(251 days)
Not Found
No
The device is a chemical indicator that changes color based on exposure to ethylene oxide, relying on a pH indicator and chemical reactions, not AI/ML. The summary explicitly states "Mentions AI, DNN, or ML: Not Found".
No.
The device is a process indicator used to distinguish between processed and unprocessed packaged medical devices after sterilization, not to treat any medical condition.
No
Explanation: The device is a process indicator used to determine if medical devices have been exposed to ethylene oxide during sterilization. It does not diagnose medical conditions in patients.
No
The device is a physical chemical indicator that changes color based on exposure to ethylene oxide, not a software program.
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 and unprocessed packaged medical devices after ethylene oxide sterilization. This is a quality control measure for the sterilization process, not a diagnostic test performed on a biological sample to diagnose a condition or disease.
- Device Description: The device is a chemical indicator that changes color based on exposure to ethylene oxide. It does not interact with biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition.
- Using reagents or assays to detect specific analytes in biological samples.
The device is clearly described as a process indicator for sterilization, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
JOJ
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.
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 EOGas 4 Ethylene Oxide Gas Sterilizer using the 3 hour cycles at 50 ℃.
Tests performed:
- Functionality: Critical parameters include temperature, time, and gas concentration under a relative humidity of 35-90%; ISO 11140-1 Class 1 process indicator; Indicate EO exposure in the CIER and in the EOGas 4 sterilizer. Result: Pass.
- Biocompatibility: Not direct or indirect patient-contacting devices; Non-toxic ingredients; Provides reasonable assurance for safety. Result: 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. Result: Pass.
- Shelf Life: Maintains performance specifications throughout the shelf life. For storage, AN85/AN86 indicators should be kept away from EO or products that affect pH such as acids or alkalis, and in an environment of 20-30°C and 30-50% relative humidity. Under the conditions, AN85/AN86 indicators have a shelf life of 2 years from date of manufacture. Result: Pass.
Key results: 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.
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.
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
§ 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).
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
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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:
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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 | ||
| Humiditv | Ethylene Oxide | |||
| Exposure Time | Total Cycle | |||
| 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 | |
| under a relative humidity of 35-90%; |
- ISO 11140-1 Class 1 process indicator;
- 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 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. For
storage, AN85/AN86 indicators should be kept away from EO or products
that affect pH such as acids or alkalis, and in an environment of 20-30°C
and 30-50% relative humidity. Under the conditions, AN85/AN86
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
Chemical Indicator | AN85/AN86 EO
Indicators | Comparison |
|--------------------------|------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| Intended Use | Process indicator to indicate
exposure to EO | Process indicator to indicate
exposure to EO | Same |
| | Insert labels | Adhesive-backed labels | AN85/AN86 may
be used to secure
wrapping materials |
| Sterilization
Method | Traditional EO sterilizer
100% and blended EO process | The EOGas 4 sterilizer
100% EO process 3 hr cycles at
50°C | Do not affect safety
or effectiveness |
| Design | Indicator changes color when
exposed to EO | Indicator changes color when
exposed to EO | Equivalent |
| Indicator
Agent | pH indicator | pH indicator | Equivalent |
| Device
Materials | Paper | Plastic films | AN85/AN86 :
plastic layer above
and below the ink
prevents direct
contact with the ink |
| Endpoint
Color Change | Orange to red color | Yellow-green to blue color | Equivalent |
| Technology | Chemical reactions with EO
changes the pH and the color
of the indicator ink | Chemical reactions with EO
changes the pH and the color
of the indicator ink | Equivalent |
| Performance | Correctly indicated EO
exposure; Class 1 process
indicator. | Correctly indicated EO
exposure; Class 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, VERIFY EO Valueline Chemical Indicator, cleared under K991418.