The CONMED Aer Defense™ Smoke Evacuator is designed to remove smoke, aerosols and mitigate odors produced by surgical smoke during electrosurgical procedures.

Device Description

The CONMED Aer Defense™ Smoke Evacuator has been designed with a high suction, high flow rate, two-stage thru flow vacuum motor. Its motor is used to draw the surgical smoke from the surgical site, through the vacuum tubing and into the CONMED Aer Defense™ Smoke Evacuator's filter where the surgical smoke is processed by a series of filtration stages. A single disposable filter is used to simplify the installation and removal during filter changes.

AI/ML Overview

The CONMED® Aer Defense™ Smoke Evacuator's acceptance criteria are based on its substantial equivalence to predicate devices (Porta Plumesafe™ 601 Smoke Evacuation System, K924732 and the Smoke Evacuation section of the ConMed Integrated Service Manager SM40SE, K053464) in terms of design, composition, function, performance, and safety.

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1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Technological Characteristics
Filter Efficiency	Filter efficiency of 99.9995% for particle sizes of 0.12um or greater for ULPA grade filter (identical to predicate filters).	Met: "The FilterOne™ is an Ultra Low Penetration Air (ULPA) grade with carbon filter that has a filter efficiency of 99.9995% for particle sizes of 0.12um or greater. These characteristics are identical to the predicate filters."
Filter Life	Substantially equivalent filter life to predicate devices (predicate: 8 hrs maximum).	Met: "Bench testing has shown that the filter life for the Aer Defense™ Smoke Evacuator is substantially equivalent to the predicate filters based on bench testing." (Aer Defense: 35 hrs in Lap Mode, 10 hrs at maximum flow in Normal Mode).
Suction Flow Rate	Substantially equivalent to predicate flow range (predicate: 20 LPM in Normal Mode and 34 CFM in Boost Mode).	Met: "The maximum suction flow rate for the Aer Defense™ Smoke Evacuator ranges from a maximum 20 LPM in Laparoscopic Mode to 25 CFM in Normal Mode and is substantially equivalent to the flow range of 20 LPM in Normal Mode and 34 CFM in Boost Mode for the predicate devices."
Performance Characteristics
Electrical Verification	Meets operational mode and electrical design requirements; substantially equivalent to predicate devices.	Met: "Electrical Verification testing showed that the Aer Defense™ Smoke Evacuator met its operational mode and electrical design requirements as specified in the test protocol. Test results indicate that the Aer Defense™ Smoke Evacuator is substantially equivalent to the predicate devices."
Mechanical Verification	Meets mechanical design requirements; substantially equivalent to predicate devices.	Met: "Mechanical Verification testing has shown that the Aer Defense™ Smoke Evacuator has met its mechanical design requirements as specified in the protocol. Test results indicate that the Aer Defense™ Smoke Evacuator is substantially equivalent to the predicate devices."
Software Verification	Meets operational mode and software design requirements; substantially equivalent to predicate devices.	Met: "Software Verification testing has shown that the Aer Defense™ Smoke Evacuator has met the operational mode and software design requirements as specified in the protocol. Test results indicate that the Aer Defense™ Smoke Evacuator is substantially equivalent to the predicate devices."
Validation Testing	Meets operational mode and validation requirements; substantially equivalent to predicate devices.	Met: "Validation testing has shown that the Aer Defense™ Smoke Evacuator has met its operational mode and validation requirements. Test results indicate that the Aer Defense™ Smoke Evacuator is substantially equivalent to the predicate devices."
Electrical Safety	Meets standards of IEC 60601-1-1, IEC 60601-1-2, and UL 60601-1; substantially equivalent to predicate devices.	Met: "Electrical Safety testing that was conducted for the Aer Defense™ Smoke Evacuator was done according to IEC 60601-1-1, IEC 60601-1-2, and UL 60601-1. This testing indicates that the electrical safety for the Aer Defense™ Smoke Evacuator is substantially equivalent to the predicate devices."
Modes of Operation
Normal Mode	Substantially equivalent to predicate devices.	Met: "The Normal Mode is substantially equivalent to the Normal Mode and Boost Mode in predicate devices, K924732 and K053464."
Laparoscopic Mode	Substantially equivalent to predicate devices.	Met: "The Laparoscopic Mode is substantially equivalent to the Laparoscopic Mode and the Normal Mode in predicate devices K053464 and K924732 respectively."
Footswitch Mode	Functions the same as predicate devices.	Met: "This mode functions the same as the Footswitch Mode for the predicate devices, K924732 and K053464."
Continuous Activation Mode	As safe and effective as normal operation; substantially equivalent to predicate devices (despite not being present in predicate).	Met: "Electrical and Software Verification bench testing has shown this mode to be as safe and effective as the normal operation of the device and is substantially equivalent to the predicate devices."
ConMed ESU Automatic Mode	As safe and effective as normal operation; substantially equivalent to predicate devices (despite not being present in predicate).	Met: "Electrical and Software Verification bench testing has shown this mode to be as safe and effective as the normal operation of the device and is substantially equivalent to the predicate devices."
Integrated Operating Room Interface Mode	As safe and effective as normal operation; substantially equivalent to predicate devices (despite not being present in predicate).	Met: "Electrical and Software Verification bench testing has shown this mode to be as safe and effective as the normal operation of the device and is substantially equivalent to the predicate devices."
Biocompatibility	Does not contact the patient; substantially equivalent to predicate devices.	Met: "The CONMED® Aer Defense™ Smoke Evacuator and the predicate devices do not contact the patient and are substantially equivalent regarding biocompatibility."
Indication for Use	Designed to remove smoke, aerosols, and mitigate odors produced by surgical smoke during electrosurgical procedures; substantially equivalent to predicate devices.	Met: "The CONMED® Aer Defense™ Smoke Evacuator is designed to remove smoke, aerosols and mitigate odors produced by surgical smoke during electrosurgical procedures. This indication is substantially equivalent to the indications of the predicate devices."

Study that Proves the Device Meets Acceptance Criteria

The study described is a Design Verification & Validation bench testing program. The primary methodology employed is demonstrating substantial equivalence to existing predicate devices.

All sections below will contain "Not applicable" unless explicitly stated otherwise in the provided text.

2. Sample size used for the test set and the data provenance

Sample Size: The document does not specify a distinct "test set" sample size in terms of number of units or data points. The testing is described as "bench testing" and "Verification & Validation testing" on the device itself.
Data Provenance: The tests were "bench testing," meaning they were conducted in a laboratory or controlled environment. There is no mention of country of origin for specific data or whether it was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This study does not involve human interpretation or the establishment of ground truth by medical experts in the context of diagnostic accuracy. The "ground truth" for this device's performance is objective measurement against specified engineering and safety standards, and comparison to predicate device characteristics.

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

None. This type of adjudication is typically used in clinical studies involving interpretation of medical images or data by multiple readers. For engineering performance and safety testing, the results are typically objectively measured and compared to specifications or predicate device performance.

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

No MRMC study was done. This device is a smoke evacuator, not an AI-assisted diagnostic tool or an imaging device that would typically involve human readers.

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

The device itself is a standalone electrosurgical smoke evacuator. Performance tests (electrical, mechanical, software, validation, safety) were conducted on the device operating independently to demonstrate its functionality and safety characteristics, confirming it meets its design requirements. Therefore, in a sense, a "standalone" performance assessment of the hardware and software functionality was conducted. There is no AI algorithm involved in the traditional sense.

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

The "ground truth" for this device's performance is based on:

Objective Engineering Specifications: Electrical design requirements, mechanical design requirements, software design requirements, operational mode requirements, and validation requirements.
Established Safety Standards: IEC 60601-1-1, IEC 60601-1-2, and UL 60601-1 for electrical safety.
Predicate Device Characteristics: Performance parameters (filter efficiency, filter life, suction flow rate, modes of operation) were directly compared to those of the legally marketed predicate devices.

8. The sample size for the training set

Not applicable. This study does not involve machine learning or AI models that require a training set.

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

Not applicable. As no training set was used, no ground truth needed to be established for it.

Summary

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K091139

4.	Summary of Safety and Effectiveness
Submitted by:	CONMED Electrosurgery Division14603 East Fremont AvenueCentennial, CO 80112 USATelephone: 303-269-8296Facsimile: 303-699-9854
Contact Person:	Damaris Velez
Date Prepared:	February 12, 2009
Proprietary Name:	CONMED® Aer Defense™ Smoke Evacuator
Common Name:	Electrosurgical Surgical Smoke Evacuator
Classification Name:	Apparatus, Exhaust, SurgicalFYD
Predicate Device:	This product is similar in design, composition, and function to thePorta Plumesafe™ 601 Smoke Evacuation System, K924732 andthe Smoke Evacuation section of the ConMed Integrated ServiceManager SM40SE, K053464.

Technological Characteristics

Smoke Evacuator:

Filter:

The filter for the Aer Defense™ Smoke Evacuator, like the filters for the predicate devices, is a replaceable self-contained filter that is completely enclosed to help protect the health care personnel from potential contamination during filter changes. The FilterOne™ is an Ultra Low Penetration Air (ULPA) grade with carbon filter that has a filter efficiency of 99.9995% for particle sizes of 0.12um or greater. These characteristics are identical to the predicate filters.

The filter life for the FilterOne™ is based on the flow rate through the filter and is 35 hrs in Lap Mode, and 10 hrs at maximum flow in Normal Mode. The filter life for the

Aer Defense™ Smoke Evacuator

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predicate devices is based on time of use and is 8 hrs maximum. Bench testing has shown that the filter life for the Aer Defense™ Smoke Evacuator is substantially equivalent to the predicate filters based on bench testing.

Suction Flow Rate:

The maximum suction flow rate for the Aer Defense™ Smoke Evacuator ranges from a maximum 20 LPM in Laparoscopic Mode to 25 CFM in Normal Mode and is substantially equivalent to the flow range of 20 LPM in Normal Mode and 34 CFM in Boost Mode for the predicate devices, K924732 and K053464.

Performance Characteristics:

Performance Testing: Design Verification & Validation bench testing was designed and conducted to show that the Aer Defense™ Smoke Evacuator operates as safe and effective as the predicate devices. K924732 and K053464.

Electrical Verification testing showed that the Aer Defense™ Smoke Evacuator met its operational mode and electrical design requirements as specified in the test protocol. Test results indicate that the Aer Defense™ Smoke Evacuator is substantially equivalent to the predicate devices, K924732 and K053464.

Mechanical Verification testing has shown that the Aer Defense™ Smoke Evacuator has met its mechanical design requirements as specified in the protocol. Test results indicate that the Aer Defense™ Smoke Evacuator is substantially equivalent to the predicate devices, K924732 and K053464.

Software Verification testing has shown that the Aer Defense™ Smoke Evacuator has met the operational mode and software design requirements as specified in the protocol. Test results indicate that the Aer Defense™ Smoke Evacuator is substantially equivalent to the predicate devices. K924732 and K053464.

Validation testing has shown that the Aer Defense™ Smoke Evacuator has met its operational mode and validation requirements. Test results indicate that the Aer Defense™ Smoke Evacuator is substantially equivalent to the predicate devices, K924732 and K053464.

These acceptable test results for the non-clinical bench testing indicate that the Aer Defense™ Smoke Evacuator operation is substantially equivalent to the predicate devices, K924732 and K053464.

Electrical Safety:

Electrical Safety testing that was conducted for the Aer Defense™ Smoke Evacuator was done according to IEC 60601-1-1, IEC 60601-1-2, and UL 60601-1. This testing

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indicates that the electrical safety for the Aer Defense™ Smoke Evacuator is substantially equivalent to the predicate devices, K924732 and K053464.

Modes of Operation:

Normal Mode - Normal mode is the default activation mode. The smoke evacuator will run in this mode when none of the available modes have been selected and illuminated on the control panel (Laparoscopic, Continuous, Automatic, or Footswitch). While in Normal Mode, the smoke evacuator will start suction upon activation from an ESU. The Normal Mode is substantially equivalent to the Normal Mode and Boost Mode in predicate devices, K924732 and K053464.

Laparoscopic Mode - This mode is designed to provide a low flow suction control range for use in minimally invasive procedures. Laparoscopic mode is controlled by Normal, ConMed ESU Automatic, Footswitch, or Continuous activation modes. The Laparoscopic Mode is substantially equivalent to the Laparoscopic Mode and the Normal Mode in predicate devices K053464 and K924732 respectively.

Footswitch Mode - This mode starts suction upon activation of the Pneumatic Footswitch only. The smoke evacuator can be turned on or off by depressing the footswitch once to turn suction on and once again to turn suction off. This mode functions the same as the Footswitch Mode for the predicate devices, K924732 and K053464.

Continuous Activation Mode - This mode runs the smoke evacuator at the selected power level continuously, without activation of the Handpiece, until the mode has been deselected, another mode is selected, or the unit is turned off. This operating mode is not available in the predicate devices.

Electrical and Software Verification bench testing has shown this mode to be as safe and effective as the normal operation of the device and is substantially equivalent to the predicate devices, K924732 and K053464.

ConMed ESU Automatic Mode - This mode starts suction upon Handpiece activation from either a ConMed System 5000 or System 2450 ESU. The smoke evacuator will also employ automatic adjustments of the flow level based on the ConMed ESU power usage. This operating mode is not available in the predicate devices.

Integrated Operating Room Interface Mode - This mode allows the smoke evacuator front panel controls to be set through the devices serial port by an integrated operating room control center. This operating mode is not available in the predicate devices,

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Biocompatibility:

The CONMED® Aer Defense™ Smoke Evacuator and the predicate devices do not contact the patient and are substantially equivalent regarding biocompatibility.

Indication for Use:

The CONMED® Aer Defense™ Smoke Evacuator is designed to remove smoke, aerosols and mitigate odors produced by surgical smoke during electrosurgical procedures. This indication is substantially equivalent to the indications of the predicate devices. K924732 and K053464.

Summary:

The Electrical, Mechanical, Software, and Safety testing indicate that the CONMED Aer Defense Smoke Evacuator is substantially equivalent to the predicate devices identified in K924732 and K053464.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services, USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged around the top half of the circle. In the center of the seal is an emblem that resembles an eagle or other bird-like figure. The emblem is stylized and abstract, with flowing lines that suggest movement or flight.

MAY - 5 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Underwriters Laboratories, Incorporated C/O Mr. Jeff D. Rongero Responsible Third Party Official Conmed Corporation 12 Laboratory Drive Research Triangle Park, North Carolina 27709

Re: K091139

Trade/Device Name: Conmed Aer Defense Smoke Evacuator Regulation Number: 21 CFR 878.5070 Regulatory Class: Il Product Code: FYD Dated: April 17, 2009 Received: April 20, 2009

Dear Mr. Rongero:

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 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2- Mr. Rongero

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0100. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Susan Runner

Susan Runner, D.D.S., M.A. Acting 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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510(k) Number (if known):	K091139
---------------------------	---------

Device Name:	CONMED ® Aer Defense ™ Smoke Evacuator
--------------	--------------------------------------------------------------

Indications for Use:

The CONMED Aer Defense™ Smoke Evacuator is designed to remove smoke, aerosols and mitigate odors produced by surgical smoke during electrosurgical 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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Suan Dionnes

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

Page of

Kagillag 510(k) Number: _______________________________________________________________________________________________________________________________________________________________

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.