AN85/AN86 EO Indicators

• K Number: K170426
• Device Name: AN85/AN86 EO Indicators
• Manufacturer: Andersen Sterilizers,Inc.
• Date Cleared: 2017-10-30 ( 259 days)
• Product Code: JOJ
• Regulation Number: 880.2800

Intended Use

AN85/AN86 EO Indicators are single-use Type 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 12 hour sterilization cycle at 20-29°C in the Anprolene AN75 Ethylene Oxide Gas Sterilizer manufactured by Andersen Sterilizers, Inc. Critical process parameters for the cycle are summarized in Table 1.

Device Description

AN85/AN86 EO Indicators are adhesive-backed Type 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.

Predicate Devices

K150644

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on a chemical indicator that changes color based on exposure to ethylene oxide, with no mention of AI or ML technologies.

Therapeutic

No
This device is a chemical indicator used to distinguish between processed and unprocessed medical devices after ethylene oxide sterilization; it does not treat or diagnose any medical condition.

Diagnostic

No

The device is an indicator for ethylene oxide sterilization, used to distinguish between processed and unprocessed medical devices through a color change. It does not diagnose a condition or disease in a patient.

SaMD (Software as a Medical Device)

No

The device description clearly states that the device is a physical indicator containing a pH indicator ink laminated between two layers of plastic material. It is a physical, chemical indicator, not software.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use is to distinguish between processed packaged medical devices through a visible color change after exposure to ethylene oxide sterilization. This is a process indicator for sterilization, not a test performed on biological samples to diagnose a condition or provide information about a patient's health.
• Device Description: The device is a chemical indicator that reacts to ethylene oxide gas. It does not involve the analysis of biological specimens.
• Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
  • Testing biological samples (blood, urine, tissue, etc.)
  • Providing diagnostic information about a patient
  • Measuring analytes in biological fluids

The device's function is solely to indicate whether a sterilization process has occurred, which is a quality control measure for medical devices, not a diagnostic test for a patient.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

AN85/AN86 EO Indicators are single-use Type 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 12 hour sterilization cycle at 20-29°C in the Anprolene AN75 Ethylene Oxide Gas Sterilizer manufactured by Andersen Sterilizers, Inc. 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

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

Product codes (comma separated list FDA assigned to the subject device)

JOJ

Device Description

AN85/AN86 EO Indicators are adhesive-backed Type 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The performance of AN85/AN86 EO Indicators was characterized in a Chemical Indicator Evaluator Resistometer (CIER) as well as in an Anprolene AN75 Ethylene Oxide Gas Sterilizer using the 12 hour cycle at 20-29°C. 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 at
a relative humidity of 35-90%;

2. ISO 11140-1 Type 1 process indicator;
3. Indicate EO exposure in the CIER and in the Anprolene AN75
   sterilizer. | Pass |
   | Biocompatibility | Not direct or indirect patient-contacting devices;
   Non-toxic ingredients;
   Provides reasonable assurance for safety. | Pass |
   | Endpoint Color
   Stability | Stable for at least 12 months at 20-25°C and 30-50% relative humidity
   away from direct sunlight;
   Stability demonstrates reasonable assurance for effectiveness. | Pass |
   | Shelf Life | Maintains performance specifications throughout the shelf life of 2 years. | Pass |

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, the AN85/AN86 EO Indicators (K150644).

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K150644

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 880.2800 Sterilization process indicator.

(a)
Biological sterilization process indicator —(1)Identification. A biological sterilization process indicator is 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.(2)
Classification. Class II (performance standards).(b)
Physical/chemical sterilization process indicator —(1)Identification. A physical/chemical sterilization process indicator is 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.(2)
Classification. Class II (performance standards).

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym followed by the words "U.S. FOOD & DRUG ADMINISTRATION" on the right. The FDA part of the logo is in blue, with the acronym in a larger font size than the rest of the text.

October 30, 2017

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

Re: K170426

Trade/Device Name: AN85/AN86 EO Indicators Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: JOJ 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 (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/MedicalDevices/ResourcesforYou/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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K170426

Device Name AN85/AN86 EO Indicators

Indications for Use (Describe)

AN85/AN86 EO Indicators are single-use Type 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 12 hour sterilization cycle at 20-29°C in the Anprolene AN75 Ethylene Oxide Gas Sterilizer manufactured by Andersen Sterilizers, Inc. 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

Ethylene Oxide	Temperature	Relative Humidity	Ethylene Oxide 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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K170426

510(k) Summary

5.1 Applicant's Name and Address

Andersen Sterilizers, Inc. Establishment Registration Number 3004634710 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

September 28, 2017

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

AN85/AN86 EO Indicators K150644 Andersen Sterilizers, Inc.

The predicate AN85 and AN86 EO Indicators (K150644) are approved for use with the EOGas 4 Ethylene Oxide Gas Sterilization system manufactured by Andersen Sterilizers, Inc.

In this submission, the sterilization temperature and time claims of the predicate devices were modified in order to indicate the AN85 and AN86 EO Indicators for use in the Anprolene AN75 Ethylene Oxide Gas Sterilization System. No modifications were made to the manufacturing method, technology, or intended use.

5.6 Device Description

AN85/AN86 EO Indicators are adhesive-backed Type 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

AN85/AN86 EO Indicators are single-use Type 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 12 hour sterilization cycle at 20-29°C in the Anprolene AN75 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 sterilization cycle parameters in the Anprolene AN75 Ethylene Oxide Gas Sterilizer

Ethylene Oxide	Temperature	Relative Humidity	Ethylene Oxide Exposure Time	Total Cycle Time
17.6 g ± 5%	20-29°C	35-90%	12 hours	14 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 Anprolene AN75 Ethylene Oxide Gas Sterilizer using the 12 hour cycle at 20-29°C. 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 at
a relative humidity of 35-90%;

2. ISO 11140-1 Type 1 process indicator;
3. Indicate EO exposure in the CIER and in the Anprolene AN75
   sterilizer. | Pass |
   | Biocompatibility | Not direct or indirect patient-contacting devices;
   Non-toxic ingredients;
   Provides reasonable assurance for safety. | Pass |
   | Endpoint Color
   Stability | Stable for at least 12 months at 20-25°C and 30-50% relative humidity
   away from direct sunlight;
   Stability demonstrates reasonable assurance for effectiveness. | Pass |
   | Shelf Life | Maintains performance specifications throughout the shelf life of 2 years. | 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, the AN85/AN86 EO Indicators (K150644).

5.10 Device Comparison

AN85/AN86 EO Indicators used in the Anprolene AN75 Sterilizer are substantially equivalent to the AN85/AN86 EO Indicators (K150644) used in the EOGas 4 sterilizer. Both the subject and predicate indicators have the same intended use, design, and technical characteristics. A comparison between the indicators is listed in Table 5-3.

| | Predicate AN85/AN86 EO
Indicators (K150644) | Subject AN85/AN86 EO
Indicators | Comparison |
|-----------------------------|-----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|---------------------------------------------------------|
| Intended Use | Process indicator to indicate
exposure to EO
Adhesive-backed labels | Process indicator to
indicate exposure to EO
Adhesive-backed labels | Identical |
| Sterilization
Method | EOGas 4 sterilizer;
100% EO process;
3 hr EO exposure at 50±3°C | Anprolene AN75 sterilizer;
100% EO process;
12 hr EO exposure at 20-
29°C | Difference does not
alter safety or
effectiveness |
| Design | Indicator changes color when
exposed to EO | Indicator changes color
when exposed to EO | Identical |
| Indicator
Agent | pH indicator | pH indicator | Identical |
| Device
Materials | Plastic films;
Plastic layer above and
below the ink prevents direct
contact with the ink. | Plastic films;
Plastic layer above and
below the ink prevents
direct contact with the ink. | Identical |
| Endpoint
Color
Change | Yellow-green to blue color | Yellow-green to blue color | Identical |
| Technology | Chemical reactions with EO
change the pH and the color
of the indicator ink. | Chemical reactions with
EO change the pH and the
color of the indicator ink. | Identical |
| Performance | Type 1 process indicator | Type 1 process 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, the AN85/AN86 EO Indicators used in the EOGas 4 sterilization system, cleared under K150644.