GETINGE 800HC- SERIES STEAM STERILIZER

{0}------------------------------------------------ K122625 # 510(k) SUMMARY # MAY 2 2 2013 # Getinge 800HC-E Series Steam Sterilizer | Submitted by: | Getinge Sourcing LLC<br>1777 E Henrietta Road<br>Rochester, NY 14623-3133 | |------------------------|----------------------------------------------------------------------------------------------------| | Contact Person: | Barb Smith, RAC<br>Sr. Manager, Regulatory Affairs<br>Phone: (585) 214-6049<br>Fax: (585) 272-5299 | | Date prepared: | August 15, 2012 | | Proprietary Name: | Model 800HC-E Series Steam Sterilizer | | Common Name: | Steam Sterilizer | | Device Classification: | Steam Sterilizer (80 FLE)<br>Class II, as listed per 21 CFR 880.6880 | | Predicate Device: | Getinge Model 700HC-E Series Steam Sterilizer [K120441] | ## · Description of Device: The Getinge 800HC-E Series Steam Sterilizer is designed for sterilization of heat and moisture stable materials used in healthcare facilities. The only model designation provided in the 800HC-E Series Steam Sterilizer is 833HC-E. The model 833HC-E is available in 2 chamber sizes; 42 inches long (39.6 cu ft) and 76 inches long (72.0 cu ft). The Getinge 800HC-E Series Steam Sterilizer employs both gravity/downward displacement with positive pulse conditioning and pressure/vacuum pulsing for dynamic air removal. Up to 17 cycles can be easily accessed and custom cycle names can be designated by the user (duplicate cycles are provided to allow for user designated names). All cycle phases are sequenced and monitored by the control system, providing both audible and visual notification of deviation from certain operating parameters. {1}------------------------------------------------ Getinge Sourcing LLC FDA 510(k) Summary Device: 800HC-E Series Steam Sterilizer ## List of available cycles: # Getinge 800HC-E Series Steam Sterilizer Model 833HC-E Cycles and Load Chart | Cycle Type | No. of<br>Cycles | Factory Settings | | | Load Configuration<br>(Note 1) | Maximum Items per<br>Chamber Length | | |-----------------------------|------------------|----------------------|------------------|------------------------------------------|------------------------------------------------------------------------------|-------------------------------------|---------------------| | | | Exp.<br>Temp. | Exp.<br>Time | Drying<br>Time | | 42 in.<br>(1067 mm) | 76 in.<br>(1930 mm) | | vac<br>PREVAC 1 | 6 | 135.0°C<br>(275.0°F) | 3 min | 16 min | Double-wrapped<br>instrument trays, up<br>to 11.3 kg (25.0 lb)<br>(per tray) | 12 | 24 | | | | | | | Fabric Packs | 36 | 72 | | vac<br>PREVAC 4 | 1 | 132.2°C<br>(270.0°F) | 4 min | 16 min | Double-wrapped<br>instrument trays, up<br>to 11.3 kg (25.0 lb)<br>(per tray) | 12 | 24 | | | | | | | Fabric packs | 36 | 72 | | vac<br>B & D TEST | 1 | 133.9°C<br>(273.0°F) | 3 min,<br>30 sec | 0 min | S.M.A.R.T. Pack or<br>equivalent (1 max.) in<br>an EMPTY chamber | 1 Test<br>Pack | 1 Test<br>Pack | | grv<br>GRAVITY 1 | 3 | 121.1°C<br>(250.0°F) | 30 min | 30 min | Double-wrapped<br>instrument trays, up<br>to 11.3 kg (25.0 lb)<br>(per tray) | 12 | 24 | | | | | | | Fabric packs | 36 | 72 | | grv<br>GRAVITY 2 | 3 | 135.0°C<br>(275.0°F) | 10 min | 30 min | Double-wrapped<br>instrument trays, up<br>to 11.3 kg (25.0 lb)<br>(per tray) | 12 | 24 | | | | | | | Fabric packs | 36 | 72 | | grv<br>GRAVITY 3 | 1 | 132.2°C<br>(270.0°F) | 15 min | 30 min | Double-wrapped<br>instrument trays, up<br>to 11.3 kg (25.0 lb)<br>(per tray) | 12 | 24 | | | | | | | Fabric packs | 36 | 72 | | liq<br>LIQUIDS 1 | 1 | 121.1°C<br>(250.0°F) | 45 min | 5.17<br>kPa/min<br>(0.75<br>psi/min) | Each container<br>1000 mL (34 fl oz) or<br>smaller<br>(Notes 4, 5) | 160 | 320 | | | | | | (Note 3) | | | | | lk<br>LEAK TEST<br>(Note 2) | 1 | 131.1°C<br>(268.0°F) | 3 min. | 15 min dry, 5 min equalize , 15 min test | Empty Chamber<br>(other than loading accessories) | - | - | | | | | | | | | | {2}------------------------------------------------ # 00HC-E Series Steam Sterilizer ## NOTE: Liquid Cycles are not intended for the sterilization of liquids used for direct patient contact. #### TABLE NOTES: - 1. The load configurations listed in these tables are those used during testing validations of the sterilizer. These configurations follow AAM! Standard ST8: Hospital steam sterilizers where applicable (fabric packs are process challenge devices as described in ANSI/AAMI ST8 and were made to be consistent with the packs described in ANSI/AAMI ST8). For guidance on processing loads in the sterilizer, refer to AAMI Standard ST79: Comprehensive guide to steam sterilization and sterility assurance in health care facilities. 2. Vacuum leak test parameters are not adjustable. #### 3. Cooldown rate - 4. Your facility must validate the cycle if the load includes containers larger than 1000 mL (34 fl oz). 5. Use vented or open containers only. ## Intended Use: The Getinge 800HC-E Series Steam Sterilizer is intended for use by health care facilities and to be used to sterilize wrapped and unwrapped porous and nonporous heat and moisture stable items such as surgical instruments and linens by means of pressurized steam. ## Comparisons to Predicate Device: Similarities between the Getinge 800HC-E Series Steam Sterilizer and the identified predicate are: - Intended use is the same: Intended for use by health care facilities to sterilize � wrapped and unwrapped, porous and nonporous heat and moisture stable items such as surgical instruments and linens by means of pressurized steam. - Operating Principle is the same: Saturated steam is the sterilizing agent. o - Materials of construction are the same. There is no direct patient contact . associated with this device. {3}------------------------------------------------ Getinge Sourcing LLC FDA 510(k) Summary Device: 800HC-E Series Steam Sterilizer - Cycle Types: The cycle types offered are the same; Prevac (135°C, 132°C), . Gravity (121°C, 132°C, 135°C), and Liquids 121°C (not for sterilization of liquids used directly for patient contact). - Performance Testing: Factory recommended cycles were tested per industry . standards and guidelines and effectiveness of sterilizer function was demonstrated by complete kill of biological indicators. Getinge Sterilizers have been validated to meet the requirements of ANSI/AAMI ST8:2008 Hospital Steam Sterilizers. The differences between the Getinge 800HC-E Series Steam Sterilizer and the predicate device (Getinge 700HC-E Series Steam Sterilizer) are: - The Getinge 800HC-E Series Steam Sterilizer has larger vessel sizes. o Because of the larger vessel size the chamber closure (door operation) is different. The larger chamber size also allows for larger loads to be processed. Factory recommended maximum load sizes are tested for effectiveness and clearly identified in product labeling. ## Summary of Performance Testing: Factory recommended cycles were tested per industry standards and guidelines and effectiveness of sterilizer function was demonstrated by complete kill of biological indicators. Getinge Sterilizers have been validated to meet the requirements of ANSI/AAMI ST8:2008 Hospital Steam Sterilizers. The results of Getinge 800HC-E Series Steam Sterilizer validation testing demonstrate that the sterilizer performs as intended. Summary of testing: - Empty chamber testing performed for all cycles as described in ANSI/AAMI . ST8:2008 Hospital Steam Sterilizers section 5.4.2.5. The results demonstrated that the sterilizer is capable of providing steady-state thermal conditions within the chamber that are consistent with the predicated sterility assurance level (SAL) in the load. - All PREVAC and GRAVITY cycles were validated using fabric process o challenge packs as described in ANSI/AAMI ST8:2008 section 5.5.2. The results from this testing demonstrated a sterility assurance level of at least 10° through achievement of time at temperature sufficient to produce an Fo value of at least 12, complete Bl kill and moisture retention of less than 3% increase in pre-sterilization test pack weight including no visible wet spots. - All PREVAC and GRAVITY cycles were validated using wrapped instrument 0 process challenge devices as described in ANSI/AAMI ST8:2008 section 5.5.4. The results from this testing demonstrated a sterility assurance level of at least 10° through achievement of time at temperature sufficient to produce an Fo value of at least 12, complete BI kill and moisture retention of less than 20% increase in pre-sterilization weight of the towel including no visible wet spots on the outer wrapper. {4}------------------------------------------------ Getinge Sourcing LLC FDA 510(k) Summary Device: 800HC-E Series Steam Sterilizer - Liquid loads cycles were validated using 3 one liter flasks as described in � ANSI/AAMI ST8:2008 section 5.5.3. The results from this testing demonstrated a sterility assurance level of at least 10° through achievement of time at temperature sufficient to produce an Fo value of at least 12, complete Bl kill and water loss not exceeding 50ml. - Bowie Dick cycle was validated using the Bowie-Dick test pack as described in o ANSI/AAMI ST8:2008 section 5.6.1.1. - The software validation for the cycle operation was performed according to o FDA guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (5/11/2005)". #### Clinical Data: No clinical data is required for this device classification submission. #### Conclusion: The 800HC-E Series Steam Sterilizer has the same intended use and technological characteristics as the predicate device. The 800HC-E Series Steam Sterilizer meets the applicable requirements of AAMI ST8:2008 performance standards. Based on the information provided in this premarket notification, it can be concluded that the subject device is substantially equivalent to the predicate device and is safe and effective when used as intended. {5}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES 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-like figure with three stylized lines forming its body and wings. #### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 ## May 22, 2013 Ms. Barb Smith Getinge Sourcing LLC Senior Manager Regulatory Affairs 1777 East Henrietta Road ROCHESTER, New York 14623-3133 Re: K122625 Trade/Device Name: Getinge 800HC-E Series Steam Sterilizer Regulation Number: 21 CFR 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: II Product Code: FLE Dated: May 13, 2013 Received: May 14, 2013 #### Dear Ms. Smith: 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 - Ms. Smith 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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (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/ResourcesforYou/Industry/default.htm. Image /page/6/Picture/7 description: The image shows a signature and contact information. The text "Sincerely yours" is at the top of the image. Below that is the name "Tejashri Purohit-Sheth, M.D." and the title "Clinical Deputy Director". The acronym "DAGRID" is also present. Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, 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): K i 2 2 G 2 5 Device Name: Getinge 800HC-E Series Steam Sterilizer ## Indications for Use: . The Getinge 800HC-E Series Steam Sterilizer is intended for use by health care facilites to sterlizes I he Gelinge Boortes Beatle Stean Cremocous heat and moisture stable items such as surgical it writished and linens by means of pressurized steam. The 800HC-E Series Steam Sterliizer is thistriments and michs by means of prossanted by chamber and 833HC-E 42 inch chamber and 833HC-E 76 inch chamber. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use_ X (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of ____________________________________________________________________________________________________________________________________________________________________ 013 # Sreekanth Gut 2013.05.2012-2 Division Sign-Off) ·vision of Anesthesiology, General Hospital · nection Control, Dental Devices K122625 ్10(k) Number: {8}------------------------------------------------ # List of available cycles: # Getinge 800HC-E Series Steam Sterilizer Model 833HC-E Cycles and Load Chart KiZZ 625 IFU P -- 50 2 - F 3 | Cycle Type | No. of<br>Cycles | Factory Settings | | | Load Configuration<br>(Note 1) | Maximum Items per<br>Chamber Length | | |-----------------------------|------------------|----------------------|------------------|---------------------------------------------------------|------------------------------------------------------------------------------|-------------------------------------|---------------------| | | | Exp.<br>Temp. | Exp.<br>Time | Drying<br>Time | | 42 in.<br>(1067 mm) | 76 in.<br>(1930 mm) | | vac<br>PREVAC 1 | 6 | 135.0°C<br>(275.0°F) | 3 min | 16 min | Double-wrapped<br>instrument trays, up<br>to 11.3 kg (25.0 lb)<br>(per tray) | 12 | 24 | | | | | | | Fabric Packs | 36 | 72 | | vac<br>PREVAC 4 | 1 | 132.2°C<br>(270.0°F) | 4 min | 16 min | Double-wrapped<br>instrument trays, up<br>to 11.3 kg (25.0 lb)<br>(per tray) | 12 | 24 | | | | | | | Fabric packs | 36 | 72 | | vac<br>B & D TEST | 1 | 133.9°C<br>(273.0°F) | 3 min,<br>30 sec | 0 min | S.M.A.R.T. Pack or<br>equivalent (1 max.) in<br>an EMPTY chamber | 1 Test<br>Pack | 1 Test<br>Pack | | grv<br>GRAVITY 1 | 3 | 121.1°C<br>(250.0°F) | 30 min | 30 min | Double-wrapped<br>instrument trays, up<br>to 11.3 kg (25.0 lb)<br>(per tray) | 12 | 24 | | | | | | | Fabric packs | 36 | 72 | | grv<br>GRAVITY 2 | 3 | 135.0°C<br>(275.0°F) | 10 min | 30 min | Double-wrapped<br>instrument trays, up<br>to 11.3 kg (25.0 lb)<br>(per tray) | 12 | 24 | | | | | | | Fabric packs | 36 | 72 | | grv<br>GRAVITY 3 | 1 | 132.2°C<br>(270.0°F) | 15 min | 30 min | Double-wrapped<br>instrument trays, up<br>to 11.3 kg (25.0 lb)<br>(per tray) | 12 | 24 | | | | | | | Fabric packs | 36 | 72 | | liq<br>LIQUIDS 1 | 1 | 121.1°C<br>(250.0°F) | 45 min | 5.17<br>kPa/min<br>(0.75<br>psi/min)<br>(Note 3) | Each container<br>1000 mL (34 fl oz) or<br>smaller<br>(Notes 4, 5) | 160 | 320 | | lk<br>LEAK TEST<br>(Note 2) | 1 | 131.1°C<br>(268.0°F) | 3 min. | 15 min<br>dry, 5<br>min<br>equalize<br>, 15 min<br>test | Empty Chamber<br>(other than loading<br>accessories) | - | - | {9}------------------------------------------------ K122625 IFU C 3 NOTE: Liquid Cycles are not intended for the sterilization of liquids used for direct patient contact. #### TABLE NOTES: - 1. The load configurations listed in these tables are those used during testing validations of the sterilizer. These configurations follow AAM Standard ST8: Hospital steam sterilizers where applicable (fabric packs are process challenge devices as described in ANSI/AAMI ST8 and were made to be consistent with the packs described in ANSI/AAMI ST8). For guidance on processing loads in the sterilizer, refer to AAMI Standard ST79: Comprehensive guide to steam sterilization and sterility assurance in health care facilities. 2. Vacuum leak test parameters are not adjustable. - 3. Cooldown rate 4. Your facility must validate the cycle if the load includes containers larger than 1000 mL (34 fl oz). - 5. Use vented or open containers only.