AN87 Dosimeter

K170439 · Andersen Sterilizers, Inc. · JOJ · Nov 1, 2017 · General Hospital

Device Facts

• Record ID: K170439
• Device Name: AN87 Dosimeter
• Applicant: Andersen Sterilizers, Inc.
• Product Code: JOJ · General Hospital
• Decision Date: Nov 1, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

AN87 Dosimeter is a single-use color change chemical indicator that is calibrated for sterilization temperature and used to verify adequate cumulative ethylene oxide exposure in the 12 hour sterilization cycle at 20-29°C in the Anprolene AN75 Ethylene Oxide Gas Sterilizer manufactured by Andersen Sterilizers, Inc.

Device Story

AN87 Dosimeter is a single-use chemical indicator for monitoring cumulative ethylene oxide (EO) exposure; used as an accessory for the Anprolene AN75 Ethylene Oxide Gas Sterilizer. Device consists of a pH indicator within a glass capillary tube mounted on a plastic tray. During sterilization, EO exposure triggers a chemical reaction changing the indicator ink from yellow-orange to dark blue; color progression from the open end toward the closed end is proportional to cumulative EO exposure. A calibration mark indicates exposure sufficient to inactivate a 6-Log Bacillus atrophaeus biological indicator. Healthcare providers use the visual color change to verify sterilization cycle adequacy. The device is not a replacement for biological indicators.

Clinical Evidence

Bench testing only. Validation performed per FDA 2003 guidance and AAMI/ANSI/ISO 11140-1. Testing in an Andersen Chemical Indicator Evaluator Resistometer and Anprolene AN75 sterilizer confirmed performance parallels a 6-Log Bacillus atrophaeus biological indicator. Results demonstrated stable color endpoint for 28 days at 20-25°C and a 3-year shelf life.

Technological Characteristics

Single-use chemical indicator; pH-sensitive indicator ink in a glass capillary tube on a plastic tray. Operates via chemical reaction with ethylene oxide. Calibrated for 20-29°C, 35-90% relative humidity, 12-hour exposure. Complies with AAMI/ANSI/ISO 11140-1.

Indications for Use

Indicated for use as a single-use chemical indicator to verify adequate cumulative ethylene oxide exposure during 12-hour sterilization cycles at 20-29°C in the Anprolene AN75 Ethylene Oxide Gas 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

• AN1087 Dosimeter (K150645)

Submission Summary (Full Text)

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November 1, 2017

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

Re: K170439

Trade/Device Name: AN87 Dosimeter Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: 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/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 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

indica

Device Name AN87 Dosimeter

Indications for Use (Describe)

AN87 Dosimeter is a single-use color change chemical indicator that is calibrated for sterilization temperature and used to verify adequate cumulative ethylene oxide exposure in 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 $\pm$ 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)

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#### FOR FDA USE ONLY

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

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## K170439 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 AN87 Dosimeter®<br>Common Name Indicator, Physical/Chemical Sterilization Process<br>Classification Class II (21 CFR 880.2800) Chemical Indicator<br>Product Code JOJ |
| 5.5 Predicate Device | |
| | Device Name AN1087 Dosimeter®<br>510(k) number K150645<br>Manufacturer Andersen Sterilizers, Inc. |

The predicate AN1087 Dosimeters are approved for use with the EOGas 4® Ethylene Oxide Gas Sterilization system manufactured by Andersen Sterilizers, Inc.

The sterilization temperature and time claims of the predicate devices were modified in order to indicate the AN87 Dosimeters for use in the Anprolene Oxide Gas Sterilization System. No modifications were made to the manufacturing method, technology, or intended use.

5.6 Device Description

The AN87 Dosimeter is a single-use chemical indicator for cumulative ethylene oxide exposure. It is an accessory for the Anprolene AN75 Ethylene Oxide Gas Sterilizer.

The AN87 Dosimeter contains a proprietary pH indicator in a glass capillary tube that is sealed on one end and mounted on a plastic tray. It is calibrated for a 20-29°C sterilization temperature, and responds to ethylene oxide concentration and sterilization time. With exposure to ethylene oxide, the indicator turns from yellow-orange to a dark blue color from the open end toward the closed end. The extent of the color change is proportional to the cumulative ethylene oxide exposure. The calibration mark represents adequate cumulative ethylene oxide exposure to inactivate a 6-Log Bacillus atrophaeus biological indicator at the location of the AN87 Dosimeter. The AN87 Dosimeter is not a replacement for a biological indicator.

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## 5.7 Indications for Use

AN87 Dosimeter is a single-use color change chemical indicator that is calibrated for sterilization temperature and used to verify adequate cumulative ethylene oxide exposure in 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<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 Substantial Equivalence Comparison

The AN87 Dosimeter is substantially equivalent to the predicate device - AN1087 Dosimeter (K150645): there is no difference in intended use, design, technical characteristics, or performance between the devices. The differences between the AN1087 and AN87 Dosimeters are the sterilization temperature and time in the indications for use; the differences raise no issues related to safety or effectiveness because the devices are calibrated and validated for the sterilization temperatures and times claimed. A comparison between the indicators is listed in Table 5-2.

| | Predicate AN1087 Dosimeter<br>(K150645) | Subject AN87 Dosimeter | Comparison |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Intended Use | Chemical indicator for<br>cumulative EO exposure in the<br>EOGas 4 sterilizer | Chemical indicator for<br>cumulative EO exposure in the<br>Anprolene AN75 sterilizer | Substantially<br>Equivalent |
| Design | A pH indicator changes color<br>when exposed to EO;<br>The extent of the color changes<br>is proportional to cumulative<br>EO exposure;<br>Calibrated for use at 50±3°C. | A pH indicator changes color<br>when exposed to EO;<br>The extent of the color<br>changes is proportional to<br>cumulative EO exposure;<br>Calibrated for use at 20-29°C. | Substantially<br>Equivalent |
| Technology | Chemical reactions with EO<br>change the pH, and therefore<br>the color, of the indicator ink | Chemical reactions with EO<br>change the pH, and therefore<br>the color, of the indicator ink | Identical |
| Performance | Accurately indicates<br>cumulative EO exposure | Accurately indicates<br>cumulative EO exposure | Equivalent |
| Shelf Life | 3 years | 3 years | Equivalent |
| Endpoint<br>Specifications | Endpoint blue color is stable<br>for at least 28 days at 20-25°C | Endpoint blue color is stable<br>for at least 28 days at 20-25°C<br>and 3 days at 50°C | Equivalent |

Table 5-2. Comparison between AN87 Dosimeter and the predicate AN1087 Dosimeter

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## 5.9 Performance Testing

The AN87 Dosimeters were validated using applicable tests in:

- 1) FDA 2003 guideline, "Premarket Notification [510(k)] Submissions for Chemical Indicators: Guidance for Industry and FDA Staff"; and
- 2) AAMI/ANSI/ISO 11140-1, "Sterilization of health care products Chemical Indicators -Part 1: General requirements" (FDA Recognition Number 14-459).

The performance of the AN87 Dosimeter was characterized in an Andersen Chemical Indicator Evaluator Resistometer as well as in an Anprolene AN75 Ethylene Oxide Gas Sterilizer using the 12 hour cycle at 20-29°C. The critical parameters to which the AN87 responds include temperature, time, and gas concentration in a relative humidity controlled environment. The AN87 indicates adequate cumulative EO exposure in the cycle for all validated loads in the Anprolene AN75 sterilizer. The AN87 performance parallels the performance of a 6-Log Bacillus atrophaeus biological indicator. A strong correlation is observed between cumulative EO exposure and the distance the blue color travels in the AN87 Dosimeter. Using the AN87 Dosimeter at various stages of shelf life, the distance the blue line travels is stable for a minimum of 28 days after the sterilization cycle when AN87 Dosimeters are stored at room temperature (20-25°C). Real-time shelf stability testing with the AN87 Dosimeter supports a shelf life of 3 years.

Performance testing is summarized in Table 5-3.

| Test | Description | Result |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Functionality | 1) Critical parameters include temperature, time, and gas concentration<br>at a relative humidity of 35-90%;<br>2) Performance parallels that of a biological indicator;<br>3) A correlation exists between the extent the blue color travels and<br>cumulative EO exposure. | 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 28 days at 20-25°C;<br>Stability demonstrates reasonable assurance for effectiveness | Pass |
| Shelf Life | Maintains performance specifications throughout the stated shelf life of<br>3 years | Pass |

Table 5-3. Summary of bench tests performed to demonstrate safety and effectiveness of the AN87 Dosimeter

The nonclinical tests demonstrate that the AN87 Dosimeter, used in the Anprolene AN75 Ethylene Oxide Gas Sterilizer, is as safe, as effective, and performs as well as the legally marketed device, the AN1087 Dosimeter (K150645) used in the EOGas 4 Ethylene Oxide Gas Sterilizer.