(130 days)
Not Found
No
The summary describes a steam sterilizer with various pre-programmed cycles and validation against established standards. There is no mention of AI, ML, or any technology that learns or adapts based on data.
No
Explanation: This device is designed for sterilization of materials used in healthcare facilities, not for treating patients.
No
Explanation: The device is a sterilizer for materials used in healthcare facilities. Its function is to sterilize, not to diagnose.
No
The device is a steam sterilizer, which is a piece of hardware. While it contains software for cycle operation, it is not a software-only medical device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is for the sterilization of heat and moisture-stable materials used in healthcare facilities. This is a process to render medical devices and materials sterile, not to perform tests on biological samples or specimens.
- Device Description: The description details a steam sterilizer with different cycle types for sterilization. It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases
- Using reagents or calibrators for testing
The device is clearly designed for the physical process of sterilization, which is a crucial step in healthcare but distinct from in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Amsco Evolution Medium Steam Sterilizer models HC-600 and HC-1500 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.
Product codes
FLE
Device Description
The Amsco Evolution Medium Steam Sterilizer is designed for sterilization of heat and moisture-stabile 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 Steam Sterilizer is offered in the following chamber sizes:
- 26" x 26" x 39" (660 mm x 660 mm x 991 mm) HC-600
- HC-1500 . 26" x 37½" x 60" (660mm x 950mm x 1524mm)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare facilities
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 10-6 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 Sterilizer was validated to meet the requirements of ANSVAAMI ST8, Fourth Edition, November 2001.
The results of the Amsco Evolution Steam Sterilizer validation studies demonstrate that the sterilizer performs as intended. The results are summarized as follows:
- 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 sterilizer 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 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 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 ANSVAAMI-ST8, were qualified according to Section 5.5.2 ANSVAAMI-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 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 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 ANSVAAMI-ST8. These cycles demonstrated a sterility assurance level of at least 100 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, 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 an Fo value of at least 12, water loss not exceeding 50 ml, and automatic sealing of the flask closure.
- The DART cycle validated using the Bowie-Dick Test Pack, as described in 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)."
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
STERIS®
DEC 3 0 2008
Image /page/0/Picture/3 description: The image shows a black and white abstract pattern. The pattern consists of a series of horizontal lines that are stacked on top of each other. The lines are not straight, but rather have a wavy or jagged appearance. The overall effect is one of texture and movement.
510(k) Summary For Amsco Evolution Medium Steam Sterilizer
STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 639-4459
Contact:
Robert F. Sullivan. Sr Director FDA Regulatory Affairs Telephone: (440) 392-7695 Fax No: (440) 357-9198
Summary Date:
December 29, 2008
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
December 29, 2008
1
1. Device Name
| Trade Name: | Amsco Evolution Medium Steam Sterilizer |
|---|---|
| Common/usual Name: | Amsco Evolution Medium Steam Sterilizer |
| Classification Name: | Steam Sterilizer (21 CFR 880.6880, Product Code |
| FLE. |
2. Predicate Devices
- K010865, Amsco Century Medium Steam Sterilizer, product code [FLE] . cleared May 31, 2001.
- K020747 Amsco Century Medium Steam Sterilizer, product code [FLE] . cleared May 17, 2002.
3. Description of Device
The Amsco Evolution Medium Steam Sterilizer is designed for sterilization of heat and moisture-stabile 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 Steam Sterilizer is offered in the following chamber sizes:
- 26" x 26" x 39" (660 mm x 660 mm x 991 mm) � HC-600
- HC-1500 . 26" x 37½" x 60" (660mm x 950mm x 1524mm)
4. Intended Use
The Amsco Evolution Medium Steam Sterilizer models HC-600 and HC-1500 are designed for sterilization of heat and moisture-stabile 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 cycles values (Table 5-1):
| Cycles | Sterilize Temperature | Sterilize 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. Fabric | ||||
| Packs. Refer to Table 5-3 | ||||
| for recommended | ||||
| quantities. | ||||
| Prevac | ||||
| Gravity | 250°F (121°C) | |||
| 270°F (132°C) | 4 minutes | |||
| 30 minutes | 5 minutes | |||
| 15 minutes | Single Fabric Pack | |||
| Fabric Packs. Refer to | ||||
| Table 5-3 for recommended | ||||
| quantities. | ||||
| Liquid* | 250°F (121°C) | 45 minutes | N/A | Refer to Table 5-4 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 5-3 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 5-3 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 5-3 for recommended | ||||
| quantities. | ||||
| Gravity | 270°F (132°C) | 25 minutes | 15 minutes | Fabric Packs. Refer to |
| Table 5-3 for recommended | ||||
| quantities. | ||||
| DART | ||||
| 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, |
| 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, | ||||
| maximum weight 25 lbs | ||||
| (11.3 kg) each. Fabric | ||||
| Packs. Refer to Table 5-3 | ||||
| for recommended | ||||
| quantities. | ||||
| SFPP | 275°F (135°C) | 3 minutes | 30 minutes | Double wrapped |
| instrument trays, | ||||
| maximum weight 25 lbs | ||||
| (11.3 kg) each. Refer to | ||||
| Table 5-3 for | ||||
| recommended quantities. | ||||
| Prevac | 270°F (132°C) | 4 minutes | 30 minutes | Double wrapped |
| instrument trays, | ||||
| maximum weight 25 lbs | ||||
| (11.3 kg) each. Fabric | ||||
| Packs. Refer to Table 5-3 | ||||
| for recommended | ||||
| quantities. | ||||
| Gravity | 250°F (121°C) | 30 minutes | 15 minutes | Fabric Packs. Refer to |
| Table 5-3 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 5-3 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 5-3 for | ||||
| recommended quantities. | ||||
| Liquid* | 250°F (121°C) | 45 minutes | N/A | Refer to Table 5-4 for |
| recommended quantities. | ||||
| DART | ||||
| 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, |
| DART Test Pack | ||||
| Leak Test | N/A | N/A | N/A | N/A |
Table 5-1. 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 5-2);
Table 5-2. Amsco Evolution Medium Steam Flush Pressure-Pulse (SFPP) Sterilizer factory-programmed sterilization cycles and cycle values
December 29, 2008
・・・・・
4
STERIS Response to 12/23/08 Request for Additional Information K082435 / Amsco Evolution Medium Steam Sterllizer
*The liquid cycle is for non-patient contact use only.
The following table (Table 5-3) lists STERIS's recommended loads by sterilizer size:
Table 5-3. Amsco Evolution Medium Steam Sterilizer recommended loads
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The following table (Table 5-4) provides a guideline for liquid cycle processing. The liquid cycle is for non-patient contact use only.
Table 5-4. Amsco Evolution Medium Steam Sterilizer liquid cycle processing guideline
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The Amsco Evolution Medium Steam Sterilizer is offered in the following chamber sizes:
- . Model HC-600 26" x 26" x 39" (660 mm x 660 mm x 991 mm)
- 26'' x 37½' x 60" (660mm x 950mm x 1524mm) . Model HC-1500
Description of Safety and Substantial Equivalence ഗ്
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
Features | Amsco Evolution
Medium Steam
Sterilizer (subject of this
Abbreviated 510(k)
submission) | Amsco Century
Medium Steam
Sterilizer 26" x 26"
(K020747, cleared
05/17/02) | Amsco Century
Medium Steam
Sterilizer (K010865,
cleared 5/31/01) |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | A steam sterilizer
intended for sterilization
of non-porous and porous,
heat- and moisture-stabile
materials in healthcare
facilities. | A steam sterilizer
intended for sterilization
of non-porous and
porous, heat- and
moisture-stabile materials
in healthcare facilities. | A steam sterilizer
intended for sterilization
of non-porous and
porous, heat- and
moisture-stabile materials
in healthcare facilities. |
| Operating Principle | Steam is the sterilizing
agent. | Steam is the sterilizing
agent. | Steam is the sterilizing
agent. |
| Sterilization Cycles
Offered | Prevac
Gravity
SFPP
Liquid | Prevac
Gravity
Wrap/SFPP
SFPP
Liquid | Prevac
Gravity
Wrap/SFPP
SFPP
Liquid |
| Chamber Sizes | 26" x 26" x 39"
26" x 37.5" x 60" | 26" x 26" x 39"
26" x 26" x 49"
26" x 26" x 61" | 26" x 37.5" x 36"
26" x 37.5" x 48"
26" x 37.5" x 60" |
| Chamber Door | Type 316L stainless steel
Vertical Sliding
(26"x26")
Hinged or Horizontal
Sliding (26"x $37\frac{1}{2}$ ") | Type 316L stainless steel
Vertical Sliding only | Type 316L stainless steel
Hinged or Horizontal
Sliding |
| Shell Assembly | Type 316L stainless steel
ASME certified | Type 316L stainless steel
ASME certified | Type 316L stainless steel
ASME certified |
| Control Technology | Unity Controller
Touch Screen
8.4" Display
Ink on Paper Printer | Century Controller
Touch Screen
Vacuum Fluorescent
Display
Ink on Paper Printer | Century Controller
Touch Screen
Vacuum Fluorescent
Display
Ink on Paper Printer |
| Process Monitors | Chamber Transducer
Dual Element Chamber
Drain Sensor | Chamber Transducer
Chamber Drain Sensor | Chamber Transducer
Chamber Drain Sensor |
| Safety Devices | Pressure Relief Valve
Chamber Float Switch | Pressure Relief Valve
Chamber Float Switch | Pressure Relief Valve
Chamber Float Switch |
Table 5-5. Summary of the Proposed and Predicate Devices Technological Characteristics
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 10-6 probability of survival. STERIS validates its stcrilization cycles using recommended practices, standards and guidelines developed by independent organizations such as the Association for the Advancement of Medical
6
Instrumentation (AAMI). The Amsco Evolution Steam Sterilizer was validated to meet the requirements of ANSVAAMI ST8, Fourth Edition, November 2001.
The results of the Amsco Evolution Steam Sterilizer validation studies demonstrate that the sterilizer performs as intended. The results are summarized as follows:
- . 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 sterilizer 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 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 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 ANSVAAMI-ST8, were qualified according to Section 5.5.2 ANSVAAMI-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 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 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 ANSVAAMI-ST8. These cycles demonstrated a sterility assurance lèvel of at least 100 using half-cycle analysis, moisture retention of less than 20% increase
7
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, 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 an Fo value of at least 12, water loss not exceeding 50 ml, and automatic sealing of the flask closure.
- The DART cycle validated using the Bowie-Dick Test Pack, as described in . 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.
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
8
patient infections that have resulted from steam sterilizer failures. 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.
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.
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Image /page/9/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three overlapping wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 3 0 2008
Mr. Robert Sullivan Senior Director FDA Regulatory Affairs STERIS Corporation 5960 Heisley Road Mentor, Ohio 44060
Re: K082435
Trade/Device Name: Amsco Evolution Medium Steam Sterilizer Regulation Number: 21 CFR 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: II Product Code: FLE Dated: December 08, 2008 Received: December 09, 2008
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 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 - 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); 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html,
Sincerely vours.
Chiu S. Lin, Ph. D.
Chiu S. Lin. Ph. D Division 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
510(k) Number (if known): K082435
Device Name:
Amsco Evolution Medium Steam Sterilizer
Indications For Use:
The Amsco Evolution Medium Steam Sterilizer models HC-600 and HC-1500 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, t 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
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. |
Table 4-1. Amsco Evolution Medium Prevacuum Steam Sterilizer Factory-programmed sterilization cycles and cycle values
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STERIS Response to 12/23/08 Request for Additional Information K082435 / Amsco Evolution Medium Steam Sterilizer
| 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 | 270°F (132°C) | 3 minutes | 1 minute | N/A | |
| DART | 270°F (132°C) | 3 ½ minutes | 1 minute | Bowie-Dick Test Pack, DART Test Pack | |
| Leak Test | N/A | N/A | N/A | N/A |
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
| Cycles | Sterilize Temperature | Sterilize Time | Dry Time | Recommended Load |
|---|---|---|---|---|
| SFPP | 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. |
| SFPP | 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 |
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STERIS Response to 12/23/08 Request for Additional Information K082435 / Amsco Evolution Medium Steam Sterilizer
| 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 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, DART Test Pack |
| Leak Test | N/A | N/A | N/A | N/A |
The following table (Table 4-3) lists STERIS's recommended loads by sterilizer size:
Table 4-3. Amsco Evolution Medium Steam Sterilizer recommended loads per sterilizer size
.
| Sterilizer Size | Wrapped Instrument
Trays | Fabric Packs |
|-------------------|-----------------------------|--------------|
| 26" x 26" x 39" | 9 | 12 |
| 26" x 37 ½" x 60" | 20 | 36 |
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The following table (Table 4-4) is a guideline for liquid cycle processing:
Table 4-4. Amsco Evolution Medium Steam Sterilizer Liquid Cycle Guideline
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|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | minutes |
The Amsco Evolution Medium Steam Sterilizer is offered in the following chamber sizes:
- 26" x 26" x 39" (660 mm x 660 mm x 991 mm), Model HC-600 해
- 26" x 37½" x 60" (660mm x 950mm x 1524mm), Model HC-1500 .
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use X (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 M. Murphyko
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K08243
Page 1 of 1
CONFIDENTIAL
December 29, 2008
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