RapidVac Smoke Evacuator System

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 January 14, 2015 Covidien Jose Marquez Regulatory Affairs Manager 15 Hampshire Street Mansfield, MA 02048 Re: K142335 > Trade/Device Name: RapidVac™ Smoke Evacuator System (Model: SE3690) Regulation Number: 21 CFR 878.5070 Regulation Name: Air-Handling Apparatus For A Surgical Operating Room Regulatory Class: Class II Product Code: FYD Dated: December 17, 2014 Received: December 18, 2014 Dear Mr. Marquez, 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. {1}------------------------------------------------ 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 yours, Tejashri Purohit-Sheth, M.D. Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR Erin Keith 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) K142335 Device Name RapidVacTM Smoke Evacuator System (Model: SE3690) Indications for Use (Describe) The indications for use of the RapidVac™ Smoke Evacuator System are to remove and filter smoke and aerosols from a surgical site produced during electrosurgical and laser procedures. 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) ## 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) 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. 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The logo is divided into smaller squares of varying shades of blue. ## 510(k) Summary Date summary prepared: January 13, 2015 ## 510(k) Submitter/Holder Covidien 15 Hampshire Street Mansfield, MA 02048 ## Contact Jose Marquez Regulatory Affairs Manager Telephone: 508-452-4160 Fax: 508-452-1941 Email: jose.a.marquez@covidien.com ## Name of Device | Trade Name: | RapidVac™ Smoke Evacuator System (Model: SE3690) | |----------------------|----------------------------------------------------------------------------------------| | Common Name: | Smoke Evacuation System | | Classification Name: | Air-handling apparatus for surgical operating room (21 CFR § 878.5070, Class II, FYD). | #### Predicate Device The RapidVac™ Smoke Evacuator System was compared and found to be substantially equivalent to the following products of comparable type in commercial distribution: Device Common Name: Smoke Evacuation System Trade Name: Visiclear™ Smoke Evacuation System Catalog Number: VV120, VV220 510(k) Number: K131402 (cleared 3/3/2014) Manufacturer: Buffalo Filter, LLC Device Common Name: Smoke Evacuation System Trade Name: Optimumm™ Smoke Evacuation System Catalog Number: Optimumm 510(k) Number: K980915 (cleared 6/29/1998) Manufacturer: Valleylab, Inc. ## Device Description The RapidVac™ Smoke Evacuator System consists of a painted aluminum housing, a painted solid polyurethane front panel, a high suction/high flow rate variable speed centrifugal action pump, and a multi stage filter. The system can also use accessories such as sterile tubing sets in various sizes/diameters which are single-use and are used in conjunction with ultrasonic, laser or electrosurgery generators to remove and filter the smoke from the surgical field,. The RapidVac™ Smoke Evacuator System captures particulates and adsorbs gases from surgical smoke. The smoke evacuator is specifically designed to improve visibility and reduce potential health hazards associated with surgical smoke. It can be used in both open and laparoscopic procedures with available accessories. The RapidVac Smoke Evacuator System is designed with a high suction, {4}------------------------------------------------ high flow rate variable speed centrifygal action pump. The ultra-quiet motor is used to draw the smoke from the surgical site through the vacuum tubing and into the system where it is passed through four stages of filtration. ## Intended Use The RapidVac™ Smoke Evacuator System is to remove and filter smoke and aerosols from asurgical site produced during electrosurgical and laser procedures. #### Summary comparing the technological characteristics of the subject and predicate devices The RapidVac Smoke Evacuation System is substantially equivalent to the predicate devices with reqard to smoke evacuation technologies. #### Technological and Performance Characteristics | | RapidVac™ Smoke Evacuator<br>System (Proposed) | Visiclear Smoke<br>Evacuation<br>System (Predicate) | Optimmum™ Smoke<br>Evacuation System (Predicate) | |-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | Smoke evacuation and filtration | same | same | | Indications | The Indications for Use of the<br>RapidVac Smoke Evacuator<br>System is to remove and filter<br>smoke and aerosols from a<br>surgical site produced during<br>electrosurgical and laser<br>procedures. | same | The Indications for Use of the<br>Valleylab OptiMumm™ Smoke<br>Evacuator system are for the<br>removal of smoke and incidental<br>fluids produced during<br>electrosurgery and/or laser<br>surgery. The removal of smoke<br>from the surgical site improves<br>visibility and reduces potential<br>health hazards associated with<br>surgical smoke. | | Target Population | For physicians and trained<br>hospital staff during the use of<br>lasers or electrosurgery | same | same | | Materials of Construction | Painted Aluminum Housing,<br>Painted solid polyurethane front<br>panel, Four-stage filter (prefilter,<br>ULPA grade filter, virgin<br>activated carbon, woven<br>fiberglass) | Powder-Coated Aluminum<br>Housing, ABS-PC Plastic Fascia,<br>Insulation, Four-stage filter<br>(prefilter, ULPA grade filter,<br>virgin activated carbon, woven<br>fiberglass) | Aluminum housing, Plastic front<br>panel, Three-stage filter<br>(prefilter, ULPA grad filter,<br>integrated charcoal component) | | Energy Used | Electrical Current | same | same | | Intended Marketed Accessories | Electrosurgical pencils, tubing,<br>hoses & adapters, sterile and<br>non-sterile | same | same | | Filtration | The ULPA filter is 99.999%<br>efficiency at .1 to .2 micron<br>particle size | same | The ULPA filter is 99.999%<br>efficiency at .12 micron particle<br>size minimum | | Filter Life | 25 hours | 35 hours | same | | Electrical Safety | Tested and compliant with IEC<br>60601-1 and IEC 60601-1-2. | same | same | | Mechanical Safety | Tested and compliant with IEC<br>60601-1 | same | same | | Chemical Safety | Neutral pH, non-patient contact | same | same | | Thermal Safety | Operation of device does not<br>result in harmful temperatures, | same | same | #### Technical Characteristics to Support Substantial Equivalence {5}------------------------------------------------ | | tested and compliant per IEC<br>60601-1 | | | |------------------|-----------------------------------------|------|------| | Radiation Safety | Non-radioactive | same | same | ### Performance The performance verification of the RapidVac Smoke Evacuator System showed that the device met the technical and performance design requirements. Filter life verification testing was conducted for the device to confirm that the ULPA (Ultra Low Penetration Air) efficiency of the filter for the maximum flow rate (25 hours) and filter lifetime. Flow verification testing was conducted for the RapidVac device to verify flow performance outlined in the design specification. The results indicated that the product met all specified flow requirement for each mode of operation. Product verification and validation testing was confirm that the RapidVac Smoke Evacuator System meets all product requirements. Smoke removal verification testing was completed through flow verification testing. Reliability testing was conducted to demonstrate the of the device and show no degradation in performance over that life span. Laparoscopic Smoke Evacuation Verification was conducted for the RapidVac Smoke Evacuation System to confirm the ability to maintain pneumoperitoneum while effectively clearing smoke. Smoke Removal Effectiveness was also conducted with the subject device to demonstrate and quantify via particulate count, the ability of RapidVac to remove aerosols from electrosurgical and laser surgeries. There was no clinical or pre-clinical performance testing needed to determine the performance of the RapidVac™ Smoke Evacuator System and to make a substantial equivalence comparison. The RapidVac™ Smoke Evacuator System and accessories were evaluated for mechanical, electrical, performance, and sterility safety using the following standards: IEC 60601-1:2005 and IEC 60601-1-2:2007 . ## Conclusion The Electrical (IEC 60601-1:2005), Mechanical, Software, and Safety (IEC 60601-1-2:2007) and performance testing of the RapidVac™ Smoke Evacuator System has shown it to be substantially equivalent to the predicate devices, Visiclear™ Smoke Evacuation System (K131402) and Optimmum™ Smoke Evacuation System (K980915).