BELIMED STEAM STERILIZER MODEL TOP 5000 SERIES 24

{0}------------------------------------------------ OCT 5 2007 Image /page/0/Picture/1 description: The image contains a sequence of handwritten digits and letters. The sequence appears to be "k072087". The characters are written in a simple, slightly irregular style, typical of handwriting. 510(k) Summary | Date: | June, 19, 2007 | |-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter's Name / Address: | Belimed Sauter AG<br>Zelgstrasse 8<br>CH- 8583 Sulgen / Switzerland | | Contact Person: | Hans Stadler, Head of Product Development,<br>Email: hans.stadler@belimed-sauter.ch<br>Phone: +41 71 644 85 97<br>Fax: +41 71 644 86 00 | | Trade Name: | Belimed Steam Sterilizer TOP 5000<br>Series 24 | | Classification: | Steam Sterilizer -- Class II, as listed per 21 CFR 880.6880 | | Predicate Devices: | Belimed Steam Sterilizer TOP 5000<br>Series 9 - 18 (K021223) and<br>Series 4-8 (K033538) | ## DEVICE DESCRIPTION: The Belimed Steam Sterilizers TOP 5000 Series 24 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 9 - 18. The larger chamber size (higher chamber) incorporates additional flexibility, and allows operating the sterilizers in an economical way (less floor space required). # NONCLINICAL COMPARISON TO THE PREDICATE DEVICE: The Belimed Steam Sterilizer TOP 5000 series 24, are very similar to the predicate device. Modifications made from the predicate device include: - Larger chamber size (chamber height increased) . - Vacuum-pump power was increased according to larger chamber volume. . - Improved functionallity (as done for series 4-8 K033538) . ## CLINICAL DATA No clinical data is required for this device classification submission ## INDICATIONS FOR USE: The Belimed Steam Sterilizer TOP 5000 series 24 is designed for sterilization of non porous and porous heat and moisture-stable materials used in healthcare facilities. {1}------------------------------------------------ The Belimed Steam Sterilizer TOP 5000 series 24 is equipped with the following factory-The belined Steam Sterilizer For Sales, which correspond with Series 9-18 (Table 1). | CYCLES | STERILIZE TEMP | STERILIZE TIME(min) | DRY TIME (min) | RECOMMENDED LOAD | |---------------------------|-------------------|---------------------|----------------|-------------------------------------------------------------------------------------------------------------------------------------------| | PREVAC<br>270° F (132°C) | 270° F<br>(132°C) | 4 | 20 | Double-wrapped Instrument Trays, max.<br>weight of 20 lbs (9 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.<br>Refer to Table 2 for recommended quantities<br>Packs are to place horizontally on shelves | | LIQUID<br>250° F (121°C) | 250° F<br>(121°C) | 45 | - | 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 20 lbs) | Table 1: Factory programmed sterilization cycles The following table (Table 2) shows BELIMED SAUTER AG´s recommended load by sterilizer sizes: Do not sterilize a mix load of instrument trays and Fabric packs. | Series | Model<br>single door<br><i>double door</i> | Sterilizer<br>Chamber Size<br>(HxWxD) | Wrapped Instrument<br>Trays 20"x10"<br>max. 20 lbs each | Fabric Packs<br>11"x11"x9"<br>max.6.6 lbs each | Fabric Packs<br>23"x11"x11"<br>max. 17 lbs each | |--------|--------------------------------------------|---------------------------------------|---------------------------------------------------------|------------------------------------------------|-------------------------------------------------| | 24 | GR15-6-18 HS1<br>GR15-6-18 HS2 | 63"x26"x79" | 24 | 56 | 24 | #### Table 2: Recommended Loads The following table (Table 3) is BELIMED SAUTER AG's guidelines for liquid cycle processing for models: | Series | Model<br>single door<br>double door | Sterilizer<br>Chamber Size<br>(HxWxD) | Volume of Liquid in one<br>bottle | Max. number of<br>bottles | |--------|-------------------------------------|---------------------------------------|-----------------------------------|---------------------------| | 24 | GR15-6-18 HS1<br>GR15-6-18 HS2 | 63"x26"x79" | 1000 ml | 336 | Table 3: Guidelines for liquid 250°F cycle processing {2}------------------------------------------------ | Model | Con-<br>figuration | Chamber size<br>(H x W x D)<br>(inch) | (mm) | Overall Dimensions<br>(H x W x D)<br>(inch) | (mm) | |----------------|-----------------------------------|---------------------------------------|-----------------|---------------------------------------------|------------------| | GR 15-6-18 HS1 | Floor flush<br>design,<br>1 door | 63"x 26"x 79" | 1600x 660x 2000 | 79"x 75"x 98" | 2000x 1900x 2500 | | GR 15-6-18 HS2 | Floor flush<br>design,<br>2 doors | 63"x 26"x 79" | 1600x 660x 2000 | 79"x 75"x 98" | 2000x 1900x 2500 | The Belimed Steam Sterilizer TOP 5000 Series 24 are offered in the following size configurations: Table 4: Dimensions The Belimed Steam Sterilizer TOP 5000 Series 24 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 may be sterilized. The Belimed Steam Sterilizer TOP 5000 Series 24 is factory equipped with cycles which has been tested in accordance with AAMI/ANSI ST-8:2001 under defined load conditions. The predicate devices with a chamber volume between 752 l (series 9) and 1900 l (series 18) have been tested in 2002. The new models have a chamber volume of 2480 1. The sterilizer has been validated. #### EFFECTIVENESS: Efficacy of sterilizer function and exposure time recommendations are ultimately shown by complete kill of biological indicators and verifying an appropriate safety factor or sterility assurance level (SAL) of at least 106 reduction. BELIMED SAUTER AG validates its sterilization cycles by recommended practices, standards and guidelines developed by various independent organizations such as the Association for Advancement of Medical Instrumentation (AAMI). Prior to release, Belimed Steam Sterilizer TOP 5000 series 24 was 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 sterility assurance level of at least 10° through achievement of a time-attemperature sufficient to produce an FO of at least 12 by half cycle, moisture retention of fess than 3% increase in pre-sterilization test pack weight, and exhibited no wet spots. - All PREVAC cycles verified using full load instruments trays were qualified according to section t 5.5.4 of ANSI/AAMI-ST8: 2001. These cycles 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 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. {3}------------------------------------------------ - All FLASH cycles verified using the unwrapped instrument tray were qualified according to . All 1 LAJT Cycles Vernico asing the Lind ANSI/AAMI ST37:1996 section 7.7.3. These cycles Section 3.5.3.1 ANMARKSTOFS.COM of at least 10 * through achievement of a time at demonstated '6' stemly '450, and east 12 by half cycle and exhibited no wet spots. - tellipendial sameline to produce three 1'000 ml flasks, as described in section 5.5.3 of . All ElQUD Cycles Venned asing to section 5.5.3.5. These cycles demonstrated a AxiMirANST 516.2017 16:26 10° through achievement of a time-at-temperature sufficient stenlity assurance ferer of at 12 by half cycle, a water loss not exceeding 50 ml, and automatic to produce and of at least to bperature of 121°C was achieved and maintained in the center of the liquid for at least 12 minutes. - of the ngore for at 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 test sheet. - 5.0 of halfaller validation for the cycle operation was performed according to FDA's moderate . The Software Nandation Total of Torided in the document "Guidance for the Content for Prelever of Colbmissions for Software Contained in Medical Devices (May 2005)". #### SAFETY: BELIMED SAUTER AG's 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: - ing requirences: Underwriter Laboratory (UL) Code UL 61010A-1:2002 and UL 61010A-2-041:2002 1. and IEC 61010-1:2001 and IEC 61010-2-041:1995 - IEC / EN 61326:2001 2. - AAMI ST8:2001 3. - AAMI ST37:1996 4. - American Society of Mechanical Engineers (ASME), Section Vill, Division 1 for unfired pressure 5. vessels: 2004. # HAZARDS-FAILURE OF PERFORMANCES Failure of the sterilization process can lead to incidence of cross contamination, the transmission of i unar of the stemlednon prisess 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 thoroughly cleaned, that will as been validated, that the sterilizer has been maintained in ascordance 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. stemization process managers in daily use in hospitals throughout the United States. The incident of sterilizer malfunction or sterilization process failure is relatively rare considering the wide medies of steam sterilizers. Further, there are no known reports in the literature of patient spread ass - thave resulted from steam sterilizer failure. The technology designed in Belimed Steam Sterilizer TOP 5000 provides microprocessor controller safeguard that aborts the cycle and give appropriate signals, alerts and warnings when required conditions have not been met or when a malfunction occurs. {4}------------------------------------------------ ## USER INFORMATION BELIMED SAUTER AG provides information to the user that is intended to insure SatureR AG BELIMED JAOTER / AS provides Information of the International and other labeling. BELIMED SAUTER AG use of stemsedian in to accomment the AAMI steam sterilization standards to enclude asso and recomments the asse and point offective use of steam sterilization equipment in health care facilities. ## CONCLUSION The Belimed Steam Sterilizer Top 5000 Series 24 is a substanially equivalent device to that of the predicate device. There have been no substantial changes in technology and intended use of this device. The control system and the hardware interface remain unchanged to predicate device series 4-8 (K033538). This steam sterilizer meets the appicable 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. {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Belimed Sauter AG C/O Mr. Stefan Preiss Responsible Third Party Official TUV SUD America, Incorporated 1775 Old Highway 8 NW New Brighton, Minnesota 55112-1891 OCT 5 ี 2007 Re: K072087 Trade/Device Name: Belimed Steam Sterilizer TOP 5000 Regulation Number: 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: II Product Code: FLE Dated: September 20, 2007 Received: September 24, 2007 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. 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 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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Chiu Lin, Ph.D. 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, series 24, is designed for sterilization of non porous and porous heat and moisture-stable materials used in healthcare facilities. The Belimed Steam Sterilizer TOP 5000, series 24, is equipped with the following factory-programmed Sterilization cycles and cycle values (Table 1). The Belimed Steam Sterilizer TOP5000, series 24, 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) Concurrence of CDRH, Office of Device Evaluation (ODE) Clus (Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices 510(k) Number: K072087 Page 1 of 2 {8}------------------------------------------------ | CYCLES | STERILIZE<br>TEMP | STERILIZE<br>TIME(min) | DRY 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 20 lbs (9 kg) each 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,<br>Refer to Table 2 for recommended quantities<br>Packs are to place horizontally on shelves. | | LIQUID<br>250°F (121°C) | 250° F<br>(121°C) | 45 | 0 | Liquids not intended for direct patient 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 Trays with non porous<br>multiple instruments (max. weight of 20 lbs) | Table 1: Factory programmed Sterilization Cycles The following table (Table 2) shows Belimed Sauter AG's recommended load by sterilizer size: Do not sterilize a mix load of instrument trays and fabric packs. | ( " " " " " " " " " " " " " " "<br>148 - 28860. Bu | vode.<br>1341 114 11<br>single door<br>1201-1-1 2 22 - 11 - 35: 4<br>「テートが意書から出版を<br>年本月の行きを読む 流行し<br>ouble door | Sterilizer Sterilizer<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>イ・アイテル・アイテム、アルター、アルキーストーム・アー<br>An "E" 1 " 1 " 1 " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " "<br>"HxWxD) == | Wrapped Instrument Fabric Packs<br>1 2 3 3 - 5 - 5 - 1 - 8 6 - 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 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1<br> Chamber Size Trays 20"x10" = " = "<br>o gos "Thesels rices in not<br>- 14 malder = " =<br>nilhe pa<br> | :<br>11*x11"x9" ===================================================================================================================================================================<br>The Fact "Fact . I be de .<br><br>max 6 6 lbs | abrical<br>*92"x11"x11"<br>-23-11-12<br>and Extraction in the<br>rach Emar = | |----------------------------------------------------|------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------| | | | | | | | | | GR15-6-18<br>r | | | | | Table 2: Recommended Loads The following table (Table 3) is Belimed Sauter AG's guidelines for liquid cycle: | Series --<br>.<br>Comments of the count | Model Model<br>i single goor<br>double door | Chamber Size ==== bottle<br>(HxWxD) i ----- | Sterilizer Volume of Liquid in one Max. number of<br>17 15 4 5 4 5 4 3 4 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 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 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1<br>1 - 1 - 1 7 - 1 1 3 6 - 1 - 1 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2<br>"+ }<br><br> | bottles<br>r - 1 - 1 | |-----------------------------------------|---------------------------------------------|---------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------| | | . GR15-6-18 HS1<br>GR15-6-18 HS2 | ، 63"x26"x79" | 1000 ml | 250 | Table 3: Guidelines for liquid 250°F cycle processing ASON SIGN-Off) vision of Anesthesiology, General Holsiger, 2 of 2 Infection Control, Dental Devices KD72087