Amsco Evolution Medium Steam Sterilizer (Models HC-900 and HC-1200),Evolution Automated Loading and Unloading System (ALUS); Amsco EvolutionMedium Steam Sterilizer (Models HC-600 and HC-1500),Evolution Automated Loading and Unloading System (ALUS); Amsco EvolutionMedium Steam Sterilizer (Models HC-800 and HC-1000),Evolution Automated Loading and Unloading System (ALUS)
Device Facts
| Record ID | K203061 |
|---|---|
| Device Name | Amsco Evolution Medium Steam Sterilizer (Models HC-900 and HC-1200),Evolution Automated Loading and Unloading System (ALUS); Amsco EvolutionMedium Steam Sterilizer (Models HC-600 and HC-1500),Evolution Automated Loading and Unloading System (ALUS); Amsco EvolutionMedium Steam Sterilizer (Models HC-800 and HC-1000),Evolution Automated Loading and Unloading System (ALUS) |
| Applicant | STERIS Corporation |
| Product Code | FLE · General Hospital |
| Decision Date | Nov 6, 2020 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 880.6880 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended Use
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.
Device Story
Steam sterilizer for heat/moisture-stable materials in healthcare facilities; utilizes Prevacuum, Gravity, Liquid, Leak Test, and DART cycles. Includes Automated Loading and Unloading System (ALUS) with conveyors, loading cars, and barcode reader to automate transport of goods into/out of chamber. Reduces manual handling by central supply staff. Barcode reader identifies load; system initiates appropriate sterilization cycle. Benefits include standardized processing and reduced worker physical strain. Operates via factory-programmed cycles with defined temperature, time, and dry time parameters.
Clinical Evidence
Bench testing only. Functional testing confirmed automatic loading/unloading and correct cycle initiation. ETL certification obtained per UL 73:2011 Ed.10 (2018).
Technological Characteristics
Steam sterilization; chamber sizes range from 26"x26"x39" to 26"x37.5"x66". Hardware includes conveyors, loading cars, and barcode reader. Connectivity via barcode scanning for cycle initiation. ETL certified per UL 73:2011.
Indications for Use
Indicated for sterilization of heat and moisture-stable materials in healthcare facilities. Compatible with Prevacuum, Gravity, Liquid, Leak Test, and DART (Bowie-Dick) cycles. Liquid cycle is for non-patient contact use only.
Regulatory Classification
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.
Predicate Devices
- AMSCO Evolution Medium Steam Sterilizer (Models HC-900 and HC-1200) (K173481)
- AMSCO Evolution Medium Steam Sterilizer (Models HC-600 and HC-1500) (K173485)
- AMSCO Evolution Medium Steam Sterilizer (Models HC-800 and HC-1000) (K173490)
Related Devices
- K211500 — AMSCO 600 Medium Steam Sterilizer · STERIS Corporation · Aug 25, 2021
- K173481 — Amsco Evolution Medium Steam Sterilizer · STERIS Corporation · Mar 9, 2018
- K173485 — Amsco Evolution Medium Steam Sterilizer · STERIS Corporation · Feb 22, 2018
- K091731 — AMSCO EVOLUTION MEDIUM STEAM STERILIZER · STERIS Corporation · Sep 17, 2009
- K120532 — GETINGE 633HC STEAM STERILIZER AIR GLIDE SYSTEM · Getinge Sourcing, LLC · May 2, 2013
Submission Summary (Full Text)
{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 | Sterilize<br>Temperature | Sterilize<br>Time | Dry Time | Recommended Load |
|-----------------|--------------------------|-------------------|------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Prevac | 270°F (132°C) | 4 minutes | 30 minutes | Double wrapped instrument<br>trays, maximum weight 25<br>lbs (11.3 kg) each and<br>Fabric Packs. Refer to<br>Table 5-3 for recommended<br>quantities. |
| Prevac | 270°F (132°C) | 4 minutes | 5 minutes | Single Fabric Pack |
| Gravity | 250°F (121°C) | 30 minutes | 15 minutes | Fabric Packs. Refer to<br>Table 5-3 for recommended<br>quantities. |
| Liquid* | 250°F (121°C) | 45 minutes | N/A | Refer to Table 5-4 for<br>recommended quantities. |
| Prevac | 275°F (135°C) | 3 minutes | 30 minutes | Double wrapped instrument<br>trays, maximum weight 25<br>lbs (11.3 kg) each. Refer to<br>Table 5-3 for recommended<br>quantities. |
| Gravity | 270°F (132°C) | 15 minutes | 30 minutes | Double wrapped instrument<br>trays, maximum weight 25<br>lbs (11.3 kg) each. Refer to<br>Table 5-3 for recommended<br>quantities. |
| Gravity | 250°F (121°C) | 30 minutes | 30 minutes | Double wrapped instrument<br>trays, maximum weight 25<br>lbs (11.3 kg) each. Refer to<br>Table 5-3 for recommended<br>quantities. |
| Gravity | 270°F (132°C) | 25 minutes | 15 minutes | Fabric Packs. Refer to<br>Table 5-3 for recommended<br>quantities. |
| DART<br>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,<br>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 | Sterilize<br>Temperature | Sterilize<br>Time | Dry Time | Recommended Load |
|-----------------|--------------------------|-------------------|------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| SFPP | 270°F (132°C) | 4 minutes | 30 minutes | Double wrapped<br>instrument trays,<br>maximum weight 25 lbs<br>(11.3 kg) each and Fabric<br>Packs. Refer to Table 5-3<br>for recommended<br>quantities. |
| SFPP | 275°F (135°C) | 3 minutes | 30 minutes | Double wrapped<br>instrument trays,<br>maximum weight 25 lbs<br>(11.3 kg) each. Refer to<br>Table 5-3 for<br>recommended quantities. |
| Prevac | 270°F (132°C) | 4 minutes | 30 minutes | Double wrapped<br>instrument trays,<br>maximum weight 25 lbs<br>(11.3 kg) each and Fabric<br>Packs. Refer to Table 5-3<br>for recommended<br>quantities. |
| Gravity | 250°F (121°C) | 30 minutes | 15 minutes | Fabric Packs. Refer to<br>Table 5-3 for<br>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<br>instrument trays,<br>maximum weight 25 lbs<br>(11.3 kg) each. Refer to<br>Table 5-3 for<br>recommended quantities. |
| Gravity | 270°F (132°C) | 15 minutes | 30 minutes | Double wrapped<br>instrument trays,<br>maximum weight 25 lbs<br>(11.3 kg) each. Refer to<br>Table 5-3 for<br>recommended quantities. |
| Liquid* | 250°F (121°C) | 45 minutes | N/A | Refer to Table 5-4 for<br>recommended quantities. |
| DART<br>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,<br>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 Instrument<br>Trays | 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 of<br>Containers | Volume of Liquid In One<br>Container | Minimum Recommended<br>Sterilize 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)
K203061
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 | Sterilize<br>Temperature | Sterilize<br>Time | Dry Time | Recommended Load |
|-----------------|--------------------------|-------------------|------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Prevac | 270°F (132°C) | 4 minutes | 30 minutes | Double wrapped instrument trays, maximum weight 25 lbs (11.3 kg) each and<br>Fabric Packs. Refer to<br>Table 5-3 for recommended<br>quantities. |
| Prevac | 270°F (132°C) | 4 minutes | 5 minutes | Single Fabric Pack |
| Gravity | 250°F (121°C) | 30 minutes | 15 minutes | Fabric Packs. Refer to<br>Table 5-3 for recommended<br>quantities. |
| Liquid* | 250°F (121°C) | 45 minutes | N/A | Refer to Table 5-4 for<br>recommended quantities. |
| Prevac | 275°F (135°C) | 3 minutes | 30 minutes | Double wrapped instrument trays, maximum weight 25 lbs (11.3 kg) each. Refer to<br>Table 5-3 for recommended<br>quantities. |
| Gravity | 270°F (132°C) | 15 minutes | 30 minutes | Double wrapped instrument trays, maximum weight 25 lbs (11.3 kg) each. Refer to<br>Table 5-3 for recommended<br>quantities. |
| Gravity | 250°F (121°C) | 30 minutes | 30 minutes | Double wrapped instrument trays, maximum weight 25 lbs (11.3 kg) each. Refer to<br>Table 5-3 for recommended<br>quantities. |
| Gravity | 270°F (132°C) | 25 minutes | 15 minutes | Fabric Packs. Refer to<br>Table 5-3 for recommended<br>quantities. |
| DART<br>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,<br>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 | Sterilize<br>Temperature | Sterilize<br>Time | Dry Time | Recommended Load |
|-----------------|--------------------------|-------------------------|------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| SFPP | 270°F (132°C) | 4 minutes | 30 minutes | Double wrapped<br>instrument trays,<br>maximum weight 25 lbs<br>(11.3 kg) each and Fabric<br>Packs. Refer to Table 5-3<br>for recommended<br>quantities. |
| SFPP | 275°F (135°C) | 3 minutes | 30 minutes | Double wrapped<br>instrument trays,<br>maximum weight 25 lbs<br>(11.3 kg) each. Refer to<br>Table 5-3 for<br>recommended quantities. |
| Prevac | 270°F (132°C) | 4 minutes | 30 minutes | Double wrapped<br>instrument trays,<br>maximum weight 25 lbs<br>(11.3 kg) each and Fabric<br>Packs. Refer to Table 5-3<br>for recommended<br>quantities. |
| Gravity | 250°F (121°C) | 30 minutes | 15 minutes | Fabric Packs. Refer to<br>Table 5-3 for<br>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<br>instrument trays,<br>maximum weight 25 lbs<br>(11.3 kg) each. Refer to<br>Table 5-3 for<br>recommended quantities. |
| Gravity | 270°F (132°C) | 15 minutes | 30 minutes | Double wrapped<br>instrument trays,<br>maximum weight 25 lbs<br>(11.3 kg) each. Refer to<br>Table 5-3 for<br>recommended quantities. |
| Liquid* | 250°F (121°C) | 45 minutes | N/A | Refer to Table 4-4 for<br>recommended quantities. |
| DART<br>Warm-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,<br>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 Instrument<br>Trays | 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 of<br>Containers | Volume of Liquid In One<br>Container | Minimum Recommended<br>Sterilize 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 | Sterilize<br>Temperature | Sterilize<br>Time | Dry Time | Recommended Load |
|-----------------|--------------------------|----------------------------|------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Prevac | 270°F (132°C) | 4 minutes | 30 minutes | Double wrapped instrument<br>trays, maximum weight 25<br>lbs (11.3 kg) each and<br>Fabric Packs. Refer to<br>Table 5-3 for recommended<br>quantities. |
| Prevac | 270°F (132°C) | 4 minutes | 5 minutes | Single Fabric Pack |
| Gravity | 250°F (121°C) | 30 minutes | 15 minutes | Fabric Packs. Refer to<br>Table 5-3 for recommended<br>quantities. |
| Liquid* | 250°F (121°C) | 45 minutes | N/A | Refer to Table 5-4 for<br>recommended quantities. |
| Prevac | 275°F (135°C) | 3 minutes | 30 minutes | Double wrapped instrument<br>trays, maximum weight 25<br>lbs (11.3 kg) each. Refer to<br>Table 5-3 for recommended<br>quantities. |
| Gravity | 270°F (132°C) | 15 minutes | 30 minutes | Double wrapped instrument<br>trays, maximum weight 25<br>lbs (11.3 kg) each. Refer to<br>Table 5-3 for recommended<br>quantities. |
| Gravity | 250°F (121°C) | 30 minutes | 30 minutes | Double wrapped instrument<br>trays, maximum weight 25<br>lbs (11.3 kg) each. Refer to<br>Table 5-3 for recommended<br>quantities. |
| Gravity | 270°F (132°C) | 25 minutes | 15 minutes | Fabric Packs. Refer to<br>Table 5-3 for recommended<br>quantities. |
| DART<br>Warm-Up | 270°F (132°C) | 3 minutes | 1 minute | N/A |
| DART | 270°F (132°C) | $3 \frac{1}{2}$<br>minutes | 1 minute | Bowie-Dick Test Pack,<br>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 | Sterilize<br>Temperature | Sterilize<br>Time | Dry Time | Recommended Load |
|-----------------|--------------------------|-------------------|------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| SFPP | 270°F (132°C) | 4 minutes | 30 minutes | Double wrapped<br>instrument trays,<br>maximum weight 25 lbs<br>(11.3 kg) each and Fabric<br>Packs. Refer to Table 5-3<br>for recommended<br>quantities. |
| SFPP | 275°F (135°C) | 3 minutes | 30 minutes | Double wrapped<br>instrument trays.<br>maximum weight 25 lbs<br>(11.3 kg) each. Refer to<br>Table 5-3 for<br>recommended quantities. |
| Prevac | 270°F (132°C) | 4 minutes | 30 minutes | Double wrapped<br>instrument trays.<br>maximum weight 25 lbs<br>(11.3 kg) each and Fabric<br>Packs. Refer to Table 5-3<br>for recommended<br>quantities. |
| Gravity | 250°F (121°C) | 30 minutes | 15 minutes | Fabric Packs. Refer to<br>Table 5-3 for<br>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<br>instrument trays,<br>maximum weight 25 lbs<br>(11.3 kg) each. Refer to<br>Table 5-3 for<br>recommended quantities. |
| Gravity | 270°F (132°C) | 15 minutes | 30 minutes | Double wrapped<br>instrument trays.<br>maximum weight 25 lbs<br>(11.3 kg) each. Refer to<br>Table 5-3 for<br>recommended quantities. |
| Liquid* | 250°F (121°C) | 45 minutes | N/A | Refer to Table 5-4 for<br>recommended quantities. |
| DART<br>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,<br>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 Instrument<br>Trays | 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 of<br>Containers | Volume of Liquid In One<br>Container | Minimum Recommended<br>Sterilize 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 and<br>HC-1200)<br>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:
2.
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 | Sterilize<br>Temperature | Sterilize<br>Time | Dry Time | Recommended Load |
|-----------------|--------------------------|-------------------|------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| Prevac | 270°F (132°C) | 4 minutes | 30 minutes | Double wrapped instrument trays,<br>maximum weight 25 lbs (11.3 kg)<br>each and Fabric Packs. Refer to<br>Table 6-3 for recommended<br>quantities. |
| Prevac | 270°F (132°C) | 4 minutes | 5 minutes | Single Fabric Pack |
| Gravity | 250°F (121°C) | 30 minutes | 15 minutes | Fabric Packs. Refer to Table 6-3<br>for recommended quantities. |
| Liquid* | 250°F (121°C) | 45 minutes | N/A | Refer to Table 6-4 for<br>recommended quantities. |
| Prevac | 275°F (135°C) | 3 minutes | 30 minutes | Double wrapped instrument trays,<br>maximum weight 25 lbs (11.3 kg)<br>each. Refer to Table 6-3 for<br>recommended quantities. |
| Gravity | 270°F (132°C) | 15 minutes | 30 minutes | Double wrapped instrument trays,<br>maximum weight 25 lbs (11.3 kg)<br>each. Refer to Table 6-3 for<br>recommended quantities. |
| Gravity | 250°F (121°C) | 30 minutes | 30 minutes | Double wrapped instrument trays,<br>maximum weight 25 lbs (11.3 kg)<br>each. Refer to Table 6-3 for<br>recommended quantities. |
| Gravity | 270°F (132°C) | 25 minutes | 15 minutes | Fabric Packs. Refer to Table 6-3<br>for recommended quantities. |
| DART<br>Warm-Up | 270°F (132°C) | 3 minutes | 1 minute | N/A |
| DART | 270°F (132°C) | 3 ½<br>minutes | 1 minute | Bowie-Dick Test Pack, DART Test<br>Pack |
| 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 | Sterilize<br>Temperature | Sterilize<br>Time | Dry Time | Recommended Load |
|-----------------|--------------------------|------------------------|------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| SFPP | 270°F<br>(132°C) | 4 minutes | 30 minutes | Double wrapped instrument trays,<br>maximum weight 25 lbs (11.3 kg)<br>each and Fabric Packs. Refer to<br>Table 6-3 for recommended<br>quantities. |
| SFPP | 275°F<br>(135°C) | 3 minutes | 30 minutes | Double wrapped instrument trays,<br>maximum weight 25 lbs (11.3 kg)<br>each. Refer to Table 6-3 for<br>recommended quantities. |
| Prevac | 270°F<br>(132°C) | 4 minutes | 30 minutes | Double wrapped instrument trays,<br>maximum weight 25 lbs (11.3 kg)<br>each and Fabric Packs. Refer to<br>Table 6-3 for recommended<br>quantities. |
| Gravity | 250°F<br>(121°C) | 30 minutes | 15 minutes | Fabric Packs. Refer to Table 6-3<br>for recommended quantities. |
| SFPP | 270°F<br>(132°C) | 4 minutes | 5 minutes | Single Fabric Pack |
| Prevac | 275°F<br>(135°C) | 3 minutes | 30 minutes | Double wrapped instrument trays,<br>maximum weight 25 lbs (11.3 kg)<br>each. Refer to Table 6-3 for<br>recommended quantities. |
| Gravity | 270°F<br>(132°C) | 15 minutes | 30 minutes | Double wrapped instrument trays,<br>maximum weight 25 lbs (11.3 kg)<br>each. Refer to Table 6-3 for<br>recommended quantities. |
| Liquid* | 250°F<br>(121°C) | 45 minutes | N/A | Refer to Table 6-4 for<br>recommended quantities. |
| DART<br>Warm-Up | 270°F<br>(132°C) | 3 minutes | 1 minute | N/A |
| DART | 270°F<br>(132°C) | $3\frac{1}{2}$ minutes | 1 minute | Bowie-Dick Test Pack, DART Test<br>Pack |
| 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.
| Device<br>Modification | Verification /<br>Validation Activity | Acceptance<br>Criteria | Verification /<br>Validation Results |
|------------------------------|----------------------------------------|--------------------------------------------------------------------------|--------------------------------------|
| Addition of<br>ALUS hardware | Functional testing | Automatic loading and<br>unloading and initiation<br>of the proper cycle | Pass |
| | UL 73: 2011 Ed.10<br>(2018) evaluation | Meet requirements for<br>ETL 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 and<br>HC-1500)<br>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 | Sterilize<br>Temperature | Sterilize<br>Time | Dry Time | Recommended Load |
|-----------------|--------------------------|-------------------|------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| Prevac | 270°F (132°C) | 4 minutes | 30 minutes | Double wrapped instrument trays,<br>maximum weight 25 lbs (11.3 kg)<br>each and Fabric Packs. Refer to<br>Table 6-7 for recommended<br>quantities. |
| Prevac | 270°F (132°C) | 4 minutes | 5 minutes | Single Fabric Pack |
| Gravity | 250°F (121°C) | 30 minutes | 15 minutes | Fabric Packs. Refer to Table 6-7<br>for recommended quantities. |
| Liquid* | 250°F (121°C) | 45 minutes | N/A | Refer to Table 6-8 for<br>recommended quantities. |
| Prevac | 275°F (135°C) | 3 minutes | 30 minutes | Double wrapped instrument trays,<br>maximum weight 25 lbs (11.3 kg)<br>each. Refer to Table 6-7 for<br>recommended quantities. |
| Gravity | 270°F (132°C) | 15 minutes | 30 minutes | Double wrapped instrument trays,<br>maximum weight 25 lbs (11.3 kg)<br>each. Refer to Table 6-7 for<br>recommended quantities. |
| Gravity | 250°F (121°C) | 30 minutes | 30 minutes | Double wrapped instrument trays,<br>maximum weight 25 lbs (11.3 kg)<br>each. Refer to Table 6-7 for<br>recommended quantities. |
| Gravity | 270°F (132°C) | 25 minutes | 15 minutes | Fabric Packs. Refer to Table 6-7<br>for recommended quantities. |
| DART<br>Warm-Up | 270°F (132°C) | 3 minutes | 1 minute | N/A |
| DART | 270°F (132°C) | 3½<br>minutes | 1 minute | Bowie-Dick Test Pack, DART Test<br>Pack |
| 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 | Sterilize<br>Temperature | Sterilize<br>Time | Dry Time | Recommended Load |
|-----------------|--------------------------|-------------------------|------------|----------------------------------------------------------------------------------------------------------------------------------------|
| SFPP | 270°F<br>(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<br>(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<br>(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<br>(121°C) | 30 minutes | 15 minutes | Fabric Packs. Refer to Table 6-7 for recommended quantities. |
| SFPP | 270°F<br>(132°C) | 4 minutes | 5 minutes | Single Fabric Pack |
| Prevac | 275°F<br>(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<br>(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<br>(121°C) | 45 minutes | N/A | Refer to Table 6-8 for recommended quantities. |
| DART<br>Warm-Up | 270°F<br>(132°C) | 3 minutes | 1 minute | N/A |
| DART | 270°F<br>(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 | Wrapped<br>Instrument 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 of<br>Containers | Volume of Liquid In One<br>Container | Minimum Recommended<br>Sterilize 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.
| Device<br>Modification | Verification /<br>Validation Activity | Acceptance<br>Criteria | Verification /<br>Validation Results |
|------------------------------|----------------------------------------|--------------------------------------------------------------------------|--------------------------------------|
| Addition of<br>ALUS hardware | Functional testing | Automatic loading and<br>unloading and initiation<br>of the proper cycle | Pass |
| | UL 73: 2011 Ed.10<br>(2018) evaluation | Meet requirements for<br>ETL 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 and<br>HC-1000)<br>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 | Sterilize<br>Temperature | Sterilize<br>Time | Dry Time | Recommended Load |
|-----------------|--------------------------|-------------------|------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Prevac | 270°F (132°C) | 4 minutes | 30 minutes | Double wrapped instrument trays,<br>maximum weight 25 lbs (11.3 kg)<br>each and Fabric Packs. Refer to<br>Table 6-11 for recommended<br>quantities. |
| Prevac | 270°F (132°C) | 4 minutes | 5 minutes | Single Fabric Pack |
| Gravity | 250°F (121°C) | 30 minutes | 15 minutes | Fabric Packs. Refer to Table 6-11<br>for recommended quantities. |
| Liquid* | 250°F (121°C) | 45 minutes | N/A | Refer to Table 6-12 for<br>recommended quantities. |
| Prevac | 275°F (135°C) | 3 minutes | 30 minutes | Double wrapped instrument trays,<br>maximum weight 25 lbs (11.3 kg)<br>each. Refer to Table 6-11 for<br>recommended quantities. |
| Gravity | 270°F (132°C) | 15 minutes | 30 minutes | Double wrapped instrument trays,<br>maximum weight 25 lbs (11.3 kg)<br>each. Refer to Table 6-11 for<br>recommended quantities. |
| Gravity | 250°F (121°C) | 30 minutes | 30 minutes | Double wrapped instrument trays,<br>maximum weight 25 lbs (11.3 kg)<br>each. Refer to Table 6-11 for<br>recommended quantities. |
| Gravity | 270°F (132°C) | 25 minutes | 15 minutes | Fabric Packs. Refer to Table 6-11<br>for recommended quantities. |
| DART<br>Warm-Up | 270°F (132°C) | 3 minutes | 1 minute | N/A |
| DART | 270°F (132°C) | 3 1/2<br>minutes | 1 minute | Bowie-Dick Test Pack, DART Test<br>Pack |
| 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 | Sterilize<br>Temperature | Sterilize<br>Time | Dry Time | Recommended Load |
|-----------------|--------------------------|-------------------|------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| SFPP | 270°F<br>(132°C) | 4 minutes | 30 minutes | Double wrapped instrument trays,<br>maximum weight 25 lbs (11.3 kg)<br>each and Fabric Packs. Refer to<br>Table 6-11 for recommended<br>quantities. |
| SFPP | 275°F<br>(135°C) | 3 minutes | 30 minutes | Double wrapped instrument trays,<br>maximum weight 25 lbs (11.3 kg)<br>each. Refer to Table 6-11 for<br>recommended quantities. |
| Prevac | 270°F<br>(132°C) | 4 minutes | 30 minutes | Double wrapped instrument trays,<br>maximum weight 25 lbs (11.3 kg)<br>each and Fabric Packs. Refer to<br>Table 6-11 for recommended<br>quantities. |
| Gravity | 250°F<br>(121°C) | 30 minutes | 15 minutes | Fabric Packs. Refer to Table 6-11<br>for recommended quantities. |
| SFPP | 270°F<br>(132°C) | 4 minutes | 5 minutes | Single Fabric Pack |
| Prevac | 275°F<br>(135°C) | 3 minutes | 30 minutes | Double wrapped instrument trays,<br>maximum weight 25 lbs (11.3 kg)<br>each. Refer to Table 6-11 for<br>recommended quantities. |
| Gravity | 270°F<br>(132°C) | 15 minutes | 30 minutes | Double wrapped instrument trays,<br>maximum weight 25 lbs (11.3 kg)<br>each. Refer to Table 6-11 for<br>recommended quantities. |
| Liquid* | 250°F<br>(121°C) | 45 minutes | N/A | Refer to Table 6-12 for<br>recommended quantities. |
| DART<br>Warm-Up | 270°F<br>(132°C) | 3 minutes | 1 minute | N/A |
| DART | 270°F<br>(132°C) | 3 ½ minutes | 1 minute | Bowie-Dick Test Pack, DART Test<br>Pack |
| 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 of<br>Containers | Volume of Liquid In One<br>Container | Minimum Recommended<br>Sterilize 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.
| Device<br>Modification | Verification /<br>Validation Activity | Acceptance<br>Criteria | Verification /<br>Validation Results |
|------------------------------|----------------------------------------|--------------------------------------------------------------------------|--------------------------------------|
| Addition of<br>ALUS hardware | Functional testing | Automatic loading and<br>unloading and initiation<br>of the proper cycle | Pass |
| | UL 73: 2011 Ed.10<br>(2018) evaluation | Meet requirements for<br>ETL 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.
