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 Description

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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the 3M Steri-Vac Sterilizer/Aerator Models GS5 and GS8:

Acceptance Criteria and Device Performance for 3M Steri-Vac Sterilizer/Aerator Models GS5 and GS8

The device in question, the 3M Steri-Vac Sterilizer/Aerator, is an Ethylene Oxide (EO) gas sterilizer intended for sterilizing heat- and/or moisture-sensitive medical devices. The study to prove the device meets acceptance criteria is primarily based on performance testing against recognized consensus standards for EO sterilizers.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are derived from the AAMI ST24:1999/(R) 2009 standard, which outlines requirements for automatic, general-purpose ethylene oxide sterilizers. The reported device performance is based on efficacy and physical testing.

Acceptance Criteria (from AAMI ST24)	Device Performance (3M Steri-Vac GS5 & GS8)
Efficacy Testing:
Complete inactivation of AAMI challenge test pack in three consecutive runs (Empty Chamber)	Demonstrated complete inactivation of an AAMI challenge test pack in three consecutive sterilization runs.
Complete inactivation of AAMI challenge test pack in three consecutive runs with 10% chamber volume load (Simulated Load)	Demonstrated complete inactivation of a load of AAMI challenge test packs representing 10% of the chamber volume in three consecutive sterilization runs.
>10⁻⁶ sterility assurance level (SAL) using ISO 11135-1 "Overkill" approach with half of normal gas exposure time (Sterility Assurance Test)	Demonstrated complete inactivation of a load of AAMI challenge test packs representing 10% of the chamber volume with half of normal gas exposure time in three consecutive runs.
Physical Testing:
Control air temperature to set value ± 3 degrees Celsius (ST 24 Clause 5.1.5.1)	Demonstrated to control the air temperature to set value ± 3 degrees Celsius.
Control exposure times to set value ± 2% (ST 24 Clause 5.1.5.2)	Demonstrated to control exposure times to set value ± 2%.
Maintain relative humidity (prior to gas exposure) at ≥ 30% (ST 24 Clause 5.1.5.3)	Demonstrated to control relative humidity prior to gas exposure at a level ≥ 30%.
Ensure entire contents of single-dose 100% EO cartridge are consumed	All models use a single-dose cartridge of 100% ethylene oxide where the entire contents are consumed in each cycle (implicitly meeting concentration control).
Safety Testing:
Compliance to IEC 61010-1 (2001) Second Edition	Tested for safety by Underwriters Laboratory to verify compliance.
Compliance to IEC 61010-2-010 (2003) Second Edition	Tested for safety by Underwriters Laboratory to verify compliance.
Compliance to IEC 61010-2-040 (2005) First Edition	Tested for safety by Underwriters Laboratory to verify compliance.
Electromagnetic Compatibility (EMC) Testing:
Compliance to USA Title 47, Code of Federal Regulations (2009) for Radiated Emissions (FCC Part 15, Subpart B, Class A)	Tested by a certified testing laboratory to verify electromagnetic compatibility.
Compliance to USA Title 47, Code of Federal Regulations (2009) for Conducted Emissions (FCC Part 15, Subpart B, Class A)	Tested by a certified testing laboratory to verify electromagnetic compatibility.
Compliance to IEC 61326: Electrical Equipment for Measurement, Control and Laboratory Use-EMC Requirements	Tested by a certified testing laboratory to verify electromagnetic compatibility.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size:
- For efficacy testing (Empty Chamber, Simulated Load, Sterility Assurance): "three consecutive sterilization runs" for each test scenario, for both the GS5 and GS8 models. This means a minimum of 3 runs per model per scenario, so 3 runs x 2 models x 3 scenarios = 18 efficacy runs.
- For physical testing (temperature, exposure time, RH): The number of runs is not explicitly stated, but it's implied that the controls were "demonstrated" to meet the criteria.
- For safety and EMC testing: The sample size is not specified, but it implies a single device or a representative sample was tested for certification.
Data Provenance: The data provenance is internal to 3M Health Care, as they conducted or commissioned the tests to demonstrate compliance with national and international standards. The country of origin for the data is not explicitly stated, but given the company location (St. Paul, MN, USA) and the standards used (AAMI, ISO, IEC, FCC), it's highly likely the testing was conducted in the United States or by labs accredited to these standards globally. The studies are prospective in nature, as they involve testing the performance of the manufactured devices against predefined criteria.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This type of device (sterilizer) performance evaluation does not typically rely on "experts" to establish a "ground truth" in the same way an AI diagnostic algorithm would. Instead, the ground truth is established by:

Reference Standards: The AAMI ST24:1999/(R) 2009 standard itself defines the acceptable parameters and methodologies for assessing sterilizer performance, which represents a consensus of experts in sterilization science and engineering.
Laboratory Procedures: The "ground truth" for sterilization efficacy is the complete inactivation of biological indicators (AAMI challenge test packs). This is determined by standard microbiological culture techniques, not by expert opinion. The "ground truth" for physical parameters (temperature, humidity, time) is measured by calibrated sensors and instruments.

Therefore, the concept of "number of experts used to establish ground truth" with specific qualifications like radiologists is not applicable to this type of device submission.

4. Adjudication Method for the Test Set

Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., image reading) where disagreement among readers needs to be resolved. This is not applicable to the performance testing of a sterilizer. The acceptance criteria are objective and measurable; either the device meets the specified inactivation levels or physical parameter ranges, or it does not. Discrepancies would lead to troubleshooting and re-testing, not adjudication of "expert opinions."

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating diagnostic aids or AI algorithms that assist human readers in tasks like image interpretation. The 3M Steri-Vac Sterilizer is a standalone medical device that performs a physical process (sterilization), not an AI system that assists human decision-making. Therefore, the concept of "how much human readers improve with AI vs. without AI assistance" is not applicable.

6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in a sense, a "standalone" study was done. The efficacy and physical performance testing of the sterilizer is inherently a standalone evaluation of the device's capability to perform its intended function without human intervention during the sterilization cycle. The device's performance (sterilization efficacy, parameter control) is assessed directly. There is no human-in-the-loop during the sterilization process being evaluated. Humans operate the device and interpret the results of the tests, but the device's performance in achieving sterilization is evaluated independently.

7. The Type of Ground Truth Used

The ground truth used is primarily based on:

Biological Indicators (BIs): For efficacy testing, the ground truth for "sterilization" is the complete inactivation of highly resistant microbial spores (e.g., Bacillus atrophaeus) in AAMI challenge test packs, as evidenced by negative culture results after exposure to the sterilization cycle. This is a well-established microbiological method.
Physical Measurements: For parameters like temperature, exposure time, and relative humidity, the ground truth is established by direct measurement using calibrated sensors and instruments, compared against the specified ranges in the AAMI ST24 standard.
Safety and EMC Standards: For safety and electromagnetic compatibility, the ground truth is compliance with the specified international and national regulatory standards (e.g., IEC, FCC), verified by accredited testing laboratories.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable to this device. This is a hardware device (sterilizer), not an AI algorithm that learns from data. Therefore, there is no training set in the machine learning sense. The device is designed, engineered, and then tested against established performance standards.

9. How the Ground Truth for the Training Set Was Established

As stated above, there is no training set for this device in the context of AI/machine learning. Therefore, the question of how its ground truth was established is not relevant. The device's design and operational parameters are based on scientific principles of ethylene oxide sterilization and engineering specifications, which are themselves derived from research and industry standards.

Summary

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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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: (651) 737-2670 FAX Number: (651) 737-5320

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:

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 ExposeTime (min.)	Temperature(°C)	EOConcentration(mg/L)	RelativeHumidity(%)*
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-Vac™ 8XL
Intended Use	The 3M™ Steri-Vac™ GasSterilizer/Aerator is acompact unit designed tosterilize heat- and/ormoisture-sensitive devices.This gas sterilizer/aerator isintended for indoor useonly.	Same
Designed for	EO sterilization inhealthcare facilities	Same
EPA Registered Sterilant	YES, 100% EO CanistersReg. No. 7182-1	Same
Chamber Size (W x H x D)	17" x 15" x 32.5" (GS5)20" x 18" x 38" (GS8)	Same
Chamber Volume	4.8 cu. ft. (GS5)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 usingcompressed air	Same
Process Monitoring andControl Devices	• Interactive touch panelwith color display• Thermal Printer• Pressure gauge (analog)• Wall and chamber tempsensors• RH sensor• Pressure sensor	• LCD displayw/keypad• Thermal printer• Pressure gauge(analog)• Wall and chambertemp sensors• RH sensor• Pressure sensor
Safety Devices	• Locking door• Automatic chamber testin every cycle• Vacuum-controlled gascartridge puncture• Thermal cutouts• Automated errordetection and recovery• Integral vent hood	Same
Temperature	55 °C / 38 °C	55 °C / 37 °C
Exposure Time	60 min. / 270 min.	60 min. / 180 min.
Nominal EOConcentration	736 mg/L (GS5);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.

Regulation Number and Section

§ 880.6860 Ethylene oxide gas sterilizer.

(a)
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.(b)
Classification. Class II (performance standards).