BLOWER/MISTER

K983135 · Cardiothoracic Systems, Inc. · FQH · Nov 13, 1998 · General Hospital

Device Facts

• Record ID: K983135
• Device Name: BLOWER/MISTER
• Applicant: Cardiothoracic Systems, Inc.
• Product Code: FQH · General Hospital
• Decision Date: Nov 13, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5475
• Device Class: Class 2

Intended Use

The CTS Blower/Mister is intended to clear an anastomotic site or other surgical sites for improved visibility.

Device Story

CTS Blower/Mister is a manual surgical instrument consisting of a handpiece and a malleable shaft. It connects to external standard gas and saline sources. The device allows the surgeon to deliver an adjustable flow of gas and a saline mist to a targeted surgical site. Used in the operating room, it enables the surgeon to clear blood or debris from the field of view, facilitating visualization during procedures such as anastomoses. It provides no automated processing or diagnostic output; it is a mechanical tool for site maintenance.

Clinical Evidence

Bench testing only.

Technological Characteristics

Manual surgical instrument; handpiece with malleable shaft; connects to external gas and saline sources; provides adjustable gas flow and saline mist delivery. No electronic components, software, or energy source integral to the device.

Indications for Use

Indicated for clearing anastomotic or other surgical sites to improve visibility during surgical procedures.

Regulatory Classification

Identification

A jet lavage is a device used to clean a wound by a pulsatile jet of sterile fluid. The device consists of the pulsing head, tubing to connect to a container of sterile fluid, and a means of propelling the fluid through the tubing, such as an electric roller pump.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.

Predicate Devices

• ClearView Blower/Mister (Medtronic)
• FlexiView CO2 Blower with Mist (Ethicon)

Submission Summary (Full Text)

{0}------------------------------------------------

K983135

NOV 1 3 1998

## 510(k) Summary CardioThoracic Systems, Inc. Blower/Mister 510(k) Notification K983135

## GENERAL INFORMATION

| Manufacturer: | CardioThoracic Systems, Inc.<br>10600 North Tantau Avenue<br>Cupertino, California<br>[phone]<br>[phone] FAX<br>Est. Reg. No. 9027735 |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Michael J. Billig |

Vice President, Regulatory, Quality, and Clinical Research

| Date Prepared: | September 03, 1998 |
|----------------|--------------------|
|----------------|--------------------|

#### DEVICE DESCRIPTION

| Classification: | Jet Lavage 21 CFR 880.5475 |
|----------------------|-----------------------------|
| Trade Name: | CTS Blower/Mister |
| Generic/Common Name: | Lavage or irrigation device |

#### PREDICATE DEVICES

ClearView Blower/Mister manufactured by Medtronic FlexiView CO2 Blower with Mist manufactured by Ethicon

#### INTENDED USE

The CTS Blower/Mister is intended to clear an anastomotic site or other surgical sites for improved visibility.

{1}------------------------------------------------

## PRODUCT DESCRIPTION

The CTS Blower/Mister is comprised of a handpiece and malleable shaft enabling positioning of the device near the targeted site. Connectors on the device allow for hook-up to standard gas and saline sources. The device permits both an adjustable flow of gas and a mist of saline to be deposited at the targeted site.

#### SUBSTANTIAL EQUIVALENCE

The CTS Blower/Mister is intended to clear a wound or surgical site for improved visibility. The Blower/Mister is substantially equivalent to Medtronic's ClearView Blower/Mister and Ethicon's FlexiView CO2 Blower with Mist in regards to intended use, patient population, functionality and performance.

Functional bench testing has been conducted and the results of the testing verified that the Blower / Mister performs as designed and is suitable for its intended use.

## SUMMARY

As contained in this 510(k) summary, the CTS Blower/Mister is substantially equivalent to the predicate device identified in that the Blower/Mister has a similar intended use, patient population and performance as the predicate device.

{2}------------------------------------------------

Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three swooping lines forming its body and wings. The bird is positioned to the right of a circular text element that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". The text is arranged around the circumference of the circle, with the bird figure in the center.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 3 1998

Mr. Michael J. Billig Vice President, Regulatory, Quality, and Clinical Research CardioThoracic Systems, Incorporated 10600 North Tantau Avenue Cupertino, California 95014

Re : K983135 Blower/Mister Trade Name: Regulatory Class: II Product Code: FQH September 3, 1998 Dated: September 8, 1998 Received:

Dear Mr. Billig:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਜੋ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in Please note: this response to your the Federal Reqister. premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

{3}------------------------------------------------

Page 2 - Mr. Billig

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda,gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Timothy A. Ulatowski Directbr Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

K983/35

## CardioThoracic Systems, Inc. CTS Blower/Mister 510(k) Premarket Notification

# STATEMENT OF INDICATIONS FOR USE

The CTS Blower/Mister is intended to clear an anastomotic site or other surgical sites for improved visibility.

Patricia Cuccurullo

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

510(k) Number 4963135