Belimed Steam Sterilizer MST-H TOP 5000

{0}------------------------------------------------ Image /page/0/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 May 12, 2017 Belimed AG Jay Upchurch Product Engineer, U.S. Agent Belimed. Inc. 2325 Charleston Regional Parkway Charleston, South Carolina 29412 Re: K170228 Trade/Device Name: Belimed Steam Sterilizer MST-H TOP 5000 Regulation Number: 21 CFR 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: Class II Product Code: FLE Dated: April 6, 2017 Received: April 12, 2017 Dear Jay Upchurch: 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 {1}------------------------------------------------ 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 (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. # Michael J. Ryan -S 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) K170228 Device Name Belimed Steam Sterilizer MST-H TOP 5000 Indications for Use (Describe) The Belimed Steam Sterilizer TOP 5000 is designed for sterilization of non-porous and porous heat and moisture stable materials used in healthcare facilities. The Belimed Steam Sterilizer MST-H TOP 5000 is equipped with the following factory programmed sterilization cycles and cycle values. This is shown in Table 1. | Type of Use (Select one or both, as applicable) | | |-----------------------------------------------------------------------|---------------------------------------------------------------------------------| | <input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | <input checked="" type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) | |X | 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}------------------------------------------------ # Table 1: Factory programmed sterilization cycles and cycle values. | CYCLES | STERILIZE<br>TEMP | STERILIZE<br>TIME | DRY<br>TIME | RECOMMENDED LOAD | |-----------------------------------------------|-------------------|-------------------|-------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | PREVAC 270F<br>(132°C) | 270°F<br>(132°C) | 4 minutes | 30 minutes | Double-wrapped instrument trays.<br>Maximum weight of 25 lbs. each for the following models: 9-6-12 HS2, 9-6-15 HS1, and GR 9-6-18 HS2.<br>Maximum weight of 17 lbs. each for the following models: 9-6-9 HS1, 9-6-9 HS2, 9-6-12 HS1, 9-6-15 HS2, 9-6-18 HS1, 9-6-18 HS2, GR 9-6-9 HS1, GR 9-6-9 HS2, GR 9-6-12 HS1, GR 9-6-12 HS2, GR 9-6-15 HS1, GR 9-6-15 HS2, GR 9-6-15 HS2, GR 9-6-18 HS1.<br>Fabric Packs. | | PreVac 270F 4S<br>/ 5Dry (132°C) | 270°F<br>(132°C) | 4 minutes | 5 minutes | Fabric Packs. | | Liquid 250F<br>(121°C) | 250°F<br>(121°C) | 45 minutes | 0 minute | Max 1000 ml of Liquid per bottle. Use only vented bottles, type I, borosilicate glass. | | Express 270F<br>(132°C) | 270°F<br>(132°C) | 4 minutes | 3 minutes | Single wrapped instrument tray with non-porous single instrument. | | Immediate Use<br>270F - Single Ins<br>(132°C) | 270°F<br>(132°C) | 3 minutes | 1 minute | Unwrapped instrument tray with a single instrument. | | Immediate Use<br>270F - Multi Ins<br>(132°C) | 270°F<br>(132°C) | 10 minutes | 1 minute | Unwrapped instrument tray with non-porous multiple instruments.<br>Maximum weight of 25 lbs each for the following models: 9-6-12 HS2, 9-6-15 HS1, and GR 9-6-18 HS2.<br>Maximum weight of 17 lbs. each for the following models: 9-6-9 HS1, 9-6-9 HS2, 9-6-12HS1, 9-6-15 HS2, 9-6-18 HS1, 9-6-18 HS2, GR 9-6-9 HS1, GR 9-6-9 HS2, GR 9-6-12 HS1, GR 9-6-12 HS2, GR 9-6-15 HS1, GR 9-6-15 HS1, GR 9-6-15 HS2, GR 9-6-18 HS1. Maximum of 4 instrument trays. | {4}------------------------------------------------ # 510(k) Summary K170228 #### Date: May 5, 2017 Owner's Name / Address: Belimed AG Grienbachstrasse 11 CH-6300 Zug / Switzerland Preparer's Name / Address: Belimed, Inc. 2325 Charleston Regional Parkway Charleston, SC 29412 USA Contact Person: Jay Upchurch Email: Jay.Upchurch@Belimed.com Phone: (843) 216-7424 x133 (843) 216-7707 Fax: Trade Name: Belimed Steam Sterilizer MST-H TOP 5000 9-6-9 HS1, 9-6-9 HS2, 9-6-12 HS1, 9-6-12 Models: HS2, 9-6-15 HS1, 9-6-15 HS2, 9-6-18 HS1, 9-6-18 HS2, GR 9-6-9 HS1, GR 9-6-9 HS2, GR 9-6-12 HS1, GR 9-6-12 HS2, GR 9-6-15 HS1, GR 9-6-15 HS2, GR 9-6-18 HS1, and GR 9-6-18 HS2. Classification: Steam Sterilizer - Class II, as listed per 21 CFR 880.6880 Product Code: FLE Predicate Device: Belimed Steam Sterilizer TOP 5000 Series 9-18 (K021223) ### INTENDED USE: The Belimed Steam Sterilizer TOP 5000 is designed for sterilization of non-porous and porous heat and moisture stable materials used in healthcare facilities. The Belimed Steam Sterilizer MST-H TOP 5000 is equipped with the following factory programmed sterilization cycles and cycle values. This is shown in Table 1. {5}------------------------------------------------ # Table 1: Factory programmed sterilization cycles and cycle values. | CYCLES | STERILIZE<br>TEMP | STERILIZE<br>TIME | DRY<br>TIME | RECOMMENDED LOAD | |-----------------------------------------------|-------------------|-------------------|---------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | PREVAC 270F<br>(132°C) | 270°F<br>(132°C) | 4 minutes | 30<br>minutes | Double-wrapped instrument trays.<br>Maximum weight of 25 lbs. each for the following models: 9-<br>6-12 HS2, 9-6-15 HS1, and GR 9-6-18 HS2.<br>Maximum weight of 17 lbs. each for the following models: 9-<br>6-9 HS1, 9-6-9 HS2, 9-6-12 HS1, 9-6-15 HS2, 9-6-18 HS1,<br>9-6-18 HS2, GR 9-6-9 HS1, GR 9-6-9 HS2, GR 9-6-12 HS1,<br>GR 9-6-12 HS2, GR 9-6-15 HS1, GR 9-6-15 HS1, GR 9-6-<br>15 HS2, GR 9-6-18 HS1.<br>Fabric Packs. | | PreVac 270F 4S<br>/ 5Dry (132ºC) | 270°F<br>(132°C) | 4 minutes | 5<br>minutes | Fabric Packs. | | Liquid 250F<br>(121°C) | 250°F<br>(121°C) | 45 minutes | 0<br>minute | Max 1000 ml of Liquid per bottle. Use only vented bottles,<br>type I, borosilicate glass. | | Express 270F<br>(132°C) | 270°F<br>(132°C) | 4 minutes | 3<br>minutes | Single wrapped instrument tray with non-porous single<br>instrument. | | Immediate Use<br>270F - Single Ins<br>(132°C) | 270°F<br>(132°C) | 3 minutes | 1<br>minute | Unwrapped instrument tray with a single instrument. | | Immediate Use<br>270F - Multi Ins<br>(132°C) | 270°F<br>(132°C) | 10 minutes | 1<br>minute | Unwrapped instrument tray with non-porous multiple<br>instruments.<br>Maximum weight of 25 lbs each for the following models: 9-<br>6-12 HS2, 9-6-15 HS1, and GR 9-6-18 HS2.<br>Maximum weight of 17 lbs. each for the following models: 9-<br>6-9 HS1, 9-6-9 HS2, 9-6-12HS1, 9-6-15 HS2, 9-6-18 HS1,<br>9-6-18 HS2, GR 9-6-9 HS1, GR 9-6-9 HS2, GR 9-6-12 HS1,<br>GR 9-6-12 HS2, GR 9-6-15 HS1, GR 9-6-15 HS1, GR 9-6-<br>15 HS2, GR 9-6-18 HS1. Maximum of 4 instrument trays. | {6}------------------------------------------------ # DESCRIPTION OF DEVICE: The Belimed Steam Sterilizers MST-H, models 9-6-9, 9-6-12, 9-6-15, and 9-6-18 are available in a single door (HS1) or double door (HS2) version. The sterilizers are available in a carriage loader and a ground loader (GR) version. The sterilizers are equipped with Prevacuum, Gravity, Liquid, Air Leak Test and Bowie-Dick Test cycles. The Belimed Steam Sterilizers TOP 5000 are equipped with the following predefined cycles (Table 2): Table 2: Factory programmed sterilization and test cycles. {7}------------------------------------------------ | No. | CYCLE | PRE-<br>TREATMENT | STERILIZE<br>TEMP | STERILIZE<br>TIME | DRY<br>TIME | RECOMMENDED LOAD | |-----|---------------------------------------|--------------------------------------------|-------------------|-------------------|---------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 1 | PreVac 270F<br>4S / 30Dry | 4 pulses | 270°F | 4 minutes | 30<br>minutes | Double-wrapped instrument trays.<br>Maximum weight of 25 lbs each for the<br>following models: 9-6-12 HS2, 9-6-15<br>HS1, and GR 9-6-18 HS2.<br>Maximum weight of 17 lbs. each for the<br>following models: 9-6-9 HS1, 9-6-9 HS2,<br>9-6-12 HS1, 9-6-15 HS2, 9-6-18 HS1, 9-6-18 HS2, GR 9-6-9 HS1, GR 9-6-9 HS2,<br>GR 9-6-12 HS1, GR 9-6-12 HS2, GR 9-6-15 HS1, GR 9-6-15 HS2, GR 9-6-18 HS1.<br>Fabric Packs. | | 2 | PreVac 270F<br>4S / 5Dry | 4 pulses | 270°F | 4 minutes | 5<br>minutes | Fabric Packs. | | 3 | Immediate<br>Use 270F -<br>Single Ins | Purge | 270°F | 3 minutes | 1 minute | Unwrapped instrument tray with a single<br>instrument | | 4 | Immediate<br>Use 270F -<br>Multi Ins | Purge | 270°F | 10 minutes | 1 minute | Unwrapped instrument tray with non<br>porous multiple instruments.<br>Maximum weight of 25 lbs each for the<br>following models: 9-6-12 HS2, 9-6-15<br>HS1, and GR 9-6-18 HS2.<br>Maximum weight of 17 lbs. each for the<br>following models: 9-6-9 HS1, 9-6-9 HS2,<br>9-6-12HS1, 9-6-15 HS2, 9-6-18 HS1, 9-6-18 HS2, GR 9-6-9 HS1, GR 9-6-9 HS2,<br>GR 9-6-12 HS1, GR 9-6-12 HS2, GR 9-6-15 HS1, GR 9-6-15 HS2, GR 9-6-15 HS2,<br>GR 9-6-18 HS1. Maximum of 4<br>instrument trays. | | 5 | Express 270F | 2 pulses | 270°F | 4 minutes | 3<br>minutes | Single wrapped instrument tray with non<br>porous single instrument | | 6 | Bowie-Dick<br>Test | 4 pulses | 273°F | 3.5 minutes | 1 minute | One DART or Bowie-Dick-Test-Pack | | 7 | Leak Test | Vacuum:<br>65 mbar<br>Test time:<br>15 min | - | - | - | Empty chamber | | 8 | Warm up &<br>Leak Test | Vacuum:<br>65 mbar<br>Test time:<br>15 min | 270°F | 4 minutes | 3<br>minutes | Empty chamber | | 10 | Liquid 250F | Purge | 250°F | 45 minutes | Max 1000 ml of Liquid per bottle. Use only vented bottles, type I, borosilicate glass<br>Cycle disabled | | {8}------------------------------------------------ Notes on Table 2: 1. Factory set sterilize time is recommended. 2. Factory set dry time. 3. Recommended load: Refer to table 4 and 5. 4. Fabric load should be preconditioned between 68°F and 75°F and at a relative humidity of at least 35% to 60% for at least 2 hours. 5. The liquid cycle is for non-patient contact use only. The Belimed Steam Sterilizers MST-H are offered in the following versions: | Model<br>Single Door<br>Double Door | Configuration | Chamber Size (H x W x D) (mm) | Overall Size (H x W x D) (mm) | |-------------------------------------|---------------|-------------------------------|-------------------------------| | 9-6-9 HS1 | 1 door | 1080 x 660 x 1040 | 2000 x 1700 x 1280 | | GR 9-6-9 HS1 | | 1230 x 660 x 1100 | 2000 x 1900 x 1600 | | 9-6-9 HS2 | 2 door | 1080 x 660 x 1040 | 2000 x 1700 x 1300 | | GR 9-6-9 HS2 | | 1230 x 660 x 1100 | 2000 x 1900 x 1600 | | 9-6-12 HS1 | 1 door | 1080 x 660 x 1398 | 1970 x 1700 x 1714 | | GR 9-6-12 HS1 | | 1230 x 660 x 1400 | 2000 x 1900 x 1900 | | 9-6-12 HS2 | 2 door | 1080 x 660 x 1398 | 1970 x 1700 x 1714 | | GR 9-6-12 HS2 | | 1230 x 660 x 1400 | 2000 x 1900 x 1900 | | 9-6-15 HS1 | 1 door | 1080 x 660 x 1700 | 1970 x 1700 x 2022 | | GR 9-6-15 HS1 | | 1230 x 660 x 1706 | 2000 x 1900 x 2200 | | 9-6-15 HS2 | 2 door | 1080 x 660 x 1700 | 1970 x 1700 x 2022 | | GR 9-6-15 HS2 | | 1230 x 660 x 1706 | 2000 x 1900 x 2200 | | 9-6-18 HS1 | 1 door | 1080 x 660 x 2014 | 1970 x 1700 x 2330 | | GR 9-6-18 HS1 | | 1230 x 660 x 2000 | 2000 x 1900 x 2500 | | 9-6-18 HS2 | 2 door | 1080 x 660 x 2014 | 1970 x 1700 x 2330 | | GR 9-6-18 HS2 | | 1230 x 660 x 2000 | 2000 x 1900 x 2500 | Table 3. Versions and dimensions. {9}------------------------------------------------ The following tables show the recommended loads for the Belimed Steam Sterilizers MST-H: | Sterilizer Chamber Size (mm) | Model | Wrapped Instrument Trays 20"x10" max. 17lb each | Fabric Packs 11"x11"x9" max 6.6lb each | Fabric Packs 23"x11"x11" max. 17lb each | |-------------------------------------|---------------------------------|-------------------------------------------------|----------------------------------------|-----------------------------------------| | 26"x 42.5"x 41" (660 x 1080 x 1040) | 9-6-9 HS1 and 9-6-9 HS2 | 9 | 18 | 9 | | 26"x 42.5"x 55" (660 x 1080 x 1400) | 9-6-12 HS1 | 12 | 30 | 12 | | 26"x 42.5"x 67" (660 x 1080 x 1700) | 9-6-15 HS2 | 15 | 36 | 15 | | 26"x 42.5"x 79" (660 x 1080 x 2000) | 9-6-18 HS1 and 9-6-18 HS2 | 18 | 42 | 18 | | 26"x 48.5"x 43" (660 x 1230 x 1100) | GR 9-6-9 HS1 and GR 9-6-9 HS2 | 9 | 18 | 9 | | 26"x 48.5"x 55" (660 x 1230 x 1400) | GR 9-6-12 HS1 and GR 9-6-12 HS2 | 12 | 30 | 12 | | 26"x 48.5"x 67" (660 x 1230 x 1700) | GR 9-6-15 HS1 and GR 9-6-15 HS2 | 15 | 36 | 15 | | 26"x 48.5"x 79" (660 x 1230 x 2000) | GR 9-6-18 HS1 | 18 | 42 | 18 | Table 4: Recommended loads by sterilizer for 17 lb. instrument trays and fabric packs. Table 5: Recommended loads by sterilizer for 25 lb. instrument trays and fabric packs. | Sterilizer Chamber Size<br>(mm) | Model | Wrapped<br>Instrument<br>Trays 20"x10"<br>max. 25 lb.<br>each | Fabric<br>Packs<br>11"x11"x9"<br>max 6.6lb<br>each | Fabric<br>Packs<br>23"x11"x11"<br>max. 17lb<br>each | |----------------------------------------|---------------|---------------------------------------------------------------|----------------------------------------------------|-----------------------------------------------------| | 26"x 42.5"x 55" (660 x 1080<br>x 1400) | 9-6-12 HS2 | 12 | 30 | 12 | | 26"x 42.5"x 67" (660 x 1080<br>x 1700) | 9-6-15 HS1 | 15 | 36 | 15 | | 26"x 48.5"x 79" (660 x 1230<br>x 2000) | GR 9-6-18 HS2 | 18 | 42 | 18 | {10}------------------------------------------------ | Model | Volume of Liquid in One<br>Container | Number of Containers | |-----------|--------------------------------------|----------------------| | 9-6-9 | 1000 mL | 126 | | GR 9-6-9 | 1000 mL | 126 | | 9-6-12 | 1000 mL | 168 | | GR 9-6-12 | 1000 mL | 168 | | 9-6-15 | 1000 mL | 210 | | GR 9-6-15 | 1000 mL | 210 | | 9-6-18 | 1000 mL | 252 | | GR 9-6-18 | 1000 mL | 252 | Table 6. Recommended loads for liquid cycle 250F. The Belimed Steam Sterilizer TOP 5000 is designed for sterilization of non-porous and porous heat and moisture stable materials used in healthcare facilities. The Belimed Steam Sterilizer TOP 5000 is offered in the following medium-size configurations: 26"x 42.5"x 41" (660 mm x 1080 mm x 1040 mm) Single Door, Prevacuum 26"x 42.5"x 41" (660 mm x 1080 mm x 1040 mm) Double Door, Prevacuum 26"x 42.5"x 55" (660 mm x 1080 mm x 1400 mm) Single Door, Prevacuum 26"x 42.5"x 55" (660 mm x 1080 mm x 1400 mm) Double Door, Prevacuum 26"x 42.5"x 67" (660 mm x 1080 mm x 1700 mm) Single Door, Prevacuum 26"x 42.5"x 67" (660 mm x 1080 mm x 1700 mm) Double Door, Prevacuum 26"x 42.5"x 79" (660 mm x 1080 mm x 2000 mm) Single Door, Prevacuum 26"x 42.5"x 79" (660 mm x 1080 mm x 2000 mm) Double Door, Prevacuum 26"x 48.5"x 43" (660 mm x 1230 mm x 1100 mm) Single Door, Floor Flush Design, Prevacuum 26"x 48.5"x 43" (660 mm x 1230 mm x 1100 mm) Double Door, Floor Flush Design, Prevacuum 26"x 48.5"x 55" (660 mm x 1230 mm x 1400 mm) Single Door, Floor Flush Design, Prevacuum 26"x 48.5"x 55" (660 mm x 1230 mm x 1400 mm) Double Door, Floor Flush Design, Prevacuum 26"x 48.5"x 67" (660 mm x 1230 mm x 1700 mm) Single Door, Floor Flush Design, Prevacuum 26"x 48.5"x 67" (660 mm x 1230 mm x 1700 mm) Double Door, Floor Flush Design, Prevacuum 26"x 48.5"x 79" (660 mm x 1230 mm) Single Door, Floor Flush Design, Prevacuum 26"x 48.5"x 79" (660 mm x 1230 mm) Double Door, Floor Flush Design, Prevacuum The Belimed Steam Sterilizers MST-H, models 9-6-9 HS1, 9-6-9 HS2, 9-6-12 HS1, 9-6-12 HS2, 9-6-15 HS1, 9-6-15 HS2, 9-6-18 HS1, 9-6-18 HS2, GR 9-6-9 HS1, GR 9-6-9 HS2, GR 9-6-12 HS1, GR 9-6-12 HS2, GR 9-6-15 HS1, GR 9-6-15 HS2, GR 9-6-18 HS1, and GR 9-6-18 HS2 are designed for the sterilization of non-porous and porous heat and moisture stable materials used in healthcare facilities. {11}------------------------------------------------ # NONCLINICAL COMPARISON TO THE PREDICATE DEVICE: The Belimed Steam Sterilizers MST-H, models 9-6-9, 9-6-12, 9-6-15, and 9-6-18 are very similar to the predicate device. A summary of the differences to the predicate device is included in Table 7. | General Sterilizer<br>Features | Belimed Steam Sterilizer<br>TOP 5000 Series 9-18<br>(K021223) | Belimed Steam<br>Sterilizer TOP 5000<br>Series 9-18 | Comparison | |------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | Intended Use | Terminal Sterilization of non-<br>porous and porous heat and<br>moisture-stable materials<br>used in healthcare facilities | Terminal Sterilization<br>of non-porous and<br>porous heat and<br>moisture-stable<br>materials used in<br>healthcare facilities | Same | | Operating<br>principle | The sterilizing agent is<br>steam. | The sterilizing agent<br>is steam. | Same | | Built according to<br>standard | ANSI/AAMI ST8:1994<br>Hospital Steam Sterilizers | ANSI/AAMI ST8:2013<br>Hospital Steam<br>Sterilizers | Same | | Chamber sizes | (H x W x D) in mm: | (H x W x D) in mm: | Same | | Model:<br>9-6-9 / 9-6-12 /<br>GR9-6-12<br>9-6-15 / GR9-6-<br>15<br>9-6-18 / GR9-6-<br>18 | 1080x660x1040<br>1080x660x1400 /<br>1230x660x1400<br>1080x660x1700 /<br>1230x660x1700<br>1080x660x2000 /<br>1230x660x2000 | 1080x660x1040<br>1080x660x1400 /<br>1230x660x1400<br>1080x660x1700 /<br>1230x660x1700<br>1080x660x2000 /<br>1230x660x2000 | Same | | Sterilization<br>cycles | PreVac 270 °F<br>Gravity 270 °F<br>Liquid 250 °F<br>Bowie Dick Test<br>Air Leak Test | PreVac 270 °F<br>Gravity 270 °F<br>Liquid 250 °F<br>Bowie Dick Test<br>Air Leak Test | Same | | Max. instrument<br>tray weight | 17 lbs. | 17 lbs. for 9-6-9 HS1<br>9-6-9 HS2, GR 9-6-9<br>HS1, GR 9-6-9 HS2,<br>9-6-12 HS1, GR 9-6-<br>12HS1,<br>9-6-15 HS2, GR 9-6-<br>15 HS1, GR 9-6-15<br>HS2, 9-6-18 HS1, 9- | Same | | 6-18 HS2, GR 9-6-18<br>HS1 | | | | | 25 lbs. for 9-6-12<br>HS2, 9-6-15 HS1,<br>and GR 9-6-18 HS2 | | | | | Load capacity<br>instrument trays | | | | | Model: | | | | | 9-6-9 / 9-6-12 /<br>GR9-6-12 | 9 | 9 | Same | | 9-6-15 / GR9-6- | 12 | 12 | | | 15 | 15 | 15 | | | 9-6-18 / GR9-6-<br>18 | 18 | 18 | | | Chamber<br>material | Stainless steel 316L | Stainless steel 316L | Same | | Chamber design<br>pressure | 39 psi | 39 psi | Same | | Door construction | Automated horizontal sliding<br>door(s) | Automated horizontal<br>sliding door(s) | Same | | Safety (pressure<br>relief) valves | ASME approved | ASME approved | Same | | Piping | Stainless steel 316 L | Stainless steel 316 L | Same | | Electrical | 3 phase 208V 60Hz | 3 phase 208V 60Hz | Same | | HMI Technology | LCD color / 5.7" | LCD color / 5.7" | Same | | Control<br>Technology | PLC | PLC | Same | | Printer<br>Technology | Matrix Dot Technology | Matrix Dot<br>Technology | Same | | Vacuum pump | 9-6-9 / GR 9-6-9: 95m3/h<br><br>9-6-12 / GR 9-6-12: 95m3/h<br><br>9-6-15 / GR 9-6-15: 130m3/h<br><br>9-6-18 / GR 9-6-18: 130m3/h | 9-6-9 / GR 9-6-9:<br>95m3/h<br><br>9-6-12 / GR 9-6-12:<br>95m3/h<br><br>9-6-15 / GR 9-6-15:<br>130m3/h<br><br>9-6-18 / GR 9-6-18:<br>130m3/h | Same | | Air filter | 0.3 microns | 0.3 microns | Same | Table 7. A summary of the differences to the predicate device. {12}------------------------------------------------ {13}------------------------------------------------ ## CLINICAL DATA: No clinical data is required for this device classification submission. ### SUMMARY OF PERFORMANCE TESTING: Belimed validates its sterilization cycles by recommended practices, standards and quidelines developed by various independent organizations such as the Association for Advancement of Medical Instrumentation (AAMI). Prior to release, Belimed Steam Sterilizer MST-H were validated to meet the requirements of ANSI/AAMI ST8:2013. The results of the Belimed Steam Sterilizer MST-H verification studies demonstrate that the sterilizer performs as intended and is summarized as follows: - The Prevac cycle where the maximum tray capacity is changing to 25 lbs. was qualified according to AAMI ST8:2013 section 5.5.4. This cycle demonstrated a sterility assurance level of at least 10° through achievement of a time-at-temperature sufficient to produce an F0 of at least 12 minutes by half cycle, moisture retention of less than 20% increase in pre-sterilization weight of the towel, and exhibited no wet spots on the outer wrapper. - The Immediate Use Gravity cycle where the maximum tray capacity is changing from 17 lbs. to 25 lbs. was qualified according to AAMI ST8:2013 section 5.5.5.1. # STANDARDS USED: Belimed's sterilizers, including the Belimed Steam Sterilizer MST-H, models 9-6-12, and 9-6-18, have been designed and constructed to meet the safety and performance requirements of various national safety codes and standards. The Belimed Steam Sterilizer MST-H complies with the following safety standards: - 1. ANSI/AAMI ST8:2013 - 2. ANSI/AAMI ST79:2010+A1:2010 - 3. IEC EN 62304:2006 - 4. EN ISO 14971:2012 - ISO 13485:2012 Medical Devices Quality management systems. Requirements for 5. regulatory purposes - 6. IEC EN 60601-1-2:2007 - American Society of Mechanical Engineers (ASME), Section VIII, Division 1 for unfired 7. pressure vessels Ed. 2015. - 8. UL 61010-1:2004 Safety requirements for electrical equipment for measurement, control and laboratory use -Part 1: General requirements. - 9. IEC 61010-2-040:2005 Safety requirements for electrical equipment for measurement, control and laboratory use -Part 2: Particular requirements for sterilizers and washerdisinfectors used to treat medical materials. {14}------------------------------------------------ # CONCLUSION The Belimed Steam Sterilizer MST-H Top 5000 is substantially equivalent device to that of the predicate device (K021223). The nonclinical tests and accompanying in this premarket notification demonstrate that this device is as safe, as effective, and performs as well or better than the predicate device series (K021223).