(128 days)
Not Found
No
The summary describes a system for insufflation and smoke evacuation during robotic-assisted laparoscopic procedures. It focuses on mechanical components and gas flow control, with no mention of AI or ML technologies for image analysis, decision support, or other functions.
Yes.
The device is used to facilitate endoscopic procedures, which can be diagnostic and/or therapeutic. It creates and maintains a path for instruments and also evacuates surgical smoke, directly supporting therapeutic interventions.
No
The device is intended for use in endoscopic procedures to distend a cavity with gas, maintain an instrument path, and evacuate surgical smoke, which are therapeutic and procedural support functions, not diagnostic ones.
No
The device description explicitly lists physical components (Cannula Cap, Obturator, Bifurcated Filtered Tube Set) made of materials like polycarbonate, polypropylene, and stainless steel. It is a sterile, single-use physical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used during surgical procedures to distend a cavity, create an instrument path, and evacuate smoke. This is a surgical assist device, not a device used to examine specimens in vitro (outside the body) for diagnostic purposes.
- Device Description: The description reinforces its role in surgical procedures, working in conjunction with other surgical equipment.
- No mention of diagnostic testing: There is no mention of analyzing biological samples, detecting markers, or providing diagnostic information based on in vitro analysis.
The device's function is entirely focused on facilitating surgical interventions in vivo (within the body).
N/A
Intended Use / Indications for Use
The AirSeal® dV Solution, AirSeal Cannula Cap and AirSeal Bifurcated Filtered Tube Set, is intended for use in diagnostic and/or therapeutic endoscopic procedures in conjunction with the ConMed AirSeal iFS and an Intuitive da Vinci Xi and da Vinci X Cannula 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 (≥ 20kg) procedures where insufflation is desired to facilitate the use of various 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. The obturator of the Cannula Cap is indicated for use with or without visualization.
The AirSeal Cannula Cap and Bifurcated Filtered Tube Set must be used with the Intuitive da Vinci X 8 mm Instrument Cannula, an Inturtive 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 pneumoperitoneum and continuous smoke evacuation during robotic assisted laparoscopic procedures using the da Vinci Xi or da Vinci X systems. The Bifurcated Filtered Tube Set is used to connect the Cannula Seal to the AirSeal iFS.
Product codes
HIF, GCJ
Device Description
The ConMed AirSeal dV Solution consists of the following major components: (1) AirSeal® Cannula Cap with a cannula cap and an obturator, 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 Xi\X 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, polypropylene, and stainless steel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal, thoracic
Indicated Patient Age Range
pediatric (≥ 20kg)
Intended User / Care Setting
Healthcare Facility
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 device as it relates to safety and effectiveness. The following testing were conducted to support substantial equivalence:
- Penetration Force
- Flow Rate
- Pressure/Leak Testing
All results demonstrated acceptable performance.
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.
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 19, 2021
ConMed Corporation Ally Xu Lead Specialist, Regulatory Affairs 525 French Road Utica, NY 13502
Re: K21104
Trade/Device Name: AirSeal dV Solution - AirSeal Cannula Cap and AirSeal Bifurcated Filtered Tube Set Regulation Number: 21 CFR 884.1730 Regulation Name: Laparoscopic insufflator Regulatory Class: Class II Product Code: HIF, GCJ Dated: April 12, 2021 Received: April 13, 2021
Dear Ally Xu:
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
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 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) K21104
Device Name
AirSeal® dV Solution- AirSeal® Cannula Cap and AirSeal® Bifurcated Filtered Tube Set
Indications for Use (Describe)
The AirSeal® dV Solution, AirSeal Cannula Cap and AirSeal Bifurcated Filtered Tube Set, is intended for use in diagnostic and/or therapeutic endoscopic procedures in conjunction with the ConMed AirSeal iFS and an Intuitive da Vinci Xi and da Vinci X Cannula 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 (≥ 20kg) procedures where insufflation is desired to facilitate the use of various 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. The obturator of the Cannula Cap is indicated for use with or without visualization.
The AirSeal Cannula Cap and Bifurcated Filtered Tube Set must be used with the Intuitive da Vinci X 8 mm Instrument Cannula, an Inturtive 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 pneumoperitoneum and continuous smoke evacuation during robotic assisted laparoscopic procedures using the da Vinci Xi or da Vinci X systems. The Bifurcated Filtered Tube Set is used to connect the Cannula Seal to the AirSeal iFS.
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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510(k) Summary
CONMED AirSeal dV Solution
Date Prepared: August 17, 2021
A. Submitter
ConMed Corporation 525 French Road Utica, NY 13502 Establishment Registration: 1320894
B. Company Contact
Ally Xu Lead Regulatory Affairs T: (720) 546-8941
C. Device Name
| Proprietary Name: | AirSeal dV Solution- AirSeal® Cannula Cap and
AirSeal® Bifurcated Filtered Tube Set | |
|------------------------|-------------------------------------------------------------------------------------------------------------------------|--|
| Common Name: | Disposable Endoscopic Trocar and Cannula
Carbon Dioxide Insufflation Tubes for Laparoscopy
Endoscopic Insufflator | |
| Regulation Name: | Laparoscopic Insufflator | |
| Regulation Number: | 21 CFR 884.1730 | |
| Product Code: | HIF, GCJ | |
| Device Classification: | II | |
| Panel: | Obstetrics and Gynecology | |
D. Predicate Device
| Primary Device Name: | AirSeal iFS System |
|---|---|
| Company Name: | CONMED Corporation |
| 510(k): | K190303 |
The predicate device has not been subject to a design-related recall.
E. Device Description
The ConMed AirSeal dV Solution consists of the following major components: (1) AirSeal® Cannula Cap with a cannula cap and an obturator, 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 Xi\X 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, polypropylene, and stainless steel.
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Intended Use / Indications for Use
The AirSeal dV Solution®, AirSeal Cannula Cap and AirSeal Bifurcated Filtered Tube Set, 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 (≥ 20kg) 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 qas 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 AirSeal Cannula Cap and Bifurcated Filtered Tube Set must be used with the Intuitive da Vinci Xi or da Vinci X 8 mm 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 AirSeal Cannula Cap and Intuitive Cannula Seal to the AirSeal iFS.
F. Comparison to Predicate Device
The predicate device has the following 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."
| Feature | AirSeal dV Solution | AirSeal iFS System (K190303) |
|---|---|---|
| Product Code | HIF, GCJ | HIF, GCJ |
| System Components | Cannula Cap/Obturator, | |
| Filtered Tube set | Insufflator, | |
| Cannula/Obturator, | ||
| Tube set | ||
| Gas Flow (LPM) | Adult Range: 1-40 | Adult Range: 1-40 |
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| Pediatric Range: 0.1-20 | Pediatric Range: 0.1-20 | |
|---|---|---|
| Cannula Cap Inner | ||
| Diameter | 8 mm | 5, 8, 12 mm |
| Pressure | 5-20 mmHg | 5-20 mmHg |
| Smoke Evacuation | ||
| Levels | Adult: Low - 3LPM | |
| High - 8 LPM | ||
| Pediatric: Low - 2 LPM | ||
| High - 5 LPM | Adult: Low - 3LPM | |
| High - 8 LPM | ||
| Pediatric: Low - 2 LPM | ||
| High - 5 LPM | ||
| Use Environment | Healthcare Facility | Healthcare Facility |
The indications for use of the subject device are foundationally based on the indications for use of the predicate device. The subject and predicate device have the same intended use of distending a cavity with gas, creating a path for endoscopic equipment, and evacuating surgical smoke. The difference in indications for use does not constitute a new intended use, and the technological characteristics do not raise different questions of safety or effectiveness as compared to the predicate device. Technological differences were evaluated through performance testing, described below.
G. Summary of Non-Clinical Performance Data
Biocompatibility
AirSeal dV Solution has undergone biocompatibility testing in accordance with the 2020 FDA guidance document "Use of International Standard ISO 10993-1, Biological Evaluation of Medical Devices - Part 1: Evaluation and testing within a risk management process." Testing included:
- · Cytotoxicity (ISO 10993-5:2009)
- · Sensitization (ISO 10993-10:2010)
- · Irritation (ISO 10993-10:2010)
- · Acute Systemic Toxicity (ISO 10993- 11:2017)
- · Pyrogenicity (ISO 10993- 11:2017)
Due to identical materials and manufacturing processes, some testing was leveraged from the predicate device. Results of the testing determined that the subject device is noncytotoxic, non-sensitizing, non-irritating, not systemically toxic and non-pyrogenetic.
Shelf Life
The AirSeal dV Solution has a three-year shelf-life based on results of an accelerated aging study. The shelf-life study evaluated the device specifications and package inteqrity/sterile barrier. The device met all acceptance criteria to support a shelf-life of three years.
Performance
Benchtop testing was completed to support substantial equivalence to the predicate device as it relates to safety and effectiveness. The following testing were conducted to support substantial equivalence:
- · Penetration Force
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- Flow Rate
- Pressure/Leak Testing
All results demonstrated acceptable performance.
H. Conclusion
The results of performance testing described above demonstrate that the AirSeal dV Solution is as safe and effective as the predicate device and supports a determination of substantial equivalence.