BELIMED STEAM STERILIZER TOP 5000, MODEL 5-5-9

{0}------------------------------------------------ #### Special 510(k) Summary 1.2 K060337 | Date: | Dec.20, 2005 | MAR 8 2006 | |-----------------------------|-----------------------------------------------------------------------|------------| | Submitter's Name / Address: | Sauter AG<br>Zelgstrasse 8<br>CH- 8583 Sulgen / Switzerland | | | Contact Person: | Hans Stadler, Head of Product Development,<br>Email: hst@sauterag.com | | | Trade Name: | Belimed Steam Sterilizer TOP 5000<br>Model 5-5-9 | | | Classification: | Steam Sterilizer - Class II, as listed per 21C.F.R. 880.6880 | | | Predicate Device: | Belimed Steam Sterilizer TOP 5000<br>Series 4 - 8 | | #### DEVICE DESCRIPTION: The Belimed Steam Sterilizer TOP 5000 model 5-5-9 is intended for use in hospital and health care facilities and is intended to be used in an identical manner as the Belimed Steam Sterilizer TOP 5000 Series 4 -- 8. The smaller Chamber size incorporates additional flexibility, in comparison to Series 4 -8, and allows to operate the sterilizer in an economical way. Motorized or manually operated vertical door movement leads to an optimal compact design, and allows the operation of the sterilizer, where space is limited. # COMPARISON TO THE PREDICATE DEVICE: The Belimed Steam Sterilizer TOP 5000 model 5-5-9, is very similar to the predicate device. Modifications made from the predicate device include: - . Smaller chamber size - . Vacuum-pump according to smaller chamber size - Vertical door movement manual actuated or motorized - Software updates . ### INDICATIONS FOR USE: The Belimed Steam Sterilizer TOP 5000 model 5-5-9 is designed for sterilization of non porous and porous heat and moisture-stable materials used in healthcare facilities. The Belimed Steam Sterilizer TOP 5000 model 5-5-9 is equipped with the following factoryprogrammed Sterilization cycles and cycle values, which are identical with Series 4 - 8 (Table 1). {1}------------------------------------------------ | CYCLES | STERILI<br>ZE<br>TEMP | STERILIZ<br>E<br>TIME(min) | DRY<br>TIME<br>(min) | RECOMMENDED LOAD | |---------------------------|-----------------------|----------------------------|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------| | PREVAC<br>270° F (132°C) | 270° F<br>(132°C) | 4 | 20 | Double-wrapped Instrument Trays, max.<br>weight of 17 lbs (7.7 kg) each<br>or Fabric packs.<br>Refer to Table 2 for recommended quantities. | | PREVAC<br>270° F (132°C) | 270° F<br>(132°C) | 4 | 5 | Fabric Packs. | | LIQUID<br>250° F (121°C) | 250° F<br>(121°C) | 45 | 0 | Liquids not intended for direct patient<br>contact!<br>Refer to Table 3 for Guidelines | | EXPRESS<br>270° F (132°C) | 270° F<br>(132°C) | 4 | 3 | Single Wrapped Instrument Tray with non<br>porous single instrument | | FLASH<br>270° F (132°C) | 270° F<br>(132°C) | 3 | 1 | Unwrapped Instrument Tray with a single<br>Instrument | | FLASH 270° F<br>(132°C) | 270° F<br>(132°C) | 10 | 1 | Unwrapped Instrument Tray with non porous<br>multiple instruments (max. weight of 17 lbs) | Table 1: Factory programmed Sterilization Cycles The following table (Table 2) shows SAUTER AG's recommended load by sterilizer size, model 5-5- g: Do not sterilize a mix load of instrument trays and Fabric packs. | Model<br>single door<br>double door | Sterilizer Chamber<br>Size | Wrapped<br>Instrument Trays<br>20"x10"<br>max. 17lb each | Wrapped<br>Instrument Trays<br>17"x12"<br>max. 17lb each | Fabric<br>Packs<br>11"x11"x9"<br>max. 6.6lb<br>each | Fabric Packs<br>9"x9"x6"<br>max. 3.3lb<br>each | |-------------------------------------|----------------------------------------|----------------------------------------------------------|----------------------------------------------------------|-----------------------------------------------------|------------------------------------------------| | 5-5-9 VS1<br>5-5-9 VS2 | 21"x 21" x 38"<br>(535 x 535 x 965) mm | 2 | 4 | 6 | 12 | Table 2: Recommended Loads The following table (Table 3) is SAUTER AG's guidelines for liquid cycle processing for model 5-5-9: | Model<br>single door<br>double door | Sterilizer Chamber Size | Volume of Liquid in One<br>Container /Bottle | Number of containers /<br>bottles | |-------------------------------------|----------------------------------------|----------------------------------------------|-----------------------------------| | 5-5-9 VS1<br>5-5-9 VS2 | 21"x 21" x 38"<br>(535 x 535 x 965) mm | 1000 ml | 36 | {2}------------------------------------------------ #### Table 3: Guidelines for liquid 250°F cycle processing The Belimed Steam Sterilizer TOP 5000 model 5-5-9 is offered in the following size configurations: 21″x 21″ x 38″ (535 mm x 535 mm x 965 mm) Single Door, Prevacuum 21"x 21″ x 38″ (535 mm x 535 mm x 965 mm) Double Door, Prevacuum The Belimed Steam Sterilizer TOP 5000 model 5-5-9 is designed to be used for the terminal Sterilization of porous and non porous, heat and moisture stabile materials in the healthcare facilities. Depending of the chosen cycle materials as different as textiles, glassware, unwrapped or wrapped instrument trays with single or multiple instruments. The Belimed Steam Sterilizer TOP 5000 model 5-5-9 are factory equipped with cycles which has been tested in accordance with AAMI/ANSI ST-8:2001 under defined load conditions. #### EFFECTIVENESS: Efficacy of sterilizer function and exposure time recommendations ate ultimately shown by complete kill of biological indicators and verifying an appropriate safety factor or sterility assurance level (SAL) of at least 10 ° reduction. SAUTER AG vaiidates its sterilization cycles by recommented bractions, standards and guidelines developed by various independent organizations such as the Association, for Advancement of Medical Instrumentation (AAMI). Prior to release, the Belilizer TOP 5000 were validated to meet the requirements of AAMI/ANSI-ST8-2001. The results of the Belimed Steam Sterilizer TOP 5000 verification studies demonstrate that the sterilizer performs as intended and are summarized as follows: - All PREVAC cycles verified using the fabric test pack, as described in Section 5.5.2 AAMI/ANSI-. ST8:2001 were qualified according to section 5.5.2.5 ANSI/AAMI-ST8. These cycles demonstrated a sterlity assurance level of at least 10f through achievement of a time-at-temperature sufficient to produce an F0 of at least 12 by ½ cycle, a moisture retention of tess than 3% increase in presterilization test pack weight, and exhibited no wet spots. - All PREVAC cycles verified using full load instruments trays were qualified according to section 5.5.4 . of ANSI/AAMI-ST8: 2001. These cycles demonstrated a sterility assurance level of at least 10through achievement of a time-at-temperature sufficient to produce an F0 of a least 10 by 10 vole, a moisture retention of less than 20% increase in pre-sterilization weight of the towel, and exhibited no wet spots on the outer wrapper. - All FLASH cycles verified using the unwrapped instrument tray were qualified according to section . 5.5.5.1 AAMI/ANSI-ST8:2001 and ANSI/AAMI ST37:1996 section 7.7.3 . These cycles demonstrated a sterility assurance level of at least 106 through achievement of a time-attemperature sufficient to produce an F0 of at least 12 by ½ cycle and exhibited no we's spos. - All LIQUID cycles verified using three 1'000 ml flasks, as described in section 5.5.3 of AAMI/ANSI-. ST8:2001, were qualified according to section 5.5.3.5. These cycles demonstrated a sterility assurance level of at least 10-6 through achievement of a time-at-temperature sufficient to produce an FO of at least 12 by ½ cycle, a water loss not exceeding 50 ml, and automatic sealing of the flask closure. A temperature of 121°C was achieved and maintained in the ligulation of the liquid for at least 12 minutes. - The BD cycle was verified using the Bowie-Dick Test Pack were qualified according to section 5.6 of . AAMI/ANSI-ST8, and demonstrated a uniform color change throughout the teost sheet. {3}------------------------------------------------ - The software validation for the cycle operation was performed according to FDA's moderate level of . concern recommendations provided in the document "Guidance for the Content for Pre-market Submissions for Software Contained in Medical Devices (May 2005)". . : . {4}------------------------------------------------ ## SAFETY: SAUTER AG sterilizers including the Belimed Steam Sterilizer TOP 5000 have been designed, constructed and tested to meet the safety and performance requirements of various national safety codes and standards. The Belimed Steam Sterilizer TOP 5000 complies with the following requirements: . ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------Underwriter Laboratory (UL) Code UL 61010A-1:2002 and UL 61010A-2-041:2002 2. Canadian Standards Association (CSA) Standard C22.2 No. 1010-1 (IEC61010-1.2001) ന് American Society of Mechanical Engineers (ASME), Section VIII, Division 1 for unfired pressure vessels :2004. ### HAZARDS-FAILURE OF PERFORMANCES Failure of the sterilization process can lead to incidence of cross contamination, the transmission of potentially infectious organisms from one infected person to another who was not otherwise infected prior to the incident. To avoid failure, the user must ensure the materials, instruments and devices to be sterilized are thoroughly cleaned, that the manufacturer's instructions for use are followed., that the cycle to be used for each type of sterilizer load has been validated, that the sterilizer has been maintained in accordance with the sterilizer's manufacturer's maintenance schedule and is operating properly, and that each sterilizer load is monitored with available and validated biological and chemical sterilization process indicators. Today, there are many steam sterilizers in daily use in hospitals throughout the United States. The incident of sterilizer malfunction or sterilization process failure is relatively 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 TOP 5000 provides microprocessor controller safeguards that aborts the cvcle and give appropriate signals, alerts and warnings when required conditions have not been met or when a malfunction occurs. ### USER INFORMATION SAUTER AG provides information to the user that is intended to insure safe and effective use of steam sterilization in its detailed Operator's Manual and other labeling. SAUTER AG also recommends the use and periodic review of the AAMI steam sterilization stand rds one me futher assurance of the safe and effective use of steam sterilization equipment in health care facilitio i {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name in a circular arrangement around a stylized caduceus symbol. The caduceus is depicted with a single snake winding around a staff, which is a common symbol associated with medicine and healthcare. The text reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA". Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 2006 MAR 8 2006 Sauter AG C/O Mr. Stefan Preiss TUV America, Incorporated 1775 Old Highway 8 New Brighton, Minnesota 55112-1891 Re: K060337 Trade/Device Name: Belimed Steam Sterilizer TOP 5000 Regulation Number: 21 CFR 880.6880 Regulation Name: Steam sterilizer Regulatory Class: II Product Code: FLE Dated: March 1, 2006 Received: March 3, 2006 Dear Mr. Preiss: We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becater over is substantially equivalent (for the It it it a doove and have the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mersule conmisered press that have been reclassified in accordance with the provisions of Amendments, or to avrivend Cosmetic Act (Act) that do not require approval of a premarket the rederal 1 00d, Drag, the Connenay, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provisions of a 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 such additional controls. Existing major regulations affecting (1 nr 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. Stefan Preiss Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA s Issualice of a subscriments with other requirements mean that FDA has made a determination that your devices with other Federal agencies. mean that FDA has made a deleminations administered by other Federal agencies. of the Act or any Federal statutes and regulations and rolled to: registration of the Act or any Federal statues and reginations and limited to: registration You must comply with all the Act s requirements, including, but not ice You must comply with an the Act 3 requirements interest 801); good manufacturing practice and listing (21 CFR Part 807); labeling (21 CFR Part 801); and i and listing (21 CFR Part 807), labelling (21 CFR Parvos), Secon (21 CFR Part 820); and if requirements as set forth in the quality systems (QS) regulation (21 -542 of the Ar requirements as set forth in the quality systems (SS) 10galaxin (Sections 531-542 of the Act); applicable, the electronic product radiation control provisions (Sections 531-5 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section This letter will allow you to begin mankting your download many and equivalence of your device and thus 510(k) premarket nothleation. The PDA intuing of bassamment to a legally marketed predicate device results in a classification for your device and thus, to a logarry in device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), If you desire specific advice for your device of (240) 276-0115. Also, please note the regulation please contact the Office of Comphance at (210) = 10 = 10 = 10 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 entitled, "Misbranding by reference to premaries ander the Act from the may obtain offer gelleral mionnation on your i app Consumer Assistance at its toll-free Division of Simall Manata. (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Sue Sumner Chiu Lin, Ph.D. 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 510(k) Number (if known): Device Name: Belimed Steam Sterilizer TOP 5000 Indications For Use: The Belimed Steam Sterilizer TOP 5000, model 5-5-9, is designed for sterilization of The Bellinou Otoun Clehest and moisture-stable materials used in healthcare facilities. The Belimed Steam Sterilizer TOP 5000 model 5-5-9 is equipped with the following factory-programmed Sterilization cycles and cycle values (Table 1). The Belimed Steam Sterilizer TOP5000 model 5-5-9 is available as a single door prevacuum or a double door prevacuum version. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use x OTC (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Sheila Murphy MD 3/7/06 logy General Hospit and Dental Devices K 966 333 Page 1 of 2