(233 days)
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.
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.
The provided FDA 510(k) summary describes the AirSeal iFS System and AirSeal dV Solution, which are laparoscopic insufflators. This document is a premarket notification for a medical device seeking substantial equivalence to a predicate device. As such, the "acceptance criteria" and "device performance" in this context refer to engineering and regulatory compliance testing rather than clinical performance metrics typically associated with AI/ML algorithms.
Here's an analysis based on the provided text, addressing your questions where applicable and noting when particular information is not present in this type of regulatory submission:
1. Table of Acceptance Criteria and Reported Device Performance
The document lists performance data categories. The specific quantitative acceptance criteria and detailed reported performance values for each test are not explicitly provided in this summary document. This level of detail is typically found in full test reports submitted to the FDA but is summarized for the 510(k) public abstract.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Packaging testing | Compliant (ISO 11607-1) |
| Software verification and validation | Compliant (IEC 62304) |
| Electrical safety | Compliant (IEC 60601-1) |
| Electromagnetic compatibility (EMC and Immunity) | Compliant (IEC 60601-1-2) |
| Set pressure | Performance validated |
| Initial insufflation | Performance validated |
| Obturator removal and Instrument insertion | Performance validated |
| Leak compensation | Performance validated |
Study Proving Acceptance Criteria Met:
The study proving the device meets the acceptance criteria consists of benchtop testing and non-clinical testing. The document states:
- "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..." (followed by the list in the table above).
- "Based upon the findings of non-clinical testing, the differences present no issues of safety and efficacy and the subject AirSeal iFS System and AirSeal dV Solution are substantially equivalent to the predicate PneumoSure (K063367)."
2. Sample Size Used for the Test Set and Data Provenance
This document does not specify sample sizes for individual tests. The testing conducted is primarily engineering verification and validation (V&V) on device prototypes or production units. Data provenance (e.g., country of origin, retrospective/prospective) is not applicable or provided for these types of engineering tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not relevant to the described studies, as they are engineering performance tests of a physical medical device, not clinical studies involving expert interpretation of data or images. "Ground truth" in this context refers to established engineering specifications and regulatory standards.
4. Adjudication Method for the Test Set
Not applicable. The tests are objective measurements against predefined engineering specifications and regulatory standards, not subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
An MRMC comparative effectiveness study was not done. This device is not an AI/ML algorithm that assists human readers; it is a laparoscopic insufflator.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable. The device is a physical medical instrument, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the tests described would be established engineering specifications, design requirements, and recognized international standards (e.g., ISO, IEC) to which the device's performance is compared. For example, for "set pressure," the ground truth is the specified pressure values the device is designed to maintain.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm developed with a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for an AI/ML algorithm.
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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, 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.
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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 (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
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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 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
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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 DeviceK230239 | PredicateDeviceK063367 |
|---|---|---|
| Device Name | CONMED AirSealiFS System | WOM 45L COREInsufflator Fl 14 |
| Manufacturer | CONMED | WOM (World OfMedicine) |
| Device Name | AirSeal iFS System | 45L CORE InsufflatorF1 14 |
| Regulation Number | 21 CFR 884.173021 CFR 876.1500 | 21 CFR 884.173021 CFR 876.1500 |
| Product Code | HIFGCJ | HIFGCJ |
| Device Class/Name | Class II/Insufflator | Class II/Insufflator |
| Fundamental Scientific Technology | Digital insufflationpressure regulationsystem | Digital Insufflationpressure regulationsystem |
| Intended Use | AirSeal® iFS System isintended for use indiagnostic and/ortherapeutic endoscopicprocedures to distend acavity by filling it withgas, to establish andmaintain a path of entryfor endoscopicinstruments and toevacuate surgical smoke. | The 45L COREInsufflator F1 14 (the"Fl 14) is a C02insufflator intended foruse in diagnostic and/ortherapeutic endoscopicprocedures to distend acavity by filling it withgas. |
| Indications for Use | The ConMed AirSeal®iFS System is intendedfor use in diagnosticand/or therapeuticendoscopic procedures todistend a cavity by fillingit with gas, to create andmaintain a gas-sealedobstruction-free path ofentry for endoscopicinstruments, and toevacuate surgical smoke.It is indicated for use inabdominal, thoracic, andpediatric procedureswhere insufflation isdesired to facilitatethe use of variousthoracoscopic andlaparoscopic instrumentsby filling the abdominalor thoracic cavity withgas to distend it, bycreating and maintaininga gas sealed obstruction-free instrument path andby evacuating surgicalsmoke. This instrumentcan also be used toinsufflate the rectum andcolon to facilitateendoscopic observation,diagnosis, and treatment. | The 45L core insufflatorfl 14 is a co2 insufflatorintended for use indiagnostic and/ortherapeutic endoscopicprocedures to distend acavity by filling it withgas. The high flowapplication, the lowflow application and thebariatric application ofthe device are eachindicated for use infacilitating the use of alaparoscope by fillingthe peritoneal cavitywith gas to distend it.The low flowapplication of thedevice is indicated forpediatric use. Thevessel harvestingapplication of the fl 14is indicated for useduring endoscopicvessel harvestingprocedures to create acavity along thesaphenous vein and/orradial artery duringendoscopic vesselharvesting 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 procedureswhere 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 inAirSeal 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. |
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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 <20kg). Any differences in technological characteristics were evaluated via performance testing, described below.
VI. PERFORMANCE DATA
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
VII. CONCLUSION
The subject AirSeal iFS System and AirSeal dV Solution are substantially equivalent in design, materials, indications for use, principles of operation and technological characteristics to the predicate PneumoSure. Based upon the findings of non-clinical testing, the differences present no issues of safety and efficacy and the subject AirSeal iFS System and AirSeal dV Solution are substantially equivalent to the predicate PneumoSure (K063367).
§ 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.