The SurgiQuest AirSeal® iFS System is intended for use in diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas, to establish and maintain a path of entry for endoscopic instruments and to evacuate surgical smoke.

It is indicated to facilitate the use of various thoracoscopic and laparoscopic instruments by filling the abdominal or thoracic cavity with gas to distend it, by creating and maintaining a gas sealed obstruction-free instrument path and by evacuating surgical smoke. This instrument can also be used to insufflate the rectum and colon to facilitate endoscopic observation, diagnosis and treatment. The trocar of the AirSeal® iFS System is indicated for use with or without visualization.

Device Description

The SurgiQuest AirSeal®iFS System (cleared as AirSeal® Optical Trocar & Cannula System with integrated Insufflator DPIS 2000) consists of the following major components: (1) a trocar, (2) a cannula, (3) tube sets, and (4) a micro-processor-controlled insufflation, recirculation and filtration unit (the "AirSeal" iFS"). The cannula, trocar and tube sets are sterile, single-use products. The AirSeal iFS System is an active medical device, nonsterile and reusable and is intended to insufflate a body cavity. The AirSeal iFS System is designed to function in one of three (3) separate modes of operation: (a) Insufflation Mode; (b) AirSeal Mode; or (c) Smoke Evacuation Mode. The device contains software. The device is designed for use in Medical Centers, hospitals and medical clinics.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: SurgiQuest AirSeal iFS System

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily derived from the device's functional and performance specifications, ensuring it operates as intended. The "Results" column in the table below directly indicates compliance.

Acceptance Criteria (Verification/Validation Test)	Reported Device Performance
Verification AirSeal mode launches automatically after initial insufflation is completed.	Pass
Verification the iFS will maintain the actual pressure within a specified range of the set pressure.	Pass
Verification the AirSeal System venting feature activates appropriately and effectively reduces cavity pressure within the specified time.	Pass
Verification the iFS will maintain an average actual pressure within a specified range of the set pressure when an instrument is inserted into the Access Port and manipulated.	Pass
Compliance with AAMI ANSI ES60601-1 (Basic safety and essential performance)	Confirmed (listed as standard followed)
Compliance with IEC 60601-1-2 (Electromagnetic compatibility)	Confirmed (listed as standard followed)
Compliance with IEC 60601-2-18 (Endoscopic equipment safety and performance)	Confirmed (listed as standard followed)
Compliance with IEC 62304 (Medical device software life cycle processes)	Confirmed (listed as standard followed)
Compliance with ISO 10993-1, -5, -7, -10, -11 (Biocompatibility)	Confirmed (listed as standard followed)
Compliance with ISO 11135, ISO 11137-1, ISO 11137-2 (Sterilization)	Confirmed (listed as standard followed)
Compliance with ISO 11607-1 (Packaging for sterile medical devices)	Confirmed (listed as standard followed)
Compliance with ISO 14971 (Risk management)	Confirmed (listed as standard followed)
Compliance with AAMI ANSI ST67 (Sterility assurance level)	Confirmed (listed as standard followed)
Meeting all system medical/clinical design input requirements (via clinical/in vivo and simulated use testing)	Validated (confirmed by studies)
Absence of adverse events in clinical evaluations for thoracic use (Robotically-Assisted Thoracic Surgery / Video Assisted Thoracoscopic Surgery)	None reported across 4 studies

2. Sample Size Used for the Test Set and Data Provenance

The test set for clinical/in vivo and simulated use testing involved a total of 71 patients across four cited studies.

Cerfolio et al. 2016: 8 patients
Gonde et al. 2017: 10 patients
Kneuertz et al. 2017: 20 patients
Suda et al. 2014: 33 patients

The text does not explicitly state the country of origin for these clinical studies. It also doesn't specify if they were retrospective or prospective, though the nature of supporting clinical evidence often leans towards prospective or a mix. The phrase "real-world clinical evaluation" suggests observation in actual clinical settings.

For the bench/in vitro verification testing, the sample size is not quantified in terms of units tested, but it's stated that "extensive bench testing" was performed to confirm "all functional and performance attributes."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not provided in the document. The clinical studies are referenced by author names and publication years, but details on how the ground truth (e.g., successful procedure, absence of complications) was established by experts, or the qualifications of those experts, are absent. The mention of "testimonial letter from the author" for Cerfolio et al. 2016 confirms the study's findings but doesn't detail the expert review process within the study itself.

4. Adjudication Method for the Test Set

The adjudication method for establishing ground truth in the clinical studies is not explicitly stated.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

This aspect is not applicable to the SurgiQuest AirSeal iFS System. This device is an insufflation system, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance was not performed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This aspect is not applicable. The SurgiQuest AirSeal iFS System is a physical medical device with software control, but it's not a standalone algorithm/AI system whose performance would be measured without human interaction. It's an instrument used by surgeons.

7. The Type of Ground Truth Used

For the clinical/in vivo testing, the ground truth appears to be based on clinical outcomes and observations during surgical procedures, specifically the successful use of the device without reported adverse events. This implies confirmation by the physicians performing the procedures.

For the bench/in vitro verification testing, the ground truth was established by meeting predefined engineering specifications and requirements for functional and performance attributes. Compliance with recognized industry standards also serves as a ground truth baseline for safety and performance characteristics.

8. The Sample Size for the Training Set

The document does not provide information regarding a "training set" in the context of machine learning or AI. The device contains software ("The device contains software"), but it is not described as an AI/ML device that requires a separate training set for its algorithms to learn. Its software likely orchestrates control functions (e.g., pressure regulation, mode switching) based on hard-coded logic and control loops, rather than learned patterns from a training dataset.

9. How the Ground Truth for the Training Set Was Established

Since no training set for AI/ML is mentioned, this information is not applicable. The software's "ground truth" or correct functioning would have been established through traditional software verification and validation, ensuring it correctly implements its design specifications and requirements.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 16, 2018

ConMed Corporation % Michael Daniel President Daniel & Daniel Consulting, LLC 340 Jones Lane Gardnerville, Nevada 89460

Re: K172516

Trade/Device Name: SurgiOuest AirSeal iFS System Regulation Number: 21 CFR 884.1730 Regulation Name: Laparoscopic Insufflator Regulatory Class: Class II Product Code: HIF, GCJ Dated: February 13, 2018 Received: February 14, 2018

Dear Michael Daniel:

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, 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.

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 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);

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

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely. Jennifer R. Stevenson -S For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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6. Indications for Use Statement

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

Indications for Use

510(K) Number (if known)

K172516

Device Name

SurgiQuest AirSeal iFS System

· Indications for Use (Describe)

Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

FORM FDA 3881 (1/14)

Page 1 of 1

PSC Publishing Services (301) 443-6740 EB

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Premarket Notification 510(k) Summary

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

510(k) Number: K172516

Applicant Information:

Date Prepared:	August 18, 2017
Date Modified:	March 15, 2018
Name:	ConMed CorporationAddress: 488 Wheelers Farms RoadMilford, CT 06461
Contact Person:	Michael A Daniel, Consultantmadaniel@clinregconsult.com
Mobile Number:	(415) 407-0223
Office Number:	(775) 392-2970
Facsimile Number:	(610) 545-0799
Alternate Contact:	Lisa B. Anderson, Manager, Regulatory AffairsConMed Corporationlisaanderson@conmed.com
Mobile Number:	(941) 713-2035

Device Information:

Trade Name:	SurgiQuest AirSeal iFS System
Common Names:	Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy Endoscopic Insufflator
Classification Name(s):	Laparoscopic Insufflator
Product Code/ Regulation:	HIF 21 CFR 884.1730 GCJ
Classification:	Class II

Predicate Device:

SurgiQuest AirSeal iFS System K143404 ●

Device Description:

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Insufflation Mode; (b) AirSeal Mode; or (c) Smoke Evacuation Mode. The device contains software. The device is designed for use in Medical Centers, hospitals and medical clinics.

Intended Use

Indications for Use:

It is indicated to facilitate the use of various thoracoscopic instruments by filling the abdominal or thoracic cavity with gas to distend it, by creating and maintaining a gas sealed obstructionfree instrument path and by evacuating surgical smoke. This instrument can also be used to insufflate the rectum and colon to facilitate endoscopic observation, diagnosis and treatment. The trocar of the AirSeal® iFS System is indicated for use with or without visualization.

Comparison to Predicate Device

The tables on the following pages provide a summary of substantial equivalence between the subject device and the cited predicate. The subject device has the same intended use and identical technological characteristics with no new questions of safety or effectiveness raised. Clinical data are being provided to support safety and effectiveness for thoracic use. The questions remain the same, e.g.,

Can the insufflation pressures be adequately controlled and adjusted? 1)
1. Are the blood/tissue contacting materials biocompatible and sterile?
1. Are there any other risks to internal organs or tissues?

Summary Comparison to Predicate:

	Subject Device	Predicate Device	Comparison topredicate andreference devices
Device Name	SurgiQuest AirSeal iFS System	SurgiQuest AirSeal iFS System
Manufacturer	SurgiQuest	SurgiQuest	Same
510(k) #	K172516	K143404	N/A
RegulationNumber	21 CFR 884.1730	21 CFR 884.1730	Same
Class	Class II	Class II	Same
ClassificationAdvisoryCommittee	General & Plastic Surgery	General & Plastic Surgery	Same
DeviceClass/Name	Insufflator	Insufflator	Same
Product Code	HIF, GCJ	HIF, GCJ	Same

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	Subject Device	Predicate Device	Comparison topredicate andreference devices
Fundamentalscientifictechnology	Digital insufflation pressureregulation system.	Digital insufflation pressureregulation system	Same
Intended Use	The SurgiQuest AirSeal® iFSSystem is intended for use indiagnostic and/or therapeuticendoscopic procedures to distenda cavity by filling it with gas, toestablish and maintain a path ofentry for endoscopic instrumentsand to evacuate surgical smoke.	The SurgiQuest AirSeal® iFSSystem is intended for use indiagnostic and/or therapeuticendoscopic procedures to distenda cavity by filling it with gas, toestablish and maintain a path ofentry for endoscopic instrumentsand to evacuate surgical smoke.	Same
Indication for Use	It is indicated to facilitate the useof various thoracoscopic andlaparoscopic instruments byfilling the abdominal or thoraciccavity with gas to distend it, bycreating and maintaining a gassealed obstruction-free instrumentpath and by evacuating surgicalsmoke. This instrument can alsobe used to insufflate the rectumand colon to facilitate endoscopicobservation, diagnosis andtreatment. The trocar of theAirSeal® iFS System is indicatedfor use with or withoutvisualization.	It is indicated to facilitate the useof various thoracoscopic andlaparoscopic instruments byfilling the abdominal cavity withgas to distend it, by creating andmaintaining a gas sealedobstruction-free instrument pathand by evacuating surgicalsmoke. This instrument can alsobe used to insufflate the rectumand colon to facilitate endoscopicobservation, diagnosis andtreatment. The trocar of theAirSeal® iFS System is indicatedfor use with or withoutvisualization.	Substantially equivalentbased upon clinicalevidence provided.

List of Standards Used:

Verification and validation testing was completed in compliance with the following standards:

AAMI ANSI ES60601-1:2005(R)2012 and A1:2012, C1:2009(R)2012 and A2:2010(R)2012 . (Consolidated Text) Medical electrical equipment – Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD). FDA recognition number: 19-4
IEC 60601-1-2:2007/AC:2010, Medical electrical equipment Part 1-2: General requirements for . basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests (Edition 3). FDA recognition number: 19-2
IEC 60601-2-18 Edition 3.0 2009-08, Medical electrical equipment Part 2-18: Particular . requirements for the basic safety and essential performance of endoscopic equipment. FDA recognition number: 9-61
. IEC 62304:2015. Medical device software – Software life cycle processes. FDA recognition number: 13-79
ISO 10993-1:2009(R) 2013, Biological evaluation of medical devices Part 1: Evaluation and . testing within a risk management process (Biocompatibility). FDA recognition number: 2-156

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ISO 10993-5: 2009/(R) 2014, Biological evaluation of medical devices Part 5: Tests for in vitro . cytotoxicity. (Biocompatibility). FDA recognition number: 2-153
. ISO 10993-7:2008, Biological evaluation of medical devices – Part 7: Ethylene oxide sterilization residuals (Including technical corrigendum 1, 2009). FDA recognition number: 14-408
ISO 10993-10: 2010, Biological evaluation of medical devices Part 10: Tests for irritation and . skin sensitization. (Biocompatibility). FDA recognition number: 2-173
ISO 10993-11: 2006/(R)2010, Biological evaluation of medical devices -11: tests for systemic . toxicity. (Biocompatibility). FDA recognition number: 2-118
ISO 11135:2014, Sterilization of heath care products Ethylene oxide Requirements for the . development, validation, and routine control of a sterilization process for medical devices. FDA recognition number: 14-452
. ISO 11137-1 First edition 2006-04-15, Sterilization of health care products - Radiation - Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices (Including: Amendment 1, 2013). FDA recognition number: 14-428
. ISO 11137-2:2013, Sterilization of health care products – Radiation- Part 2: Establishing the sterilization dose. FDA recognition number: 14-409
. ISO 11607-1:2006, Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems. FDA recognition number: 14-454
ISO 14971:2007, Medical devices Application of risk management to medical devices. FDA . recognition number: 5-40
. AAMI ANSI ST67:2011, Sterilization of health care products - Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled "sterile". FDA recognition number: 14-314

Testing described in this 510(k) consisted of verification of all design input requirements and product specifications. All clinical input requirements were validated.

Summary of Testing Completed:

Bench/In vitro Verification Testing:

All system specifications were verified as having been met through extensive bench testing included confirming all functional and performance attributes of the system met their respective specifications and requirements. This testing included, but was not limited, to confirming compliance with each of the applicable portions of the FDA/industry recognized standards listed in the previous section. This testing included:

Test	Results
Verification AirSeal mode launches automatically after initial insufflation is completed.	Pass
Verification the iFS will maintain the actual pressure within a specified range of the set pressure.	Pass
Verification the AirSeal System venting feature activates appropriately and effectively reduces cavitypressure within the specified time.	Pass
Verification the iFS will maintain an average actual pressure within a specified range of the set pressurewhen an instrument is inserted into the Access Port and manipulated.	Pass

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Clinical/In vivo and Simulated Use Testing

All system medical/clinical design input requirements were validated as having been met through extensive performance and simulated use testing. This testing confirmed all functional and performance attributes of the system met their respective design input requirements in compliance with ConMed's design control procedures and systems. This validation testing included but was not limited to real-world clinical evaluation and simulated use testing utilizing bench models of the thoracic cavity simulating pressure and volume conditions.

Robotically-Assisted Thoracic Surgery / Video Assisted Thoracoscopic Surgery
Data Source	Number of Patients	Subject Device Used	Adverse Events
Cerfolio et al. 20161	8	yes	none
Gonde et al. 2017	10	yes	none
Kneuertz et al. 2017	20	yes	none
Suda et al. 2014	33	yes	none

Article Citations and Summary

Summary:

Based upon the Intended Use, Indications for Use, product technical information, performance evaluation, and standards compliance provided in this premarket notification, the SurgiQuest AirSeal iFS Insufflation System, has been shown to be substantially equivalent to the cited predicate.

1 Confirmed by testimonial letter from the author.

Regulation Number and Section

§ 884.1730 Laparoscopic insufflator.

(a)
Identification. A laparoscopic insufflator is a device used to facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it.(b)
Classification. (1) Class II (performance standards).(2) Class I for tubing and tubing/filter kits which include accessory instruments that are not used to effect intra-abdominal insufflation (pneumoperitoneum). The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.