FLEXVIEW CO2 BLOWER WITH MIST

K973803 · Ethicon Endo-Surgery, Inc. · FQH · Dec 16, 1997 · General Hospital

Device Facts

• Record ID: K973803
• Device Name: FLEXVIEW CO2 BLOWER WITH MIST
• Applicant: Ethicon Endo-Surgery, Inc.
• Product Code: FQH · General Hospital
• Decision Date: Dec 16, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5475
• Device Class: Class 2

Intended Use

The FlexiView CO2 Blower is designed to improve visibility at the anastomotic site or other surgical sites where opaque bodily fluid interferes with visualization. It can be used to assist in anastomoses of tubular structures, such as vessels, nerves, ducts, during procedures such as CABG, MIDCAB, trauma, dialysis access graft procedures, femoral-popliteal, tibial or distal bypasses, and in situ bypass. The FlexiView CO2 Blower has application in open surgical procedures, such as cardiovascular, peripheral vascular, thoracic, general, gynecological, and urological procedures.

Device Story

FlexiView CO2 Blower with Mist is a sterile, single-patient-use surgical instrument. Input: standard CO2 source and saline supply. Device consists of handle, 6-inch malleable shaft, and nozzle. Operation: surgeon-controlled flow of CO2 clears blood/fluids from surgical site; optional saline mist prevents tissue desiccation. Used in open surgical procedures (cardiovascular, peripheral vascular, thoracic, general, gynecological, urological) to maintain clear view of anastomotic sites or arteriotomies. Output: directed gas/mist stream. Benefit: improved visualization during delicate surgical procedures, facilitating precise anastomosis.

Clinical Evidence

Bench testing only. Pre-clinical laboratory evaluations were performed to ensure device functionality and performance consistent with the predicate device.

Technological Characteristics

Sterile, single-patient-use instrument. Components: handle, 6-inch malleable shaft, nozzle, connectors for CO2 and saline. Energy source: external CO2 gas supply. Manual operation. No software or electronic components.

Indications for Use

Indicated for patients undergoing open surgical procedures (cardiovascular, peripheral vascular, thoracic, general, gynecological, urological) where visualization of anastomotic or surgical sites is obscured by bodily fluids. Used to assist in anastomoses of tubular structures (vessels, nerves, ducts) including CABG, MIDCAB, trauma, and bypass 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.

Submission Summary (Full Text)

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K973803 Dec. 16, 1997

## Appendix A 510(k) Summary of Safety and Effectiveness

| Statement | Information supporting claims of substantial equivalence, as defined under the Federal Food, Drug and Cosmetic Act, respecting safety and effectiveness is summarized below. For the convenience of the Reviewer, this summary is formatted in accordance with the Agency's final rule "...510(k) Summaries and 510(k) Statements..." (21 CFR §807) and can be used to provide a substantial equivalence summary to anyone requesting it from the Agency. |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device description | The FlexiView CO2 Blower With Mist is a sterile, single patient use instrument designed to improve visibility at an anastomotic site or other surgical sites by providing an adjustable flow of CO2 to clear blood or obscuring fluid away and assist in maintaining an open incision or arteriotomy. The optional saline mist helps to prevent desiccation of the graft and surrounding tissue.<br>The FlexiView CO₂ Blower consists of a handle, a 6" malleable shaft with a nozzle, and connectors for hook up to standard CO2 source and saline. |
| Indication for use statement | The FlexiView CO2 Blower is designed to improve visibility at the anastomotic site or other surgical sites where opaque bodily fluid interferes with visualization.<br>It can be used to assist in anastomoses of tubular structures, such as vessels, nerves, ducts, during procedures such as CABG, MIDCAB, trauma, dialysis access graft procedures, femoral-popliteal, tibial or distal bypasses, and <i>in situ</i> bypass.<br>The FlexiView CO2 Blower has application in open surgical procedures, such as cardiovascular, peripheral vascular, thoracic, general, gynecological, and urological procedures. |

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## Appendix A 510(k) Summary of Safety and Effectiveness,

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| Technological<br>characteristics | The technological characteristics of the New Device are the same as the<br>Predicate Device. |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance<br>data | Pre-clinical laboratory evaluations were performed to ensure that the device<br>can be used as designed. The studies demonstrated acceptable performance to<br>the Predicate Device. |
| Conclusion | Based on the 510(k) summaries and 510(k) statements (21 CFR §807) and the<br>information provided herein, we conclude that the New Device is substantially<br>equivalent to the Predicate Device under the Federal Food, Drug and<br>Cosmetic Act. |
| Contact | Lonnie Pace<br>Project Manager<br>Regulatory Affairs Department<br>Ethicon Endo-Surgery, Inc.<br>4545 Creek Road<br>Cincinnati, Ohio 45242 |
| Date | October 2, 1997 |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 16 1997

Ms. Lorri Chavez Project Manager, Regulatory Affairs Ethicon Endo-Surgery, Incorporated 4545 Creek Road 45242-2839 Cincinnati, Ohio

Re : K973803 Flexview CO2 Blower With Mist Trade Name: Requlatory Class: II Product Code: FOH October 2, 1997 Dated: October 6, 1997 Received:

Dear Ms. Chavez:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the marice 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਉ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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

Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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K 973803

## Indications for Use Statement Appendix B

Following is the Indications for Use Statement: Statement

> 510(k) Number: K_973803 Device Name: FlexiView CO2 Blower With Mist

## Indications for Use:

The FlexiView CO2 Blower is designed to improve visibility at the anastomotic site or other surgical sites where opaque bodily fluid interferes with visualization.

It can be used to assist in anastomoses of tubular structures, such as vessels, nerves, ducts, during procedures such as CABG, MIDCAB, trauma, dialysis access graft procedures, femoral-popliteal, tibial or distal bypasses, and in situ bypass.

The Flexi View CO2 Blower has application in open surgical procedures, such as cardiovascular, peripheral vascular, thoracic, general, gynecological, and urological procedures.

Pauline Cassanet

and Gen 5 i O(k) Number

Ethicon Endo-Surgery, Inc. FlexiView CO2 Blower With Mist

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