Ultravision Visual Field Clearing System

{0}------------------------------------------------ Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 May 26, 2017 Alesi Surgical Ltd. David Broderick Quality & Regulatory Manager Cardiff Medicentre, Heath Park Cardiff, CF14 4UJ GB Re: K170178 Trade/Device Name: Ultravision™ Visual Field Clearing System Regulation Number: 21 CFR 878.5050 Regulation Name: Surgical Smoke Precipitator Regulatory Class: Class II Product Code: PQM Dated: April 26, 2017 Received: May 1, 2017 Dear David Broderick: 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 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device {1}------------------------------------------------ related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely, # Lori A. Wiggins -S6 for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K170178 #### Device Name Ultravision™ Visual Field Clearing System Indications for Use (Describe) The Ultravision™ Visual Field Clearing System is indicated for the clearance of smoke and other that is created during laparoscopic surgery. The Ultravision 5mm Trocar component also establishes a path of entry for instruments used in laparoscopic surgery. | 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) | | | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## SECTION 6 ## 510(K) SUMMARY {4}------------------------------------------------ ### 510(K) SUMMARY As required by 21 CFR 807.92 ### Submitter Information: | Submitter's Name: | Alesi Surgical Ltd | |--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Address: | Cardiff Medicentre<br>Heath Park<br>Cardiff<br>CF14 4UJ | | Telephone:<br>Fax: | ++44 (0)2920 682106<br>++44 (0)2920 750239 | | Contact Person:<br>Telephone : | Michele Lucey<br>603-748-1374 | | Date Prepared: | 19th May 2017 | | Device Trade Name: | Ultravision™ Visual Field Clearing System | | Classification: | Class II | | Product Code(s): | POM | | Regulation Number(s): | 878.5050 | | Predicate Devices: | Ultravision™ Visual Field Clearing System DEN150022 | | Intended Use: | The Ultravision™ Visual Field Clearing System is indicated for<br>the clearance of smoke and other particulate matter that is created<br>during laparoscopic surgery. | | | The Ultravision 5mm Trocar component also establishes a path of<br>entry for instruments used in laparoscopic surgery. | | Device Description: | The Ultravision™ Visual Clearing System removes surgical smoke<br>from the visual field during laparoscopic surgery by means of<br>electrostatic precipitation. The System consists of the Ultravision<br>Generator, the Ionwand Sterile Pack, and the Ionwand 5mm<br>Trocar. The Ionwand is connected to the energy source and is<br>then introduced into the body cavity near the smoke generating<br>electrosurgical device. The Ultravision™ 5mm Trocar is a new<br>accessory device intended for use only with the Ultravision™<br>Visual Field Clearing System to introduce the Ionwand while | {5}------------------------------------------------ > providing a pathway for laparoscopic instruments through one 5 mm trocar incision. The Ultravision™ 5mm Trocar provides an alternative to the currently available Ultravision™ Visual Field Clearing System Ionwand™ Sterile Pack for introduction of the Ionwand. The Ultravision™ 5mm Trocar is a standard dilating laparoscopic trocar compatible for use with 5mm instruments. The trocar design includes a discrete lumen that is positioned separate from the main trocar channel and which accepts the Ionwand component of the system. The trocar design allows the distal tip of the Ionwand to exit the trocar some 12mm from its distal point and at an angle to the trocar body that positions the Ionwand at a point close to but not interfering with the 5mm energy instruments that are intended to be accommodated by the trocar. The Ultravision™ 5mm trocar and Ionwand are provided packaged together in the same sterile barrier packaging. The trocar may be used with or without the Ionwand component of the system. ### Nonclinical testing: The equivalence of the Ultravision 5mm Trocar to the predicate devices has been though the following tests and assessments: | Test | Description | Results | |-------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------| | Performance of the system to<br>clear the visual field of smoke<br>and particulate matter | Performance comparison to the<br>predicate device under<br>simulated use conditions | Equivalent to<br>predicate - Pass | | Usability | Complexity of use compared to<br>the predicate and reference<br>device | Equivalent to<br>predicate and<br>reference - Pass | | Ionwand removal and<br>reinsertion | Repeated insertions/removals<br>performed and forces both<br>quantitative and qualitative<br>evaluations performed | Equivalent to<br>predicate and<br>reference - Pass | | Leak resistance and sealing,<br>maintenance of<br>pneumoperitoneum during use | Pressure tests under high and<br>low pressures with and without<br>instruments or Ionwand<br>inserted, including multiple<br>cycles of use | Equivalent to<br>predicate or<br>reference - Pass | | Strength, resistance to bending | Tensile or pressure forces<br>applied to shaft, trocar, and<br>connections | Equivalent to<br>predicate or<br>reference - Pass | {6}------------------------------------------------ | Dimensional Verification | Confirmation of dimensional<br>characteristics by dimensional<br>evaluation | Pass | |-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------| | Luer fitting | Confirmation of compliance<br>with industry standard luer<br>fitting | Pass | | Electrical Safety | Dielectric breakdown, radio-<br>frequency applied parts,<br>capacitive coupling | Pass | | Biocompatibility per ISO<br>10993 | Appropriate biocompatibility<br>based on tissue contact and<br>duration | Pass | | Sterilization and shelf life<br>studies | Validated sterilization cycle<br>according to industry standard,<br>shelf life studies on accelerated<br>aging conditions including<br>product and package<br>evaluations | Pass | The results of the testing demonstrated acceptable performance for the device and substantial equivalence to the predicate device. {7}------------------------------------------------ | Feature/<br>Specification | Ultravision™<br>Visual Field<br>Clearing System | Ultravision™<br>Visual Field<br>Clearing System | Ethicon Endopath<br>Excel Bladeless<br>Trocar with<br>Stability Sleeve 5 -<br>12mm | Comparison | |--------------------------------|--------------------------------------------------------------------|--------------------------------------------------------------------|------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------| | | Subject Device | Primary Predicate<br>Device | Reference Device | | | Regulatory<br>Clearance/ | Pending | DEN150022 | K032676 | N/A | | Product Code | PQM | PQM | GCJ | N/A | | Regulation<br>Number | 878.5050 | 878.5050 | 876.1500 | Equivalent | | Regulation<br>Name | Surgical Smoke<br>Precipitator | Surgical Smoke<br>Precipitator | Endoscopes and<br>Accessories. | Equivalent | | Where<br>used<br>(environment) | Laparoscopic surgery | Laparoscopic surgery | Abdominal, thoracic<br>and gynecological<br>minimally invasive<br>procedures | Equivalent (laparoscopic surgery<br>includes all the predicate<br>anatomical sites) | | Anatomical<br>Sites | Abdominal and<br>gynecological<br>minimally invasive<br>procedures | Abdominal and<br>gynecological<br>minimally invasive<br>procedures | As above | Equivalent | | Trocar type | Blunt trocar with<br>dilating tip | N/A | Blunt trocar with<br>dilating tip | Equivalent | | Trocar material | Thermoplastic | N/A | Thermoplastic | Equivalent | | Retention<br>features | Micro- ridges | N/A | Ridges | Similar feature but different<br>dimension with no impact on<br>performance or safety | | Type of sealing<br>employed | Duckbill valve and<br>separate seal | N/A | Duckbill valve and<br>separate seal | Equivalent | | Valve and seal<br>material | Elastomer | Elastomer | Elastomer | Equivalent | ## Summary of Technological Characteristics Demonstrating Substantial Equivalence: {8}------------------------------------------------ | Feature/<br>Specification | Ultravision™<br>Visual Field<br>Clearing System<br>Subject Device | Ultravision™<br>Visual Field<br>Clearing System<br>Primary Predicate<br>Device | Ethicon Endopath<br>Excel Bladeless<br>Trocar with<br>Stability Sleeve 5 -<br>12mm<br>Reference Device | Comparison | |-------------------------------------------|-------------------------------------------------------------------|--------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------| | Trocar working<br>length | 94mm | N/A | 100 / 102mm | Similar feature but different<br>dimension with no impact on<br>performance or safety | | Trocar main<br>lumen | 5.8mm | N/A | 5.95 / 13mm | Similar feature but different<br>dimension with no impact on<br>performance or safety | | Trocar O/D | 10.0mm | N/A | 8.0 / 15.2mm<br>(Covers the range of<br>items from predicate<br>submission) | Similar feature but different<br>dimension with no impact on<br>performance or safety | | Ionwand™M<br>working length | 129mm | 109mm | N/A | Similar feature but different<br>dimension with no impact on<br>performance or safety | | Ionwand™M<br>overall diameter | 1.4mm | 2.0mm | N/A | Similar feature but different<br>dimension with no impact on<br>performance or safety | | Ionwand™ tip<br>material | Implant grade<br>Stainless steel.<br>annealed | Implant grade<br>Stainless steel.<br>annealed. | N/A | Equivalent | | Ionwand™ tip,<br>exposed length | 4.0mm | 4.0mm | N/A | Equivalent | | Ionwand™M<br>insulation wall<br>thickness | 0.4mm | 0.7mm | N/A | Similar feature but different<br>dimension with no impact on<br>performance or safety | | Plug and cable<br>length | 2.5mm | 2.5mm | N/A | Equivalent | | Generator | Ultravision™<br>generator (fixed<br>power output) | Ultravision™<br>generator (fixed<br>power output) | N/A | Equivalent | | How Supplied | Supplied sterile in<br>single pouches | Supplied sterile in<br>single blister | Supplied sterile in<br>single pouches | Equivalent | {9}------------------------------------------------ | Feature/<br>Specification | Ultravision™<br>Visual Field<br>Clearing System<br>Subject Device | Ultravision™M<br>Visual Field<br>Clearing System<br>Primary Predicate<br>Device | Ethicon Endopath<br>Excel Bladeless<br>Trocar with<br>Stability Sleeve 5 -<br>12mm<br>Reference Device | Comparison | |------------------------------|-------------------------------------------------------------------|---------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------| | Biocompatibility | Meets ISO 10993<br>Part 5,10 and 11 | Meets ISO 10993 Part<br>5,10 and 11 | Unknown | Assume predicate is<br>biocompatible since it is an<br>approved device | | Sterilization | EtO | EtO | Gamma Irradiation | Similar feature but different<br>dimension with no impact on<br>performance or safety | | Sterilitv<br>Assurance Level | 10-6 | 10-6 | 10-6 | Assume predicate has the<br>standard sterility assurance level<br>since it is an approved device | ### Conclusion: The subject device is substantially equivalent to the predicate device.