(579 days)
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 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 STERIS Eagle Century Steam Sterilizer is a Class II medical device used for the terminal sterilization of heat and moisture-stabile materials.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criterion for sterilization is achieving a Sterility Assurance Level (SAL) of less than 10^-6 (probability of less than one chance out of one million of a non-sterile indicator). The device's performance is reported by demonstrating complete kill of biological indicators and verifying this SAL.
A summary of the device's performance against its intended cycles and loads is provided in the tables below. These tables represent the reported performance as validated by STERIS.
Prevacuum Configuration - Performance Summary
| 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 17lbs. each). Up to six fabric packs. |
| *Note: Five minutes dry time can be used for processing a single fabric pack. |
Gravity Configuration - Performance Summary
| 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 (121°C) | 30 minutes | 15 minutes | Fabric Packs |
| *Note: A 270°F (132°C) cycle adjusted to 25 minute Sterilize Time can be used for processing Fabric Packs. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state a specific "sample size" for the test set in terms of number of sterilization cycles or tests performed. However, it does refer to "Validation Studies" which imply testing was conducted.
The data provenance is presented as internal validation studies conducted by STERIS Corporation to comply with U.S. standards (AAMI-ST8 and AAMI-ST37). This suggests the data is retrospective as it has been collected and analyzed for submission. The country of origin for the data is implicitly the United States, given the reference to U.S. standards and the company's location.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
The document does not specify the number or qualifications of individual experts. However, it states that 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)." This indicates that the "ground truth" (the definition of effective sterilization) is established by widely recognized industry standards and guidance, rather than by a specific panel of individual experts for this particular submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe an adjudication method for the test set. The validation process relies on meeting established benchmarks (complete kill of biological indicators and SAL < 10^-6) as defined by AAMI standards, rather than expert consensus on individual test results.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This question is not applicable to the provided document. The device is a steam sterilizer, not an AI-assisted diagnostic or imaging tool involving "human readers" or "cases" in the medical imaging sense. The study described is a device validation study, not a comparative effectiveness study involving human interpretation with and without AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not directly applicable in the typical sense of "standalone AI performance." However, the validation studies described are effectively "standalone" in the context of the sterilizer's function. The sterilizer operates autonomously through its programmed cycles. Its performance is evaluated based on its ability to achieve sterility without human intervention in the sterilization process itself (beyond loading, selecting cycles, and maintenance). The "algorithm" here refers to the device's internal control system that executes the sterilization cycles. The validation studies demonstrate the efficacy of these programmed cycles.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the validation studies is based on:
- Biological Indicators: Demonstrated complete kill of biological indicators (which contain highly resistant bacterial spores).
- Sterility Assurance Level (SAL): Verification of an SAL of less than 10^-6.
- Compliance with Standards: Adherence to recommended practices, standards, and guidelines established by organizations like AAMI (e.g., AAMI-ST8 for hospital sterilizers, AAMI-ST37 for flash sterilization). These standards themselves are derived from extensive scientific research and expert consensus within the field of sterilization.
8. The sample size for the training set
This question is not applicable. The device is a physical steam sterilizer, not a machine learning or AI model that requires a "training set" of data in the computational sense. The design and engineering of the sterilizer would be based on scientific principles and engineering specs, not iterative training on data.
9. How the ground truth for the training set was established
This question is not applicable for the same reasons as #8. There is no "training set" for a steam sterilizer in the context of machine learning. The "ground truth" for the device's design and operation principles would be established through established scientific and engineering principles for steam sterilization, regulatory requirements, and industry standards.
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JUN 1 1998
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 (440) 354-2600 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 witha Single Instrument |
| FLASH | 270°F (132°C) | 10 minutes | 1 minute | Unwrapped Instrument Tray withnon-porous multiple instruments(maximum weight of 17lbs) |
| EXPRESS | 270°F (132°C) | 4 minutes | 3 minutes | Single Wrapped Instrument Traywith a single instrument. Non-porous goods only. |
| PREVAC | 270°F (132°C) | 4 minutes | 20 minutes* | Up to two double wrappedinstrument trays (maximumweight 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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| CYCLES | STERILIZE TEMP. | STERILIZE TIME | DRY TIME | RECOMMENDED LOAD |
|---|---|---|---|---|
| FLASH | 270°F (132°C) | 3 minutes | 1 minute | Unwrapped Instrument tray witha single instrument |
| FLASH | 270°F (132°C) | 10 minutes | 1 minute | Unwrapped Instrument Tray withnon-porous multiple instruments(maximum weight of 17 lbs.) |
| GRAVITY | 270°F (132°C) | 15 minutes | 30 minutes | Up to two double wrappedinstrument trays (maximumweight of 17lbs. each) |
| GRAVITY* | 250°F (132°C) | 30 minutes | 15 minutes | Fabric Packs |
GRAVITY CONFIGURATION
- 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-ST8'. 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
Association for the Advancement of Medical Instrumentation, "Hospital Steam Sterilizers", ANSUAAMI-ST8-1994 (revision of ANSI/AAMI-ST8-1988).
2 Association for the Advancement of Medical Instrumentation, "Flash 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:
- Underwriters Laboratory (UL) Electromedical Code 544 as certified by ETL 1. Testing Laboratories, Inc .;
- Canadian Standards Association (CSA) Standard C22.2 No. 125 or 151; 2.
- American Society of Mechanical Engineers (ASME), Section VIII, Division 1 కి. for unfired pressure vessels;
- American Society of Mechanical Engineers (ASME), Section I, Part PMB for 4. power boilers;
- રું. California Seismic Pre-Approval; and
- National Fire Protection Association Standard 99. 6.
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.
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Image /page/4/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 image of three human profiles facing right, arranged in a way that they appear to be connected or overlapping. The profiles are simple and abstract, with flowing lines that suggest movement or connection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN । 1998
Mr. Raymond Ursick · Senior Director Regulatory Affairs and Quality Systems STERIS Corporation 2424 West 23rd Street Erie, Pennsylvania 16506
K964332 Re : Eagle Century Steam Sterilizer Trade Name: Requlatory Class: II Product Code: FLE March 12, 1998 Dated: 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 reqistration, 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 Requlations, 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 General requlation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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 enrough Siz or on Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA acboirison in formalence 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 (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its internet address
"http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours
Timothy A. Ulatowski
Timo 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 USE Ch
EAGLE CENTURY STEAM STERILIZER DEVICE NAME:
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" Single Door Prevacuum |
|---|---|
| 16" x 16" x 26" Double Door Gravity | 16" x 16" x 26" Double Door Prevacuum |
| 20" x 20" x 38" Single Door Gravity | 20" x 20" x 38" Single Door Prevacuum |
| 20" x 20" x 38" Double Door Gravity | 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 | RECOMMENDEDLOADS | STERILIZETEMP. | STERILIZETIME | DRY TIME |
|---|---|---|---|---|
| FLASH | UnwrappedInstrument tray with asingle instrument | 270°F(132°C) | 3 minutes | 1 minute |
| FLASH | Unwrapped instrumenttray with non-porousmultiple instruments,maximum weight17lbs | 270°F(132°C) | 10 minutes | 1 minute |
| EXPRESS | Single wrappedinstrument tray with asingle instrument.Non-porous goodsonly. | 270°F(132°C) | 4 minutes | 3 minutes |
| PREVAC | Up to two doublewrapped instrumenttrays, maximumweight 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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USC I NO ICATIONS OR
GRAVITY CONFIGURATION
| CYCLES | RECOMMENDEDLOAD | STERILIZETEMP. | STERILIZETIME | DRY TIME |
|---|---|---|---|---|
| FLASH | UnwrappedInstrument tray witha single instrument. | 270°F(132°C) | 3 minutes | 1 minute |
| FLASH | UnwrappedInstrument tray withnon-porous multipleinstruments,maximum weight17lbs | 270 °F(132°C) | 10 minutes | 1 minute |
| GRAVITY | Up to two doublewrapped instrumenttrays, maximumweight 17lbs | 270°F(132°C) | 15 minutes | 30 minutes |
| GRAVITY | 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)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
Reorge A. Miller for
Q, s, 7, a
(Optional Format 1-2-96)
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number req
§ 880.6880 Steam sterilizer.
(a)
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.(b)
Classification. Class II (performance standards).