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

K173490 · STERIS Corporation · FLE · Feb 22, 2018 · General Hospital

Device Facts

• Record ID: K173490
• Device Name: Amsco Evolution Medium Steam Sterilizer (Models HC-800 and HC-1000)
• Applicant: STERIS Corporation
• Product Code: FLE · General Hospital
• Decision Date: Feb 22, 2018
• Decision: SESE
• Submission Type: Traditional
• 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 and HC-1000) performs steam sterilization of heat/moisture-stable materials. Device utilizes Prevacuum or Steam Flush Pressure-Pulse (SFPP) cycles, alongside Gravity, Liquid, Leak Test, and DART (Bowie-Dick) cycles. Operated by healthcare facility staff in clinical settings. Device processes wrapped instrument trays and fabric packs; liquid cycle restricted to non-patient contact items. System provides automated sterilization cycles with factory-programmed temperature, time, and dry time parameters. Output includes sterilized medical devices/materials for clinical use. Benefits include effective sterilization of reusable medical equipment, supporting infection control workflows.

Clinical Evidence

Bench testing only. Verification activities included performance testing per ST8, electrical safety per IEC 61010-1, and software validation. All modifications passed acceptance criteria.

Technological Characteristics

Steam sterilizer; chamber sizes 26"x26"x49" (HC-800) and 26"x26"x61" (HC-1000). Operates via Prevacuum or SFPP cycles. Includes control system, vacuum pump, valves, and printer. Software-controlled. Complies with ST8 and IEC 61010-1 standards.

Indications for Use

Indicated for sterilization of heat and moisture-stable materials in healthcare facilities. Includes instrument trays 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 (Models HC-800 and HC-1000) (K091731)

Submission Summary (Full Text)

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February 22, 2018

STERIS Corporation Anthony Piotrkowski Senior Manager Regulatory Affairs 5960 Heisley Rd Mentor, Ohio 44060

Re: K173490

Trade/Device Name: Amsco Evolution Medium Steam Sterilizer (Models HC-800 and HC-1000) Regulation Number: 21 CFR 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: Class II Product Code: FLE Dated: December 12, 2017 Received: December 26, 2017

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. 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

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)

K173490

### Device Name

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

### 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. 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) | $3 \frac{1}{2}$<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.

FORM FDA 3881 (7/17)

PSC Publishing Services [phone] EF

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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. 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 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 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.

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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)

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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: K173490

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

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#### Device Name 1.

Amsco® Evolution Medium Steam Sterilizer (Models HC-800 and Trade Name: HC-1000)

| 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-800 and HC-1000), K091731.

#### 3. 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:

- 26" x 26" x 42" (Model HC 800) ●
- 26" x 26" x 54" (Model HC 1000) .

#### 4. 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.

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The Amsco Evolution Medium Prevacuum Steam Sterilizer is equipped with the following factory-programmed sterilization cycles and cycle values (Table 6-1):

| 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 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<br>Table 6-3 for recommended<br>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<br>trays, maximum weight 25<br>lbs (11.3 kg) each. Refer to<br>Table 6-3 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 6-3 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 6-3 for recommended<br>quantities. |
| Gravity | 270°F (132°C) | 25 minutes | 15 minutes | Fabric Packs. Refer to<br>Table 6-3 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 |
| Cycles | Sterilize<br>Temperature | Sterilize<br>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 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 and 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. |
| Cycles | Sterilize<br>Temperature | Sterilize<br>Time | Dry Time | Recommended Load |
| 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 |

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.

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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):

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

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### K173490 STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION Amsco Evolution Medium Steam Sterilizer (Models HC-800 and HC-1000)

*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 37 ½" x 42" | 12 | 16 |
| 26" x 37 ½" x 54" | 15 | 20 |

## Table 6-3. Amsco Evolution Medium Steam Sterilizer recommended loads per sterilizer size

The following table is a guideline for liquid cycle processing:

Table 6-4. Amsco Evolution Medium Steam Sterilizer Liquid Cvcle* 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 49" (Model HC - 800)
- 26" x 26" x 61" (Model HC = 1000) .

#### 5. Discussion of Technology 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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| Device<br>Modification | Verification /<br>Validation<br>Activity | Acceptance<br>Criteria | Results of<br>Verification<br>/Validation |
|---------------------------------------|------------------------------------------|-----------------------------------------------------------|-------------------------------------------|
| Control replacement | Performance testing<br>Electrical safety | Per ST8<br>Per IEC 61010-1 | Pass |
| Software modifications | Software validation | Software shall be appropriately<br>verified and validated | Pass |
| Vacuum pump<br>replacement | Performance testing | Per ST8 | Pass |
| Printer replacement | Software validation | Software shall be appropriately<br>verified and validated | Pass |
| Valve modifications | Performance testing | Per ST8 | Pass |
| Switch modification | Actuation | Proper actuation, no alarms | Pass |
| Door mounting bracket<br>modification | Door operation check | Proper function after<br>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 (K091731), Class II (21 CFR 880.6880), product code FLE.