(156 days)
No
The device description and performance studies focus on biological and chemical indicators for sterilization efficacy, with no mention of AI or ML technologies.
No
The device is a biological indicator used to monitor the efficacy of an ethylene oxide gas sterilizer, not to treat a medical condition.
Yes
The device, a biological indicator, is used to monitor the efficacy of a sterilization process. By detecting the presence or absence of microbial growth after exposure to a sterilant, it provides information that helps determine if the sterilization cycle was successful or failed. This indicates a diagnostic function for the sterilization process.
No
The device is a biological indicator, which is a physical product containing bacterial spores used to monitor sterilization processes. It is not software.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to monitor the efficacy of a sterilization process (ethylene oxide gas sterilization). It does this by determining if viable bacterial spores are killed during the sterilization cycle.
- Mechanism: The device contains bacterial spores and a culture medium. After the sterilization cycle, the spores are incubated to see if they grow. Growth indicates a failed sterilization cycle, while no growth indicates a successful cycle. This is a test of the sterilization process itself, not a test performed in vitro on a biological specimen from a human or animal to provide information about a disease or condition.
- Lack of IVD Characteristics: The description does not mention analyzing biological samples (blood, urine, tissue, etc.) from patients, diagnosing diseases, or providing information for clinical decision-making related to a patient's health.
The device is a biological indicator used to validate and monitor the effectiveness of a sterilization process for medical devices.
N/A
Intended Use / Indications for Use
The EOGas 4 Endo-SteriTest Rapid Readout Biological Indicator consists of a self-contained biological indicator inoculated with viable Bacillus atrophaeus bacterial spores that is placed in a dedicated biological indicator receptacle mounted on the purge probe in the sterilizer. It monitors the efficacy of the 6-hour gas exposure at 50°C in the EOGas 4 Ethylene Oxide Gas Sterilizer.
Critical process parameters for the cycle are summarized in Table 1.
Table 1. Critical parameters for the 6-hour gas exposure in the EOGas 4 Ethylene Oxide Gas Sterilizer
| Ethylene Oxide | Temperature | Relative Humidity | EO Exposure Time | Total Cycle Time |
|---|---|---|---|---|
| 17.6 g ± 5% | 50°C ± 3°C | 35-90% | 6 hours | 7 hours |
Product codes (comma separated list FDA assigned to the subject device)
FRC
Device Description
The EOGas 4 Endo-SteriTest Rapid Readout Biological Indicator (RRBI) consists of a single-use self-contained biological indicator (SCBI) placed in a reusable biological indicator (BI) receptacle. It is designed for monitoring the efficacy of the 6-hour gas exposure at 50°C in an EOCas 4 Ethylene Oxide Gas Sterilizer.
The Bionova BT110 Rapid Readout Biological Indicator (K191021) consists of a plastic vial that serves as the culture tube and a cap including a filter material port to allow ethylene oxide to enter the vial. The plastic vial contains Bacillus atrophaeus spores inoculated onto a paper carrier, and a glass ampoule containing culture medium and a pH indicator. There is a chemical indicator printed on the unit label of the SCBI to indicate EO exposure by changing color from brown/red to green.
Following manufacturer's instructions, the operator inserts the Bionova BT110 Rapid Readout Biological Indicator into the reusable BI receptacle on the dedicated purge probe of the EOGas 4 Ethylene Oxide Gas Sterilizer, and initiates a 6-hour gas exposure at 50°C. After cycle completion, the SCBI is retrieved and activated by crushing the glass ampoule. The chemical indicator on the SCBI changes from brown/red to a green color after ethylene oxide exposure.
The activated SCBI and an unprocessed control are incubated in a Terragene Bionova IC10/20FR, IC10/20FRLCD or MiniBio Auto-Reader Incubator for 4 hours to detect fluorescent activity or 48 hours to detect color change. Evidence of microbial growth by presence of fluorescent activity or color change from blue to yellow must be interpreted as a failure to meet the conditions necessary for sterilization (cycle failed); no fluorescence or no color change indicates conditions for sterilization were achieved (cycle passed).
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 EOGas 4 Endo-SteriTest RRBI has been validated using applicable tests in FDA 2007 "Guidance for Industry and FDA Staff: Biological Indicator (BI) Premarket Notification [510(k)] Submissions", and ANSI/AAMI/ISO 11138-1:2017 "Sterilization of health care products -Biological indicators - Part 1: General requirements" (FDA Recognition Number 14-502).
For the Bionova BT110 Rapid Readout Biological Indicators (K191021), tests included viable spore population assay, resistance characteristics study, carrier and primary packaging materials (growth inhibition) evaluation, holding time assessment, reduced incubation time validation, recovery protocols for recovery medium, visual readout stability, and in-field evaluation. The results of all studies met the established acceptance criteria.
The EOGas 4 Endo-SteriTest RRBI represents a rigorous challenge to the EOGas 4 sterilization process. Its resistance characteristics are greater than the same biological indicator placed in the worst-case location of the endoscope validation loads. The performance of the EOGas 4 Endo-SteriTest RRBI in the 6-hour gas exposure at 50°C in an EOGas 4 Ethylene Oxide Gas Sterilizer is summarized in Table 3.
Table 3. Summary of bench tests performed to demonstrate safety and effectiveness of the EOGas 4 Endo-SteriTest RRBI
| Test | Description | Result |
|---|---|---|
| Functionality | 1) Critical parameters include time, temperature, gas concentration, and relative humidity 35-90%; 2) Device is appropriate for monitoring the efficacy of the sterilization process claimed | Pass |
| Shelf Life | Maintains performance specifications (resistance characteristics and correctly indicate pass/fail in cycles) throughout the stated shelf life of 2 years: Stability demonstrates reasonable assurance for effectiveness | Pass |
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.
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/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 and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 3, 2021
Andersen Sterilizers, Inc. William Andersen President 3154 Caroline Drive Haw River, North Carolina 27258
Re: K202879
Trade/Device Name: EOGas 4 Endo-SteriTest RRBI Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC Dated: February 3, 2021 Received: February 4, 2021
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Clarence W. Murray, III, Ph.D. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K202879
Device Name EOGas 4 Endo-SteriTest RRBI
Indications for Use (Describe)
The EOGas 4 Endo-SteriTest Rapid Readout Biological Indicator consists of a self-contained biological indicator inoculated with viable Bacillus atrophaeus bacterial spores that is placed in a dedicated biological indicator receptacle mounted on the purge probe in the sterilizer. It monitors the efficacy of the 6-hour gas exposure at 50°C in the EOGas 4 Ethylene Oxide Gas Sterilizer.
Critical process parameters for the cycle are summarized in Table 1.
Table 1. Critical parameters for the 6-hour gas exposure in the EOGas 4 Ethylene Oxide Gas Sterilizer
| Ethylene Oxide | Temperature | Relative Humidity | EO Exposure Time | Total Cycle Time |
|---|---|---|---|---|
| 17.6 g $\pm$ 5% | 50°C $\pm$ 3°C | 35-90% | 6 hours | 7 hours |
Type of Use (Select one or both, as applicable)
_ Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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4
K202879 510(k) Summary
Applicant's Name and Address
| Andersen Sterilizers, Inc. |
|---|
| 3154 Caroline Drive |
| Haw River, NC 27258 |
Contact Person
| William K. Andersen, BE, MD, FAAOS |
|---|
| President |
| Phone: 336-376-8622, Fax: 336-376-5428 |
Date of Preparation
March 3, 2021
Device
| Proprietary Name | EOGas 4 Endo-SteriTest RRBI |
|---|---|
| Common Name | Biological Sterilization Process Indicator |
| Classification | Class II (21 CFR 880.2800) |
| Product Code | FRC |
Predicate Device
| Device Name | EOGas 4 SteriTest |
|---|---|
| 510(k) number | K151585 |
| Manufacturer | Andersen Sterilizers, Inc. |
The current 510(k) submission modifies the predicate device to add a process challenge device for a 6-hour gas exposure. No modifications were made to the technology or intended use.
Device Description
The EOGas 4 Endo-SteriTest Rapid Readout Biological Indicator (RRBI) consists of a single-use self-contained biological indicator (SCBI) placed in a reusable biological indicator (BI) receptacle. It is designed for monitoring the efficacy of the 6-hour gas exposure at 50°C in an EOCas 4 Ethylene Oxide Gas Sterilizer.
The Bionova BT110 Rapid Readout Biological Indicator (K191021) consists of a plastic vial that serves as the culture tube and a cap including a filter material port to allow ethylene oxide to enter the vial. The plastic vial contains Bacillus atrophaeus spores inoculated onto a paper carrier, and a glass ampoule containing culture medium and a pH indicator. There is a chemical
5
indicator printed on the unit label of the SCBI to indicate EO exposure by changing color from brown/red to green.
Following manufacturer's instructions, the operator inserts the Bionova BT110 Rapid Readout Biological Indicator into the reusable BI receptacle on the dedicated purge probe of the EOGas 4 Ethylene Oxide Gas Sterilizer, and initiates a 6-hour gas exposure at 50°C. After cycle completion, the SCBI is retrieved and activated by crushing the glass ampoule. The chemical indicator on the SCBI changes from brown/red to a green color after ethylene oxide exposure.
The activated SCBI and an unprocessed control are incubated in a Terragene Bionova IC10/20FR, IC10/20FRLCD or MiniBio Auto-Reader Incubator for 4 hours to detect fluorescent activity or 48 hours to detect color change. Evidence of microbial growth by presence of fluorescent activity or color change from blue to yellow must be interpreted as a failure to meet the conditions necessary for sterilization (cycle failed); no fluorescence or no color change indicates conditions for sterilization were achieved (cycle passed).
Indications for Use
The EOGas 4 Endo-SteriTest Rapid Readout Biological Indicator consists of a self-contained biological indicator inoculated with viable Bacillus atrophaeus bacterial spores that is placed in a dedicated biological indicator receptacle mounted on the purge probe in the sterilizer. It monitors the efficacy of the 6-hour gas exposure at 50°C in the EOGas 4 Ethylene Oxide Gas Sterilizer.
Critical process parameters for the cycle are summarized in Table 1.
Table 1. Critical parameters for the 6-hour gas exposure 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% | 6 hours | 7 hours |
Technological Characteristics
Table 2 below compares the technological characteristics of the EOGas 4 Endo-SteriTest RRBI to the technological characteristics of the predicate device, EOGas 4 SteriTest (K151585).
6
| Element | EOGas 4 SteriTest
(K151585) | EOGas 4 Endo-SteriTest RRBI
(K202879) | Comparison |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Intended Use | Sterilization method: EO gas
Process parameters: EO
concentration, time, temperature,
and relative humidity | Sterilization method: EO gas
Process parameters: EO
concentration, time, temperature, and
relative humidity | Same |
| Organism | Bacillus atrophaeus (ATCC
9372) | Bacillus atrophaeus (ATCC 9372) | Same |
| Viable Spore
Population | $≥1.0 x 10^6$ | $≥1.0 x 10^6$ | Same |
| Device Design | EZTest-Gas BI (K930683)
Paper strip containing indicator
organism; Glass ampoule
containing growth medium;
Capped vial serving as a culture
tube; pH indicator in medium for
color change; Process indicator
indicating EO exposure. | Bionova BT110 RRBI (K191021)
Paper strip containing indicator
organism; Glass ampoule containing
growth medium; Capped vial serving
as a culture tube; pH indicator in
medium for color change; Process
indicator indicating EO exposure;
Fluorescent enzymatic activity
detection. | Similar |
| | BI receptacle:
Creates a greater challenge to the
sterilization process than the
worst-case location of the worst-
case load in the IFU statement;
For the 3-hour gas exposure
Purge probe:
Blue color | BI receptacle:
Creates a greater challenge to the
sterilization process than the worst-
case location of the worst-case load
in the IFU statement;
For the 6-hour gas exposure
Purge probe:
Gold color | Different |
| Materials of
Construction | Paper, glass, polypropylene, and
aluminum | Paper, glass, polypropylene, and
stainless steel | Different |
| Configuration
in Load | SCBI in a receptacle | SCBI in a receptacle | Same |
| Indications for
Use | The EOGas 4 SteriTest consists
of a self-contained biological
indicator inoculated with viable
Bacillus atrophaeus bacterial
spores that is placed in a
dedicated BI receptacle in the
sterilizer. It monitors the
efficacy of the 3-hour gas
exposure at 50°C in the EOGas 4
Ethylene Oxide Gas Sterilizer. | The EOGas 4 Endo-SteriTest RRBI
consists of a self-contained
biological indicator inoculated with
viable Bacillus atrophaeus bacterial
spores that is placed in a dedicated
biological indicator receptacle
mounted on the purge probe in the
sterilizer. It monitors the efficacy of
the 6-hour gas exposure at 50°C in
the EOGas 4 Ethylene Oxide Gas
Sterilizer. | Different |
Table 2. Device Comparison
7
Performance Testing
The EOGas 4 Endo-SteriTest RRBI has been validated using applicable tests in FDA 2007 "Guidance for Industry and FDA Staff: Biological Indicator (BI) Premarket Notification [510(k)] Submissions", and ANSI/AAMI/ISO 11138-1:2017 "Sterilization of health care products -Biological indicators - Part 1: General requirements" (FDA Recognition Number 14-502).
For the Bionova BT110 Rapid Readout Biological Indicators (K191021), tests included viable spore population assay, resistance characteristics study, carrier and primary packaging materials (growth inhibition) evaluation, holding time assessment, reduced incubation time validation, recovery protocols for recovery medium, visual readout stability, and in-field evaluation. The results of all studies met the established acceptance criteria.
The EOGas 4 Endo-SteriTest RRBI represents a rigorous challenge to the EOGas 4 sterilization process. Its resistance characteristics are greater than the same biological indicator placed in the worst-case location of the endoscope validation loads. The performance of the EOGas 4 Endo-SteriTest RRBI in the 6-hour gas exposure at 50°C in an EOGas 4 Ethylene Oxide Gas Sterilizer is summarized in Table 3.
Table 3. Summary of bench tests performed to demonstrate safety and effectiveness of the EOGas 4 Endo-SteriTest RRBI
| Test | Description | Result |
|---|---|---|
| Functionality | 1) Critical parameters include time, temperature, gas concentration, and | |
| relative humidity 35-90%; |
- Device is appropriate for monitoring the efficacy of the sterilization
process claimed | Pass |
| Shelf Life | Maintains performance specifications (resistance characteristics and
correctly indicate pass/fail in cycles) throughout the stated shelf life of 2
years:
Stability demonstrates reasonable assurance for effectiveness | Pass |
Conclusion:
In conclusion, the EOGas 4 Endo-SteriTest RRBI is substantially equivalent to the legally marketed predicate, the EOGas 4 SteriTest (K151585).