Who is the manufacturer of Belimed Steam Sterilizer MST-H TOP 5000?

Belimed AG filed the 510(k) submission for Belimed Steam Sterilizer MST-H TOP 5000 (K191896).

What is the FDA product code for Belimed Steam Sterilizer MST-H TOP 5000?

FLE. It is classified under 21 CFR 880.6880 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for Belimed Steam Sterilizer MST-H TOP 5000?

510(k) clearance (submission type: Abbreviated).

What are the predicate devices for Belimed Steam Sterilizer MST-H TOP 5000?

Belimed Steam Sterilizer MST-H TOP 5000 (K170228).

Who can help prepare an FDA 510(k) submission like Belimed Steam Sterilizer MST-H TOP 5000?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Belimed Steam Sterilizer MST-H TOP 5000

K191896 · Belimed AG · FLE · Oct 31, 2019 · General Hospital

Device Facts

Record ID	K191896
Device Name	Belimed Steam Sterilizer MST-H TOP 5000
Applicant	Belimed AG
Product Code	FLE · General Hospital
Decision Date	Oct 31, 2019
Decision	SESE
Submission Type	Abbreviated
Regulation	21 CFR 880.6880
Device Class	Class 2

Indications for Use

The Belimed Steam Sterilizers MST-H TOP 5000, 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. 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.

Device Story

The Belimed Steam Sterilizer MST-H TOP 5000 is a steam-based sterilization system for healthcare facilities. It processes non-porous and porous heat/moisture-stable materials, including instrument trays and fabric packs. The device operates via factory-programmed cycles (PreVac, Gravity, Liquid, Air Leak, Bowie-Dick) controlled by a PLC. Users load materials into the chamber (single or double door, carriage or ground loader versions). The system uses steam as the sterilizing agent. The HMI features a 5.7" color LCD. The device provides automated sterilization, which helps ensure the sterility of medical instruments, thereby supporting infection control and patient safety.

Clinical Evidence

No clinical data. Bench testing only. Sterilization efficacy validated per ANSI/AAMI ST8:2013 using biological indicators (SAL 10^-6) and physical temperature profiling. All tests passed.

Technological Characteristics

Chamber/piping: 316L stainless steel. Pressure: 39 psi. HMI: 5.7" color LCD. Control: PLC. Vacuum pump: 95-130 m3/h. Air filter: 0.3 microns. Standards: ANSI/AAMI ST8:2013, ASME Section VIII Div 1, IEC 61010-2-040, UL 61010-1.

Indications for Use

Indicated for sterilization of non-porous and porous heat and moisture stable materials in healthcare facilities.

Regulatory Classification

Identification

A steam sterilizer (autoclave) is a device that is intended for use by a health care provider to sterilize medical products by means of pressurized steam.

Predicate Devices

Belimed Steam Sterilizer MST-H TOP 5000 (K170228)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows 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. October 31, 2019 Belimed AG Marc Lüthi Head of R&D Sustaining Grienbachstrasse 11 CH-6300 Zug / Switzerland Re: K191896 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: September 20, 2019 Received: September 25, 2019 Dear Marc Lüthi: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, For Elizabeth Claverie, M.S. Assistant Director for THT4B2 Acting Assistant Director for THT4B1 DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ### Indications for Use 510(k) Number (if known) K191896 Device Name Belimed Steam Sterilizer MST-H TOP 5000 #### Indications for Use (Describe) Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. The Belimed Steam Sterilizer MST-H TOP 5000 models 9-6-9 HS1, 9-6-12 HS1, 9-6-12 HS1, 9-6-15 HS1, 9-6-15 HS2, 9-6-18 HS1, 9-6-18 HS2, GR 9-6-9 HS1, GR 9-6-12 HS1, GR 9-6-12 HS1, 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. 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) Prescription Use (Part 21 CFR 801 Subpart D) Z 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 TEMP | STERI LIZE TIME | DRY TIME | RECOMMENDED LOAD | |-------------------------------------|-------------------|-----------------------|---------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | PreVac 270F 4S / 30Dry | 270°F | 4 minutes | 30 minutes | Double-wrapped instrument trays. Maximum weight of 25 Ib each for the following models: 9-6-12 HS2, 9-6-15 HS1, GR 9-6-15 HS2 and GR 9-6-18 HS2. Maximum weight of 17 Ib 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 9-6-15 HS1 and GR 9- 6-18 HS1. Fabric Packs. | | PreVac 270F 4S / 5Dry | 270°F | 4 minutes | 5 minutes | Fabric Packs. | | Liquid 250F | 250°F | 45 minutes | | Max 1000 ml of Liquid per bottle. Use only vented bottles, type I, borosilicate glass Cycle disabled | | Express 270F | 270°F | 4 minutes | 3 minutes | Single wrapped instrument tray with non porous single instrument | | Immediate Use 270F Single Ins | 270°F | 4 minutes | 3 minutes | Unwrapped instrument tray with non porous single instrument | | Immediate Use 270F Multi Ins | 270°F | 10 minutes | 1 minute | Unwrapped instrument tray with non porous multiple instruments. Maximum weight of 25 lb each for the following models: 9-6-12 HS2, 9-6-15 HS1, and GR 9-6-18 HS2. 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 HS2, GR 9-6-18 HS1. Maximum of 4 instrument trays. | . : . : . {4}------------------------------------------------ # 510(k) Summary | K191896 | | |----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Date: | October 25, 2019 | | Owner's Name / Address: | Belimed AG Grienbachstrasse 11 CH-6300 Zug / Switzerland | | Preparer's Name / Address: | Belimed AG Grienbachstrasse 11 CH-6300 Zug / Switzerland | | Contact Person: | Marc Lüthi Email: marc.luethi@belimed.com Phone: +41 71 644 87 80 Fax: +41 41 449 78 89 | | Trade Name: | Belimed Steam Sterilizer MST-H TOP 5000 | | 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, 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 MST-H TOP 5000 (K170228) | {5}------------------------------------------------ ### Intended Use: The Belimed Steam Sterilizers MST-H TOP 5000, 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. 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. | CYCLES | STERILIZE TEMP | STERI LIZE TIME | DRY TIME | RECOMMENDED LOAD | |-------------------------------------|-------------------|-----------------------|---------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | PreVac 270F 4S / 30Dry | 270°F | 4 minutes | 30 minutes | Double-wrapped instrument trays. Maximum weight of 25 lb each for the following models: 9-6-12 HS2, 9-6-15 HS1, GR 9-6-15 HS2 and GR 9-6-18 HS2. Maximum weight of 17 lb 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 9-6-15 HS1 and GR 9- 6-18 HS1. Fabric Packs. | | PreVac 270F 4S / 5Dry | 270°F | 4 minutes | 5 minutes | Fabric Packs. | | Liquid 250F | 250°F | 45 minutes | - | Max 1000 ml of Liquid per bottle. Use only vented bottles, type I, borosilicate glass Cycle disabled | | Express 270F | 270°F | 4 minutes | 3 minutes | Single wrapped instrument tray with non porous single instrument | | Immediate Use 270F Single Ins | 270°F | 4 minutes | 3 minutes | Unwrapped instrument tray with non porous single instrument | | Immediate Use 270F Multi Ins | 270°F | 10 minutes | 1 minute | Unwrapped instrument tray with non porous multiple instruments. Maximum weight of 25 lb each for the following models: 9-6-12 HS2, 9-6-15 HS1, and GR 9-6-18 HS2. Maximum weight of 17 lb 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 HS2, GR 9-6-18 HS1. Maximum of 4 instrument trays. | Table 1: Factory programmed sterilization cycles and cycle values. {6}------------------------------------------------ ### Description of Device: The Belimed Steam Sterilizers MST-H TOP 5000, 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 BowieDick Test cycles. The Belimed Steam Sterilizers TOP 5000 are equipped with the following predefined cycles (Table 2): {7}------------------------------------------------ | No | CYCLE | PRE- TREATM ENT | STERILIZE TEMP | STERI LIZE TIME | DRY TIME | RECOMMENDED LOAD | |----|-------------------------------|--------------------------------------------|-------------------|-----------------------|---------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 1 | PreVac 270F 4S / 30Dry | 4 pulses | 270°F | 4 minutes | 30 minutes | Double-wrapped instrument trays. Maximum weight of 25 lb each for the following models: 9-6-12 HS2, 9-6-15 HS1, GR 9-6-15 HS2 and GR 9-6-18 HS2. Maximum weight of 17 lb 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 9-6-15 HS1 and GR 9-6-18 HS1. Fabric Packs. | | 2 | PreVac 270F 4S / 5Dry | 4 pulses | 270°F | 4 minutes | 5 minutes | Fabric Packs. | | 3 | Flash 270F - Single Ins | Purge | 270°F | 3 minutes | 1 minute | Unwrapped instrument tray with a single instrument | | 4 | Flash 270F - Multi Ins | Purge | 270°F | 10 minutes | 1 minute | Unwrapped instrument tray with non porous multiple instruments. Maximum weight of 25 Ib each for the following models: 9-6-12 HS2, 9-6-15 HS1, and GR 9-6-18 HS2. Maximum weight of 17 Ib 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 HS2, GR 9-6-18 HS1. Maximum of 4 instrument trays. | | 5 | Express 270F | 2 pulses | 270°F | 4 minutes | 3 minutes | Single wrapped instrument tray with non porous single instrument | | 6 | Bowie- Dick Test | 4 pulses | 273°F | 3.5 minutes | 1 minute | One DART or Bowie-Dick-Test-Pack | | 7 | Leak Test | Vacuum: 65 mbar Test time: 15 min | - | - | - | Empty chamber | | 8 | Warm up & Leak Test | Vacuum: 65 mbar Test time: 15 min | 270°F | 4 minutes | 3 minutes | Empty chamber | | 9 | - | - | - | - | - | - | | 10 | Liquid 250F | Purge | 250°F | 45 minutes | - | Max 1000 ml of Liquid per bottle. Use only vented bottles, type I, borosilicate glass Cycle disabled | ### Table 2: Factory programmed Sterilization cycles Notes on Table 2: - 1. Factory set sterilize time is recommended. - 2. Factory set dry time. - 3. Recommended load: Refer to table 3 and 4. - 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. {8}------------------------------------------------ The Belimed Steam Sterilizers MST-H TOP 5000 are offered in the following versions: | Model | Configuration | Chamber Size (H x W x D) (mm) | Overall Size (H x W x D) (mm) | |---------------|---------------|-------------------------------|-------------------------------| | Single Door | | | | | Double Door | | | | | 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 TOP 5000: | Model single door double door | Wrapped instrument trays, max. 17 lb each | Fabric Packs 11"*x11"x9" max.6.6 lb each | Fabric Packs 23"x11"x11" max. 17 lb each | |-------------------------------------|----------------------------------------------------|------------------------------------------------|------------------------------------------------| | 9-6-9 HS1 | 9 | 18 | 9 | | 9-6-9 HS2 | | | | | GR 9-6-9 HS1 | | | | | GR 9-6-9 HS2 | | | | | 9-6-12 HS1 | 12 | 30 | 12 | | GR 9-6-12HS1 | | | | | GR 9-6-12HS2 | | | | | 9-6-15 HS2 | 15 | 36 | 15 | | GR 9-6-15 HS1 | | | | | 9-6-18 HS1 | 18 | 42 | 18 | | 9-6-18 HS2 | | | | | GR 9-6-18 HS1 | | | | 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. | Model single door double door | Wrapped instrument trays, max. 25 lb each | Fabric Packs 11*x11"x9" max.6.6 lb each | Fabric Packs 23"x11"x11" max. 17 lb each | |-------------------------------------|----------------------------------------------------|-----------------------------------------------|------------------------------------------------| | 9-6-12 HS2 | 12 | 30 | 12 | | 9-6-15 HS1 | 15 | 36 | 15 | | GR 9-6-15 HS2 | | | | | GR 9-6-18 HS2 | 18 | 42 | 18 | {10}------------------------------------------------ | Model | Volume of Liquid in One Container | Number of Containers | |---------------------|--------------------------------------|----------------------| | 9-6-9 GR 9-6-9 | 1000 mL | 126 | | 9-6-12 GR 9-6-12 | 1000 mL | 168 | | 9-6-15 GR 9-6-15 | 1000 mL | 210 | | 9-6-18 GR 9-6-18 | 1000 mL | 252 | Table 6. Recommended loads for liquid cycle 250F. The Belimed Steam Sterilizer MST-H 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 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 x 2000 mm) Single Door, Floor Flush Design, Prevacuum 26"x 48.5"x 79" (660 mm x 1230 mm x 2000 mm) Double Door, Floor Flush Design, Prevacuum {11}------------------------------------------------ # Technological Characteristics Table: | Shown below is a comparison of the subject device versus the predicate device: | | | | |--------------------------------------------------------------------------------|--|--|--| | | | | | | General Sterilizer Features | Belimed Steam Sterilizer MST-H TOP 5000 (K170228) | Belimed Steam Sterilizer MST-H TOP 5000 (K191896) | Comparison | |------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | Intended Use | Terminal Sterilization of non- porous and porous heat and moisture-stable materials used in healthcare facilities | Terminal Sterilization of non- porous and porous heat and moisture-stable materials used in healthcare facilities | Same | | Operating principle | The sterilizing agent is steam. | The sterilizing agent is steam. | Same | | Built according to standard | ANSI/AAMI ST8:2013 Hospital Steam Sterilizers | ANSI/AAMI ST8:2013 Hospital Steam Sterilizers | Same | | Chamber sizes Model: | (H x W x D) in mm: | (H x W x D) in mm: | Same | | 9-6-9 9-6-12 GR9-6-12 | 1080x660x1040 1080x660x1400 1230x660x1400 | 1080x660x1040 1080x660x1400 1230x660x1400 | | | 9-6-15 GR9-6-15 | 1080x660x1700 1230x660x1700 | 1080x660x1700 1230x660x1700 | | | 9-6-18 GR9-6-18 | 1080x660x2000 1230x660x2000 | 1080x660x2000 1230x660x2000 | | | Sterilization cycles | PreVac 270 °F | PreVac 270 °F | Same | | | Gravity 270 °F | Gravity 270 °F | | | | Liquid 250 °F | Liquid 250 °F | | | | Bowie Dick Test | Bowie Dick Test | | | | Air Leak Test | Air Leak Test | | | Max. instrument tray weight | Double-wrapped instrument trays. Maximum weight of 25 lb each for the following models: 9-6-12 HS2, 9-6-15 HS1 and GR 9-6-18 HS2. Maximum weight of 17 lb 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- 15 HS1, GR 9-6-15 HS2 and GR 9-6-18 HS1. Fabric Packs | Double-wrapped instrument trays. Maximum weight of 25 lb each for the following models: 9-6-12 HS2, 9-6-15 HS1, GR 9-6-15 HS2 and GR 9-6-18 HS2. Maximum weight of 17 lb 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- 15 HS1 and GR 9-6-18 HS1. Fabric Packs | Similar | | General Sterilizer Features | Belimed Steam Sterilizer MST-H TOP 5000 (K170228) | Belimed Steam Sterilizer MST-H TOP 5000 (K191896) | Comparison | | Load capacity instrument trays | | | | | Model: | | | | | 9-6-9 / 9-6-12 / GR9-6-12 | 9 | 9 | same | | 9-6-15 / GR9-6-15 | 12 | 12 | | | 9-6-18 / GR9-6-18 | 15 | 15 | | | | 18 | 18 | | | Chamber material | Stainless steel 316L | Stainless steel 316L | same | | Chamber design pressure | 39 psi | 39 psi | same | | Door construction | Automated horizontal sliding door(s) | Automated horizontal sliding door(s) | same | | Safety (pressure 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 Technology | PLC | PLC | Same | | Printer Technology | Matrix Dot Technology | Matrix Dot Technology | Same | | Vacuum pump | 9-6-9 / GR 9-6-9: 95m3/h 9-6-12 / GR 9-6-12: 95m3/h 9-6-15 / GR 9-6-15: 130m3/h 9-6-18 / GR 9-6-18: 130m3/h | 9-6-9 / GR 9-6-9: 95m3/h 9-6-12 / GR 9-6-12: 95m3/h 9-6-15 / GR 9-6-15: 130m3/h 9-6-18 / GR 9-6-18: 130m3/h | Same | | Air filter | 0.3 microns | 0.3 microns | Same | {12}------------------------------------------------ Based on the comparison above the subject device and the predicate device demonstrate many of the same technological characteristics. {13}------------------------------------------------ ## Clinical Data: No clinical data is required for this device classification submission. ## Summary of Performance Testing: Show below is a summary of the non-clinical testing that was performed with this device. | Test Performed | Device Describtion/ Sample Size | Test Method/ Applicable Standards | Acceptance Criteria | Results | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------| | Biological Performance Tests: | | | | | | Sterilization Efficacy Validation PreVac 132°C (270°F) for 4 minutes Exposure and 30 min. Dry 25 lbs wrapped instrument PCD 1: Full cycle / 3 runs | MST-H TOP 5000 GR 9-6-15 HS2 | ANSI AAMI ST8:2013 5.5.4. Biological performance with wrapped instrument PCD BI's used in testing comply with ANSI/AAMI/ISO 11138-3 | Sterility assurance level (SAL) 10-6 time-at-temperature sufficient to produce an F0 of at least 12 minutes by half cycle, moisture retention of less than 20% increase ANSI/AAMI ST8:2013 5.5.4.5 ANSI/AAMI/ISO 14161 | Pass | | Sterilization Efficacy Validation PreVac 132°C (270°F) for 4 minutes Exposure 25 lbs wrapped instrument PCD 1: Full cycle / 3 runs 2: Half cycle 2 minutes / 3 runs | MST-H TOP 5000 GR 9-6-15 HS2 | ANSI AAMI ST8:2013 5.5.4. Biological performance with wrapped instrument PCD BI's used in testing comply with ANSI/AAMI/ISO 11138-3 | Sterility assurance level (SAL) 10-6 time-at-temperature sufficient to produce an F0 of at least 12 minutes by half cycle ANSI/AAMI ST8:2013 5.5.4.5 ANSI/AAMI/ISO 14161 | Pass | | Physical Performance Test: | | | | | | Chamber temperature profile | MST-H TOP 5000 GR 9-6-15 HS2 | ANSI AAMI ST8:2013 5.4.2.5 with empty chamber | +3°C (or +6°F) and -0°C (or -0°F) of the selected sterilization exposure temperature | Pass | {14}------------------------------------------------ ### Standards Used: Belimed's sterilizers, including the Belimed Steam Sterilizer MST-H TOP 5000 series 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 TOP 5000 complies with the following standards: - 1. ANSI/AAMI ST8:2013 - 2. ANSI/AAMI ST79:2017 - 3. IEC EN 62304:2006 - 4. EN ISO 14971:2012 - 5. ISO 13485:2016 Medical Devices - Quality management systems. Requirements for regulatory purposes - 6. American Society of Mechanical Engineers (ASME), Section VIII, Division 1 for unfired pressure vessels Ed. 2017. - UL 61010-1:2004 Safety requirements for electrical equipment for measurement, control 7. and laboratory use -Part 1: General requirements. - 8. 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. - 9. IEC 61326-1 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: General requirements ### Conclusion: The nonclinical tests in this premarket notification demonstrate that this device is as safe, as effective, and performs as well or better than the predicate device series (K170228).

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