AMSCO EVOLUTION MEDIUM STEAM STERILIZER

• K Number: K091731
• Device Name: AMSCO EVOLUTION MEDIUM STEAM STERILIZER
• Manufacturer: STERIS Corporation
• Date Cleared: 2009-09-17 ( 98 days)
• Product Code: FLE
• Regulation Number: 880.6880

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 Description

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) .

Predicate Devices

K082435

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a steam sterilizer with standard sterilization cycles and does not mention any AI/ML capabilities.

Therapeutic

No
This device is a sterilizer for heat and moisture-stable materials used in healthcare facilities, not a device for treating patients.

Diagnostic

No
The device is a steam sterilizer designed for sterilizing materials, not for diagnosing medical conditions.

SaMD (Software as a Medical Device)

No

The device description clearly describes a physical steam sterilizer with specific chamber sizes, indicating it is a hardware device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use is for the "sterilization of heat and moisture-stable materials used in healthcare facilities." This describes a process for making medical devices or materials safe for use, not for performing tests on biological samples to diagnose conditions.
• Device Description: The description focuses on the physical characteristics of a steam sterilizer, including chamber size and available sterilization cycles. This aligns with a device used for sterilization, not for in vitro diagnostic testing.
• Lack of IVD Indicators: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.

IVD devices are specifically designed to perform tests on specimens taken from the human body (like blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease. This device's function is entirely different.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

The Amsco Evolution Medium Prevacuum Steam Sterilizer is equipped with the Fillowing 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

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

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

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

Sterilizer Size	Wrapped Instrument Trays	Fabric Packs
26" x 26" x 49"	12	16
26" x 26" x 61"	15	20

The following table is a guideline for liquid cycle processing:

Number of Containers	Volume of Liquid In One Container	Minimum Recommended 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)

Product codes (comma separated list FDA assigned to the subject device)

80 FLE

Device Description

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) .

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

healthcare facilities

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K082435

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 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).

Summary

0

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

1

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)
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.

2

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.

3

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

4

| Cycles | Sterilize
Temperature | Sterilize
Time | Dry Time | Recommended Load |
|-----------------|--------------------------|-------------------|----------|---------------------------------------------------|
| Liquid | 250°F (121°C) | 45 minutes | N/A | Refer to Table 4-4 for
recommended quantities. |
| DART
Warm-Up | 270°F (132°C) | 3 minutes | 1 minute | N/A |
| DART | 270°F (132°C) | 3 ½ minutes | 1 minute | Bowie-Dick Test Pack,
DART Test Pack |
| Leak Test | N/A | N/A | N/A | N/A |

*The 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

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.

5

Image /page/5/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in all caps. The text is in a bold, sans-serif font. The words are arranged on a single line and are centered horizontally.

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of an abstract human figure with three arms or branches extending upwards. To the left of the graphic, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the graphic.

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.

6

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

7

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

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

8

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

*The 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

9

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

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

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

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

10

The following table is a guideline for liquid cycle processing:

Table 4-4. Amsco Evolution Medium Steam

| Number of
Containers | Volume of Liquid In One
Container | Minimum Recommended
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