BELIMED STEAM STERILIZER, MODEL MST-V 3-3-6

{0}------------------------------------------------ ### 510(k) Summary K10 0622 | Date: | August, 10, 2010 | | | |-----------------------------|------------------------------------------------------------------------------------------------------------------------|--|--------------| | Submitter's Name / Address: | Belimed Sauter AG<br>Zelgstrasse 8<br>CH-8583 Sulgen / Switzerland | | AUG 2 7 2010 | | Contact Person: | Hans Stadler, Head of R&D<br>Email: hans.stadler@belimed-sauter.ch<br>Phone: +41 71 644 85 97<br>Fax: +41 71 644 85 11 | | | | Trade Name: | Belimed Steam Sterilizer MST-V | | | | Model: | 3-3-6 | | | | Classification: | Steam Sterilizer – Class II, as listed per 21 CFR<br>880.6880<br>Product Code 80 FLE | | | | Predicate Device: | Belimed Steam Sterilizer TOP 5000<br>Model 5-5-9 (K060337) | | | ### DEVICE DESCRIPTION: The Belimed Steam Sterlilzers MST-V 3-3-6 is intended for use in hospital and health ed Steam Sterist be interested to be used in an identical manner as the Belimed Steam The Belimed Steam Sterlizers MST-V 3-3-6 is mended for accurrent in the procession care facilities and is intended to be used in an identical manner as the Belimed Steam Care Sterilizer Model 5-5-9. The small chamber size incorporates flexibility, and allows operating the sterilizers in the The small omited space conditions. ... .. .. # nonclinical comparison to the predicate device: The Belimed Steam Sterilizer MST-V 3-3-6, is very similar to the predicate device. The Belimed Steam Sterity on discts device include: The Belimed Steam Otenilizer MOV. Modifications made from the predicate device include: - Smaller chamber size . - Optional Steam Generator Integrated . - Optional Otcam Scham Scharating panel) . #### CLINICAL DATA: No clinical data is required for this device classification submission. #### INTENDED USE: INTERESED and Sterilizer MST-V 3-3-6 is designed for sterilization of non-porous and The Belimed Steam Sterials materials used in health care facilities.. The Belimed Steam Sterlizer MST-V 5-3-0 is dolgined for the believed in health care facilities... porous heat and moisture-stable materials used in health care facilities... The Belimed Steam Sterilizer MST-V 3-3-6 is equipped with the following factorythe Steam Sterling System and cycle values (Table 1). The Belimed Steam Stemizer MST 7 - 8 - 8 - 8 - 8 - 8 - 8 - 4 - 4 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - - . ". :年! Belimed Steam Sterilizer MST-V 3-3-6 FDA 510(K) Author: HST/ KHA Release 1.2 / August 10, 2010 Page 1 of 5 {1}------------------------------------------------ | Table 1: Factory programmed sterilization cycles | | | | | | | |--------------------------------------------------|-------------------------|--------------------------------------------------------------------------|----------------------------------|-------------------|-------------|-------------------------------------------------------------------------------------------------------------------------------------------| | No. | CYCLE | PRE-TREATMENT | STERILIZE<br>TEMP. &<br>PRESSURE | STERILIZE<br>TIME | DRY<br>TIME | RECOMMENDED LOAD | | 1 | PreVac 270<br>long Dry | 3 vacuum pulses:<br>90/100/100 mbar<br>2 Steam pulses:<br>1500/1500 mbar | 270 °F<br>2880mbar | 4 min | 30 min | Two double wrapped instrument<br>trays, maximum total weight of<br>50 lbs or 25lbs / tray | | 2 | PreVac 270<br>short Dry | 3 vacuum pulses:<br>90/100/100 mbar<br>2 Steam pulses:<br>1500/1500mbar | 270 °F<br>2880mbar | 4 min | 5 min | Two Fabric Packs total weight of<br>Maximum 9 lbs or<br>One single wrapped instrument tray<br>with non- porous single instrument | | 3 | Prevac Flash<br>270 | 1 vacuum pulse:<br>90mbar | 270 °F<br>2880mbar | 4 min | 1 min | One unwrapped instrument tray,<br>maximum weight of 25 lbs or<br>One unwrapped instrument tray with<br>single instrument | | 4 | Gravity 250 | Purge time 4 min<br>& Temp. > 98°C | 250 °F<br>2050mbar | 25 min | 0 min | One unwrapped non-porous<br>instrument tray,<br>maximum weight of 25 lbs | | 5 | Bowie-Dick<br>Test | 3 vacuum pulses:<br>90/100/100 mbar<br>2 Steam pulses:<br>1500/1500mbar | 273 °F<br>3030mbar | 3.5 min | 1 min | Bowie-Dick- or other FDA cleared<br>air removal test pack | | 6 | Leak Test | Vacuum:<br>65mbar<br>Test time: 15min | - | | | Empty chamber | | 7 | Warm up &<br>leak test | Vacuum:<br>65mbar<br>Test time: 15min | 270 °F<br>2880mbar | 3 min | 3 min | Empty chamber | | 8 | PreVac<br>270 long Dry | 3 vacuum pulses:<br>90/100/100 mbar<br>2 Steam pulses:<br>1500/1500mbar | 270 °F<br>2880mbar | 10 min | 30 min | One double wrapped instrument tray,<br>maximum total weight of 25 lbs | | 9 | PreVac<br>Flash 270 | 1 vacuum pulse:<br>90mbar | 270 °F<br>2880mbar | 10 min | 1 min | One unwrapped instrument tray,<br>maximum weight of 25 lbs or<br>One single wrapped instrument tray<br>with non- porous single instrument | ## mmed sterilization cycles Note on table 1: Factory set dry time is recommended minimum. Extended dry time may be required. The saling and seel conditions Note on table 1: Paciory Ser dry time is recomment Fabric load should be preconditions: Fabric load should be preconditioned between 68°F and at a relative humidity of at 60% for at least 2 hours. > . {2}------------------------------------------------ The Belimed Steam Sterilizer MST-V 3-3-6 is offered in the following configurations: | Table 2: Dimensions | | |---------------------|--| |---------------------|--| | Model<br>single door<br>double door | Configuration | Chamber size<br>(Volume)<br>(L) | Chamber size<br>(H x W x D)<br>(inch) | Chamber size<br>(H x W x D)<br>(mm) | Overall Dimensions<br>(H x W x D)<br>(inch) | Overall Dimensions<br>(H x W x D)<br>(mm) | |-------------------------------------|------------------|---------------------------------|---------------------------------------|-------------------------------------|---------------------------------------------|-------------------------------------------| | 3-3-6 VS1<br>3-3-6 VS2 | 1 door<br>2 door | 73 | 13"x 13"x 25" | 335 x<br>335 x 640 | 60"x 25"x 31" | 1530 x<br>640 x 800 | The Belimed Steam Sterilizer MST-V 3-3-6 is designed to be used for the temmal The Belimed Steam Sterlizer MST-V 3-5-6 1s designed to 10-2001 sterilization of porous and non-porous, heat and moisture stabile materials in the healthcare facilities. healthcare facilities. Depending of the chosen cycle materials as different as textiles, unwrapped or wrapped Depending of the chosen oyolo materials assisted as a be sterilized. The Belimed Steam Sterlizer MST-V 3-3-6 is factory equipped with cycles which have s The Belimed States of the AMANSLCTR:2008 under defined load conditions. The The Belimed Steam Stellizer WS L-V S-3-0 1s accory oquipped on the Unditions. The been tested in accordance with AAMI/ANS ST8:2008 under defined headly been tested in accordance with A thin INST Oven validated previously. predicate device with a chamber volume 73 I has been validated previously. ### EFFECTIVENESS: Efficacy of sterilizer function and exposure time recommendations are ultimately shown Efficacy of sterilizer function and exposure undersens and version of by complete kill of biological indicators and verifying an appropriate safety factor of by complete kill of biological indications and welling and sparter AG validates its sterility assurance level (SAL) of at least 10° reduction. Belimed Sauter AG validates its sterility assurance level (SAL) of at least 10 - 1east 10 guidelines developed by sterilization cycles by recommended practices, standards and guidelines developed of Medical sterilization cycles by recommended practices, standation for Advancement of Medical various independent organizations such as the Association Sterilizer MSTvarious independent organizations such as the Association of Arantes of Steam Steam Steam Steam Steam Steam Instrumentation (AAMI). Prior release, Belimed Steam Steam Steam S instrumentation (7V ann). The results of the Belimed Steam Sterilizer MST-V 3-3-6 verfication studies demonstrate s for the Belimed Steam Sterial and and are oummarized as follows: The results of the Bellined Steam Otenized MS - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - Empty chamber testing performed as described in Section 5.4.2.5 of ANSI/AMMI Charles of the Market Marker Mas Flash, ond Gravity, cycles, These cycles, These cycles Empty chamber testing periormed as described in Ocouity cycles. These oycles ST8:2008, for the PreVac, PreVac, PreVac, PreVac, Themal Conditions . ST8:2008, for the PreVac, FreVac Flash and Shawly State the Bronditions demonstrated the sterlizer's capability to provide steady state the assurance level demonstrated the sterlizers capability to provide sterility assurance level within the chamber that are corresponding with the predicted tooling as and one of the steel of Section 4.4.2.5 of ANSI/AAMI ST8. - of ANSI/AAMI ST8. All PreVac cycles verified using the fabric test pack, as described in Section 5.5.2.5 ANSI/AAMI ST8. All PreVac cycles verified using the fabric test pack, as asociated in ST8. AAMI/ANSI ST8:2008 were qualified according to section 5.5.2.5 ANSI/AAMI ST8. ● AAMI/ANSI ST8:2008 were qualified assurance level of at least 10° through These cycles demonstrated a sterility assurance level of at least 10° through These cycles demonstrated a stellity assurance level of an Far of at least 12 achievement of a time-at-temperature sufficient to produce an Foresterilization achievement of a time-at-temperature retention of less than 3 % increase in pre-sterilization minutes by half cycle, moisture retention of less than 3 % increase in pre-steri test pack weight, and exhibited no wet spots. - test pack weight, and exhibited no were spots. All PreVac cycles verified using full load instruments trays were qualified a sterility All PreVac cycles verified using tull load instruments trays world in the mail. section 5.5.4 of ANSI/AAM ST8:2008 These cycles demonstrature . section 5.5.4 of ANSIAAMI S 18:2008 These cycles donited assurance level of at least 10° through achievement of a time and the produce and {3}------------------------------------------------ less than 20 % increase in pre-sterilization weight of the towel, and exhibited no wet spots on the outer wrapper. - spots on the outer wrapped or single wrapped or single wrapped instrument trays . All Flash cycles vernied using the unwrapped of eingle star. were qualified according to section 5.5.5.2 AAMI/ANSL ST8:2008 and ANSI/AAM were qualified according to Section 2.0.12 19:00:21 assurance level of at ST79:2006 section 10.7. These cycles demonstrated a sterlity assurance level of For S / 79.2006 section 10.7. These cycles demonstrated a commy least 10° through achievement of a time-at-temperature sufficient to produce an F。of at least 12 minutes by half cycle. - All Gravity cycles verified using the unwrapped instrument tray, were qualified . according to section 5.5.5.1 AAMI/ANSI ST8:2008. These cycles demonstrated a according to section 5.3.3.1 Anni/ANOT Of Schievement of a time at temperature sterility assurance level of at least 10 fthrough actually half a time at temperature sufficient to produce an Fo of at least 12 minutes by half cycle. - The Bowie Dick Test cycle was verified using the Bowie-Dick Test Pack was qualified . according to section 5.6 of AAMI/ANSI STB, and democrative devices, attained the according to section 5.6 of AnimANO. One temperature devices attained the change infoughout the test sheet and the normal similar made prosure phase. - exposure temperature within To seconds or progress performed according to FDA's The software validation for the cycle operation was performed according to FDA's . moderate level of concern recommendations provided in the document "Guidance for moderate level of concern recommendations provided in the are and in Medical Devices (May 2005)". ### SAFETY: Belimed Sauter AG's sterilizers including the Belimed Steam Steam Stealizer MST-V 3-6 have Belimed Sauter AG's stemizes including the Belined Cetuand performance requirements been designed, constructed and tested to meet the safety and performance requirements been designed, constructed and tested to hieet the Saley and porchile of the most of the Steam Sterilizer MST-V complies with the following safety standards: - UL 61010-1:2005 1. - IEC EN 61010-2-040:2005 2. - IEC EN 60601-1-2:2001 +A1:2006 3. - IEC EN 62304:2006 4. - IEC EN 62304:2006 American Society of Mechanical Engineers (ASME), Section VIII, Division 1 for American Society of Mechanical Engineers (Add, 2008 5. unfired pressure vessels Ed. 2007 +Add. 2008 - EN ISO 14971:2007 6. Belimed has a certified quality management system according to ISO 9001 and ISO 13485. ### HAZARDS-FAILURE OF PERFORMANCES Failure of the sterilization process can lead to incidence of cross contamination, the Failure of the sterilization process can lead to includes or order common and the world. transmission of potentially infectious organisms from one infected person to another was not otherwise infected prior to the incident. was not otherwise intected pror to the includent. To avoid failure, the user music ensure the materials, instructions for use are To avoid failure, the user must ensure the manufacturer's instructions for use are sterilized are thoroughly cleaned, that the manufacturer's instructions for use are sterilized are thoroughly cleaned, that the manufacturer of has been validated, that followed, that the cycle to be used for each type of sterliizer's manufacturer's followed, that the cycle to be used to each type of sterliizers manufacturers manufacturers manufacturers and is the sterilizer has been mantained in accordance with the time startiizer load is maintenance schedule and is operating properly, and themical sterilization process maintenance schedule and is operating propeny, and that oach end of the are and interest in indicators. Today, there are many steam sterlizers in daily use in hospitals throughout the United The Sun States of Schooline assefyration or sterilization process failure is relativel Today, there are many steam sterlizers in daily use in nospitals and organisations is relatively {4}------------------------------------------------ rare considering the wide spread use of steam sterilizers. Further, there are no known reports in the literature of patient infection that have resulted from steam sterilizer failure. The technology designed in Belimed Steam Sterilizer MST-V provides microprocessor controller safeguards that abort the cycle and give appropriate signals, alerts and warnings when required conditions have not been met or when a malfunction occurs. ### USER INFORMATION Belimed Sauter AG provides information to the user that is intended to insure safe and effective use of steam sterilization in its detailed User's Manual and other labeling. Belimed Sauter AG also recommends the use and periodic review of the AAMI steam sterilization standards to ensure further assurance of the safe and effective use of steam sterilization equipment in health care facilities. #### CONCLUSION The Belimed Steam Sterilizer MST-V 3-3-6 is a substantially equivalent device to that of the predicate device. There have been no substantial changes in technology and intended use to the predicate device model 5-5-9 (K060337). This steam sterilizer MST-V 3-3-6 meets the applicable requirements of the applicable standards. Based on the provided information in this premarket notification, it can be concluded that the subject device is substantial equivalent to the predicate device and is safe and effective when used as intended. Belimed Steam Sterilizer MST-V 3-3-6 FDA 510(K) Author: HST/ KHA Release 1.2 / August 10, 2010 Page 5 of 5 {5}------------------------------------------------ ### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. #### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Belimed Sauter AG C/O Mr. Stefan Preiss Responsible Third Party Official TÜV SÜD America 1775 Old Highway 8 NW New Brighton, Minnesota 55112-1891 AUG 27 2010 Re: K100622 Trade/Device Name: Belimed Steam Sterilizer MST-V 3-3-6 Regulation Number: 21 CFR 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: II Product Code: FLE Dated: August 16, 2010 Received: August 23, 2010 Dear Mr. Preiss: 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. {6}------------------------------------------------ ### Page 2- Mr. Preiss . 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 (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours. Susan Kanrer Anthony D. Watson, B.S. M.S. M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {7}------------------------------------------------ ## Indications for Use K100622 M10-9 AUG 2 7 2010 510(k) Number: K100622 Device Name: Belimed Steam Sterilizer MST-V 3-3-6 Indications for Use: The Belimed Steam Sterilizer MST-V 3-3-6 is designed for sterilization of non porous and porous heat and moisture-stable materials used in healthcare facilities ... The Belimed Steam Sterilizer MST-V 3-3-6 is equipped with the following factory-programmed Sterilization cycles and cycle values (Table 1). Table 1: Factory programmed sterilization cycles | No. | CYCLE | PRE-TREATMENT | STERILIZE<br>TEMP. &<br>PRESSURE | STERILIZE<br>TIME | DRY<br>TIME | RECOMMENDED LOAD | |-----|-------------------------|--------------------------------------------------------------------------|----------------------------------|-------------------|-------------|-------------------------------------------------------------------------------------------------------------------------------------------| | 1 | PreVac 270<br>long Dry | 3 vacuum pulses:<br>90/100/100 mbar<br>2 Steam pulses:<br>1500/1500 mbar | 270 °F<br>2880mbar | 4 min | 30 min | Two double wrapped instrument<br>trays, maximum total weight of<br>50 lbs (max. 25lbs / tray) | | 2 | PreVac 270<br>short Dry | 3 vacuum pulses:<br>90/100/100 mbar<br>2 Steam pulses:<br>1500/1500mbar | 270 °F<br>2880mbar | 4 min | 5 min | Two Fabric Packs total weight of<br>Maximum 9 lbs or<br>One single wrapped instrument tray<br>with non- porous single instrument | | 3 | Prevac Flash<br>270 | 1 vacuum pulse:<br>90mbar | 270 °F<br>2880mbar | 4 min | 1 min | One unwrapped instrument tray,<br>maximum weight of 25 lbs or<br>One single wrapped instrument tray<br>with non- porous single instrument | | 4 | Gravity 250 | Purge time 4 min<br>& Temp. > 98°C | 250 °F<br>2050mbar | 25 min | 0 min | One unwrapped non-porous<br>instrument tray,<br>maximum weight of 25 lbs | | 5 | Bowie-Dick<br>Test | 3 vacuum pulses:<br>90/100/100 mbar<br>2 Steam pulses:<br>1500/1500mbar | 273 °F<br>3030mbar | 3.5 min | 1 min | Bowie-Dick- or other FDA cleared<br>air removal test pack | | 6 | Leak Test | Vacuum:<br>65mbar<br>Test time: 15min | | | | Empty chamber | Page 1 of 2 {8}------------------------------------------------ | No. | CYCLE | PRE-TREATMENT | STERILIZE<br>TEMP. &<br>PRESSURE | STERILIZE<br>TIME | DRY<br>TIME | RECOMMENDED LOAD | |-----|------------------------|-------------------------------------------------------------------------|----------------------------------|-------------------|-------------|-------------------------------------------------------------------------------------------------------------------------------------------| | 7 | Warm up &<br>leak test | Vacuum:<br>65mbar<br>Test time: 15min | 270 °F<br>2880mbar | 3 min | 3 min | Empty chamber | | 8 | PreVac<br>270 long Dry | 3 vacuum pulses:<br>90/100/100 mbar<br>2 Steam pulses:<br>1500/1500mbar | 270 °F<br>2880mbar | 10 min | 30 min | One double wrapped instrument<br>tray,<br>maximum total weight of 25 lbs | | 9 | PreVac<br>Flash 270 | 1 vacuum pulse:<br>90mbar | 270 °F<br>2880mbar | 10 min | 1 min | One unwrapped instrument tray,<br>maximum weight of 25 lbs or<br>One single wrapped instrument tray<br>with non- porous single instrument | Note on table 1: Factory set dry time is recommended minimum. Extended dry time may be required depending on local conditions. local conditions. Fabric load should be preconditioned between 68°F and at a relative humidity of at least 35% to 60% for at least 2 hours. The Belimed Steam Sterilizer MST-V 3-3-6 is offered in the following configurations: Table 2: Dimensions | Model<br>single door<br>double door | Configuration | Chamber size<br>(Volume)<br>(L) | Chamber size<br>(H x W x D) | | Overall Dimensions<br>(H x W x D) | | |-------------------------------------|------------------|---------------------------------|-----------------------------|-----------------------|-----------------------------------|----------------------| | 3-3-6 VS1<br>3-3-6 VS2 | 1 door<br>2 door | 73 | (inch)<br>13"x 13"x 25" | (mm)<br>335x 335x 640 | (inch)<br>60"x 25"x 31" | (mm)<br>1530x640x800 | Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use x_OTC (21 CFR 807 Subpart C) Concurrence of CDRH, Office of Device Evaluation (ODE) f Device Evaluation (ODE) Susa Rusa (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices 510(k) Number: K006623 Page 2 of 2