VISICLEAR SMOKE EVACUATION SYSTEM by BUFFALO FILTER CO., INC.

The VISICLEAR smoke evacuation system is a self-contained system that is used to remove and filter surgical smoke. The device is intended for general electrosurgical and laser applications for removing smoke generated by electrosurgery and laser procedures.

The device is constructed using the same materials and design specifications commonly found in the predicate devices in the smoke evacuation marketplace. The smoke evacuator is comprised of a vacuum motor, aluminum, and plastic components combined with sound reducing insulation. The vacuum motor is used to draw the smoke from the surgical site, through the vacuum tubing and into the VISICLEAR filter where the surgical smoke is processed by a series of filtration stages.

The vacuum flow rate for the VISICLEAR smoke evacuation device ranges from a minimum of 5 liters per minute (LPM) in Laparoscopic Mode to 30 cubic feet per minute in Open Mode. These flow rates are substantially equivalent to the flow range for the predicate devices.

The filter for the VISICLEAR smoke evacuation system, like the filters for the predicate devices, is a replaceable self-contained filter that is completely enclosed to protect health care personnel from potential contamination during filter changes. The VIROSAFE 135 filter ("VS135") is an Ultra Low Penetration Air (ULPA) grade with carbon fitter that has filter efficiency of 99.999% for particle sizes of 0.1 to 0.2 microns or greater. These characteristics are consistent with the predicate devices.

AI/ML Overview

The provided document is a 510(k) summary for the VISICLEAR Smoke Evacuation System. It outlines the device's characteristics and compares it to predicate devices to establish substantial equivalence.

Here's an analysis of the acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

Study Details

The document describes bench testing for verification and validation to demonstrate substantial equivalence to predicate devices, rather than a clinical study involving patients or human readers.

Sample size used for the test set and the data provenance:
- The document primarily refers to "bench testing" and does not specify a "test set" in terms of patient data or clinical images. It implies testing of the device itself and its components.
- Data provenance is not explicitly stated in terms of country of origin, but the company, Buffalo Filter LLC, is based in Lancaster, NY, USA. The testing appears to be "retrospective" in the sense that it's based on engineering tests rather than prospective patient recruitment.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable as the "ground truth" for this device's performance is established through objective engineering measurements (e.g., flow rate, filter efficiency, safety standards compliance) rather than expert interpretation of data.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable, as this was not a study involving human interpretation or adjudication of results.
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:
- Not applicable. This device is a smoke evacuation system and does not involve AI or human readers for diagnostic interpretation.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. The device is a physical system, not an algorithm. Its performance is inherent to its physical design and operation.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" is defined by established engineering and regulatory standards for air handling devices and smoke evacuator performance. This includes:
  - ULPA efficiency standards: 99.999% for particle sizes of 0.1 to 0.2 microns or greater.
  - Flow rate measurements: Minimum 5 LPM (Laparoscopic Mode) to 30 CFM (Open Mode).
  - Filter life: 35 hours (Laparoscopic Mode), 18 hours (Open Mode).
  - Electrical safety standards: IEC/ANSI/AAMI 60601-1 and IEC/ANSI/AAMI 60601-1-2.
  - Mechanical safety standards: IEC/ANSI/AAMI 60601-1.
  - Software functionality: Verification that the filter life decrementing feature works as intended.
  - Smoke removal effectiveness: Quantified ability to remove smoke aerosols.
The sample size for the training set:
- Not applicable. This refers to a physical device, not a machine learning algorithm that requires a training set.
How the ground truth for the training set was established:
- Not applicable. See point 7.

Summary

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K131402

MAR - 3 2014

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510(k) Summary For VISICLEAR SMOKE EVACUATION SYSTEM

Buffaló Filter LLC 5900 Genesee Street Lančašter NY 14086 Phone (716) 835 7000 Fax No (716) 835 3414

Contact

Carrie Fermin Director of Quality and Regulatory Affairs Phone (716) 835-7000 Fax No (716) 835 3414

October 21, 2013 Summary Date

CONFIDENTIAL

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1. Device Name

Trade Name:	VISICLEAR Smoke Evacuation System
Common Name:	Smoke Evacuator
Classification Name:	Air Handling Device for a surgical operating room(21 CFR 878.5070, Product Code FYD). Class II

2. Predicate Device

Buffalo Filter, LLC ("Buffalo Filter") claims substantial equivalence to:

a. Conmed Corporation. Conined Aer Defense Smoke Evacuator (K091139)
b. Buffalo Filter. Porta PlumeSafe 601 Smoke Evacuation System (K924732)

3. Description of Device

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The filter life of the VS135 is based on flow rate through the filter and is 35 hours in Laparoscopic Mode, and 18 hours at Open Mode. The filter life for the predicate devices is based on a time of use of 35 hours on Lap Mode and 18 hours on Open Mode. Bench testing has shown the filter life is substantially equivalent to the predicate filters.

The life of the filter is based on the initial time decrementing during operation. specifically when the smoke evacuator motor is operating. The smoke evacuator software is programmed to decrement the filter at the appropriate rate dependent on the selected mode. The filter life is an initial integer stored on an RFID tag during filter assembly that is programmed with the maximum filter life time. During operation, the smoke evacuator decrements that filter time from the RFID tag until the time expires. Since the filter life is stored directly on the RFIL tag located on each filter, when the filter is moved from one smoke evacuator to another, remaining filter life is recognized by any smoke evacuator. Once the filter is expired, time has decremented to zero, the filter will no longer operate in any smoke evacuation system. This operation cannot be bypassed, as time cannot be added back to the filter by the end user. The software verification confirmed the effectiveness of this feature to limit the filter use to only the intended life. The testing per IEC 60601-1-2 and IEC 60601-1-1 confirmed the safety and effectiveness of the technology for use in the smoke evacuation system.

4. Intended Use

The VISICLEAR Smoke Evacuation System is designed to remove and filter smoke, aerosols produced during electrosurgical and laser procedures.

Indications for use for the VISICLEAR smoke evacuation system include:

a. To remove and filter smoke and aerosols from a surgical site produced during electrosurgical and laser procedures

ડ. Description of Safety and Substantial Equivalence

Substantial equivalence is based on two (2) predicate devices. All the above referenced predicates are Air-Handling Apparatus for a surgical operating room defined in 21 CFR 878.5070.

The Buffalo Filter VISICLEAR smoke evacuation system was verified and validated through bench testing designed and conducted to show that the device operates as safe and as effective as the predicate devices, K091139 and K924732.

Like the predicate devices, the VISICLEAR is used in hospitals, operating room theaters, and doctor's offices and requires physician's prescription for use. The device and all predicates are not intended for patient contact.

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The VISICLEAR is equivalent in technological characteristics to the predicate devices in that like VISICLEAR, all predicate devices use a vacuum motor, user interface with motor control features, sound reducing insulation, a filter with a specific life expectancy, and accessories such as tubing to capture the surgical smoke. The device utilizes the same materials found in predicate device, "Aer Defense' with the housing comprised of a combination of plastic and metal, and sound reducing insulation. The VISICLEAR filter is equivalent in design characteristics to the predicate devices, in that multiple layers of filtration are utilized to achieve designed efficiency. These layers include a pre-filter to trap and remove gross particulate; an ULPA grade filter media that captures particulates from 0.1 to 0.2 microns ar an efficiency of 99.999%; another layer comprised of virgin activated carbon; and a final filter laver intended to reduce the migration of granular activated carbon from the self-contained filter.

Verification for the VISICLEAR smoke evacuation system included mechanical. electrical, and software testing.

The electrical verification testing showed that the device met its operational mode and electrical design requirements as specified in the test protocol. Electrical safety testing was conducted for the VISICLEAR smoke evacuation system according to IEC/ANSI/AAMI 60601-1 and 1EC/ANSI/AAMI 60601-1-2. This testing indicated that the VISICLEAR met all electrical safety requirements for the referenced standards.

The mechanical/performance verification testing showed that the device met its mechanical/performance design requirements as specified in the test protocol. Filter life verification testing was conducted for the VISICLEAR smoke evacuation system to confirm the ULPA efficiency of the filter for the maximum flow rate and filter life time. This testing indicated the filter successfully passed ULPA efficiency after 18 hours of saturation of particles at 30CFM flow rate. Flow Verification testing was conducted for the VISICLEAR smoke evacuation system to verify flow performance outlined in the design specification. This testing indicated that the VISICLEAR met all the specified flow requirements at each of the data points for each of the modes of operation. Laparoscopic Smoke Evacuation Verification was conducted for the VISICLEAR smoke evacuation system to confirm effectiveness at clearing smoke while not reducing the pneumoperitoneum. Smoke removal effectiveness verification testing was completed to demonstrate and quantify the ability of the VISICLEAR to remove smoke aerosols resulting from electrosurgical and laser procedures. Reliability testing was conducted for the VISICLEAR smoke evacuation system to demonstrate the use life of the device and no degradation in performance over that time span. Efficiency testing was conducted to ensure the fourth stage of filtration is adequately capturing the carbon fines.

The software verification testing showed that the device met the operational mode and software design requirements as specified in the protocol.

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All test results for the non-clinical bench testing indicate that the VISICLEAR smoke evacuation system is substantially equivalent to the predicate devices, K091139 and K924732.

Validation testing has shown that the VISICLEAR smoke evacuation system has met its operation mode and validation requirements. Test results indicate that the VISICLEAR is substantially equivalent to the predicate devices, K091139 and K924732.

The VISICLEAR smoke evacuation system and the predicate devices do not contact the patient and are substantially equivalent regarding biocompatibility.

Parameters
Models	PPS 601	Aer Defense	VISICLEAR
Intended Use	Smoke Evacuationand Filtration	Smoke Evacuationand Filtration	Smoke Evacuationand Filtration
Indications forUse	Evacuation of smokeplume and odorgenerated duringlaser orelectrosurgeryprocedures	To remove smoke,aerosols and mitigateodors produced bysurgical smokeduring electrosurgicalprocedures	To remove smokeand aerosols from asurgical site; tomitigate odorsproduced by surgicalsmoke duringelectrosurgical andlaser procedures.
TargetPopulation	For physicians andtrained hospital staffduring the use oflasers orelectrosurgery	For physicians andtrained hospital staffduring the use oflasers orelectrosurgery	For physicians andtrained hospital staffduring the use oflasers orelectrosurgery
User Interface	Touch Keypad withLED Indicator Lights	Touch Keypad withLED Indicator Lights	Touch Keypad withLED Indicator Lights
Energy Used	Electrical Current	Electrical Current	Electrical Current
OperationalSettings	On/Off Switch,Suction level buttonsfor Motor Control	On/Off Switch,Suction level buttonsfor Motor Control	On/Off Switch,Suction level buttonsfor Motor Control
CompatibilitywithEnvironment& OtherDevices	Compatible, neutralto other devices	Compatible, neutralto other devices	Compatible, neutralto other devices

Technical Characteristics to Support Substantial Equivalence:

CONFIDENTIAL

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IntendedMarketedAccessories
Tubing, Hoses, &Adaptors – Sterileand Non-Sterile	Electrosurgicalpencils, Tubing,Hoses, & Adaptors –Sterile and Non-Sterile	Electrosurgicalpencils, Tubing,Hoses, & Adaptors –Sterile and Non-Sterile
Materials ofConstruction	Stainless SteelHousing, Insulation,Glass micro fiberfilter media, granularactivated carbon	Coated AluminumHousing and ABSPlastic Fascia,Insulation, Glassmicro fiber filtermedia, coconut shellcarbon	Powder-CoatedAluminum Housing,ABS -PC PlasticFascia, Insulation,Glass micro fiberfilter media, granularactivated carbon
Specifications	Flow Up to 60 CFM,Filter Efficiency of99.99995% at 0.12microns	Flow up to 25 CFM,ULPA FilterEfficiency of99.9995% at 0.12microns or greater	Flow up to 30 CFM,Filter Efficiency of99.999% at 0.1 to 0.2microns
DeviceMechanism ofAction	Vacuum source witha mechanical meansof filtration	Vacuum source witha mechanical meansof filtration	Vacuum source witha mechanical meansof filtration
Air Flow Path	Through Vacuumhose or tubing, into afilter, then vacuummotor, and ventedinto the room	Through Vacuumhose or tubing, into afilter, then vacuummotor, and ventedinto the room	Through Vacuumhose or tubing, into afilter, then vacuummotor, and ventedinto the room
Performance	25 Hours filter life,capture and filtrationof smoke plume at99.99995% efficiency	The ULPA-gradefilter is 99.9995%efficiency at 0.12micron particle sizewith a filter life of upto 35 hours	The ULPA-gradefilter is 99.999%efficiency at 0.10 to0.20 micron particlesize with a filter lifeof up to 35 hours
Human Factors	Used by surgeons andtrained health careprofessionals	Used by surgeons andtrained health careprofessionals	Used by surgeons andtrained health careprofessionals
ElectricalSafety	Tested and Compliantto IEC 60601-1:1990	IEC 60601-1 testedand compliant	Tested and Compliantto IEC 60601-1 andIEC 60601-1-2
MechanicalSafety	Tested and compliantper IEC60601-1 formechanical safety	Tested and compliantper IEC60601-1 formechanical safety	Tested and compliantper IEC60601-1 formechanical safety
ChemicalSafety	Neutral pH, non-patient contact	Neutral pH, non-patient contact	Neutral pH, non-patient contact

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Thermal Safety	Operation of thedevice does not result	Operation of thedevice does not result	Operation of thedevice does not result
	in harmfultemperatures, testedand compliant perIEC60601-1	in harmfultemperatures, testedand compliant perIEC60601-1	in harmfultemperatures, testedand compliant perIEC60601-1
RadiationSafety	Non-radioactive	Non-radioactive	Non-radioactive

The design, operational and technical characteristics, performance and non-clinical testing of the VISICLEAR smoke evacuation system are substantially equivalent to and as effective as that of the predicate devices.

The differences noted in the chart between the VISICLEAR smoke evacuation system and the listed predicates are the filter life performance and maximum air flow performance. Testing has demonstrated the VISICLEAR system operates as effective as the listed predicate devices.

The VISICLEAR is as safe and performs as well as the previously identified legally marketed predicate devices. The VISICLEAR's intended use and indications statement for use are substantially supported by the previously cleared predicate devices; and do not impact the safety and effectiveness of the device when used as labeled.

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Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with outstretched wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the bird symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 3, 2014

Buffalo Filter, LLC Ms. Carrie Termin Director of Ouality and Regulatory Affairs 5900 Genesee Street Lancaster, NY 14086

Re: K131402

Trade/Device Name: VISICLEAR Smoke Evacuation System Regulation Number: 21 CFR 878.5070 Regulation Name: Air Handling Device for a Surgical Operating Room Regulatory Class: II Product Code: FYD Dated: January 17, 2014 Received: January 24, 2014

Dear Ms. Termin:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 - Ms. Termin

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

FOR

Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Sincerely yours.

Enclosure

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Indications for Use

510(k) Number: K131402

Device Name: VisiClear Smoke Evacuation System

Indications For Use:

The VisiClear Smoke Evacuation System is designed to remove and filter smoke and aerosols from a surgical site produced during electrosurgical and laser procedures

Prescription Use X (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)

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CONFIDENTIAL

October 21, 2013

Section 004, Page 4-1

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.

Acceptance Criteria / Parameter	Predicate Device (Conmed Aer Defense K091139) Reported Performance	Predicate Device (Buffalo Filter Porta PlumeSafe 601 K924732) Reported Performance	VISICLEAR Smoke Evacuation System Reported Performance
Intended Use	Smoke Evacuation and Filtration	Smoke Evacuation and Filtration	Smoke Evacuation and Filtration
Indications for Use	To remove smoke, aerosols and mitigate odors produced by surgical smoke during electrosurgical procedures	Evacuation of smoke plume and odor generated during laser or electrosurgery procedures	To remove smoke and aerosols from a surgical site; to mitigate odors produced by surgical smoke during electrosurgical and laser procedures.
Target Population	Physicians and trained hospital staff during the use of lasers or electrosurgery	For physicians and trained hospital staff during the use of lasers or electrosurgery	For physicians and trained hospital staff during the use of lasers or electrosurgery
User Interface	Touch Keypad with LED Indicator Lights	Touch Keypad with LED Indicator Lights	Touch Keypad with LED Indicator Lights
Energy Used	Electrical Current	Electrical Current	Electrical Current
Operational Settings	On/Off Switch, Suction level buttons for Motor Control	On/Off Switch, Suction level buttons for Motor Control	On/Off Switch, Suction level buttons for Motor Control
Compatibility with Environment & Other Devices	Compatible, neutral to other devices	Compatible, neutral to other devices	Compatible, neutral to other devices
Materials of Construction	Coated Aluminum Housing and ABS Plastic Fascia, Insulation, Glass micro fiber filter media, coconut shell carbon	Stainless Steel Housing, Insulation, Glass micro fiber filter media, granular activated carbon	Powder-Coated Aluminum Housing, ABS -PC Plastic Fascia, Insulation, Glass micro fiber filter media, granular activated carbon
Maximum Flow Rate	Up to 25 CFM	Up to 60 CFM	Up to 30 CFM
Filter Efficiency	ULPA Filter Efficiency of 99.9995% at 0.12 microns or greater	99.99995% at 0.12 microns	99.999% at 0.1 to 0.2 microns
Device Mechanism of Action	Vacuum source with a mechanical means of filtration	Vacuum source with a mechanical means of filtration	Vacuum source with a mechanical means of filtration
Air Flow Path	Through Vacuum hose or tubing, into a filter, then vacuum motor, and vented into the room	Through Vacuum hose or tubing, into a filter, then vacuum motor, and vented into the room	Through Vacuum hose or tubing, into a filter, then vacuum motor, and vented into the room
Filter Life	Up to 35 hours	25 Hours filter life	Up to 35 hours (Laparoscopic Mode), 18 hours (Open Mode)
Human Factors	Used by surgeons and trained health care professionals	Used by surgeons and trained health care professionals	Used by surgeons and trained health care professionals
Electrical Safety	IEC 60601-1 tested and compliant	Tested and Compliant to IEC 60601-1:1990	Tested and Compliant to IEC 60601-1 and IEC 60601-1-2
Mechanical Safety	Tested and compliant per IEC60601-1 for mechanical safety	Tested and compliant per IEC60601-1 for mechanical safety	Tested and compliant per IEC60601-1 for mechanical safety
Chemical Safety	Neutral pH, non-patient contact	Neutral pH, non-patient contact	Neutral pH, non-patient contact
Thermal Safety	Operation of the device does not result in harmful temperatures, tested and compliant per IEC60601-1	Operation of the device does not result in harmful temperatures, tested and compliant per IEC60601-1	Operation of the device does not result in harmful temperatures, tested and compliant per IEC60601-1
Radiation Safety	Non-radioactive	Non-radioactive	Non-radioactive
Laparoscopic Smoke Evacuation Verification	Not explicitly detailed, but implied by intended use	Not explicitly detailed, but implied by intended use	Confirmed effectiveness at clearing smoke while not reducing the pneumoperitoneum
Software Verification (for filter life decrementing)	Not explicitly detailed, but implied by predicate filter life	Not explicitly detailed, but implied by predicate filter life	Confirmed the effectiveness of this feature to limit the filter use to only the intended life.