst Applicator has been shown<br>to be substantially equivalent to a predicate device under<br>the Federal Food, Drug and Cosmetic Act. | |

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services, USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized caduceus, a symbol often associated with healthcare. The caduceus consists of a staff with two snakes coiled around it, topped with a pair of wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 3 0 2007

Ms. Kristine Burke Regulatory Affairs Manager Confluent Surgical, Incorporated 101A First Avenue Waltham, Massachusetts 02451

Re: K070814

Trade/Device Name: Confluent Surgical MicroMyst™ Applicator and Air Pump Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: May 09, 2007 Received: May 10, 2007

Dear Ms. Burke:

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 - Ms. Burke

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 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.

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

K074814

Page 1_of 1

## Indications for Use Statement

| 510(k) Number (if known): | |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Confluent Surgical MicroMyst™ Applicator and Air Pump |
| Indications for Use: | The Confluent Surgical MicroMyst Applicator and Air Pump are indicated for use in the simultaneous delivery of two non-homogenous fluids or solutions onto a surgical site. |

Prescription Use
(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)

Arun

ா Sign-Off) Cosion of Anesthesiology, General Hospital, imection Control, Dental Devices

2(k) Number: k479814

Confluent Surgical, Inc. MicroMyst Applicator

Special Premarket Notification [510(k)]: Device Modification March 23, 2007

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