(29 days)
The Amsco Evolution Medium Steam Sterilizer Models HC-900 and HC-1200 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 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.
The Amsco Evolution Medium Steam Sterilizer Models HC-800 and HC-1000 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 Medium Steam Sterilizer models HC-900 and HC-1200 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 Medium Steam Sterilizer Models are as follows: - · 26' x 371/2' x 42" (Model HC 900)
- · 26' x 371/2' x 54" (Model HC 1200)
The Automated Load/Unload System (ALUS) automatically feeds loading cars packed with goods into and/or out of the sterilizer chamber, reducing the amount of handling by central supply workers. This includes ALUS tables for use with AMSCO Evolution medium steam sterilizers having automated chamber doors and the following chamber dimensions (width and height): - · 26 x 26" (660 x 660 mm)
- 26 x 37½" (660 x 953 mm)
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.
The chamber sizes of the proposed Amsco Evolution Medium Steam Sterilizer Models are as follows: - · 26" x 26" x 39" (Model HC 600)
- · 26'' x 37 ½' x 66" (Model HC 1500)
The Automated Load/Unload System (ALUS) automatically feeds loading cars packed with goods into and/or out of the sterilizer chamber, reducing the amount of handling by central supply workers. This includes ALUS tables for use with AMSCO Evolution medium steam sterilizers having automated chamber doors and the following chamber dimensions (width and height): - · 26 x 26" (660 x 660 mm)
- · 26 x 37-1/2" (660 x 953 mm)
The Amsco Evolution Medium Steam Sterilizer models HC-800 and HC-1000 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 Medium Steam Sterilizer Models are as follows: - 0 26" x 26" x 49" (Model HC - 800)
- 26" x 26" x 61" (Model HC 1000) 0
The Automated Load/Unload System (ALUS) automatically feeds loading cars packed with goods into and/or out of the sterilizer chamber, reducing the amount of handling by central supply workers. This includes ALUS tables for use with AMSCO Evolution medium steam sterilizers having automated chamber doors and the following chamber dimensions (width and height): - · 26 x 26" (660 x 660 mm)
- · 26 x 37-1/2" (660 x 953 mm)
This document describes the premarket notification (510(k)) for the STERIS Amsco Evolution Medium Steam Sterilizer with Evolution Automated Loading and Unloading System (ALUS) in various models (HC-900 & HC-1200; HC-600 & HC-1500; HC-800 & HC-1000). The submission focuses on the addition of the ALUS hardware to existing sterilizer models.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Device Modification | Verification / Validation Activity | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Addition of ALUS hardware | Functional testing | Automatic loading and unloading and initiation of the proper cycle | Pass |
| UL 73: 2011 Ed.10 (2018) evaluation | Meet requirements for ETL certification | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a separate "test set" in the context of typical AI/software testing with data samples. Instead, the testing appears to be hardware-focused verification of the ALUS system with the sterilizers. The data provenance is not explicitly stated as retrospective or prospective clinical data, but rather as results from functional and electrical safety testing. Given the nature of the device (steam sterilizer and its automated loading system), this would typically involve testing performed by the manufacturer (STERIS Corporation) at their facilities or certified testing laboratories.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. The "ground truth" for this device's performance is objective compliance with engineering and safety standards (e.g., automatic loading/unloading functionality, ETL certification requirements) rather than expert interpretation of medical data.
4. Adjudication Method for the Test Set
Not applicable. The testing described is compliance-based functional and safety testing, not a study requiring expert adjudication of results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic or screening devices where human readers interpret medical images or data, and the effect of AI assistance on their performance is measured. The device in question is a steam sterilizer with an automated loading system, which does not involve human interpretation of medical cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm-only performance study was not explicitly done in the context of typical AI algorithm evaluation. The "device" here includes hardware (sterilizer, ALUS) and software components for automation. The functional testing of the ALUS system demonstrates its standalone operation in terms of loading, unloading, and cycle initiation. However, this is not an "AI algorithm" in the conventional sense requiring standalone performance metrics like sensitivity/specificity on a dataset.
7. The Type of Ground Truth Used
The ground truth used for this device is based on engineering specifications and regulatory/safety standards.
- For functional testing: The ground truth is the successful execution of the specified actions (automatic loading, unloading, and proper cycle initiation) according to the device's design and operational requirements.
- For UL 73: 2011 Ed.10 (2018) evaluation: The ground truth is compliance with the electrical safety and performance requirements outlined in that specific UL standard, leading to ETL certification.
8. The Sample Size for the Training Set
Not applicable. The document describes a medical device (steam sterilizer with automated loading) whose functionality is based on electromechanical design and software programming, not on machine learning algorithms trained on a dataset. Therefore, there is no "training set" in the context of AI.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI algorithm. The device's operational parameters and safety features are established through engineering design, development, and adherence to relevant industry standards and regulations.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
November 6, 2020
STERIS Corporation Anthony Piotrkowski Director Regulatory Affairs 5960 Heislev Rd Mentor, Ohio 44060
Re: K203061
Trade/Device Name: Amsco Evolution Medium Steam Sterilizer (Models HC-900 and HC-1200), Evolution Automated Loading and Unloading System (ALUS); Amsco Evolution Medium Steam Sterilizer (Models HC-600 and HC-1500), Evolution Automated Loading and Unloading System (ALUS); Amsco Evolution Medium Steam Sterilizer (Models HC-800 and HC-1000), Evolution Automated Loading and Unloading System (ALUS) Regulation Number: 21 CFR 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: Class II Product Code: FLE, PEC Dated: October 7, 2020 Received: October 8, 2020
Dear Anthony Piotrkowski:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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
{1}------------------------------------------------
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Clarence W. Murray III -S
For Kapil Panguluri, Ph.D. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known)
K2033061
Device Name
Amsco Evolution Medium Steam Sterilizer (Models HC-900 and HC-1200), Evolution Automated Loading and Unloading System (ALUS)
Indications for Use (Describe)
The Amsco Evolution Medium Steam Sterilizer Models HC-900 and HC-1200 are designed for sterilization of heat and moisturestable 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 Prevacuum Steam Sterilizer is equipped with the following factory-programmed sterilization cycles and cycle values (Table 5-1):
Table 5-1. Amso Evolution Medium Steam Sterilizer factory-programmed sterilization cycles and cycle values
| 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 5-3 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 5-3 for recommendedquantities. |
| Liquid* | 250°F (121°C) | 45 minutes | N/A | Refer to Table 5-4 forrecommended quantities. |
| Prevac | 275°F (135°C) | 3 minutes | 30 minutes | Double wrapped instrumenttrays, maximum weight 25lbs (11.3 kg) each. Refer toTable 5-3 for recommendedquantities. |
| Gravity | 270°F (132°C) | 15 minutes | 30 minutes | Double wrapped instrumenttrays, maximum weight 25lbs (11.3 kg) each. Refer toTable 5-3 for recommendedquantities. |
| Gravity | 250°F (121°C) | 30 minutes | 30 minutes | Double wrapped instrumenttrays, maximum weight 25lbs (11.3 kg) each. Refer toTable 5-3 for recommendedquantities. |
| Gravity | 270°F (132°C) | 25 minutes | 15 minutes | Fabric Packs. Refer toTable 5-3 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.
{3}------------------------------------------------
The Amsco Evolution Medium Steam Fluse (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
| Cycles | SterilizeTemperature | SterilizeTime | Dry Time | Recommended Load |
|---|---|---|---|---|
| SFPP | 270°F (132°C) | 4 minutes | 30 minutes | Double wrappedinstrument trays,maximum weight 25 lbs(11.3 kg) each and FabricPacks. Refer to Table 5-3for recommendedquantities. |
| SFPP | 275°F (135°C) | 3 minutes | 30 minutes | Double wrappedinstrument trays,maximum weight 25 lbs(11.3 kg) each. Refer toTable 5-3 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 5-3for recommendedquantities. |
| Gravity | 250°F (121°C) | 30 minutes | 15 minutes | Fabric Packs. Refer toTable 5-3 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 5-3 forrecommended quantities. |
| Gravity | 270°F (132°C) | 15 minutes | 30 minutes | Double wrappedinstrument trays,maximum weight 25 lbs(11.3 kg) each. Refer toTable 5-3 forrecommended quantities. |
| Liquid* | 250°F (121°C) | 45 minutes | N/A | Refer to Table 5-4 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
{4}------------------------------------------------
The following table lists STERIS's recommended loads by sterilizer size: Table 5-3. Amsco Evolution Medium Steam Sterilizer recommended loads per sterilizer size
| Sterilizer Size | Wrapped InstrumentTrays | Fabric Packs |
|---|---|---|
| 26" x 37 ½" x 42" | 12 | 18 |
| 26" x 37 ½" x 54" | 16 | 30 |
The following table is a guideline for liquid cycle processing: Table 5-4. Amsco Evolution Medium 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 liquid cycle is for non-patient contact use only.
The Amsco Evolution Medium Steam Sterilizer is offered in the following chamber sizes:
- 26" x 37½" x 42" (Model HC 900) .
- 26" x 37½" x 54" (Model HC — 1200)
{5}------------------------------------------------
Type of Use (Select one or both, as applicable)
_ | Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{6}------------------------------------------------
Indications for Use
510(k) Number (if known)
Device Name
Amsco Evolution Medium Steam Sterilizer (Models HC-600 and HC-1500), Evolution Automated Loading and Unloading System (ALUS)
Indications for Use (Describe)
The Amsco Evolution Medium Steam Sterilizer models HC-600 and HC-1500 are designed for sterilization of heat and moisturestable 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 Prevacuum Steam Sterilizer is equipped with the following factory-programmed sterilization cycles and cycle values (Table 5-1):
Table 5-1. Amsco Evolution Medium Steam Sterilizer factory-programmed sterilization cycles and cycle values
| Cycles | SterilizeTemperature | SterilizeTime | 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 andFabric Packs. Refer toTable 5-3 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 5-3 for recommendedquantities. |
| Liquid* | 250°F (121°C) | 45 minutes | N/A | Refer to Table 5-4 forrecommended quantities. |
| Prevac | 275°F (135°C) | 3 minutes | 30 minutes | Double wrapped instrument trays, maximum weight 25 lbs (11.3 kg) each. Refer toTable 5-3 for recommendedquantities. |
| Gravity | 270°F (132°C) | 15 minutes | 30 minutes | Double wrapped instrument trays, maximum weight 25 lbs (11.3 kg) each. Refer toTable 5-3 for recommendedquantities. |
| Gravity | 250°F (121°C) | 30 minutes | 30 minutes | Double wrapped instrument trays, maximum weight 25 lbs (11.3 kg) each. Refer toTable 5-3 for recommendedquantities. |
| Gravity | 270°F (132°C) | 25 minutes | 15 minutes | Fabric Packs. Refer toTable 5-3 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.
{7}------------------------------------------------
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
| Cycles | SterilizeTemperature | SterilizeTime | Dry Time | Recommended Load |
|---|---|---|---|---|
| SFPP | 270°F (132°C) | 4 minutes | 30 minutes | Double wrappedinstrument trays,maximum weight 25 lbs(11.3 kg) each and FabricPacks. Refer to Table 5-3for recommendedquantities. |
| SFPP | 275°F (135°C) | 3 minutes | 30 minutes | Double wrappedinstrument trays,maximum weight 25 lbs(11.3 kg) each. Refer toTable 5-3 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 5-3for recommendedquantities. |
| Gravity | 250°F (121°C) | 30 minutes | 15 minutes | Fabric Packs. Refer toTable 5-3 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 5-3 forrecommended quantities. |
| Gravity | 270°F (132°C) | 15 minutes | 30 minutes | Double wrappedinstrument trays,maximum weight 25 lbs(11.3 kg) each. Refer toTable 5-3 forrecommended quantities. |
| 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) | $3 \frac{1}{2}$ 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.
{8}------------------------------------------------
The following table lists STERIS's recommended loads by sterilizer size:
| Sterilizer Size | Model Number | Wrapped InstrumentTrays | Fabric Packs |
|---|---|---|---|
| 26" x 26" x 39" | HC-600 | 9 | 12 |
| 26" x 37 ½" x 60" | HC-1500 | 20 | 36 |
Table 5-3. Amsco Evolution Medium Steam Sterilizer recommended loads per sterilizer size
The following table is a guideline for liquid cycle processing:
Table 5-4. Amsco Evolution Medium 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 liquid cycle is for non-patient contact use only.
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 .
- . 26" x 37½" x 60" (660mm x 950mm x 1524mm), Model HC-1500
{9}------------------------------------------------
Type of Use (Select one or both, as applicable)
_ | Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{10}------------------------------------------------
Indications for Use
510(k) Number (if known)
K203061
Device Name
Amsco Evolution Medium Steam Sterilizer (Models HC-800 and HC-1000), Evolution Automated Loading and Unloading System (ALUS)
Indications for Use (Describe)
The Amsco Evolution Medium Steam Sterilizer Models HC-800 and HC-1000 are designed for sterilization of heat and moisturestable 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 Prevacuum Steam Sterilizer is equipped with the following factory-programmed sterilization cycles and cycle values (Table 5-1):
Table 5-1. Amsco Evolution Medium Steam Sterilizer factory-programmed sterilization cycles and cycle values
| 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 5-3 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 5-3 for recommendedquantities. |
| Liquid* | 250°F (121°C) | 45 minutes | N/A | Refer to Table 5-4 forrecommended quantities. |
| Prevac | 275°F (135°C) | 3 minutes | 30 minutes | Double wrapped instrumenttrays, maximum weight 25lbs (11.3 kg) each. Refer toTable 5-3 for recommendedquantities. |
| Gravity | 270°F (132°C) | 15 minutes | 30 minutes | Double wrapped instrumenttrays, maximum weight 25lbs (11.3 kg) each. Refer toTable 5-3 for recommendedquantities. |
| Gravity | 250°F (121°C) | 30 minutes | 30 minutes | Double wrapped instrumenttrays, maximum weight 25lbs (11.3 kg) each. Refer toTable 5-3 for recommendedquantities. |
| Gravity | 270°F (132°C) | 25 minutes | 15 minutes | Fabric Packs. Refer toTable 5-3 for recommendedquantities. |
| DARTWarm-Up | 270°F (132°C) | 3 minutes | 1 minute | N/A |
| DART | 270°F (132°C) | $3 \frac{1}{2}$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.
PSC Publishing Services (301) 443-6740 EF
{11}------------------------------------------------
The Amsco Evolution Medium Steam Flush Pressure-Pulse (SFPP) Sterilizer is equipped with the following factoryprogrammed sterilization cycles and cycle values (Table 5-2):
Table 5-2. Amso Evolution Medium Steam Flush Pressure-Pulse (SFPP) Sterilizer factory-programmed sterilization cycles and cycle values
| Cycles | SterilizeTemperature | SterilizeTime | Dry Time | Recommended Load |
|---|---|---|---|---|
| SFPP | 270°F (132°C) | 4 minutes | 30 minutes | Double wrappedinstrument trays,maximum weight 25 lbs(11.3 kg) each and FabricPacks. Refer to Table 5-3for recommendedquantities. |
| SFPP | 275°F (135°C) | 3 minutes | 30 minutes | Double wrappedinstrument trays.maximum weight 25 lbs(11.3 kg) each. Refer toTable 5-3 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 5-3for recommendedquantities. |
| Gravity | 250°F (121°C) | 30 minutes | 15 minutes | Fabric Packs. Refer toTable 5-3 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 5-3 forrecommended quantities. |
| Gravity | 270°F (132°C) | 15 minutes | 30 minutes | Double wrappedinstrument trays.maximum weight 25 lbs(11.3 kg) each. Refer toTable 5-3 forrecommended quantities. |
| Liquid* | 250°F (121°C) | 45 minutes | N/A | Refer to Table 5-4 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.
{12}------------------------------------------------
The following table lists STERIS's recommended loads by sterilizer size:
| Sterilizer Size | Wrapped InstrumentTrays | Fabric Packs |
|---|---|---|
| 26" x 26" x 49" | 12 | 16 |
| 26" x 26" x 61" | 15 | 20 |
Table 5-3. Amsco Evolution Medium Steam Sterilizer recommended loads per sterilizer size
The following table is a guideline for liquid cycle processing:
Table 5-4. Amsco Evolution Medium 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 Medium Steam Sterilizer is offered in the following chamber sizes:
- 26" x 26" x 49" (Model HC 800)
- 26" x 26" x 61" (Model HC 1000) .
{13}------------------------------------------------
Type of Use (Select one or both, as applicable)
_ | Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{14}------------------------------------------------
STEI
510(k) Summary For Amsco Evolution Medium Steam Sterilizer (Models HC-900 and HC-1200) Evolution Automated Loading and Unloading System (ALUS)
STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440)354-2600 Fax No: (440) 357-9198
Contact:
Tony Piotrkowski Director, Regulatory Affairs Tel: 440-392-7437 Fax: 440-357-9198 e-mail: tony_piotrkowski@steris.com
October 7, 2020 Submission Date:
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
{15}------------------------------------------------
1. Device Name
| Trade Name: | Amsco® Evolution Medium Steam Sterilizer (Models HC-900 andHC-1200)Evolution Automated Loading and Unloading System (ALUS) | ||
|---|---|---|---|
| Device Class: | Class II | ||
| Common/usual Name: | Steam Sterilizer | ||
| Classification Name: | Sterilizer, Steam | ||
| Classification Number: | 21 CFR 880.6880 |
Predicate Device
Product Code:
AMSCO Evolution Medium Steam Sterilizer (Models HC-900 and HC-1200), K173481.
FLE, PEC
3. Description of Device
The Amsco Evolution Medium Steam Sterilizer models HC-900 and HC-1200 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 Medium Steam Sterilizer Models are as follows:
- · 26' x 371/2' x 42" (Model HC 900)
- · 26' x 371/2' x 54" (Model HC 1200)
The Automated Load/Unload System (ALUS) automatically feeds loading cars packed with goods into and/or out of the sterilizer chamber, reducing the amount of handling by central supply workers. This includes ALUS tables for use with AMSCO Evolution medium steam sterilizers having automated chamber doors and the following chamber dimensions (width and height):
- · 26 x 26" (660 x 660 mm)
- 26 x 37½" (660 x 953 mm)
4. Intended Use/Indications for Use
The Amsco Evolution Medium Steam Sterilizer Models HC-900 and HC-1200 are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are available in two configurations:
{16}------------------------------------------------
- · 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 Prevacuum Steam Sterilizer is equipped with the following factory-programmed sterilization cycles and cycle values (Table 6-1):
Table 6-1. Evolution Medium Prevacuum Steam Sterilizer factory-programmed sterilization cycles and cycle values
| Cycles | SterilizeTemperature | SterilizeTime | 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 toTable 6-3 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 to Table 6-3for recommended quantities. |
| Liquid* | 250°F (121°C) | 45 minutes | N/A | Refer to Table 6-4 forrecommended 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 6-3 forrecommended 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 6-3 forrecommended 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 6-3 forrecommended quantities. |
| Gravity | 270°F (132°C) | 25 minutes | 15 minutes | Fabric Packs. Refer to Table 6-3for recommended quantities. |
| DARTWarm-Up | 270°F (132°C) | 3 minutes | 1 minute | N/A |
| DART | 270°F (132°C) | 3 ½minutes | 1 minute | Bowie-Dick Test Pack, DART TestPack |
| Leak Test | N/A | N/A | N/A | N/A |
*The liquid cycle is for non-patient contact use only.
The Amsco Evolution Medium Steam Flush Pressure-Pulse (SFPP) Sterilizer is equipped with the following factory-programmed sterilization cycles and cycle values (Table 6-2):
{17}------------------------------------------------
| Table 6-2. Evolution Medium Steam Flush Pressure-Pulse (SFPP) Sterilizer factory- | |
|---|---|
| programmed sterilization cycles and cycle values |
| Cycles | SterilizeTemperature | SterilizeTime | 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 toTable 6-3 for recommendedquantities. |
| SFPP | 275°F(135°C) | 3 minutes | 30 minutes | Double wrapped instrument trays,maximum weight 25 lbs (11.3 kg)each. Refer to Table 6-3 forrecommended quantities. |
| 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 toTable 6-3 for recommendedquantities. |
| Gravity | 250°F(121°C) | 30 minutes | 15 minutes | Fabric Packs. Refer to Table 6-3for 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 6-3 forrecommended 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 6-3 forrecommended quantities. |
| Liquid* | 250°F(121°C) | 45 minutes | N/A | Refer to Table 6-4 forrecommended quantities. |
| DARTWarm-Up | 270°F(132°C) | 3 minutes | 1 minute | N/A |
| DART | 270°F(132°C) | $3\frac{1}{2}$ minutes | 1 minute | Bowie-Dick Test Pack, DART TestPack |
| Leak Test | N/A | N/A | N/A | N/A |
*The liquid cycle is for non-patient contact use only.
|--|
| Sterilizer Size | Wrapped Instrument Trays | Fabric Packs |
|---|---|---|
| 26" x 37 ½" x 42" | 12 | 18 |
| 26" x 37 ½" x 54" | 16 | 30 |
{18}------------------------------------------------
The following table is a guideline for liquid cycle processing:
| 0 7. 27 0100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000 | ||||||
|---|---|---|---|---|---|---|
| Number of | Volume of Liquid In One | Minimum Recommended | ||||
| Containers | Container | Sterilize Time at 250°F (121°C) | ||||
| 1000 ml | 45 minutes | |||||
| VTI 1 |
Table 6-4. Evolution Medium Steam Sterilizer Liquid Cycle* Guideline
*The liquid cycle is for non-patient contact use only.
The Amsco Evolution Medium Steam Sterilizer is offered in the following chamber sizes:
- 26" x 37½" x 42" (Model HC 900) ●
- 26" x 37½" x 54" (Model HC 1200) ●
The Evolution Automated Loading and Unloading System (ALUS) is used for automated loading and unloading the Evolution Medium Steam Sterilizers.
ട്. Summary of Design and Verification Activities
No changes have been made to the sterilizer for addition of the ALUS system. All software to allow loading and cycle initiation was present in the predicate device including functionality to read the barcode and initiate the cycle.
The modification is inclusion of the hardware: conveyors, loading cars and barcode reader.
| DeviceModification | Verification /Validation Activity | AcceptanceCriteria | Verification /Validation Results |
|---|---|---|---|
| Addition ofALUS hardware | Functional testing | Automatic loading andunloading and initiationof the proper cycle | Pass |
| UL 73: 2011 Ed.10(2018) evaluation | Meet requirements forETL certification | Pass |
The AMSCO Evolution Medium Steam Sterilizer with Automated Loading and Unloading System has met the established performance criteria.
6. Conclusion
The conclusions drawn from the nonclinical and clinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device (K173481), Class II (21 CFR 880.6880), product code FLE.
{19}------------------------------------------------
Image /page/19/Picture/1 description: The image shows the STERIS logo. The word STERIS is in all caps and in a serif font. Below the word STERIS is an image of several horizontal wavy lines.
510(k) Summary For Amsco Evolution Medium Steam Sterilizer (Models HC-600 and HC-1500) Evolution Automated Loading and Unloading System (ALUS)
STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 357-9198
Contact: Tony Piotrkowski Director, Regulatory Affairs Tel: 440-392-7437 Fax: 440-357-9198 e-mail: tony_piotrkowski@steris.com
October 7, 2020 Submission Date:
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
{20}------------------------------------------------
7. Device Name
| Trade Name: | Amsco® Evolution Medium Steam Sterilizer (Models HC-600 andHC-1500)Evolution Automated Loading and Unloading System (ALUS) | ||
|---|---|---|---|
| Device Class: | Class II | ||
| Common/usual Name: | Steam Sterilizer | ||
| Classification Name: | Sterilizer, Steam | ||
| Classification Number: | 21 CFR 880.6880 |
Predicate Device 8.
Product Code:
AMSCO Evolution Medium Steam Sterilizer (Models HC-600 and HC-1500), K173485.
FLE, PEC
9. Description of Device
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.
The chamber sizes of the proposed Amsco Evolution Medium Steam Sterilizer Models are as follows:
- · 26" x 26" x 39" (Model HC 600)
- · 26'' x 37 ½' x 66" (Model HC 1500)
The Automated Load/Unload System (ALUS) automatically feeds loading cars packed with goods into and/or out of the sterilizer chamber, reducing the amount of handling by central supply workers. This includes ALUS tables for use with AMSCO Evolution medium steam sterilizers having automated chamber doors and the following chamber dimensions (width and height):
- · 26 x 26" (660 x 660 mm)
- · 26 x 37-1/2" (660 x 953 mm)
Intended Use/Indications for Use 10.
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:
{21}------------------------------------------------
- · 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 Prevacuum Steam Sterilizer is equipped with the following factory-programmed sterilization cycles and cycle values (Table 6-5):
Table 6-5. Evolution Medium Prevacuum Steam Sterilizer factory-programmed sterilization cycles and cycle values
| Cycles | SterilizeTemperature | SterilizeTime | 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 toTable 6-7 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 to Table 6-7for recommended quantities. |
| Liquid* | 250°F (121°C) | 45 minutes | N/A | Refer to Table 6-8 forrecommended 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 6-7 forrecommended 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 6-7 forrecommended 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 6-7 forrecommended quantities. |
| Gravity | 270°F (132°C) | 25 minutes | 15 minutes | Fabric Packs. Refer to Table 6-7for recommended quantities. |
| DARTWarm-Up | 270°F (132°C) | 3 minutes | 1 minute | N/A |
| DART | 270°F (132°C) | 3½minutes | 1 minute | Bowie-Dick Test Pack, DART TestPack |
| Leak Test | N/A | N/A | N/A | N/A |
*The liquid cycle is for non-patient contact use only.
The Amsco Evolution Medium Steam Flush Pressure-Pulse (SFPP) Sterilizer is equipped with the following factory-programmed sterilization cycles and cycle values (Table 6-6):
{22}------------------------------------------------
| Table 6-6. Evolution Medium Steam Flush Pressure-Pulse (SFPP) Sterilizer factory- | |
|---|---|
| programmed sterilization cycles and cycle values |
| Cycles | SterilizeTemperature | SterilizeTime | 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 6-7 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 6-7 for recommended quantities. |
| 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 6-7 for recommended quantities. |
| Gravity | 250°F(121°C) | 30 minutes | 15 minutes | Fabric Packs. Refer to Table 6-7 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 6-7 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 6-7 for recommended quantities. |
| Liquid* | 250°F(121°C) | 45 minutes | N/A | Refer to Table 6-8 for recommended quantities. |
| DARTWarm-Up | 270°F(132°C) | 3 minutes | 1 minute | N/A |
| DART | 270°F(132°C) | $3 \frac{1}{2}$ 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.
| Table 6-7. Evolution Medium Steam Sterilizer recommended loads per sterilizer size | ||||||
|---|---|---|---|---|---|---|
| -- | -- | -- | -- | -- | ------------------------------------------------------------------------------------ | -- |
| Sterilizer Size | Model Number | WrappedInstrument Trays | Fabric Packs |
|---|---|---|---|
| 26" x 26" x 39" | HC-600 | 9 | 12 |
| 26" x 37 ½" x 66" | HC-1500 | 20 | 36 |
{23}------------------------------------------------
The following table is a guideline for liquid cycle processing:
| Number ofContainers | Volume of Liquid In OneContainer | Minimum RecommendedSterilize Time at 250°F (121°C) |
|---|---|---|
| 3 | 1000 ml | 45 minutes |
| *The liquid cycle is for non-patient contact use only. |
Table 6-8. Evolution Medium Steam Sterilizer Liquid Cvcle* Guideline
The liquid cycle is for non-patient contact use only.
The Evolution Automated Loading and Unloading System (ALUS) is used for automated loading and unloading the Evolution Medium Steam Sterilizers.
11. Summary of Design and Verification Activities
No changes have been made to the sterilizer for addition of the ALUS system. All software to allow loading and cycle initiation was present in the predicate device including functionality to read the barcode and initiate the cycle.
The modification is inclusion of the hardware: conveyors, loading cars and barcode reader.
| DeviceModification | Verification /Validation Activity | AcceptanceCriteria | Verification /Validation Results |
|---|---|---|---|
| Addition ofALUS hardware | Functional testing | Automatic loading andunloading and initiationof the proper cycle | Pass |
| UL 73: 2011 Ed.10(2018) evaluation | Meet requirements forETL certification | Pass |
The AMSCO Evolution Medium Steam Sterilizer with Automated Loading and Unloading System has met the established performance criteria.
Conclusion 12.
The conclusions drawn from the nonclinical and clinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device (K173485), Class II (21 CFR 880.6880), product code FLE.
{24}------------------------------------------------
Image /page/24/Picture/10 description: The image shows the logo for STERIS. The word "STERIS" is in large, bold, sans-serif font at the top of the image. Below the word is an image of several horizontal, curved lines that are blue. The lines are meant to represent water.
510(k) Summary For Amsco Evolution Medium Steam Sterilizer (Models HC-800 and HC-1000) Evolution Automated Loading and Unloading System (ALUS)
STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440)354-2600 Fax No: (440) 357-9198
Contact:
Tony Piotrkowski Director, Regulatory Affairs Tel: 440-392-7437 Fax: 440-357-9198 e-mail: tony piotrkowski@steris.com
Submission Date: October 7, 2020
STERIS Corporation = 5960 Heisley Road = Mentor, OH 44060-1834 USA = 440-354-2600
{25}------------------------------------------------
13. Device Name
| Trade Name: | Amsco® Evolution Medium Steam Sterilizer (Models HC-800 andHC-1000)Evolution Automated Loading and Unloading System (ALUS) |
|---|---|
| ------------- | ------------------------------------------------------------------------------------------------------------------------------------ |
| Device Class: | Class II |
|---|---|
| Common/usual Name: | Steam Sterilizer |
| Classification Name: | Sterilizer, Steam |
| Classification Number: | 21 CFR 880.6880 |
| Product Code: | FLE, PEC |
14. Predicate Device
AMSCO Evolution Medium Steam Sterilizer (Models HC-800 and HC-1000), K173490.
15. Description of Device
The Amsco Evolution Medium Steam Sterilizer models HC-800 and HC-1000 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 Medium Steam Sterilizer Models are as follows:
- 0 26" x 26" x 49" (Model HC - 800)
- 26" x 26" x 61" (Model HC 1000) 0
The Automated Load/Unload System (ALUS) automatically feeds loading cars packed with goods into and/or out of the sterilizer chamber, reducing the amount of handling by central supply workers. This includes ALUS tables for use with AMSCO Evolution medium steam sterilizers having automated chamber doors and the following chamber dimensions (width and height):
- · 26 x 26" (660 x 660 mm)
- · 26 x 37-1/2" (660 x 953 mm)
Intended Use/Indications for Use 16.
The Amsco Evolution Medium Steam Sterilizer Models HC-800 and HC-1000 are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are available in two configurations:
{26}------------------------------------------------
- · 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 Prevacuum Steam Sterilizer is equipped with the following factory-programmed sterilization cycles and cycle values (Table 6-1):
Table 6-9. Evolution Medium Prevacuum Steam Sterilizer factory-programmed sterilization cycles and cycle values
| Cycles | SterilizeTemperature | SterilizeTime | 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 toTable 6-11 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 to Table 6-11for recommended quantities. |
| Liquid* | 250°F (121°C) | 45 minutes | N/A | Refer to Table 6-12 forrecommended 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 6-11 forrecommended 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 6-11 forrecommended 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 6-11 forrecommended quantities. |
| Gravity | 270°F (132°C) | 25 minutes | 15 minutes | Fabric Packs. Refer to Table 6-11for recommended quantities. |
| DARTWarm-Up | 270°F (132°C) | 3 minutes | 1 minute | N/A |
| DART | 270°F (132°C) | 3 1/2minutes | 1 minute | Bowie-Dick Test Pack, DART TestPack |
| Leak Test | N/A | N/A | N/A | N/A |
*The liquid cycle is for non-patient contact use only.
The Amsco Evolution Medium Steam Flush Pressure-Pulse (SFPP) Sterilizer is equipped with the following factory-programmed sterilization cycles and cycle values (Table 6-2):
{27}------------------------------------------------
| Table 6-10. Evolution Medium Steam Flush Pressure-Pulse (SFPP) Sterilizer factory- | |
|---|---|
| programmed sterilization cycles and cycle values |
| Cycles | SterilizeTemperature | SterilizeTime | 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 toTable 6-11 for recommendedquantities. |
| SFPP | 275°F(135°C) | 3 minutes | 30 minutes | Double wrapped instrument trays,maximum weight 25 lbs (11.3 kg)each. Refer to Table 6-11 forrecommended quantities. |
| 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 toTable 6-11 for recommendedquantities. |
| Gravity | 250°F(121°C) | 30 minutes | 15 minutes | Fabric Packs. Refer to Table 6-11for 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 6-11 forrecommended 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 6-11 forrecommended quantities. |
| Liquid* | 250°F(121°C) | 45 minutes | N/A | Refer to Table 6-12 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 TestPack |
| Leak Test | N/A | N/A | N/A | N/A |
*The liquid cycle is for non-patient contact use only.
| Table 6-11. Evolution Medium Steam Sterilizer recommended loads per sterilizer size |
|---|
| ------------------------------------------------------------------------------------- |
| Sterilizer Size | Wrapped Instrument Trays | Fabric Packs |
|---|---|---|
| 26" x 26" x 49" | 12 | 16 |
| 26" x 26" x 61" | 15 | 20 |
{28}------------------------------------------------
The following table is a guideline for liquid cycle processing:
| Number ofContainers | Volume of Liquid In OneContainer | Minimum RecommendedSterilize Time at 250°F (121°C) |
|---|---|---|
| 3 | 1000 ml | 45 minutes |
| Table 6-12. Evolution Medium Steam Sterilizer Liquid Cycle* Guideline | |||||
|---|---|---|---|---|---|
| -- | ----------------------------------------------------------------------- | -- | -- | -- | -- |
*The liquid cycle is for non-patient contact use only.
The Amsco Evolution Medium Steam Sterilizer is offered in the following chamber sizes:
- 26" x 26" x 49" (Model HC = 800) ●
- 26" x 26" x 61" (Model HC = 1000) ●
The Evolution Automated Loading and Unloading System (ALUS) is used for automated loading and unloading the Evolution Medium Steam Sterilizers.
17. Summary of Design and Verification Activities
No changes have been made to the sterilizer for addition of the ALUS system. All software to allow loading and cycle initiation was present in the predicate device including functionality to read the barcode and initiate the cycle.
The modification is inclusion of the hardware: conveyors, loading cars and barcode reader.
| DeviceModification | Verification /Validation Activity | AcceptanceCriteria | Verification /Validation Results |
|---|---|---|---|
| Addition ofALUS hardware | Functional testing | Automatic loading andunloading and initiationof the proper cycle | Pass |
| UL 73: 2011 Ed.10(2018) evaluation | Meet requirements forETL certification | Pass |
The AMSCO Evolution Medium Steam Sterilizer with Automated Loading and Unloading System has met the established performance criteria.
18. Conclusion
The conclusions drawn from the nonclinical and clinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device (K173490), Class II (21 CFR 880.6880), product code FLE.
§ 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).