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 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.

AI/ML Overview

The provided text describes bench verification tests for the LapEvac device rather than a comprehensive study with acceptance criteria and specific performance metrics in the format requested. The document is a 510(k) summary for a medical device submitted to the FDA, which focuses on demonstrating substantial equivalence to a predicate device through various tests.

Based on the provided text, the following information can be extracted, and where information is not available, it is noted:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Implied)	Reported Device Performance
Ability to clear smoke from the chamber in a time comparable to commonly used smoke filtration devices during laparoscopic surgeries	Verified LapEvac's ability to clear smoke from the chamber in a time comparable to smoke filtration devices commonly used during laparoscopic surgeries.
No effect on pneumoperitoneal pressure	Verified that LapEvac has no effect on the pneumoperitoneal pressure.
No effect on pneumoperitoneal temperature	Verified that LapEvac has no effect on the pneumoperitoneal temperature.
No effect on pneumoperitoneal relative humidity	Verified that LapEvac has no effect on the pneumoperitoneal relative humidity.
Operating life to exceed 4 hours	Verified power consumption and assures that LapEvac operation exceeds 4 hours.
Filtration of gases using activated charcoal and ULPA filtration	Filtration is accomplished using activated charcoal filtration media and ULPA filtration media.
Recirculation rate of approximately 4 liters per minute	The system filters and recirculates at an approximate rate of 4 liters per minute.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified. The document states "Three sets of bench verification tests were conducted," but does not detail the number of runs, devices, or data points for each test.
Data Provenance: The tests were "bench verification tests," implying they were conducted in a laboratory setting, likely in the US (given the US company address and FDA submission). The document does not specify if the data was retrospective or prospective, but as it's for a new device's premarket notification, it would be prospective data gathered specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Number of Experts: Not applicable. The tests performed are bench verification tests evaluating physical characteristics and performance of the device (smoke clearing time, pressure, temperature, humidity, battery life), not diagnostic assessments requiring interpretations from medical experts.
Qualifications of Experts: Not applicable for this type of testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Adjudication Method: Not applicable. As mentioned above, these are bench tests measuring physical properties, not evaluations requiring human adjudication of medical findings.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

MRMC Study: No, an MRMC comparative effectiveness study was not done. The device is a smoke evacuation system, not an AI-powered diagnostic tool. The "Clarity of View and Evacuation Efficiency" test compares the device's ability to clear smoke to "smoke filtration devices commonly used during laparoscopic surgeries" but does not involve human readers/interpreters or AI.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone Performance: The described tests reflect standalone performance of the device (the "algorithm" in this context being the device's physical mechanism of filtration and recirculation). The device functions independently to clear smoke.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Type of Ground Truth: The ground truth for these bench tests would be various established physical and engineering standards. For example:
- Clarity of View and Evacuation Efficiency: Comparison to the performance of "commonly used smoke filtration devices" (implied industry standard or predicate device performance data).
- Effect on Pneumoperitoneum: Expected physiological ranges for pressure, temperature, and humidity within a pneumoperitoneum.
- Power Budget: The manufacturer's specified operating life of "approximately 4 hours."

8. The sample size for the training set

Sample Size for Training Set: Not applicable. This is a physical medical device, not an AI or machine learning algorithm that requires a "training set" in the conventional sense.

9. How the ground truth for the training set was established

Ground Truth for Training Set: Not applicable. As this is not an AI/ML device, a training set and its associated ground truth establishment methods are irrelevant.

Summary

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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.

K052797

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 thePneumoperitoneum
Common Name:	Smoke Evacuator
Classification Name:	Apparatus, exhaust, surgical878.5070
Predicate Device:	Sun Medical SFE-200Sun Medical Smoke Evacuator CircuitReviewed 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:

Intended Use:

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 (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

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Indications for Use

510(k) Number (if known): K052797

Device Name: LapEvac, Filtration device for the pneumoperitoneum

Indications For Use:

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

Page 1 of 1

K052 747

Regulation Number and Section

§ 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.