AirSeal iFS System; AirSeal dV Solution

K230239 · Conmed Corporation · HIF · Sep 20, 2023 · Obstetrics/Gynecology

Device Facts

• Record ID: K230239
• Device Name: AirSeal iFS System; AirSeal dV Solution
• Applicant: Conmed Corporation
• Product Code: HIF · Obstetrics/Gynecology
• Decision Date: Sep 20, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1730
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

AirSeal iFS System The ConMed AirSeal® iFS System is intended for use in diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas, to create and maintain a gas-sealed obstruction-free path of entry for endoscopic instruments, and to evacuate surgical smoke. It is indicated for use in abdominal, thoracic, and pediatric procedures where insufflation is desired 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. AirSeal dV Solution The AirSeal Robotic Solution (ARS) is intended for use in diagnostic and/or therapeutic endoscopic procedures in conjunction with the ConMed AirSeal iFS and an Intuitive da Vinci X Cannula and Cannula Seal to distend a cavity by filling it with gas, to create and maintain a gas-sealed obstruction-free path of entry for endoscopic instruments, and to evacuate surgical smoke. It is indicated for use in abdominal, thoracic, and pediatric procedures where insufflation is desired to facilitate the use of various laparoscopic and thoracoscopic 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. The Cannula Cap is indicated for use with or without visualization. The ARS System must be used with the Intuitive da Vinci X 8mm Instrument Cannula, an Intuitive Cannula Seal and the AirSeal iFS in AirSeal mode. When used in AirSeal mode, the Cannula Cap and Bifurcated Tube Set are designed to provide CO2 gas delivery with stable pneumoperitoneum and continuous smoke evacuation during robotic assisted laparoscopic and thoracoscopic procedures using the da Vinci Xi or da Vinci X systems. The Bifurcated Filtered Tube Set is used to connect the Cannula Cap and Cannula Seal to the AirSeal iFS.

Device Story

System comprises trocar, cannula, tube sets, and microprocessor-controlled insufflation/recirculation/filtration unit. Operates in Insufflation, AirSeal (adult/pediatric), or Smoke Evacuation modes. Inputs: CO2 gas source; outputs: regulated gas flow and smoke evacuation. Used in OR by surgeons/staff. AirSeal dV Solution integrates with Intuitive da Vinci X/Xi systems via cannula cap/bifurcated tube set to maintain stable pneumoperitoneum during robotic surgery. Microprocessor regulates pressure/flow to maintain obstruction-free instrument path. Benefits: stable cavity distension, continuous smoke evacuation, improved visualization. Healthcare providers monitor system via interface to adjust insufflation parameters; output facilitates surgical access and visibility.

Clinical Evidence

Bench testing only. Testing included packaging (ISO 11607-1), software V&V (IEC 62304), electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), and performance metrics including set pressure, initial insufflation, obturator removal, instrument insertion, and leak compensation.

Technological Characteristics

Digital insufflation pressure regulation system. Components: polycarbonate/stainless steel cannula/cap, bifurcated filtered tube sets. Connectivity: connects to robotic surgical systems. Software: microprocessor-controlled. Sterilization: sterile single-use components (cannula/cap/tubes); reusable insufflation unit.

Indications for Use

Indicated for abdominal, thoracic, and pediatric patients requiring insufflation for diagnostic/therapeutic endoscopic procedures; facilitates instrument entry and smoke evacuation. Includes rectal/colonic insufflation. ARS indicated for robotic-assisted laparoscopic/thoracoscopic procedures using da Vinci Xi/X systems.

Regulatory Classification

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.

Predicate Devices

• WOM 45L CORE Insufflator, Model F114 (K063367)

Submission Summary (Full Text)

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September 20, 2023

CONMED Corporation Tina Mornak Manager, Regulatory Affairs 525 French Road Utica, NY 13502

K230239 Re: Trade/Device Name: AirSeal iFS System AirSeal dV Solution Regulation Number: 21 CFR§ 884.1730 Regulation Name: Laparoscopic Insufflator Regulatory Class: II Product Code: HIF, GCJ Dated: August 17, 2023 Received: August 17, 2023

Dear Tina Mornak:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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.

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Jason Roberts -S

Jason R. Roberts, Ph.D. Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K230239

Device Name AirSeal iFS System AirSeal dV Solution

# Indications for Use (Describe)

### AirSeal iFS System

The ConMed AirSeal® iFS System is intended for use in diagnostic endoscopic procedures to distend a cavity by filling it with gas, to create and maintain a gas-sealed obstruction-free path of entry for endoscopic instruments, and to evacuate surgical smoke.

It is indicated for use in abdominal, thoracic, and pediatric procedures where insufflation is desired 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 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.

### AirSeal dV Solution

The AirSeal Robotic Solution (ARS) is intended for use in diagnostic and/or therapeutic endoscopic procedures in conjunction with the ConMed AirSeal iFS and an Intuitive da Vinci X Cannula and Cannula Seal to distend a cavity by filling it with gas, to create and maintain a gas-sealed obstruction-free path of entry for endoscopic instruments, and to evacuate surgical smoke.

It is indicated for use in abdominal, thoracic, and pediatric procedures where insufflation is dese of various laparoscopic and thoracoscopic 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. The obturator of the Cannula Cap is indicated for use with or without visualization.

The ARS System must be used with the Intuitive da Vinci X 8mm Instrument Cannula, an Intuitive Cannula Seal and the AirSeal mode. When used in AirSeal mode, the Cannula Cap and Bifurcated Tube Set are designed to provide CO2 gas delivery with stable pneumoperioneum and continuous smoke evacuation during robotic assisted laparoscopic and thoracoscopic procedures using the da Vinci X systems. The Bifurcated Filtered Tube Set is used to connect the Cannula Cap and Cannula Seal to the AirSeal iFS.

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)

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# 510(k) Summary

# AirSeal iFS System

In accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92, ConMed Corporation is hereby submitting the 510(k) Summary of Safety and Effectiveness for this 510(k).

#### l. SUBMITTER

ConMed Corporation 525 French Road Utica, NY 13502

Company Contact:

Tina Mornak Manager, Requlatory Affairs 724-518-3191 [e-mail]

September 19, 2023 Date Prepared:

#### II. DEVICE NAME

Proprietary Name: AirSeal iFS System AirSeal dV Solution

AirSeal iFS System Model Numbers:

AirSeal dV Solution

AS-iFS1, iAS12-100, iAS12-100LPi, iAS12-120, iAS12-120LPi, iAS12-150, iAS12-150LPi, iAS5-100LP, iAS5-120LP, iAS5-75LP, iAS8-100LP, iAS8-120LP, iASB12-100, iASB12-120, iASB5-150, SEM-EVAC, SIM-TUB, ASM-EVAC, ASM-EVAC1

| Model Numbers: | ASM-EVAC1-Bi, iAS8-DV, iAS8-DVL |
|--------------------|-------------------------------------------------------------------|
| Common Name: | Insufflator, Laparoscopic; Laparoscope, General & Plastic Surgery |
| Regulation Name: | Laparoscopic Insufflator |
| Product Code: | HIF; GCJ |
| Device Class: | II |
| Regulation Number: | 21 CFR 884.1730; 21 CFR 876.1500 |

#### lll. PREDICATE/LEGALLY MARKETED DEVICE

| Predicate | |
|---------------|-----------------------------------------------------------------------|
| Device Name: | WOM 45L CORE Insufflator, Model F114 |
| Company Name: | W.O.M. World of Medicine GmBH |
| 510(k): | K063367 (Marketed by Stryker as the PneumoSure High Flow Insufflator) |

The predicate device has not been subject to a design-related recall.

# DEVICE DESCRIPTION

The ConMed AirSeal iFS System consists of the following major components: (1) a trocar, (2) a cannula, (3) tube sets, and (4) a microprocessor-controlled insufflation, recirculation

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and filtration unit. 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 (Adult and Pediatric); or (c) Smoke Evacuation Mode.

The ConMed AirSeal dV Solution (or AirSeal Robotic Solution) consists of the following major components: (1) AirSeal® Cannula Cap with a cannula cap and an obturator (in standard and long lengths), and (2) AirSeal® Bifurcated Filtered Tube Set. The cannula cap, obturator and tube set are sterile, single-use products. The AirSeal dV Solution, in conjunction with Intuitive daVinci XiX Cannula and Cannula Seal, is operated in the Airseal Mode with the AirSeal iFS System to distend a cavity by filling it with gas, to create and maintain a gas-sealed obstruction-free path of entry for endoscopic instruments, and to evacuate surgical smoke. The ConMed AirSeal dV Solution is a sterile, single use device, primarily composed of polycarbonate, and stainless steel,

#### IV. INTENDED USE / INDICATIONS FOR USE

### AirSeal iFS System

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

It is indicated for use in abdominal, thoracic, and pediatric procedures where insufflation is desired 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 as sealed obstruction-free instrument path and by evacuating surgical smoke. The 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.

# AirSeal dV Solution

The AirSeal Robotic Solution (ARS) is intended for use in diagnostic and/or therapeutic endoscopic procedures in conjunction with the ConMed AirSeal iFS and an Intuitive da Vinci X Cannula and Cannula Seal to distend a cavity by filling it with gas, to create and maintain a gassealed obstruction-free path of entry for endoscopic instruments, and to evacuate surgical smoke.

It is indicated for use in abdominal, thoracic, and pediatric procedures where insufflation is desired to facilitate the use of various laparoscopic and thoracoscopic 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. The Cannula Cap is indicated for use with or without visualization.

The ARS System must be used with the Intuitive da Vinci X 8mm Instrument Cannula, an Intuitive Cannula Seal and the AirSeal iFS in AirSeal mode. When used in AirSeal mode, the Cannula Cap and Bifurcated Tube Set are designed to provide CO2 gas delivery with stable pneumoperitoneum and continuous smoke evacuation during robotic assisted laparoscopic and thoracoscopic procedures using the da Vinci Xi or da Vinci X systems. The Bifurcated Filtered Tube Set is used to connect the Cannula Cap and Cannula Seal to the AirSeal iFS.

#### V. COMPARISON OF THE TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

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| Device & Predicate Device(s): | Subject Device<br>K230239 | Predicate<br>Device<br>K063367 |
|-----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | CONMED AirSeal<br>iFS System | WOM 45L CORE<br>Insufflator Fl 14 |
| Manufacturer | CONMED | WOM (World Of<br>Medicine) |
| Device Name | AirSeal iFS System | 45L CORE Insufflator<br>F1 14 |
| Regulation Number | 21 CFR 884.1730<br>21 CFR 876.1500 | 21 CFR 884.1730<br>21 CFR 876.1500 |
| Product Code | HIF<br>GCJ | HIF<br>GCJ |
| Device Class/Name | Class II/Insufflator | Class II/Insufflator |
| Fundamental Scientific Technology | Digital insufflation<br>pressure regulation<br>system | Digital Insufflation<br>pressure regulation<br>system |
| Intended Use | AirSeal® iFS System is<br>intended for use in<br>diagnostic and/or<br>therapeutic endoscopic<br>procedures to distend a<br>cavity by filling it with<br>gas, to establish and<br>maintain a path of entry<br>for endoscopic<br>instruments and to<br>evacuate surgical smoke. | The 45L CORE<br>Insufflator F1 14 (the<br>"Fl 14) is a C02<br>insufflator intended for<br>use in diagnostic and/or<br>therapeutic endoscopic<br>procedures to distend a<br>cavity by filling it with<br>gas. |
| Indications for Use | The ConMed AirSeal®<br>iFS System is intended<br>for use in diagnostic<br>and/or therapeutic<br>endoscopic procedures to<br>distend a cavity by filling<br>it with gas, to create and<br>maintain a gas-sealed<br>obstruction-free path of<br>entry for endoscopic<br>instruments, and to<br>evacuate surgical smoke.<br>It is indicated for use in<br>abdominal, thoracic, and<br>pediatric procedures<br>where insufflation is<br>desired to facilitate<br>the use of various<br>thoracoscopic and<br>laparoscopic instruments<br>by filling the abdominal<br>or thoracic cavity with<br>gas to distend it, by<br>creating and maintaining<br>a gas sealed obstruction-<br>free instrument path and<br>by evacuating surgical<br>smoke. This instrument<br>can also be used to<br>insufflate the rectum and<br>colon to facilitate<br>endoscopic observation,<br>diagnosis, and treatment. | The 45L core insufflator<br>fl 14 is a co2 insufflator<br>intended for use in<br>diagnostic and/or<br>therapeutic endoscopic<br>procedures to distend a<br>cavity by filling it with<br>gas. The high flow<br>application, the low<br>flow application and the<br>bariatric application of<br>the device are each<br>indicated for use in<br>facilitating the use of a<br>laparoscope by filling<br>the peritoneal cavity<br>with gas to distend it.<br>The low flow<br>application of the<br>device is indicated for<br>pediatric use. The<br>vessel harvesting<br>application of the fl 14<br>is indicated for use<br>during endoscopic<br>vessel harvesting<br>procedures to create a<br>cavity along the<br>saphenous vein and/or<br>radial artery during<br>endoscopic vessel<br>harvesting procedures |
| | | |
| indicated for use with or | | |
| without visualization. | | |
| | | |
| The AirSeal Robotic | | |
| Solution (ARS) is | | |
| intended for use in | | |
| diagnostic and/or | | |
| therapeutic endoscopic | | |
| procedures in conjunction | | |
| with the ConMed AirSeal | | |
| iFS and an Intuitive da | | |
| Vinci Xi or da Vinci X | | |
| Cannula and Cannula Seal | | |
| to distend a cavity by | | |
| filling it with gas, to | | |
| create and maintain a gas- | | |
| sealed obstruction-free | | |
| path of entry for | | |
| endoscopic instruments,<br>and to evacuate surgical | | |
| smoke. | | |
| | | |
| It is indicated for use in | | |
| abdominal, thoracic, and | | |
| pediatric procedures<br>where insufflation is | | |
| desired to facilitate the | | |
| use of various | | |
| laparoscopic and | |…