The Getinge 800HC-E Series Steam Sterilizer is intended for use by health care facilities and to be used to sterilize wrapped and unwrapped porous and nonporous heat and moisture stable items such as surgical instruments and linens by means of pressurized steam.

Device Description

The Getinge 800HC-E Series Steam Sterilizer is designed for sterilization of heat and moisture stable materials used in healthcare facilities. The only model designation provided in the 800HC-E Series Steam Sterilizer is 833HC-E. The model 833HC-E is available in 2 chamber sizes; 42 inches long (39.6 cu ft) and 76 inches long (72.0 cu ft).

The Getinge 800HC-E Series Steam Sterilizer employs both gravity/downward displacement with positive pulse conditioning and pressure/vacuum pulsing for dynamic air removal. Up to 17 cycles can be easily accessed and custom cycle names can be designated by the user (duplicate cycles are provided to allow for user designated names). All cycle phases are sequenced and monitored by the control system, providing both audible and visual notification of deviation from certain operating parameters.

AI/ML Overview

The Getinge 800HC-E Series Steam Sterilizer is a device designed for the sterilization of heat and moisture-stable materials in healthcare facilities. The pivotal study for this device is the "Summary of Performance Testing" which demonstrates its ability to reliably sterilize under various cycle types and load configurations.

1. Table of Acceptance Criteria and Reported Device Performance:

The acceptance criteria for the Getinge 800HC-E Series Steam Sterilizer are aligned with the requirements of ANSI/AAMI ST8:2008 Hospital Steam Sterilizers. The device performance is deemed successful if these criteria are met.

Acceptance Criteria (ANSI/AAMI ST8:2008)	Reported Device Performance
Empty Chamber Testing (Section 5.4.2.5):	Met: 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.
PREVAC and GRAVITY Cycles (Fabric Process Challenge Packs - Section 5.5.2): - Sterility Assurance Level (SAL) of at least 10^-6 - F₀ value of at least 12 - Complete Biological Indicator (BI) kill - Moisture retention of less than 3% increase in pre-sterilization test pack weight - No visible wet spots	Met: The results from this testing demonstrated a sterility assurance level of at least 10^-6 through achievement of time at temperature sufficient to produce an F₀ value of at least 12, complete BI kill, and moisture retention of less than 3% increase in pre-sterilization test pack weight, including no visible wet spots.
PREVAC and GRAVITY Cycles (Wrapped Instrument Process Challenge Devices - Section 5.5.4): - Sterility Assurance Level (SAL) of at least 10^-6 - F₀ value of at least 12 - Complete Biological Indicator (BI) kill - Moisture retention of less than 20% increase in pre-sterilization weight of the towel - No visible wet spots on the outer wrapper	Met: The results from this testing demonstrated a sterility assurance level of at least 10^-6 through achievement of time at temperature sufficient to produce an F₀ value of at least 12, complete BI 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.
Liquid Loads Cycles (Using 3 one-liter flasks - Section 5.5.3): - Sterility Assurance Level (SAL) of at least 10^-6 - F₀ value of at least 12 - Complete Biological Indicator (BI) kill - Water loss not exceeding 50ml	Met: The results from this testing demonstrated a sterility assurance level of at least 10^-6 through achievement of time at temperature sufficient to produce an F₀ value of at least 12, complete BI kill, and water loss not exceeding 50ml. (Note: Liquid Cycles are not intended for the sterilization of liquids used for direct patient contact.)
Bowie Dick Cycle (Section 5.6.1.1): - Successful completion according to the Bowie-Dick test pack	Met: Bowie Dick cycle was validated using the Bowie-Dick test pack as described in ANSI/AAMI ST8:2008 section 5.6.1.1. (Implies successful completion, as failure would have been noted).
Software Validation: - Compliance with FDA guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (5/11/2005)"	Met: 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 (5/11/2005)".

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: The document does not explicitly state a numerical sample size in terms of the number of sterilization cycles or tests performed. However, it indicates that "Factory recommended cycles were tested," and for specific validation types (e.g., liquid loads), it mentions "3 one liter flasks." The implied sample size for each specific test type (empty chamber, fabric packs, instrument packs, liquid loads, Bowie-Dick) would be the minimum required by ANSI/AAMI ST8:2008 to demonstrate a statistically significant number of successful sterilizations to achieve the required Sterility Assurance Level (SAL). Given the nature of sterilization validation, this typically involves multiple successful runs to establish consistency and reliability.
Data Provenance: The testing was conducted by Getinge Sourcing LLC, the manufacturer, at their facilities. This is considered prospective validation testing performed during the development and verification phase of the device. The country of origin for the data is implicitly the United States, as Getinge Sourcing LLC is located in Rochester, NY, and the submission is to the FDA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

The document does not specify the "number of experts" or their specific qualifications for establishing the ground truth during the performance testing. However, the ground truth itself is established by adherence to recognized industry standards: ANSI/AAMI ST8:2008 Hospital Steam Sterilizers. This standard defines the methodologies for testing, including the use of Biological Indicators (BIs), F₀ value calculations, and other physical and chemical indicators. Therefore, the "experts" are the developers of the AAMI standard and the trained personnel (e.g., sterilization validation engineers, microbiologists, quality assurance personnel) who conducted the tests according to these established protocols. Their qualification is their adherence to these standards.

4. Adjudication Method for the Test Set:

There is no mention of an "adjudication method" in the context of expert consensus, such as 2+1 or 3+1. For a steam sterilizer, validation is typically based on objective, measurable criteria defined by the AAMI standard. The success or failure of a sterilization cycle is determined by the physical parameters (temperature, pressure, time), the F₀ value, the kill of Biological Indicators (a direct measure of sterility), and physical assessments like moisture retention and wet spots. These are not subject to expert interpretation in the same way clinical image analysis might be.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not performed. This type of study is relevant for diagnostic devices where human readers interpret outputs, and the AI's impact on their performance is being evaluated. The Getinge 800HC-E Series Steam Sterilizer is an automated sterilization device, not an AI-powered diagnostic tool, so such studies are not applicable.

6. Standalone (Algorithm Only Without Human-in-the Loop) Performance:

Yes, a standalone performance evaluation was conducted. The "Summary of Performance Testing" implicitly describes the standalone performance of the sterilizer. The device's ability to achieve sterilization (complete BI kill, F₀ value, etc.) is assessed based on its own operational cycles and parameters, without human intervention during the sterilization process itself. The "software validation" also attests to the standalone performance of the control algorithms.

7. Type of Ground Truth Used:

The primary ground truth used for the performance testing is a combination of:

Biological Kill (Microbiological Data): Complete kill of Biological Indicators (BIs) is the ultimate confirmation of sterility, directly demonstrating the achievement of a sterility assurance level (SAL).
Physical Parameters and F₀ Value (Engineering/Process Data): Achievement of specified temperature, pressure, and time parameters, and calculation of the Fo value, which quantifies the lethality of the steam sterilization process.
Physical Assessment: Evaluation of moisture retention, presence of wet spots, and water loss, as defined by the AAMI standard.
Standard Adherence: Compliance with the methodologies and acceptance criteria outlined in ANSI/AAMI ST8:2008 Hospital Steam Sterilizers.

8. Sample Size for the Training Set:

This information is not applicable (N/A). The Getinge 800HC-E Series Steam Sterilizer is a physical electromechanical device for sterilization, which does not employ machine learning or AI models that require "training sets" in the conventional sense of data-driven algorithm development. Its "training" involves engineering design, calibration, and iterative physical testing to optimize its performance before formal validation.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable (N/A) for the same reasons as above. The "ground truth" for the device's development relates to fundamental scientific principles of steam sterilization (e.g., thermal death kinetics of microorganisms, heat transfer, pressure dynamics) and engineering design specifications, rather than a labeled dataset for an AI model.

Summary

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K122625

510(k) SUMMARY

MAY 2 2 2013

Getinge 800HC-E Series Steam Sterilizer

Submitted by:	Getinge Sourcing LLC1777 E Henrietta RoadRochester, NY 14623-3133
Contact Person:	Barb Smith, RACSr. Manager, Regulatory AffairsPhone: (585) 214-6049Fax: (585) 272-5299
Date prepared:	August 15, 2012
Proprietary Name:	Model 800HC-E 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 Model 700HC-E Series Steam Sterilizer [K120441]

· Description of Device:

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Getinge Sourcing LLC FDA 510(k) Summary Device: 800HC-E Series Steam Sterilizer

List of available cycles:

Getinge 800HC-E Series Steam Sterilizer Model 833HC-E Cycles and Load Chart

Cycle Type	No. ofCycles	Factory Settings			Load Configuration(Note 1)	Maximum Items perChamber Length
		Exp.Temp.	Exp.Time	DryingTime		42 in.(1067 mm)	76 in.(1930 mm)
vacPREVAC 1	6	135.0°C(275.0°F)	3 min	16 min	Double-wrappedinstrument trays, upto 11.3 kg (25.0 lb)(per tray)	12	24
					Fabric Packs	36	72
vacPREVAC 4	1	132.2°C(270.0°F)	4 min	16 min	Double-wrappedinstrument trays, upto 11.3 kg (25.0 lb)(per tray)	12	24
					Fabric packs	36	72
vacB & D TEST	1	133.9°C(273.0°F)	3 min,30 sec	0 min	S.M.A.R.T. Pack orequivalent (1 max.) inan EMPTY chamber	1 TestPack	1 TestPack
grvGRAVITY 1	3	121.1°C(250.0°F)	30 min	30 min	Double-wrappedinstrument trays, upto 11.3 kg (25.0 lb)(per tray)	12	24
					Fabric packs	36	72
grvGRAVITY 2	3	135.0°C(275.0°F)	10 min	30 min	Double-wrappedinstrument trays, upto 11.3 kg (25.0 lb)(per tray)	12	24
					Fabric packs	36	72
grvGRAVITY 3	1	132.2°C(270.0°F)	15 min	30 min	Double-wrappedinstrument trays, upto 11.3 kg (25.0 lb)(per tray)	12	24
					Fabric packs	36	72
liqLIQUIDS 1	1	121.1°C(250.0°F)	45 min	5.17kPa/min(0.75psi/min)	Each container1000 mL (34 fl oz) orsmaller(Notes 4, 5)	160	320
				(Note 3)
lkLEAK TEST(Note 2)	1	131.1°C(268.0°F)	3 min.	15 min dry, 5 min equalize , 15 min test	Empty Chamber(other than loading accessories)	-	-

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00HC-E Series Steam Sterilizer

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 AAMI Standard ST79: Comprehensive guide to steam sterilization and sterility assurance in health care facilities.

Vacuum leak test parameters are not adjustable.

3. Cooldown rate

1. Your facility must validate the cycle if the load includes containers larger than 1000 mL (34 fl oz).

Use vented or open containers only.

Intended Use:

Comparisons to Predicate Device:

Similarities between the Getinge 800HC-E Series Steam Sterilizer and the identified predicate 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. o
Materials of construction are the same. There is no direct patient contact . associated with this device.

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Getinge Sourcing LLC FDA 510(k) Summary Device: 800HC-E Series Steam Sterilizer

Cycle Types: The cycle types offered are the same; Prevac (135°C, 132°C), . Gravity (121°C, 132°C, 135°C), and Liquids 121°C (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 ST8:2008 Hospital Steam Sterilizers.

The differences between the Getinge 800HC-E Series Steam Sterilizer and the predicate device (Getinge 700HC-E Series Steam Sterilizer) are:

The Getinge 800HC-E Series Steam Sterilizer has larger vessel sizes. o Because of the larger vessel size the chamber closure (door operation) is different. The larger chamber size also allows for larger loads to be processed. Factory recommended maximum load sizes are tested for effectiveness and clearly identified in product labeling.

Summary of 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 ST8:2008 Hospital Steam Sterilizers.

The results of Getinge 800HC-E Series Steam Sterilizer validation testing demonstrate that the sterilizer performs as intended. Summary of testing:

Empty chamber testing performed for all cycles as described in ANSI/AAMI . ST8:2008 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 o challenge packs as described in ANSI/AAMI ST8:2008 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 and GRAVITY cycles were validated using wrapped instrument 0 process challenge devices as described in ANSI/AAMI ST8:2008 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 BI 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.

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Getinge Sourcing LLC FDA 510(k) Summary Device: 800HC-E Series Steam Sterilizer

Liquid loads cycles were validated using 3 one liter flasks as described in � ANSI/AAMI ST8:2008 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 o ANSI/AAMI ST8:2008 section 5.6.1.1.
The software validation for the cycle operation was performed according to o FDA guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (5/11/2005)".

Clinical Data:

No clinical data is required for this device classification submission.

Conclusion:

The 800HC-E Series Steam Sterilizer has the same intended use and technological characteristics as the predicate device. The 800HC-E Series Steam Sterilizer meets the applicable requirements of AAMI ST8:2008 performance standards. Based on the information provided in this premarket notification, it can be concluded that the subject device is substantially equivalent to the predicate device and is safe and effective when used as intended.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird-like figure with three stylized lines forming its body and wings.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 22, 2013

Ms. Barb Smith Getinge Sourcing LLC Senior Manager Regulatory Affairs 1777 East Henrietta Road ROCHESTER, New York 14623-3133

Re: K122625

Trade/Device Name: Getinge 800HC-E Series Steam Sterilizer Regulation Number: 21 CFR 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: II Product Code: FLE Dated: May 13, 2013 Received: May 14, 2013

Dear Ms. 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. 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.

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Page 2 - Ms. Smith

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Image /page/6/Picture/7 description: The image shows a signature and contact information. The text "Sincerely yours" is at the top of the image. Below that is the name "Tejashri Purohit-Sheth, M.D." and the title "Clinical Deputy Director". The acronym "DAGRID" is also present.

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices

Office of Device Evaluation

Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K i 2 2 G 2 5

Device Name: Getinge 800HC-E Series Steam Sterilizer

Indications for Use: .

The Getinge 800HC-E Series Steam Sterilizer is intended for use by health care facilites to sterlizes I he Gelinge Boortes Beatle Stean Cremocous heat and moisture stable items such as surgical it writished and linens by means of pressurized steam. The 800HC-E Series Steam Sterliizer is thistriments and michs by means of prossanted by chamber and 833HC-E 42 inch chamber and 833HC-E 76 inch chamber.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use_ X (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

013

Sreekanth Gut 2013.05.2012-2

Division Sign-Off) ·vision of Anesthesiology, General Hospital · nection Control, Dental Devices

K122625 ్10(k) Number:

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List of available cycles:

Getinge 800HC-E Series Steam Sterilizer Model 833HC-E Cycles and Load Chart

KiZZ 625
IFU P -- 50 2 - F 3

Cycle Type	No. ofCycles	Factory Settings			Load Configuration(Note 1)	Maximum Items perChamber Length
		Exp.Temp.	Exp.Time	DryingTime		42 in.(1067 mm)	76 in.(1930 mm)
vacPREVAC 1	6	135.0°C(275.0°F)	3 min	16 min	Double-wrappedinstrument trays, upto 11.3 kg (25.0 lb)(per tray)	12	24
					Fabric Packs	36	72
vacPREVAC 4	1	132.2°C(270.0°F)	4 min	16 min	Double-wrappedinstrument trays, upto 11.3 kg (25.0 lb)(per tray)	12	24
					Fabric packs	36	72
vacB & D TEST	1	133.9°C(273.0°F)	3 min,30 sec	0 min	S.M.A.R.T. Pack orequivalent (1 max.) inan EMPTY chamber	1 TestPack	1 TestPack
grvGRAVITY 1	3	121.1°C(250.0°F)	30 min	30 min	Double-wrappedinstrument trays, upto 11.3 kg (25.0 lb)(per tray)	12	24
					Fabric packs	36	72
grvGRAVITY 2	3	135.0°C(275.0°F)	10 min	30 min	Double-wrappedinstrument trays, upto 11.3 kg (25.0 lb)(per tray)	12	24
					Fabric packs	36	72
grvGRAVITY 3	1	132.2°C(270.0°F)	15 min	30 min	Double-wrappedinstrument trays, upto 11.3 kg (25.0 lb)(per tray)	12	24
					Fabric packs	36	72
liqLIQUIDS 1	1	121.1°C(250.0°F)	45 min	5.17kPa/min(0.75psi/min)(Note 3)	Each container1000 mL (34 fl oz) orsmaller(Notes 4, 5)	160	320
lkLEAK TEST(Note 2)	1	131.1°C(268.0°F)	3 min.	15 mindry, 5minequalize, 15 mintest	Empty Chamber(other than loadingaccessories)	-	-

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K122625 IFU C 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 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 AAMI Standard ST79: Comprehensive guide to steam sterilization and sterility assurance in health care facilities.

Vacuum leak test parameters are not adjustable.

1. Cooldown rate

Your facility must validate the cycle if the load includes containers larger than 1000 mL (34 fl oz).

1. Use vented or open containers only.

Regulation Number and Section

§ 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).