(234 days)
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).
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
This document is about the FDA 510(k) clearance for the Getinge GSS610N Series Steam Sterilizer (K201927). It describes the device, its intended use, and the non-clinical testing performed to demonstrate its substantial equivalence to a predicate device.
Here's the breakdown of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance:
| Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biological Performance Tests | ||
| Sterilization Efficacy Validation Biological Performance with a fabric PCD | Sterility Assurance Level (SAL) 10⁻⁶ | Pass |
| Biological Performance with liquid loads | Sterility Assurance Level (SAL) 10⁻⁶ | Pass |
| Biological Performance with a wrapped instrument PCD | Sterility Assurance Level (SAL) 10⁻⁶ | Pass |
| Biological performance of immediate-use steam sterilization for single-wrapped or unwrapped nonporous items | Sterility Assurance Level (SAL) 10⁻⁶ | Pass |
| Physical Performance Test | ||
| Chamber Temperature Profile | +3°C (or +6°F) and -0°C (or -0°F) of the selected sterilization exposure temperature | Pass |
| Mechanical Air Removal Test | Load reaching exposure temperature within 10 secs; Color change on B&D chemical indicator sheet | Pass |
| Air Leak Rate Test | Average leak rate of 1 mmHg (0.13 kPa) (0.019 psia) per minute or less over the measured time interval | Pass |
| Moisture Retention Test | < 3% increase in presterilization test pack weight for fabric pack & <20% increase for wrapped instrument pack | Pass |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: The document does not explicitly state the numerical sample size for each test (e.g., number of sterilization runs, number of items per test). It mentions "Full instrument packs" and "Full fabric packs" for various cycles, and "1 B&D Test Pack." The results are simply reported as "Pass," indicating that the tests were conducted according to the specified standards and the outcomes met the criteria.
- Data Provenance: The tests were "non-clinical testing" performed by Maquet GmbH, located in Rastatt, Germany. The document indicates these were validation tests for the device, implying they were prospective studies conducted specifically for this 510(k) submission. No information about country of origin of the data in terms of patient data (as this is a sterilizer, not a diagnostic device using human data).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable to this type of device and study. The "ground truth" for a steam sterilizer is defined by objective physical and biological parameters related to sterilization efficacy (e.g., Sterility Assurance Level, temperature profiles, air removal) as established by consensus standards (like AAMI ST8). Human expert interpretation of images or clinical outcomes is not part of establishing the ground truth for a sterilizer's performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
No adjudication method is described because this involves objective physical and biological measurements, not subjective human assessments that require adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for medical imaging AI devices where human readers interpret medical images with and without AI assistance. This document is for a medical device (steam sterilizer) where the efficacy is determined by objective physical and biological tests, not by human interpretation of clinical cases.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The concept of "standalone performance" for an algorithm is not directly applicable here. The device itself (the sterilizer) performs its function (sterilization) based on its design and programmed cycles. The tests conducted (biological and physical performance tests) are in essence evaluating the "standalone" performance of the machine in achieving sterilization. There is no human "in the loop" assisting the sterilizer during the sterilization process itself.
7. The type of ground truth used:
The ground truth for this device's performance is established by:
- Sterility Assurance Level (SAL) 10⁻⁶: This is a widely accepted measure that indicates a probability of one in a million chance of a single viable microorganism remaining after sterilization. Biological indicators (spore tests) are used to confirm this.
- Physical Parameters: Objective measurements of temperature (e.g., within +/-3°C or 6°F of target), air removal (e.g., load reaching exposure temperature within 10 seconds), and moisture retention (e.g., <3% weight increase for fabric packs, <20% for wrapped instrument packs).
- Chemical Indicators: Color change on B&D (Bowie-Dick) chemical indicator sheets.
These ground truths are based on established consensus standards, specifically AAMI ST8:2013 (R2018).
8. The sample size for the training set:
This information is not applicable. This document describes the clearance of a physical medical device (steam sterilizer) and its performance through validation testing. It is not an AI/ML device that requires training data and a training set.
9. How the ground truth for the training set was established:
This information is not applicable as there is no "training set" for this device.
{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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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. 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
{1}------------------------------------------------
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 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_Kehler Strasse 31Rastatt DE-BWGermany 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(Note 1) | Maximum Items perChamber Length | ||||
|---|---|---|---|---|---|---|---|
| Exp.Temp. | Exp.Time | DryingTime | 610N101040 mm40.9 in | 610N141400 mm51.1 in | 610N151540 mm60.6 in | ||
| P1PREVAC 1 | 135.0°C(275.0°F) | 3 min | 16 min | Full instrument packs | 18 | 24 | 24 |
| P2PREVAC 2 | 135.0°C(275.0°F) | 3 min | 3 min | Full fabric packs | 40 | 40 | 60 |
| P3PREVAC 4 | 132.2°C(270.0°F) | 4 min | 30 min | Full instrument packs | 18 | 24 | 24 |
| P4PREVAC 5 | 132.2°C(270.0°F) | 4 min | 5 min | Full fabric packs | 40 | 40 | 60 |
| P5B & D TEST | 134°C(273.0°F) | 3 min,30 sec | 0 min | 1 B&D Test Pack in anEMPTY chamber (otherthan loading accessories) | 1 TestPack | 1 TestPack | 1 TestPack |
| P6GRAVITY 1 | 121.1°C(250.0°F) | 30 min | 45 min | Full instrument packsFull fabric packs | 1840 | 2440 | 2460 |
| P7GRAVITY 2 | 135.0°C(275.0°F) | 10 min | 45 min | Full instrument packsFull fabric packs | 1840 | 2440 | 2460 |
| P8GRAVITY 3 | 132.2°C(270.0°F) | 15 min | 45 min | Full instrument packsFull fabric packs | 1840 | 2440 | 2460 |
| P9IUSS 1 | 135.0°C(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 | ||||
|---|---|---|---|---|---|---|---|---|
| P10IUSS 2Grav | 135.0°C(270.0°F) | 10 min | 30 sec | Full instrument packs | 1 | 1 | 1 | |
| Full fabric packs | 1 | 1 | 1 | |||||
| P11IUSS 3Grav | 132.2°C(270.0°F) | 4 min | 1 min | Full instrument packs | 1 | 1 | 1 | |
| Full fabric packs | 1 | 1 | 1 | |||||
| P12VentedBottles | 121.1°C(250.0°F) | 45 min | 3kPa/min(0.44psi/min)(Note 2) | Each container 1000 mL(34 fl oz) or smaller(Note 3) | 3 | 3 | 3 |
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/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.
-
Cooldown rate
-
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[Subject device] | Getinge GSS67N[Predicate Device]K172159 | Comparison |
|---|---|---|---|
| Pressure Vessel | |||
| Chamber Sizes | Model 610N10: 26.4" x42.5" x 40.9" (672 x1080x1040 mm) | Model 6710: 26.4" x 27.6" x39.4" (672 x700 x1000 mm) | Different ChamberSizes |
| Model 610N14: 26.4" x42.5" x 55.1" (672 x1080x1400 mm) | Model 6713: 26.4" x 27.6" x51.2" (672 x700 x1300 mm) | Different ChamberSizes | |
| Model 610N15: 26.4" x42.5" x 60.6" (672x1080 x1540 mm) | Model 6717: 26.4" x 27.6" x66.9" (672 x700 x1700 mm) | Different ChamberSizes | |
| Chamber Volumes | Model 610N10: Single Door26.52 Cu Ft (751L), DoubleDoor 26.59 Cu Ft (753L) | Model 6710: Single Door 17Cu Ft (481L), Double Door16.5 Cu Ft (468L) | The chamber volumescorrespond to thechamber sizes |
| Model 610N14: Single Door35.73 Cu Ft (1012L) | |||
| Double Door 35.77 Cu Ft(1013L)Model 610N15: Single Door39.3 Cu Ft (1113L), DoubleDoor 39.34 Cu Ft (1114L) | Model 6713: Single Door 22Cu Ft (621L), Double Door21.5 Cu Ft (609L)Model 6717: Single Door 28.6Cu Ft (809L), Double Door28.11 Cu Ft (796L) | ||
| ASME Pressure Vessel | All pressure vessels arebuilt to ASME Sect. VIII,Div. 1 | All pressure vessels are builtto ASME Sect. VIII, Div. 1 | Same |
| "U" Stamped UnfiredPressure Vessel) | Chamber: 45 psiJacket: 45 psi | Chamber: 43.5 psiJacket: 51 psi | The pressure ratingdiffers slightly |
| Material of Jacket | Stainless Steel (SA240- 304 ) | Stainless Steel (SA240- 304 ) | Same |
| Material of Chamber | Stainless Steel (SA240-316L ) | Stainless Steel (SA240-316L ) | Same |
| Vacuum method | Vacuum pump standard. | Vacuum pump standard. | Same |
| Chamber Closure | |||
| Door Operation | Horizontal opening/closingdoor design operated byan electrical motor. | Vertical opening/closing doordesign with pneumaticcylinder actuator | Different doordesign. |
| Safety and Interlocks | |||
| Door switchsystem/steam tochamber interlock | Electro-mechanical logic | Electro-mechanical logic | Same |
| Cycles | |||
| Types of cycles offered | Prevac 132.2°C, 4min; 135°C, 3 min,Gravity 121°C, 30 min;135°C 10 min; 132.2°15 min;IUSS 135°C, 3 min,;135C, 10 min; 132.2°C4 minVented Bottles 121°C45min.BD Test | Prevac 132.2°C, 4 min;135°C, 3 min,Gravity 121°C, 30 min;135°C 10 min; 132.2° 15min;IUSS 135°C, 3 min,;135C, 10 min; 132.2°C 4minVented Bottles 121°C45min.BD Test | Same |
| Maximum LoadCapacities | Reference chart formaximum loads withinGSS610N - up to 25lbsper tray | Reference chart formaximum loads withinGSS67N - up to 25lbs pertray | Same |
| Utility Requirements | |||
| PrimaryElectricalConnection | GSS610N are available forconnection to:208V 3ph 60Hz (NotGSS61015N with integratedelectrical heated steamboiler)460V 3ph 60Hz480V 3ph 60Hz | GSS67N are available forconnection to:208V 3ph 60Hz460V 3ph 60Hz480V 3ph 60Hz600V 3ph 60Hz (Not withintegrated electrical heatedsteam boiler) | Similar electricalconnections |
{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:.
| TestPerformed | DeviceDescription | Test Method | AcceptanceCriteria | Results |
|---|---|---|---|---|
| Biological Performance Tests | ||||
| SterilizationEfficacy ValidationBiologicalPerformance witha fabric PCD | GSS610N10GSS610N14GSS610N15 | AAMI ST8:2013(R2018)§5.5.2 | Sterility AssuranceLevel (SAL) 10-6 | Pass |
| BiologicalPerformance withliquid loads | GSS610N10GSS610N14GSS610N15 | AAMI ST8:2013(R2018)§5.5.3 | Sterility AssuranceLevel (SAL) 10-6 | Pass |
| BiologicalPerformance witha wrappedinstrument PCD | GSS610N10GSS610N14GSS610N15 | AAMI ST8:2013(R2018)§5.5.4 | Sterility AssuranceLevel (SAL) 10-6 | Pass |
| Biologicalperformance ofimmediate-usesteam sterilizationfor single-wrappedor unwrappednonporous items | GSS610N10GSS610N14GSS610N15 | AAMI ST8:2013(R2018)§5.5.5 | Sterility AssuranceLevel (SAL) 10-6 | Pass |
| Physical Performance Test | ||||
| ChamberTemperatureProfile | GSS610N10GSS610N14GSS610N15 | AAMI ST8:2013(R2018)§5.4.2.5 | +3°C (or +6°F) and -0°C (or -0°F) of theselected sterilizationexposure 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 AirRemoval Test | GSS610N10GSS610N14GSS610N15 | AAMI ST8:2013(R2018)§5.6.1 | Load reachingexposuire temperaturewitin 10 secsColor change on BDchemical indicatorsheet | Pass |
|---|---|---|---|---|
| Air Leak Rate Test | GSS610N10GSS610N14GSS610N15 | AAMI ST8:2013(R2018)§5.6.2 | Average leak rate of 1mmHg (0.13 kPa) (0.019psia) per minute or lessover the measured timeinterval. | Pass |
| MoistureRetention Rest | GSS610N10GSS610N14GSS610N15 | AAMI ST8:2013(R2018)§5.7 | < 3% increase inpresterilization testpack weight for fabricpack & <20% increasefor wrapped instrumentpack | 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)
§ 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).