AMSCO EVOLUTION MEDIUM STEAM STERILIZER

K091731 · STERIS Corporation · FLE · Sep 17, 2009 · General Hospital

Device Facts

• Record ID: K091731
• Device Name: AMSCO EVOLUTION MEDIUM STEAM STERILIZER
• Applicant: STERIS Corporation
• Product Code: FLE · General Hospital
• Decision Date: Sep 17, 2009
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.6880
• Device Class: Class 2

Intended Use

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.

Device Story

Amsco Evolution Medium Steam Sterilizer (Models HC-800, HC-1000) provides automated steam sterilization for heat/moisture-stable medical materials. Device operates via Prevacuum or Steam Flush Pressure-Pulse (SFPP) configurations. Cycles include Prevacuum, Gravity, Liquid, Leak Test, and DART (Bowie-Dick). Healthcare facility staff load materials into chamber; select cycle based on load type (wrapped instruments, fabric packs, or non-patient contact liquids). Device controls steam temperature, pressure, and exposure time to ensure sterilization. Output is a sterilized load ready for clinical use. Benefits include standardized, validated sterilization processes for surgical instruments and facility supplies.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Steam sterilizer; chamber sizes 26"x26"x49" (HC-800) and 26"x26"x61" (HC-1000). Operates via steam injection, vacuum, and pressure-pulse cycles. Factory-programmed cycles for temperature (121°C-135°C) and time. Standalone unit.

Indications for Use

Indicated for sterilization of heat and moisture-stable materials in healthcare facilities. Compatible with wrapped instrument trays (max 25 lbs) and fabric packs. 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 (K082435)

Submission Summary (Full Text)

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# K091731 STERIS®

# 510(k) Summary For Amsco Evolution Medium Steam Sterilizer Models HC-800 and HC-1000

STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: [phone] Fax No: [phone]

Contact:

Robert F. Sullivan Senior Director FDA Regulatory Affairs Telephone:[phone] Fax No: [phone]

Summary Date:

June 10, 2009

STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600

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#### 1. Device Name

| Trade Name: | Amsco Evolution Medium Steam Sterilizer |
|----------------------|-----------------------------------------------------------|
| Models: | HC-800 and HC-1200 |
| Common/Usual Name: | Steam Sterilizer |
| Classification Name: | Steam Sterilizer (21 CFR 880.6880)<br>Product Code 80 FLE |

#### 2. Predicate Device

K082435, Amsco Evolution Medium Steam Sterilizer, product code [FLE] cleared December 30, 2008.

#### Description of Device 3.

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:

- 26" x 26" x 49" (Model HC 800) .
- 26" x 26" x 61" (Model HC 1000) .

#### Intended Use 4.

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.

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# STERIS ABBREVIATED 510(k) PREMARKET NOTIFICATION STERIO ABDREVIEW Steam Sterilizer (Models HC-800 and HC-1000)

The Amsco Evolution Medium Prevacuum Steam Sterilizer is equipped with the following factory-programmed sterilization cycles and cycle values (Table 4-1):

| Cycles | Sterilize Temperature | Sterilize Time | Dry Time | Recommended Load |
|--------------|-----------------------|----------------|------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Prevac | 270°F (132°C) | 4 minutes | 30 minutes | Double wrapped instrument trays, maximum weight 25 lbs (11.3 kg) each and Fabric Packs. Refer to Table 4-3 for recommended quantities. |
| Prevac | 270°F (132°C) | 4 minutes | 5 minutes | Single Fabric Pack |
| Gravity | 250°F (121°C) | 30 minutes | 15 minutes | Fabric Packs. Refer to Table 4-3 for recommended quantities. |
| Liquid | 250°F (121°C) | 45 minutes | N/A | Refer to Table 4-4 for recommended quantities. |
| Prevac | 275°F (135°C) | 3 minutes | 30 minutes | Double wrapped instrument trays, maximum weight 25 lbs (11.3 kg) each. Refer to Table 4-3 for recommended quantities. |
| Gravity | 270°F (132°C) | 15 minutes | 30 minutes | Double wrapped instrument trays, maximum weight 25 lbs (11.3 kg) each. Refer to Table 4-3 for recommended quantities. |
| Gravity | 250°F (121°C) | 30 minutes | 30 minutes | Double wrapped instrument trays, maximum weight 25 lbs (11.3 kg) each. Refer to Table 4-3 for recommended quantities. |
| Gravity | 270°F (132°C) | 25 minutes | 15 minutes | Fabric Packs. Refer to Table 4-3 for recommended quantities. |
| DART Warm-Up | 270°F (132°C) | 3 minutes | 1 minute | N/A |
| DART | 270°F (132°C) | 3 ½ minutes | 1 minute | Bowie-Dick Test Pack, DART Test Pack |
| Leak Test | N/A | N/A | N/A | N/A |
| Cycles | Sterilize Temperature | Sterilize Time | Dry Time | Recommended Load |
| SFPP | 270°F (132°C) | 4 minutes | 30 minutes | Double wrapped instrument trays, maximum weight 25 lbs (11.3 kg) each and Fabric Packs. Refer to Table 4-3 for recommended quantities. |
| SFPP | 275°F (135°C) | 3 minutes | 30 minutes | Double wrapped instrument trays, maximum weight 25 lbs (11.3 kg) each. Refer to Table 4-3 for recommended quantities. |
| Prevac | 270°F (132°C) | 4 minutes | 30 minutes | Double wrapped instrument trays, maximum weight 25 lbs (11.3 kg) each and Fabric Packs. Refer to Table 4-3 for recommended quantities. |
| Gravity | 250°F (121°C) | 30 minutes | 15 minutes | Fabric Packs. Refer to Table 4-3 for recommended quantities. |
| SFPP | 270°F (132°C) | 4 minutes | 5 minutes | Single Fabric Pack |
| Prevac | 275°F (135°C) | 3 minutes | 30 minutes | Double wrapped instrument trays, maximum weight 25 lbs (11.3 kg) each. Refer to Table 4-3 for recommended quantities. |
| Gravity | 270°F (132°C) | 15 minutes | 30 minutes | Double wrapped instrument trays, maximum weight 25 lbs (11.3 kg) each. Refer to Table 4-3 for recommended quantities. |

Table 4-1. Amsco Evolution Medium Prevacuum Steam Sterilizer factory-programmed sterilization cycles and cycle values

*The liquid cycle is for non-patient contact use only.

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The Amsco Evolution Medium Steam Flush Pressure-Pulse (SFPP) Sterilizer is The Amseo Lyonation Necatall Brown and sterilization cycles and cycle values (Table 4-2):

| Table 4-2. Amsco Evolution Medium Steam Flush Pressure-Pulse (SFPP) | |
|---------------------------------------------------------------------|--|
| Sterilizer factory-programmed sterilization cvcles and cvcle values | |

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| Cycles | Sterilize<br>Temperature | Sterilize<br>Time | Dry Time | Recommended Load |
|-----------------|--------------------------|-------------------|----------|---------------------------------------------------|
| 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 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.

The following table lists STERIS's recommended loads by sterilizer size:

| Sterilizer recommended loads per 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 4-3. Amsco Evolution Medium Steam

The following table is a guideline for liquid cycle processing:

# Table 4-4. Amsco Evolution Medium Steam Sterilizer Liquid Cycle Guideline

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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) .

#### Description of Safety and Substantial Equivalence 5.

A summary of the technological characteristics of the device subject of this premarket notification in comparison to those of the predicate devices is included in Table 5-5.

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**SEP 17 2009**

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Mr. Robert F. Sullivan Senior Director of FDA Regulatory Affairs STERIS Corporation 5960 Heisley Road Mentor, Ohio 44060-1834

Re: K091731

Trade/Device Name: Amsco Evolution Medium Steam Sterilizer Regulation Number: 21 CFR 880. 6880 Regulation Name: Steam Sterilizer Regulatory Class: II Product Code: FLE Dated: August 13, 2009 Received: August 14, 2009

Dear Mr. Sullivan;

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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### Page 2 - Mr. Sullivan

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA. has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820): and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Anthony O. Winston ber.

Susan Runner, D.D.S., M.A. Acting Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known):

Device Name:

Amsco Evolution Medium Steam Sterilizer (Models HC-800 and HC-1000)

Indications For Use:

The Amsco Evolution Medium Steam Sterilizer Models HC-800 and HC-1000 are r no rimboo 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 Prevacuum Steam Sterilizer is equipped with the Fillowing factory-programmed sterilization cycles and cycle values (Table 4-1):

| Cycles | Sterilize<br>Temperature | Sterilize 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 4-3 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 4-3 for recommended<br>quantities. |
| Liquid | 250°F (121°C) | 45 minutes | N/A | Refer to Table 4-4 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 4-3 for recommended<br>quantities. |

Table 4-1. Amsco Evolution Medium Prevacuum Steam Sterilizer factory-programmed sterilization cycles and cycle values

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| Cycles | Sterilize<br>Temperature | Sterilize<br>Time | Dry Time | Recommended Load |
|-----------------|--------------------------|-------------------|------------|-----------------------------------------------------------------------------------------------------------------------------------|
| 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 4-3 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 4-3 for recommended<br>quantities. |
| Gravity | 270°F (132°C) | 25 minutes | 15 minutes | Fabric Packs. Refer to<br>Table 4-3 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.

The Amsco Evolution Medium Steam Flush Pressure-Pulse (SFPP) Sterilizer is equipped with the following factory-programmed sterilization cycles and cycle values (Table 4-2): '

| Cycles | Sterilize Temperature | Sterilize Time | Dry Time | Recommended Load |
|--------|-----------------------|----------------|------------|----------------------------------------------------------------------------------------------------------------------------------------|
| SFPP | 270°F (132°C) | 4 minutes | 30 minutes | Double wrapped instrument trays, maximum weight 25 lbs (11.3 kg) each and Fabric Packs. Refer to Table 4-3 for recommended quantities. |
| SFPP | 275°F (135°C) | 3 minutes | 30 minutes | Double wrapped instrument trays, maximum weight 25 lbs (11.3 kg) each. Refer to Table 4-3 for recommended quantities. |

# Table 4-2. Amsco Evolution Medium Steam Flush Pressure-Pulse (SFPP) Sterilizer factory-programmed sterilization cycles and cycle values

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| Cycles | Sterilize<br>Temperature | Sterilize<br>Time | Dry Time | Recommended Load |
|-----------------|--------------------------|-------------------|------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 4-3<br>for recommended<br>quantities. |
| Gravity | 250°F (121°C) | 30 minutes | 15 minutes | Fabric Packs. Refer to<br>Table 4-3 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 4-3 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 4-3 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 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.

The following table lists STERIS's recommended loads by sterilizer size:

| 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 |

# Table 4-3. Amsco Evolution Medium Steam

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The following table is a guideline for liquid cycle processing:

# Table 4-4. Amsco Evolution Medium Steam

| 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 |

# Sterilizer Liquid Cycle Guideline

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)

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use X (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

K 09173 i Shuli M. Murphy, MD

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K091731