AMSCO 600 Medium Steam Sterilizer

K211500 · STERIS Corporation · FLE · Aug 25, 2021 · General Hospital

Device Facts

• Record ID: K211500
• Device Name: AMSCO 600 Medium Steam Sterilizer
• Applicant: STERIS Corporation
• Product Code: FLE · General Hospital
• Decision Date: Aug 25, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6880
• Device Class: Class 2

Intended Use

The AMSCO 600 Steam Sterilizers are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are equipped with the following factory-programmed cycles (Table 1): [Table 1 omitted for brevity] The Automated Load and Unload System (ALUS) provides semi-automated loading and unloading from an AMSCO 600 steam sterilizer when a cycle is complete. Alternatively, the ALUS may also be used to provide automatic unloading only in combination with manual loading. The ALUS can start a cycle automatically when equipped with the optional bar code reader.

Device Story

AMSCO 600 Steam Sterilizer uses saturated steam to sterilize heat-stable healthcare products; removes air via gravity displacement or mechanical vacuum; exposes load to steam at defined temperature/time; dries load using latent heat and vacuum. Operated by technicians in central sterile processing or surgical suites. Includes Automated Load and Unload System (ALUS) for semi-automated transfer of loading carts; optional barcode reader initiates cycles. Output includes sterilized medical instruments/materials. Benefits include standardized sterilization, improved workflow via automation, and IUSS capability for urgent instrument needs.

Clinical Evidence

Bench testing only. Performance validated against ANSI/AAMI ST8:2013 requirements, including temperature distribution (-0 to +4.3°F), air removal (CI pass), moisture retention (≤16% mass increase), and biological performance (F0 ≥ 87, BI pass). Electrical safety confirmed per IEC 61010-1:2012, IEC 61010-2-040:2016, and IEC 61326-1:2012. ALUS functionality verified against performance specifications.

Technological Characteristics

Chamber: 316L stainless steel; Door: 304L stainless steel. Sensing: Dual element RTDs in chamber/jacket drains and heat exchanger; pressure transducer in chamber. Energy: Saturated steam, electricity, water, air. Connectivity: Optional barcode reader for cycle initiation. Software: Embedded controller. Sterilization: Prevacuum and gravity displacement cycles. ALUS: Conveyor-based automated loading/unloading system.

Indications for Use

Indicated for sterilization of heat and moisture-stable materials in healthcare facilities, including surgical suites and central sterile processing departments. Suitable for fabric packs and double-wrapped instrument trays (max 25 lbs each). Includes Immediate Use Steam Sterilization (IUSS) for unwrapped trays.

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 600 Steam Sterilizer (K183410)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".

August 25, 2021

Steris Corporation Anthony Piotrkowski Director, Regulatory Affairs 5960 Heisley Rd Mentor, Ohio 44060

Re: K211500

Trade/Device Name: AMSCO 600 Medium Steam Sterilizer Regulation Number: 21 CFR 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: Class II Product Code: FLE Dated: June 2, 2021 Received: June 3, 2021

Dear Anthony Piotrkowski:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of 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

{1}------------------------------------------------

801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Clarence W. Murray, III, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known)

K211500

Device Name

AMSCO 600 Steam Sterilizer

Indications for Use (Describe)

The AMSCO 600 Steam Sterilizers are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are equipped with the following factory-programmed cycles (Table 1):

| Cycles | Sterilize<br>Temperature | Sterilize Time | Dry Time | Maximum Recommended Load |
|-----------------|--------------------------|----------------|------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Prevac | 270°F (132°C) | 4 minutes | 20 minutes | Fabric Packs. Refer to Table 2 for<br>recommended quantities. |
| Prevac | 270°F (132°C) | 4 minutes | 30 minutes | Double wrapped instrument trays,<br>maximum weight 25 lbs. (11.3 kg)<br>each and Fabric Packs. Refer to<br>Table 2 for recommended<br>quantities. |
| Prevac | 270°F (132°C) | 10 minutes | 30 minutes | Double wrapped instrument trays,<br>maximum weight 25 lbs. (11.3<br>kg) each . Refer to Table 2 for<br>recommended quantities. |
| Prevac | 270°F (132°C) | 4 minutes | 5 minutes | Single Fabric Pack. |
| Prevac | 275°F (135°C) | 3 minutes | 30 minutes | Double wrapped instrument trays,<br>maximum weight 25 lbs. (11.3 kg)<br>each. Refer to Table 2 for<br>recommended quantities. |
| Prevac-<br>IUSS | 270°F (132°C) | 4 minutes | 1 minutes | Immediate use - single<br>unwrapped tray |
| Gravity | 250°F (121°C) | 30 minutes | 30 minutes | Double wrapped instrument trays,<br>maximum weight 25 lbs. (11.3 kg)<br>each. Refer to Table 2 for<br>recommended quantities. |
| Warm-Up | 270°F (132°C) | 3 minutes | 1 minute | N/A |
| DART | 270°F (132°C) | 3.5 minutes | 1 minute | Bowie-Dick Test Pack, DART |
| Leak<br>Test | N/A | N/A | N/A | N/A |

Table 1. AMSCO 600 Steam Sterilizer factory-validated sterilization cvcles and cvcle values

{3}------------------------------------------------

| Sterilizer Size | Wrapped Instrument Trays | Fabric Packs |
|-----------------|--------------------------|--------------|
| 26" x 26" x 39" | 9 | 12 |
| 26" x 26" x 51" | 12 | 16 |
| 26" x 26" x 63" | 15 | 20 |

ize

The Automated Load and Unload System (ALUS) provides semi-automated loading and unloading from an AMSCO 600 steam sterilizer when a cycle is complete. Alternatively, the ALUS may also be used to provide automatic unloading only in combination with manual loading. The ALUS can start a cycle automatically when equipped with the optional bar code reader.

Type of Use (Select one or both, as applicable)

- Prescription Use (Part 21 CFR 801 Subpart D)

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

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for STERIS. The word STERIS is in all caps and in a serif font. Below the word STERIS is a graphic of several horizontal wavy lines in blue. The STERIS logo is simple and clean.

# 510(k) Summary For AMSCO 600 Steam Sterilizer K211500

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

Tony Piotrkowski Contact: Director, Regulatory Affairs

Telephone: [phone] Fax No: [phone] e-mail: [e-mail]

Summary Date: August 23, 2021

Premarket Notification Number: K211500

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

{5}------------------------------------------------

### STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION K211500 AMSCO 600 Steam Sterilizer

#### Device Name 1.

| Trade Name: | AMSCO 600 Steam Sterilizer |
|------------------------|----------------------------------------------------------|
| Device Class: | Class II |
| Common/usual Name: | Steam Sterilizer |
| Classification Name: | Sterilizer, Steam<br>Sterilizer Automated Loading System |
| Classification Number: | 21 CFR 880.6880 |
| Product Code: | FLE, PEC |

#### 2. Predicate Device

K183410 AMSCO 600 Steam Sterilizer

### 3. Description of Device

The AMSCO 600 Steam Sterilizer uses saturated steam, generated from a house steam utility (e.g. boiler system) or from a steam generator, to sterilize heat-stable health care products.

The sterilizer accomplishes this by removing the air in the chamber, exposing the load to saturated steam for a defined combination of time and temperature, and drying the load. Removal of air from the chamber occurs using either of two methods, gravity displacement or mechanical vacuum. Once the air removal phase is completed, the sterilizer progresses to the steam exposure phase. During the steam exposure phase, every surface of the load is exposed to saturated steam for a defined combination of time and temperature. Once the steam exposure phase is completed, steam is removed from the chamber and the load is dried using the latent heat in the load and the vacuum pump.

The sterilizers are generally operated by technicians in a central service or sterile processing department of healthcare facilities. Sterilizers may also be located in a surgical suite to allow for Immediate Use Steam Sterilization (IUSS) for instances where an instrument is needed immediately for a procedure (e.g. after an instrument has been dropped and there is no replacement readily available). Standard practices for use of sterilizers in health care facilities are provided by various organizations (e.g. ANSI/AAMI ST79).

The ALUS is used with the AMSCO 600 Steam Sterilizer's existing transfer carriages and loading carts. It consists of a conveyor system which attaches to the

{6}------------------------------------------------

### STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION K211500 AMSCO 600 Steam Sterilizer

load and/or unload ends of the steam sterilizer. It has a series of barcode labels which correspond to pre-programmed cycles and an optional scanner which when fitted to the system will communicate to the sterilizer which cycle to initiate.

#### 4. Intended Use/Indications for Use

The AMSCO 600 Steam Sterilizers are designed for sterilization of heat and moisturestable materials used in healthcare facilities and are equipped with the following factoryprogrammed cycles (Table 1):

| Cycles | Sterilize<br>Temperature | Sterilize<br>Time | Dry Time | Maximum Recommended Load |
|-----------------|--------------------------|-------------------|------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Prevac | 270°F (132°C) | 4 minutes | 20 minutes | Fabric Packs. Refer to Table 2 for<br>recommended quantities. |
| Prevac | 270°F (132°C) | 4 minutes | 30 minutes | Double wrapped instrument trays,<br>maximum weight 25 lbs. (11.3 kg) each<br>and Fabric Packs. Refer to Table 2 for<br>recommended quantities. |
| Prevac | 270°F (132°C) | 10 minutes | 30 minutes | Double wrapped instrument trays,<br>maximum weight 25 lbs. (11.3 kg) each.<br>Refer to Table 2 for recommended<br>quantities. |
| Prevac | 270°F (132°C) | 4 minutes | 5 minutes | Single Fabric Pack. |
| Prevac | 275°F (135°C) | 3 minutes | 30 minutes | Double wrapped instrument trays,<br>maximum weight 25 lbs. (11.3 kg) each.<br>Refer to Table 2 for recommended<br>quantities. |
| Prevac-<br>IUSS | 270°F (132°C) | 4 minutes | 1 minutes | Immediate use - single unwrapped tray |
| Gravity | 250°F (121°C) | 30 minutes | 30 minutes | Double wrapped instrument trays,<br>maximum weight 25 lbs. (11.3 kg) each.<br>Refer to Table 2 for recommended<br>quantities. |
| Warm-Up | 270°F (132°C) | 3 minutes | 1 minute | N/A |
| DART | 270°F (132°C) | 3.5 minutes | 1 minute | Bowie-Dick Test Pack, DART |
| Leak Test | N/A | N/A | N/A | N/A |

Table 1. AMSCO 600 Steam Sterilizer factory-validated sterilization cycles and cycle values

Table 2 AMSCO 600 Steam Sterilizer full load per sterilizer size

| Sterilizer Size | Wrapped Instrument<br>Trays | Fabric Packs |
|-----------------|-----------------------------|--------------|
| 26" x 26" x 39" | 9 | 12 |
| 26" x 26" x 51" | 12 | 16 |
| 26" x 26" x 63" | 15 | 20 |

{7}------------------------------------------------

The Automated Load and Unload System (ALUS) provides semi-automated loading and unloading from an AMSCO 600 steam sterilizer when a cycle is complete. Alternatively, the ALUS may also be used to provide automatic unloading only in combination with manual loading. The ALUS can start a cycle automatically when equipped with the optional bar code reader.

### 5. Technological Characteristics Comparison

| Feature | AMSCO 600 Steam Sterilizer<br>(Modified Device) | AMSCO 600 Steam Sterilizer<br>(Predicate Device/K183410) | Comparison |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Intended<br>Use | The AMSCO 600 Steam Sterilizer<br>is designed for sterilization of heat<br>and moisture-stable materials used<br>in healthcare facilities. | The AMSCO 600 Steam Sterilizer<br>is designed for sterilization of heat<br>and moisture-stable materials used<br>in healthcare facilities. | Same |
| Critical<br>Process<br>Parameters | • Time<br>• Chamber Temperature<br>• Pressure | • Time<br>• Chamber Temperature<br>• Pressure | Same |
| Control | Embedded Controller | Embedded Controller | Same |
| SAL | 10-6 | 10-6 | Same |
| Sterilant | Saturated Steam | Saturated Steam | Same |
| Utilities | Steam, Water, Electricity, Air | Steam, Water, Electricity, Air | Same |
| Chamber<br>Material | 316L Stainless Steel | 316L Stainless Steel | Same |
| Nominal<br>Chamber<br>Size | • 26" w x 26" h x 39" d<br>• 26" w x 26" h x 49" d<br>• 26" w x 26" h x 61" d | • 26" w x 26" h x 39" d<br>• 26" w x 26" h x 49" d<br>• 26" w x 26" h x 61" d | Same |
| Door | 304L Stainless Steel<br>26" x 26" Power vertical sliding | 304L Stainless Steel<br>26" x 26" Power vertical sliding | Same |
| Chamber<br>Pressure<br>Rating | 45 psig, 300°F | 45 psig, 300°F | Same |
| Door Seal | Steam activated door seal | Steam activated door seal | Same |
| External<br>Process<br>Monitors | • Electronic Control<br>• Printer | • Electronic Control<br>• Printer | Same |
| Internal<br>Process<br>Monitors | Temperature<br>-Dual element RTD located in<br>chamber drain<br>- RTD located in the jacket drain<br>- RTD located in heat exchanger<br><br>Pressure<br>-Pressure transducer in chamber | Temperature<br>-Dual element RTD located in<br>chamber drain<br>- RTD located in the jacket drain<br>- RTD located in heat exchanger<br><br>Pressure<br>-Pressure transducer in chamber | Same |
| Performance | Meets ANSI/AAMI ST8:2013 | Meets ANSI/AAMI ST8:2013 | Same |
| Accessories | BI, CI, Pouches, Trays, Wraps,<br>Tape, Containers, Shelves,<br>Loading Equipment, automated<br>loading system | BI, CI, Pouches, Trays, Wraps,<br>Tape, Containers, Shelves,<br>Loading Equipment | Added automated<br>loading system.<br>Software validation<br>demonstrates<br>proper performance |
| Test Cycles | Warm Up, Leak Test, DART<br>(Bowie Dick) Test | Warm Up, Leak Test, DART<br>(Bowie Dick) Test | Same |
| Feature | AMSCO 600 Steam Sterilizer<br>(Modified Device) | AMSCO 600 Steam Sterilizer<br>(Predicate Device/K183410) | Comparison |
| Cycles | 270F, Prevac, 4' Full fabric pack<br>270F, Prevac, 4' Full tray<br>270F, Prevac, 4' One fabric pack<br>270F, Prevac, 4' IUSS<br>275F, Prevac, 3' Full fabric<br>250F, Gravity, 30' Full tray<br>270F, Prevac, 10' Full tray | 270F, Prevac, 4' Full fabric pack<br>270F, Prevac, 4' Full tray<br>270F, Prevac, 4' One fabric pack<br>270F, Prevac, 4' IUSS<br>275F, Prevac, 3' Full fabric<br>250F, Gravity, 30' Full tray | Added 10-minute<br>270F, prevacuum<br>cycle. Testing<br>performer per<br>AAMI ST8<br>demonstrates<br>proper performance |
| Full Loads | • 39": 9, 25-lb double wrapped<br>trays or 12, fabric packs<br>• 51": 12, 25-lb double wrapped<br>trays or 16, fabric packs<br>• 63": 15, 25-lb double wrapped<br>trays or 20, fabric packs | • 39": 9, 25-lb double wrapped<br>trays or 12, fabric packs<br>• 51": 12, 25-lb double wrapped<br>trays or 16, fabric packs<br>• 63": 15, 25-lb double wrapped<br>trays or 20, fabric packs | Same |

### Table 5-1. Device Comparison Table for AMSCO 600 Modified and Predicate

{8}------------------------------------------------

### STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION K211500 AMSCO 600 Steam Sterilizer

The proposed device has the same intended use as the predicate with the same technological characteristics. The modifications, subject of this submission, are addition a 10-minute, 270 °F (132 °C) prevacuum, steam sterilization cycle and addition of an automated loading and unloading system (ALUS). Sterilizer automated loading systems are described under FDA product code PEC so the resulting product will be under product codes FLE and PEC. Other design modifications since the last clearance have been made to improve manufacturability, allow for sale outside the United States and add convenience features to sterilizer.

#### Summary of Nonclinical Tests 6.

| Test | Criterion | Results | | |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|-------------------------------|
| Sterilizer<br>performance | Meets ST 8 requirements:<br>Temperature distribution: - 0 to + 6 °F<br>Air removal – CI pass, 270 -276 °F<br>Moisture retention - ≤ 20% mass increase<br>Biological performance – F0 ≥ 12, BI pass | 0 to + 4.3 °F<br>CI pass, 271 - 273 °F<br>≤ 16 % mass increase<br>F0 ≥ 87, BI pass | | |
| | Electrical safety | Meets IEC 61010-1:2012, IEC 61010-2-040:2016 and<br>IEC 61326-1:2012 requirements for electrical safety | Conforms with:<br>IEC 61010-1:2012<br>IEC 61010-2-040:2016<br>IEC 61326-1:2012 | |
| | | Software validation | Meets documented software specifications | Software meets specifications |
| | | ALUS Function | Meets documented performance specifications | Properly loads and unloads |

#### 6. Conclusion

Based on the intended uses, technological characteristics and non-clinical performance data, the subject device is as safe, as effective and performs as well as or better than the legally marketed predicate device K183410, Class II (21 CFR 880.6860), product code FLE.