(196 days)
Not Found
No
The document describes a standard steam sterilizer with a control system that monitors and sequences cycle phases. There is no mention of AI, ML, or any related technologies in the device description, intended use, or performance studies. The software validation is described as being performed according to standard FDA guidance for software in medical devices, not specifically for AI/ML.
No.
The device is a steam sterilizer intended for sterilizing medical items, not for providing direct therapy to patients.
No
The device is a steam sterilizer, used for sterilizing medical instruments and linens, not for diagnosing diseases or conditions.
No
The device is a steam sterilizer, which is a physical piece of equipment with a chamber, control system, and other hardware components for sterilization. While it mentions software validation, it is clearly not a software-only device.
Based on the provided information, the Getinge GSS67N Series Steam Sterilizer is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to sterilize medical devices and materials (surgical instruments, linens) used in healthcare facilities. This is a process applied to items before they are used on or with a patient, not a test performed on a sample taken from a patient.
- Device Description: The description focuses on the physical characteristics and operational mechanisms of a steam sterilizer, which is a piece of equipment used for disinfection/sterilization.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status, diagnosis, or treatment
- Using reagents or assays
- Measuring specific analytes
The device's function is to render medical items sterile, which is a crucial step in preventing the spread of infection in a healthcare setting. This falls under the category of medical devices used for processing or preparing other medical devices, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Getinge GSS67N 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 GSS67N Series Steam Sterilizer is available in 3 models differentiated by chamber length; GSS67N Model 6710 (39 inch chamber), GSS67N Model 6713 (51 inch chamber) and GSS67N Model 6717 (67 inch chamber).
Product codes (comma separated list FDA assigned to the subject device)
FLE
Device Description
The Getinge GSS67N Series Steam Sterilizer is designed for sterilization of heat and moisture stable materials used in healthcare facilities. There are three model designations to identify three different chamber lengths. The model 6710 is 1000 mm (39") long, model 6713 is 1300 mm (51") long and model 6717 is 1700 mm (67") lona.
The Getinge GSS67N Series Steam Sterilizer employs both gravity/downward displacement with positive pulse conditioning and pressure/vacuum pulsing for dynamic air removal. Up to 11 standard cycles can be easily accessed and custom cycle names can be designated by the user. All cycle phases are sequenced and monitored by the control system, providing both audible and visual notification of deviation from certain operating parameters.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care facilities
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Factory recommended cycles were tested per industry standards and quidelines and effectiveness of sterilizer function was demonstrated by complete kill of biological indicators. Getinge GSS67N Series Steam Sterilizers have been validated to meet the requirements of ANSI/AAMI ST8:2013 Hospital Steam Sterilizers.
The results of Getinge GSS67N Series Steam Sterilizer validation testing demonstrate that the sterilizer performs as intended. Summary of testing:
- Empty chamber testing performed for all cvcles as described in ANSI/AAMI . ST8:2013 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 challenge packs as described in ANSI/AAMI ST8:2013 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 (excluding PREVAC 2 and PREVAC 5 that have shortened drying . times) and GRAVITY cycles were validated using wrapped instrument process challenge devices as described in ANSI/AAMI ST8:2013 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 Bl 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.
- . All Immediate Use (IUSS) cycles were validated using an unwrapped nonporous process challenge device as described in ANSI/AAMI ST8:2013 section 5.5.5. 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 and complete BI kill.
- Liquid loads cycles were validated using 3 one liter flasks as described in . ANSI/AAMI ST8:2013 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 . ANSI/AAMI ST8:2013 section 5.6.1.1.
- . The software validation for the cycle operation was performed according to FDA guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
- . The electrical safety and EMC testing was completed per IEC 61010-1 "Safety requirements for electrical equipment for measurement, control, and laboratory use, Part 1: General requirements" (IEC 61010-1:2010 (Third Edition) +A1:2016; IEC 6101-2-040 "Safety requirements for electrical equipment for measurement, control, and laboratory use Part 2-040, Particular requirements for sterilizers and washer-disinfectors used to treat medical materials; and IEC 61326:2013 "Electrical Equipment for Meassurement, Control and Laboratory Use - EMC requirements", Part 1: General Requirements".
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.6880 Steam sterilizer.
(a)
Identification. A steam sterilizer (autoclave) is a device that is intended for use by a health care provider to sterilize medical products by means of pressurized steam.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 30, 2018
Maquet GmbH Holger Ullrich Director Product Compliance Kehler Strasse 31 Rastatt, 76437 De
Re: K172159
Trade/Device Name: Getinge GSS67N Series Steam Sterilizer Regulation Number: 21 CFR 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: Class II Product Code: FLE Dated: December 27, 2017 Received: December 28, 2017
Dear Holger Ullrich:
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.
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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K172159
Device Name Getinge GSS67N Series Steam Sterilizer
Indications for Use (Describe)
The Getinge GSS67N 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 GSS67N Series Steam Sterilizer is available in 3 models differentiated by chamber length; GSS67N Model 6710 (39 inch chamber), GSS67N Model 6713 (51 inch chamber) and GSS67N Model 6717 (67 inch chamber).
List of available cycles: See table below
| 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)
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3
Getinge GSS67N Series Steam Sterilizer Cycles and Load Chart
| Cycle Type | Factory Settings | | | Load Configuration
(Note 1) | Maximum Items per
Chamber Length | | |
|----------------------------|----------------------|------------------|--------------------------------------------|----------------------------------------------------------------------------|-------------------------------------|----------------------------|----------------------------|
| | Exp.
Temp. | Exp.
Time | Drying
Time | | 6710
1000mm
(39 in.) | 6713
1300mm
(51 in.) | 6717
1700mm
(67 in.) |
| PREVAC 1 | 135.0°C
(275.0°F) | 3 min | 16 min | Double-wrapped instrument
trays, up to 11.3 kg (25.0 lb)
(per tray) | 8 | 12 | 16 |
| PREVAC 2 | 135.0°C
(275.0°F) | 3 min | 3 min
(Note 4) | Fabric Packs | 18 | 24 | 30 |
| PREVAC 4 | 132.2°C
(270.0°F) | 4 min | 30 min | Double-wrapped instrument
trays, up to 11.3 kg (25.0 lb)
(per tray) | 8 | 12 | 16 |
| PREVAC 5 | 132.2°C
(270.0°F) | 4 min | 5 min
(Note 4) | Fabric packs | 18 | 24 | 30 |
| B & D TEST | 134°C
(273.0°F) | 3 min,
30 sec | 0 min | 1 B&D Test Pack in an
EMPTY chamber (other than
loading accessories) | 1 Test
Pack | 1 Test
Pack | 1 Test
Pack |
| GRAVITY 1 | 121.1°C
(250.0°F) | 30 min | 45 min | Double-wrapped instrument
trays, up to 11.3 kg (25.0 lb)
(per tray) | 8 | 12 | 16 |
| GRAVITY 1 | | | | Fabric packs | 18 | 24 | 30 |
| GRAVITY 2 | 135.0°C
(275.0°F) | 10 min | 45 min | Double-wrapped instrument
trays, up to 11.3 kg (25.0 lb)
(per tray) | 8 | 12 | 16 |
| GRAVITY 2 | | | | Fabric packs | 18 | 24 | 30 |
| GRAVITY 3 | 132.2°C
(270.0°F) | 15 min | 45 min | Double-wrapped instrument
trays, up to 11.3 kg (25.0 lb)
(per tray) | 8 | 12 | 16 |
| GRAVITY 3 | | | | Fabric packs | 18 | 24 | 30 |
| IUSS 1
Vac
(Note 7) | 135.0°C
(275.0°F) | 3 min | 1 min
(Note 4) | Instrument Tray (25lb) | 1 | 1 | 1 |
| (Note 7) | | | | Single Instrument Tray | 1 | 1 | 1 |
| IUSS 2
Grav
(Note 7) | 135.0°C
(275.0°F) | 10 min | 0.5 min
(Note 4) | Instrument Tray (25lb) | 1 | 1 | 1 |
| | | | | Single Instrument/Tray | 1 | 1 | 1 |
| IUSS 3
Grav
(Note 7) | 132.2°C
(270.0°F) | 4 min | 1 min
(Note 4) | Instrument Tray (25lb) | 1 | 1 | 1 |
| | | | | Single Instrument/Tray | 1 | 1 | 1 |
| LIQUIDS | 121.1°C
(250.0°F) | 45 min | 3 kPa/min
(0.44
psi/min)
(Note 3) | Each container
1000 mL (34 fl oz) or smaller
(Notes 5, 6) | 3 | 3 | 3 |
| LEAK TEST
(Note 2) | 131.1°C
(268.0°F) | N/A | N/A | Empty Chamber
(other than loading
accessories) | – | – | – |
4
NOTE: Liquid Cycles are not intended for the sterilization of liquids used for direct patient contact.
TABLE NOTES:
-
- 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 sterility assurance in health care facilities.
-
- Vacuum leak test parameters are not adjustable.
-
- Cooldown rate
-
- Items may NOT be dry at the end of the following cycles:
- · IUSS 1, 2, 3
- PREVAC 2
- PREVAC 5
Drying time may be added if required.
-
- Facility must validate the cycle if the load includes containers larger than 1000 mL (34 fl oz).
-
- Use vented or open containers only.
-
- The recommended minimum exposure time and temperature for unwrapped, nonporous loads (e.g., metal instruments) that are sterilized for immediate use is 3 minutes at 132°C (270°F) or 135°C (275°F).
5
K172159 510(k) SUMMARY
Getinge GSS67N Series Steam Sterilizer
| Submitted by: | Maquet GmbH
Kehler Strasse 31
Rastatt DE-BW
Germany 76437 |
|------------------------|----------------------------------------------------------------------------------------------------------------|
| Contact Person: | Barb Smith, RAC
Sr. Regulatory Affairs Specialist
Phone: (585) 214-6049
Email: barb.smith@getinge.com |
| Date prepared: | Jan 30, 2018 |
| Proprietary Name: | GSS67N Series Steam Sterilizer |
| Common Name: | Steam Sterilizer |
| Device Classification: | Steam Sterilizer (80 FLE)
Class II, as listed per 21 CFR 880.6880 |
| Predicate Device: | Getinge 633HC Series Steam Sterilizer [K070657] |
Description of Device:
The Getinge GSS67N Series Steam Sterilizer is designed for sterilization of heat and moisture stable materials used in healthcare facilities. There are three model designations to identify three different chamber lengths. The model 6710 is 1000 mm (39") long, model 6713 is 1300 mm (51") long and model 6717 is 1700 mm (67") lona.
The Getinge GSS67N Series Steam Sterilizer employs both gravity/downward displacement with positive pulse conditioning and pressure/vacuum pulsing for dynamic air removal. Up to 11 standard cycles can be easily accessed and custom cycle names can be designated by the user. All cycle phases are sequenced and monitored by the control system, providing both audible and visual notification of deviation from certain operating parameters.
Intended Use:
The Getinge GSS67N 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 GSS67N Series Steam Sterilizer is available in 3 models differentiated by chamber length; GSS67N Model 6710 (39 inch chamber), GSS67N Model 6713 (51 inch chamber) and GSS67N Model 6717 (67 inch chamber).
6
List of available cycles:
| Cycle Type | Factory Settings | | | Load Configuration
(Note 1) | Maximum Items per
Chamber Length | | |
|----------------------------|----------------------|------------------|--------------------------------------------|----------------------------------------------------------------------------|-------------------------------------|----------------------------|----------------------------|
| | Exp.
Temp | Exp.
Time | Drying
Time | | 6710
1000mm
(39 in.) | 6713
1300mm
(51 in.) | 6717
1700mm
(67 in.) |
| PREVAC 1 | 135.0°C
(275.0°F) | 3 min | 16 min | Double-wrapped instrument
trays, up to 11.3 kg (25.0 lb)
(pertray) | 8 | 12 | 16 |
| PREVAC 2 | 135.0°C
(275.0°F) | 3 min | 3 min
(Note 4) | Fabric Packs | 18 | 24 | 30 |
| PREVAC 4 | 132.2°C
(270.0°F) | 4 min | 30 min | Double-wrapped instrument
trays, up to 11.3 kg (25.0 lb)
(pertray) | 8 | 12 | 16 |
| PREVAC 5 | 132.2°C
(270.0°F) | 4 min | 5 min
(Note 4) | Fabric packs | 18 | 24 | 30 |
| B & D TEST | 134°C
(273.0°F) | 3 min,
30 sec | 0 min | 1 B&D Test Pack in an
EMPTY chamber (other than
loading accessories) | 1 Test
Pack | 1 Test
Pack | 1 Test
Pack |
| GRAVITY 1 | 121.1°C
(250.0°F) | 30 min | 45 min | Double-wrapped instrument
trays, up to 11.3 kg (25.0 lb)
(pertray) | 8 | 12 | 16 |
| | | | | Fabric packs | 18 | 24 | 30 |
| GRAVITY 2 | 135.0°C
(275.0°F) | 10 min | 45 min | Double-wrapped instrument
trays, up to 11.3 kg (25.0 lb)
(pertray) | 8 | 12 | 16 |
| | | | | Fabric packs | 18 | 24 | 30 |
| GRAVITY 3 | 132.2°C
(270.0°F) | 15 min | 45 min | Double-wrapped instrument
trays, up to 11.3 kg (25.0 lb)
(pertray) | 8 | 12 | 16 |
| | | | | Fabric packs | 18 | 24 | 30 |
| IUSS 1
Vac
(Note 7) | 135.0°C
(275.0°F) | 3 min | 1 min
(Note 4) | Instrument Tray (25lb) | 1 | 1 | 1 |
| | | | | Single Instrument Tray | 1 | 1 | 1 |
| IUSS 2
Grav
(Note 7) | 135.0°C
(275.0°F) | 10 min | 0.5 min
(Note 4) | Instrument Tray (25lb) | 1 | 1 | 1 |
| | | | | Single Instrument/Tray | 1 | 1 | 1 |
| IUSS 3
Grav
(Note 7) | 132.2°C
(270.0°F) | 4 min | 1 min
(Note 4) | Instrument Tray (25lb) | 1 | 1 | 1 |
| | | | | Single Instrument/Tray | 1 | 1 | 1 |
| LIQUIDS | 121.1°C
(250.0°F) | 45 min | 3 kPa/min
(0.44
psi/min)
(Note 3) | Each container
1000 mL (34 fl oz) or smaller
(Notes 5, 6) | 3 | 3 | 3 |
| LEAK TEST
(Note 2) | 131.1°C
(268.0°F) | N/A | N/A | Empty Chamber
(other than loading
accessories) | — | — | — |
Getinge GSS67N Series Steam Sterilizer Cycles and Load Chart
7
Maquet GmbH Getinge Group FDA 510(k) Summary Device: GSS67N Series Steam Sterilizer
NOTE: Liquid Cycles are not intended for the sterilization of liquids used for direct patient contact.
TABLE NOTES:
-
- 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 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 sterility assurance in health care facilities.
-
- Vacuum leak test parameters are not adjustable.
-
- Cooldown rate
-
- Items may NOT be dry at the end of the following cycles:
- · IUSS 1, 2, 3
- PREVAC 2
- PREVAC 5
Drying time may be added if required.
- Facility must validate the cycle if the load includes containers larger than 1000 mL (34 fl oz).
-
- Use vented or open containers only.
- The recommended minimum exposure time and temperature for unwrapped, nonporous loads (e.g., metal instruments) that are sterilized for immediate use is 3 minutes at 132°C (270°F) or 135°C (275°F).
8
Comparisons to Predicate Device:
Similarities between the Getinge GSS67N Series Steam Sterilizer and the identified predicate device (Getinge 633HC Series Steam Sterilizer) 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.
- · Materials of construction are the same: Vessel material is Stainless Steel SA240. There is no direct patient contact associated with this device.
- · Cycle Types: The cycle types offered are the same; Prevacuum, Gravity, Immediate Use (Flash) and Liquids (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 Hospital Steam Sterilizers.
The differences between the Getinge GSS67N Series Steam Sterilizer and the predicate device (Getinge 633HC Series Steam Sterilizer) are:
- · The Getinge GSS67N series provides standard cycles validated to the current AAMI ST8:2013 Hospital Steam Sterilizers standard and thus provides testing of instrument trays up to 25 lbs. In addition the GSS67N has included 132°C cycles that were not validated on the predicate device.
- · The Getinge GSS67N Series Steam Sterilizer offers one larger vessel size than the 633HC Series.
- · The Getinge GSS67N Series Steam Sterilizer removes air from the chamber by means of a vacuum pump as opposed to a water injector (used in 633HC predicate) thus allowing for less water usage.
- · The Getinge GSS67N Series Steam Sterilizer has an updated touchscreen display.
9
Summary of Performance Testing:
Factory recommended cycles were tested per industry standards and quidelines and effectiveness of sterilizer function was demonstrated by complete kill of biological indicators. Getinge GSS67N Series Steam Sterilizers have been validated to meet the requirements of ANSI/AAMI ST8:2013 Hospital Steam Sterilizers.
The results of Getinge GSS67N Series Steam Sterilizer validation testing demonstrate that the sterilizer performs as intended. Summary of testing:
- Empty chamber testing performed for all cvcles as described in ANSI/AAMI . ST8:2013 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 challenge packs as described in ANSI/AAMI ST8:2013 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 (excluding PREVAC 2 and PREVAC 5 that have shortened drying . times) and GRAVITY cycles were validated using wrapped instrument process challenge devices as described in ANSI/AAMI ST8:2013 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 Bl 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.
- . All Immediate Use (IUSS) cycles were validated using an unwrapped nonporous process challenge device as described in ANSI/AAMI ST8:2013 section 5.5.5. 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 and complete BI kill.
- Liquid loads cycles were validated using 3 one liter flasks as described in . ANSI/AAMI ST8:2013 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 . ANSI/AAMI ST8:2013 section 5.6.1.1.
10
- . The software validation for the cycle operation was performed according to FDA guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
- . The electrical safety and EMC testing was completed per IEC 61010-1 "Safety requirements for electrical equipment for measurement, control, and laboratory use, Part 1: General requirements" (IEC 61010-1:2010 (Third Edition) +A1:2016; IEC 6101-2-040 "Safety requirements for electrical equipment for measurement, control, and laboratory use Part 2-040, Particular requirements for sterilizers and washer-disinfectors used to treat medical materials; and IEC 61326:2013 "Electrical Equipment for Meassurement, Control and Laboratory Use - EMC requirements", Part 1: General Requirements".
Clinical Data:
No clinical data is required for this device classification submission.
Conclusion:
The GSS67N Series Steam Sterilizer meets the applicable requirements of AAMI ST8:2013 performance standards. The conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device K070657.