(100 days)
Terragene Bionova® SCBI (BT96) is a self-contained biological indicator inoculated with viable 10% Geobacillus stearothermophilus bacterial spores and is intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes. BT96 has Super Rapid readout at 30 minutes at 60°C.
Terragene Bionova® Reader Incubators (IC10/20FRLCD, Mini-Bio) incubate at 60°C and 37°C and read the Terragene Bionova® SCBI for fluorescent results at the times prescribed in the User Manuals.
Terragene Chemdye® (CD42) is a chemical process indicator intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes. The chemical indicator changes from red to yellow for CD42 to indicate that the conditions of the cycle have been met.
Terragene Cintape® CT40 is a chemical process indicator tape intended for monitoring the efficacy of Vaporized Hydrogen Peroxide sterilization processes. The indicating tape changes from purple to green when exposure to vaporized hydrogen peroxide.
The self-contained biological indicator and chemical processing indicators are intended for use with the STERLINK™ FPS-15s Plus when operating in chamber mode.
Terragene® Bionova® BT96 Fluorescence Super Rapid Readout Biological Indicators are singleuse Self-Contained Biological Indicators (SCBIs) that consist of a polypropylene tube, a spore carrier, and a glass ampoule with a culture medium, enclosed with a colored cap. Each tube contains a population of Geobacillus stearothermophilus ATCC 7953 spores inoculated on a spore carrier, a plastic cap with holes and a barrier permeable to Plasma or Vaporized Hydrogen Peroxide. Each BT96 has a Process Indicator on label that changes from purple to green when exposed to hydrogen peroxide. The Bionova® BT96 Biological Indicators have been designed for monitoring of Vaporized Hydrogen Peroxide sterilization processes when used in conjunction with Bionova® IC10/20FR, IC10/20FRLCD or MiniBio Auto-Readers Incubators.
Chemdye® CD42 Process Indicators (Type 1 according to ISO 11140-1:2014 standard) are singleuse chemical indicators that consist of plastic strips printed with indicator ink. These indicators have been designed to monitor Plasma or Vaporized Hydrogen Peroxide sterilization processes within loads, ensuring an adequate exposure to the sterilizing agent during the sterilization process and allowing to distinguish between processed and unprocessed items.
Cintape® CT40 Process Indicators (Type 1 according to ISO 11140-1:2014 standard) are singleuse chemical indicators that consist of a roll of self-adhesive plastic tape printed with indicator ink. These indicators have been designed to monitor Plasma or Vaporized Hydrogen Peroxide sterilization processes, ensuring an adequate exposure to the sterilizing agent during the sterilization process and allowing to distinguish between processed and unprocessed items. The adhesive component of the tape allows the adhesion to different types of packaging and wraps, such as cloth, paper and plastic.
The provided text describes a 510(k) premarket notification for sterilization process indicators (biological and chemical) for use with a specific sterilizer. The study is a non-clinical performance test, and as such, several of the requested sections regarding AI/human reader performance, ground truth establishment, and training sets are not applicable.
Here's an analysis of the acceptance criteria and study as presented:
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for each test are implicitly defined by the "Pass" result, meaning the device met the requirements of the referenced standard or guidance document. The actual quantitative thresholds for "Pass" are not detailed in this summary but would be specified within the referenced standards (e.g., ANSI/AAMI/ISO 11138-1:2017).
| Test Performed | Referenced Standard/Guidance | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|---|
| Self-Contained Biological Indicator (BT96) | |||
| Viable spore population assay | ANSI/AAMI/ISO 11138-1:2017 | Met the requirements of the standard | Pass |
| Resistance characteristics study | ANSI/AAMI/ISO 11138-1:2017 | Met the requirements of the standard | Pass |
| Carrier and primary packaging materials evaluation | ANSI/AAMI/ISO 11138-1:2017 | Met the requirements of the standard | Pass |
| Holding time assessment | Guidance for Industry and FDA Staff - Biological Indicator (BI) Premarket Notification [510(k)] Submissions | Met the requirements of the guidance | Pass |
| Reduced incubation time validation test | Guidance for Industry and FDA Staff - Biological Indicator (BI) Premarket Notification [510(k)] Submissions | Met the requirements of the guidance | Pass |
| Recovery protocols: Recovery medium test | ANSI/AAMI/ISO 11138-1:2017 | Met the requirements of the standard | Pass |
| Visual readout stability: Visual inspection test | ANSI/AAMI/ISO 11138-1:2017 | Met the requirements of the standard | Pass |
| Shelf life study | ANSI/AAMI/ISO 11138-1:2017 | Met the requirements of the standard (Demonstrated 2 years) | 2 years |
| Resistance Validation for Biological Indicator | ISO 11138-1:2017 | Met the requirements of the standard | Pass |
| BI & Test Pack Validation | Guidance for Industry and FDA Staff - Biological Indicator (BI) Premarket Notification [510(k)] Submissions | Met the requirements of the guidance | Pass |
| Chemical Indicator (CD42, CT40) | |||
| Performance characteristics obtained from resistometer | Guidance for Industry and FDA Staff - Premarket Notification [510(k)] Submissions for Chemical Indicators / ANSI/AAMI/ISO 11140-1:2014 | Met the requirements of the guidance/standard | Pass |
| Biocompatibility | Guidance for Industry and FDA Staff - Premarket Notification [510(k)] Submissions for Chemical Indicators / ANSI/AAMI/ISO 11140-1:2014 | Met the requirements of the guidance/standard | Pass |
| Endpoint stability | ANSI/AAMI/ISO 11140-1:2014 | Met the requirements of the standard | Pass |
| Shelf life study | Premarket Notification [510(k)] Submissions for Chemical Indicators | Met the requirements of the guidance (Demonstrated 5 years) | 5 years |
| Chemical Indicator Validation | ANSI/AAMI/ISO 11140-1:2014 | Met the requirements of the standard | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each specific test. However, the tests are non-clinical, laboratory-based studies rather than human subject trials. The data provenance would be the laboratory where these tests were conducted, likely in South Korea (Plasmapp Co., Ltd. is based there, and Terragene® S.A. is the manufacturer). These studies are inherently prospective in nature as they involve testing the devices against established standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. This is a non-clinical performance study of sterilization indicators, not a study evaluating human interpretation of medical images or diagnoses. The "ground truth" for these tests is defined by the physical or chemical standards and performance requirements outlined in the referenced ANSI/AAMI/ISO standards and FDA guidance documents.
4. Adjudication Method for the Test Set
Not applicable. There is no human interpretation or subjective assessment that would require an adjudication method in this type of non-clinical performance testing. The tests yield objective, quantitative or qualitative results (e.g., spore kill, color change, D-value measurements) that are then compared against predefined criteria in the standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC study was not done. This is a non-clinical performance study of sterilization process indicators, not a diagnostic device that would involve human readers interpreting results.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This concept is not directly applicable. The device itself (the biological and chemical indicators) is not an "algorithm" in the typical sense of AI. The performance tests evaluate the physical and chemical characteristics of the indicators in a standalone manner against the specified standards, without human intervention in the measurement of their performance (though human technicians certainly perform the tests).
7. The Type of Ground Truth Used
The ground truth used for these performance studies is based on established industry standards and regulatory guidance documents. Specifically:
- ANSI/AAMI/ISO 11138-1:2017: Sterilization of Health Care Products - Biological Indicators - Part 1: General Requirements.
- ANSI/AAMI/ISO 11140-1:2014: Sterilization of Health Care Products - Chemical Indicators - Part 1: General Requirements.
- FDA Guidance for Industry and FDA Staff - Biological Indicator (BI) Premarket Notification [510(k)] Submissions.
- FDA Guidance for Industry and FDA Staff - Premarket Notification [510(k)] Submissions for Chemical Indicators.
These standards define the expected performance characteristics (e.g., spore population, resistance, color change properties, stability) that the devices must meet.
8. The Sample Size for the Training Set
Not applicable. This is a non-clinical performance study of physical devices, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. As this is not an AI model, there is no training set and therefore no ground truth established for one. The "ground truth" for the device's acceptable performance is defined by the rigorous specifications and testing protocols within the aforementioned international standards and FDA guidance documents.
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October 22, 2021
Plasmapp Co., Ltd. % Candace Cederman Consultant CardioMed Device Consultants LLC 1783 Forest Drive. Suite 254 Annapolis, Maryland 21401
Re: K212193
Trade/Device Name: Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40) Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC, JOJ Dated: September 20, 2021 Received: September 21, 2021
Dear Candace Cederman:
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.
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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) 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 (QS) 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 medical devices and radiation-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, PhD 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
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Indications for Use
510(k) Number (if known) K212193
Device Name
Terragene Bionova® SCBI (BT96), Terragene Bionova® Reader Incubators (IC10/20FRLCD, Mini-Bio), Terragene Chemdye® (CD42), Terragene Cintape® (CT40)
Indications for Use (Describe)
Terragene Bionova® SCBI (BT96) is a self-contained biological indicator inoculated with viable 10% Geobacillus stearothermophilus bacterial spores and is intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes. BT96 has Super Rapid readout at 30 minutes at 60°C.
Terragene Bionova® Reader Incubators (IC10/20FRLCD, Mini-Bio) incubate at 60°C and 37°C and read the Terragene Bionova® SCBI for fluorescent results at the times prescribed in the User Manuals.
Terragene Chemdye® (CD42) is a chemical process indicator intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes. The chemical indicator changes from red to yellow for CD42 to indicate that the conditions of the cycle have been met.
Terragene Cintape® CT40 is a chemical process indicator tape intended for monitoring the efficacy of Vaporized Hydrogen Peroxide sterilization processes. The indicating tape changes from purple to green when exposure to vaporized hydrogen peroxide.
The self-contained biological indicator and chemical processing indicators are intended for use with the STERLINK™ FPS-15s Plus when operating in chamber mode.
| 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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1. General Information
| Applicant/Submitter: | Plasmapp Co., Ltd.BVC-111, 125, Gwahak-ro,Yuseong-gu, Daejeon, 34141,Rep. of Korea (South Korea)Tel: +82 (0)42 716 2115 |
|---|---|
| Contact Person: | Candace Cederman |
| Address: | CardioMed Device Consultants LLC3168 Braverton StreetSuite 200Edgewater, MD 21037Tel: +1 410 674 2060 |
| Preparation Date: | October 7, 2021 |
2. Device Name and Code
| Device Trade Name: | Terragene Bionova® SCBI (BT96); Terragene Bionova® ReaderIncubators (IC10/20FRLCD, Mini-Bio); Terragene Chemdye®(CD42); Terragene Cintape® (CT40) |
|---|---|
| Common Name: | Self-Contained Biological Indicator, Self-Contained BiologicalIndicator Incubator, Chemical Indicator |
| Classification Name: | Sterilization Process Indicator |
| Product Code: | FRC, JOJ |
| Regulation Number: | 21 CFR 880.2800 |
| Classification: | Class II |
| Review Panel: | General Hospital |
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3. Device Description
Terragene® Bionova® BT96 Fluorescence Super Rapid Readout Biological Indicators are singleuse Self-Contained Biological Indicators (SCBIs) that consist of a polypropylene tube, a spore carrier, and a glass ampoule with a culture medium, enclosed with a colored cap. Each tube contains a population of Geobacillus stearothermophilus ATCC 7953 spores inoculated on a spore carrier, a plastic cap with holes and a barrier permeable to Plasma or Vaporized Hydrogen Peroxide. Each BT96 has a Process Indicator on label that changes from purple to green when exposed to hydrogen peroxide. The Bionova® BT96 Biological Indicators have been designed for monitoring of Vaporized Hydrogen Peroxide sterilization processes when used in conjunction with Bionova® IC10/20FR, IC10/20FRLCD or MiniBio Auto-Readers Incubators.
Chemdye® CD42 Process Indicators (Type 1 according to ISO 11140-1:2014 standard) are singleuse chemical indicators that consist of plastic strips printed with indicator ink. These indicators have been designed to monitor Plasma or Vaporized Hydrogen Peroxide sterilization processes within loads, ensuring an adequate exposure to the sterilizing agent during the sterilization process and allowing to distinguish between processed and unprocessed items.
Cintape® CT40 Process Indicators (Type 1 according to ISO 11140-1:2014 standard) are singleuse chemical indicators that consist of a roll of self-adhesive plastic tape printed with indicator ink. These indicators have been designed to monitor Plasma or Vaporized Hydrogen Peroxide sterilization processes, ensuring an adequate exposure to the sterilizing agent during the sterilization process and allowing to distinguish between processed and unprocessed items. The adhesive component of the tape allows the adhesion to different types of packaging and wraps, such as cloth, paper and plastic.
4. Indications for Use / Intended Use
The revised indications for use are as follows:
Terragene Bionova® SCBI (BT96) is a self-contained biological indicator inoculated with viable 106 Geobacillus stearothermophilus bacterial spores and is intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes. BT96 has Super Rapid readout at 30 minutes at 60°C.
Terragene Bionova® Reader Incubators (IC10/20FRLCD, Mini-Bio) incubate at 60°C and 37°C and read the Terragene Bionova® SCBI for fluorescent results at the times prescribed in the User Manuals.
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Terragene Chemdye® (CD42) is a chemical process indicator intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes. The chemical indicator changes from red to yellow to indicate that the conditions of the cycle have been met.
Terragene Cintape® CT40 is a chemical process indicator tape intended for monitoring the efficacy of Vaporized Hydrogen Peroxide sterilization processes. The indicating tape changes from purple to green when exposure to vaporized hydrogen peroxide.
The self-contained biological indicator and chemical processing indicators are intended for use with the STERLINK™ FPS-15s Plus when operating in chamber mode.
5. Technical Characteristics in Comparison to Predicate Devices
The subject device uses identical technology as the cited predicate devices and has the same intended uses. Based upon the overall performance characteristics for the sterilization process indicators used with the STERLINK" sterilizer, Plasmapp Co., Ltd. believes that there are no significant differences in usage for the underlying technological principles between the subject devices and predicate devices.
| Subject Device | Predicate Device | |
|---|---|---|
| Sponsor | Plasmapp Co., Ltd. | Terragene® S.A. |
| Device Name | Terragene Bionova® SCBI (BT96);Terragene Bionova® Reader Incubators(IC10/20FRLCD, Mini-Bio);Terragene Chemdye® (CD42);Terragene Cintape® (CT40) | Same |
| 510(k) Number | K212193 | K191021 |
| Manufacturer | Terragene® S.A. | Same |
| Device ClassificationName | Sterilization Process Indicator | Same |
| Classification ProductCode | FRC (biological indicators)JOJ (chemical indicators) | Same |
| Regulation Number | 21 CFR 880.2800 | Same |
| Subject Device | Predicate Device | |
| Sponsor | Plasmapp Co., Ltd. | Terragene® S.A. |
| Indications for Use | Terragene Bionova® SCBI (BT96) is a self-contained biological indicator inoculatedwith viable 106 Geobacillusstearothermophilus bacterial spores and isintended for monitoring the efficacy ofvaporized hydrogen peroxide sterilizationprocesses. BT96 has Super Rapid readout at30 minutes at 60°C.Terragene Bionova® Reader Incubators(IC10/20FRLCD, Mini-Bio) incubate at60°C and 37°C and read the TerrageneBionova® SCBI for fluorescent results at thetimes prescribed in the User Manuals.Terragene Chemdye® (CD42) is a chemicalprocess indicator intended for monitoringthe efficacy of vaporized hydrogen peroxidesterilization processes. The chemicalindicator changes from red to yellow forCD42 to indicate that the conditions of thecycle have been met.Terragene Cintape® CT40 is a chemicalprocess indicator tape intended for monitoring | Excerpted from K191021:Terragene Bionova® SCBI (BT96) is a self-contained biological indicator inoculated withviable 106 Geobacillus stearothermophilusbacterial spores and is intended for monitoringthe efficacy of vaporized hydrogen peroxidesterilization processes. BT96 has Super Rapidreadout at 30 minutes at 60°C.TerrageneBionova® ReaderIncubators(IC10/20FRLCD, Mini-Bio) incubate at 60°Cand 37°C and read the Terragene Bionova®SCBI for fluorescent results at the timesprescribed in the User Manuals.Terragene Chemdye® (CD40, CD42) is achemical process indicator intended formonitoring the efficacy of vaporized hydrogenperoxide sterilization processes. The chemicalindicator changes from purple to green forCD40 and red to yellow for CD42 to indicatethat the conditions of the cycle have been met.Terragene Cintape® CT40 is a chemicalprocess indicator tape intended for monitoringthe efficacy of Vaporized Hydrogen Peroxidesterilization processes. The indicating tapechanges from purple to green when exposureto vaporized hydrogen peroxide. |
| Intended Use: CyclesTerragene Bionova® SCBI (BT96) | Vaporized Hydrogen PeroxideModelsCycleBT96, CD42,STERLINK™ FPS-15sCT40Plus - Chamber mode | Vaporized Hydrogen PeroxideModelsCyclesBT96, CD42,STERRAD 100S (54CT40minutes)STERRAD Standard andExpress CyclesV-Pro Max and SterizoneVP4 |
| Type of BiologicalIndicator | Self-Contained | Same |
| Organism Spore,Species, Strain | Geobacillus stearothermophilus ATCC 7953spores inoculated on a strip (spore carrier) | Same |
| Viable SporePopulation | ≥ 106 | Same |
| Resistancecharacteristics | D-valueSurvival time/Kill window | Same |
| Subject Device | Predicate Device | |
| Sponsor | Plasmapp Co., Ltd. | Terragene® S.A. |
| Intended SterilizationCycles | STERLINK™ FPS-15s Plus - Chamber mode(overall cycle: 36 minutes) | STERRAD® 100S (54-minute Short cycle, 72-minute Long cycle), STERRAD® 100NX(Standard Cycle - 47 minutes, Express Cycle- 24 minutes), V-Pro® maX (Non Lumen Cycle- 28 minutes, Flexible Cycle - 35 minutes,Lumen Cycle - 55 minutes), Sterizone® VP4(Cycle 1) |
| Shelf Life | 2 years | Same |
| Terragene Chemdye® (CD42), Terragene Chemdye® (CT40) | ||
| Intended SterilizationCycles | STERLINK™ FPS-15s Plus - Chamber mode(overall cycle: 36 minutes) | STERRAD® 100S sterilization cycles:• 54-minute Short cycle for most surgicalinstruments• 72-minute Long cycle for flexibleendoscopes and instruments with longerlumenSTERRAD® 100NX® sterilization cycles:• 24-minute express cycle for fast turnaroundendoscopes and many other instruments• 47-minute standard cycle for most surgicalinstrumentsAMSCO® V-PRO maX cycles:• 28-minute non-lumen cycle for mostsurgical instruments• 35-minute flexible cycle for single or dualchannel flexible endoscopes and any non-lumen devices• 55-minute lumen cycle for stainless steellumen instruments with a single, dual ortriple channel.Sterizone VP4 cycle. |
| Device design | Strip, Tape | Same |
| Color Change uponExposure to H2O2 | CD42: red to yellowCT40: purple to green | Same |
| Recommended StorageConditions | Dry place, away from sunlight, at temperaturebetween 10-30°C, 30-80% relative humidity.Do not wet. Do not store close to sterilizingagents. | Same |
| Shelf Life | 5 years | Same |
| The subject and predicate devices are identical with respect to the organism, accessories, spore population, resistancecharacteristics, culture conditions, carrier materials, packaging, storage conditions and claimed shelf life. The onlydifference between the subject and predicate devices are the proposed indications for use, to label the indicators for usewith the STERLINK™ FPS-15s Plus when operating in chamber mode. |
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510(k) Summary - K212193
6. Performance Data
Non-clinical tests were performed using following standards:
| Item | Test | Standard/Guidance Document | Result |
|---|---|---|---|
| Self-ContainedBiologicalIndicator(BT96) | Viable spore population assay | ANSI/AAMI/ISO 11138-1:2017 | Pass |
| Resistance characteristics study | ANSI/AAMI/ISO 11138-1:2017 | Pass | |
| Carrier and primary packagingmaterials evaluation | ANSI/AAMI/ISO 11138-1:2017 | Pass | |
| Holding time assessment | Guidance for Industry and FDA Staff -Biological Indicator (BI) PremarketNotification [510(k)] Submissions | Pass | |
| Reduced incubation time validationtest | Guidance for Industry and FDA Staff -Biological Indicator (BI) PremarketNotification [510(k)] Submissions | Pass | |
| Recovery protocols: Recoverymedium test | ANSI/AAMI/ISO 11138-1:2017 | Pass | |
| Visual readout stability: Visualinspection test | ANSI/AAMI/ISO 11138-1:2017 | Pass | |
| Shelf life study | ANSI/AAMI/ISO 11138-1:2017 | 2 years | |
| Resistance Validation for BiologicalIndicator | ISO 11138-1:2017 | Pass | |
| BI & Test Pack Validation | Guidance for Industry and FDA Staff-Biological Indicator (BI) PremarketNotification [510(k)] Submissions | Pass | |
| ChemicalIndicator(CD42,CT40) | Performance characteristics obtainedfrom resistometer | Guidance for Industry and FDA Staff -Premarket Notification [510(k)]Submissions for Chemical IndicatorsANSI/AAMI/ISO 11140-1:2014 | Pass |
| Biocompatibility | Guidance for Industry and FDA Staff -Premarket Notification [510(k)]Submissions for Chemical IndicatorsANSI/AAMI/ISO 11140-1:2014 | Pass | |
| Endpoint stability | ANSI/AAMI/ISO 11140-1:2014 | Pass | |
| Shelf life study | Premarket Notification [510(k)]Submissions for Chemical Indicators | 5 years | |
| Chemical Indicator Validation | ANSI/AAMI/ISO 11140-1:2014 | Pass |
7. Conclusions
The conclusions drawn from the non-clinical tests demonstrates that the device in 510(k) submission K212193, Terragene Bionova® SCBI (BT96); Terragene Bionova® Reader Incubators (IC10/20FRLCD, Mini-Bio); Terragene Chemdye® (CD42); Terragene Cintape® (CT40) are as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K191021.
§ 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).