EAGLE CENTURY STEAM STERILIZER

K964332 · Amsco Intl., Inc. · FLE · Jun 1, 1998 · General Hospital

Device Facts

• Record ID: K964332
• Device Name: EAGLE CENTURY STEAM STERILIZER
• Applicant: Amsco Intl., Inc.
• Product Code: FLE · General Hospital
• Decision Date: Jun 1, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6880
• Device Class: Class 2

Intended Use

The STERIS Eagle Century Steam Sterilizer is designed for efficient, sterilization of non-porous and porous, heat and moisture-stabile materials used in healthcare facilities.

Device Story

Eagle Century Steam Sterilizer; sliding door unit; prevacuum or gravity configurations. Operates by exposing heat/moisture-stabile materials to saturated steam at controlled temperatures/times. Microprocessor controller monitors cycle parameters; aborts cycle and provides alerts if conditions unmet or malfunction occurs. Used in healthcare facilities; operated by trained personnel. Output includes sterilization of medical instruments/fabric packs. Benefits patient by reducing risk of cross-contamination/infection via effective sterilization. Includes leak test and Daily Air Removal Test (DART) cycles for system integrity verification.

Clinical Evidence

No clinical data. Validation performed via bench testing per AAMI-ST8 (hospital steam sterilizers) and AAMI-ST37 (flash sterilization). Efficacy demonstrated by achieving sterility assurance level (SAL) of <10⁻⁶ and complete kill of biological indicators.

Technological Characteristics

Steam sterilizer; prevacuum or gravity configurations; sliding door. Materials: ASME-certified pressure vessels. Energy: Saturated steam (house steam or electric generator). Connectivity: Microprocessor controller for cycle management. Standards: AAMI-ST8, AAMI-ST37, UL 544, CSA C22.2, ASME Section VIII/I, NFPA 99. Features: Leak test, DART cycle, liquid cycle.

Indications for Use

Indicated for sterilization of non-porous and porous, heat and moisture-stabile materials in healthcare facilities. Applicable to wrapped and unwrapped 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.

Submission Summary (Full Text)

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# A 510(k) SUMMARY PERTAINING TO THE SAFETY AND EFFECTIVENESS OF THE EAGLE CENTURY STEAM STERILIZER

## Submitter Information

STERIS Corporation
Raymond Ursick
Senior Director
Regulatory Affairs and Quality Systems
5960 Heisley Road
Mentor, Ohio 44060
[phone] Phone
Date Summary Prepared: March 5, 1998

## Introduction

The AMSCO brand Eagle Century Steam Sterilizer is a Class II medical device as defined by 21 CFR §880.6880. The Eagle Century Steam Sterilizer is a sliding door sterilizer, offered in either a prevacuum or gravity configuration, intended for the terminal sterilization of heat and moisture-stabile materials.

The Eagle Century Steam Sterilizer is offered for sale with the following factory-set sterilization cycles and cycle values:

### PREVACUUM CONFIGURATION*

| CYCLES | STERILIZE TEMP. | STERILIZE TIME | DRY TIME | RECOMMENDED LOAD |
| --- | --- | --- | --- | --- |
| FLASH | 270°F (132°C) | 3 minutes | 1 minute | Unwrapped Instrument Tray with a Single Instrument |
| FLASH | 270°F (132°C) | 10 minutes | 1 minute | Unwrapped Instrument Tray with non-porous multiple instruments (maximum weight of 17lbs) |
| EXPRESS | 270°F (132°C) | 4 minutes | 3 minutes | Single Wrapped Instrument Tray with a single instrument. Non-porous goods only. |
| PREVAC | 270°F (132°C) | 4 minutes | 20 minutes* | Up to two double wrapped instrument trays (maximum weight of lbs. each). Up to six fabric packs. |

*Five minutes dry time can be used for processing a single fabric pack.
Also offered with the Prevacuum configuration are the Leak Test Cycle that provides verification of door seal and piping system integrity, and the Daily Air Removal Test (DART) Cycle that provides verification of effective removal of residual air in the chamber and load during testing when combined with a DART or Bowie-Dick test pack.

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# GRAVITY CONFIGURATION

| CYCLES | STERILIZE TEMP. | STERILIZE TIME | DRY TIME | RECOMMENDED LOAD |
| --- | --- | --- | --- | --- |
| FLASH | 270°F (132°C) | 3 minutes | 1 minute | Unwrapped Instrument tray with a single instrument |
| FLASH | 270°F (132°C) | 10 minutes | 1 minute | Unwrapped Instrument Tray with non-porous multiple instruments (maximum weight of 17 lbs.) |
| GRAVITY | 270°F (132°C) | 15 minutes | 30 minutes | Up to two double wrapped instrument trays (maximum weight of 17lbs. each) |
| GRAVITY* | 250°F (132°C) | 30 minutes | 15 minutes | Fabric Packs |

*A 270°F (132°C) cycle adjusted to 25 minute Sterilize Time can be used for processing Fabric Packs.

## Effectiveness

Efficacy of sterilizer function and exposure time recommendations are ultimately shown by showing complete kill of biological indicators and verifying an appropriate safety factor or sterility assurance level (SAL) of less than 10⁶ (probability of less than one chance out of one million of a non-sterile indicator). STERIS validates its sterilization cycles by recommended practices, standards and guidelines developed by various independent organizations such as the Association for Advancement of Medical Instrumentation (AAMI).

The results of the Eagle Century Validation demonstrate that the sterilizer performs as intended and are summarized as follows:

- Validation Studies for Compliance to AAMI-ST8¹. This standard establishes the minimum construction and performance requirements for hospital sterilizers that use saturated steam as the sterilizing agent and have a volume greater than 2 cubic feet. The Eagle Century Steam Sterilizer cycles validated per AAMI-ST8 are the 250°F Gravity, 270°F Prevac and the DART test.
- Validation Studies for Compliance to AAMI-ST37². This recommended practice covers flash sterilization in health care facilities and includes guidelines for sterilization processing procedures. The Eagle Century Steam Sterilizer cycles validated per AAMI-ST37 are the 270°F Flash and the 270°F Express.
- Validation Studies for Century with Electric Steam Generator. The customer has the choice to operate the Eagle Century on house steam, an independently purchased steam generator or a generator supplied by STERIS. STERIS conducted testing of the Century with the Electric Steam Generator to ensure that the generator recommended

¹Association for the Advancement of Medical Instrumentation, “Hospital Steam Sterilizers”, ANSI/AAMI-ST8-1994 (revision of ANSI/AAMI-ST8-1988).

²Association for the Advancement of Medical Instrumentation, “Flash Sterilization: Steam Sterilization of patient care items for immediate use”, ANSI/AAMI-ST37-1996, (Revision of ANSI/AAMI-ST37-1992).

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would provide sufficient efficiency to perform sterilization cycles. The Eagle Century Steam Sterilizer cycles validated with the Electric Steam Generator are the 270°F Prevac, 270°F Gravity and the 250°F Liquid.

♦ Validation Studies for Century for Liquid Cycle Efficacy. The Eagle Century Steam Sterilizer optional Liquid Cycle was validated to ensure that 100ml, 1000ml and 2000ml liquid loads with vented self-sealing closures processed properly.

## Safety

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

1. Underwriters Laboratory (UL) Electromedical Code 544 as certified by ETL Testing Laboratories, Inc.;
2. Canadian Standards Association (CSA) Standard C22.2 No. 125 or 151;
3. American Society of Mechanical Engineers (ASME), Section VIII, Division 1 for unfired pressure vessels;
4. American Society of Mechanical Engineers (ASME), Section I, Part PMB for power boilers;
5. California Seismic Pre-Approval; and
6. National Fire Protection Association Standard 99.

A Reliability Analysis and Failure Modes and Effects and Criticality Analysis has been conducted on the Eagle Century Steam Sterilizer’s electrical system, mechanical system and piping system as well.

## 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 the materials, instruments and devices to be sterilized are thoroughly cleaned, that the manufacturer’s instructions for use are followed, that the cycle to be used for each type of sterilizer load has been validated, that the sterilizer has been maintained in accordance with the sterilizer manufacturer’s recommended maintenance schedule and is operating properly, and that 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 considering the widespread use of steam sterilizers. Further, there are no known reports in the literature of patient infections that have resulted from steam sterilizer failure. The technology designed in AMSCO brand steam sterilizers including the Eagle Century 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.

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## User Information

STERIS conducts in-house user 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’s 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.

MAY 28'98 07:42 814-870-8233 STERIS CONC. ENGR/RD 906 P32

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DEPARTMENT OF HEALTH &amp; HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

JUN 1 1998

Mr. Raymond Ursick
Senior Director
Regulatory Affairs and Quality Systems
STERIS Corporation
2424 West 23rd Street
Erie, Pennsylvania 16506

Re: K964332
Trade Name: Eagle Century Steam Sterilizer
Regulatory Class: II
Product Code: FLE
Dated: March 12, 1998
Received: March 13, 1998

Dear Mr. Ursick:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski
Director
Division of Dental, Infection Control, and General Hospital Devices
Office of Device Evaluation
Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

# DEVICE NAME: EAGLE CENTURY STEAM STERILIZER

# INDICATIONS FOR USE

The STERIS Eagle Century Steam Sterilizer is designed for efficient, sterilization of non-porous and porous, heat and moisture-stabile materials used in healthcare facilities. The Eagle 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

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

Prevacuum Configuration

| CYCLES | 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 non-porous mutiple instruments, maximum weight 17lbs | 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 17lbs. Up to six fabric packs. | 270°F (132°C) | 4 minutes | 20 minutes¹ |

¹Five minute Dry Time can be used for processing a single fabric pack.

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# GRAVITY CONFIGURATION

| CYCLES | RECOMMENDED LOAD | 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 non-porous multiple instruments, maximum weight 17lbs | 270°F (132°C) | 10 minutes | 1 minute |
| GRAVITY | Up to two double wrapped instrument trays, maximum weight 17lbs | 270°F (132°C) | 15 minutes | 30 minutes |
| GRAVITY | Fabric Packs | 250°F (121°C) | 30 minutes² | 15 minutes |

²A 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)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

George A. Miller for Jim S. Lin PhD
(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices
510(k) Number K964332

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