AN85/AN86 EO Indicators

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure in profile, with three overlapping faces suggesting a sense of community or interconnectedness. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure, emphasizing the organization's name and national affiliation. 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ #### 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) {3}------------------------------------------------ This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ #### 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. 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. {5}------------------------------------------------ # 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 | {6}------------------------------------------------ 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.