(133 days)
91154/A
Not Found
No
The device description and performance studies focus on mechanical filtration and flow rate, with no mention of AI or ML algorithms for analysis, control, or decision-making. The "Mentions AI, DNN, or ML" field is also explicitly marked as "Not Found".
No
The device is described as a smoke evacuation system designed to remove airborne particles to improve visualization during laparoscopic surgery, not to treat or diagnose a disease or condition.
No
The device is described as a smoke evacuation system designed to remove airborne particles, not to diagnose medical conditions or provide diagnostic information.
No
The device description clearly states it is a "battery operated smoke evacuation system" with physical components like a "LapEvac unit," "connection tubing," "activated charcoal filtration media," "ULPA filtration media," and a "slide switch." This indicates it is a hardware device with filtration capabilities, not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The LapEvac device is designed to filter airborne particles (smoke) generated during laparoscopic surgery within the pneumoperitoneum. It operates on gaseous media within the body cavity, not on specimens taken from the body.
- Intended Use: The intended use is to improve visualization during surgery by removing smoke, not to diagnose, treat, or prevent disease based on analysis of bodily specimens.
The device is a surgical accessory designed to improve the surgical environment, not a diagnostic tool that analyzes biological samples.
N/A
Intended Use / 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
Product codes
FYD
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Sun Medical SFE-200, Sun Medical Smoke Evacuator Circuit, 510(k) 91154/A
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.5070 Air-handling apparatus for a surgical operating room.
(a)
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.(b)
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.
0
Image /page/0/Picture/0 description: The image is a logo for Buffalo Filter. The logo features the words "BUFFALO" and "Filter" in bold, black letters. The word "BUFFALO" is on top of the word "Filter", and there is a registered trademark symbol next to the word "Filter". To the left of the words is a black square with white lines inside.
FEB 1 3 2006
' Leader in V Smoke Plume Evacuation and Aerosol Management "
595 Commerce Drive Buffalo, NY 14228 (800) 343-2324 (716) 835-7000 (716) 835-3414 fax www.buffalofilter.com email to: Infɔ@buffalofilter.com
510(k) SUMMARY
Buffalo Filter 595 Commerce Drive Buffalo, NY 14228
| Phone: | (800) 343.2324 |
|---|---|
| (716) 835.700 | |
| Fax: | (716) 835.3414 |
| Contact Person: | Robert O. Dean |
|---|---|
| Date Prepared: | September 30, 2005 |
| Device Name: | LapEvac, Filtration Device for the |
| Pneumoperitoneum | |
| Common Name: | Smoke Evacuator |
| Classification Name: | Apparatus, exhaust, surgical |
| 878.5070 | |
| Predicate Device: | Sun Medical SFE-200 |
| Sun Medical Smoke Evacuator Circuit | |
| 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".
1
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.
2
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.
3
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 (800) 638-2041 or (301) 443-6597 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
4
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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K052 747