AMSCO 600 Steam Sterilizer

K183410 · STERIS Corporation · FLE · Mar 27, 2019 · General Hospital

Device Facts

• Record ID: K183410
• Device Name: AMSCO 600 Steam Sterilizer
• Applicant: STERIS Corporation
• Product Code: FLE · General Hospital
• Decision Date: Mar 27, 2019
• 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):

Device Story

AMSCO 600 Steam Sterilizer uses saturated steam to sterilize heat-stable healthcare products; operates via gravity displacement or mechanical vacuum air removal; followed by steam exposure and drying phases. Used in central sterile processing departments or surgical suites; operated by technicians. Inputs include steam, water, electricity, and air; monitored by internal RTDs and pressure transducers. Output is a sterilized load; verified by electronic control and printer logs. Benefits include effective sterilization of surgical instruments and fabric packs; supports immediate use steam sterilization (IUSS) for urgent needs.

Clinical Evidence

Bench testing only. Performance validated against ANSI/AAMI ST8:2013, IEC 61010-1, IEC 61010-2-40, FCC 47 CFR Part 15, and ASME Boiler Pressure Vessel Code Section VIII. No clinical data presented.

Technological Characteristics

Chamber: 316L stainless steel; Door: 304L stainless steel. Sensing: Dual element RTDs (chamber drain, jacket drain, heat exchanger) and pressure transducers. Energy: Saturated steam. Connectivity: Electronic control with printer. Standards: ANSI/AAMI ST8:2013, IEC 61010-1/2-40, ASME Section VIII. Sterilization: Gravity or prevacuum steam cycles.

Indications for Use

Indicated for sterilization of heat and moisture-stable materials in healthcare facilities, including fabric packs and double-wrapped instrument trays, using factory-programmed gravity or prevacuum steam cycles.

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 Chimeron Steam Sterilizer (K112403)

Submission Summary (Full Text)

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March 27, 2019

STERIS Corporation Anthony Piotrkowski Director of Regulatory Affairs 5960 Heisley Rd. Mentor, Ohio 44060

Re: K183410

Trade/Device Name: AMSCO 600 Steam Sterilizer Regulation Number: 21 CFR 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: Class II Product Code: FLE Dated: March 1, 2019 Received: March 4, 2019

### 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

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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,

# Clarence W. Murray lii III -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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# Indications for Use

510(k) Number (if known) K183410

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<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)<br>each and Fabric Packs. Refer to Table<br>2 for 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-IUSS | 270°F (132°C) | 4 minutes | 1 minute | Immediate use – single unwrapped<br>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 Test<br>Pack |
| 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 Trays | Fabric Packs |
|---------------------|--------------------------|--------------|
| 26.5" x 26.5" x 39" | 9 | 12 |
| 26.5" x 26.5" x 51" | 12 | 16 |
| 26.5" x 26.5" x 63" | 15 | 20 |

FORM FDA 3881 (7/17)

PSC Publishing Services [phone] EF

Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2020

See PRA Statement below.

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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 600 Steam Sterilizer

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: March 1, 2019

Premarket Notification Number: K183410

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

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### STERIS ABBREVIATED 510(k) PREMARKET NOTIFICATION 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 |
| Classification Number: | 21 CFR 880.6880 |
| Product Code: | FLE |

#### 2. Predicate Device

K112403 AMSCO Chimeron Steam Sterilizer (later renamed AMSCO 400)

#### 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).

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

The AMSCO 600 Steam Sterilizers are designed for sterilization of heat and moisturestable materials used in healthcare facilities and are equipped with the following factory-

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

programmed cycles (Table 1):

| Cycles | Sterilize<br>Temperature | Sterilize<br>Time | Dry<br>Time | Maximum Recommended<br>Load |
|-----------------|--------------------------|-------------------|-------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Prevac | 270°F (132°C) | 4 minutes | 20 minutes | Fabric Packs. Refer to Table 2<br>for recommended quantities. |
| Prevac | 270°F (132°C) | 4 minutes | 30 minutes | Double wrapped instrument<br>trays, maximum weight 25 lbs.<br>(11.3 kg) each and Fabric Packs.<br>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<br>trays, maximum weight 25 lbs.<br>(11.3 kg) each. Refer to Table 2<br>for 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<br>trays, maximum weight 25 lbs.<br>(11.3 kg) each. Refer to Table 2<br>for 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<br>Test Pack |
| 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 |
|---------------------|-----------------------------|--------------|
| 26.5" x 26.5" x 39" | 9 | 12 |
| 26.5" x 26.5" x 51" | 12 | 16 |
| 26.5" x 26.5" x 63" | 15 | 20 |

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#### 5. Technological Characteristics

### Table 3. Technological Characteristics Comparison Table for AMSCO 600 and AMSCO Chimeron

| Feature | AMSCO 600 Steam Sterilizer<br>(K183410) | AMSCO Chimeron Steam<br>Sterilizer<br>(Predicate Device/K112403) | 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 Chimeron Medium<br>Steam Sterilizer (Models 39SL and<br>39CSL) are designed for<br>sterilization of heat and moisture-<br>stable materials used in healthcare<br>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 | Proposed offered in<br>additional sizes, all<br>validated per<br>ANSI/AAMI ST8 |
| Door | 304L Stainless Steel<br>26" x 26" Power vertical sliding | 316L Stainless Steel<br>26" x 26" Power vertical sliding | Both stainless steel,<br>same operation |
| 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 |

| Feature | AMSCO 600 Steam Sterilizer<br>(K183410) | AMSCO Chimeron Steam<br>Sterilizer<br>(Predicate Device/K112403) | Comparison |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| 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>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>Pressure<br>-Pressure transducer in chamber | Same |
| Performance | Meets ANSI/AAMI ST8:2013 | Meets ANSI/AAMI ST8:2006 | Proposed sterilizer<br>meets current<br>revision of the<br>sterilizer standard |
| Accessories | BI, CI, Pouches, Trays, Wraps,<br>Tape, Containers, Shelves,<br>Loading Equipment | BI, CI, Pouches, Trays, Wraps,<br>Tape, Containers, Shelves,<br>Loading Equipment | Same |

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| Test Cycles | Warm Up, Leak Test, DART<br>(Bowie Dick) Test | Warm Up, Leak Test, DART<br>(Bowie Dick) Test | Same |
|-------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| 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 | 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>250F, Gravity, 30' Full fabric<br>270F, Gravity, 15' Full tray<br>270F, Gravity, 25' Full fabric<br>270F, Gravity, 3' IUSS<br>270F, Gravity, 10' IUSS<br>250F, Liquid, 45', 80-1L bottles | All cycles available<br>on the proposed<br>sterilizer were also<br>available on the<br>predicate |
| 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 | 4, 25-lb double wrapped trays or<br>12, fabric packs | Proposed sterilizer<br>can sterilize larger<br>loads – maximum<br>load configurations<br>validated per<br>ANSI/AAMI ST8 |

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

The proposed device has the same intended use and similar indications for use as the predicate with similar technological characteristics. The subject device slightly differ in their design and indications and features to the predicate device.

#### Summary of Nonclinical Tests 6.

The AMSCO 600 Steam Sterilizer nonclinical test was performed according to the standards described below in Table 4. The testing demonstrated that subject device met the acceptance criteria described in these standards.

| Test | Result | Conclusion |
|----------------------------------|--------------------------------------------------------------------------------------|------------|
| Performance | Meets requirements of ANSI/AAMI ST8 | PASS |
| General Electrical<br>Safety | Meets requirements of IEC 61010-1 | PASS |
| Sterilizer Electrical<br>Safety | Meets requirements of IEC 61010-2-40 | PASS |
| Electromagnetic<br>Compatibility | Meets requirements of FCC 47 CFR Part 15 -<br>Subpart B | PASS |
| Pressure Vessel<br>Safety | Meets requirements of ASME Boiler Pressure<br>Vessel Code, Section VIII (Division 1) | PASS |

Table 4: Non-Clinical Testing of AMSCO 600 Steam Sterilizer

#### 7. 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 or better than the legally marketed predicate device K112403, Class II (21 CFR 880.6860), product code FLE.