40 L HIGH FLOW INSUFFLATOR F113

K060723 · W.O.M. World of Medicine AG · HIF · May 25, 2006 · Obstetrics/Gynecology

Device Facts

• Record ID: K060723
• Device Name: 40 L HIGH FLOW INSUFFLATOR F113
• Applicant: W.O.M. World of Medicine AG
• Product Code: HIF · Obstetrics/Gynecology
• Decision Date: May 25, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1730
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The 40 L High Flow Insufflator F113 is a CO2 insufflator intended for use in diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas. The high flow application and the low flow application of the device are each indicated for use in facilitating the use of a laparoscope by filling the peritoneal cavity with gas to distend it. The low flow application of the device is indicated for pediatric use. The vessel harvesting application of the F113 is indicated for use during endoscopic vessel harvesting procedures to create a cavity along the saphenous vein and/or radial artery during endoscopic vessel harvesting procedures.

Device Story

Microprocessor-controlled CO2 insufflator; manages gas flow for laparoscopic and vessel harvesting procedures. Inputs: CO2 gas source; user-defined pressure settings via interface. Operation: continuous redundant pressure measurement; software-controlled active pressure reduction; gas heating; fluid sensing. Outputs: regulated CO2 gas delivery; overpressure alarms; status displays. Used in clinical settings by physicians; provides controlled cavity distension to facilitate endoscopic access. Benefits: maintains stable cavity pressure; enhances safety through automated pressure monitoring and alarm systems.

Clinical Evidence

No clinical trials performed. Evidence consists of a summary of peer-reviewed literature and questionnaire results regarding the use of CO2 insufflation for endoscopic vessel harvesting, demonstrating safety and effectiveness comparable to predicate devices.

Technological Characteristics

Microprocessor-controlled CO2 insufflator. Features: pressure reducers, venting system, fluid sensor, gas heater, display elements, and optional remote control. Software-controlled active pressure reduction. Connectivity: optional remote control. Sterilization: not specified. Materials: not specified.

Indications for Use

Indicated for diagnostic/therapeutic endoscopic procedures requiring cavity distension via CO2 gas. High/low flow applications for peritoneal cavity distension during laparoscopy; low flow application indicated for pediatric patients. Vessel harvesting application indicated for creating cavities along saphenous vein or radial artery during endoscopic vessel harvesting.

Regulatory Classification

Identification

A laparoscopic insufflator is a device used to facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it.

Predicate Devices

• 40 L High Flow Insufflator F108 (K030837)
• Guidant VasoView Endoscopic Vessel Harvesting System (K030512)
• VasoView Dissection / Vessel Harvesting System (K981700)
• Cardiovations Optical Bipolar Device (K031846)

Submission Summary (Full Text)

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# 6723

## 510(k) SUMMARY

| Submitter: | W.O.M. WORLD OF MEDICNE AG<br>Alte Poststraße 11<br>96337 Ludwigsstadt<br>Germany<br>Phone: [phone]<br>Fax: [phone] |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official<br>Correspondent: | Susanne Raab<br>Regulatory Affairs Consultant<br>1480 Cambridge Street<br>Cambridge, MA 02139<br>Phone: [phone]<br>e-mail: [e-mail] |
| Trade Name: | 40 L High Flow Insufflator F113 |
| Common Name: | Carbon Dioxide Insufflator for Laparoscopy and Endoscopic<br>Vessel Harvesting |
| Classification<br>Name: | Laparoscopic Insufflator, 21 C.F.R. 884.1730<br>Insufflator, Automatic Carbon Dioxide for Endoscope,<br>21 C.F.R. § 876.1500 |
| Regulatory Class: | II |
| Product Code: | HIF / FCX |
| Predicate Devices: | <ul><li>40 L High Flow Insufflator F108 (K030837),<br/>manufactured by W.O.M. WORLD OF MEDICINE AG</li><li>Guidant VasoView Endoscopic Vessel Harvesting<br/>System (K030512), manufactured by Guidant Corp.</li><li>VasoView Dissection / Vessel Harvesting System<br/>(K981700), manufactured by Guidant Corp.</li><li>Cardiovations Optical Bipolar Device (K031846),<br/>manufactured by Ethicon, Inc.</li></ul> |
| Device Description: | The 40 L High Flow Insufflator F113 is a microprocessor<br>controlled CO2 insufflator designed with a high flow<br>application, a low flow application and a vessel harvesting<br>application. The device incorporates the following major<br>components and features: a housing, a world power supply, |

MAY 25 2006

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| | pressure reducers, a venting system, a fluid sensor, a gas<br>heater and various setting keys and display elements. A<br>continuous redundant pressure measurement controls the<br>conformity of the actual pressure in the peritoneal or<br>extraperitoneal cavity with the pre-set nominal pressure. In<br>addition, a software controlled active pressure reduction<br>ensures that the preset nominal pressure value conforms to<br>the actual pressure that is measured in the cavity. Finally,<br>the 40 L High Flow Insufflator F113 is designed with several<br>alarms to inform the operator in case of an overpressure.<br>The device may be used with a heating tube and with an<br>optional remote control. |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use /<br>Indication for Use: | The 40 L High Flow Insufflator F113 is a CO2 insufflator<br>intended for use in diagnostic and/or therapeutic endoscopic<br>procedures to distend a cavity by filling it with gas. The<br>high flow application and the low flow application of the<br>device are each indicated for use in facilitating the use of a<br>laparoscope by filling the peritoneal cavity with gas to<br>distend it. The low flow application of the device is<br>indicated for pediatric use. The vessel harvesting application<br>of the F113 is indicated for use during endoscopic vessel<br>harvesting procedures to create a cavity along the saphenous<br>vein and/or radial artery during endoscopic vessel harvesting<br>procedures. |
| Substantial<br>Equivalence: | The 40 L High Flow Insufflator F113 is substantially<br>equivalent to the 40 L High Flow Insufflator F108<br>(K030837) manufactured by W.O.M. Specifically, the F113<br>and the F108 are both intended for use during diagnostic<br>and/or therapeutic endoscopic procedures to distend a cavity<br>by filling it with gas. In addition, the high flow application<br>and low flow application of both devices are indicated for<br>use in facilitating the use of a laparoscope by filling the<br>peritoneal cavity with gas to distend it. The minor<br>technological differences between the F113 and the F108 are<br>primarily related to the implementation of a special vessel<br>harvesting application similar to the existing low flow<br>application for pediatric use in laparoscopy, which allows for<br>the expansion of the indication for use of the F113 to include<br>use of the device during endoscopic vessel harvesting<br>procedures. Performance testing and a clinical evaluation<br>consisting of a summary of peer reviewed literature and<br>information on questionnaire results regarding endoscopic<br>vessel harvesting with the aid of CO2 insufflation<br>demonstrate that these minor technical differences and the |

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expansion of the device's indication for use do not raise new questions of safety or effectiveness.

Furthermore, with regards to its expanded indication for use the F113 is substantially equivalent to the Guidant VasoView Endoscopic Vessel Harvesting System (K030512), the VasoView Dissection / Vessel Harvesting System (K981700), and to the Cardiovations Optical Bipolar Device (K031846). Specifically, the F113 is substantially equivalent to the VasoView systems and to the Cardiovations Optical Bipolar Device as all three of these predicate devices are indicated to be used in conjunction with CO2 insufflation to create a cavity along the saphenous vein and/or radial artery during endoscopic vessel harvesting procedures.

March 13, 2006 Date Prepared:

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

MAY 2 5 2006

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

W. O.M. World of Medicine AG % Ms. Susanne Raab Regulatory Affairs Consultant 1490 Cambridge Street CANBRIDGE MA 02139

Re: K060723

Trade/Device Name: 40L High Flow Insufflator F113 Regulation Number: 21 CFR 884.1730 Regulation Name: Laparoscopic insufflator Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: HIF and GCJ Dated: March 13, 2006 Received: March 17, 2006

#### Dear Ms. Raab:

We have reviewed your Section 510(k) premarket notification of intent to market the device wo have review a your books and have is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce ass success in 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 therefore, mainter are were 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 Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Image /page/3/Picture/10 description: The image is a black and white circular logo. The logo commemorates the centennial anniversary from 1906 to 2006. The letters FDA are in the center of the logo in a stylized font. The word Centennial is written below the letters FDA.

wing Public 9

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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 one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indication for Use

# 510(k) Number (if known): K060723

Device Name: 40 L High Flow Insufflator F113

Indications for Use:

The 40 L High Flow Insufflator F113 is a CO2 insufflator intended for use in diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas. The high flow application and the low flow application of the device are each indicated for use in facilitating the use of a laparoscope by filling the peritoneal cavity with gas to distend it. The low flow application of the device is indicated for pediatric use. The vessel harvesting application of the F113 is indicated for use during endoscopic vessel harvesting procedures to create a cavity along the saphenous vein and/or radial artery during endoscopic vessel harvesting procedures.

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. Brogdon

(Division Sign Off) Division of Reproducti and Radiological Device 510(k) Number _

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