Getinge GSS610N Series Steam Sterilizer

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March 1, 2021 Maquet GmbH % Mark Smith Regulatory Affairs Manager Getinge 45 Barbour Pond Road Wayne, New York 07470 Re: K201927 Trade/Device Name: Getinge GSS610N Series Steam Sterilizer Regulation Number: 21 CFR 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: Class II Product Code: FLE Dated: February 1, 2021 Received: February 2, 2021 Dear Mark 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. 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. 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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 medical devices and radiation-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, Clarence W. Murray III, Ph.D. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K201927 Device Name Getinge GSS610N Series Steam Sterilizer Indications for Use (Describe) {3}------------------------------------------------ | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| | Prescription Use (Part 21 CFR 801 Subpart D) X 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." {4}------------------------------------------------ # 510(k) Summary - K201927 Getinge GSS610N Series Steam Sterilizer | Submitted by | Maquet GmbH_<br>Kehler Strasse 31<br>Rastatt DE-BW<br>Germany 76437 | |--------------|---------------------------------------------------------------------| |--------------|---------------------------------------------------------------------| - Mark N. Smith Contact person Manager, Regulatory Affairs Phone: 585-272-5274 Email: mark.n.smith@getinge.com - K201927 510(k) number - Date Prepared February 26, 2021 # Proprietary Device Name - Trade Name: Getinge GSS610N Series Steam Sterilizer 610N10 40.9 inch (1000 mm) long chamber Models: 610N14 51.1 inch (1400 mm) long chamber 610N15 60.6 inch (1540 mm) long chamber Common Name: Steam Sterilizer - Classification: Steam Sterilizer (21CFR880.6880, Product Code 80 FLE) # Predicate Devices [K172159] Getinge GSS67N Series Steam Sterilizer Getinge. Date 01/30/2018 {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Getinge, a company that provides equipment and systems for healthcare and life sciences. The logo consists of the word "GETINGE" in a bold, sans-serif font, followed by a stylized symbol that resembles a four-pointed star or a stylized flower. The logo is simple and modern, and the colors are muted, giving it a professional and trustworthy appearance. # Description of Device The steam sterilizer is used 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. The Getinge GSS610N Series Steam Sterilizer employs both with gravity/downward displacement with positive pulse conditioning and pressure/vacuum pulsing for dynamic air removal. All cycle phases are sequenced and monitored by the control system, providing both audible and visual notification of deviation from certain operating parameters # Indications for Use The Getinge GSS610N Series Steam Sterilizer is 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. The GSS610N Series Steam Sterilizer is available in 3 models differentiated by chamber length: GSS610N Model 610N10 (40.9 inch chamber), GSS610N Model 610N14 (51.1 inch chamber), and GSS610N Model 610N15 (60.6 inch chamber). # Cycles and Load Chart | Cycle Type | Factory Settings | | Load Configuration<br>(Note 1) | Maximum Items per<br>Chamber Length | | | | |------------------|----------------------|------------------|--------------------------------|----------------------------------------------------------------------------|------------------------------|------------------------------|------------------------------| | | Exp.<br>Temp. | Exp.<br>Time | Drying<br>Time | | 610N10<br>1040 mm<br>40.9 in | 610N14<br>1400 mm<br>51.1 in | 610N15<br>1540 mm<br>60.6 in | | P1<br>PREVAC 1 | 135.0°C<br>(275.0°F) | 3 min | 16 min | Full instrument packs | 18 | 24 | 24 | | P2<br>PREVAC 2 | 135.0°C<br>(275.0°F) | 3 min | 3 min | Full fabric packs | 40 | 40 | 60 | | P3<br>PREVAC 4 | 132.2°C<br>(270.0°F) | 4 min | 30 min | Full instrument packs | 18 | 24 | 24 | | P4<br>PREVAC 5 | 132.2°C<br>(270.0°F) | 4 min | 5 min | Full fabric packs | 40 | 40 | 60 | | P5<br>B & D TEST | 134°C<br>(273.0°F) | 3 min,<br>30 sec | 0 min | 1 B&D Test Pack in an<br>EMPTY chamber (other<br>than loading accessories) | 1 Test<br>Pack | 1 Test<br>Pack | 1 Test<br>Pack | | P6<br>GRAVITY 1 | 121.1°C<br>(250.0°F) | 30 min | 45 min | Full instrument packs<br>Full fabric packs | 18<br>40 | 24<br>40 | 24<br>60 | | P7<br>GRAVITY 2 | 135.0°C<br>(275.0°F) | 10 min | 45 min | Full instrument packs<br>Full fabric packs | 18<br>40 | 24<br>40 | 24<br>60 | | P8<br>GRAVITY 3 | 132.2°C<br>(270.0°F) | 15 min | 45 min | Full instrument packs<br>Full fabric packs | 18<br>40 | 24<br>40 | 24<br>60 | | P9<br>IUSS 1 | 135.0°C<br>(275.0°F) | 3 min | 1 min | Full instrument packs | 1 | 1 | 1 | # Getinge GSS610N Series Steam Sterilizer Cvcles and Load Chart 510k Summary GSS610N K201927 {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Getinge. The word "GETINGE" is written in a bold, sans-serif font in dark blue. To the right of the word is a stylized symbol, also in blue, that resembles four curved arrows pointing inward towards a central point. The logo is simple and modern. | Vac | | | | | Full fabric packs | 1 | 1 | 1 | |--------------------------|----------------------|--------|-------------------------------------------|--|-------------------------------------------------------------|---|---|---| | P10<br>IUSS 2<br>Grav | 135.0°C<br>(270.0°F) | 10 min | 30 sec | | Full instrument packs | 1 | 1 | 1 | | | | | | | Full fabric packs | 1 | 1 | 1 | | P11<br>IUSS 3<br>Grav | 132.2°C<br>(270.0°F) | 4 min | 1 min | | Full instrument packs | 1 | 1 | 1 | | | | | | | Full fabric packs | 1 | 1 | 1 | | P12<br>Vented<br>Bottles | 121.1°C<br>(250.0°F) | 45 min | 3kPa/min<br>(0.44<br>psi/min)<br>(Note 2) | | Each container 1000 mL<br>(34 fl oz) or smaller<br>(Note 3) | 3 | 3 | 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 AAMI Standard ST8: Hospital steam sterilizers where applicable (fabric packs are process challenge devices as described in ANSI/AAM ST8 and were made to be consistent with the packs described in ANSI/AAM ST8). For guidance on processing loads in the sterilizer, refer to AAMI Standard ST79: Comprehensive guide to sterility assurance in health care facilities. 2. Cooldown rate 3. Use vented or open containers only. # Technological Characteristics Table: Shown below is a comparison of the subject device Getinge GSS610N Series Steam Sterilizer versus the predicate device (Getinge GSS67N Series Steam Sterilizer): | Item | Getinge GSS610N<br>[Subject device] | Getinge GSS67N<br>[Predicate Device]<br>K172159 | Comparison | |-----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------| | Pressure Vessel | | | | | Chamber Sizes | Model 610N10: 26.4" x<br>42.5" x 40.9" (672 x1080<br>x1040 mm) | Model 6710: 26.4" x 27.6" x<br>39.4" (672 x700 x1000 mm) | Different Chamber<br>Sizes | | | Model 610N14: 26.4" x<br>42.5" x 55.1" (672 x1080<br>x1400 mm) | Model 6713: 26.4" x 27.6" x<br>51.2" (672 x700 x1300 mm) | Different Chamber<br>Sizes | | | Model 610N15: 26.4" x<br>42.5" x 60.6" (672<br>x1080 x1540 mm) | Model 6717: 26.4" x 27.6" x<br>66.9" (672 x700 x1700 mm) | Different Chamber<br>Sizes | | Chamber Volumes | Model 610N10: Single Door<br>26.52 Cu Ft (751L), Double<br>Door 26.59 Cu Ft (753L) | Model 6710: Single Door 17<br>Cu Ft (481L), Double Door<br>16.5 Cu Ft (468L) | The chamber volumes<br>correspond to the<br>chamber sizes | | | Model 610N14: Single Door<br>35.73 Cu Ft (1012L) | | | | | Double Door 35.77 Cu Ft<br>(1013L)<br><br>Model 610N15: Single Door<br>39.3 Cu Ft (1113L), Double<br>Door 39.34 Cu Ft (1114L) | Model 6713: Single Door 22<br>Cu Ft (621L), Double Door<br>21.5 Cu Ft (609L)<br><br>Model 6717: Single Door 28.6<br>Cu Ft (809L), Double Door<br>28.11 Cu Ft (796L) | | | ASME Pressure Vessel | All pressure vessels are<br>built to ASME Sect. VIII,<br>Div. 1 | All pressure vessels are built<br>to ASME Sect. VIII, Div. 1 | Same | | "U" Stamped Unfired<br>Pressure Vessel) | Chamber: 45 psi<br>Jacket: 45 psi | Chamber: 43.5 psi<br>Jacket: 51 psi | The pressure rating<br>differs slightly | | Material of Jacket | Stainless Steel (SA240- 304 ) | Stainless Steel (SA240- 304 ) | Same | | Material of Chamber | Stainless Steel (SA240-<br>316L ) | Stainless Steel (SA240-316L ) | Same | | Vacuum method | Vacuum pump standard. | Vacuum pump standard. | Same | | Chamber Closure | | | | | Door Operation | Horizontal opening/closing<br>door design operated by<br>an electrical motor. | Vertical opening/closing door<br>design with pneumatic<br>cylinder actuator | Different door<br>design. | | Safety and Interlocks | | | | | Door switch<br>system/steam to<br>chamber interlock | Electro-mechanical logic | Electro-mechanical logic | Same | | Cycles | | | | | Types of cycles offered | Prevac 132.2°C, 4<br>min; 135°C, 3 min,<br>Gravity 121°C, 30 min;<br>135°C 10 min; 132.2°<br>15 min;<br>IUSS 135°C, 3 min,;<br>135C, 10 min; 132.2°C<br>4 min<br>Vented Bottles 121°C<br>45min.<br>BD Test | Prevac 132.2°C, 4 min;<br>135°C, 3 min,<br>Gravity 121°C, 30 min;<br>135°C 10 min; 132.2° 15<br>min;<br>IUSS 135°C, 3 min,;<br>135C, 10 min; 132.2°C 4<br>min<br>Vented Bottles 121°C<br>45min.<br>BD Test | Same | | Maximum Load<br>Capacities | Reference chart for<br>maximum loads within<br>GSS610N - up to 25lbs<br>per tray | Reference chart for<br>maximum loads within<br>GSS67N - up to 25lbs per<br>tray | Same | | Utility Requirements | | | | | Primary<br>Electrical<br>Connection | GSS610N are available for<br>connection to:<br>208V 3ph 60Hz (Not<br>GSS61015N with integrated<br>electrical heated steam<br>boiler)<br>460V 3ph 60Hz<br>480V 3ph 60Hz | GSS67N are available for<br>connection to:<br>208V 3ph 60Hz<br>460V 3ph 60Hz<br>480V 3ph 60Hz<br>600V 3ph 60Hz (Not with<br>integrated electrical heated<br>steam boiler) | Similar electrical<br>connections | {7}------------------------------------------------ # GETINGE {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the word "GETINGE" in a sans-serif font. To the right of the word is a stylized four-pointed star or asterisk-like symbol. The text and symbol are in a dark blue color. # Summary of Non-Clinical Testing Shown below is a summary of the non-clinical testing that was performed with this device:. | Test<br>Performed | Device<br>Description | Test Method | Acceptance<br>Criteria | Results | |-------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|--------------------------------------|------------------------------------------------------------------------------------------------|---------| | <b>Biological Performance Tests</b> | | | | | | Sterilization<br>Efficacy Validation<br>Biological<br>Performance with<br>a fabric PCD | GSS610N10<br>GSS610N14<br>GSS610N15 | AAMI ST8:2013<br>(R2018)<br>§5.5.2 | Sterility Assurance<br>Level (SAL) 10-6 | Pass | | Biological<br>Performance with<br>liquid loads | GSS610N10<br>GSS610N14<br>GSS610N15 | AAMI ST8:2013<br>(R2018)<br>§5.5.3 | Sterility Assurance<br>Level (SAL) 10-6 | Pass | | Biological<br>Performance with<br>a wrapped<br>instrument PCD | GSS610N10<br>GSS610N14<br>GSS610N15 | AAMI ST8:2013<br>(R2018)<br>§5.5.4 | Sterility Assurance<br>Level (SAL) 10-6 | Pass | | Biological<br>performance of<br>immediate-use<br>steam sterilization<br>for single-wrapped<br>or unwrapped<br>nonporous items | GSS610N10<br>GSS610N14<br>GSS610N15 | AAMI ST8:2013<br>(R2018)<br>§5.5.5 | Sterility Assurance<br>Level (SAL) 10-6 | Pass | | <b>Physical Performance Test</b> | | | | | | Chamber<br>Temperature<br>Profile | GSS610N10<br>GSS610N14<br>GSS610N15 | AAMI ST8:2013<br>(R2018)<br>§5.4.2.5 | +3°C (or +6°F) and -<br>0°C (or -0°F) of the<br>selected sterilization<br>exposure temperature | Pass | {9}------------------------------------------------ Image /page/9/Picture/0 description: The image contains the word "GETINGE" in a bold, sans-serif font. The text is a dark blue color. To the right of the word is a stylized logo, also in blue, that resembles four curved arrows pointing inward towards a central point. | Mechanical Air<br>Removal Test | GSS610N10<br>GSS610N14<br>GSS610N15 | AAMI ST8:2013<br>(R2018)<br>§5.6.1 | Load reaching<br>exposuire temperature<br>witin 10 secs<br><br>Color change on BD<br>chemical indicator<br>sheet | Pass | |--------------------------------|-------------------------------------|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|------| | Air Leak Rate Test | GSS610N10<br>GSS610N14<br>GSS610N15 | AAMI ST8:2013<br>(R2018)<br>§5.6.2 | Average leak rate of 1<br>mmHg (0.13 kPa) (0.019<br>psia) per minute or less<br>over the measured time<br>interval. | Pass | | Moisture<br>Retention Rest | GSS610N10<br>GSS610N14<br>GSS610N15 | AAMI ST8:2013<br>(R2018)<br>§5.7 | < 3% increase in<br>presterilization test<br>pack weight for fabric<br>pack & &lt20% increase<br>for wrapped instrument<br>pack | Pass | # Conclusion: The conclusion drawn from the nonclinical test demonstrates that the subject device is as safe, as effective and performs as well as or better than the legally marketed predicate device, Class II (21 CFR 880.6880, Product code FLE)