Who is the manufacturer of AMSCO EVOLUTION SERIES STEAM STERILIZER, MODEL: HC-2000 AND HC-3000?

STERIS Corporation filed the 510(k) submission for AMSCO EVOLUTION SERIES STEAM STERILIZER, MODEL: HC-2000 AND HC-3000 (K092490).

What is the FDA product code for AMSCO EVOLUTION SERIES STEAM STERILIZER, MODEL: HC-2000 AND HC-3000?

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 SERIES STEAM STERILIZER, MODEL: HC-2000 AND HC-3000?

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

What are the predicate devices for AMSCO EVOLUTION SERIES STEAM STERILIZER, MODEL: HC-2000 AND HC-3000?

Amsco Evolution Medium Steam Sterilizer (K082435); Amsco Evolution Medium Steam Sterilizer (K091136).

Who can help prepare an FDA 510(k) submission like AMSCO EVOLUTION SERIES STEAM STERILIZER, MODEL: HC-2000 AND HC-3000?

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 SERIES STEAM STERILIZER, MODEL: HC-2000 AND HC-3000

K092490 · STERIS Corporation · FLE · Nov 4, 2009 · General Hospital

Device Facts

Record ID	K092490
Device Name	AMSCO EVOLUTION SERIES STEAM STERILIZER, MODEL: HC-2000 AND HC-3000
Applicant	STERIS Corporation
Product Code	FLE · General Hospital
Decision Date	Nov 4, 2009
Decision	SESE
Submission Type	Abbreviated
Regulation	21 CFR 880.6880
Device Class	Class 2

Intended Use

The Amsco Evolution Series Steam Sterilizer Models HC-2000 and HC-3000 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, Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles.

Device Story

Steam sterilizer for healthcare facilities; processes heat/moisture-stable materials. Inputs: steam as sterilizing agent. Operation: utilizes Prevacuum, Gravity, Liquid, Leak Test, and Steam Flush Pressure-Pulse (SFPP) cycles. Outputs: sterilized instrument trays and fabric packs. Operated by healthcare staff; PC-based controller monitors chamber conditions via transducers and sensors. Provides alerts/aborts if parameters fail. Benefits: ensures sterility of medical equipment, reducing cross-contamination risk.

Clinical Evidence

Bench testing only. Validation performed per ANSI/AAMI ST8, 5th Ed. Studies included empty chamber testing, fabric process challenge devices, and wrapped instrument process challenge devices. Endpoints: sterility assurance level (SAL) of at least 10^-6, thermal steady-state conditions, moisture retention limits, and biological indicator kill. Software validated per FDA moderate level of concern guidance.

Technological Characteristics

Materials: Type 316L stainless steel shell and door. Energy: Steam. Dimensions: 26" x 61" x 49" (HC-2000) and 26" x 61" x 72" (HC-3000). Control: Unity Controller with 8.4" touch screen and printer. Safety: Pressure relief valve, chamber float switch, control lockout. Standards: ANSI/AAMI ST8, UL 61010-1, CSA C22.2 No. 61010-1/2-040, ASME Section VIII Div 1.

Indications for Use

Indicated for sterilization of heat and moisture-stable materials in healthcare facilities. Not for patient contact use in liquid cycles.

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 Evolution Medium Steam Sterilizer (K082435)
Amsco Evolution Medium Steam Sterilizer (K091136)

Related Devices

K091136 — AMSCO EVOLUTION MEDIUM STEAM STERILIZER, MODEL HC-900 AND HC-1200 · STERIS Corporation · Jun 29, 2009
K100622 — BELIMED STEAM STERILIZER, MODEL MST-V 3-3-6 · Belimed Sauter AG · Aug 27, 2010
K120149 — SKYRON INTEGRITY 215 STEAM STERILIZER SKYTRON INTEGRITY 215 SG STEAM STERILIZER SAKURA STEAM STERILIZER ASSV-AB09 SAKURA · Sakura Seiki Co., Ltd. · May 8, 2012
K130172 — BELIMED STEAM STERILIZER MST-V · Belimed, Inc. · Sep 23, 2013
K103841 — BELIMED STEAM STERILIZER MST-V · Sauter AG · Mar 15, 2011

Submission Summary (Full Text)

{0}------------------------------------------------ кояачао Image /page/0/Picture/1 description: The image shows the STERIS logo. The logo consists of the word "STERIS" in a bold, sans-serif font, with the registered trademark symbol to the right of the word. Below the word "STERIS" is an image of several horizontal wavy lines stacked on top of each other. NOV - 4 2009 # 510(k) Summary For Amsco Evolution Series Steam Sterilizer Models HC-2000 and HC-3000 STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 639-4459 Contact: Robert F. Sullivan Senior Director FDA Regulatory Affairs Telephone: (440) 392-7695 Fax No: (440) 357-9198 August 12, 2009 Summary Date: STERIS Corporation = 5960 Heisley Road = Mentor, OH 44060-1834 USA = 440-354-2600 ﻳﺘ {1}------------------------------------------------ ## Device Name | Trade Name: | Amsco Evolution Series Steam Sterilizer | |----------------------|----------------------------------------------------------| | Models: | HC-2000 and HC-3000 | | Common/Usual Name: | Steam Sterilizer | | Classification Name: | Steam Sterilizer (21 CFR 880.6880, Product Code 80 FLE ) | | Predicate Devices: | | K082435, Amsco Evolution Medium Steam Sterilizer (Models HC-600 and HC-1500) cleared December 30, 2008. K091136, Amsco Evolution Medium Steam Sterilizer (Models HC-900 and HC-1200) cleared June 29, 2009. #### Description of Device The Amsco Evolution Series Steam Sterilizer, Models HC-2000 and HC-3000, 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, Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles. The chamber sizes of the proposed Amsco Evolution Series Steam Sterilizer Models are as follows: - 26" x 61" x 49" (Model HC-2000) . - 26" x 61" x 72" (Model HC-3000) . ### Intended Use The Amsco Evolution Series Steam Sterilizer Models HC-2000 and HC-3000 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, . Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles. The Amsco Evolution Series Prevacuum Steam Sterilizer is equipped with the following factory-programmed sterilization cycles and cycle values (Table 5-1): {2}------------------------------------------------ | 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. | | Gravity | 270°F (132°C) | 15 minutes | 45 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 | 45 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 | | Table 5-1. Amsco Evolution Series Prevacuum Steam Sterilizer | |--------------------------------------------------------------| | factory-programmed sterilization cycles and cycle values | *The liquid cycle is for non-patient contact use only. {3}------------------------------------------------ The Amsco Evolution Series Steam Flush Pressure-Pulse (SFPP) Sterilizer is equipped with the following factory-programmed sterilization cycles and cycle values (Table 5-2): | Cycles | Sterilize Temperature | Sterilize Time | Dry Time | Recommended Load | |-----------------|--------------------------|-------------------|------------|----------------------------------------------------------------------------------------------------------------------------------------------------------| | SFPP | 270°F (132°C) | 4 minutes | 45 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 | 45 minutes | Double wrapped instrument trays, maximum weight 25 lbs (11.3 kg) each. Refer to Table 4-3 for recommended quantities. | | Prevac | 270°F (132°C) | 4 minutes | 30 minutes | Double wrapped instrument trays, maximum weight 25 lbs (11.3 kg) each 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 | 45 minutes | Double wrapped instrument trays, maximum weight 25 lbs (11.3 kg) each. Refer to Table 4-3 for recommended quantities. | | Cycles | Sterilize Temperature | Sterilize Time | Dry Time | Recommended Load | | 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 | Table 5-2. Amsco Evolution Series Steam Flush Pressure-Pulse (SFPP) Sterilizer factory-programmed sterilization cycles and cycle values {4}------------------------------------------------ *The liquid cycle is for non-patient contact use only. The following table lists STERIS's recommended loads by sterilizer size: | Sterilizer Size | Wrapped Instrument Trays | Fabric Packs | |----------------------------|--------------------------|--------------| | 26" x 61" x 49" HC-2000 | 15 | 40 | | 26" x 61" x 72" HC-3000 | 25 | 60 | #### Table 5-3. Amsco Evolution Series Steam Sterilizer recommended loads per sterilizer size The following table is a guideline for liquid cycle processing: #### Table 5-4. Amsco Evolution Series Steam Sterilizer Liquid Cycle Guideline | Number of Containers | Volume of Liquid In One Container | Minimum Recommended Sterilize Time at 250°F (121°C) | |-------------------------|--------------------------------------|--------------------------------------------------------| | 3 | 1000 ml | 45 minutes | The Amsco Evolution Series Steam Sterilizer is offered in the following chamber sizes: - · 26" x 61" x 61" x 49" (Model HC 2000) - · 26" x 61" x 72" (Model HC 3000) # Description of Safety and Substantial Equivalence 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 (K091136) | Amsco Evolution Medium Steam Sterilizer (K082435) | Amsco Evolution Series Steam Sterilizer (HC-2000 and HC-3000) | |-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | A steam sterilizer intended for sterilization of non- porous and porous, heat- and moisture-stable materials in healthcare facilities. | A steam sterilizer intended for sterilization of non-porous and porous, heat- and moisture-stable materials in healthcare facilities. | A steam sterilizer intended for sterilization of non- porous and porous, heat- and moisture-stable 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 SFPP Liquid | Prevac Gravity SFPP Liquid | | Chamber Sizes | 26" x 26" x 39" 26" x 37.5" x 60" | 26" x 37.5" x 42" 26" x 37.5" x 54" | 26" x 61" x 49" 26" x 61" x 72" | | Chamber Door | Type 316L stainless steel Vertical Sliding (26"x26") Hinged or Horizontal Sliding (26"x37½") | Type 316L stainless steel Vertical Sliding (26"x26") Hinged or Horizontal Sliding (26"x37½") | Type 316L stainless steel Power 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 | Unity Controller Touch Screen 8.4" Display Ink on Paper Printer | Unity Controller Touch Screen 8.4" Display Ink of Paper Printer | | Process Monitors | Chamber Transducer Dual Element Chamber Drain Sensor | Chamber Transducer Dual Element Chamber Drain Sensor | Chamber Transducer Dual Element Chamber Drain Sensor | | Safety Devices | Pressure Relief Valve Chamber Float Switch Control Lockout Switch | Pressure Relief Valve Chamber Float Switch Control Lockout Switch | Pressure Relief Valve Chamber Float Switch Control Lockout 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 100 probability of survival. STERIS validates its sterilization cycles using recommended practices, standards and guidelines developed by independent organizations such as the Association for the Advancement of Medical Instrumentation (AAMI). The Amsco Evolution Steam Sterilizers have been validated to meet the requirements of ANSVAAMI ST8, Fifth Edition, December 2008. {6}------------------------------------------------ The results of the Amsco Evolution Series 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 process challenge device, 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 100 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 the wrapped instrument process challenge devices, described in 5.5.4.1 of ANSVAAMI-ST8, were qualified according to Section 5.5.4 ANSI/AAMI-ST8. These cycles demonstrated a sterility assurance level of at least 106 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 process challenge device. described in Section 5.5.2.1 of ANSI/AAMI-ST8, were qualified according to Section 5.5.2 ANSVAAMI-ST8. These cycles demonstrated a sterility assurance level of at least 10th 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 the wrapped instrument process challenge . device, described in 5.5.4.1 of ANSVAAMI-ST8, were qualified according to section 5.5.4 ANSVAAMI-ST8. These cycles demonstrated a sterility assurance level of at least 106 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 process challenge device, . described in Section 5.5.2.1 of ANSI/AAMI-ST8, were qualified according to Section 5.5.2 ANSVAAMI-ST8. These cycles demonstrated a sterility assurance level of at least 10th 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 the wrapped instrument process challenge . device, 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 level of at least 10th using half-cycle analysis, moisture retention of {7}------------------------------------------------ less than 20% increase in presterilization weight of the towel, and no evidence of wet spots on the outer wrapper. - All LIOUID cycles validated using three 1,000 ml flasks, described in Section . 5.5.3.1 of the ANSVAAMI-ST8, and 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. 61010-1 as certified . by Intertek Testing Services. - . Canadian Standards Association (CSA) Standard C22.2 No. 61010-2-040 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. {8}------------------------------------------------ The technology designed into STERIS steam sterilizers including the Amsco Evolution Series 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 and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized eagle or bird in flight. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002 Mr. Robert F. Sullivan Senior Director Steris Corporation 5960 Heisley Road Mentor, Ohio 44060 NOV - 4 2009 Re: K092490 Trade/Device Name: The Amsco Evolution Series Steam Sterilizer is offered in the Following Chamber Sizes: Model HC-2000 36"x61"x49" Model HC-3000 26"x 61"x72". Regulation Number: 21CFR 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: II Product Code: FLE Dated: August 12, 2009 Received: August 13, 2009 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 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}------------------------------------------------ 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.goy/MedicalDevices/Resourcesfor-You/Industry/default.htm. Sincerely yours, Susan Funser Susan Runner, D.D.S., M.A. Acting Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health {11}------------------------------------------------ # Indications for Use 510(k) Number (if known): Device Name: Amsco Evolution Series Steam Sterilizer (HC-2000 and HC-3000) Indications for Use: The Amsco Evolution Series Steam Sterilizer Models HC-2000 and HC-3000 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, . Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles. The Amsco Evolution Series 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 Series Prevacuum Steam Sterilizer factory-programmed sterilization cycles and cycle values {12}------------------------------------------------ | Cycles | Sterilize Temperature | Sterilize Time | Dry Time | Recommended Load | |-----------------|--------------------------|-------------------|------------|-----------------------------------------------------------------------------------------------------------------------------------| | Gravity | 270°F (132°C) | 15 minutes | 45 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 | 45 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 liquid cycle is for non-patient contact use only. The Amsco Evolution Series Steam Flush Pressure-Pulse (SFPP) Sterilizer is equipped with the following factory-programmed sterilization cycles and cycle values (Table 4-2): | Cycles | Sterilize Temperature | Sterilize Time | Dry Time | Recommended Load | |--------|--------------------------|-------------------|------------|----------------------------------------------------------------------------------------------------------------------------------------------------| | SFPP | 270°F (132°C) | 4 minutes | 45 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 | 45 minutes | Double wrapped instrument trays, maximum weight 25 lbs (11.3 kg) each. Refer to Table 4-3 for recommended quantities. | | | Table 4-2. Amsco Evolution Series Steam Flush Pressure-Pulse (SFPP) | | | | | |--|---------------------------------------------------------------------|--|--|--|--| | | Sterilizer factory-programmed sterilization cycles and cycle values | | | | | {13}------------------------------------------------ | 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. | | 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 | 45 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 ½ minutes | 1 minute | Bowie-Dick Test Pack, DART Test Pack | | Leak Test | N/A | N/A | N/A | N/A | *The liquid cycle is for non-patient contact use only. The following table lists STERIS's recommended loads by sterilizer size: Table 4-3. Amsco Evolution Series Steam Sterilizer recommended loads per sterilizer size | Sterilizer Size | Wrapped Instrument Trays | Fabric Packs | |-------------------------|--------------------------|--------------| | 26" x 61" x 49" HC-2000 | 15 | 40 | | 26" x 61" x 72" HC-3000 | 25 | 60 | The following table is a guideline for liquid cycle processing: {14}------------------------------------------------ # Table 4-4. Amsco Evolution Series Steam Sterilizer Liquid Cycle Guideline | ースになると、このようなんているということです。 Can been and the | THE CAN THE SECT AND THE CHANDE THE Container | Volume of Liquid In One Minimum Recommended ar 1 12 12 12 12 12 12 12 12 12 12 12 12 12 12 12 12 12 12 12 12 12 12 12 12 12 12 12 12 12 12 12 12 12 12 12 12 12 12 12 12 12 12 12 12 12 12 12 12 12 12 12 12 12 12 12 12 12 1 16. LOUID USINGLANDLY 1508E (121%C) 41 Carles Comments of Concerner terinz | |----------------------------------------------|--------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | 1 117 | minutes | The Amsco Evolution Series Steam Sterilizer is offered in the following chamber sizes: - 26" x 61" x 49" Model HC - 2000 . - 26" x 61" x 72" Model HC - 3000 ● 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) Elizabet D. Clamin - Wel (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices 510(k) Number: K092490 Page 4 of 4

AMSCO EVOLUTION SERIES STEAM STERILIZER, MODEL: HC-2000 AND HC-3000

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Related Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

AMSCO EVOLUTION SERIES STEAM STERILIZER, MODEL: HC-2000 AND HC-3000

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Related Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

Create Alert

Search Filters

Agent Token

Welcome

Check your email

Welcome!