3M STERI-VAC STERILIZER/AERATOR

K142034 · 3M Company · FLF · Jan 8, 2015 · General Hospital

Device Facts

• Record ID: K142034
• Device Name: 3M STERI-VAC STERILIZER/AERATOR
• Applicant: 3M Company
• Product Code: FLF · General Hospital
• Decision Date: Jan 8, 2015
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.6860
• Device Class: Class 2

Intended Use

The 3M™ Steri-Vac™ Gas Sterilizer/Aerator is a compact unit designed to sterilize heat- and/or moisture-sensitive devices in the following cycles: Model Cycle Gas Expose Time (min.) Temperature (deg C) EO Concentration (mg/L) Relative Humidity (%) GS5 Cool 270 38 736 40-80 GS5 Warm 60 55 736 40-80 GS8 Cool 270 38 759 40-80 GS8 Warm 60 55 759 40-80 Single or dual channel rigid and flexible scopes can be sterilized with non-lumened medical instruments in any of the GS sterilizer cycles provided the cycle parameters match the instructions. The load per cycle should not exceed 20 lumens.

Device Story

Compact ethylene oxide (EO) gas sterilizer/aerator for heat/moisture-sensitive medical devices; used in healthcare facilities. Operates by discharging 100% EO gas cartridge into vacuum vessel; utilizes automated cycle processing and error handling. Inputs: medical instruments; process parameters (time, temperature, gas concentration, relative humidity). Outputs: sterilized instruments; process documentation via thermal printer. Operated by trained personnel. Healthcare providers use output to ensure instrument sterility for patient procedures; benefits include safe reuse of sensitive medical equipment. System features interactive touch panel, pressure gauges, and sensors for wall/chamber temperature, humidity, and pressure. Safety mechanisms include locking door, automatic chamber testing, vacuum-controlled gas puncture, thermal cutouts, and integral vent hood.

Clinical Evidence

No clinical data included. Effectiveness demonstrated via bench testing per AAMI ST24:1999/(R) 2009. Testing included empty chamber tests, simulated load tests (10% chamber volume), and sterility assurance tests (half-cycle 'overkill' approach) achieving >10^-6 sterility assurance level. Physical testing confirmed control of temperature (+/- 3°C), exposure time (+/- 2%), and relative humidity (>= 30%).

Technological Characteristics

Chamber material: 6061-T6 aluminum. Heating: electric heater blankets. Vacuum: Venturi effect using compressed air. Process control: interactive touch panel, thermal printer, analog pressure gauge, temperature/RH/pressure sensors. Sterilant: 100% EO cartridges. Safety: locking door, automated error detection, thermal cutouts. Compliance: IEC 61010-1, IEC 61010-2-010, IEC 61010-2-040, FCC Part 15 Class A, IEC 61326.

Indications for Use

Indicated for sterilization of heat- and/or moisture-sensitive medical devices, including single or dual channel rigid and flexible scopes and non-lumened instruments, in healthcare facilities. Load limit: 20 lumens per cycle.

Regulatory Classification

Identification

An ethylene gas sterilizer is a nonportable device intended for use by a health care provider that uses ethylene oxide (ETO) to sterilize medical products.

Predicate Devices

• Steri-Vac™ 8XL EO Gas Sterilizer (K941748)

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-000

January 8, 2015

3M Health Care Matt S. Mortensen, Ph.D., RAC Regulatory Affairs Specialist 3M Center, Bldg. 275-5W-06 St. Paul. MN 55144

Re: K142034

Trade/Device Name: 3M Steri-Vac Sterilizer/Aerator Models GS5 and GS8 Regulation Number: 21 CFR 880.6860 Regulation Name: Sterilizer, Ethylene Oxide Gas Regulatory Class: II Product Code: FLF Dated: December 8, 2014 Received: December 10, 2014

#### Dear Dr. Mortensen

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.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. 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)

#### K142034

#### Device Name

3M™ Steri-Vac™ Sterilizer/Aerator models GS5 and GS8

Indications for Use (Describe)

The 3M™ Steri-Vac™ Gas Sterilizer/Aerator is a compact unit designed to sterilize heat- and/or moisture-sensitive devices in the following cycles:

| Model | Cycle | Gas Expose Time (min.) | Temperature (deg C) | EO Concentration (mg/L) | Relative Humidity (%) |
|-------|-------|------------------------|---------------------|-------------------------|-----------------------|
| GS5 | Cool | 270 | 38 | 736 | 40-80 |
| GS5 | Warm | 60 | 55 | 736 | 40-80 |
| GS8 | Cool | 270 | 38 | 759 | 40-80 |
| GS8 | Warm | 60 | 55 | 759 | 40-80 |

Single or dual channel rigid and flexible scopes can be sterilized with non-lumened medical instruments in any of the GS sterilizer cycles provided the cycle parameters match the instructions. The load per cycle should not exceed 20 lumens.

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

_ Prescription Use (Part 21 CFR 801 Subpart D)

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

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## Premarket Notification (510(k)) Summary

# 3M

## Sponsor Information:

3M Health Care 3M Center, Bldg. 275-5W-06 St. Paul, MN 55144-1000

Contact Person: Matt S. Mortensen, Ph.D., RAC Regulatory Affairs Phone Number: [phone] FAX Number: [phone]

# Date of Summary: July 18, 2014

# Device Name and Classification:

Common or Usual Name: EO Gas Sterilizer Proprietary Name: 3M™ Steri-Vac™ Sterilizer/Aerator GS5 and GS8 Classification Name: Sterilizer, Ethylene-Oxide Gas (21 CFR § 880.6860) Device Class: II Product Code: FLF

# Predicate Devices:

- K941748 Steri-Vac™ 8XL EO Gas Sterilizer .
# Description of Device:

The 3M Steri-Vac™ GS5 and 3M Steri-Vac™ GS8 models are traditional ethylene oxide (EO) sterilizers that use 100% EO cartridges in a vacuum vessel. The sterilizers use fully automated controls for cycle processing and error handling.

# Nonclinical Comparison to the Predicate Device

The 3M Steri-Vac™ GS5 and 3M Steri-Vac™ GS8 sterilizers use the same principle of operation as the predicate device, a heated and humidified vessel inside of which a cartridge of 100% ethylene oxide gas is discharged. The cartridges of ethylene oxide used are identical to the predicate device. The sub-systems for heating, humidifying, introducing the gas, and safety

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controls are modernized versions of the same sub-systems in the predicate device. 3M Steri-Vac™ GS5 and 3M Steri-Vac™ GS8 sterilizers and the predicate device employ critical parameters (time, temp, gas concentration, and relative humidity) in the ranges specified by national and international standards and agency guidance documents.

## Summary of Clinical Testing

No clinical data was included in this premarket application submission.

## Indications for Use

The 3M™ Steri-Vac™ Gas Sterilizer/Aerator is a compact unit designed to sterilize heat- and/or moisture-sensitive devices in the following cycles:

| Model | Cycle | Gas Expose<br>Time (min.) | Temperature<br>(°C) | EO<br>Concentration<br>(mg/L) | Relative<br>Humidity<br>(%)* |
|-------|-------|---------------------------|---------------------|-------------------------------|------------------------------|
| GS5 | Cool | 270 | 38 | 736 | 40-80 |
| | Warm | 60 | 55 | 736 | 40-80 |
| GS8 | Cool | 270 | 38 | 759 | 40-80 |
| | Warm | 60 | 55 | 759 | 40-80 |

Single or dual channel rigid and flexible scopes can be sterilized with non-lumened medical instruments in any of the GS sterilizer cycles provided the cycle parameters match the instrument's sterilization instructions. The load per cycle should not exceed 20 lumens.

### Comparison to Predicate Devices

| Feature | Submission Device | K941748 – Steri-<br>Vac™ 8XL |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| Intended Use | The 3M™ Steri-Vac™ Gas<br>Sterilizer/Aerator is a<br>compact unit designed to<br>sterilize heat- and/or<br>moisture-sensitive devices.<br>This gas sterilizer/aerator is<br>intended for indoor use<br>only. | Same |
| Designed for | EO sterilization in<br>healthcare facilities | Same |
| EPA Registered Sterilant | YES, 100% EO Canisters<br>Reg. No. 7182-1 | Same |
| Chamber Size (W x H x D) | 17" x 15" x 32.5" (GS5)<br>20" x 18" x 38" (GS8) | Same |
| Chamber Volume | 4.8 cu. ft. (GS5)<br>7.9 cu. ft. (GS8) | 7.9 cu. ft. |
| Chamber Material | 6061-T6 aluminum | Same |
| Means of Heating | Electric heater blankets | Same |

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| Means of Vacuum | Venturi effect using<br>compressed air | Same |
|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Process Monitoring and<br>Control Devices | • Interactive touch panel<br>with color display<br>• Thermal Printer<br>• Pressure gauge (analog)<br>• Wall and chamber temp<br>sensors<br>• RH sensor<br>• Pressure sensor | • LCD display<br>w/keypad<br>• Thermal printer<br>• Pressure gauge<br>(analog)<br>• Wall and chamber<br>temp sensors<br>• RH sensor<br>• Pressure sensor |
| Safety Devices | • Locking door<br>• Automatic chamber test<br>in every cycle<br>• Vacuum-controlled gas<br>cartridge puncture<br>• Thermal cutouts<br>• Automated error<br>detection and recovery<br>• Integral vent hood | Same |
| Temperature | 55 °C / 38 °C | 55 °C / 37 °C |
| Exposure Time | 60 min. / 270 min. | 60 min. / 180 min. |
| Nominal EO<br>Concentration | 736 mg/L (GS5);<br>759 mg/L (GS8) | 759 mg/L (8XL) |

### Effectiveness

The effectiveness of the sterilization cycles included on the 3M Steri-Vac™ GS5 and 3M Steri-Vac™ GS8 sterilizers is demonstrated by the application of testing and acceptance criteria described in the Recognized Consensus Standard:

· AAMI ST24:1999/(R) 2009 Third Edition; Automatic, general purpose ethylene oxide sterilizers and ethylene oxide sterilant sources intended for use in health care facilities,

Summary of efficacy testing:

- Empty Chamber Test The sterilizer cycles were demonstrated in both models to provide complete inactivation of an AAMI challenge test pack in three consecutive sterilization runs.
- Simulated Load Test The sterilizer cycles were demonstrated in both models to provide complete inactivation of a load of AAMI challenge test packs representing 10% of the chamber volume in three consecutive sterilization runs.
- Sterility Assurance Test The sterilizer cycles were demonstrated in both models to provide complete inactivation of a load of AAMI challenge test packs representing 10% of the chamber volume in three consecutive sterilization runs which were run at half of normal gas exposure time. This test assures >10° sterility assurance level using the ISO 11135-1 "Overkill" approach.

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The basis for effective inactivation of microbial spores is control over the critical physical parameters of exposure time, temperature, gas concentration and relative humidity. The performance of the sub-systems controlling these parameters meets the acceptance criteria when tested according to the prescribed methods in AAMI ST 24.

Summary of physical testing:

- Chamber air temperature All models were demonstrated to control the air temperature to set value +/- 3 degrees Celsius according to ST 24 Clause 5.1.5.1 Exposure time – All models were demonstrated to control exposure times to set value +/- 2% according to ST 24 Clause 5.1.5.2
- Gas concentration All models use a single-dose cartridge of 100% ethylene oxide where the entire contents are consumed in each cycle.
- Relative humidity All models were demonstrated to control relative humidity prior to gas exposure at a level ≥ 30% according to ST 24 Clause 5.1.5.3.

# Safety

The 3M Steri-Vac™ GS5 and 3M Steri-Vac™ GS8 sterilizers were tested for safety by Underwriters Laboratory to verify compliance to:

- · IEC 61010-1 (2001) Second Edition: Safety requirements for electrical equipment for measurement, control, and laboratory use – Part 1: General requirements,
- IEC 61010-2-010 (2003) Second Edition; Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-010: Particular requirements for laboratory equipment for the heating of materials,

· IEC 61010-2-040 (2005) First Edition: Safety requirements for electrical equipment for measurement, control and laboratory use – Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials

In addition. 3M Steri-Vac™ GS5 and 3M Steri-Vac™ GS8 sterilizers have been tested by a certified testing laboratory to verify electromagnetic compatibility per:

- USA Title 47, Code of Federal Regulations (2009) for:
- Radiated Emissions (FCC Part 15, Subpart B, Class A), and
- Conducted Emissions (FCC Part 15, Subpart B, Class A)
- IEC 61326: Electrical Equipment for Measurement, Control and Laboratory Use-EMC Requirements.

# Failure Hazards

Failure of the sterilizer can lead to delayed access to medical instruments, the potential for spread of infection, and the exposure of operators to ethylene oxide. When an error occurs, the system controller aborts the cycle, performs automated error recovery, and displays the error code(s).

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To avoid hazardous situations, it is essential for users to follow all instructions provided by 3M and the manufacturers of the medical instruments which are being sterilized. The sterilizer must be installed and maintained according to the instructions provided. Operators of the sterilizer must be trained. Only supplies cleared for use in EO sterilization should be used in conjunction with the sterilizer. All applicable national and international standards and recommendations for ethylene oxide sterilization processes should be followed. Improper and incomplete cleaning has been specifically identified by industry and regulatory bodies as a major barrier to ultimately providing sterile medical instruments. Always follow instructions provided by the instrument manufacture for disassembling and cleaning.

### User Information

3M provides users with installation manuals, operator manuals and other labeling describing appropriate use of the sterilizers, including information related to safety while working with ethylene oxide. In addition to labeling 3M provides users with in-person and online training, as well as technical assistance over the phone or in-person. Trained and certified service personnel located throughout the world are available for maintenance requests and other field support services.

#### Conclusion

The 3M Steri-Vac™ GS5 and 3M Steri-Vac™ GS8 sterilizers meet the performance standards of AAMI ST 24 and are substantially equivalent to the predicate device in terms of their intended use, physical properties and technological characteristics. There are no new questions of safety or effectiveness.