(14 days)
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 singleinstrument | 270°F (132°C) | 3 minutes | 1 minute |
| Flash | Unwrapped instrument tray with multiplenon-porous instruments, maximum weight 17pounds 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 |
2 A 270°F (132°C) cycle adjusted to 25 minute Sterilize Time can be used for processing fabric packs.
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.
The provided text describes the Amsco Century Steam Sterilizer and its various sterilization cycles, along with information about its effectiveness and safety. However, it does not contain a study that describes device performance against specific acceptance criteria. Instead, it states that the device's effectiveness is demonstrated by compliance with industry standards and the complete kill of biological indicators.
Here's an analysis based on the information available:
1. Table of acceptance criteria and the reported device performance:
The document doesn't explicitly lay out "acceptance criteria" in a typical table format with corresponding "device performance" results for a comparative study. Instead, it outlines the standard for effectiveness and states that the device meets it.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Complete kill of biological indicators | Demonstrated by complete kill of biological indicators. |
| Sterility Assurance Level (SAL) no greater than 10⁻⁶ (implied by "appropriate safety factor" and alignment with AAMI standards) | Sterility assurance level (SAL) or probability of surviving micro-organism that is no greater than 10⁻⁶ (stated as 10⁻⁶ in the text, but often implied by "no greater than 10⁻⁴" in common sterilization standards; the text explicitly states "no greater than 10⁻⁶"). |
| Compliance with ANSI/AAMI ST8:2001, "Hospital Steam Sterilizers" | The Amsco Century 135°C (275°F) for 3-minute prevac steam sterilization cycle was validated to meet the requirements of ANSI/AAMI ST8:2001, "Hospital Steam Sterilizers", November 11, 2001. |
| Compliance with safety standards | - 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. |
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 provide details on the specific sample size of biological indicators or test loads used in the validation study. The data provenance is not explicitly stated as a "country of origin" but implies internal testing by STERIS Corporation, which is based in Erie, Pennsylvania, USA. The validation is described as an "effectiveness" demonstration, which implicitly would be prospective testing using biological indicators and sterilization challenges.
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):
This information is not applicable and not provided. The ground truth for sterilization effectiveness is based on scientific principles of microbial inactivation and established by regulatory standards (like AAMI ST8) and verified by biological indicator testing, not expert consensus on image interpretation or similar diagnostic tasks.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This is not applicable to a sterilization validation study. Adjudication methods are typically used in studies involving subjective assessment (e.g., medical image interpretation) where multiple reviewers' opinions need to be reconciled.
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 is not applicable. The device is a steam sterilizer, not an AI-assisted diagnostic tool or an imaging system that would involve human readers or cases.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This is implicitly stated. The validation of the sterilizer's "effectiveness" (complete kill of biological indicators and SAL achievement) refers to the performance of the machine and its cycles without human "in-the-loop" performance during the sterilization process itself. The sterilizer operates autonomously once the cycle is initiated.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth used for effectiveness is the complete kill of biological indicators and the achievement of a specified Sterility Assurance Level (SAL), which is a quantitative measure of the probability of a surviving microorganism. This is based on microbiological principles and validated against recognized international standards (ANSI/AAMI ST8:2001).
8. The sample size for the training set:
This is not applicable. Sterilization validation does not involve training sets in the context of machine learning or AI.
9. How the ground truth for the training set was established:
This is not applicable. As stated above, sterilization validation does not involve training sets in this context.
{0}------------------------------------------------
510(k) SUMMARY
MAR 2 6 2003
Submitter Information Lori Haller STERIS Corporation Manager, Regulatory Affairs 2424 West 23rd Street Erie, Pennsylvania 16506 (814) 870-8559 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.
{1}------------------------------------------------
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.
{2}------------------------------------------------
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.
{3}------------------------------------------------
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 (301) 594-4618. 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 (800) 638-2041 or (301) 443-6597 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
{4}------------------------------------------------
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 singleinstrument | 270°F (132°C) | 3 minutes | 1 minute |
| Flash | Unwrapped instrument tray with multiplenon-porous instruments, maximum weight 17pounds 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 |
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
§ 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).