The Getinge 400HC-E/500HC-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 400HC-E/500HC-E Series Steam Sterilizer is designed for sterilization of heat and moisture stable materials used in healthcare facilities. The model designations provided in the 400HC-E/500HC-E Series Steam Sterilizer are 422HC-E. 433HC-E. 522HC-E and 533HC-E.

400HC-E/500HC-E Steam Sterilizer employs both gravity/downward The displacement with positive pulse conditioning and pressure/vacuum pulsing for dynamic air removal. Up to 24 cycles can be easily accessed and custom cvcle 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

This is a 510(k) premarket notification for a Class II medical device, specifically a steam sterilizer. The FDA's 510(k) clearance process is based on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring new clinical trials to prove efficacy and safety in the same way a PMA (Pre-Market Approval) does. Therefore, typical "acceptance criteria" and "study results" related to diagnostic performance metrics (like sensitivity, specificity, AUC) from a multi-reader, multi-case study are not applicable here.

Instead, the acceptance criteria for this device are based on performance testing to demonstrate that the sterilizer effectively sterilizes various loads according to established industry standards and guidelines. The "study" here refers to validation testing against these standards.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Performance)	Reported Device Performance
Sterilization Efficacy (General): Complete kill of biological indicators (BI) and achievement of a sterility assurance level (SAL) of at least 10⁻⁶ (for PREVAC and GRAVITY cycles) or 10⁻³ (implied, as F₀ value of at least 12 is sufficient for 10⁻⁶ SAL, this is the main metric).	Demonstrated by complete kill of biological indicators and achievement of a Sterility Assurance Level (SAL) of at least 10⁻⁶ through time at temperature sufficient to produce an F₀ value of at least 12 (for PREVAC and GRAVITY cycles).
Empty Chamber Testing: Capable of providing steady-state thermal conditions within the chamber consistent with the predicated SAL.	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.
Moisture Retention (Fabric Packs - PREVAC & GRAVITY): Less than 3% increase in pre-sterilization test pack weight, including no visible wet spots.	Demonstrated moisture retention of less than 3% increase in pre-sterilization test pack weight including no visible wet spots for PREVAC and GRAVITY cycles using fabric process challenge packs.
Moisture Retention (Wrapped Instruments - PREVAC & GRAVITY): Less than 20% increase in pre-sterilization weight of the towel, including no visible wet spots on the outer wrapper.	Demonstrated moisture retention of less than 20% increase in pre-sterilization weight of the towel including no visible wet spots on the outer wrapper for PREVAC (excluding PREVAC 2 & 5 with shortened drying times) and GRAVITY cycles using wrapped instrument process challenge devices.
Immediate Use Cycles (Flash Sterilization): Achievement of a sterility assurance level of at least 10⁻⁶ through time at temperature sufficient to produce an F₀ value of at least 12 and complete BI kill.	The results 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 and complete BI kill, using unwrapped non-porous process challenge devices.
Liquid Loads Cycles: Achievement of a sterility assurance level of at least 10⁻⁶ through time at temperature sufficient to produce an F₀ value of at least 12, complete BI kill, and water loss not exceeding 50ml.	The results 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, using 3 one-liter flasks.
Bowie Dick Cycle: Proper operation for air removal and steam penetration.	Bowie Dick cycle was validated using the Bowie-Dick test pack as described in ANSI/AAMI ST8:2008 section 5.6.1.1. (The text implies successful validation without detailing specific pass/fail criteria from the standard, but acceptance is based on meeting the standard's requirements for the test pack indicator).
Software Validation: Compliance with FDA guidance for software in medical devices.	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)". (Acceptance is based on adherence to the guidance, implying successful validation).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: The document does not specify exact "sample sizes" in terms of number of sterilization runs or individual items tested for each cycle type. Instead, it refers to using "fabric process challenge packs," "wrapped instrument process challenge devices," "unwrapped non-porous process challenge device," "3 one liter flasks," and "Bowie-Dick test pack." The number of items per chamber for each load configuration is specified in the tables (e.g., 2 double-wrapped instrument trays for 433HC-E, 12 fabric packs for 533HC-E), indicating various representative loads were tested.
Data Provenance: This was "Factory recommended cycles were tested," implying prospective testing performed by the manufacturer, Getinge Sourcing LLC, located in Rochester, NY, USA. The testing was conducted according to US (ANSI/AAMI) standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. For a steam sterilizer, "ground truth" for sterilization efficacy is established through objective biological and physical indicators (e.g., biological indicators (BI) demonstrating complete kill of spores, F₀ value measurements, moisture retention measurements, Bowie-Dick test pack color changes). This is not a diagnostic device relying on expert interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as this is not a diagnostic device involving expert interpretation or adjudication of subjective outcomes. The outcomes are objective measurements of sterilization efficacy.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a standalone medical device (steam sterilizer), not an AI-powered diagnostic tool, and involves no human "readers" or AI assistance in interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, the performance testing described is for the standalone device (the sterilizer itself) without direct human intervention in the sterilization process once the cycle is initiated. The "algorithm" here would refer to the control system and its programmed cycles. The testing demonstrates the sterilizer's ability to achieve sterilization based on its internal programming and physical processes.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for sterilization efficacy is defined by objective biological and physical endpoints:

Complete kill of biological indicators (BI): Absence of viable spores after sterilization.
Sterility Assurance Level (SAL) of at least 10⁻⁶: A statistical measure of the probability of a single viable microorganism occurring on an item after sterilization (achieved through F₀ values).
F₀ value of at least 12: A measure of thermal lethality, indicating the equivalent time in minutes at 121.1°C (250°F) delivered to the load.
Moisture retention percentages: Quantitative measurement of water absorbed by or remaining on sterilized items.
Bowie-Dick test pack results: Visual indicator change confirming adequate air removal and steam penetration (a physical/chemical indicator).
Water loss not exceeding 50ml: For liquid loads.

These are objective, scientifically measurable ground truths defined by industry standards (ANSI/AAMI ST8:2008).

8. The sample size for the training set

Not applicable. This device is not an AI/ML model that requires a "training set." Its effectiveness is based on physical and chemical principles of steam sterilization, validated by performance testing.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this type of device.

Summary

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K122071

510(k) SUMMARY

MAR 1 2 2013

Getinge 400HC-E/500HC-E Series Steam Sterilizer

Submitted by:

Getinge Sourcing LLC 1777 E Henrietta Road Rochester, NY 14623-3133

Contact Person:

Barb Smith, RAC Sr. Manager, Regulatory Affairs Phone: (585) 214-6049 Fax: (585) 272-5299

Date prepared:	July 10, 2012
Proprietary Name:	Model 400HC-E/500HC-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]
	Getinge Model 400HC/500HC Series Steam Sterilizer [K103504]

Description of Device:

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List of available cycles: Model 433HC-E and 533HC-E 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-E	533HC-E
PREVAC 1(vac)	3	275°F(135°C)	3 min	16 min	Double-wrapped instrumenttrays, up to 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, singleinstrument	1	1
					Single wrapped instrumenttrays, up to 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-porous single instrument	1	1
					Unwrapped porous & non-porous instrument trays, up to25 lbs. per tray.	2	2
PREVAC 4(vac)	1	270°F(132°C)	4 min	16 min	Double-wrapped instrument trays,up to 25 lb per tray	2	3
					Fabric Packs	4	12
PREVAC 5(vac)	1	270°F(132°C)	4 min	3 min(Note 4)	Fabric Packs	4	12
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 instrumenttrays, 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 instrumenttrays, up to 25lb per tray	2	3
					Fabric packs	4	12
IMMED USE3+(ius)(Notes 1,7)	4	275°F(135°C)	3 min	30 sec(Note 4)	Unwrapped non-porous singleinstrument	1	1
					Unwrapped non-porousinstrument trays, up to 25 lb pertray	2	2
IMMED USE10+(ius)(Notes 1,7)	2	275°F(135°C)	10 min	30 sec(Note 4)	Unwrapped porous or non-porous single instrument	1	1
					Unwrapped porous & non-porous instrument 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 min equalize,15 min test	Empty chamber	--	--

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

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

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

Cycle Type	No. ofAvailableCycles	Factory Settings			Load Configuration(Note 1)	Maximum Itemsper Chamber Size
		Exp.Temp.	Exp.Time	Dry Time		422HC-E	522HC-E
GRAVITY 1(grv)	3	250°F(121°C)	30 min	45 min	Double-wrapped instrumenttrays, 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 instrumenttrays, up to 25 lb per tray	2	3
					Fabric packs	4	12
IMMED USE3+(ius)(Notes 1, 7)	4	275°F(135°C)	3 min	30 sec(Note 4)	Unwrapped non-porous singleinstrument	1	1
					Unwrapped non-porousinstrument trays, up to 25 lb pertray	2	2
IMMED USE10+(ius)(Notes 1, 7)	2	275°F(135°C)	10 min	30 sec(Note 4)	Unwrapped porous or non-porous single instrument	1	1
					Unwrapped porous & non-porous instrument trays, up to25 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

l . 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

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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.
1. Vacuum leak test parameters are not adjustable.
Cooldown rate 3.
1. . At the end of an immediate use cycle, PREVAC 2 cycle, PREVAC 3 cycle, or a PREVAC 5 cycle items may NOT be dry. Drying time may be added if required.
1. User facility must validate the cycle if the load includes containers larger than 1000 mL.
1. Use vented or open containers only.
1. The recommended minimum exposure time and temperature for unwrapped, nonporous, flash cycle loads (e.g. metal instruments) is 3 minutes at 275°F (135°C) or 4 minutes at 270°C (132°C).
1. A small load of one-liter containers requires an exposure time of 45 min.

Intended Use:

Comparisons to Predicate Device:

Similarities between the Getinge 400HC-E/500HC-E Series Steam Sterilizer and the identified predicates are:

. Intended use is the same: Intended for use by health care facilities to sterilize wrapped and unwrapped, porous and nonporous heat and moisture stable items such as surgical instruments and linens by means of pressurized steam.
Operating Principle is the same: Saturated steam is the sterilizing agent. ●
Materials of construction are the same: Vessel material is Stainless Steel SA240-316Ti. There is no direct patient contact associated with this device.
. Cycle Types: The cycle types offered are the same; Prevac (135°C, 132°C), Gravity (121°C, 135°C), Immediate Use (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.

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The differences between the Getinge 400HC-E/500HC-E Series Steam Sterilizer and the predicate devices are:

The Getinge 400HC-E/500HC-E Series Steam Sterilizer provides the addition . of 132°C Prevac cycles and a touch screen user interface as cleared on the 700HC-E Series Steam Sterilizer as K120441.

Summary of Performance Testing:

Factory recommended cycles were tested per industry standards and quidelines and effectiveness of sterilizer function was demonstrated by complete kill of biological indicators. Getinge Sterilizers have been validated to meet the requirements of ANSI/AAMI ST8:2008 Hospital Steam Sterilizers.

The results of Getinge 400HC-E/500HC-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 . 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 (excluding PREVAC 2 and PREVAC 5 that have shortened drying . times) and GRAVITY cycles were validated using wrapped instrument process challenge devices as described in ANSI/AAMI ST8.2008 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.
All Immediate Use (Flash) cycles were validated using a unwrapped non-. porous process challenge device as described in ANSI/AAMI ST8:2008 section 5.5.5. The results from this testing demonstrated a sterility assurance level of at least 106 through achievement of time at temperature sufficient to produce an Fo value of at least 12 and complete BI kill.
Liquid loads cycles were validated using 3 one liter flasks as described in . ANSI/AAMI ST8:2008 section 5.5.3. The results from this testing demonstrated a sterility assurance level of at least 108 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.

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

Bowie Dick cycle was validated using the Bowie-Dick test pack as described in . ANSI/AAMI ST8:2008 section 5.6.1.1.
The software validation for the cycle operation was performed according to . FDA guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (5/11/2005)".

Clinical Data:

No clinical data is required for this device classification submission.

Conclusion:

The 400HC-E/500HC-E Series Steam Sterilizer has the same intended use and technological characteristics as the predicate devices. The 400HC-E/500HC-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

Public Health Service

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

March 12, 2013

Ms. Barb Smith, RAC Senior, Manager Regulatory Getinge Sourcing, LLC 1777 East Henrietta Road ROCHESTER NY 14623-3133

Re: K122071

Trade/Device Name: 400HC-E/500HC-E Series Steam Sterilizer Regulation Number: 21 CFR 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: II Product Code: FLE Dated: February 6, 2013 Received: February 7, 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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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 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.

Image /page/7/Picture/7 description: The image shows a signature with the name "Rohith" written in cursive. The signature is stylized with loops and flourishes, and it appears to be written in black ink. The signature is placed on a document or surface with some other markings or text around it.

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

KIZOTI 510(k) Number (if known):

Device Name: 400HC-E/500HC-E Series Steam Sterilizer

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

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

Over-The-Counter Use (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 ব

Elizabethī 2013.03.07 -05'00'

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number:_ 1/22071

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List of available cycles

Model 433HC-E and 533HC-E Steam Sterilizer Cycles and Load Chart

No. ofCycle TypeAvailable			Factory Settings		Load Configuration(Note 1)	Maximum Itemsper Chamber Size
	Cycles	Exp.Temp.	Exp.Time	Dry Time			433HC-E 533HC-E
PREVAC 1(vac)	3	275°F(135°C)	3 min	16 min	Double-wrapped instrument trays,up to 25 Ib per tray	2	3
					Fabric packs	4	12
PREVAC 2(vac)	2	275°F(135℃)	3 min	3 min(Note 4)	Single wrapped, single instrument	l	l
					Single wrapped instrument trays, upto 25 Ib per tray	2	3
					Fabric packs	4	12
PREVAC 3(vac)	1	275°F(135°C)	3 min	() min(Note 4)	Unwrapped porous or non-poroussingle instrument	l	l
					Unwrapped porous & non-porousinstrument trays, up to 25 lbs. pertray.	2	2
PREVAC 4(vac)	I	270ºF(132°C)	4 mm	16 min	Double-wrapped instrument trays,up to 25 ib per tray	2	3
					Fabric Packs	4	12
PREVAC 5(vec)	l	270°F(132°C)	4 min	3 min(Note 4)	Fabric Packs	4	12
B & D Test(vac)	l	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	l 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
IMMED USEડેન(ius)	4	275°F(135°C)	3 min	30 sec(Note 4)	Unwrapped non-porous singleinstrument	l	l
(Notes 1,7)					Unwrapped non-porous instrumenttrays, up to 25 ib per tray	2	2
IMMED USE10+(ius)(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 pertray	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	--	--

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

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

Cycle Type	No. ofAvailableCycles	Factory Settings			Load Configuration(Note 1)	Maximum Itemsper Chamber Size
		Exp.Temp.	Exp.Time	Dry Time		422HC-E	522HC-E
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
IMMED USE3+(ius)(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
IMMED USE10+(ius)(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 pertray	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

The load configurations listed in these tables are those used during testing validations of the 1. sterilizer. These configurations follow AAMI Standard ST8: Hospital steam sterilizers where applicable (fabric packs are process challenge devices as described in ANSVAAMI 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.

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1. Vacuum leak test parameters are not adjustable.
Cooldown rate 3.
1. At the end of an immediate use cycle, PREVAC 2 cycle, PREVAC 3 cycle, or a PREVAC 5 cycle items may NOT be dry. Drying time may be added if required.
User facility must validate the cycle if the load includes containers larger than 1000 mL. ર.
ર્ણ Use vented or open containers only.
1. The recommended minimum exposure time and temperature for unwrapped, nonporous, flash cycle loads (e.g. metal instruments) is 3 minutes at 275°F (135°C).
1. A small load of one-liter containers requires an exposure time of 45 min.

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

$10(k) Number; 1122071

.
••

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).