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.

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.

AI/ML Overview

Here's an analysis of the provided text regarding the AN85/AN86 EO Indicators, focusing on the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the "Functionality" test in Table 5-2, which refers to ISO 11140-1 Class 1 process indicator standards and the device's ability to indicate EO exposure under specific conditions. The reported performance is a simple "Pass" for all criteria.

Acceptance Criteria	Reported Device Performance
Functionality:
1. Critical parameters include temperature, time, and gas concentration under a relative humidity of 35-90%.	Pass
2. ISO 11140-1 Class 1 process indicator.	Pass
3. Indicate EO exposure in the CIER (Chemical Indicator Evaluator Resistometer) and in the EOGas 4 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 3 months at 50°C; Stability demonstrates reasonable assurance for effectiveness.	Pass
Shelf Life: Maintains performance specifications throughout the shelf life (2 years from manufacture under specified storage conditions: away from EO/pH affecting products, 20-30°C, 30-50% RH).	Pass

Study Details:

The information provided only describes "Performance Testing" which consists of "bench studies." There is no detailed study protocol, raw data, or statistical analysis provided in this summary.

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

Sample Size for Test Set: The document doesn't explicitly state the sample size (number of indicators) used for each test. It mentions "bench studies" and that the "AN85/AN86 EO Indicators perform as intended," but no specific counts are given for the number of devices tested in the CIER or EOGas 4 sterilizer.
Data Provenance: The studies were conducted by Andersen Sterilizers, Inc., the manufacturer. They are described as "bench studies," implying prospective testing. The country of origin for the data is not explicitly stated but implied to be the US given the manufacturer's address and FDA submission.

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

This type of device (chemical indicator) does not involve expert interpretation for ground truth. The "ground truth" is based on objective chemical reactions and physical changes (color change) when exposed to specific sterilization conditions. The assessment of whether the color change occurred and meets the Class 1 indicator definition is likely done by trained laboratory personnel following an established protocol, not by medical experts like radiologists.

4. Adjudication Method for the Test Set

Not applicable for this type of device. The assessment is objective (color change from yellow-green to blue) and does not involve subjective interpretation or multi-reader adjudication.

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

No. An MRMC study is not relevant for this type of device. This device is a chemical indicator that shows a visible color change, not an interpretive diagnostic tool requiring human reader assessment or comparison with AI.

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

Yes, in a way. The device itself (the chemical indicator) performs as a standalone tool that changes color. There is no "algorithm" in the digital sense, but the chemical reaction within the indicator operates independently to display the result. Its performance is assessed directly (i.e., whether it correctly changes color under specified conditions and remains unchanged under others).

7. The Type of Ground Truth Used

The ground truth is established by the known exposure conditions to ethylene oxide within controlled environments (CIER and EOGas 4 sterilizer) and the expected chemical reaction/physical change (color change from yellow-green to blue) as defined by ISO 11140-1 for Class 1 process indicators. Essentially, it's a physical/chemical ground truth based on controlled experimental conditions.

8. The Sample Size for the Training Set

Not applicable. This device is a chemical indicator, not a machine learning or AI model that requires a training set. Its performance is based on its inherent chemical and physical properties.

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

Not applicable, as there is no training set for this type of device.

Summary

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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: 336-376-8622 Fax: 336-376-5428
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.

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5.7 Indications for Use

			Table 5-1. Critical parameters for the 3 hour cycle in the EOGas 4 Ethylene Oxide Gas Sterilizer
Ethylene Oxide	Temperature	RelativeHumiditv	Ethylene OxideExposure Time	Total CycleTime
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 concentrationunder a relative humidity of 35-90%;2) ISO 11140-1 Class 1 process indicator;3) Indicate EO exposure in the CIER and in the EOGas 4 sterilizer.	Pass
Biocompatibility	Not direct or indirect patient-contacting devices;Non-toxic ingredients;Provides reasonable assurance for safety	Pass
Endpoint ColorStability	Stable for at least 12 months at 20-25°C and 3 months at 50°C;Stability demonstrates reasonable assurance for effectiveness	Pass
Shelf Life	Maintains performance specifications throughout the shelf life. Forstorage, AN85/AN86 indicators should be kept away from EO or productsthat affect pH such as acids or alkalis, and in an environment of 20-30°Cand 30-50% relative humidity. Under the conditions, AN85/AN86indicators 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 ValuelineChemical Indicator	AN85/AN86 EOIndicators	Comparison
Intended Use	Process indicator to indicateexposure to EO	Process indicator to indicateexposure to EO	Same
	Insert labels	Adhesive-backed labels	AN85/AN86 maybe used to securewrapping materials
SterilizationMethod	Traditional EO sterilizer100% and blended EO process	The EOGas 4 sterilizer100% EO process 3 hr cycles at50°C	Do not affect safetyor effectiveness
Design	Indicator changes color whenexposed to EO	Indicator changes color whenexposed to EO	Equivalent
IndicatorAgent	pH indicator	pH indicator	Equivalent
DeviceMaterials	Paper	Plastic films	AN85/AN86 :plastic layer aboveand below the inkprevents directcontact with the ink
EndpointColor Change	Orange to red color	Yellow-green to blue color	Equivalent
Technology	Chemical reactions with EOchanges the pH and the colorof the indicator ink	Chemical reactions with EOchanges the pH and the colorof the indicator ink	Equivalent
Performance	Correctly indicated EOexposure; Class 1 processindicator.	Correctly indicated EOexposure; Class 1 processindicator.	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.

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).