GSS610N21 Series Steam Sterilizer

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May 18, 2022 Maquet GmbH % Barb Smith Sr. Regulatory Affairs Specialist Getinge 45 Barbour Pond Wayne, New Jersey 07470 Re: K214120 Trade/Device Name: GSS610N21 Series Steam Sterilizer Regulation Number: 21 CFR 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: Class II Product Code: FLE Dated: April 13, 2022 Received: April 14, 2022 Dear Barb 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. 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. {1}------------------------------------------------ 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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 mediation-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, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K214120 Device Name Getinge GSS610N21 Steam Sterilizer Indications for Use (Describe) The Getinge GSS610N21 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. Please see "GSS610N Load chart table" (1 page) as attachment to this form. Type of Use (Select one or both, as applicable) | <input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | <input checked="" type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) | |-----------------------------------------------------------------------|---------------------------------------------------------------------------------| |-----------------------------------------------------------------------|---------------------------------------------------------------------------------| |X | Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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The color of the logo is a dark blue. | Cycle Type | Factory Settings | | | Load Configuration<br>(Note 1) | Maximum Items for<br>Model 61021<br>[2100 mm or 82.7 in<br>chamber length] | |--------------------------|----------------------|------------------|--------------------------------------------|----------------------------------------------------------------------------|----------------------------------------------------------------------------| | | Exp.<br>Temp. | Exp.<br>Time | Drying<br>Time | | | | P1 PREVAC 1 | 135.0°C<br>(275.0°F) | 3 min | 16 min | Full instrument packs | 36 | | P2 PREVAC 2 | 135.0°C<br>(275.0°F) | 3 min | 3 min | Full fabric packs | 80 | | P3 PREVAC 4 | 132.2°C<br>(270.0°F) | 4 min | 30 min | Full instrument packs | 36 | | P4 PREVAC 5 | 132.2°C<br>(270.0°F) | 4 min | 5 min | Full fabric packs | 80 | | P5 B & D TEST | 134°C<br>(273.0°F) | 3 min,<br>30 sec | 0 min | 1 B&D Test Pack in an EMPTY<br>chamber (other than loading<br>accessories) | 1 B&D Test Pack | | P6 GRAVITY 1 | 121.1°C<br>(250.0°F) | 30 min | 45 min | Full instrument packs | 36 | | | | | | Full fabric packs | 80 | | P7 GRAVITY 2 | 135.0°C<br>(275.0°F) | 10 min | 45 min | Full instrument packs | 36 | | | | | | Full fabric packs | 80 | | P8 GRAVITY 3 | 132.2°C<br>(270.0°F) | 15 min | 45 min | Full instrument packs | 36 | | | | | | Full fabric packs | 80 | | P9 IUSS 1<br>Vac | 135.0°C<br>(275.0°F) | 3 min | 1 min | Full instrument packs | 1 | | P10 IUSS 2<br>Grav | 135.0°C<br>(270.0°F) | 10 min | 30 sec | Full instrument packs | 1 | | P11 IUSS 3<br>Grav | 132.2°C<br>(270.0°F) | 4 min | 1 min | Full instrument packs | 1 | | P12<br>Vented<br>Bottles | 121.1°C<br>(250.0°F) | 45 min | 3kPa/min<br>(0.44 psi/<br>min)<br>(Note 2) | Each container 1000 mL (34 fl<br>oz) or smaller (Note 3) | 3 | #### Getinge GSS610N21 Series Steam Sterilizer Cycles and Load Chart #### 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 AAM Standard ST79: Comprehensive guide to steam sterilization and sterility assurance in health care facilities. #### 2. Cooldown rate 3. Use vented or open containers only. {4}------------------------------------------------ # GETT # 510(k) Summary Getinge GSS610N21 Series Steam Sterilizer K214120 | Submitted by | Maquet GmbH | |--------------|-------------------| | | Kehler Strasse 31 | | | Rastatt DE-BW | | | Germany 76437 | - Contact person Barb Smith Sr. Regulatory Affairs Specialist Phone: 585-370-6101 Email: barb.smith@getinge.com - K214120 510(k) number - Date Prepared December 22, 2021 #### Proprietary Device Name - Trade Name: Getinge GSS610N21 Series Steam Sterilizer Models: 610N21 82.7 inch (2100 mm) long chamber Common Name: Steam Sterilizer Classification: Steam Sterilizer (21CFR880.6880, Product Code 80 FLE) #### Predicate Devices [K201927] Getinge GSS610N Series Steam Sterilizer Getinge Models 610N10, 610N14 and 610N15. SE Date 03/01/2021 {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Getinge. The logo consists of the word "GETINGE" in a bold, sans-serif font. To the right of the word is a stylized symbol that looks like four curved arrows pointing inward towards a central point. The logo is in a dark blue color. ### 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 GSS610N21 Series Steam Sterilizer employs both 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 GSS610N21 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. # Cycles and Load Chart | Cycle Type | Factory Settings | | | Load Configuration<br>(Note 1) | Maximum<br>Items for<br>Model<br>61021<br>[2100 mm or<br>82.7 in<br>chamber<br>length] | |---------------|----------------------|---------------------|-------------|----------------------------------------------------------------------------|----------------------------------------------------------------------------------------| | | Exp.<br>Temp. | Exp.<br>Time | Drying Time | | | | P1 PREVAC 1 | 135.0°C (275.0°F) | 3 min | 16 min | Full instrument packs | 36 | | P2 PREVAC 2 | 135.0°C<br>(275.0°F) | 3 min | 3 min | Full fabric packs | 80 | | P3 PREVAC 4 | 132.2°C (270.0°F) | 4 min | 30 min | Full instrument packs | 36 | | P4 PREVAC 5 | 132.2°C (270.0°F) | 4 min | 5 min | Full fabric packs | 80 | | P5 B & D TEST | 134°C (273.0°F) | 3 min,<br>30<br>sec | 0 min | 1 B&D Test Pack in an EMPTY<br>chamber (other than loading<br>accessories) | 1 B&D Test<br>Pack | | P6 GRAVITY 1 | 121.1°C (250.0°F) | 30 min | 45 min | Full instrument packs<br>Full fabric packs | 36<br>80 | | P7 GRAVITY 2 | 135.0°C (275.0°F) | 10 min | 45 min | Full instrument packs<br>Full fabric packs | 36<br>80 | | P8 GRAVITY 3 | 132.2°C (270.0°F) | 15 min | 45 min | Full instrument packs<br>Full fabric packs | 36<br>80 | #### Getinge GSS610N21 Series Steam Sterilizer Cycles and Load Chart {6}------------------------------------------------ | P9 IUSS 1<br>Vac | 135.0°C (275.0°F) | 3 min | 1 min | Full instrument packs | 1 | |-----------------------|-------------------|--------|----------------------------------------|----------------------------------------------------------|---| | P10 IUSS 2<br>Grav | 135.0°C (270.0°F) | 10 min | 30 sec | Full instrument packs | 1 | | P11 IUSS 3<br>Grav | 132.2°C (270.0°F) | 4 min | 1 min | Full instrument packs | 1 | | P12<br>Vented Bottles | 121.1°C (250.0°F) | 45 min | 3kPa/min<br>(0.44 psi/min)<br>(Note 2) | Each container 1000 mL (34 fl oz)<br>or smaller (Note 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/AAMI ST8 andwere 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. Cooldown rate - 3. Use vented or open containers only. #### Technological Characteristics Table: Shown below is a comparison of the subject device Getinge GSS610N21 Series Steam Sterilizer versus the predicate device (Getinge GSS610N Series Steam Sterilizer models 610N10, 610N14, 610N15). The GSS610N21 sterilizer is the largest model in the GSS610N series of steam sterilizers: | Item | Getinge GSS610N<br>[Predicate device]<br>K201927 | Getinge GSS610N21<br>[Subject Device] | Comparison | |-------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------| | Pressure Vessel | | | | | Chamber Sizes | Model 610N10: 26.4" x<br>42.5" x 40.9" (672 x1080<br>x1040 mm) | Model 610N21: 26.4" x<br>42.5" x 82.7" (672 x 1080<br>x 2100 mm) | Different Chamber<br>Sizes | | | Model 610N14: 26.4" x<br>42.5" x 55.1" (672 x1080<br>x1400 mm) | | Different Chamber<br>Sizes | | Item | Getinge GSS610N<br>[Predicate device]<br>K201927 | Getinge GSS610N21<br>[Subject Device] | Comparison | | | Model 610N15: 26.4" x<br>42.5" x 60.6" (672<br>x1080 x1540 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)<br>Model 610N14: Single Door<br>35.73 Cu Ft (1012L),<br>Double Door 35.77 Cu Ft<br>(1013L)<br>Model 610N15: Single Door<br>39.3 Cu Ft (1113L), Double<br>Door 39.34 Cu Ft (1114L) | Model 610N21: Double Door<br>53.67 Cu Ft<br>(1520L) | The chamber<br>volumes correspond<br>to the chamber sizes.<br>Only double door<br>configuration<br>available for<br>subject device. | | 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: 45 psi<br>Jacket: 45 psi | Same | | Material of Jacket | Stainless Steel (SA240-<br>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. | Horizontal opening/closing<br>door design operated by an<br>electrical motor. | Same | | 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; | 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; | Same | | Item | Getinge GSS610N<br>[Predicate device]<br>K201927 | Getinge GSS610N21<br>[Subject Device] | Comparison | | | 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 | 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 | | | 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>GSS610N21 - up to 25lbs<br>per tray | Maximum load<br>increases with<br>larger chamber size | | Utility Requirements<br>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 | Available for connection to:<br>208V 3ph 60Hz (Not<br>GSS61021N with integrated<br>electrical heated steam<br>boiler) 460V 3ph 60Hz<br>480V 3ph 60Hz<br>600V 3ph 60Hz | Same<br>Limited for<br>Subject device due<br>to dual boilers | {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for Getinge. The word "GETINGE" is written in a bold, sans-serif font in a dark blue color. To the right of the word is a stylized asterisk symbol, which is also in a dark blue color. The asterisk is made up of four curved arrows pointing inward. {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for Getinge. The logo consists of the word "GETINGE" in a bold, sans-serif font. To the right of the word is a stylized symbol that looks like four curved arrows pointing inward towards a central point. The logo is simple and modern. # Summary of Performance 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 | |----------------------------------------------------------------------------------------|-----------------------|------------------------------------|-----------------------------------------|---------| | Biological Performance Tests | | | | | | Sterilization<br>Efficacy Validation<br>Biological<br>Performance with<br>a fabric PCD | GSS610N21 | AAMI ST8:2013<br>(R2018)<br>§5.5.2 | Sterility Assurance<br>Level (SAL) 10-6 | Pass | | Biological<br>Performance with<br>liquid loads | GSS610N21 | 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 | GSS610N21 | AAMI ST8:2013<br>(R2018)<br>§5.5.4 | Sterility Assurance<br>Level (SAL) 10-6 | Pass | 510k Summary GSS610N21_ {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the logo for GETINGE. The text "GETINGE" is written in a bold, sans-serif font, with each letter in uppercase. To the right of the text is an abstract symbol that looks like four stylized arrows pointing towards the center. The logo has a blue color. | Biological<br>performance of<br>immediate-use<br>steam sterilization<br>for single-wrapped<br>or unwrapped<br>nonporous items | GSS610N21 | AAMI ST8:2013<br>(R2018)<br>§5.5.5 | Sterility Assurance<br>Level (SAL) 106 | Pass | |-------------------------------------------------------------------------------------------------------------------------------|-----------|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|--------------| | Physical Performance Test | | | | | | Chamber<br>Temperature<br>Profile | GSS610N21 | 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 | | Mechanical Air<br>Removal Test | GSS610N21 | AAMI ST8:2013<br>(R2018)<br>§5.6.1 | Load reaching<br>exposure temperature<br>within 10 secs<br>Color change on BD<br>chemical indicator<br>sheet | Pass<br>Pass | | Air Leak Rate Test | GSS610N21 | 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 | GSS610N21 | AAMI ST8:2013<br>(R2018)<br>§5.7 | < 3% increase in<br>presterilization test<br>pack weight for fabric<br>pack & <20% increase<br>for wrapped instrument<br>pack | Pass | ## Conclusion: The conclusions 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.