CONFLUENT SURGICAL MICROMYST APPLICATOR AND AIR PUMP, MODELS 20-5000, AP-A-6063

K050998 · Confluent Surgical,Inc · FMF · Jun 15, 2005 · General Hospital

Device Facts

• Record ID: K050998
• Device Name: CONFLUENT SURGICAL MICROMYST APPLICATOR AND AIR PUMP, MODELS 20-5000, AP-A-6063
• Applicant: Confluent Surgical,Inc
• Product Code: FMF · General Hospital
• Decision Date: Jun 15, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Device consists of applicator with flexible tip, air line with filter, and air pump. Used for simultaneous delivery of two non-homogenous fluids or solutions to surgical site. Operates by pneumatic delivery; intended for use by clinicians in surgical settings. Provides controlled application of fluids; facilitates surgical procedures requiring dual-fluid delivery.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

System includes applicator with flexible tip, air line with filter, and air pump. Piston syringe-based delivery mechanism. Class II device (21 CFR 880.5860).

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

• HemaMyst Surgical Applicator System (K994023)
• FibriJet Aerosol Applicator (K012868)

Submission Summary (Full Text)

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## JUN 1 5 2005

K050998
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## 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 15, 2005 |
|-------------------------------|--------------------------------------------------------------------|
| 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 MicroMyst Applicator and Air Pump |
| Classification Name | Piston Syringe (21 CFR 880.5860) |
| | Class II |
| | Product Code: FMF |
| Common Name | MicroMyst Applicator and Air Pump |
| Predicate Device(s) | HemaMyst Surgical Applicator System<br>FibriJet Aerosol Applicator |

DEVICE DESCRIPTION

| Product Description | The MicroMyst Applicator and Air Pump will be configured using the following components: |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | <ul><li>Applicator with flexible tip</li><li>Air line with filter</li><li>Air Pump</li></ul> |
| Indications for Use | The Confluent Surgical MicroMyst Applicator and Air Pump is indicated for use in the simultaneous delivery of two non- homogenous fluids or solutions onto a surgical site. |

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| 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 MicroMyst Applicator and Air<br>Pump.<br>The data provided support that the MicroMyst Applicator<br>and Air Pump is substantially equivalent to the currently<br>marketed HemaMyst Surgical Applicator System<br>(K994023) and the FibriJet® Aerosol Applicator (K<br>012868) |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion | Based on 1) safety and performance data, and 2)<br>similarities in indication for use, operating principle,<br>components and materials the Confluent MicroMyst<br>Applicator and Air Pump has been shown to be<br>substantially equivalent to a predicate device under the<br>Federal Food, 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 consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with three stylized lines representing its wings or feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 5 2005

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

Re: K050998

Trade/Device Name: Confluent Surgical MicroMyst™ Applicator and Air Pump Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: April 15, 2005 Received: April 21, 2005

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 Eederal 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 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 yours,

Senatie f. Michien Ond.

'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

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Confluent Surgical MicroMyst TM Applicator and Air Pump Device Name: The Confluent Surgical MicroMyst Applicator and Air Indications For Use: Pump 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)

Aaron Kagin For ADW

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

510(k) Number: _______________________________________________________________________________________________________________________________________________________________ Page 1 of