AMSCO CENTURY STEAM STERILIZER

K030789 · STERIS Corporation · FLE · Mar 26, 2003 · General Hospital

Device Facts

• Record ID: K030789
• Device Name: AMSCO CENTURY STEAM STERILIZER
• Applicant: STERIS Corporation
• Product Code: FLE · General Hospital
• Decision Date: Mar 26, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.6880
• Device Class: Class 2

Intended Use

The Amsco Century Steam Sterilizer is designed for efficient sterilization of non-porous and porous, heat and moisturestabile materials used in healthcare facilities. The Amsco Century Steam Sterilizer is available in the following configurations: 16" x 16" x 26" Single Door Gravity* 16" x 16" x 26" Double Door Gravity 20" x 20" x 38" Single Door Gravity 20" x 20" x 38" Double Door Gravity 16" x 16" x 26" Single Door Prevacuum 16" x 16" x 26" Double Door Prevacuum 20" x 20" x 38" Single Door Prevacuum 20" x 20" x 38" Double Door Prevacuum *Note: No changes are being made to the gravity sterilizers program.

Device Story

Amsco Century Steam Sterilizer provides terminal sterilization for heat/moisture-stable medical materials. Device operates via factory-programmed steam sterilization cycles (Flash, Express, Prevac, Gravity) using specific temperature, time, and drying parameters. Microprocessor controller monitors cycle conditions; aborts cycle and provides alerts/warnings upon malfunction or failure to meet required conditions. Used in healthcare facilities; operated by trained personnel. Output consists of sterilized instruments/packs. Benefits include reduction of cross-contamination risk through validated sterilization processes.

Clinical Evidence

Bench testing only. Sterilization cycles validated per ANSI/AAMI ST8:2001 standards. Effectiveness demonstrated by complete kill of biological indicators and achievement of sterility assurance level (SAL) ≤ 10^-6.

Technological Characteristics

Steam sterilizer; microprocessor-controlled. Complies with UL 3101, CSA C22.2 No. 1010-1, and ASME Section VIII, Division 1. Available in multiple chamber sizes (16"x16"x26" and 20"x20"x38").

Indications for Use

Indicated for terminal sterilization of non-porous and porous, heat and moisture-stable materials in healthcare facilities. Loads include unwrapped instruments, wrapped instrument trays, and fabric packs.

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

• Eagle Century Steam Sterilizer (K964332)
• Castle 400HC/500HC Series Steam Sterilizer (K012573)

Submission Summary (Full Text)

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### 510(k) SUMMARY

K030789

MAR 2 6 2003

Submitter Information Lori Haller STERIS Corporation Manager, Regulatory Affairs 2424 West 23rd Street Erie, Pennsylvania 16506 [phone] Date Summary Prepared: March 10, 2003

### Introduction

The Amsco Century Steam Sterilizer is a Class II medical device as defined by 21 CFR 880.6880. This sterilizer is intended for the terminal sterilization of non-porous, heat and moisture-stabile materials used in healthcare facilities. The Amsco Century Steam Sterilizer is substantially equivalent with the predicate device Eagle Century Steam Sterilizer, K964332, cleared June 1, 1998 and also substantially equivalent to Castle 400HC/500HC Series Steam Sterilizer, K012573, cleared September 5, 2001 for the 135℃ (275°F) for 3 minutes prevac cycle claim.

The Amsco Century Prevaum Steam Sterlizer (16" x 26" x 20" x 38") is equipped with the following factory-programmed sterilization cycle values:

| Cycle | Recommended Loads | Sterilize Temp | Sterilize Time | Dry Time |
|---------|-------------------------------------------------------------------------------------------------------|----------------|----------------|-------------|
| Flash | Unwrapped instrument tray with a single instrument | 270°F (132°C) | 3 minutes | 1 minute |
| Flash | Unwrapped instrument tray with multiple non-porous instruments, maximum weight 17 pounds per tray. | 270°F (132°C) | 10 minutes | 1 minute |
| Express | Single wrapped instrument tray with a single instrument. Non-porous goods only. | 270°F (132°C) | 4 minutes | 3 minutes |
| Prevac | Up to two double wrapped instrument trays, maximum weight 17 pounds per tray. Up to six fabric packs. | 270°F (132°C) | 4 minutes | 20 minutes¹ |
| Prevac | Up to two double wrapped instrument trays, maximum weight 17 pounds per tray. | 275°F (135°C) | 3 minutes | 16 minutes |

#### Prevacuum Configuration

1Five minute dry time can be used for processing a single fabric pack.

The Amsco Century Graniy Steam Sterilizer (16'' x 26' and 20" x 20" x 38") is equipped with the following factory-programmed sterilization cycle values:

### Gravity Configuration

| Cycle | Recommended Loads | Sterilize Temp | Sterilize Time | Dry Time |
|---------|----------------------------------------------------------------------------------------------------|----------------|----------------|------------|
| Flash | Unwrapped instrument tray with a single instrument | 270°F (132°C) | 3 minutes | 1 minute |
| Flash | Unwrapped instrument tray with multiple non-porous instruments, maximum weight 17 pounds per tray. | 270°F (132°C) | 10 minutes | 1 minute |
| Gravity | Up to two double wrapped instrument trays, maximum weight 17 pounds per tray. | 270°F (132°C) | 15 minutes | 30 minutes |
| Gravity | Fabric Packs up to six Fabric Packs | 250°F (121°C) | 30 minutes2 | 15 minutes |

2A 270ºF (132ºC) cycle adjusted to 25 minute Sterilize Time can be used for processing fabric packs.

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### Effectiveness

Effectiveness of sterilizer function and exposure time recommendations is demonstrated by complete kill of biological indicators and by verifying an appropriate safety factor that is a sterility assurance level (SAL) or probability of surviving micro-organism that is no greater than 104. 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 Century 135°C (275°F) for 3-minute prevac steam sterlization cycle was validated to meet the requirements of ANSI/AAMI ST8:2001, "Hospital Steam Sterilizers", November 11, 2001.

# Safety

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

- Underwriters Laboratory (UL) Electromedical Code 3101 as 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 patient infections that have resulted from steam sterilizer failures. The technology designed into STERIS steam sterilizers including the Amsco Century Steam Sterilizer provides microprocessor 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 health care facilities.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol that resembles a bird or a series of interconnected human profiles, rendered in black.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# MAR 2 6 2003

Ms. Lori A. Haller Manager, Regulatory Affairs Steris Corporation 2424 West 23rd Street Erie, Pennsylvania 16506

Re: K030789

Trade/Device Name: AMSCO Century Steam Sterilizer Regulation Number: 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: II Product Code: FLE Dated: March 11, 2003 Received: March 12, 2003

Dear Ms. Haller:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Haller

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 Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/dsma/dsmamain.html

Sincerely yours,

Susan Runore

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### INDICATIONS FOR USE STATEMENT

#### Device Name:

· Amsco Century Steam Sterilizer

#### Indications for Use:

The Amsco Century Steam Sterilizer is designed for efficient sterilization of non-porous and porous, heat and moisturestabile materials used in healthcare facilities. The Amsco Century Steam Sterilizer is available in the following configurations:

16" x 16" x 26" Single Door Gravity* 16" x 16" x 26" Double Door Gravity 20" x 20" x 38" Single Door Gravity 20" x 20" x 38" Double Door Gravity

16" x 16" x 26" Single Door Prevacuum 16" x 16" x 26" Double Door Prevacuum 20" x 20" x 38" Single Door Prevacuum 20" x 20" x 38" Double Door Prevacuum

*Note: No changes are being made to the gravity sterilizers program.

The Amsco Century Steam Sterilizer is equipped with the following factory-programmed set sterilization cycle values:

| Cycle | Recommended Loads | Sterilize Temp | Sterilize Time | Dry Time |
|---------|-------------------------------------------------------------------------------------------------------|----------------|----------------|-------------|
| Flash | Unwrapped instrument tray with a single instrument | 270°F (132°C) | 3 minutes | 1 minute |
| Flash | Unwrapped instrument tray with multiple non-porous instruments, maximum weight 17 pounds per tray. | 270°F (132°C) | 10 minutes | 1 minute |
| Express | Single wrapped instrument tray with a single instrument. Non-porous goods only. | 270°F (132°C) | 4 minutes | 3 minutes |
| Prevac | Up to two double wrapped instrument trays, maximum weight 17 pounds per tray. Up to six fabric packs. | 270°F (132°C) | 4 minutes | 20 minutes¹ |
| Prevac | Up to two double wrapped instrument trays, maximum weight 17 pounds per tray. | 275°F (135°C) | 3 minutes | 16 minutes |

#### Prevacuum Configuration

1Five minute dry time can be used for processing a single fabric pack.

#### Gravity Configuration

| Cycle | Recommended Loads | Sterilize Temp | Sterilize Time | Dry Time |
|---------|----------------------------------------------------------------------------------------------------------|----------------|----------------|------------|
| Flash | Unwrapped instrument tray with a single<br>instrument | 270°F (132°C) | 3 minutes | 1 minute |
| Flash | Unwrapped instrument tray with multiple<br>non-porous instruments, maximum weight 17<br>pounds per tray. | 270°F (132°C) | 10 minutes | 1 minute |
| Gravity | Up to two double wrapped instrument trays,<br>maximum weight 17 pounds per tray. | 270°F (132°C) | 15 minutes | 30 minutes |
| Gravity | Fabric Packs up to six Fabric Packs | 250°F (121°C) | 30 minutes2 | 15 minutes |

2 A 270°F (132°C) cycle adjusted to 25 minute Sterilize Time can be used for processing fabric packs.

(Please Do Not Write Below This Line - Continue on Another Page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE)

Concurrence of CDRH, Office of Device Evaluation (

Prescription Use (Per 21 CFR 801.109) OR

Over-the-counter Use

(Optional Formal Quision Sign

510(k) Number. K030789