The Amsco Evolution Medium Steam Sterilizer models HC-600 and HC-1500 are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are available in two configurations:

Prevacuum is equipped with Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles.
Steam Flush Pressure-Pulse (SFPP) is equipped with SFPP, Prevacuum, t Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles.

Device Description

The Amsco Evolution Medium Steam Sterilizer is designed for sterilization of heat and moisture-stabile materials used in healthcare facilities and are available in two configurations:

Prevacuum is equipped with Prevacuum, Gravity, Liquid, Leak Test and . DART (Bowie-Dick) cycles.
Steam Flush Pressure-Pulse (SFPP) is equipped with SFPP, Prevacuum, . Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles.
The Amsco Evolution Medium Steam Sterilizer is offered in the following chamber sizes:
26" x 26" x 39" (660 mm x 660 mm x 991 mm) HC-600
HC-1500 . 26" x 37½" x 60" (660mm x 950mm x 1524mm)

AI/ML Overview

The STERIS Amsco Evolution Medium Steam Sterilizer is a medical device designed for sterilization of heat and moisture-stabile materials in healthcare facilities. The information provided outlines the device's technical specifications and the validation studies conducted to demonstrate its effectiveness and safety.

1. Table of Acceptance Criteria and Reported Device Performance:

The acceptance criteria for the Amsco Evolution Steam Sterilizer are based on the requirements of ANSI/AAMI ST8, Fourth Edition, November 2001, and are primarily focused on achieving a sterility assurance level (SAL) of at least 10⁻⁶ probability of survival and satisfying specific physical parameters for each cycle type.

Acceptance Criterion (from ANSI/AAMI ST8)	Reported Device Performance (Amsco Evolution Steam Sterilizer)
Empty Chamber Testing:	Performed as described in Section 5.4.2.5 of ANSI/AAMI-ST8 for Prevac, Gravity, Liquid, and SFPP cycles. Demonstrated capability of providing steady-state thermal conditions consistent with predicted SAL in the load. Meets requirements of Sections 4.4.2.2 and 4.4.2.5 of ANSI/AAMI-ST8.
SFPP Cycles (Fabric Test Pack, Section 5.5.2.1):	Qualified according to Section 5.5.2 ANSI/AAMI-ST8. Demonstrated a sterility assurance level of at least 10⁻⁶ through achievement of a time-at-temperature sufficient to produce an Fo value of at least 12, moisture retention of less than 3% increase in presterilization test pack weight, and no evidence of wet spots.
SFPP Cycles (Full Load Instrument Trays, Section 5.5.4.1):	Qualified according to Section 5.5.4 ANSI/AAMI-ST8. Demonstrated a sterility assurance level of at least 10⁻⁶ using half-cycle analysis, moisture retention of less than 20% increase in presterilization weight of the towel, and no evidence of wet spots on the outer wrapper.
GRAVITY Cycles (Fabric Test Pack, Section 5.5.2.1):	Qualified according to Section 5.5.2 ANSI/AAMI-ST8. Demonstrated a sterility assurance level of at least 10⁻⁶ through achievement of a time-at-temperature sufficient to produce an Fo value of at least 12, moisture retention of less than 3% increase in presterilization test pack weight, and no evidence of wet spots.
GRAVITY Cycles (Full Load Instrument Trays, Section 5.5.4.1):	Qualified according to Section 5.5.4 ANSI/AAMI-ST8. Demonstrated a sterility assurance level of at least 10⁻⁶ using half-cycle analysis, moisture retention of less than 20% increase in presterilization weight of the towel, and no evidence of wet spots on the outer wrapper.
PREVAC Cycles (Fabric Test Pack, Section 5.5.2.1):	Qualified according to Section 5.5.2 ANSI/AAMI-ST8. Demonstrated a sterility assurance level of at least 10⁻⁶ through achievement of a time-at-temperature sufficient to produce an Fo value of at least 12, moisture retention of less than 3% increase in presterilization test pack weight, and exhibited no wet spots.
PREVAC Cycles (Full Load Instrument Trays, Section 5.5.4.1):	Qualified according to Section 5.5.4 ANSI/AAMI-ST8. Demonstrated a sterility assurance level of at least 10⁻⁶ using half-cycle analysis, moisture retention of less than 20% increase in presterilization weight of the towel, and no evidence of wet spots on the outer wrapper.
LIQUID Cycles (Three 1,000 ml flasks, Section 5.5.3.1):	Qualified according to Section 5.5.3 of ANSI/AAMI-ST8. Demonstrated a sterility assurance level of at least 10⁻⁶ through achievement of a time-at-temperature sufficient to produce an Fo value of at least 12, water loss not exceeding 50 ml, and automatic sealing of the flask closure.
DART Cycle (Bowie-Dick Test Pack, Section 5.6.1.1):	Qualified according to Section 5.6.1 of the ANSI/AAMI-ST8, and demonstrated a uniform color change throughout the test sheet.
Software Validation (Moderate Level of Concern, FDA Guidance 05/11/05):	Performed according to FDA's moderate level of concern recommendations provided in the document "Guidance for the Content for Premarket Submissions for Software Contained in Medical Devices (05/11/05)." (Specific performance details of software validation are not provided in the excerpt, only that it was performed to the standard).
Electrical Safety Code Compliance:	Underwriters Laboratory (UL) Electrical Safety Code 61010-1 certified by Intertek Testing Services (ITS), Canadian Standards Association (CSA) Standard C22.2 No. 1010-1 as certified by Intertek Testing Services. (Compliance is stated; specific performance metrics are not detailed).
Pressure Vessel Standards Compliance:	American Society of Mechanical Engineers (ASME), Section VIII, Division 1 for unfired pressure vessels. (Compliance is stated; specific performance metrics are not detailed).

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

The document describes validation studies that demonstrate the effectiveness of the sterilizer, but does not specify numerical sample sizes for biological indicator (BI) tests or specific material loads beyond "full load instrument trays," "fabric test pack," or "three 1,000 ml flasks." It implies that these tests were conducted as per ANSI/AAMI ST8, which would dictate appropriate sample sizes for validation.

The data provenance is prospective, as STERIS "validates its sterilization cycles using recommended practices, standards and guidelines developed by independent organizations." This indicates that tests were conducted specifically for the purpose of validating the Amsco Evolution Steam Sterilizer. The country of origin of the data is not explicitly stated, but given STERIS Corporation is based in Mentor, Ohio, USA, and the validation references ANSI/AAMI standards, it is reasonable to infer the data is primarily from the USA or follows international standards adopted in the USA.

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

The document does not specify the number or qualifications of experts used to establish ground truth for the validation studies. The ground truth (sterility assurance) is established through the complete kill of biological indicators and verification of an appropriate SAL, which are objective measurements performed in accordance with established standards (ANSI/AAMI ST8) by those conducting the validation.

4. Adjudication Method for the Test Set:

Not applicable. The validation studies involve objective measurements of physical parameters and biological indicator kill rates, not subjective assessments requiring adjudication by experts.

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 device is a steam sterilizer, a physical apparatus. It does not involve "human readers" or "AI assistance" in its operation or performance assessment.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable for the primary function of sterilization. While the device does include software for cycle operation, and software validation was performed, it is a physical sterilizer and not an "algorithm only" device in the context of medical imaging or diagnostic AI. The software validation ensures the algorithm controlling the sterilizer operates correctly.

7. The Type of Ground Truth Used:

The ground truth for the effectiveness of the sterilizer function is established through:

Biological Indicator (BI) Kill: Complete kill of biological indicators.
Sterility Assurance Level (SAL): Verification of an appropriate SAL of at least 10⁻⁶ probability of microbial survival.
Physical Parameters: Achievement of specific time-at-temperature (Fo value of at least 12), moisture retention limits, and absence of wet spots.
Bowie-Dick Test Pack Results: Uniform color change for the DART cycle.

These are objective, quantitative biological and physical measurements, rather than expert consensus, pathology, or outcomes data in the typical sense of medical device validation for diagnostic or therapeutic devices.

8. The Sample Size for the Training Set:

Not applicable. This device does not use an "AI" or "machine learning" algorithm in the sense of requiring a training set of data. The "software validation" mentioned refers to traditional software engineering verification and validation, ensuring the control logic functions as designed, not a learning algorithm trained on data.

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

Not applicable. As noted in point 8, there is no "training set" or "ground truth for a training set" in the context of machine learning for this type of device. The software validation would typically involve comparing software behavior to predefined functional specifications and requirements.

Summary

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STERIS®

DEC 3 0 2008

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510(k) Summary For Amsco Evolution Medium Steam Sterilizer

STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 639-4459

Contact:

Robert F. Sullivan. Sr Director FDA Regulatory Affairs Telephone: (440) 392-7695 Fax No: (440) 357-9198

Summary Date:

December 29, 2008

STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600

December 29, 2008

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1. Device Name

Trade Name:	Amsco Evolution Medium Steam Sterilizer
Common/usual Name:	Amsco Evolution Medium Steam Sterilizer
Classification Name:	Steam Sterilizer (21 CFR 880.6880, Product CodeFLE.

2. Predicate Devices

K010865, Amsco Century Medium Steam Sterilizer, product code [FLE] . cleared May 31, 2001.
K020747 Amsco Century Medium Steam Sterilizer, product code [FLE] . cleared May 17, 2002.

3. Description of Device

The Amsco Evolution Medium Steam Sterilizer is designed for sterilization of heat and moisture-stabile materials used in healthcare facilities and are available in two configurations:

Prevacuum is equipped with Prevacuum, Gravity, Liquid, Leak Test and . DART (Bowie-Dick) cycles.
Steam Flush Pressure-Pulse (SFPP) is equipped with SFPP, Prevacuum, . Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles.

The Amsco Evolution Medium Steam Sterilizer is offered in the following chamber sizes:

26" x 26" x 39" (660 mm x 660 mm x 991 mm) � HC-600
HC-1500 . 26" x 37½" x 60" (660mm x 950mm x 1524mm)

4. Intended Use

The Amsco Evolution Medium Steam Sterilizer models HC-600 and HC-1500 are designed for sterilization of heat and moisture-stabile materials used in healthcare facilities and are available in two configurations:

Prevacuum is equipped with Prevacuum, Gravity, Liquid, Leak Test and . DART (Bowie-Dick) cycles.
Steam Flush Pressure-Pulse (SFPP) is equipped with SFPP, Prevacuum, . Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles.

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The Amsco Evolution Medium Prevacuum Steam Sterilizer is equipped with the following factory-programmed sterilization cycles and cycles values (Table 5-1):

Cycles	Sterilize Temperature	Sterilize Time	Dry Time	Recommended Load
Prevac	270°F (132°C)	4 minutes	30 minutes	Double wrapped instrumenttrays, maximum weight 25lbs (11.3 kg) each. FabricPacks. Refer to Table 5-3for recommendedquantities.
PrevacGravity	250°F (121°C)270°F (132°C)	4 minutes30 minutes	5 minutes15 minutes	Single Fabric PackFabric Packs. Refer toTable 5-3 for recommendedquantities.
Liquid*	250°F (121°C)	45 minutes	N/A	Refer to Table 5-4 forrecommended quantities.
Prevac	275°F (135°C)	3 minutes	30 minutes	Double wrapped instrumenttrays, maximum weight 25lbs (11.3 kg) each. Refer toTable 5-3 for recommendedquantities.
Gravity	270°F (132°C)	15 minutes	30 minutes	Double wrapped instrumenttrays, maximum weight 25lbs (11.3 kg) each. Refer toTable 5-3 for recommendedquantities.
Gravity	250°F (121°C)	30 minutes	30 minutes	Double wrapped instrumenttrays, maximum weight 25lbs (11.3 kg) each. Refer toTable 5-3 for recommendedquantities.
Gravity	270°F (132°C)	25 minutes	15 minutes	Fabric Packs. Refer toTable 5-3 for recommendedquantities.
DARTWarm-Up	270°F (132°C)	3 minutes	1 minute	N/A
DART	270°F (132°C)	3 ½ minutes	1 minute	Bowie-Dick Test Pack,DART Test Pack
Leak Test	N/A	N/A	N/A	N/A
Cycles	SterilizeTemperature	SterilizeTime	Dry Time	Recommended Load
SFPP	270°F (132°C)	4 minutes	30 minutes	Double wrappedinstrument trays,maximum weight 25 lbs(11.3 kg) each. FabricPacks. Refer to Table 5-3for recommendedquantities.
SFPP	275°F (135°C)	3 minutes	30 minutes	Double wrappedinstrument trays,maximum weight 25 lbs(11.3 kg) each. Refer toTable 5-3 forrecommended quantities.
Prevac	270°F (132°C)	4 minutes	30 minutes	Double wrappedinstrument trays,maximum weight 25 lbs(11.3 kg) each. FabricPacks. Refer to Table 5-3for recommendedquantities.
Gravity	250°F (121°C)	30 minutes	15 minutes	Fabric Packs. Refer toTable 5-3 forrecommended quantities.
SFPP	270°F (132°C)	4 minutes	5 minutes	Single Fabric Pack
Prevac	275°F (135°C)	3 minutes	30 minutes	Double wrappedinstrument trays,maximum weight 25 lbs(11.3 kg) each. Refer toTable 5-3 forrecommended quantities.
Gravity	270°F (132°C)	15 minutes	30 minutes	Double wrappedinstrument trays,maximum weight 25 lbs(11.3 kg) each. Refer toTable 5-3 forrecommended quantities.
Liquid*	250°F (121°C)	45 minutes	N/A	Refer to Table 5-4 forrecommended quantities.
DARTWarm-Up	270°F (132°C)	3 minutes	1 minute	N/A
DART	270°F (132°C)	3 ½ minutes	1 minute	Bowie-Dick Test Pack,DART Test Pack
Leak Test	N/A	N/A	N/A	N/A

Table 5-1. Amsco Evolution Medium Prevacuum Steam Sterilizer factory-programmed Sterilization cycles and cycle values

*The liquid cycle is for non-patient contact use only.

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The Amsco Evolution Medium Steam Flush Pressure-Pulse (SFPP) Sterilizer is equipped with the following factory-programmed sterilization cycles and cycle values (Table 5-2);

Table 5-2. Amsco Evolution Medium Steam Flush Pressure-Pulse (SFPP) Sterilizer factory-programmed sterilization cycles and cycle values

December 29, 2008

・・・・・

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STERIS Response to 12/23/08 Request for Additional Information K082435 / Amsco Evolution Medium Steam Sterllizer

*The liquid cycle is for non-patient contact use only.

The following table (Table 5-3) lists STERIS's recommended loads by sterilizer size:

Table 5-3. Amsco Evolution Medium Steam Sterilizer recommended loads

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The following table (Table 5-4) provides a guideline for liquid cycle processing. The liquid cycle is for non-patient contact use only.

Table 5-4. Amsco Evolution Medium Steam Sterilizer liquid cycle processing guideline

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The Amsco Evolution Medium Steam Sterilizer is offered in the following chamber sizes:

. Model HC-600 26" x 26" x 39" (660 mm x 660 mm x 991 mm)
26'' x 37½' x 60" (660mm x 950mm x 1524mm) . Model HC-1500

Description of Safety and Substantial Equivalence ഗ്

A summary of the technological characteristics of the device subject of this premarket notification in comparison to those of the predicate devices is included in Table 5-5.

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General SterilizerFeatures	Amsco EvolutionMedium SteamSterilizer (subject of thisAbbreviated 510(k)submission)	Amsco CenturyMedium SteamSterilizer 26" x 26"(K020747, cleared05/17/02)	Amsco CenturyMedium SteamSterilizer (K010865,cleared 5/31/01)
Intended Use	A steam sterilizerintended for sterilizationof non-porous and porous,heat- and moisture-stabilematerials in healthcarefacilities.	A steam sterilizerintended for sterilizationof non-porous andporous, heat- andmoisture-stabile materialsin healthcare facilities.	A steam sterilizerintended for sterilizationof non-porous andporous, heat- andmoisture-stabile materialsin healthcare facilities.
Operating Principle	Steam is the sterilizingagent.	Steam is the sterilizingagent.	Steam is the sterilizingagent.
Sterilization CyclesOffered	PrevacGravitySFPPLiquid	PrevacGravityWrap/SFPPSFPPLiquid	PrevacGravityWrap/SFPPSFPPLiquid
Chamber Sizes	26" x 26" x 39"26" x 37.5" x 60"	26" x 26" x 39"26" x 26" x 49"26" x 26" x 61"	26" x 37.5" x 36"26" x 37.5" x 48"26" x 37.5" x 60"
Chamber Door	Type 316L stainless steelVertical Sliding(26"x26")Hinged or HorizontalSliding (26"x $37\frac{1}{2}$ ")	Type 316L stainless steelVertical Sliding only	Type 316L stainless steelHinged or HorizontalSliding
Shell Assembly	Type 316L stainless steelASME certified	Type 316L stainless steelASME certified	Type 316L stainless steelASME certified
Control Technology	Unity ControllerTouch Screen8.4" DisplayInk on Paper Printer	Century ControllerTouch ScreenVacuum FluorescentDisplayInk on Paper Printer	Century ControllerTouch ScreenVacuum FluorescentDisplayInk on Paper Printer
Process Monitors	Chamber TransducerDual Element ChamberDrain Sensor	Chamber TransducerChamber Drain Sensor	Chamber TransducerChamber Drain Sensor
Safety Devices	Pressure Relief ValveChamber Float Switch	Pressure Relief ValveChamber Float Switch	Pressure Relief ValveChamber Float Switch

Table 5-5. Summary of the Proposed and Predicate Devices Technological Characteristics

Effectiveness

Effectiveness of sterilizer function and exposure time recommendations was demonstrated by complete kill of biological indicators and by verifying an appropriate safety factor or sterility assurance level (SAL) of at least 10-6 probability of survival. STERIS validates its stcrilization cycles using recommended practices, standards and guidelines developed by independent organizations such as the Association for the Advancement of Medical

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Instrumentation (AAMI). The Amsco Evolution Steam Sterilizer was validated to meet the requirements of ANSVAAMI ST8, Fourth Edition, November 2001.

The results of the Amsco Evolution Steam Sterilizer validation studies demonstrate that the sterilizer performs as intended. The results are summarized as follows:

. Empty chamber testing performed as described in Section 5.4.2.5 of ANSI/AAMI-ST8, for the Prevac, Gravity, Liquid and SFPP cycles. These cycles demonstrated that the sterilizer is capable of providing steady state thermal conditions within the chamber that are consistent with the predicted sterility assurance level (SAL) in the load. The sterilizer meets the requirements of Sections 4.4.2.2 and 4.4.2.5 of ANSI/AAMI-ST8.
All SFPP cycles validated using the fabric test pack, described in Section . 5.5.2.1 of ANSI/AAMI-ST8, were qualified according to Section 5.5.2 ANSI/AAMI-ST8. These cycles demonstrated a sterility assurance level of at least 10 through achievement of a time-at-temperature sufficient to produce an Fo value of at least 12, moisture retention of less than 3% increase in presterilization test pack weight, and no evidence of wet spots.
All SFPP cycles validated using full load instrument trays, described in 5.5.4.1 . of ANSI/AAMI-ST8, were qualified according to Section 5.5.4 ANSI/AAMI-ST8. These cycles demonstrated a sterility assurance level of at least 10° using half-cycle cycle analysis, moisture retention of less than 20% increase in presterilization weight of the towel, and no evidence of wet spots on the outer wrapper.
All GRAVITY cycles validated using the fabric test pack, described in Section . 5.5.2.1 of ANSVAAMI-ST8, were qualified according to Section 5.5.2 ANSVAAMI-ST8. These cycles demonstrated a sterility assurance level of at least 10° through achievement of a time-at-temperature sufficient to produce an Fo value of at least 12, moisture retention of less than 3% increase in presterilization test pack weight, and no evidence of wet spots.
All GRAVITY cycles validated using full load instrument trays, described in . 5.5.4.1 of ANSI/AAMI-ST8, were qualified according to Section 5.5.4 ANSI/AAMI-ST8. These cycles demonstrated a sterility assurance level of at least 100 using half-cycle cycle analysis, moisture retention of less than 20% increase in presterilization weight of the towel, and no evidence of wet spots on the outer wrapper.
. All PREVAC cycles validated using the fabric test pack, described in Section 5.5.2.1 of ANSI/AAMI-ST8, were qualified according to Section 5.5.2 ANSI/AAMI-ST8. These cycles demonstrated a sterility assurance level of at least 10° through achievement of a time-at-temperature sufficient to produce an Fo value of at least 12, moisture retention of less than 3% increase in presterilization test pack weight, and exhibited no wet spots.
All PREVAC cycles validated using full load instrument trays, described in . 5.5.4.1 of ANSI/AAMI-ST8, were qualified according to Section 5.5.4 ANSVAAMI-ST8. These cycles demonstrated a sterility assurance lèvel of at least 100 using half-cycle analysis, moisture retention of less than 20% increase

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in presterilization weight of the towel, and no evidence of wet spots on the outer wrapper.

All LIQUID cycles validated using three 1,000 ml flasks, described in Section . 5.5.3.1 of the ANSI/AAMI-ST8, were qualified according to Section 5.5.3 of ANSI/AAMI-ST8. These cycles demonstrated a sterility assurance level of at least 10° through achievement of a time-at-temperature sufficient to produce an Fo value of at least 12, water loss not exceeding 50 ml, and automatic sealing of the flask closure.
The DART cycle validated using the Bowie-Dick Test Pack, as described in . 5.6.1.1 of the ANSI/AAMI-ST8, was qualified according to Section 5.6.1 of the ANSI/AAMI-ST8, and demonstrated a uniform color change throughout the test sheet.
· The software validation for the cycle operation was performed according to FDA's moderate level of concern recommendations provided in the document "Guidance for the Content for Premarket Submissions for Software Contained in Medical Devices (05/11/05)."

Safety

STERIS sterilizers including the Amsco Evolution Steam Sterilizer have been designed, constructed and tested to meet the safety and performance requirements of various national safety codes and standards. The Amsco Evolution Steam Sterilizer complies with the following requirements:

. Underwriters Laboratory (UL) Electrical Safety Code 61010-1 certified by Intertek Testing Services (ITS).
. Canadian Standards Association (CSA) Standard C22.2 No. 1010-1 as certified by Intertek Testing Services.
American Society of Mechanical Engineers (ASME), Section VIII, Division 1 . for unfired pressure vessels.

Hazards - Failure of Performance

Failure of the sterilization process can lead to incidence of cross contamination, the transmission of potentially infectious organisms from one infected person to another who was not otherwise infected prior to the incident.

To avoid failure, the user must ensure that the materials, instruments and devices to be sterilized are thoroughly cleaned, the manufacturer's instructions for use are followed, the cycle to be used for each type of sterilizer load has been validated, the sterilizer has been maintained in accordance with the sterilizer manufacturer's recommended maintenance schedule and is operating properly, and each sterilizer load is monitored with available and validated biological and chemical sterilization process indicators.

Today, there are many steam sterilizers in daily use in hospitals throughout the United States. The incidence of sterilizer malfunction or sterilization process failure is relatively rare. Further, there are no known reports in the literature of

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patient infections that have resulted from steam sterilizer failures. The technology designed into STERIS steam sterilizers including the Amsco Evolution Steam Sterilizer provide PC Controller safeguards that abort the cycle and give appropriate signals, alerts and warnings when required conditions have not been met or when a malfunction occurs.

User Information

STERIS conducts in-house training and has developed a series of user training videos that provide helpful information about the appropriate use of steam sterilizers. STERIS further provides information to the user that is intended to ensure safe and effective use of steam sterilization in its detailed Operator Manual and other labeling. STERIS also recommends the use and periodic review of the AAMI steam sterilization standards to ensure further assurance of the safe and effective use of steam sterilization equipment in healthcare facilities.

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Image /page/9/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three overlapping wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 3 0 2008

Mr. Robert Sullivan Senior Director FDA Regulatory Affairs STERIS Corporation 5960 Heisley Road Mentor, Ohio 44060

Re: K082435

Trade/Device Name: Amsco Evolution Medium Steam Sterilizer Regulation Number: 21 CFR 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: II Product Code: FLE Dated: December 08, 2008 Received: December 09, 2008

Dear Mr. Sullivan:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 - Mr. Sullivan

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html,

Sincerely vours.

Chiu S. Lin, Ph. D.

Chiu S. Lin. Ph. D Division 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): K082435

Device Name:

Amsco Evolution Medium Steam Sterilizer

Indications For Use:

Prevacuum is equipped with Prevacuum, Gravity, Liquid, Leak Test and DART . (Bowie-Dick) cycles.
Steam Flush Pressure-Pulse (SFPP) is equipped with SFPP, Prevacuum, t Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles.

The Amsco Evolution Medium Prevacuum Steam Sterilizer is equipped with the following factory-programmed sterilization cycles and cycle values (Table 4-1):

Cycles	SterilizeTemperature	SterilizeTime	Dry Time	Recommended Load
Prevac	270°F (132°C)	4 minutes	30minutes	Double wrapped instrumenttrays, maximum weight 25lbs (11.3 kg) each andFabric Packs. Refer toTable 4-3 for recommendedquantities.
Prevac	270°F (132°C)	4 minutes	5 minutes	Single Fabric Pack
Gravity	250°F (121°C)	30 minutes	15minutes	Fabric Packs. Refer toTable 4-3 for recommendedquantities.
Liquid	250°F (121°C)	45 minutes	N/A	Refer to Table 4-4 forrecommended quantities.
Prevac	275°F (135°C)	3 minutes	30minutes	Double wrapped instrumenttrays, maximum weight 25lbs (11.3 kg) each. Refer toTable 4-3 for recommendedquantities.

Table 4-1. Amsco Evolution Medium Prevacuum Steam Sterilizer Factory-programmed sterilization cycles and cycle values

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STERIS Response to 12/23/08 Request for Additional Information K082435 / Amsco Evolution Medium Steam Sterilizer

Gravity	270°F (132°C)	15 minutes	30 minutes	Double wrapped instrument trays, maximum weight 25 lbs (11.3 kg) each. Refer to Table 4-3 for recommended quantities.
Gravity	250°F (121°C)	30 minutes	30 minutes	Double wrapped instrument trays, maximum weight 25 lbs (11.3 kg) each. Refer to Table 4-3 for recommended quantities.
Gravity	270°F (132°C)	25 minutes	15 minutes	Fabric Packs. Refer to Table 4-3 for recommended quantities.
DART Warm-Up	270°F (132°C)	3 minutes	1 minute	N/A
DART	270°F (132°C)	3 ½ minutes	1 minute	Bowie-Dick Test Pack, DART Test Pack
Leak Test	N/A	N/A	N/A	N/A

The Amsco Evolution Medium Steam Flush Pressure-Pulse (SFPP) Sterilizer is equipped with the following factory-programmed sterilization cycles and cycle values (Table 4-2):

Table 4-2. Amsco Evolution Medium Steam Flush Pressure-Pulse (SFPP) Sterilizer factory-programmed sterilization cycles and cycle values

Cycles	Sterilize Temperature	Sterilize Time	Dry Time	Recommended Load
SFPP	270°F (132°C)	4 minutes	30 minutes	Double wrapped instrument trays, maximum weight 25 lbs (11.3 kg) each and Fabric Packs. Refer to Table 4-3 for recommended quantities.
SFPP	275°F (135°C)	3 minutes	30 minutes	Double wrapped instrument trays, maximum weight 25 lbs (11.3 kg) each. Refer to Table 4-3 for recommended quantities

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STERIS Response to 12/23/08 Request for Additional Information K082435 / Amsco Evolution Medium Steam Sterilizer

Prevac	270°F (132°C)	4 minutes	30 minutes	Double wrapped instrument trays, maximum weight 25 lbs (11.3 kg) each and Fabric Packs. Refer to Table 4-3 for recommended quantities.
Gravity	250°F (121°C)	30 minutes	15 minutes	Fabric Packs. Refer to Table 4-3 for recommended quantities.
SFPP	270°F (132°C)	4 minutes	5 minutes	Single Fabric Pack
Prevac	275°F (135°C)	3 minutes	30 minutes	Double wrapped instrument trays, maximum weight 25 lbs (11.3 kg) each. Refer to Table 4-3 for recommended quantities.
Gravity	270°F (132°C)	15 minutes	30 minutes	Double wrapped instrument trays, maximum weight 25 lbs (11.3 kg) each. Refer to Table 4-3 for recommended quantities.
Liquid	250°F (121°C)	45 minutes	N/A	Refer to Table 4-4 for recommended quantities.
DART Warm-Up	270°F (132°C)	3 minutes	1 minute	N/A
DART	270°F (132°C)	3 1/2 minutes	1 minute	Bowie-Dick Test Pack, DART Test Pack
Leak Test	N/A	N/A	N/A	N/A

The following table (Table 4-3) lists STERIS's recommended loads by sterilizer size:

Table 4-3. Amsco Evolution Medium Steam Sterilizer recommended loads per sterilizer size

Sterilizer Size	Wrapped InstrumentTrays	Fabric Packs
26" x 26" x 39"	9	12
26" x 37 ½" x 60"	20	36

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The following table (Table 4-4) is a guideline for liquid cycle processing:

Table 4-4. Amsco Evolution Medium Steam Sterilizer Liquid Cycle Guideline

.1 44.55 - 14	Tionid In OneCallime117 7 80 7 3 4 150.240.mainer.. Ba Ba a a an annone and The Joyle Complex and the research as a miller	VITE ! You " You " !! ! " ! !! ! " " { } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } }- 1 - 0 - 1 - 1 -A Property of Canadian Color Property.MinimiBPA 11 1 8 80A MARKE LANDA CYCLASS CYCCCCC16 4 11 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1WARRAL IL CREATH ARMA UNCLOWE AND TORE THE LAW THE
		minutes

The Amsco Evolution Medium Steam Sterilizer is offered in the following chamber sizes:

26" x 26" x 39" (660 mm x 660 mm x 991 mm), Model HC-600 해
26" x 37½" x 60" (660mm x 950mm x 1524mm), Model HC-1500 .

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)

Shule M. Murphyko
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K08243

Page 1 of 1

CONFIDENTIAL

December 29, 2008

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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).