LAPEVAC, FILTRATION DEVICE FOR THE PERIOTONEUM

K052797 · Medtek Devices, Inc. · FYD · Feb 13, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K052797
• Device Name: LAPEVAC, FILTRATION DEVICE FOR THE PERIOTONEUM
• Applicant: Medtek Devices, Inc.
• Product Code: FYD · General, Plastic Surgery
• Decision Date: Feb 13, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5070
• Device Class: Class 2

Intended Use

To remove airborne particles generated by tissue combustion during laparoscopic surgery, via filtration of gaseous media contained within the distended pneumoperitoneum in order to significantly improve visualization. LapEvac may be used in any laparoscopic surgery, as appropriate. Sterile, single use only device

Device Story

LapEvac is a battery-operated, sterile, single-use smoke evacuation system for laparoscopic surgery. It connects to inlet/outlet trocars to create a closed-circuit loop for filtering pneumoperitoneum gas (typically CO2). The system uses activated charcoal and ULPA filtration media to remove smoke particles, recirculating gas at approximately 4 liters per minute. Operated by surgical staff in the OR, the device is controlled via a 3-amp slide switch and has a 4-hour operational life. By clearing smoke from the surgical field, the device improves visualization for the surgeon, facilitating the procedure without affecting pneumoperitoneal pressure, temperature, or humidity.

Clinical Evidence

Bench testing only. Three verification tests were conducted: 1) Clarity of View and Evacuation Efficiency (verified smoke clearance time comparable to existing devices); 2) Effect on Pneumoperitoneum (verified no adverse impact on pressure, temperature, or relative humidity); 3) Power Budget (verified operation exceeds 4 hours).

Technological Characteristics

Battery-operated (6V) smoke evacuation system. Components include connection tubing, activated charcoal filter, and ULPA filter. Recirculation rate: ~4 L/min. Operational life: ~4 hours. Controlled by 3-amp UL-rated slide switch. Sterile, single-use device.

Indications for Use

Indicated for patients undergoing laparoscopic surgery to remove airborne particles generated by tissue combustion via filtration of pneumoperitoneum gaseous media to improve visualization.

Regulatory Classification

Identification

Air-handling apparatus for a surgical operating room is a device intended to produce a directed, nonturbulent flow of air that has been filtered to remove particulate matter and microorganisms to provide an area free of contaminants to reduce the possibility of infection in the patient.

Special Controls

*Classification.* Class II (special controls). The device, when it is an air handling bench apparatus, an air handling room apparatus, or an air handling enclosure apparatus, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.

Predicate Devices

• Sun Medical SFE-200 (91154/A)
• Sun Medical Smoke Evacuator Circuit (91154/A)

Submission Summary (Full Text)

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K052797

FEB 1 3 2006

#### ' Leader in V Smoke Plume Evacuation and Aerosol Management "

595 Commerce Drive Buffalo, NY 14228 [phone] [phone] [phone] fax www.buffalofilter.com email to: Infɔ@buffalofilter.com

## 510(k) SUMMARY

Buffalo Filter 595 Commerce Drive Buffalo, NY 14228

| Phone: | [phone] |
|--------|----------------|
| | (716) 835.700 |
| Fax: | [phone] |

| Contact Person: | Robert O. Dean |
|----------------------|----------------------------------------------------------------------------------------------------------|
| Date Prepared: | September 30, 2005 |
| Device Name: | LapEvac, Filtration Device for the<br>Pneumoperitoneum |
| Common Name: | Smoke Evacuator |
| Classification Name: | Apparatus, exhaust, surgical<br>878.5070 |
| Predicate Device: | Sun Medical SFE-200<br>Sun Medical Smoke Evacuator Circuit<br>Reviewed and released under 510(k) 91154/A |

Image /page/0/Picture/9 description: The image shows the logo for the American Society for Quality (ASQ). The text "Member Of: American Society for Quality" is above the logo. The logo itself consists of a stylized globe with the letters "ASQ" in large, bold font to the right of the globe.

Image /page/0/Picture/10 description: The image shows two logos and some text. The first logo is a UL (Underwriters Laboratories) logo with the words "REGISTERED FIRM" below it. The second logo is a UKAS (United Kingdom Accreditation Service) logo with the number 062 below it. The text above the logos reads "ISO 9001 - ISO 13485", and the text below the logos reads "D. HALO FILTER" and "A12634".

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# KO52797

### Device Description:

LapEvac is a battery operated smoke evacuation system that connects directly to the inlet and outlet cannula/ trocars and creates a continuous closed circuit for filtering pneumoperitoneum gaseous media (typically CO2). The system contains the LapEvac unit and connection tubing. Filtration is accomplished using activated charcoal filtration media and ULPA filtration media. The system filters and recirculates at an approximate rate of 4 liters per minute. Operating life is approximately 4 hours. A 3 amp, UL rated slide switch provides on/off control.

#### Intended Use:

To remove airborne particles generated by tissue combustion during laparoscopic surgery, via filtration of gaseous media contained within the distended pneumoperitoneum in order to significantly improve visualization. LapEvac may be used in any laparoscopic surgery, as appropriate.

Sterile, single use only device

### Technological Comparison

Similarities of LapEvac and the predicate include the intended/indications for use - both devices are used in laparoscopic surgeries to filter pneumoperitoneum gas for removing smoke particles and thereby significantly increasing visualization within the pneumoperitoneum. The operating principle of the two devices is the same - the active recirculation of pneumoperitoneum gas and filtration through similar sub-micron sized filters.

Power supplies differ. LapEvac is battery operated at 6 volts versus 120volt AC for the predicate device.

Performance Data: Three sets of bench verification tests were conducted.

> Clarity of View and Evacuation Efficiency verified LapEvac's ability to clear smoke from the chamber in a time comparable to smoke filtration devices commonly used during laparoscopic surgeries.

Effect on Pneumoperitoneum verified that LapEvac has no effect on the pneumoperitoneal pressure, temperature, and relative humidity.

Power Budget verifies power consumption and assures that LapEvac operation exceeds 4 hours.

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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 stylized eagle-like symbol with three lines representing wings or feathers. The symbol is positioned to the right of the text, which is arranged in a circular pattern around the symbol. The text reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA".

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 3 2006

Mr. Robert O. Dean Vice President Medtrek Devices, Incorporated 595 Commerce Drive Buffalo, New York 14228

Re: K052797

Trade/Device Name: LapEvac, Filtration Devices for the Pneumoperitoneum Regulation Number: 21 CFR 878.5070 Regulation Name: Air-Handling Apparatus for Surgical Operating Room Regulatory Class: II Product Code: FYD Dated: January 20, 2006 Received: January 25, 2006

Dear Mr. Dean:

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 - Mr. Dean

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 requirely 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 (240) 276-. 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,

Senette Y. Michie Dm.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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# Indications for Use

510(k) Number (if known): K052797

Device Name: LapEvac, Filtration device for the pneumoperitoneum

Indications For Use:

To remove airborne particles generated by tissue combustion during laparoscopic surgery, via filtration of gaseous media contained within the distended pneumoperitoneum in order to significantly improve visualization.

LapEvac may be used in any laparoscopic surgery, as appropriate.

Sterile, single use only device

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Shula A Murphy, MD, 1/10/08

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