The Getinge 400HC/500HC 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 Models 422HC, 433HC, 522HC and 533HC steam sterilizers are the same model designations as the predicate device (K012573). Modifications to the device have been made to include control software updates, vessel material change and the options for a vacuum pump system (in place of water ejector) and stainless steel piping and components (in place of brass piping and components). The modifications made to the 400HC/500HC series Steam Sterilizer do not affect the intended use of the device and do not alter the fundamental science technology of the device. The modifications were made under the procedures and processes of the documented design control process. Performance testing of the modified device models was to ANSI/AAMI ST8:2008.

AI/ML Overview

The Getinge Model 400HC/500HC Series Steam Sterilizer (K103504) is a Class II medical device intended for sterilizing heat and moisture-stable items in healthcare facilities via pressurized steam. The submission describes modifications to a previously cleared device (K012573), including control software updates, a vessel material change, and options for a vacuum pump system and stainless steel piping.

Here's an analysis of the provided information regarding acceptance criteria and the study:

1. Acceptance Criteria and Reported Device Performance:

The device's performance aligns with the requirements of ANSI/AAMI ST8:2008. While explicit "acceptance criteria" tables with numerical targets are not directly provided, the overall implication is that the sterilizer cycles performed as specified in the "Steam Sterilizer Cycles and Load Chart" and effectively sterilized the described loads within the given parameters (exposure temperature, exposure time, dry time).

The tables in the submission (K103504, pages {1} and {2}) detail the various sterilization cycles, their factory settings (temperature, time, dry time), and the maximum load configurations applicable to each sterilizer model (433HC, 533HC, 422HC, 522HC).

For example, a "PREVAC 1 (vac)" cycle for the 433HC/533HC models has reported performance parameters of:

Exposure Temp: 275°F (135°C)
Exposure Time: 3 min
Dry Time: 16 min
Load Configuration: Double-wrapped instrument trays (up to 25 lb per tray), Fabric packs
Maximum Items: 2 (433HC)/3 (533HC) instrument trays, or 4 (433HC)/12 (533HC) fabric packs.

The statement in the conclusion ({3}) indicates: "This steam sterilizer meets the applicable requirements of AAMI ST8:2008 performance standards." This implies that the device successfully met the sterilization efficacy, safety, and performance criteria outlined in the ANSI/AAMI ST8:2008 standard.

Table of Acceptance Criteria (Implied) and Reported Device Performance:

Acceptance Criterion (Implied by ANSI/AAMI ST8:2008)	Reported Device Performance (Examples from provided charts)
Sterilization Efficacy for "PREVAC 1 (vac)"	Achieved with 275°F (135°C) for 3 min, 16 min dry time
- Double-wrapped instrument trays	- Maximum 2 trays (433HC), 3 trays (533HC)
- Fabric packs	- Maximum 4 packs (433HC), 12 packs (533HC)
Sterilization Efficacy for "GRAVITY 1 (grv)"	Achieved with 250°F (121°C) for 30 min, 45 min dry time
- Double-wrapped instrument trays	- Maximum 2 trays (422HC), 3 trays (522HC)
- Fabric packs	- Maximum 4 packs (422HC), 12 packs (522HC)
Sterilization Efficacy for "Flash 3+"	Achieved with 275°F (135°C) for 3 min, 30 sec dry time
- Unwrapped non-porous single instrument	- Maximum 1 instrument
- Unwrapped non-porous instrument trays	- Maximum 2 trays
Liquid Cycle Performance (Liquids 1 & 2)	Achieved with 250°F (121°C) for 30/45 min, 0.75 psi/min cooldown (for containers ≤ 1000 mL)
Compliance with ANSI/AAMI ST8:2008	"This steam sterilizer meets the applicable requirements of AAMI ST8:2008 performance standards." ({3})
Predicate Device Equivalence	No substantial changes in technology or intended use compared to K012573. ({3})

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

The document describes "Performance testing of the modified device models was to ANSI/AAMI ST8:2008" ({0}) and "Load configurations during testing validations follow AAMI Standard ST8 Hospital Steam Sterilizers where applicable." ({2}). It also mentions "All Fabric Packs and instrument trays formulated as described in AAMI Standard ST8 Hospital Steam Sterilizers." ({2}).

The specific numerical sample size for the test set (number of sterilization cycles, number of test devices, etc.) is not explicitly stated. However, it would have followed the recommendations and requirements for validation testing as outlined in ANSI/AAMI ST8:2008 for each specified cycle and load configuration.

The provenance of the data is that it was generated through prospective performance testing and validation conducted by Getinge Sourcing LLC according to an industry standard (ANSI/AAMI ST8:2008). The country of origin of the data is not explicitly mentioned but is presumably the United States, given the company's address and submission to the FDA.

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

This information is not provided in the submission. For a steam sterilizer, the "ground truth" for sterilization efficacy is typically established through the use of biological indicators (BIs) and physical/chemical indicators, which are standardized and provide an objective measure of microbial kill. Expert human review might be involved in interpreting these results, but their number and specific qualifications are not detailed.

4. Adjudication Method for the Test Set:

This information is not provided. Given that the "ground truth" for sterilization is established through standardized indicators and physical measurements, a traditional medical image "adjudication" process (like 2+1 or 3+1) is not applicable or described for this type of device.

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 comparing human readers with and without AI assistance is relevant for diagnostic imaging devices, not for a steam sterilizer.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Yes, in essence, the performance testing described is "standalone" for the device's function. The sterilizer operates automatically based on its programmed cycles. The performance validation (to ANSI/AAMI ST8:2008) assesses the device's ability to achieve and maintain the necessary sterilization parameters and efficacy independently. There is no "human-in-the-loop performance" in the context of the sterilization process itself; humans load and unload the device and initiate cycles.

7. The Type of Ground Truth Used:

The ground truth used for verifying the steam sterilizer's performance is based on sterilization efficacy confirmation using standardized biological indicators (BIs) and physical/chemical indicators as per the requirements of ANSI/AAMI ST8:2008. This standard outlines methods for validating that sterilization parameters (temperature, time, pressure, steam quality) are met and that a sufficient level of microbial inactivation (typically a sterility assurance level, SAL, of 10^-6) is achieved.

8. The Sample Size for the Training Set:

This information is not applicable or not provided in the context of this submission. The device is a physical steam sterilizer, not an AI/ML algorithm that requires a "training set" in the conventional sense. The "training" for the device refers to its design, engineering, and manufacturing to meet specified performance standards and safety requirements.

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

This information is not applicable or not provided since there isn't a "training set" in the AI/ML context. The device's design and operating parameters are established through engineering principles, adherence to recognized standards (like ANSI/AAMI ST8:2008), and potentially iterative testing and refinement during development.

Summary

{0}------------------------------------------------

510(k) SUMMARY

K103504 MAR 1 6 2011

Getinge Model 400HC/500HC Series Steam Sterilizer

Submitted by:	Getinge Sourcing LLC1777 E Henrietta RoadRochester, NY 14623-3133
Contact Person:	Barb SmithSr. Manager, Regulatory Affairs
	Phone: (585) 214-6049Fax: (585) 272-5299
Date prepared:	October 26, 2010
Proprietary Name:	Model 400HC/500HC Series Steam Sterilizer
Common Name:	Steam Sterilizer
Device Classification:	Steam Sterilizer (80 FLE)Class II, as listed per 21 CFR 880.6880
Predicate Device:	Model 400HC/500HC Series Steam Sterilizer [K012573]

Description of Device:

{1}------------------------------------------------

K103504

List of available cycles Model 433HC and 533HC Steam Sterilizer Cycles and Load Chart

Cycle Type	No. ofAvailableCycles	Factory Settings			Load Configuration(Note 1)	Maximum Itemsper Chamber Size
		Exp.Temp.	Exp.Time	Dry Time		433HC	533HC
PREVAC 1(vac)	3	275°F(135°C)	3 min	16 min	Double-wrapped instrument trays, upto 25 lb per tray	2	3
					Fabric packs	4	12
PREVAC 2(vac)	2	275°F(135°C)	3 min	3 min(Note 4)	Single wrapped, single instrument	1	1
					Single wrapped instrument trays, upto 25 lb per tray	2	3
					Fabric packs	4	12
PREVAC 3(vac)	1	275°F(135°C)	3 min	0 min(Note 4)	Unwrapped porous or non-poroussingle instrument	1	1
					Unwrapped porous & non-porousinstrument trays, up to 25 lbs. pertray.	2	2
B & D Test(vac)	1	273°F(134°C)	3 min,30 sec	0 min	S.M.A.R.T. Pack or equivalent (1)in an EMPTY chamber	1 TestPack	1 TestPack
GRAVITY 1(grv)	3	250°F(121°C)	30 min	45 min	Double-wrapped instrument trays,up to 25 lb per tray	2	3
					Fabric packs	4	12
GRAVITY 2(grv)	3	275°F(135°C)	10 min	45 min	Double-wrapped instrument trays,up to 25lb per tray	2	3
					Fabric packs	4	12
Flash 3+(f 3)(Notes 1,7)	4	275°F(135°C)	3 min	30 sec(Note 4)	Unwrapped non-porous singleinstrument	1	1
					Unwrapped non-porous instrumenttrays, up to 25 lb per tray	2	2
Flash 10+(f10)(Notes 1,7)	2	275°F(135°C)	10 min	30 sec(Note 4)	Unwrapped porous or non-poroussingle instrument	1	1
					Unwrapped porous & non-porousinstrument trays, up to 25 lb per tray	2	2
LIQUIDS 1(liq)	1	250°F(121°C)	30 min	0.75 psi/min(Note 3)	Each container 1000 mL or smaller	15	32
LIQUIDS 2(liq)	1	250°F(121°C)	45 min	0.75 psi/min(Note 3)	Each container 1000 mL or smaller	15	32
Leak Test(lk)(Note 2)	1	268°F(131°C)	3 min	15 min dry,5 minequalize,15 min test	Empty chamber	-	-

{2}------------------------------------------------

Getinge Sourcing LLC FDA 510(k) Summary Device: 400HC/500HC Series Steam Sterilizer

NOTE: Liquid Cycles are not intended for the sterilization of liquids used for direct patient contact.

Model 422HC and 522HC Steam Sterilizer Cycles an Load Chart

Cycle Type	No. ofAvailableCycles	Factory Settings			Load Configuration	Maximum Items perChamber Size
		Exp.Temp.	Exp.Time	Dry Time	(Note 1)	422HC	522HC
GRAVITY 1(grv)	3	250°F(121°C)	30 min	45 min	Double-wrapped instrument trays,up to 25 lb per tray	2	3
					Fabric packs	4	12
GRAVITY 2(grv)	3	275°F(135°C)	10 min	45 min	Double-wrapped instrument trays,up to 25 lb per tray	2	3
					Fabric packs	4	12
Flash 3+(f 3)	4	275°F(135°C)	3 min	30 sec(Note 4)	Unwrapped non-porous singleinstrument	1	1
(Notes 1, 7)					Unwrapped non-porous instrumenttrays, up to 25 lb per tray	2	2
Flash 10+(f10)	2	275°F(135°C)	10 min	30 sec(Note 4)	Unwrapped porous or non-poroussingle instrument	1	1
(Notes 1, 7)					Unwrapped porous & non-porousinstrument trays, up to 25 lb per tray	2	2
LIQUIDS 1(liq)	1	250°F(121°C)	30 min	0.75 psi/min(Note 3)	Each container 1000 mL or smaller(Notes 5,6,8)	15	32
LIQUIDS 2(liq)	1	250°F(121°C)	45 min	0.75 psi/min(Note 3)	Each container 1000 mL or smaller(Notes 5, 6, 8)	15	32

NOTE: Liquid Cycles are not intended for the sterilization of liquids used for direct patient contact.

TABLE NOTES

Load configurations during testing validations follow AAMI Standard ST8 Hospital Steam 1. Sterilizers where applicable. All Fabric Packs and instrument trays formulated as described in AAMI Standard ST8 Hospital Steam Sterilizers.
For quidance on loading 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. 2.
1. Cooldown rate
At the end of a flash cycle, PREVAC 2 cycle, or a PREVAC 3 cycle, items may NOT be dry. 4. Drying time may be added if required.
User facility must validate the cycle if the load includes containers larger than 1000 mL. ട.
Use vented or open containers only. 6.
The recommended minimum exposure time and temperature for unwrapped, nonporous, flash 7. cycle loads (e.g. metal instruments) is 3 minutes at 275°F (135°C).
A small load of one-liter containers requires an exposure time of 45 min. 8.

{3}------------------------------------------------

1103504

Intended Use:

The Getinge 400HC/500HC 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.

Predicate Device

Getinge 400HC/500HC Series Steam Sterilizers [K012573].

Comparisons to Predicate Device:

The modified 400HC/500HC Series Steam Sterilizer has the same model designation as the predicate device. Modifications were made to the predicate device are summarized below:

1. The operating system has been upgraded to allow more inputs and outputs but the same fundamental micro processor technology is used.
1. Vessel material has changed from Stainless Steel SA240 UNS S31803/Type 2205 to Stainless Steel SA240-316Ti. Both materials meet ASME Boiler Pressure Vessel Code Section II - Part A - Materials - Ferrous Material Specifications.
1. The modified device offers the option for a vacuum pump system in place of a water eiector. The benefit of this option is to reduce utility water consumption.
1. The modified device offers the option of stainless steel process piping and components. With this option all piping in contact with media that could contact chamber load are ANSI 304 or ANSI 316 stainless steel.
1. The modified 400HC/500HC Series Sterilizer was tested to the requirements in ANSI/AAMI ST8:2008.

Clinical Data:

No clinical data is required for this device classification submission.

Conclusion:

The 400HC/500HC Series Steam Sterilizer is a substantially equivalent device to that of the predicate device. There have been no substantial changes in technology and no changes to the intended use of this device. This steam sterilizer meets the applicable requirements of AAMI ST8:2008 performance standards.

Based on the provided information in this premarket notification, it can be concluded that the subject device is substantial equivalent to the predicate device and is safe and effective when used as intended.

{4}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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 a stylized graphic of three curved lines, resembling a person embracing another person.

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

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

MAR 16 201

Re: K103504

Trade/Device Name: 400HC/500HC Series Steam Sterilizer Regulation Number: 21 CFR 880:6880 Regulation Name: Steam Sterilizer Regulatory Class: II Product Code: FLE Dated: February 24, 2011 Received: February 25, 2011

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.

{5}------------------------------------------------

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 (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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

form I tessman

for

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

Division of Anesthesiology, General Hospital, 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): K103504

Device Name: 400HC/500HC Series Steam Sterilizer

Indications for Use: The Getinge 400HC/500HC 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.

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)

ന Page 1 of

Elijabeth D. Clarence-Wells

Division Sign-Uff) Division of Anesthesiology, General Hospital Infection Control. Dental Devices

510(k) Number: K103504

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).