(83 days)
The Amsco Evolution Series Steam Sterilizer Models HC-2000 and HC-3000 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.
The Amsco Evolution Series Steam Sterilizer, Models HC-2000 and HC-3000, 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.
The chamber sizes of the proposed Amsco Evolution Series Steam Sterilizer Models are as follows: - 26" x 61" x 49" (Model HC-2000) .
- 26" x 61" x 72" (Model HC-3000) .
Here's an analysis of the provided text, focusing on acceptance criteria, study details, and related information for the STERIS Amsco Evolution Series Steam Sterilizer Models HC-2000 and HC-3000.
Important Note: This document describes a steam sterilizer, which is a medical device designed to sterilize other medical materials. The "device" in this context is the sterilizer itself, not an AI algorithm. Therefore, many standard AI/ML study components like a "test set" for performance evaluation, "ground truth" established by experts, "adjudication methods," "MRMC studies," or "standalone (algorithm only)" performance metrics are not directly applicable in the same way they would be for an AI diagnostic device. The "acceptance criteria" here relate to the sterilizer's ability to achieve and maintain sterility, as defined by established standards.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are derived from ANSI/AAMI ST8, Fifth Edition, December 2008, a recognized standard for steam sterilization.
| Acceptance Criterion (Based on ANSI/AAMI ST8) | Reported Device Performance (Amsco Evolution Series Steam Sterilizer) |
|---|---|
| Empty Chamber Testing: Capable of providing steady-state thermal conditions consistent with predicted sterility assurance level (SAL). (Sections 4.4.2.2 and 4.4.2.5 of ANSI/AAMI-ST8) | Demonstrated capability to provide steady-state thermal conditions within the chamber consistent with the predicted SAL in the load for Prevac, Gravity, Liquid, and SFPP cycles. The sterilizer meets the requirements. |
| SFPP Cycles (Fabric Process Challenge Device): - Sterility Assurance Level: At least 10⁻⁶ - F₀ value: At least 12 - Moisture Retention: Less than 3% increase in presterilization test pack weight - Wet Spots: No evidence of wet spots (Section 5.5.2 and 5.5.2.1 of ANSI/AAMI-ST8) | Achieved a sterility assurance level of at least 10⁻⁶ through an F₀ value of at least 12, moisture retention of less than 3% increase in presterilization test pack weight, and no evidence of wet spots. |
| SFPP Cycles (Wrapped Instrument Process Challenge Device): - Sterility Assurance Level: At least 10⁻⁶ (using half-cycle analysis) - Moisture Retention: Less than 20% increase in presterilization weight of the towel - Wet Spots: No evidence of wet spots on outer wrapper (Section 5.5.4 and 5.5.4.1 of ANSI/AAMI-ST8) | Achieved a sterility assurance level of at least 10⁻⁶ 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. |
| Gravity Cycles (Fabric Process Challenge Device): - Sterility Assurance Level: At least 10⁻⁶ - F₀ value: At least 12 - Moisture Retention: Less than 3% increase in presterilization test pack weight - Wet Spots: No evidence of wet spots (Section 5.5.2 and 5.5.2.1 of ANSI/AAMI-ST8) | Achieved a sterility assurance level of at least 10⁻⁶ through an F₀ value of at least 12, moisture retention of less than 3% increase in presterilization test pack weight, and no evidence of wet spots. |
| Gravity Cycles (Wrapped Instrument Process Challenge Device): - Sterility Assurance Level: At least 10⁻⁶ (using half-cycle analysis) - Moisture Retention: Less than 20% increase in presterilization weight of the towel - Wet Spots: No evidence of wet spots on outer wrapper (Section 5.5.4.1 of ANSI/AAMI-ST8) | Achieved a sterility assurance level of at least 10⁻⁶ 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. |
| Prevac Cycles (Fabric Process Challenge Device): - Sterility Assurance Level: At least 10⁻⁶ - F₀ value: At least 12 - Moisture Retention: Less than 3% increase in presterilization test pack weight - Wet Spots: No evidence of wet spots (Section 5.5.2 and 5.5.2.1 of ANSI/AAMI-ST8) | Achieved a sterility assurance level of at least 10⁻⁶ through an F₀ value of at least 12, moisture retention of less than 3% increase in presterilization test pack weight, and exhibited no wet spots. |
| Prevac Cycles (Wrapped Instrument Process Challenge Device): - Sterility Assurance Level: At least 10⁻⁶ (using half-cycle analysis) - Moisture Retention: Less than 20% increase in presterilization weight of the towel - Wet Spots: No evidence of wet spots on outer wrapper (Section 5.5.4 and 5.5.4.1 of ANSI/AAMI-ST8) | Achieved a sterility assurance level of at least 10⁻⁶ 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. |
| Liquid Cycles (Three 1,000 ml flasks): - Sterility Assurance Level: At least 10⁻⁶ - F₀ value: At least 12 - Water Loss: Not exceeding 50 ml - Flask Closure: Automatic sealing (Section 5.5.3 and 5.5.3.1 of ANSI/AAMI-ST8) | Achieved a sterility assurance level of at least 10⁻⁶ through an F₀ value of at least 12, water loss not exceeding 50 ml, and automatic sealing of the flask closure. |
| DART Cycle: Uniform color change throughout the test sheet (Section 5.6.1 and 5.6.1.1 of ANSI/AAMI-ST8) | Demonstrated a uniform color change throughout the test sheet using the Bowie-Dick Test Pack. |
| Software Validation: Compliance with FDA's moderate level of concern recommendations. | Software validation for cycle operation was performed according to FDA's "Guidance for the Content for Premarket Submissions for Software Contained in Medical Devices (05/11/05)." (Successfully implying compliance). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not explicitly state a numerical sample size for the "test set" in terms of number of sterilization runs or items processed. Instead, it refers to validation studies performed "for the Prevac, Gravity, Liquid and SFPP cycles" using specific "process challenge devices" and "fabric process challenge devices." These devices are designed to represent challenging sterilization scenarios, and their successful sterilization across multiple runs (though not quantified) constitutes the "sample."
- Data Provenance: The studies were internal validation studies conducted by STERIS Corporation. The data provenance is therefore internal (presumably USA, where STERIS is based), and prospective in nature, as they were specifically carried out to validate the new sterilizer models.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Given this is a steam sterilizer, the "ground truth" and "expert" involvement is different from an AI diagnostic device.
- Number of Experts: Not explicitly stated in terms of individual expert count. The "ground truth" is established by adherence to and measurement against the performance requirements set forth in the recognized industry standard ANSI/AAMI ST8, Fifth Edition, December 2008. This standard itself represents a consensus of experts in sterilization science and medical device safety. STERIS's internal team, performing the validation, are implied to be experts in sterilization validation.
- Qualifications of Experts: The qualifications are implicit in the adherence to the ANSI/AAMI ST8 standard and the conduct of the validation studies by a medical device manufacturer (STERIS Corporation), which would employ engineers and scientists with expertise in sterilization.
4. Adjudication Method for the Test Set
Not applicable in the context of a steam sterilizer validation against a standard. The "adjudication" is essentially the direct measurement and verification against the physical and biological criteria outlined in the ANSI/AAMI ST8 standard (e.g., spore kill, F₀ value, moisture retention, color change). There is no "consensus" of individual human adjudicators here; it's an objective measurement against established metrics.
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
Not applicable. This device is a steam sterilizer, not an AI diagnostic device that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not directly applicable to a steam sterilizer. The sterilizer operates autonomously through its programmed cycles. The "standalone performance" is implicitly demonstrated through the validation studies discussed, where the sterilizer performs its function (sterilization) without direct human intervention during the cycle itself, but under conditions specified by human operators and validated against established standards.
7. The Type of Ground Truth Used
The ground truth used is primarily biological indicators (complete kill of spores) and physical performance metrics defined by an industry standard.
- Sterility Assurance Level (SAL): Defined as a probability of survival of at least 10⁻⁶ (meaning one in a million chance of a surviving microorganism). This is the key biological "ground truth."
- F₀ Value: A measure of the cumulative lethality of the sterilization process, with a minimum required F₀ of 12.
- Moisture Retention / Wet Spots: Physical criteria to ensure dry products.
- Uniform Color Change: For the DART (Bowie-Dick) test, indicating proper air removal and steam penetration.
- Water Loss / Flask Sealing: For liquid cycles.
These are objective, measurable outcomes as defined by ANSI/AAMI ST8.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a "training set" in the conventional sense of machine learning. The sterilizer's operational parameters are designed and engineered, not "trained" on data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for an AI/ML model for this device. The "ground truth" for the sterilizer's design and operational parameters is established by decades of sterilization science, engineering principles, and the development of consensus standards like ANSI/AAMI ST8.
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кояачао
Image /page/0/Picture/1 description: The image shows the STERIS logo. The logo consists of the word "STERIS" in a bold, sans-serif font, with the registered trademark symbol to the right of the word. Below the word "STERIS" is an image of several horizontal wavy lines stacked on top of each other.
NOV - 4 2009
510(k) Summary For Amsco Evolution Series Steam Sterilizer Models HC-2000 and HC-3000
STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 639-4459
Contact:
Robert F. Sullivan Senior Director FDA Regulatory Affairs Telephone: (440) 392-7695 Fax No: (440) 357-9198
August 12, 2009 Summary Date:
STERIS Corporation = 5960 Heisley Road = Mentor, OH 44060-1834 USA = 440-354-2600
ﻳﺘ
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Device Name
| Trade Name: | Amsco Evolution Series Steam Sterilizer |
|---|---|
| Models: | HC-2000 and HC-3000 |
| Common/Usual Name: | Steam Sterilizer |
| Classification Name: | Steam Sterilizer (21 CFR 880.6880, Product Code 80 FLE ) |
| Predicate Devices: |
K082435, Amsco Evolution Medium Steam Sterilizer (Models HC-600 and HC-1500) cleared December 30, 2008.
K091136, Amsco Evolution Medium Steam Sterilizer (Models HC-900 and HC-1200) cleared June 29, 2009.
Description of Device
The Amsco Evolution Series Steam Sterilizer, Models HC-2000 and HC-3000, 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.
The chamber sizes of the proposed Amsco Evolution Series Steam Sterilizer Models are as follows:
- 26" x 61" x 49" (Model HC-2000) .
- 26" x 61" x 72" (Model HC-3000) .
Intended Use
The Amsco Evolution Series Steam Sterilizer Models HC-2000 and HC-3000 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.
The Amsco Evolution Series Prevacuum Steam Sterilizer is equipped with the following factory-programmed sterilization cycles and cycle values (Table 5-1):
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| Cycles | SterilizeTemperature | SterilizeTime | Dry Time | Recommended Load |
|---|---|---|---|---|
| Prevac | 270°F (132°C) | 4 minutes | 30 minutes | Double wrapped instrumenttrays, maximum weight 25lbs (11.3 kg) each andFabric Packs. Refer toTable 4-3 for recommendedquantities. |
| Prevac | 270°F (132°C) | 4 minutes | 5 minutes | Single Fabric Pack |
| Gravity | 250°F (121°C) | 30 minutes | 15 minutes | Fabric Packs. Refer toTable 4-3 for recommendedquantities. |
| Liquid* | 250°F (121°C) | 45 minutes | N/A | Refer to Table 4-4 forrecommended quantities. |
| Prevac | 275°F (135°C) | 3 minutes | 30 minutes | Double wrapped instrumenttrays, maximum weight 25lbs (11.3 kg) each. Refer toTable 4-3 for recommendedquantities. |
| Gravity | 270°F (132°C) | 15 minutes | 45 minutes | Double wrapped instrumenttrays, maximum weight 25lbs (11.3 kg) each. Refer toTable 4-3 for recommendedquantities. |
| Gravity | 250°F (121°C) | 30 minutes | 45 minutes | Double wrapped instrumenttrays, maximum weight 25lbs (11.3 kg) each. Refer toTable 4-3 for recommendedquantities. |
| Gravity | 270°F (132°C) | 25 minutes | 15 minutes | Fabric Packs. Refer toTable 4-3 for recommendedquantities. |
| 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 Series Prevacuum Steam Sterilizer |
|---|
| factory-programmed sterilization cycles and cycle values |
*The liquid cycle is for non-patient contact use only.
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The Amsco Evolution Series Steam Flush Pressure-Pulse (SFPP) Sterilizer is equipped with the following factory-programmed sterilization cycles and cycle values (Table 5-2):
| Cycles | SterilizeTemperature | SterilizeTime | Dry Time | Recommended Load |
|---|---|---|---|---|
| SFPP | 270°F (132°C) | 4 minutes | 45 minutes | Double wrappedinstrument trays,maximum weight 25 lbs(11.3 kg) each and FabricPacks. Refer to Table 4-3for recommendedquantities. |
| SFPP | 275°F (135°C) | 3 minutes | 45 minutes | Double wrappedinstrument trays,maximum weight 25 lbs(11.3 kg) each. Refer toTable 4-3 forrecommended quantities. |
| Prevac | 270°F (132°C) | 4 minutes | 30 minutes | Double wrappedinstrument trays,maximum weight 25 lbs(11.3 kg) each and FabricPacks. Refer to Table 4-3for recommendedquantities. |
| Gravity | 250°F (121°C) | 30 minutes | 15 minutes | Fabric Packs. Refer toTable 4-3 forrecommended quantities. |
| SFPP | 270°F (132°C) | 4 minutes | 5 minutes | Single Fabric Pack |
| Prevac | 275°F (135°C) | 3 minutes | 30 minutes | Double wrappedinstrument trays,maximum weight 25 lbs(11.3 kg) each. Refer toTable 4-3 forrecommended quantities. |
| Gravity | 270°F (132°C) | 15 minutes | 45 minutes | Double wrappedinstrument trays,maximum weight 25 lbs(11.3 kg) each. Refer toTable 4-3 forrecommended quantities. |
| Cycles | Sterilize Temperature | Sterilize Time | Dry Time | Recommended Load |
| Liquid* | 250°F (121°C) | 45 minutes | N/A | Refer to Table 4-4 for recommended quantities. |
| DARTWarm-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 |
Table 5-2. Amsco Evolution Series Steam Flush Pressure-Pulse (SFPP) Sterilizer factory-programmed sterilization cycles and cycle values
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*The liquid cycle is for non-patient contact use only.
The following table lists STERIS's recommended loads by sterilizer size:
| Sterilizer Size | Wrapped Instrument Trays | Fabric Packs |
|---|---|---|
| 26" x 61" x 49"HC-2000 | 15 | 40 |
| 26" x 61" x 72"HC-3000 | 25 | 60 |
Table 5-3. Amsco Evolution Series Steam Sterilizer recommended loads per sterilizer size
The following table is a guideline for liquid cycle processing:
Table 5-4. Amsco Evolution Series Steam Sterilizer Liquid Cycle Guideline
| Number ofContainers | Volume of Liquid In OneContainer | Minimum RecommendedSterilize Time at 250°F (121°C) |
|---|---|---|
| 3 | 1000 ml | 45 minutes |
The Amsco Evolution Series Steam Sterilizer is offered in the following chamber sizes:
- · 26" x 61" x 61" x 49" (Model HC 2000)
- · 26" x 61" x 72" (Model HC 3000)
Description of Safety and Substantial Equivalence
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.
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| GeneralSterilizerFeatures | Amsco Evolution MediumSteam Sterilizer(K091136) | Amsco EvolutionMedium SteamSterilizer (K082435) | Amsco Evolution SeriesSteam Sterilizer(HC-2000 and HC-3000) |
|---|---|---|---|
| Intended Use | A steam sterilizer intendedfor sterilization of non-porous and porous, heat-and moisture-stablematerials in healthcarefacilities. | A steam sterilizerintended for sterilizationof non-porous and porous,heat- and moisture-stablematerials in healthcarefacilities. | A steam sterilizer intendedfor sterilization of non-porous and porous, heat-and moisture-stablematerials in healthcarefacilities. |
| OperatingPrinciple | Steam is the sterilizingagent. | Steam is the sterilizingagent. | Steam is the sterilizingagent |
| SterilizationCycles Offered | PrevacGravitySFPPLiquid | PrevacGravitySFPPLiquid | PrevacGravitySFPPLiquid |
| Chamber Sizes | 26" x 26" x 39"26" x 37.5" x 60" | 26" x 37.5" x 42"26" x 37.5" x 54" | 26" x 61" x 49"26" x 61" x 72" |
| Chamber Door | Type 316L stainless steelVertical Sliding (26"x26")Hinged or HorizontalSliding (26"x37½") | Type 316L stainless steelVertical Sliding (26"x26")Hinged or HorizontalSliding (26"x37½") | Type 316L stainless steelPower Horizontal Sliding |
| Shell Assembly | Type 316L stainless steelASME certified | Type 316L stainless steelASME certified | Type 316L stainless steelASME certified |
| ControlTechnology | Unity ControllerTouch Screen8.4" DisplayInk on Paper Printer | Unity ControllerTouch Screen8.4" DisplayInk on Paper Printer | Unity ControllerTouch Screen8.4" DisplayInk of Paper Printer |
| Process Monitors | Chamber TransducerDual Element ChamberDrain Sensor | Chamber TransducerDual Element ChamberDrain Sensor | Chamber TransducerDual Element ChamberDrain Sensor |
| Safety Devices | Pressure Relief ValveChamber Float SwitchControl Lockout Switch | Pressure Relief ValveChamber Float SwitchControl Lockout Switch | Pressure Relief ValveChamber Float SwitchControl Lockout 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 100 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 Sterilizers have been validated to meet the requirements of ANSVAAMI ST8, Fifth Edition, December 2008.
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The results of the Amsco Evolution Series 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 process challenge device, 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 100 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 the wrapped instrument process challenge devices, described in 5.5.4.1 of ANSVAAMI-ST8, were qualified according to Section 5.5.4 ANSI/AAMI-ST8. These cycles demonstrated a sterility assurance level of at least 106 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 process challenge device. described in Section 5.5.2.1 of ANSI/AAMI-ST8, were qualified according to Section 5.5.2 ANSVAAMI-ST8. These cycles demonstrated a sterility assurance level of at least 10th 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 the wrapped instrument process challenge . device, described in 5.5.4.1 of ANSVAAMI-ST8, were qualified according to section 5.5.4 ANSVAAMI-ST8. These cycles demonstrated a sterility assurance level of at least 106 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 process challenge device, . described in Section 5.5.2.1 of ANSI/AAMI-ST8, were qualified according to Section 5.5.2 ANSVAAMI-ST8. These cycles demonstrated a sterility assurance level of at least 10th 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 the wrapped instrument process challenge . device, 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 10th using half-cycle analysis, moisture retention of
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less than 20% increase in presterilization weight of the towel, and no evidence of wet spots on the outer wrapper.
- All LIOUID cycles validated using three 1,000 ml flasks, described in Section . 5.5.3.1 of the ANSVAAMI-ST8, and 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. 61010-1 as certified . by Intertek Testing Services.
- . Canadian Standards Association (CSA) Standard C22.2 No. 61010-2-040 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.
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The technology designed into STERIS steam sterilizers including the Amsco Evolution Series 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 and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized eagle or bird in flight.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Mr. Robert F. Sullivan Senior Director Steris Corporation 5960 Heisley Road Mentor, Ohio 44060
NOV - 4 2009
Re: K092490
Trade/Device Name: The Amsco Evolution Series Steam Sterilizer is offered in the Following Chamber Sizes: Model HC-2000 36"x61"x49" Model HC-3000 26"x 61"x72". Regulation Number: 21CFR 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: II Product Code: FLE Dated: August 12, 2009 Received: August 13, 2009
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 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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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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.goy/MedicalDevices/Resourcesfor-You/Industry/default.htm.
Sincerely yours,
Susan Funser
Susan Runner, D.D.S., M.A. Acting Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known):
Device Name:
Amsco Evolution Series Steam Sterilizer (HC-2000 and HC-3000)
Indications for Use:
The Amsco Evolution Series Steam Sterilizer Models HC-2000 and HC-3000 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.
The Amsco Evolution Series Prevacuum Steam Sterilizer is equipped with the following factory-programmed sterilization cycles and cycle values (Table 4-1):
| Cycles | SterilizeTemperature | SterilizeTime | Dry Time | Recommended Load |
|---|---|---|---|---|
| Prevac | 270°F (132°C) | 4 minutes | 30 minutes | Double wrapped instrumenttrays, maximum weight 25lbs (11.3 kg) each andFabric Packs. Refer toTable 4-3 for recommendedquantities. |
| Prevac | 270°F (132°C) | 4 minutes | 5 minutes | Single Fabric Pack |
| Gravity | 250°F (121°C) | 30 minutes | 15 minutes | Fabric Packs. Refer toTable 4-3 for recommendedquantities. |
| Liquid* | 250°F (121°C) | 45 minutes | N/A | Refer to Table 4-4 forrecommended quantities. |
| Prevac | 275°F (135°C) | 3 minutes | 30 minutes | Double wrapped instrumenttrays, maximum weight 25lbs (11.3 kg) each. Refer toTable 4-3 for recommendedquantities. |
Table 4-1. Amsco Evolution Series Prevacuum Steam Sterilizer factory-programmed sterilization cycles and cycle values
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| Cycles | SterilizeTemperature | SterilizeTime | Dry Time | Recommended Load |
|---|---|---|---|---|
| Gravity | 270°F (132°C) | 15 minutes | 45 minutes | Double wrapped instrumenttrays, maximum weight 25lbs (11.3 kg) each. Refer toTable 4-3 for recommendedquantities. |
| Gravity | 250°F (121°C) | 30 minutes | 45 minutes | Double wrapped instrumenttrays, maximum weight 25lbs (11.3 kg) each. Refer toTable 4-3 for recommendedquantities. |
| Gravity | 270°F (132°C) | 25 minutes | 15 minutes | Fabric Packs. Refer toTable 4-3 for recommendedquantities. |
| DARTWarm-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 liquid cycle is for non-patient contact use only.
The Amsco Evolution Series Steam Flush Pressure-Pulse (SFPP) Sterilizer is equipped with the following factory-programmed sterilization cycles and cycle values (Table 4-2):
| Cycles | SterilizeTemperature | SterilizeTime | Dry Time | Recommended Load |
|---|---|---|---|---|
| SFPP | 270°F (132°C) | 4 minutes | 45 minutes | Double wrapped instrumenttrays, maximum weight 25lbs (11.3 kg) each and FabricPacks. Refer to Table 4-3 forrecommended quantities. |
| SFPP | 275°F (135°C) | 3 minutes | 45 minutes | Double wrapped instrumenttrays, maximum weight 25lbs (11.3 kg) each. Refer toTable 4-3 for recommendedquantities. |
| Table 4-2. Amsco Evolution Series Steam Flush Pressure-Pulse (SFPP) | |||||
|---|---|---|---|---|---|
| Sterilizer factory-programmed sterilization cycles and cycle values |
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| Cycles | SterilizeTemperature | SterilizeTime | Dry Time | Recommended Load |
|---|---|---|---|---|
| Prevac | 270°F (132°C) | 4 minutes | 30 minutes | Double wrapped instrumenttrays, maximum weight 25lbs (11.3 kg) each and FabricPacks. Refer to Table 4-3 forrecommended quantities. |
| Gravity | 250°F (121°C) | 30 minutes | 15 minutes | Fabric Packs. Refer to Table4-3 for recommendedquantities. |
| SFPP | 270°F (132°C) | 4 minutes | 5 minutes | Single Fabric Pack |
| Prevac | 275°F (135°C) | 3 minutes | 30 minutes | Double wrapped instrumenttrays, maximum weight 25lbs (11.3 kg) each. Refer toTable 4-3 for recommendedquantities. |
| Gravity | 270°F (132°C) | 15 minutes | 45 minutes | Double wrapped instrumenttrays, maximum weight 25lbs (11.3 kg) each. Refer toTable 4-3 for recommendedquantities. |
| Liquid* | 250°F (121°C) | 45 minutes | N/A | Refer to Table 4-4 forrecommended quantities. |
| DARTWarm-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 liquid cycle is for non-patient contact use only.
The following table lists STERIS's recommended loads by sterilizer size:
Table 4-3. Amsco Evolution Series Steam
Sterilizer recommended loads per sterilizer size
| Sterilizer Size | Wrapped Instrument Trays | Fabric Packs |
|---|---|---|
| 26" x 61" x 49" HC-2000 | 15 | 40 |
| 26" x 61" x 72" HC-3000 | 25 | 60 |
The following table is a guideline for liquid cycle processing:
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Table 4-4. Amsco Evolution Series Steam Sterilizer Liquid Cycle Guideline
| ースになると、このようなんているということです。Can been and the | THE CAN THE SECT AND THE CHANDE THEContainer | Volume of Liquid In One Minimum Recommended ar1 12 12 12 12 12 12 12 12 12 12 12 12 12 12 12 12 12 12 12 12 12 12 12 12 12 12 12 12 12 12 12 12 12 12 12 12 12 12 12 12 12 12 12 12 12 12 12 12 12 12 12 12 12 12 12 12 12 116. LOUID USINGLANDLY1508E (121%C) 41Carles Comments of Concernerterinz |
|---|---|---|
| 1 117 | minutes |
The Amsco Evolution Series Steam Sterilizer is offered in the following chamber sizes:
- 26" x 61" x 49" Model HC - 2000 .
- 26" x 61" x 72" Model HC - 3000 ●
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)
Elizabet D. Clamin - Wel
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K092490
Page 4 of 4
§ 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).