Anprolene AN75 Ethylene Oxide Gas Sterilizer

K170432 · Andersen Sterilizers, Inc. · FLF · Oct 31, 2017 · General Hospital

Device Facts

• Record ID: K170432
• Device Name: Anprolene AN75 Ethylene Oxide Gas Sterilizer
• Applicant: Andersen Sterilizers, Inc.
• Product Code: FLF · General Hospital
• Decision Date: Oct 31, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6860
• Device Class: Class 2

Intended Use

The Anprolene AN75 Ethylene Oxide Gas Sterilizer is intended for use in hospitals and other human healthcare settings. It is designed to sterilize reusable medical devices that are sensitive to moisture, heat, chemical corrosion, or radiation. The 12 hour cycle at 20-29°C in the Anprolene AN75 Ethylene is for surface sterilization of medical devices, including mated surfaces.

Device Story

Ethylene oxide (EO) gas sterilizer for reusable medical devices sensitive to heat, moisture, or radiation; used in hospitals/healthcare settings. System utilizes unit-dose 100% EO cartridges and gas-impervious flexible sterilization bags within a ventilated cabinet. Operator places devices in bag; initiates 12-hour cycle at 20-29°C. Process monitored via AN87 Dosimeter and Bacillus atrophaeus biological indicator (AN2203) in process challenge device. Post-cycle, devices require mandatory aeration per manufacturer instructions. Output is sterilized medical equipment; ensures sterility assurance level (SAL) of 10^-6. Benefits include safe processing of delicate instruments that cannot withstand high-heat autoclaving.

Clinical Evidence

Bench testing only. Validation confirmed SAL of 10^-6 for maximum loads (24 lbs metal, 3.5 lbs plastic, 3.0 lbs fabric). Testing included simulated-use with mated surfaces, EO residual analysis per AAMI/ANSI/ISO 10993-7, and shelf-life testing of cartridges (5 years). Electromagnetic compatibility and electrical safety verified.

Technological Characteristics

Ethylene oxide gas sterilizer; 100% EO unit-dose cartridge; gas-impervious flexible sterilization bag; ventilated cabinet. Critical parameters: 17.6g EO, 20-29°C, 35-70% RH, 12-hour exposure. Complies with electromagnetic compatibility and electrical safety standards. Biological monitoring via Bacillus atrophaeus indicators.

Indications for Use

Indicated for surface sterilization of reusable medical devices sensitive to moisture, heat, chemical corrosion, or radiation in hospitals and healthcare settings. Includes metal instruments (hinged/mated surfaces), plastic devices, and fabric items.

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

• EOGas 4 Ethylene Oxide Gas Sterilizer (K150646)
• B-2270/AN70 Anprolene Sterilizer (Pre-amendment)

Submission Summary (Full Text)

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October 31, 2017

Andersen Sterilizers, Inc. William Andersen President 3154 Caroline Drive Haw River, North Carolina 27258

Re: K170432

Trade/Device Name: Anprolene AN75 Ethylene Oxide Gas Sterilizer Regulation Number: 21 CFR 880.6860 Regulation Name: Ethylene Oxide Gas Sterilizer Regulatory Class: Class II Product Code: FLF Dated: October 4, 2017 Received: October 6, 2017

Dear William Andersen:

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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.qov

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

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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# Indications for Use

510(k) Number (if known) K170432

Device Name Anprolene AN75 Ethylene Oxide Gas Sterilizer

Indications for Use (Describe)

The Anprolene AN75 Ethylene Oxide Gas Sterlizer is intended for use in hospitals and other human healthcare settings. It is designed to sterilize reusable medical devices that are sensitive to moisture, heat, chemical corrosion, or radiation.

The 12 hour cycle at 20-29°C in the Anprolene AN75 Ethylene is for surface sterilization of medical devices, including mated surfaces. The critical process parameters for the cycle are summarized in Table 1.

Table 1. Critical sterilization cycle parameters in the Anprolene AN75 Ethylene Oxide Gas Sterilizer

| EO Amount | Temperature | Relative Humidity | EO Exposure Time | Total Cycle Time |
|---------------|-------------------|-------------------|------------------|------------------|
| 17.6 $g$ ± 5% | 20-29°C (68-84°F) | 35-70% | 12 hours | 14 hours |

Maximum loads of specific materials and devices that have been validated are listed in Table 2. All validated maximum loads were processed without additional devices in the sterilizer.

Table 2. Load and material types validated in the Anprolene AN75 Ethylene Oxide Gas Sterilizer

| Device Type | Maximum Load | Device Examples | Required Aeration |
|-------------|------------------|------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Metal | 24 lbs (11 kg) | Delicate sharps and surgical<br>instruments, including those<br>with hinges and mated surfaces | Metal instruments do not absorb EO;<br>Follow pouch or wrap manufacturer's<br>instructions (Example: Sterisheet® wrap=<br>require ≥ 6 hours at 20-29°C). |
| Plastic | 3.5 lbs (1.6 kg) | Reusable power cords, trocars | Follow manufacturer's instructions;<br>24 hours at 20-29°C |
| Fabric | 3.0 lbs (1.4 kg) | Reusable cloth gowns, towels | Follow manufacturer's instructions;<br>24 hours at 20-29°C. |

Reusable medical devices must be aerated following the instructions of device manufacturers, then released for use after sterilization based on successful inactivation of an EZTest®- Gas Biological Indicator in the Anprolene SteriTest process challenge device.

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

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#### 510(k) Summary

| Applicant's Name and Address | Andersen Sterilizers, Inc.<br>Establishment Registration Number 3004634710<br>3154 Caroline Drive<br>Haw River, NC 27258 |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Contact Person | William K. Andersen, BE, MD, FAAOS<br>President<br>Phone: [phone], Fax: [phone] |
| Date of Preparation | October 27, 2017 |
| Device | |

Proprietary Name Anprolene AN75 Ethylene Oxide Gas Sterilizer Common Name Ethylene oxide gas sterilizer Classification Class II (21 CFR 880.6860) Medical Specialty General Hospital Product Code FLF

Anprolene is a registered trademark of Andersen Sterilizers, Inc. The refill kits for the Anprolene AN75 Ethylene Oxide Gas Sterilizer, including the accessories (sterilization bags, AN7514 cartridges, and AN87 Dosimeter®), are registered with the US Environmental Protection Agency (EPA#69340-9).

Primary Predicate Device - EOGas 4 Sterilizer

| Device Name | EOGas 4® Ethylene Oxide Gas Sterilizer |
|---------------|----------------------------------------|
| 510(k) number | K150646 |
| Manufacturer | Andersen Sterilizers, Inc. |

For the subject device, the sterilization temperature, sterilization time, and post-sterilization ventilation time were modified from the predicate device. The Anprolene AN75 Ethylene Oxide Sterilizer operates at 20-29°C with an exposure time of 12 hours and ventilation of 2 hours, whereas the primary predicate device operates at 50±3°C with an exposure time of 3 hours and 30 minute ventilation. The principles of operation, intended use, and technology are otherwise substantially equivalent.

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Pre-amendment Device - B-2270/AN70 Anprolene Sterilizer

Device Name B-2270/AN70 Anprolene Sterilizer Ethylene Oxide Sterilization System 510(k) number NA Manufacturer Andersen Products, Inc.

The Andersen B-2270/AN70 Anprolene Sterilizer is a pre-amendment predicate device. It was in commercial distribution and clinical use in the United States prior to May 28, 1976.

For the subject device, the material composition of the sterilization bag, the ethylene oxide delivery method, and the sterilization cabinet design of the pre-amendment device were modified. No modifications were made to the technology or intended use.

### Device Description

The Anprolene AN75 Ethylene Oxide Gas Sterilizers, model numbers AN75i (AN75.64 and AN75.65), AN75iX (AN75.84 and AN75.85), and AN75J (AN75.74 and AN75.75), are intended to sterilize moisture, temperature, chemical corrosion, or radiation-sensitive reusable medical devices in healthcare facilities. The sterilant is a unit dose of 100% ethylene oxide contained in a cartridge, and the sterilization chamber is a gas-impervious flexible sterilization bag. Each sterilization cycle is monitored using cumulative gas exposure measurement (AN87 Dosimeter), as well as a Bacillus atrophaeus biological indicator (AN2203) inserted into a process challenge device (AN7508.14 Anprolene SteriTest) that is integrated into the sterilizer.

### Indications for Use

The Anprolene AN75 Ethylene Oxide Gas Sterilizer is intended for use in hospitals and other human healthcare settings. It is designed to sterilize reusable medical devices that are sensitive to moisture, heat, chemical corrosion, or radiation.

The 12 hour cycle at 20-29℃ in the Anprolene AN75 Ethylene Oxide Gas Sterilizer is for surface sterilization of medical devices, including mated surfaces. The critical process parameters for the cycle are summarized in Table 1.

Table 1. Critical sterilization cycle parameters in the Anprolene AN75 Ethylene Oxide Gas Sterilizer

| EO Amount | Temperature | Relative Humidity | EO Exposure Time | Total Cycle Time |
|-------------|-------------------|-------------------|------------------|------------------|
| 17.6 g ± 5% | 20-29°C (68-84°F) | 35-70% | 12 hours | 14 hours |

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Maximum loads of specific materials and devices that have been validated are listed in Table 2. All validated maximum loads were processed without additional devices in the sterilizer.

| Device Type | Maximum Load | Device Examples | Required Aeration |
|-------------|------------------|---------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Metal | 24 lbs (11 kg) | Delicate sharps and surgical<br>instruments, including<br>those with hinges and<br>mated surfaces | Metal instruments do not<br>absorb EO;<br>Follow pouch or wrap<br>manufacturer's instructions<br>(Examples: Sterisheet® wrap<br>require ≥ 6 hours at 20-29°C). |
| Plastic | 3.5 lbs (1.6 kg) | Reusable power cords,<br>trocars | Follow manufacturer's<br>instructions;<br>24 hours at 20-29°C. |
| Fabric | 3.0 lbs (1.4 kg) | Reusable cloth gowns,<br>towels | Follow manufacturer's<br>instructions;<br>24 hours at 20-29°C. |

Table 2. Load and material types validated in the Anprolene AN75 Ethylene Oxide Gas Sterilizer

Reusable medical devices must be aerated following the instructions of device manufacturers and packaging material manufacturers, then released for use after sterilization based on successful inactivation of an EZTest - Gas Biological Indicator in the Anprolene SteriTest process challenge device.

# Substantial Equivalence Comparison

The Anprolene AN75 Ethylene Oxide Gas Sterilizer is substantially equivalent to the predicate devices: the B-2270/AN70 Anprolene Sterilizer and the EOGas 4 Ethylene Oxide Gas Sterilizer, because all three sterilizers are intended for the same use, designed in a similar way, use similar technology, and perform substantially equivalently.

The Anprolene AN75 Ethylene Oxide Gas Sterilizer differs from the predicate B-2270/AN70 Anprolene sterilizer in the use of a sterilization bag that is ethylene oxide impermeable, gas delivery from an ampoule in a cartridge rather than an ampoule in a gas release bag, and a ventilated sterilization cabinet surrounding the sterilization bag. Compared to the predicate EOGas 4 sterilizer, the Anprolene AN75 Ethylene Oxide Gas Sterilizer has a gas exposure of 12 hours at 20-29℃ rather than 3 hours at 50±3℃. Ventilation after sterilization is 2 hours for the subject Anprolene AN75 sterilizer, and 30 minutes for the predicate EOGas 4 sterilizer. These differences raise no issues related to safety or effectiveness of the subject device sterilization cycle. A comparison among the sterilizers is listed in Table 3.

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Table 3: Comparison among the Anprolene AN75 Ethylene Oxide Gas Sterilizer, the B-2270/AN70 Anprolene Ethylene Oxide Gas Sterilizer, and the EOGas 4 Ethylene Oxide Gas Sterilizer

| | Predicate EOGas 4<br>Sterilizer (K150646) | Predicate<br>B-2270/AN70<br>Anprolene<br>Sterilizer | Subject Anprolene<br>AN75 Sterilizer | Comparison |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Intended Use | Indoor ethylene oxide sterilizer in a healthcare setting | | | Same |
| Indications<br>for Use | Intended for use in hospitals and other human healthcare settings | | | Same |
| | Designed to sterilize reusable medical devices that are sensitive to<br>moisture, heat, chemical corrosion, or radiation | | | Same |
| | 3 hour EO exposure at<br>$50\pm3$ °C with 0.5 hr<br>mandatory ventilation | 12 hour EO exposure at 20-29°C with 2 hrs<br>mandatory ventilation | | |
| | For surface sterilization<br>and sterilization of<br>single-lumen flexible<br>endoscopes | For surface sterilization, including mated<br>surface | | Equivalent |
| Design | Ventilated cabinet | Stainless steel<br>container | Ventilated cabinet | Equivalent |
| | Unit dose EO in<br>cartridge | Unit dose EO in<br>gas release bag | Unit dose EO in<br>cartridge | |
| | Flexible sterilization chamber | | | |
| | EO impermeable<br>sterilization bag | Gas-diffusion<br>sterilization bag | EO impermeable<br>sterilization bag | |
| Technology | Use EO as sterilant; EPA registered | | | Same |
| | Critical parameters: EO concentration, RH, temperature, and time | | | |
| Biological<br>Monitoring | EOGas 4 SteriTest | AN80 Steritest | Anprolene SteriTest | Equivalent |
| Safety | Verified compliance for<br>electromagnetic<br>compatibility and<br>electrical safety; Human<br>Factors evaluation for<br>safety and effectiveness. | N/A | Verified compliance for<br>electromagnetic<br>compatibility and<br>electrical safety; Human<br>Factors evaluation for<br>safety and effectiveness. | Same |
| Performance | Sterilize reusable<br>medical devices as<br>defined in the sterilizer<br>labeling to a SAL of 10-6<br>with reasonable<br>assurance of safety and<br>effectiveness | Sterilize<br>reusable medical<br>devices as<br>defined in the<br>sterilizer<br>labeling | Sterilize reusable<br>medical devices as<br>defined in the sterilizer<br>labeling to a SAL of 10-6<br>with reasonable<br>assurance of safety and<br>effectiveness | Equivalent |

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# Performance Testing

The Anprolene AN75 Ethylene Oxide Gas Sterilizer has been validated using applicable tests in the FDA 1993 "Guidance on Premarket Notification [510(k)] Submissions for Sterilizers Intended for Use in Health Care Facilities".

The maximum loads of metal, fabric, and plastic devices that may be routinely sterilized in the Anprolene AN75 Ethylene Oxide Gas Sterilizer were defined and validated. Using the 12 hour cycle at 20-29°C, the Anprolene AN75 sterilization system reproducibly and effectively sterilizes 24 lbs of metal instruments with or without mated surfaces, 3.0 lbs of fabric, and 3.5 lbs of plastic devices, achieving a minimum sterility assurance level (SAL) of 10-6. All validated maximum loads were processed without additional devices in the sterilizer. A compatible carrier for EO sterilization (a perforated metal basket) was used to hold the metal and plastic devices, for the convenience of handling relatively large quantities of devices.

The validation testing demonstrated that exposure to EO gas under the defined loads and physical parameters achieved a minimum sterility assurance level (SAL) of 10 for surfaces, including mated surfaces. The effectiveness of the sterilization process for the loads was confirmed by successful sterilization in simulated-use testing using instruments with mated surfaces.

Process residue analysis showed that after recommended aeration. EO residuals on the most absorbent materials tested in the study met the requirements of AAMI/ANSI/ISO 10993-7. demonstrating that the Anprolene AN75 Ethylene Oxide Gas Sterilizer and its accessories are safe to use if the guidance and instructions are followed. The Anprolene AN75 Ethylene Oxide Gas Sterilizer was tested to verify compliance with requirements for electromagnetic compatibility and electrical safety.

Physical performance tests demonstrated that the Anprolene AN75 Ethylene Oxide Gas Sterilizer, gas cartridges, and sterilization bags met their performance specifications. The Anprolene AN75 sterilization system achieved and maintained the cycle specifications for EO concentration, temperature, time, and relative humidity. Both the sterilizer and the accessories consistently operated in accordance with predetermined criteria. The 12 hour cycle at 20-29°C in the Anprolene AN75 Ethylene Oxide Gas Sterilizer was repeatable and reliable under the indicated test load conditions.

Shelf Life testing demonstrated that the AN7514 cartridges maintain performance specifications (physical characteristics, released EO amount, EO concentration, and inactivation of biological indicators) throughout the stated shelf life of 5 years, demonstrating reasonable assurance for effectiveness.

# Conclusion

The Anprolene AN75 Ethylene Oxide Gas Sterilizer is substantially equivalent to the preamendment predicate Andersen B-2270/AN70 Anprolene Sterilizer, and the predicate EOGas 40 Ethylene Oxide Gas Sterilizer (K150646).