(44 days)
Not Found
No
The summary describes a microprocessor-controlled insufflation system with different operating modes. There is no mention of AI, ML, or any related concepts in the intended use, device description, or performance studies. The testing described is benchtop and verification testing, not related to training or evaluating AI/ML models.
Yes
The device is described as being used in "therapeutic endoscopic procedures" and for facilitating "treatment" in the rectum and colon.
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 further specifies its use to "facilitate endoscopic observation, diagnosis, and treatment."
No
The device description explicitly lists hardware components such as a trocar, cannula, tube sets, and a microprocessor-controlled insufflation, recirculation and filtration unit.
Based on the provided information, the ConMed AirSeal® iFS System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly describes a device used during surgical procedures to distend body cavities, create instrument paths, and evacuate smoke. This is an in vivo (within a living organism) application, not an in vitro (outside of a living organism) diagnostic test.
- Device Description: The description details components like a trocar, cannula, tube sets, and an insufflation unit. These are tools used for surgical access and manipulation, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting biomarkers, or providing diagnostic information based on laboratory analysis.
The device is a surgical insufflation system used to facilitate endoscopic procedures.
N/A
Intended Use / Indications for Use
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 (≥ 20kg ) 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal, thoracic, rectum and colon
Indicated Patient Age Range
pediatric (≥ 20kg) and adult
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
Benchtop testing demonstrates the ConMed AirSeal is substantially equivalent to the PneumoSure and predicate AirSeal iFS System regarding intended use, materials, technology, and performance. Comparison testing included the following utilizing an abdominal and thoracic pediatric (≥ 20kg) test model:
- Set pressure: Obtain pressure readings using an insufflation gas flow of 2LPM and 5LPM at set pressure points from 5 – 12mmHg. Comparison: Average pressure deviation from set pressure
- Initial insufflation: Obtain pressure readings at an insufflation gas flow of 20LPM with set pressure points at 5, 10, and 15mmHg. Comparison: Average of maximum pressures and deviation of average maximum pressure from set pressure
- Obturator removal: Obtain pressure readings at an insufflation gas flow of 10LPM and a set pressure of 12mmHg after removal of a 5mm and 12mm obturator. Comparison: Average pressure drop at removal and average pressure overshoot (system compensation)
- Instrument insertion: Obtain pressure readings at an insufflation gas flow of 10LPM and a set pressure of 12mmHg after insertion, manipulation, and removal of a test rod representing 5mm and 12mm instruments. Comparison: Average pressure drop at removal and average pressure overshoot (system compensation)
- Leak compensation: Obtain pressure readings at an insufflation gas flow of 20LPM and set pressures of 5mmHg and 12mmHg with introduced leak rates from 0-10LPM. Comparison: Average pressure deviation from set pressure
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Benchtop testing demonstrates the ConMed AirSeal is substantially equivalent to the PneumoSure and predicate AirSeal iFS System regarding intended use, materials, technology, and performance. Comparison testing included the following utilizing an abdominal and thoracic pediatric (≥ 20kg) test model. Design verification testing demonstrates the devices comply with the applicable sections of AAM/ANSI ES60601-1, and IEC 60601-1-2. Software and system verification test results demonstrate the device meets design specifications, including the following: Pressure and flow settings, display, increments; System response at various insufflation conditions; GUI settings and responses for various insufflation modes; System recognition and interaction with accessories. Analyses of these activities conclude the benefits associated with the use of the AirSeal iFS System outweigh the residual risks.
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, 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 28, 2019
ConMed Corporation Ms. Lisa Anderson Manager, Regulatory Affairs 525 French Road Utica. New York 13502
Re: K190303
Trade/Device Name: AirSeal iFS System Regulation Number: 21 CFR 884.1730 Regulation Name: Laparoscopic Insufflator Regulatory Class: Class II Product Code: HIF, GCJ Dated: February 8, 2019 Received: February 12, 2019
Dear Ms. Anderson:
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. You must comply with all the Act's
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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.
Digitally signed by Long H. Chen Lona H. Chen -S Date: 2019.03.28 09:12:52 -04'00' fOT
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
2
Indications for Use
510(k) Number (if known) K190303
Device Name AirSeal IFS System
Indications for Use (Describe)
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 (≥ 20kg ) 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.
| Type of Use (Select one or both, as applicable) |
|---|
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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K190303 Page 1/3 510(k) Summary of Safety and Effectiveness
CONMED AirSeal iFS System
In accordance with the requirements of the Safe Medical Device Act of 1990 and 21CFR 807.92, ConMed Corporation is hereby submitting the 510(k) Summary of Safety and Effectiveness for 510(k) number K190303 as of March 27, 2019.
A. Submitter
ConMed Corporation 525 French Road Utica, NY 13502 Establishment Registration: 1320894
B. Company Contact
Lisa Anderson Manager, Regulatory Affairs T: (941) 713-2035
C. Device Name
| Proprietary Name: | AirSeal iFS |
|---|---|
| Common Name: | Disposable Endoscopic Trocar and Cannula |
| Carbon Dioxide Insufflator for Laparoscopy | |
| Endoscopic Insufflator | |
| Classification Name: | Laparoscopic Insufflator |
| Endoscope and Accessories | |
| Regulation Number: | 884.1730, 876.1500 |
| Product Code: | HIF, GCJ |
| Regulatory Class: | II |
| Panel: | General and Plastic Surgery |
| D. Predicate Device | |
| Primary Device Name: | WOM 45L CORE Insufflator, Model F114 |
Primary Device Name: Company Name: 510(k):
WOM 45L CORE Insufflator, Model F 1 1 4 W.O.M. World of Medicine GmbH K063367 (Marketed by Stryker as the PneumoSure High Flow Insufflator)
Secondary Device Name: Company Name: 510(k):
AirSeal iFS System CONMED Corporation K172516
E. 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)
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K190303
K190303 Page 2/3
separate modes of operation: (a) Insufflation Mode; (b) AirSeal Mode (Adult and Pediatric); or (c) Smoke Evacuation Mode.
Intended Use / 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 (≥ 20kg) 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.
F. Technological Characteristics
The AirSeal iFS System is similar to the predicate devices in design, intended use, and indications. Like the predicates, the AirSeal iFS System is a software-driven device intended for insufflation of a surgical cavity. Dedicated modes allow for AirSeal functionality in general and pediatric populations where the patient is ≥ 20kg. The system provides audible and visual indicators to communicate system status, safety controls such as venting, occlusion or overpressure conditions, gas supply, and potential fluid ingress. Dedicated tubesets are designed to allow the system to monitor and maintain the pressure of the surgical cavity based on user settings. The subject and predicate Air Seal Systems utilize dedicated access ports for AirSeal functionality.
G. Performance Testing
Benchtop testing demonstrates the ConMed AirSeal is substantially equivalent to the PneumoSure and predicate AirSeal iFS System regarding intended use, materials, technology, and performance. Comparison testing included the following utilizing an abdominal and thoracic pediatric (≥ 20kg) test model:
| Performance | Measurement | Comparison |
|---|---|---|
| Set pressure | Obtain pressure readings using an | |
| insufflation gas flow of 2LPM and 5LPM at | ||
| set pressure points from 5 – 12mmHg. | Average pressure deviation from set | |
| pressure | ||
| Initial insufflation | Obtain pressure readings at an insufflation | |
| gas flow of 20LPM with set pressure points at | ||
| 5, 10, and 15mmHg. | Average of maximum pressures and | |
| deviation of average maximum | ||
| pressure from set pressure | ||
| Obturator removal | Obtain pressure readings at an insufflation | |
| gas flow of 10LPM and a set pressure of | ||
| 12mmHg after removal of a 5mm and 12mm | Average pressure drop at removal | |
| and average pressure overshoot | ||
| (system compensation) |
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K190303
| Performance | Measurement | Comparison |
|---|---|---|
| obturator. | ||
| Instrument insertion | Obtain pressure readings at an insufflation | |
| gas flow of 10LPM and a set pressure of | ||
| 12mmHg after insertion, manipulation, and | ||
| removal of a test rod representing 5mm and | ||
| 12mm instruments. | Average pressure drop at removal | |
| and average pressure overshoot | ||
| (system compensation) | ||
| Leak compensation | Obtain pressure readings at an insufflation | |
| gas flow of 20LPM and set pressures of | ||
| 5mmHg and 12mmHg with introduced leak | ||
| rates from 0-10LPM. | Average pressure deviation from set | |
| pressure |
Design verification testing demonstrates the devices comply with the applicable sections of AAM/ANSI ES60601-1, and IEC 60601-1-2. Software and system verification test results demonstrate the device meets design specifications, including the following:
- Pressure and flow settings, display, increments —
- System response at various insufflation conditions l
- GUI settings and responses for various insufflation modes |
- System recognition and interaction with accessories |
Analyses of these activities conclude the benefits associated with the use of the AirSeal iFS System outweigh the residual risks.
H. Substantial Equivalence
The differences between the predicate devices and the proposed device do not raise any new risks of safety or efficacy. Supporting information per this premarket submission confirms that the subject AirSeal iFS System is safe and effective for its intended use and is substantially equivalent in design, intended use, principals of operation, and technical characteristics to the Stryker PneumoSure and predicate AirSeal iFS System.
K190303 Page 3/3