Anprolene SteriTest

K170427 · Andersen Sterilizers, Inc. · FRC · Oct 31, 2017 · General Hospital

Device Facts

• Record ID: K170427
• Device Name: Anprolene SteriTest
• Applicant: Andersen Sterilizers, Inc.
• Product Code: FRC · General Hospital
• Decision Date: Oct 31, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

The Anprolene SteriTest consists of a self-contained biological indicator inoculated with viable Bacillus atrophaeus bacterial spores that is placed in a dedicated BI receptacle in the sterilizer. It monitors the efficacy of the 12 hour sterilization cycle at 20-29°C in the Anprolene AN75 Ethylene Oxide Gas Sterilizer. Critical process parameters for the cycle are summarized in Table 1.

Device Story

Anprolene SteriTest is a self-contained biological indicator (SCBI) for monitoring ethylene oxide (EO) sterilization efficacy. Input: 12-hour sterilization cycle (20-29°C) in Anprolene AN75 sterilizer. Device consists of a plastic vial containing Bacillus atrophaeus spores on a paper carrier and a glass ampoule with pH-sensitive growth medium (phenol red). Operator places SCBI in a dedicated receptacle during sterilization. Post-cycle, operator crushes the ampoule to activate the medium and incubates at 30-35°C for 48 hours. Output: Visual color change (red-orange to yellow) and/or turbidity indicates sterilization failure; no change indicates success. Used in clinical settings by healthcare personnel to verify sterilization cycle performance, ensuring patient safety by confirming the destruction of microbial contaminants on processed items.

Clinical Evidence

Bench testing only. Validated per FDA 2007 guidance and AAMI/ANSI/ISO 11138-1. Testing included viable spore population assay, resistance characteristics, growth inhibition, holding time, and reduced incubation time. Results confirmed the device provides a greater challenge than worst-case load locations, with partial positives in half-dose cycles and negatives in full-dose cycles. Shelf life of 2 years verified.

Technological Characteristics

Self-contained biological indicator (SCBI) comprising a polypropylene vial, paper spore carrier, glass ampoule with soybean casein digest broth, and phenol red pH indicator. Includes chemical indicator on label for EO exposure. Operates via biological challenge to EO gas sterilization. Complies with AAMI/ANSI/ISO 11138-1.

Indications for Use

Indicated for monitoring the efficacy of the 12-hour sterilization cycle at 20-29°C in the Anprolene AN75 Ethylene Oxide Gas Sterilizer. Uses a self-contained biological indicator (SCBI) with Bacillus atrophaeus spores.

Regulatory Classification

Identification

Biological sterilization process indicator: A device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization. Physical/chemical sterilization process indicator: A device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device.

Predicate Devices

• EOGas 4 SteriTest, AN7408.14 (K151585)

Submission Summary (Full Text)

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October 31, 2017

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

Re: K170427

Trade/Device Name: Anprolene SteriTest, AN7508.14 Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC Dated: September 28, 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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, PhD 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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known) K170427

Device Name Anprolene SteriTest, AN7508.14

Indications for Use (Describe)

The Anprolene SteriTest consists of a self-contained biological indicator inoculated with viable Bacillus atrophaeus bacterial spores that is placed in a dedicated BI receptacle in the sterilizer. It monitors the efficacy of the 12 hour sterilization cycle at 20-29°C in the Anprolene AN75 Ethylene Oxide Gas Sterilizer. 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 | 35-90% | 12 hours | 14 hours |

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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#### K170427 510(k) Summary

| 5.1 Applicant's Name and Address | Andersen Sterilizers, Inc.<br>Establishment Registration Number 3004634710<br>3154 Caroline Drive<br>Haw River, NC 27258 |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| 5.2 Contact Person | William K. Andersen, BE, MD, FAAOS<br>President<br>Phone: [phone], Fax: [phone] |
| 5.3 Date of Preparation | September 28, 2017 |
| 5.4 Device | |
| | Proprietary Name: Anprolene® SteriTest, AN7508.14 |
| | Common Name: Biological Sterilization Process Indicator |
| | Classification: Class II (21 CFR 880.2800) |
| | Product Code: FRC |
| 5.5 Predicate Device | |
| | Device Name: EOGas 4® SteriTest, AN7408.14 |
| | 510(k) number: K151585 |
| | Manufacturer: Mesa Laboratories, Inc. |

The predicate AN7408.14 EOGas 4 SteriTest (K151585) is approved for use in the EOGas 4 Ethylene Oxide Gas Sterilization System manufactured by Andersen Sterilizers, Inc.

The predicate device was modified to create the AN7508.14 Anprolene SteriTest, indicated for use in the Anprolene AN75 Ethylene Oxide Gas Sterilization System by Andersen Sterilizers, Inc. The sterilization temperature and time claims of the predicate device have been modified; no modifications were made to the manufacturing method, technology, or intended use.

#### 5.6 Device Description

The Anprolene® SteriTest consists of a single-use self-contained biological indicator (SCBI) placed in a reusable BI receptacle. It is designed for monitoring the efficacy of the 12 hour sterilization cycle at 20-29°C in an Anprolene AN75 Ethylene Oxide Gas Sterilizer.

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The SCBI, the EZTest - Gas Biological Indicator, consists of a plastic vial that serves as the culture tube and a cap including a filter material port to allow ethylene oxide to enter the vial. The plastic vial contains Bacillus atrophaeus spores inoculated onto a paper carrier, and a glass ampoule containing modified soybean casein digest broth and phenol red acting as a pH indicator. There is a chemical indicator printed on the unit label of the SCBI to indicate EO exposure.

Following manufacturer's instructions, the operator inserts the SCBI into the reusable BI receptacle on the purge probe of the Anprolene AN75 Ethylene Oxide Gas Sterilizer, and initiates a 12 hour cycle at 20-29°C. After cycle completion, the SCBI is retrieved and activated by crushing the glass ampoule. The chemical indicator on the SCBI changes from blue to a green/brown color depending on the duration of ethylene oxide exposure. The activated SCBI and an unprocessed control are incubated at 30-35℃ for 48 hours, and monitored for any color change and/or turbidity. Evidence of microbial growth by color change from red-orange to yellow and/or turbidity must be interpreted as a failure to meet the conditions necessary for sterilization (failed cycle); no color change or turbidity indicates conditions for sterilization were achieved (passed cycle).

### 5.7 Indications for Use

The Anprolene SteriTest consists of a self-contained biological indicator inoculated with viable Bacillus atrophaeus bacterial spores that is placed in a dedicated BI receptacle in the sterilizer. It monitors the efficacy of the 12 hour sterilization cycle at 20-29°C in the Anprolene AN75 Ethylene Oxide Gas Sterilizer. Critical process parameters for the cycle are summarized in Table 5-1.

| Table 5-1. Critical sterilization cycle parameters in the Anprolene AN75 sterilizer | | |
|-------------------------------------------------------------------------------------|--|--|
|-------------------------------------------------------------------------------------|--|--|

| Ethylene Oxide | Temperature | Relative<br>Humidity | Ethylene Oxide<br>Exposure Time | Total Cycle Time |
|----------------|-------------|----------------------|---------------------------------|------------------|
| 17.6 g ± 5% | 20-29°C | 35-90% | 12 hours | 14 hours |

#### 5.8 Device Comparison

The Anprolene SteriTest is substantially equivalent to the predicate device, the EOGas 4 SteriTest: both indicators are intended for the same use, use the same technology, are designed in the same way, and perform substantially equivalently.

The predicate EOGas 4 SteriTest is designed to monitor the efficacy of the 3 hour sterilization cycle at 50°C in the EOGas 4 Ethylene Oxide Gas Sterilizer, and the subject Anprolene SteriTest is designed to monitor the efficacy of the 12 hour sterilization cycle at 20-29°C in the Anprolene AN75 Ethylene Oxide Gas Sterilizer. The difference raises no issues related to safety or effectiveness of the subject device in the sterilization cycle. A comparison between the devices is listed in Table 5-2.

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| Element | Predicate EOGas 4 SteriTest (K151585) | Subject Anprolene SteriTest |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Sterilization method: EO gas<br>Process parameters: EO concentration, time,<br>temperature, and relative humidity | Identical |
| Organism | Bacillus atrophaeus (ATCC 9372) | Identical |
| Spore Population | ≥1.0 x 106 | Identical |
| BI Design | Paper strip containing indicator organism;<br>Glass ampoule containing growth medium;<br>Capped vial serving as a culture tube;<br>A pH indicator in medium for color change;<br>A process indicator indicating EO exposure | Identical |
| BI Receptacle<br>Design | Creates a greater challenge to the 3 hour cycle at<br>50±3°C in the EOGas 4 sterilizer than the same<br>BI placed in the worst-case location in the same<br>load | Create a greater challenge to the<br>12 hour cycle at 20-29°C in the<br>Anprolene AN75 sterilizer than<br>the same BI placed in the worst-<br>case location in the same load |
| Materials | Paper, glass, polypropylene, and aluminum | Identical |
| Configuration | SCBI in a receptacle | Identical |
| Indications for<br>Use | The EOGas 4 SteriTest consists of a self-<br>contained biological indicator inoculated with<br>viable Bacillus atrophaeus bacterial spores that<br>is placed in a dedicated BI receptacle in the<br>sterilizer. It monitors the efficacy of the 3 hour<br>sterilization cycle at 50±3℃ in the EOGas 4<br>Ethylene Oxide Gas Sterilizer. | The Anprolene SteriTest<br>consists of a self-contained<br>biological indicator inoculated<br>with viable Bacillus atrophaeus<br>bacterial spores that is placed in<br>a dedicated BI receptacle in the<br>sterilizer. It monitors the<br>efficacy of the 12 hour<br>sterilization cycle at 20-29°C in<br>the Anprolene AN75 Ethylene<br>Oxide Gas Sterilizer. |
| Shelf Life | 2 years for the biological indicator | 2 years for the biological<br>indicator |

## Table 5-2. Device Comparison

## 5.9 Performance Testing

The Anprolene SteriTest was validated using applicable tests in FDA 2007 "Guidance for Industry and FDA Staff: Biological Indicator (BI) Premarket Notification [510(k)] Submissions'', and AAMI/ANSI/ISO 11138-1 "Sterilization of health care products – Biological indicators -Part 1: General requirements" (FDA Recognition Number 14-296).

For the EZTest - Gas Biological Indicators, tests include viable spore population assay, resistance characteristics study, carrier and primary packaging materials (growth inhibition)

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evaluation, holding time assessment, and reduced incubation time validation. The results of all studies met the established acceptance criteria when applicable.

Under identical exposure conditions, the resistance characteristics of the EZTest - Gas Biological Indicators are equivalent when measured in a Biological Indicator Resistometer in the presence or absence of a vacuum.

The Anprolene SteriTest represents a rigorous challenge to the Anprolene AN75 sterilization process. Its resistance characteristics are greater than the same EZTest-Gas Biological Indicator placed in the worst-case locations of the maximum fabric, metal, and plastic loads. The Anprolene SteriTest was partially positive in each half dose cycle, and negative in each full dose cycle, when tested in each worst-case load. The performance of the Anprolene SteriTest in the 12 hour cycle at 20-29°C in an Anprolene AN75 Ethylene Oxide Gas Sterilizer is summarized in Table 5-3.

Table 5-3. Summary of bench tests performed to demonstrate safety and effectiveness of the Anprolene SteriTest

| Test | Description | Result |
|---------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Functionality | 1) Critical parameters include temperature, time, and gas concentration at a<br>relative humidity of 35-90%;<br>2) Device is appropriate for monitoring the efficacy of the sterilization<br>process claimed. | Pass |
| Shelf Life | Maintains performance specifications (resistance characteristics and correctly<br>indicate pass/fail in cycles) throughout the stated shelf life of 2 years;<br>Stability demonstrates reasonable assurance for effectiveness. | Pass |

In conclusion, the Anprolene SteriTest is substantially equivalent to the legally marketed predicate, the EOGas 4 SteriTest (K151585).