(207 days)
Not Found
No
The description mentions a "micro-processor-controlled insufflation, recirculation and filtration unit" and "software," but there is no mention of AI, ML, or related concepts like deep learning, neural networks, or training/test sets for algorithms. The performance studies focus on verifying system specifications and clinical performance, not on evaluating the performance of an AI/ML model.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is "intended for use in diagnostic and/or therapeutic endoscopic procedures" and can be used to "facilitate endoscopic observation, diagnosis and treatment."
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for use in diagnostic and/or therapeutic endoscopic procedures" and can be used to "facilitate endoscopic observation, diagnosis and treatment."
No
The device description explicitly states that the system consists of major hardware components including a trocar, cannula, tube sets, and a micro-processor-controlled insufflation, recirculation and filtration unit. While it contains software, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used in vivo (within a living organism) for diagnostic and therapeutic endoscopic procedures. It focuses on distending body cavities with gas, maintaining access for instruments, and evacuating smoke. This is a surgical/procedural device, not a device used to test samples in vitro (outside the body).
- Device Description: The description details components like a trocar, cannula, tube sets, and an insufflation unit. These are all consistent with a device used for surgical access and insufflation within the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any of the typical components or processes associated with in vitro diagnostic testing.
The device is a medical device used during surgical procedures, not a device used for diagnosing conditions by testing samples outside the body.
N/A
Intended Use / Indications for Use
The SurgiQuest 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.
It is indicated 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.
Product codes (comma separated list FDA assigned to the subject device)
HIF, GCJ
Device Description
The SurgiQuest AirSeal®iFS System (cleared as AirSeal® Optical Trocar & Cannula System with integrated Insufflator DPIS 2000) consists of the following major components: (1) a trocar, (2) a cannula, (3) tube sets, and (4) a micro-processor-controlled insufflation, recirculation and filtration unit (the "AirSeal" iFS"). 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; or (c) Smoke Evacuation Mode. The device contains software. The device is designed for use in Medical Centers, hospitals and medical clinics.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal or thoracic cavity, rectum and colon
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Medical Centers, hospitals and medical clinics.
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)
Bench/In vitro Verification Testing:
All system specifications were verified as having been met through extensive bench testing included confirming all functional and performance attributes of the system met their respective specifications and requirements. This testing included, but was not limited, to confirming compliance with each of the applicable portions of the FDA/industry recognized standards listed in the previous section. This testing included:
- Verification AirSeal mode launches automatically after initial insufflation is completed. (Pass)
- Verification the iFS will maintain the actual pressure within a specified range of the set pressure. (Pass)
- Verification the AirSeal System venting feature activates appropriately and effectively reduces cavity pressure within the specified time. (Pass)
- Verification the iFS will maintain an average actual pressure within a specified range of the set pressure when an instrument is inserted into the Access Port and manipulated. (Pass)
Clinical/In vivo and Simulated Use Testing:
All system medical/clinical design input requirements were validated as having been met through extensive performance and simulated use testing. This testing confirmed all functional and performance attributes of the system met their respective design input requirements in compliance with ConMed's design control procedures and systems. This validation testing included but was not limited to real-world clinical evaluation and simulated use testing utilizing bench models of the thoracic cavity simulating pressure and volume conditions.
Clinical Studies (Robotically-Assisted Thoracic Surgery / Video Assisted Thoracoscopic Surgery):
- Cerfolio et al. 2016: 8 patients, Subject Device Used: yes, Adverse Events: none
- Gonde et al. 2017: 10 patients, Subject Device Used: yes, Adverse Events: none
- Kneuertz et al. 2017: 20 patients, Subject Device Used: yes, Adverse Events: none
- Suda et al. 2014: 33 patients, Subject Device Used: yes, Adverse Events: none
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 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 16, 2018
ConMed Corporation % Michael Daniel President Daniel & Daniel Consulting, LLC 340 Jones Lane Gardnerville, Nevada 89460
Re: K172516
Trade/Device Name: SurgiOuest AirSeal iFS System Regulation Number: 21 CFR 884.1730 Regulation Name: Laparoscopic Insufflator Regulatory Class: Class II Product Code: HIF, GCJ Dated: February 13, 2018 Received: February 14, 2018
Dear Michael Daniel:
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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing, 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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. Jennifer R. Stevenson -S For 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
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6. Indications for Use Statement
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
Indications for Use
510(K) Number (if known)
Device Name
SurgiQuest AirSeal iFS System
· Indications for Use (Describe)
The SurgiQuest 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.
It is indicated 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) X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
FORM FDA 3881 (1/14)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EB
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Premarket Notification 510(k) Summary
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
510(k) Number: K172516
Applicant Information:
| Date Prepared: | August 18, 2017 |
|---|---|
| Date Modified: | March 15, 2018 |
| Name: | ConMed Corporation |
| Address: 488 Wheelers Farms Road | |
| Milford, CT 06461 | |
| Contact Person: | Michael A Daniel, Consultant |
| madaniel@clinregconsult.com | |
| Mobile Number: | (415) 407-0223 |
| Office Number: | (775) 392-2970 |
| Facsimile Number: | (610) 545-0799 |
| Alternate Contact: | Lisa B. Anderson, Manager, Regulatory Affairs |
| ConMed Corporation | |
| lisaanderson@conmed.com | |
| Mobile Number: | (941) 713-2035 |
Device Information:
| Trade Name: | SurgiQuest AirSeal iFS System |
|---|---|
| Common Names: | Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy Endoscopic Insufflator |
| Classification Name(s): | Laparoscopic Insufflator |
| Product Code/ Regulation: | HIF 21 CFR 884.1730 GCJ |
| Classification: | Class II |
Predicate Device:
- SurgiQuest AirSeal iFS System K143404 ●
Device Description:
The SurgiQuest AirSeal®iFS System (cleared as AirSeal® Optical Trocar & Cannula System with integrated Insufflator DPIS 2000) consists of the following major components: (1) a trocar, (2) a cannula, (3) tube sets, and (4) a micro-processor-controlled insufflation, recirculation and filtration unit (the "AirSeal" iFS"). 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)
4
Insufflation Mode; (b) AirSeal Mode; or (c) Smoke Evacuation Mode. The device contains software. The device is designed for use in Medical Centers, hospitals and medical clinics.
Intended Use
The SurgiQuest 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.
Indications for Use:
It is indicated 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 obstructionfree 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.
Comparison to Predicate Device
The tables on the following pages provide a summary of substantial equivalence between the subject device and the cited predicate. The subject device has the same intended use and identical technological characteristics with no new questions of safety or effectiveness raised. Clinical data are being provided to support safety and effectiveness for thoracic use. The questions remain the same, e.g.,
- Can the insufflation pressures be adequately controlled and adjusted? 1)
-
- Are the blood/tissue contacting materials biocompatible and sterile?
-
- Are there any other risks to internal organs or tissues?
Summary Comparison to Predicate:
| | Subject Device | Predicate Device | Comparison to
predicate and
reference devices |
|-----------------------------------------|-------------------------------|-------------------------------|-----------------------------------------------------|
| Device Name | SurgiQuest AirSeal iFS System | SurgiQuest AirSeal iFS System | |
| Manufacturer | SurgiQuest | SurgiQuest | Same |
| 510(k) # | K172516 | K143404 | N/A |
| Regulation
Number | 21 CFR 884.1730 | 21 CFR 884.1730 | Same |
| Class | Class II | Class II | Same |
| Classification
Advisory
Committee | General & Plastic Surgery | General & Plastic Surgery | Same |
| Device
Class/Name | Insufflator | Insufflator | Same |
| Product Code | HIF, GCJ | HIF, GCJ | Same |
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| | Subject Device | Predicate Device | Comparison to
predicate and
reference devices |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|
| Fundamental
scientific
technology | Digital insufflation pressure
regulation system. | Digital insufflation pressure
regulation system | Same |
| Intended Use | The SurgiQuest 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 SurgiQuest 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. | Same |
| Indication for Use | It is indicated 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. | It is indicated to facilitate the use
of various thoracoscopic and
laparoscopic instruments by
filling the abdominal 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. | Substantially equivalent
based upon clinical
evidence provided. |
List of Standards Used:
Verification and validation testing was completed in compliance with the following standards:
- AAMI ANSI ES60601-1:2005(R)2012 and A1:2012, C1:2009(R)2012 and A2:2010(R)2012 . (Consolidated Text) Medical electrical equipment – Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD). FDA recognition number: 19-4
- IEC 60601-1-2:2007/AC:2010, Medical electrical equipment Part 1-2: General requirements for . basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests (Edition 3). FDA recognition number: 19-2
- IEC 60601-2-18 Edition 3.0 2009-08, Medical electrical equipment Part 2-18: Particular . requirements for the basic safety and essential performance of endoscopic equipment. FDA recognition number: 9-61
- . IEC 62304:2015. Medical device software – Software life cycle processes. FDA recognition number: 13-79
- ISO 10993-1:2009(R) 2013, Biological evaluation of medical devices Part 1: Evaluation and . testing within a risk management process (Biocompatibility). FDA recognition number: 2-156
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- ISO 10993-5: 2009/(R) 2014, Biological evaluation of medical devices Part 5: Tests for in vitro . cytotoxicity. (Biocompatibility). FDA recognition number: 2-153
- . ISO 10993-7:2008, Biological evaluation of medical devices – Part 7: Ethylene oxide sterilization residuals (Including technical corrigendum 1, 2009). FDA recognition number: 14-408
- ISO 10993-10: 2010, Biological evaluation of medical devices Part 10: Tests for irritation and . skin sensitization. (Biocompatibility). FDA recognition number: 2-173
- ISO 10993-11: 2006/(R)2010, Biological evaluation of medical devices -11: tests for systemic . toxicity. (Biocompatibility). FDA recognition number: 2-118
- ISO 11135:2014, Sterilization of heath care products Ethylene oxide Requirements for the . development, validation, and routine control of a sterilization process for medical devices. FDA recognition number: 14-452
- . ISO 11137-1 First edition 2006-04-15, Sterilization of health care products - Radiation - Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices (Including: Amendment 1, 2013). FDA recognition number: 14-428
- . ISO 11137-2:2013, Sterilization of health care products – Radiation- Part 2: Establishing the sterilization dose. FDA recognition number: 14-409
- . ISO 11607-1:2006, Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems. FDA recognition number: 14-454
- ISO 14971:2007, Medical devices Application of risk management to medical devices. FDA . recognition number: 5-40
- . AAMI ANSI ST67:2011, Sterilization of health care products - Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled "sterile". FDA recognition number: 14-314
Testing described in this 510(k) consisted of verification of all design input requirements and product specifications. All clinical input requirements were validated.
Summary of Testing Completed:
Bench/In vitro Verification Testing:
All system specifications were verified as having been met through extensive bench testing included confirming all functional and performance attributes of the system met their respective specifications and requirements. This testing included, but was not limited, to confirming compliance with each of the applicable portions of the FDA/industry recognized standards listed in the previous section. This testing included:
| Test | Results |
|---|---|
| Verification AirSeal mode launches automatically after initial insufflation is completed. | Pass |
| Verification the iFS will maintain the actual pressure within a specified range of the set pressure. | Pass |
| Verification the AirSeal System venting feature activates appropriately and effectively reduces cavity | |
| pressure within the specified time. | Pass |
| Verification the iFS will maintain an average actual pressure within a specified range of the set pressure | |
| when an instrument is inserted into the Access Port and manipulated. | Pass |
7
Clinical/In vivo and Simulated Use Testing
All system medical/clinical design input requirements were validated as having been met through extensive performance and simulated use testing. This testing confirmed all functional and performance attributes of the system met their respective design input requirements in compliance with ConMed's design control procedures and systems. This validation testing included but was not limited to real-world clinical evaluation and simulated use testing utilizing bench models of the thoracic cavity simulating pressure and volume conditions.
| Robotically-Assisted Thoracic Surgery / Video Assisted Thoracoscopic Surgery | |||
|---|---|---|---|
| Data Source | Number of Patients | Subject Device Used | Adverse Events |
| Cerfolio et al. 20161 | 8 | yes | none |
| Gonde et al. 2017 | 10 | yes | none |
| Kneuertz et al. 2017 | 20 | yes | none |
| Suda et al. 2014 | 33 | yes | none |
Article Citations and Summary
Summary:
Based upon the Intended Use, Indications for Use, product technical information, performance evaluation, and standards compliance provided in this premarket notification, the SurgiQuest AirSeal iFS Insufflation System, has been shown to be substantially equivalent to the cited predicate.
1 Confirmed by testimonial letter from the author.