(233 days)
Not Found
No
The document describes a system for insufflation and smoke evacuation during endoscopic procedures. It mentions a microprocessor-controlled unit and software verification/validation, but there is no mention of AI, ML, or any features that would typically involve such technologies, such as image analysis, predictive modeling, or adaptive control based on complex data patterns. The functions described are related to gas flow, pressure regulation, and smoke evacuation, which are standard functionalities for insufflation devices.
Yes.
The device is intended for use in "diagnostic and/or therapeutic endoscopic procedures" and "to facilitate endoscopic observation, diagnosis, and treatment".
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is "intended for use in diagnostic and/or therapeutic endoscopic procedures." It also mentions being used "to insufflate the rectum and colon to facilitate endoscopic observation, diagnosis, and treatment."
No
The device description explicitly lists multiple hardware components including a trocar, cannula, tube sets, and a microprocessor-controlled insufflation, recirculation and filtration unit. It also mentions sterile, single-use products made of polycarbonate and stainless steel. While software is mentioned in the performance studies (Software verification and validation IEC 62304), the device is clearly a system with significant hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device's function as being used during diagnostic and therapeutic endoscopic procedures to distend body cavities, maintain a clear path for instruments, and evacuate smoke. It facilitates the procedure itself, rather than performing a diagnostic test on a sample taken from the body.
- Device Description: The description details components like trocars, cannulas, tube sets, and an insufflation unit. These are all tools used for surgical access and manipulation, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) in vitro (outside the body) to provide information about a physiological or pathological state.
The device is a surgical insufflation system used to create and maintain space within a body cavity during endoscopic procedures. This falls under the category of surgical instruments and accessories, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
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.
Product codes
HIF, GCJ
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal, thoracic, pediatric, rectum and colon
Indicated Patient Age Range
Adult and Pediatric
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Benchtop testing was completed to support substantial equivalence to the predicate as it relates to safety and effectiveness. The following tests were conducted to support substantial equivalence for the expanded indication:
- Packaging testing ISO 11607-1
- Software verification and validation IEC 62304
- Electrical safety IEC 60601-1
- Electromagnetic compatibility IEC 60601-1-2 (EMC and Immunity)
- Set pressure
- Initial insufflation
- Obturator removal and Instrument insertion
- Leak compensation
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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, with the letters "FDA" in a blue square. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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.
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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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3
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 christinamornak@conmed.com
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
4
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
5
| Device & Predicate Device(s): | Subject Device
K230239 | Predicate
Device
K063367 |
|-----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | CONMED AirSeal
iFS System | WOM 45L CORE
Insufflator Fl 14 |
| Manufacturer | CONMED | WOM (World Of
Medicine) |
| Device Name | AirSeal iFS System | 45L CORE Insufflator
F1 14 |
| Regulation Number | 21 CFR 884.1730
21 CFR 876.1500 | 21 CFR 884.1730
21 CFR 876.1500 |
| Product Code | HIF
GCJ | HIF
GCJ |
| Device Class/Name | Class II/Insufflator | Class II/Insufflator |
| Fundamental Scientific Technology | Digital insufflation
pressure regulation
system | Digital Insufflation
pressure regulation
system |
| Intended Use | 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. | The 45L CORE
Insufflator F1 14 (the
"Fl 14) is a C02
insufflator intended for
use in diagnostic and/or
therapeutic endoscopic
procedures to distend a
cavity by filling it with
gas. |
| Indications for Use | 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 45L core insufflator
fl 14 is a co2 insufflator
intended for use in
diagnostic and/or
therapeutic endoscopic
procedures to distend a
cavity by filling it with
gas. The high flow
application, the low
flow application and the
bariatric application of
the device are each
indicated for use in
facilitating the use of a
laparoscope by filling
the peritoneal cavity
with gas to distend it.
The low flow
application of the
device is indicated for
pediatric use. The
vessel harvesting
application of the fl 14
is indicated for use
during endoscopic
vessel harvesting
procedures to create a
cavity along the
saphenous vein and/or
radial artery during
endoscopic vessel
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,
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 obturator of | | |
| the Cannula Cap is | | |
| indicated for use with or | | |
| without visualization. | | |
| The ARS System must be | | |
| used with the Intuitive da | | |
| Vinci Xi or 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. | | |
6
The AirSeal iFS System and AirSeal dV Solution are the predicate in intended use of
distending a cavity with gas, creating a path for endoscopic equipment, and evacuating sur
7
smoke and the expanded pediatric indication is the same as the PneumoSure predicate (inclusive of pediatric population