(234 days)
Not Found
No
The summary describes a steam sterilizer with a control system that sequences and monitors cycle phases. There is no mention of AI or ML capabilities, image processing, or data sets for training or testing. The performance studies focus on sterilization efficacy and physical parameters, not algorithmic performance.
No.
therapeutic devices are used to treat illnesses or conditions, this device is used to sterilize medical equipment and supplies.
No
The device is a steam sterilizer, used for sterilizing surgical instruments and linens, which is a process to eliminate microorganisms, not diagnose medical conditions.
No
The device is a steam sterilizer, which is a piece of hardware used to sterilize medical instruments and linens. The description clearly outlines physical components and performance tests related to the hardware.
Based on the provided information, the Getinge GSS610N 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) using steam. 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 details a steam sterilization process, not a method for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information about a patient's health status.
- Performance Studies: The performance studies focus on the efficacy of the sterilization process (biological and physical performance tests), not on the accuracy of a diagnostic test.
IVD devices are used to examine specimens derived from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The Getinge GSS610N Series Steam Sterilizer's function is to prepare medical items for use, not to perform diagnostic tests.
N/A
Intended Use / 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).
Product codes (comma separated list FDA assigned to the subject device)
FLE
Device Description
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
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)
Non-Clinical Testing:
Biological Performance Tests:
- Sterilization Efficacy Validation Biological Performance with a fabric PCD. Device: GSS610N10, GSS610N14, GSS610N15. Test Method: AAMI ST8:2013 (R2018) §5.5.2. Acceptance Criteria: Sterility Assurance Level (SAL) 10^-6. Results: Pass.
- Biological Performance with liquid loads. Device: GSS610N10, GSS610N14, GSS610N15. Test Method: AAMI ST8:2013 (R2018) §5.5.3. Acceptance Criteria: Sterility Assurance Level (SAL) 10^-6. Results: Pass.
- Biological Performance with a wrapped instrument PCD. Device: GSS610N10, GSS610N14, GSS610N15. Test Method: AAMI ST8:2013 (R2018) §5.5.4. Acceptance Criteria: Sterility Assurance Level (SAL) 10^-6. Results: Pass.
- Biological performance of immediate-use steam sterilization for single-wrapped or unwrapped nonporous items. Device: GSS610N10, GSS610N14, GSS610N15. Test Method: AAMI ST8:2013 (R2018) §5.5.5. Acceptance Criteria: Sterility Assurance Level (SAL) 10^-6. Results: Pass.
Physical Performance Test:
- Chamber Temperature Profile. Device: GSS610N10, GSS610N14, GSS610N15. Test Method: AAMI ST8:2013 (R2018) §5.4.2.5. Acceptance Criteria: +3°C (or +6°F) and -0°C (or -0°F) of the selected sterilization exposure temperature. Results: Pass.
- Mechanical Air Removal Test. Device: GSS610N10, GSS610N14, GSS610N15. Test Method: AAMI ST8:2013 (R2018) §5.6.1. Acceptance Criteria: Load reaching exposure temperature within 10 secs; Color change on BD chemical indicator sheet. Results: Pass.
- Air Leak Rate Test. Device: GSS610N10, GSS610N14, GSS610N15. Test Method: AAMI ST8:2013 (R2018) §5.6.2. Acceptance Criteria: Average leak rate of 1 mmHg (0.13 kPa) (0.019 psia) per minute or less over the measured time interval. Results: Pass.
- Moisture Retention Test. Device: GSS610N10, GSS610N14, GSS610N15. Test Method: AAMI ST8:2013 (R2018) §5.7. Acceptance Criteria:
§ 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 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 31
Rastatt DE-BW
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
(Note 1) | Maximum Items per
Chamber Length | | | |
|------------------|----------------------|------------------|--------------------------------|----------------------------------------------------------------------------|------------------------------|------------------------------|------------------------------|
| | Exp.
Temp. | Exp.
Time | Drying
Time | | 610N10
1040 mm
40.9 in | 610N14
1400 mm
51.1 in | 610N15
1540 mm
60.6 in |
| P1
PREVAC 1 | 135.0°C
(275.0°F) | 3 min | 16 min | Full instrument packs | 18 | 24 | 24 |
| P2
PREVAC 2 | 135.0°C
(275.0°F) | 3 min | 3 min | Full fabric packs | 40 | 40 | 60 |
| P3
PREVAC 4 | 132.2°C
(270.0°F) | 4 min | 30 min | Full instrument packs | 18 | 24 | 24 |
| P4
PREVAC 5 | 132.2°C
(270.0°F) | 4 min | 5 min | Full fabric packs | 40 | 40 | 60 |
| P5
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 |
| P6
GRAVITY 1 | 121.1°C
(250.0°F) | 30 min | 45 min | Full instrument packs
Full fabric packs | 18
40 | 24
40 | 24
60 |
| P7
GRAVITY 2 | 135.0°C
(275.0°F) | 10 min | 45 min | Full instrument packs
Full fabric packs | 18
40 | 24
40 | 24
60 |
| P8
GRAVITY 3 | 132.2°C
(270.0°F) | 15 min | 45 min | Full instrument packs
Full fabric packs | 18
40 | 24
40 | 24
60 |
| P9
IUSS 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 | ||||
|---|---|---|---|---|---|---|---|---|
| P10 | ||||||||
| IUSS 2 | ||||||||
| Grav | 135.0°C | |||||||
| (270.0°F) | 10 min | 30 sec | Full instrument packs | 1 | 1 | 1 | ||
| Full fabric packs | 1 | 1 | 1 | |||||
| P11 | ||||||||
| IUSS 3 | ||||||||
| Grav | 132.2°C | |||||||
| (270.0°F) | 4 min | 1 min | Full instrument packs | 1 | 1 | 1 | ||
| Full fabric packs | 1 | 1 | 1 | |||||
| P12 | ||||||||
| Vented | ||||||||
| Bottles | 121.1°C | |||||||
| (250.0°F) | 45 min | 3kPa/min | ||||||
| (0.44 | ||||||||
| psi/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" x
42.5" x 40.9" (672 x1080
x1040 mm) | Model 6710: 26.4" x 27.6" x
39.4" (672 x700 x1000 mm) | Different Chamber
Sizes |
| | Model 610N14: 26.4" x
42.5" x 55.1" (672 x1080
x1400 mm) | Model 6713: 26.4" x 27.6" x
51.2" (672 x700 x1300 mm) | Different Chamber
Sizes |
| | Model 610N15: 26.4" x
42.5" x 60.6" (672
x1080 x1540 mm) | Model 6717: 26.4" x 27.6" x
66.9" (672 x700 x1700 mm) | Different Chamber
Sizes |
| Chamber Volumes | Model 610N10: Single Door
26.52 Cu Ft (751L), Double
Door 26.59 Cu Ft (753L) | Model 6710: Single Door 17
Cu Ft (481L), Double Door
16.5 Cu Ft (468L) | The chamber volumes
correspond to the
chamber sizes |
| | Model 610N14: Single Door
35.73 Cu Ft (1012L) | | |
| | Double Door 35.77 Cu Ft
(1013L)
Model 610N15: Single Door
39.3 Cu Ft (1113L), Double
Door 39.34 Cu Ft (1114L) | Model 6713: Single Door 22
Cu Ft (621L), Double Door
21.5 Cu Ft (609L)
Model 6717: Single Door 28.6
Cu Ft (809L), Double Door
28.11 Cu Ft (796L) | |
| ASME Pressure Vessel | All pressure vessels are
built to ASME Sect. VIII,
Div. 1 | All pressure vessels are built
to ASME Sect. VIII, Div. 1 | Same |
| "U" Stamped Unfired
Pressure Vessel) | Chamber: 45 psi
Jacket: 45 psi | Chamber: 43.5 psi
Jacket: 51 psi | The pressure rating
differs 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/closing
door design operated by
an electrical motor. | Vertical opening/closing door
design with pneumatic
cylinder actuator | Different door
design. |
| Safety and Interlocks | | | |
| Door switch
system/steam to
chamber interlock | Electro-mechanical logic | Electro-mechanical logic | Same |
| Cycles | | | |
| Types of cycles offered | Prevac 132.2°C, 4
min; 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°C
4 min
Vented Bottles 121°C
45min.
BD Test | Prevac 132.2°C, 4 min;
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°C 4
min
Vented Bottles 121°C
45min.
BD Test | Same |
| Maximum Load
Capacities | Reference chart for
maximum loads within
GSS610N - up to 25lbs
per tray | Reference chart for
maximum loads within
GSS67N - up to 25lbs per
tray | Same |
| Utility Requirements | | | |
| Primary
Electrical
Connection | GSS610N are available for
connection to:
208V 3ph 60Hz (Not
GSS61015N with integrated
electrical heated steam
boiler)
460V 3ph 60Hz
480V 3ph 60Hz | GSS67N are available for
connection to:
208V 3ph 60Hz
460V 3ph 60Hz
480V 3ph 60Hz
600V 3ph 60Hz (Not with
integrated electrical heated
steam boiler) | Similar electrical
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
Performed | Device
Description | Test Method | Acceptance
Criteria | Results |
|-------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|--------------------------------------|------------------------------------------------------------------------------------------------|---------|
| Biological Performance Tests | | | | |
| Sterilization
Efficacy Validation
Biological
Performance with
a fabric PCD | GSS610N10
GSS610N14
GSS610N15 | AAMI ST8:2013
(R2018)
§5.5.2 | Sterility Assurance
Level (SAL) 10-6 | Pass |
| Biological
Performance with
liquid loads | GSS610N10
GSS610N14
GSS610N15 | AAMI ST8:2013
(R2018)
§5.5.3 | Sterility Assurance
Level (SAL) 10-6 | Pass |
| Biological
Performance with
a wrapped
instrument PCD | GSS610N10
GSS610N14
GSS610N15 | AAMI ST8:2013
(R2018)
§5.5.4 | Sterility Assurance
Level (SAL) 10-6 | Pass |
| Biological
performance of
immediate-use
steam sterilization
for single-wrapped
or unwrapped
nonporous items | GSS610N10
GSS610N14
GSS610N15 | AAMI ST8:2013
(R2018)
§5.5.5 | Sterility Assurance
Level (SAL) 10-6 | Pass |
| Physical Performance Test | | | | |
| Chamber
Temperature
Profile | GSS610N10
GSS610N14
GSS610N15 | AAMI ST8:2013
(R2018)
§5.4.2.5 | +3°C (or +6°F) and -
0°C (or -0°F) of the
selected sterilization
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
Removal Test | GSS610N10
GSS610N14
GSS610N15 | AAMI ST8:2013
(R2018)
§5.6.1 | Load reaching
exposuire temperature
witin 10 secs
Color change on BD
chemical indicator
sheet | Pass |
|--------------------------------|-------------------------------------|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|------|
| Air Leak Rate Test | GSS610N10
GSS610N14
GSS610N15 | AAMI ST8:2013
(R2018)
§5.6.2 | Average leak rate of 1
mmHg (0.13 kPa) (0.019
psia) per minute or less
over the measured time
interval. | Pass |
| Moisture
Retention Rest | GSS610N10
GSS610N14
GSS610N15 | AAMI ST8:2013
(R2018)
§5.7 |