BRAVO AUTOCLAVE, MODELS 17, 17V AND 21V

{0}------------------------------------------------ Koaolo6 MAY 15 2009 ### 510(k) Summary | Submitted by: | SciCan Ltd.<br>1440 Don Mills Road<br>Toronto, Ontario Canada<br>M3B 3P9 | |----------------------|--------------------------------------------------------------------------| | Contact Person: | Brenda Murphy - Director of Regulatory Affairs<br>(416) 446-2797 | | Date of Preparation: | January 30, 2009 | | Name of Device: | BRAVO series Autoclaves (17, 17V, 21V) | | Predicate Device: | M.O.C.O.M. Millennium series Autoclaves<br>510(k) K050263 | #### Description of Device: The BRAVO series of Autoclaves are table-top vacuum steam sterilizers designed to processo medical and dental instruments to achieve successful sterilization. The units utilize saturated medical and 'dental' instramonto' to attain an effective kill of infectious bio-organisms. BRAVO autoclaves are equipped with either a 17 or 21 litre sterilization chamber and free BRAVO adtoclaves are equipped with United vacuum system to achieve complete air removal from final your characterized by an advanced fractorizied vacually some with an effective final vacuum nollow and porous makenale: "iace of condensation from the finished load. Instruments are placed onto a sterilization tray which is then inserted into the sterilization Instruments are placed onto a Stemization tray while willization cycles is selected and the chamber and the unit is closed. "One of the the forestore fully automatic for the complete sterilizing cycle. An exclusive steam generation system, combined with an advanced control system, guarantees An excidisive steam generation system, ochibithed that thermodynamic parameters during the entire sterilization process. The devices offer sterilization programs optimized for the effective and fast sterilization of various The devices oner stemization programs openilized for and dental environments. Depending on the instruments and materials used in the modical and worker's of pulses which consist of one of preset cycle criosen, the devices will progress through a sonsembling in order to remove any three vacuum draws followed by pressulization to cronet sterilization time, vent down all from the sternization Chamber. They will their mon hour more projected The dovices to atmosphenc conditions and begin a model as well as the cycle selected. The devices predetermined period of time depending on the model as well by the byth then return to atmospheric conditions so that the door can be opened to remove the processed load. {1}------------------------------------------------ An example of a standard program is the 134 POROUS/WRAPPED cycle. Once the materials have been arranged on a tray and placed into the sterilization chamber, the door is closed, the nave boon and the start key is depressed. This will activate the chamber door locking mechanism and the following sequence will then operate: - Pre-heating of the steam generator and sterilization chamber; . - Chamber air removal and steam penetration inside the load through a series of vacuum . stages and pressure phases; - Pressure rise-up, with consequent steam temperature increasing up to the preset . sterilization conditions (for this example, 134℃ /273°F); - Stabilization of the pressure and temperature conditions inside the sterilization chamber; . - Running of the sterilization process for the preset time (for this example, 4 minutes); . - Chamber pressure decreasing through steam discharge; . - Vacuum drying phase; . - Venting phase through sterile air; . - Chamber pressure leveling up to atmospheric value. . - Release of the door locking mechanism; . - Opening of the door to allow load recovery from the sterilization chamber . #### Intended use: The BRAVO Autoclaves are intended to be used in medical and dental practices, hospitals, clinics and other associated facilities to sterilize re-usable medical and dental instruments (including dental handpieces) and medical materials that are heat and moisture resistant and compatible with the steam sterilization process. Typical users of this system are trained professionals including, but not limited to, dentists, nurses, doctors, infection control and re-processing personnel. The BRAVO autoclaves are مور intended nor recommended for the sterilization of fluids, liquids, or pharmaceutical products. ### Technological Characteristics Compared to the Predicate Device: The intended use, operating principle, general materials of construction and controls are the The intended doe, operating principly, gaturated steam at high pressures and temperatures to Salne for both devices. Don't anto doo excircuitorisms. The BRAVO autoclaves generate the achieve the ochiplete doctraction of the same method as its predicate, the Millennium autoclaves. The BRAVO series of Autoclaves offer ten programmed sterilization cycles as described in the The BRAVO senes of Adidates of Adridayes, have the same ten programmed above table. The predicate devices, the Millennian autoclars of AVO and Millennium autoclaves stemazation begin a heated vacuum dry cycle that will run for a predetermined period of time autoneally bogin a houlou valuath ary by selected. For both the submitted devices and their deponding on the cycles may be interrupted at any time by pressing and holding the stop button for predicates, the oycles may be micrrapted and allows the pressure to return to atmospheric three seconds." This action tommatic the of the creation will once safe conditions conditions for the chamber door to be manage dis internet is interrupted before the are net. This proodation of the cycle, the message "MANUAL STOP, RESET Completion of the StormEditor, portial an error code will be printed if a printer is connected. {2}------------------------------------------------ The sterilization cycles with reference to established times, temperatures and indicated uses for the BRAVO autoclaves are as follows: ## TABLE OF AVAILABLE PROGRAMS FOR # BRAVO 17, BRAVO 17V, BRAVO 21V AUTOCLAVES | CYCLE | TEMP. | STER.<br>TIME | DRY<br>TIME | MAX. LOAD (KG) | | INTENDED USE | |--------------------|--------------------------------------------|---------------------------|-------------------------|----------------------------------|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | | | 17/17V | 21V | | | 134 POROUS/WRAPPED | 134°C<br>(273°F) | 4 min. | 16.5 min | 1.0<br>0.75<br>0.6<br>3.0<br>1.5 | 1.25<br>1.0<br>.075<br>4.0<br>2.0 | Unpackaged porous material<br>Porous material in single package<br>Porous material in double package<br>Solid material / handpieces in single package<br>Solid material / handpieces in double package | | 121 POROUS/WRAPPED | 121°C<br>(250°F) | 20 min. | 16.5 min | 1.0<br>0.75<br>0.6<br>3.0<br>1.5 | 1.25<br>1.0<br>.075<br>4.0<br>2.0 | Unpackaged porous material<br>Porous material in single package<br>Porous material in double package<br>Solid material / handpieces in single package<br>Solid material / handpieces in double package | | 134 HOLLOW/UNWRAP | 134°C<br>(273°F) | 4 min. | 7 min | 6.0 | 7.5 | Unpackaged handpieces | | 121 HOLLOW/UNWRAP | 121°C<br>(250°F) | 20 min. | 7 min | 6.0 | 7.5 | Unpackaged handpieces | | 134 SOLID/WRAPPED | 134°C<br>(273°F) | 4 min. | 16.5 min | 3.0 | 4.0 | Solid material in single package | | 121 SOLID/WRAPPED | 121°C<br>(250°F) | 20 min. | 16.5 min | 3.0 | 4.0 | Solid material in single package | | 134 SOLID/UNWRAP | 134°C<br>(273°F) | 4 min. | 7 min | 6.0 | 7.5 | Unpackaged solid material | | 121 SOLID/UNWRAP | 121°C<br>(250°F) | 20 min. | 7 min | 6.0 | 7.5 | Unpackaged solid material | | 134 EMERGENCY | 134°C<br>(273°F) | 3 min. | 7 min | 0.5 | 0.5 | Unpackaged solid material | | 134°C/121°C CUSTOM | 134°C<br>(273°F)<br>OR<br>121°C<br>(250°F) | >4 min.<br>OR<br>>20 min. | 16.5 min<br>OR<br>7 min | 6.0 | 7.5 | Unpackaged solid material<br>(Note: the 134°C/121°C CUSTOM programs<br>have not been validated) | | BOWIE-DICK TEST | 134°C<br>(273°F) | 3.5 min | 7 min | | | Test pack only (without any other load) | | VACUUM | --- | --- | | | | Empty chamber | {3}------------------------------------------------ Image /page/3/Picture/1 description: The image is a seal for the Department of Health & Human Services, USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract image of an eagle. #### Public Health Service 15 2009 MAY Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Ms. Brenda Murphy Director of Regulatory Affairs SciCan Limited 1440 Don Mills Road Toronto, Ontario Canada M3B 3P9 Re: K090265 Trade/Device Name: BRAVO Autoclave Regulation Number: 21 CFR 880.6880 · Regulation Name: Steam Sterilizer Regulatory Class: II Product Code: FLE Dated: April 16, 2009 Received: April 17, 2009 Dear Ms. Murphy: 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. 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. {4}------------------------------------------------ Page 2- Ms. Murphy 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 device-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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Susan Ruane . Susan Runner, D.D.S., MA Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ ### INDICATIONS FOR USE 510(k) Number (if known): Device Name: BRAVO Autoclave Indications for Use: The BRAVO series of Autoclaves are table-top vacuum autoclaves that are intended to be used The DNAVO Schess of AutoGlaros are table top cand other associated facilities to sterilize rein medical and dental proctised, noopidio, oding dental handpieces) and medical materials that usublo modiour and compatible with the steam sterilization process. Typical users of this system are trained professionals including, but not limited to, dentists, nurses, doctors, infection control and re-processing personnel. The BRAVO series of Autoclaves are not intended nor recommended for the sterilization of fluids, liquids, or pharmaceutical products. See the following page for the "Table of Available Programs" for the Bravo Autoclave units. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use _ ਮ (21 CFR 801 Subpart C) (Please do not write Below this line-continue on another Page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE) Shila A Murphy, L.Q. (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Dev 510(k) Number: K090265 {6}------------------------------------------------ ## INDICATIONS FOR USE ### TABLE OF AVAILABLE PROGRAMS FOR ### BRAVO 17, BRAVO 17V, BRAVO 21V AUTOCLAVES | CYCLE | TEMP. | STER.<br>TIME | DRY<br>TIME | MAX. LOAD (KG) | | INTENDED USE | |--------------------|------------------|---------------|-------------|----------------------------------|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 134 POROUS/WRAPPED | 134°C<br>(273°F) | 4 min. | 16.5 min | 1.0<br>0.75<br>0.6<br>3.0<br>1.5 | 1.25<br>1.0<br>.075<br>4.0<br>2.0 | Unpackaged porous material<br>Porous material in single package<br>Porous material in double package<br>Solid material / handpieces in single package<br>Solid material / handpieces in double package | | 121 POROUS/WRAPPED | 121°C<br>(250°F) | 20 min. | 16.5 min | 1.0<br>0.75<br>0.6<br>3.0<br>1.5 | 1.25<br>1.0<br>.075<br>4.0<br>2.0 | Unpackaged porous material<br>Porous material in single package<br>Porous material in double package<br>Solid material / handpieces in single package<br>Solid material / handpieces in double package | | 134 HOLLOW/UNWRAP | 134°C<br>(273°F) | 4 min. | 7 min | 6.0 | 7.5 | Unpackaged handpieces | | 121 HOLLOW/UNWRAP | 121°C<br>(250°F) | 20 min. | 7 min | 6.0 | 7.5 | Unpackaged handpieces | | 134 SOLID/WRAPPED | 134°C<br>(273°F) | 4 min. | 16.5 min | 3.0 | 4.0 | Solid material in single package | | 121 SOLID/WRAPPED | 121°C<br>(250°F) | 20 min. | 16.5 min | 3.0 | 4.0 | Solid material in single package | | 134 SOLID/UNWRAP | 134°C<br>(273°F) | 4 min. | 7 min | 6.0 | 7.5 | Unpackaged solid material | | 121 SOLID/UNWRAP | 121°C<br>(250°F) | 20 min. | 7 min | 6.0 | 7.5 | Unpackaged solid material | | 134 EMERGENCY | 134°C<br>(273°F) | 3 min. | 7 min | 0.5 | 0.5 | Unpackaged solid material | | BOWIE-DICK TEST | 134°C<br>(273°F) | 3.5 min | 7 min | | | Test pack only (without any other load) | | VACUUM | --- | --- | --- | | | Empty chamber | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Shila H. Murphy MD (Division Sign-Off) Division of Anesthesiology, General Hospital Division of Anesthesiology, General Hospital Infection Control, Dental Devices 510(k) Number: K090265 ( . . :