AN85/AN86 EO Indicators

K150644 · Andersen Sterilizers, Inc. · JOJ · Nov 18, 2015 · General Hospital

Device Facts

• Record ID: K150644
• Device Name: AN85/AN86 EO Indicators
• Applicant: Andersen Sterilizers, Inc.
• Product Code: JOJ · General Hospital
• Decision Date: Nov 18, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

The AN85/AN86 EO Indicators are single-use Class 1 process indicators used to distinguish between processed and unprocessed packaged medical devices, through a visible color change from yellow-green to blue. They are intended for the 3 hour sterilization cycle at 50°C in the EOGas 4 Ethylene Oxide Gas Sterilizer manufactured by Andersen Sterilizers, Inc.

Device Story

AN85/AN86 EO Indicators are adhesive-backed, single-use Class 1 chemical process indicators. They consist of a pH-sensitive indicator ink printed in dots (AN85) or stripes (AN86) on a substrate, laminated between two plastic film layers. When exposed to ethylene oxide gas during a 3-hour, 50°C sterilization cycle in the EOGas 4 Sterilizer, the ink undergoes a chemical reaction, changing color from yellow-green to blue. This visual change allows healthcare personnel to differentiate between processed and unprocessed medical device packaging. The device is used in clinical settings where EOGas 4 sterilization is performed. It provides a qualitative visual confirmation of exposure to the sterilization process, aiding in inventory management and ensuring that only processed items are used in clinical procedures.

Clinical Evidence

Bench testing only. Performance characterized in a Chemical Indicator Evaluator Resistometer (CIER) and the EOGas 4 Sterilizer. Testing confirmed functionality (color change) under specified parameters (17.6g EO, 50°C, 35-90% RH), endpoint color stability (12 months at 20-25°C), and a 2-year shelf life. Biocompatibility is not applicable as the device is not patient-contacting.

Technological Characteristics

Class 1 chemical process indicator; adhesive-backed plastic film construction; pH-sensitive indicator ink; conforms to AAMI/ANSI/ISO 11140-1; non-patient contacting; shelf life 2 years; storage 20-30°C, 30-50% RH.

Indications for Use

Indicated for use as a Class 1 process indicator to distinguish between processed and unprocessed packaged medical devices during ethylene oxide sterilization cycles in the EOGas 4 Sterilizer.

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

• VERIFY EO Valueline Chemical Indicator (K991418)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 18, 2015

Andersen Sterilizers, Inc. William K. Andersen, BE, MD, FAAOS President 3154 Caroline Drive Haw River, NC 27258

Re: K150644

Trade/Device Name: AN85/AN86 EO Indicators Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization process indicator Regulatory Class: Class II Product Code: JOJ Dated: October 20, 2015 Received: October 22, 2015

Dear Dr. William K. 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

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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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Erin |-Keith -S

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

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known) K150644

Device Name AN85/AN86 EO Indicators

Indications for Use (Describe)

The AN85/AN86 EO Indicators are single-use Class 1 process indicators used to distinguish between processed packaged medical devices, through a visible color change from yellow-green to blue. They are intended for the 3 hour sterilization cycle at 50°C in the EOGas 4 Ethylene Oxide Gas Sterilizer manufactured by Andersen Sterilizers, Inc. Critical process parameters for the cycle are summarized in Table 1.

Table 1. Critical parameters for the 3 hour cycle in the EOGas 4 Ethylene Oxide Gas Sterilizer

| Ethylene Oxide | Temperature | Relative Humidity | Ethylene Oxide Exposure Time | Total Cycle Time |
|----------------|-------------|-------------------|------------------------------|------------------|
| 17.6 g ± 5% | 50°C ± 3°C | 35-90% | 3 hours | 3.5 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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#### 510(k) Summary

- 5.1 Applicant's Name and Address
Andersen Sterilizers, Inc. 3154 Caroline Drive Haw River, NC 27258

- 5.2 Contact Person
William K. Andersen, BE, MD, FAAOS President Phone: [phone] Fax: [phone]

- 5.3 Date of Preparation November 17, 2015
- 5.4 Device

| Proprietary Name | AN85/AN86 EO Indicators |
|------------------|----------------------------------------------------|
| Common Name | Indicator, Physical/Chemical Sterilization Process |
| Classification | Class II (21 CFR 880.2800) Chemical Indicator |
| Product Code | JOJ |

- 5.5 Predicate Device
Device Name 510(k) number Manufacturer

VERIFY EO Valueline Chemical Indicator K991418 Steris Corporation

#### 5.6 Device Description

AN85/AN86 EO Indicators are adhesive-backed Class 1 process indicators for ethylene oxide sterilization that conform to AAMI/ANSI/ISO 11140-1.

AN85/AN86 EO Indicators contain a pH indicator. The pH indicator ink is printed in dots on the AN85 and in stripes on the AN86. The indicator ink is laminated between two layers of plastic material and changes color from yellow-green to blue by chemical reactions when exposed to ethylene oxide.

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# 5.7 Indications for Use

The AN85/AN86 EO Indicators are single-use Class 1 process indicators used to distinguish between processed and unprocessed packaged medical devices, through a visible color change from yellow-green to blue. They are intended for the 3 hour sterilization cycle at 50°C in the EOGas 4 Ethylene Oxide Gas Sterilizer manufactured by Andersen Sterilizers, Inc. Critical process parameters for the cycle are summarized in Table 5-1.

| | | | Table 5-1. Critical parameters for the 3 hour cycle in the EOGas 4 Ethylene Oxide Gas Sterilizer | |
|----------------|-------------|----------------------|--------------------------------------------------------------------------------------------------|---------------------|
| Ethylene Oxide | Temperature | Relative<br>Humiditv | Ethylene Oxide<br>Exposure Time | Total Cycle<br>Time |
| 17.6 g ± 5% | 50℃ ± 3℃ | 35-90% | 3 hours | 3.5 hours |

### 5.8 Technological Characteristics

AN85/AN86 EO Indicators contain a proprietary pH indicator which changes color by chemical reactions when exposed to ethylene oxide, allowing differentiation of ethylene oxide processed vs. unprocessed devices.

### 5.9 Performance Testing

The performance of AN85/AN86 EO Indicators was characterized in a Chemical Indicator Evaluator Resistometer (CIER) as well as in an EOGas 4 Ethylene Oxide Gas Sterilizer using the 3 hour cycles at 50 ℃. Performance testing is summarized in Table 5-2.

| Table 5-2. Summary of bench tests performed to demonstrate safety and effectiveness of |
|----------------------------------------------------------------------------------------|
| AN85/AN86 EO Indicators |

| Test | Description | Result |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Functionality | 1) Critical parameters include temperature, time, and gas concentration<br>under a relative humidity of 35-90%;<br>2) ISO 11140-1 Class 1 process indicator;<br>3) Indicate EO exposure in the CIER and in the EOGas 4 sterilizer. | Pass |
| Biocompatibility | Not direct or indirect patient-contacting devices;<br>Non-toxic ingredients;<br>Provides reasonable assurance for safety | Pass |
| Endpoint Color<br>Stability | Stable for at least 12 months at 20-25°C and 3 months at 50°C;<br>Stability demonstrates reasonable assurance for effectiveness | Pass |
| Shelf Life | Maintains performance specifications throughout the shelf life. For<br>storage, AN85/AN86 indicators should be kept away from EO or products<br>that affect pH such as acids or alkalis, and in an environment of 20-30°C<br>and 30-50% relative humidity. Under the conditions, AN85/AN86<br>indicators have a shelf life of 2 years from date of manufacture. | Pass |

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The bench studies demonstrate that AN85/AN86 EO Indicators perform as intended to indicate that the devices have been exposed to ethylene oxide, and perform as safely and effectively as the legally marketed predicate device.

#### 5.10 Device Comparison

AN85/AN86 EO Indicators are substantially equivalent to the VERIFY EO Valueline Chemical Indicator (K991418). Both the subject and predicate indicators have the same intended use, design, and technical characteristics. The difference in endpoint color changes due to different pH indicators used does not raise different questions of safety and effectiveness. A comparison between the indicators is listed in Table 5-3.

| | VERIFY EO Valueline<br>Chemical Indicator | AN85/AN86 EO<br>Indicators | Comparison |
|--------------------------|------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| Intended Use | Process indicator to indicate<br>exposure to EO | Process indicator to indicate<br>exposure to EO | Same |
| | Insert labels | Adhesive-backed labels | AN85/AN86 may<br>be used to secure<br>wrapping materials |
| Sterilization<br>Method | Traditional EO sterilizer<br>100% and blended EO process | The EOGas 4 sterilizer<br>100% EO process 3 hr cycles at<br>50°C | Do not affect safety<br>or effectiveness |
| Design | Indicator changes color when<br>exposed to EO | Indicator changes color when<br>exposed to EO | Equivalent |
| Indicator<br>Agent | pH indicator | pH indicator | Equivalent |
| Device<br>Materials | Paper | Plastic films | AN85/AN86 :<br>plastic layer above<br>and below the ink<br>prevents direct<br>contact with the ink |
| Endpoint<br>Color Change | Orange to red color | Yellow-green to blue color | Equivalent |
| Technology | Chemical reactions with EO<br>changes the pH and the color<br>of the indicator ink | Chemical reactions with EO<br>changes the pH and the color<br>of the indicator ink | Equivalent |
| Performance | Correctly indicated EO<br>exposure; Class 1 process<br>indicator. | Correctly indicated EO<br>exposure; Class 1 process<br>indicator. | Equivalent |

# Table 5-3. Comparison between AN85/AN86 EO Indicators and the predicate device

# BASIS FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE:

Based on the intended use, technological characteristics, performance data, and nonclinical tests performed, the subject AN85/AN86 EO Indicators are substantially equivalent to, and are as safe and as effective as, the legally marketed predicate device, VERIFY EO Valueline Chemical Indicator, cleared under K991418.