Who is the manufacturer of AMSCO EVOLUTION MEDIUM STEAM STERILIZER?

STERIS Corporation filed the 510(k) submission for AMSCO EVOLUTION MEDIUM STEAM STERILIZER (K082435).

What is the FDA product code for AMSCO EVOLUTION MEDIUM STEAM STERILIZER?

FLE. It is classified under 21 CFR 880.6880 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for AMSCO EVOLUTION MEDIUM STEAM STERILIZER?

510(k) clearance (submission type: Abbreviated).

What are the predicate devices for AMSCO EVOLUTION MEDIUM STEAM STERILIZER?

Amsco Century Medium Steam Sterilizer (K010865); Amsco Century Medium Steam Sterilizer (K020747).

Who can help prepare an FDA 510(k) submission like AMSCO EVOLUTION MEDIUM STEAM STERILIZER?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

AMSCO EVOLUTION MEDIUM STEAM STERILIZER

K082435 · STERIS Corporation · FLE · Dec 30, 2008 · General Hospital

Device Facts

Record ID	K082435
Device Name	AMSCO EVOLUTION MEDIUM STEAM STERILIZER
Applicant	STERIS Corporation
Product Code	FLE · General Hospital
Decision Date	Dec 30, 2008
Decision	SESE
Submission Type	Abbreviated
Regulation	21 CFR 880.6880
Device Class	Class 2
Attributes	Therapeutic

Indications for 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.

Device Story

Amsco Evolution Medium Steam Sterilizer is a large-scale steam sterilization system for healthcare facilities. It utilizes steam as the sterilizing agent to process heat and moisture-stabile materials, including wrapped instrument trays and fabric packs. The device features two configurations: Prevacuum and Steam Flush Pressure-Pulse (SFPP). It includes multiple factory-programmed cycles (Prevac, Gravity, SFPP, Liquid, Leak Test, DART/Bowie-Dick). The system is operated via a Unity Controller with an 8.4-inch touch screen display. Process monitoring is performed by chamber transducers and drain sensors. Safety features include pressure relief valves and chamber float switches. The device provides automated cycle control, including alerts and cycle aborts if parameters are not met. Healthcare personnel use the device to ensure the sterility of surgical instruments and other medical equipment, thereby preventing cross-contamination and transmission of infectious organisms.

Clinical Evidence

Bench testing only. Validation performed per ANSI/AAMI ST8 (2001) standards. Testing included empty chamber, fabric test pack, and full load instrument tray validation for Prevac, Gravity, and SFPP cycles. All cycles demonstrated a sterility assurance level (SAL) of at least 10^-6, with Fo values of at least 12, moisture retention within specified limits, and no wet spots. Liquid cycle validated using 1,000 ml flasks. DART cycle validated using Bowie-Dick test packs.

Technological Characteristics

Chamber and shell constructed of Type 316L stainless steel (ASME certified). Steam sterilization principle. Dimensions: 26"x26"x39" (HC-600) or 26"x37.5"x60" (HC-1500). Unity Controller with 8.4" touch screen. Connectivity: Ink on paper printer. Safety: Pressure relief valve, chamber float switch. Software: Moderate level of concern. Standards: ANSI/AAMI ST8, UL 61010-1, CSA C22.2 No. 1010-1.

Indications for Use

Indicated for sterilization of heat and moisture-stabile materials in healthcare facilities. Includes non-porous and porous materials. Liquid cycle is for non-patient contact use only.

Regulatory Classification

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.

Predicate Devices

Amsco Century Medium Steam Sterilizer (K010865)
Amsco Century Medium Steam Sterilizer (K020747)

Submission Summary (Full Text)

{0}------------------------------------------------ # STERIS® DEC 3 0 2008 Image /page/0/Picture/3 description: The image shows a black and white abstract pattern. The pattern consists of a series of horizontal lines that are stacked on top of each other. The lines are not straight, but rather have a wavy or jagged appearance. The overall effect is one of texture and movement. # 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 {1}------------------------------------------------ #### 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 Code FLE. | #### 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. {2}------------------------------------------------ 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 instrument trays, maximum weight 25 lbs (11.3 kg) each. Fabric Packs. Refer to Table 5-3 for recommended quantities. | | Prevac Gravity | 250°F (121°C) 270°F (132°C) | 4 minutes 30 minutes | 5 minutes 15 minutes | Single Fabric Pack Fabric Packs. Refer to Table 5-3 for recommended quantities. | | Liquid* | 250°F (121°C) | 45 minutes | N/A | Refer to Table 5-4 for recommended quantities. | | Prevac | 275°F (135°C) | 3 minutes | 30 minutes | Double wrapped instrument trays, maximum weight 25 lbs (11.3 kg) each. Refer to Table 5-3 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 5-3 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 5-3 for recommended quantities. | | Gravity | 270°F (132°C) | 25 minutes | 15 minutes | Fabric Packs. Refer to Table 5-3 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 | | 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. Fabric Packs. Refer to Table 5-3 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 5-3 for recommended quantities. | | Prevac | 270°F (132°C) | 4 minutes | 30 minutes | Double wrapped instrument trays, maximum weight 25 lbs (11.3 kg) each. Fabric Packs. Refer to Table 5-3 for recommended quantities. | | Gravity | 250°F (121°C) | 30 minutes | 15 minutes | Fabric Packs. Refer to Table 5-3 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 5-3 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 5-3 for recommended quantities. | | Liquid* | 250°F (121°C) | 45 minutes | N/A | Refer to Table 5-4 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 | 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. {3}------------------------------------------------ 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 ・・・・・ {4}------------------------------------------------ #### 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 | . In an extenza in macha . 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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. {5}------------------------------------------------ | General Sterilizer Features | Amsco Evolution Medium Steam Sterilizer (subject of this Abbreviated 510(k) submission) | Amsco Century Medium Steam Sterilizer 26" x 26" (K020747, cleared 05/17/02) | Amsco Century Medium Steam Sterilizer (K010865, cleared 5/31/01) | |---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | A steam sterilizer intended for sterilization of non-porous and porous, heat- and moisture-stabile materials in healthcare facilities. | A steam sterilizer intended for sterilization of non-porous and porous, heat- and moisture-stabile materials in healthcare facilities. | A steam sterilizer intended for sterilization of non-porous and porous, heat- and moisture-stabile materials in healthcare facilities. | | Operating Principle | Steam is the sterilizing agent. | Steam is the sterilizing agent. | Steam is the sterilizing agent. | | Sterilization Cycles Offered | Prevac Gravity SFPP Liquid | Prevac Gravity Wrap/SFPP SFPP Liquid | Prevac Gravity Wrap/SFPP SFPP Liquid | | 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 steel Vertical Sliding (26"x26") Hinged or Horizontal Sliding (26"x $37\frac{1}{2}$ ") | Type 316L stainless steel Vertical Sliding only | Type 316L stainless steel Hinged or Horizontal Sliding | | Shell Assembly | Type 316L stainless steel ASME certified | Type 316L stainless steel ASME certified | Type 316L stainless steel ASME certified | | Control Technology | Unity Controller Touch Screen 8.4" Display Ink on Paper Printer | Century Controller Touch Screen Vacuum Fluorescent Display Ink on Paper Printer | Century Controller Touch Screen Vacuum Fluorescent Display Ink on Paper Printer | | Process Monitors | Chamber Transducer Dual Element Chamber Drain Sensor | Chamber Transducer Chamber Drain Sensor | Chamber Transducer Chamber Drain Sensor | | Safety Devices | Pressure Relief Valve Chamber Float Switch | Pressure Relief Valve Chamber Float Switch | Pressure Relief Valve Chamber 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 {6}------------------------------------------------ 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 {7}------------------------------------------------ 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 {8}------------------------------------------------ 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. {9}------------------------------------------------ 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. {10}------------------------------------------------ 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 {11}------------------------------------------------ # Indications for Use 510(k) Number (if known): K082435 Device Name: Amsco Evolution Medium Steam Sterilizer Indications For Use: 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. The Amsco Evolution Medium Prevacuum Steam Sterilizer is equipped with the following factory-programmed sterilization cycles and cycle values (Table 4-1): | Cycles | Sterilize Temperature | Sterilize Time | Dry Time | Recommended Load | |---------|--------------------------|-------------------|---------------|-------------------------------------------------------------------------------------------------------------------------------------------------------| | 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. | | Prevac | 270°F (132°C) | 4 minutes | 5 minutes | Single Fabric Pack | | Gravity | 250°F (121°C) | 30 minutes | 15 minutes | Fabric Packs. 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. | | 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. | Table 4-1. Amsco Evolution Medium Prevacuum Steam Sterilizer Factory-programmed sterilization cycles and cycle values CONFIDENTIAL A-2 {12}------------------------------------------------ #### 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 | CONFIDENTIAL .. . : : . А-3 {13}------------------------------------------------ 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 Instrument Trays | Fabric Packs | |-------------------|-----------------------------|--------------| | 26" x 26" x 39" | 9 | 12 | | 26" x 37 ½" x 60" | 20 | 36 | CONFIDENTIAL . ・・ . A-4 {14}------------------------------------------------ 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 One Callime 1 17 7 80 7 3 4 1 50.240. 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. Minimi BPA 11 1 8 80 A MARKE LANDA CYCLASS CYCCCCC 16 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 1 WARRAL 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 A-5

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