AMSCO EVOLUTION MEDIUM STEAM STERILIZER, MODEL HC-900 AND HC-1200

K091136 · STERIS Corporation · FLE · Jun 29, 2009 · General Hospital

Device Facts

• Record ID: K091136
• Device Name: AMSCO EVOLUTION MEDIUM STEAM STERILIZER, MODEL HC-900 AND HC-1200
• Applicant: STERIS Corporation
• Product Code: FLE · General Hospital
• Decision Date: Jun 29, 2009
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.6880
• Device Class: Class 2

Intended Use

The Amsco Evolution Medium Steam Sterilizer models HC-900 and HC-1200 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 Unity Controller to manage sterilization cycles (Prevacuum, Gravity, SFPP, Liquid, Leak Test, DART). Outputs: sterilized materials; cycle status/data via touch screen and ink-on-paper printer. Operated by healthcare staff. Controller monitors chamber conditions via transducers/sensors; aborts cycle and provides alerts if parameters fail. Benefits: ensures sterility of instruments/materials to prevent cross-contamination/infection transmission.

Clinical Evidence

Bench testing only. Validation performed per ANSI/AAMI ST8 standards. Testing included empty chamber thermal distribution, fabric test packs, and full load instrument trays. Results confirmed SAL of at least 10^-6, moisture retention limits, and successful Bowie-Dick testing. No clinical data required for this device type.

Technological Characteristics

Materials: Type 316L stainless steel (ASME certified). Energy: Steam. Dimensions: 26" x 37.5" x 42" (HC-900) and 26" x 37.5" x 54" (HC-1200). Control: Unity Controller with 8.4" touch screen. Connectivity: Ink-on-paper printer. Safety: Pressure relief valve, chamber float switch, control lockout. Software: Moderate level of concern.

Indications for Use

Indicated for sterilization of heat and moisture-stable materials in healthcare facilities. Includes non-patient contact liquid cycle. No specific patient population age or gender restrictions.

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)

Submission Summary (Full Text)

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

STERIS®

JUN 2 9 2009

510(k) Summary For Amsco Evolution Medium Steam Sterilizer Models HC-900 and HC-1200

STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: [phone] Fax No: [phone]

Contact:

Robert F. Sullivan Senior Director FDA Regulatory Affairs Telephone:[phone] Fax No: [phone]

Summary Date:

June 17, 2009

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

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

#### 1. Device Name

| Trade Name: | Amsco Evolution Medium Steam Sterilizer |
|----------------------|-----------------------------------------------------------|
| Models: | HC-900 and HC-1200 |
| Common/Usual Name: | Steam Sterilizer |
| Classification Name: | Steam Sterilizer (21 CFR 880.6880)<br>Product Code 80 FLE |

#### 2. Predicate Device

K082435, Amsco Evolution Medium Steam Sterilizer, product code [FLE] cleared December 30, 2008.

#### 3. Description of Device

The Amsco Evolution Medium Steam Sterilizer models HC-900 and HC-1200 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 Medium Steam Sterilizer Models are as follows:

- 26" x 37½" x 42" (Model HC 900) �
- . 26" x 37½" x 54" (Model HC - 1200)

#### 4. Intended Use

The Amsco Evolution Medium Steam Sterilizer models HC-900 and HC-1200 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.

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

:

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

| Cycles | Sterilize<br>Temperature | Sterilize<br>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 | 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<br>DART | 270°F (132°C) | 3 minutes | 1 minute | N/A |
| DART | 270°F (132°C) | 3 ½ minutes | 1 minute | Bowie-Dick Test Pack,<br>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,<br>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,<br>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,<br>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,<br>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,<br>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

*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 4-2):

| Table 4-2. Amsco Evolution Medium Steam Flush Pressure-Pulse (SFPP) | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Sterilizer factory-programmed sterilization cycles and cycle values<br>A LIE LA LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE | |

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

#### STERIS Response to 06/10/09 Request for Additional Information K091136/S001: Amsco Evolution Medium Steam Sterilizer (Models HC-900 and HC-1200)

| Cycles | Sterilize<br>Temperature | Sterilize<br>Time | Dry Time | Recommended Load |
|-----------------|--------------------------|-------------------|----------|---------------------------------------------------|
| Liquid* | 250°F (121°C) | 45 minutes | N/A | Refer to Table 4-4 for<br>recommended quantities. |
| DART<br>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,<br>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:

| Sterilizer recommended loads per sterilizer size | | |
|--------------------------------------------------|--------------------------|--------------|
| Sterilizer Size | Wrapped Instrument Trays | Fabric Packs |
| 26" x 37 ½" x 42" | 12 | 18 |
| 26" x 37 ½" x 54" | 16 | 30 |

# Table 4-3. Amsco Evolution Medium Steam

The following table is a guideline for liquid cycle processing:

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

| | 120000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000<br>1403147271-2-<br>(1100 0 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 | A S M B |
|--------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| | 1000 ml | 45 minutes |
| i<br>1 | 1 | |

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

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

- 26" x 37½" x 42" (Model HC 900)
- · 26" x 371/2" x 54" (Model HC 1200)

#### ട്. 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<br>Features | Amsco Evolution Medium Steam<br>Sterilizer (Models HC-900 and HC-<br>1200) | Amsco Evolution Medium Steam<br>Sterilizer (K082435)<br>(Models HC-600 and HC-1500) |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | A steam sterilizer intended for<br>sterilization of non-porous and porous,<br>heat- and moisture-stable materials in<br>healthcare facilities. | A steam sterilizer intended for<br>sterilization of non-porous and porous,<br>heat- and moisture-stable materials in<br>healthcare facilities. |
| Operating Principle | Steam is the sterilizing agent. | Steam is the sterilizing agent. |
| Sterilization Cycles<br>Offered | Prevac<br>Gravity<br>SFPP<br>Liquid | Prevac<br>Gravity<br>SFPP<br>Liquid |
| Chamber Sizes | 26" x 26" x 39"<br>26" x 37.5" x 60" | 26" x 37.5" x 42"<br>26" x 37.5" x 54" |
| Chamber Door | Type 316L stainless steel<br>Vertical Sliding (26"x26")<br>Hinged or Horizontal Sliding<br>(26"x37½") | Type 316L stainless steel<br>Vertical Sliding (26"x26")<br>Hinged or Horizontal Sliding<br>(26"x37½") |
| Shell Assembly | Type 316L stainless steel<br>ASME certified | Type 316L stainless steel<br>ASME certified |
| Control Technology | Unity Controller<br>Touch Screen<br>8.4" Display<br>Ink on Paper Printer | Unity Controller<br>Touch Screen<br>8.4" Display<br>Ink on Paper Printer |
| Process Monitors | Chamber Transducer<br>Dual Element Chamber Drain Sensor | Chamber Transducer<br>Dual Element Chamber Drain Sensor |
| Safety Devices | Pressure Relief Valve<br>Chamber Float Switch<br>Control Lockout Switch | Pressure Relief Valve<br>Chamber Float Switch<br>Control Lockout Switch |

| Table 5-5. Summary of the Proposed and predicate Devices | | | | | |
|----------------------------------------------------------|--|--|--|--|--|
| | | | | | |

### 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 106 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 ANSI/AAMI ST8, Fourth Edition, November 2001.

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

{6}------------------------------------------------

- 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 stcrilizer 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 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 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 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 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 ANSVAAMI-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 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 ANSI/AAMI-ST8. These cycles demonstrated a sterility assurance level of at least 10° 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.
- All LIQUID cycles validated using three 1,000 ml flasks, described in Section � 5.5.3.1 of the ANSI/AAMI-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

{7}------------------------------------------------

an Fo value of at least 12, water loss not exceeding 50 ml, and automatic sealing of the flask closure. The liquid cycle is for non-patient contact use only.

- The DART cycle validated using the Bowie-Dick Test Pack, as described in o 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.

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.

{8}------------------------------------------------

### 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}------------------------------------------------

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/9/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circle around the eagle. The eagle is facing to the right.

#### JUN 29 2009

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Robert F. Sullivan Senior Director Steris Corporation 5960 Heisley Road Mentor Ohio 44060

... ... ... .. .. .. ..

Re: K091136

Trade/Device Name: Amsco Evolution Medium Steam Sterilization (Models HC-900 and HC-1200)

Regulation Number: 21 CFR 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: II Product Code: FLE Dated: June 17, 2009 Received: June 18, 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}------------------------------------------------

#### 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); 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 CER 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/cdrl/mdr/ 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Susan Penner

Susan Runner, D.D.S., M.A. Acting 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): K091136

Device Name:

Amsco Evolution Medium Steam Sterilizer (Models HC-900 and HC-1200)

Indications For Use:

The Amsco Evolution Medium Steam Sterilizer Models HC-900 and HC-1200 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 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<br>trays, maximum weight 25<br>lbs (11.3 kg) each and<br>Fabric Packs. Refer to<br>Table 4-3 for recommended<br>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<br>Table 4-3 for recommended<br>quantities. |
| Liquid* | 250°F (121°C) | 45 minutes | N/A | Refer to Table 4-4 for<br>recommended quantities. |
| Prevac | 275°F (135°C) | 3 minutes | 30 minutes | Double wrapped instrument<br>trays, maximum weight 25<br>lbs (11.3 kg) each. Refer to<br>Table 4-3 for recommended<br>quantities |

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

(Division Sign-Off)

Division of Anesthesiology, General Hospital

Infection Control, Dental Devices

510(k) Number:

{12}------------------------------------------------

### STERIS Response to 06/10/09 Request for Additional Information K091136/S001: Amsco Evolution Medium Steam Sterilizer (Models HC-900 and HC-1200)

| Cycles | Sterilize Temperature | Sterilize Time | Dry Time | Recommended Load |
|-----------------|-----------------------|----------------|------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Gravity | 270°F (132°C) | 15 minutes | 30 minutes | Double wrapped instrument<br>trays, maximum weight 25<br>lbs (11.3 kg) each. Refer to<br>Table 4-3 for recommended<br>quantities. |
| Gravity | 250°F (121°C) | 30 minutes | 30 minutes | Double wrapped instrument<br>trays, maximum weight 25<br>lbs (11.3 kg) each. Refer to<br>Table 4-3 for recommended<br>quantities. |
| Gravity | 270°F (132°C) | 25 minutes | 15 minutes | Fabric Packs. Refer to<br>Table 4-3 for recommended<br>quantities. |
| DART<br>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,<br>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 Medium Steam Flush Pressure-Pulse (SFPP) Sterilizer is equipped with the following factory-programmed sterilization cycles and cycle values (Table 4-2)

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

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

. .

{13}------------------------------------------------

### STERIS Response to 06/10/09 Request for Additional Information K091136/S001: Amsco Evolution Medium Steam Sterilizer (Models HC-900 and HC-1200)

: ..

. '

· ..

.

| Cycles | Sterilize<br>Temperature | Sterilize<br>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 | 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<br>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,<br>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:

| Sterilizer Size | Wrapped Instrument Trays | Fabric Packs |
|-------------------|--------------------------|--------------|
| 26" x 37 ½" x 42" | 12 | 18 |
| 26" x 37 ½" x 54" | 16 | 30 |

#### Table 4-3. Amsco Evolution Medium Steam Sterilizer recom 1 Parti .

·

{14}------------------------------------------------

The following table is a guideline for liquid cycle processing:

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

| Number of<br>Containers | Volume of Liquid In One<br>Container | Minimum Recommended<br>Sterilize Time at 250°F (121°C) |
|-------------------------|--------------------------------------|--------------------------------------------------------|
| 3 | 1000 ml | 45 minutes |

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

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

- 26" x 371/2" x 42" (Model HC 900) .
- 26" x 371/2' x 54" (Model HC 1200) .

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

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Shule H. Murphy
(Division-Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K091131