Amsco Evolution Medium Steam Sterilizer

• K Number: K173485
• Device Name: Amsco Evolution Medium Steam Sterilizer
• Manufacturer: STERIS Corporation
• Date Cleared: 2018-02-22 ( 101 days)
• Product Code: FLE
• Regulation Number: 880.6880

Intended Use

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, Liguid, Leak Test and DART (Bowie-. Dick) cycles.

Device Description

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" (660 mm x 660 mm x 991 mm) Model HC-600 . - Model HC-1500 26" x 37½" x 60" (660mm x 950mm x 1524mm) .

Predicate Devices

K082435

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a steam sterilizer with various sterilization cycles and physical specifications. There is no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies. The performance studies focus on standard device validation activities.

Therapeutic

No.
The device's intended use is for sterilization of materials used in healthcare facilities, not for direct therapeutic treatment of patients.

Diagnostic

No

Explanation: The device is a steam sterilizer designed for sterilizing materials in healthcare facilities. Its function is to clean and disinfect, not to diagnose medical conditions or analyze patient data.

SaMD (Software as a Medical Device)

No

The device description clearly indicates a physical steam sterilizer with specific chamber sizes and cycle types, which are hardware components. While software validation is mentioned in the performance studies, the core device is a piece of hardware.

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 sterile, not for performing diagnostic tests on biological samples.
• Device Description: The description focuses on the physical characteristics of a steam sterilizer, including chamber sizes and available sterilization cycles. This aligns with a sterilization device, not an IVD.
• Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.

IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This steam sterilizer does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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, Liguid, 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):

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

FLE

Device Description

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" (660 mm x 660 mm x 991 mm) Model HC-600 .
• Model HC-1500 26" x 37½" x 60" (660mm x 950mm x 1524mm) .

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)

The following table summarizes the verification activities that were performed with their respective acceptance criteria to ensure that these modifications do not affect the safety or effectiveness of the Evolution Medium Steam Sterilizers.

Device Modification	Verification / Validation Activity	Acceptance Criteria	Results of Verification /Validation
Control replacement	Performance testing Electrical safety	Per ST8 Per IEC 61010-1	Pass
Software modifications	Software validation	Software shall be appropriately verified and validated	Pass
Vacuum pump replacement	Performance testing	Per ST8	Pass
Printer replacement	Software validation	Software shall be appropriately verified and validated	Pass
Valve modifications	Performance testing	Per ST8	Pass
Switch modification	Actuation	Proper actuation, no alarms	Pass
Door mounting bracket modification	Door operation check	Proper function after multiple cycles	Pass

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

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure.

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

February 22, 2018

STERIS Corporation Tony Piotrkowski Sr. Manager, Regulatory Affairs 5960 Heislev Rd. Mentor, Ohio 44060

Re: K173485

Trade/Device Name: Amsco Evolution Medium Steam Sterilizer Regulation Number: 21 CFR 880.6880 Regulation Name: Sterilizer, Steam Regulatory Class: Class II Product Code: FLE Dated: December 12, 2017 Received: December 26, 2017

Dear Mr. Tony 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. 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 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

1

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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Michael J. Ryan -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K173485

Device Name

Amsco Evolution Medium Steam Sterilizer

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, Liguid, 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
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 5-3 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 5-3 for recommended
quantities. |
| Liquid* | 250°F (121°C) | 45 minutes | N/A | Refer to Table 5-4 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 5-3 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 5-3 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 5-3 for recommended
quantities. |
| Gravity | 270°F (132°C) | 25 minutes | 15
minutes | Fabric Packs. Refer to
Table 5-3 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.

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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 values

Cycles	Sterilize	Sterilize	Dry Time	Recommended Load
	Temperature	Time
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 5-3
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 5-3 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 5-3
for recommended
quantities.
Gravity	250°F (121°C)	30 minutes	15
minutes	Fabric Packs. Refer to
Table 5-3 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 5-3 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 5-3 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.

4

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

| Sterilizer Size | Model Number | Wrapped Instrument
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
Containers | Volume of Liquid In One
Container | Minimum Recommended
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

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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)

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510(k) Summary For Amsco Evolution Medium Steam Sterilizer

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

Contact:

Tony Piotrkowski Senior Manager, Regulatory Affairs Tel: [phone] Fax: [phone] e-mail: [e-mail]

Submission Date: February 12, 2018

Premarket Notification Number: K173485

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

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Device Name 1.

Trade Name: Amsco® Evolution Medium Steam Sterilizer

Device Class:	Class II
Common/usual Name:	Steam Sterilizer
Classification Name:	Sterilizer, Steam
Classification Number:	21 CFR 880.6880
Product Code:	FLE

2. Predicate Device

AMSCO Evolution Medium Steam Sterilizer (Models HC-600 and HC-1500), K082435.

3. 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" (660 mm x 660 mm x 991 mm) Model HC-600 .
• Model HC-1500 26" x 37½" x 60" (660mm x 950mm x 1524mm) .

4. Intended Use

The Amsco Evolution Medium Steam Sterilizer models HC-600 and HC-1500 are designed for sterilization of heat and moisture-stabile 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 6-1):

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| 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. Fabric
Packs. Refer to Table 6-3
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 6-3 for recommended
quantities. |
| Liquid* | 250°F (121°C) | 45 minutes | N/A | Refer to Table 6-4 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 6-3 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 6-3 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 6-3 for recommended
quantities. |
| Gravity | 270°F (132°C) | 25 minutes | 15 minutes | Fabric Packs. Refer to
Table 6-3 for recommended
quantities. |
| DART
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,
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. Fabric
Packs. Refer to Table 6-3
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 6-3 for recommended
quantities. |
| Prevac | 270°F (132°C) | 4 minutes | 30 minutes | Double wrapped instrument
trays, maximum weight 25
lbs (11.3 kg) each. Fabric
Packs. Refer to Table 6-3
for recommended
quantities. |
| Gravity | 250°F (121°C) | 30 minutes | 15 minutes | Fabric Packs. Refer to
Table 6-3 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 6-3 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 6-3 for recommended
quantities. |
| Liquid* | 250°F (121°C) | 45 minutes | N/A | Refer to Table 6-4 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 |

Table 6-1. Amsco Evolution Medium Prevacuum Steam Sterilizer factory-programmed Sterilization cycles and cycle values

*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):

9

Table 6-2. Amsco Evolution Medium Steam Flush Pressure-Pulse (SFPP) Sterilizer factory-programmed sterilization cycles and cycle values

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

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The following table (Table 6-3) lists STERIS's recommended loads by sterilizer size:

| Sterilizer Size | Model Number | Wrapped
Instrument Trays | Fabric Packs |
|-------------------|--------------|-----------------------------|--------------|
| 26" x 26" x 39" | HC-600 | 9 | 12 |
| 26" x 37 ½" x 60" | HC-1500 | 20 | 36 |

Table 6-3. Amsco Evolution Medium Steam Sterilizer recommended loads

The following table (Table 6-4) provides a guideline for liguid cycle processing. The liquid cycle is for non-patient contact use only.

Table 6-4. Amsco Evolution Medium Steam Sterilizer liquid cycle processing guideline

| 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 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

ട്. Discussion of Technological Comparison and Verification Activities

The Evolution Medium Sterilizers are the same as the predicate devices except for the specific modifications described in this submission. There are no differences in the indications for use or technology (including features, materials, and principles of operation) between the proposed and predicate devices. Therefore, the differences between the proposed and predicate devices are limited to the described modifications, and these proposed changes raise no new concerns of safety and effectiveness when compared to the predicate device.

The following table summarizes the verification activities that were performed with their respective acceptance criteria to ensure that these modifications do not affect the safety or effectiveness of the Evolution Medium Steam Sterilizers.

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K173485 STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION Amsco Evolution Medium Steam Sterilizer (Models HC-600 and HC-1500)

| Device
Modification | Verification /
Validation
Activity | Acceptance
Criteria | Results of
Verification
/Validation |
|---------------------------------------|------------------------------------------|-----------------------------------------------------------|-------------------------------------------|
| Control replacement | Performance testing
Electrical safety | Per ST8
Per IEC 61010-1 | Pass |
| Software modifications | Software validation | Software shall be appropriately
verified and validated | Pass |
| Vacuum pump
replacement | Performance testing | Per ST8 | Pass |
| Printer replacement | Software validation | Software shall be appropriately
verified and validated | Pass |
| Valve modifications | Performance testing | Per ST8 | Pass |
| Switch modification | Actuation | Proper actuation, no alarms | Pass |
| Door mounting bracket
modification | Door operation check | Proper function after
multiple cycles | Pass |

6. Conclusion

Based on the intended uses, technological characteristics and non-clinical performance data, the subject device is as safe, as effective and perform at least as well as the legally marketed predicate device (K082435), Class II (21 CFR 880.6880), product code FLE.