(222 days)
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.
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 sterilizer when operating in pouch plus and chamber mode.
Terragene® Bionova® BT96 Fluorescence Super Rapid Readout Biological Indicators are single-use 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® IC10/20FRLCD 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 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 single-use 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 is a 510(k) premarket notification for sterilization process indicators (biological and chemical). It describes the devices, their intended use, and comparison to existing predicate devices. However, the document does not contain the specific details about acceptance criteria, the study design, sample sizes, expert involvement, or adjudication methods that would be relevant for an AI/ML-based medical device where the AI algorithm's performance is being evaluated.
The document is about physical indicators and readers used to monitor sterilization processes, not an AI/ML device that analyzes data or images. Therefore, many of the questions asked in the prompt (e.g., sample size for test/training sets, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, effect size of human improvement with AI) are not applicable to the information contained in this 510(k) submission.
The "Performance Data" section (page 7 of the PDF) simply lists the standards that were used for non-clinical testing and states that the device "Pass"ed those tests. It does not provide the numerical results or the methodology for proving "Pass" beyond stating compliance with the standards.
Given the content, I can only provide information relevant to the type of device described:
Based on the provided document (K223023 for physical sterilization process indicators and readers):
1. A table of acceptance criteria and the reported device performance
The document does not detail specific quantitative acceptance criteria or reported device performance beyond stating compliance with established standards. The general "performance" is indicated by "Pass" for various tests as per the relevant ISO/ANSI/AAMI standards.
| Item | Test | Standard/Guidance Document | Acceptance Criteria (Implied by "Pass") | Reported Performance |
|---|---|---|---|---|
| Self-Contained Biological Indicator (BT96) | Viable spore population assay | ANSI/AAMI/ISO 11138-1:2017 | Must meet requirements for viable spore population (implied) | Pass |
| Resistance characteristics study | ANSI/AAMI/ISO 11138-1:2017 | Must meet requirements for D-value, survival time, and kill window (implied) | Pass | |
| Carrier and primary packaging materials evaluation | ANSI/AAMI/ISO 11138-1:2017 | Materials must be suitable and robust (implied) | Pass | |
| Holding time assessment | Guidance for Industry and FDA Staff - Biological Indicator (BI) Premarket Notification [510(k)] Submissions | Must maintain performance over shelf life (implied) | Pass | |
| Reduced incubation time validation test | Guidance for Industry and FDA Staff - Biological Indicator (BI) Premarket Notification [510(k)] Submissions | Rapid readout at 30 minutes must be validated (implied) | Pass | |
| Recovery protocols: Recovery medium test | ANSI/AAMI/ISO 11138-1:2017 | Recovery medium must be effective (implied) | Pass | |
| Visual readout stability: Visual inspection test | ANSI/AAMI/ISO 11138-1:2017 | Visual indicator must be stable (implied) | Pass | |
| Shelf life study | ANSI/AAMI/ISO 11138-1:2017 | Must maintain performance for claimed shelf life | 2 years (Passed) | |
| Resistance Validation for Biological Indicator | ISO 11138-1:2017 | BI must meet resistance requirements | Pass | |
| BI & Test Pack Validation | Guidance for Industry and FDA Staff - Biological Indicator (BI) Premarket Notification [510(k)] Submissions | BI and test pack performance must be validated | 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 | Must demonstrate appropriate color change under specified conditions (implied) | Pass |
| Biocompatibility | Guidance for Industry and FDA Staff - Premarket Notification [510(k)] Submissions for Chemical Indicators; ANSI/AAMI/ISO 11140-1:2014 | Must be biocompatible (implied) | Pass | |
| Endpoint stability | ANSI/AAMI/ISO 11140-1:2014 | Color change endpoint must be stable (implied) | Pass | |
| Shelf life study | Premarket Notification [510(k)] Submissions for Chemical Indicators | Must maintain performance for claimed shelf life | 5 years (Passed) | |
| Chemical Indicator Validation | ANSI/AAMI/ISO 11140-1:2014 | Chemical indicator performance must be validated | Pass |
2. Sample sizes used for the test set and the data provenance:
The document does not specify exact sample sizes for each test. The testing is based on compliance with international and FDA standards (e.g., ISO 11138-1, ISO 11140-1), which would define the types and minimum numbers of samples required for such tests. The provenance of the data is implied to be from testing conducted by or for Plasmapp Co., Ltd. (South Korea) to support regulatory submission. It is by nature prospective testing for regulatory clearance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This device does not involve expert interpretation of data or images to establish ground truth in the way an AI/ML device would. Ground truth for these sterilization indicators is established by physical/chemical measurements and biological assays (e.g., spore viability, color change under specific conditions) rather than expert consensus on complex diagnostic images.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. No expert adjudication is involved.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used:
The ground truth for these devices is based on established scientific principles of sterilization, microbiology, and chemistry, as defined by the referenced standards:
- For the Biological Indicator: Viable spore population counts, D-value determination (time required to reduce spore population by 90% at a given temperature), survival time, and kill window studies using standard microbiological methods.
- For Chemical Indicators: Specific color changes occurring when exposed to defined concentrations and durations of sterilant agents, tested under controlled conditions.
8. The sample size for the training set:
Not applicable. This is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established:
Not applicable.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.
May 9, 2023
Plasmapp Co.,Ltd. % Candace Cederman Consultant CardioMed Device Consultants, LLC 1783 Forest Drive Suite 254 Annapolis, Maryland 21401
Re: K223023
Trade/Device Name: Terragene Bionava 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: April 7, 2023 Received: April 10, 2023
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 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 -S
Clarence W. Murray, III, Ph.D. 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) K223023
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, Mimi-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 pouch plus mode and 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: | May 8, 2023 |
2. Device Name and Code
| Device Trade Name: | Terragene Bionova® SCBI (BT96); Terragene Bionova® Reader Incubators (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 single-use 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® IC10/20FRLCD 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 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 single-use 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 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.
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.
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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 sterilizer when operating in pouch plus and 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 pouch plus mode of the STERLINK™ FPS-15s Plus 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. | Same |
| 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 |
| 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 |
| Indications for Use | 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.Terragene Bionova® Reader Incubators(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® (CD42) is a chemicalprocess indicator intended for monitoring theefficacy of vaporized hydrogen peroxidesterilization processes. The chemical indicatorchanges from red to yellow for CD42 to indicatethat the conditions of the cycle have been met. | Same |
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| Subject Device | Predicate Device | Item | Test | Standard/Guidance Document | Result | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sponsor | Plasmapp Co., Ltd.Terragene Cintape® CT40 is a chemical processindicator tape intended for monitoring theefficacy of Vaporized Hydrogen Peroxidesterilization processes. The indicating tapechanges from purple to green when exposure tovaporized hydrogen peroxide. | Same | Self-ContainedBiologicalIndicator(BT96) | Viable spore population assay | ANSI/AAMI/ISO 11138-1:2017 | Pass | ||||||||
| Intended Use: Cycles | Vaporized Hydrogen PeroxideModels Cycle BT96, CD42,CT40 STERLINK™ FPS-15sPlus - Pouch plus modeSTERLINK™ FPS-15sPlus - Chamber mode | Vaporized Hydrogen PeroxideModels Cycle BT96, CD42,CT40 STERLINK™ FPS-15sPlus - Chamber mode | 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 | ||||||||||||
| Terragene Bionova® SCBI (BT96) | Visual readout stability: Visualinspection test | ANSI/AAMI/ISO 11138-1:2017 | Pass | |||||||||||
| Type of BiologicalIndicator | Self-Contained | Same | Shelf life study | ANSI/AAMI/ISO 11138-1:2017 | 2 years | |||||||||
| OrganismSporeSpeciesStrain | Geobacillus stearothermophilus ATCC 7953spores inoculated on a strip (spore carrier) | Same | Resistance Validation for BiologicalIndicator | ISO 11138-1:2017 | Pass | |||||||||
| Viable SporePopulation | ≥ 106 | Same | BI & Test Pack Validation | Guidance for Industry and FDA Staff -Biological Indicator (BI) PremarketNotification [510(k)] Submissions | Pass | |||||||||
| Resistancecharacteristics | D -valueSurvival time/Kill window | Same | ChemicalIndicator(CD42,CT40) | Performance characteristics obtainedfrom resistometer | Guidance for Industry and FDA Staff -Premarket Notification [510(k)] Submissionsfor Chemical IndicatorsANSI/AAMI/ISO 11140-1:2014 | Pass | ||||||||
| Intended SterilizationCycles | STERLINK™ FPS-15s Plus – Pouch plus mode(overall cycle: 14 minutes)STERLINK™ FPS-15s Plus - Chamber mode(overall cycle: 36 minutes) | STERLINK™ FPS-15s Plus - Chambermode (overall cycle: 36 minutes) | Biocompatibility | Guidance for Industry and FDA Staff -Premarket Notification [510(k)] Submissionsfor Chemical IndicatorsANSI/AAMI/ISO 11140-1:2014 | Pass | |||||||||
| Shelf Life | 2 years | Same | Endpoint stability | ANSI/AAMI/ISO 11140-1:2014 | Pass | |||||||||
| Terragene Chemdye® (CD42), Terragene Chemdye® (CT40) | Shelf life study | Premarket Notification [510(k)] Submissionsfor Chemical Indicators | 5 years | |||||||||||
| Intended SterilizationCycles | STERLINK™ FPS-15s Plus – Pouch plus mode(overall cycle: 14 minutes)STERLINK™ FPS-15s Plus - Chamber mode(overall cycle: 36 minutes) | STERLINK™ FPS-15s Plus - Chambermode (overall cycle: 36 minutes) | Chemical Indicator Validation | ANSI/AAMI/ISO 11140-1:2014 | Pass | |||||||||
| 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 foruse with the pouch plus and chamber mode of STERLINK™ FPS-15s Plus sterilizer. |
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6. Performance Data
Non-clinical tests were performed using following standards:
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 K212193.
§ 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).