Terragene Bionava SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)

K223023 · Plasmapp Co,., Ltd. · FRC · May 9, 2023 · General Hospital

Device Facts

• Record ID: K223023
• Device Name: Terragene Bionava SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)
• Applicant: Plasmapp Co,., Ltd.
• Product Code: FRC · General Hospital
• Decision Date: May 9, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

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.

Device Story

System includes self-contained biological indicator (SCBI), reader incubators, and chemical process indicators (strips and tape). SCBI (BT96) contains Geobacillus stearothermophilus spores; used to monitor vaporized hydrogen peroxide sterilization efficacy. Reader incubators (IC10/20FRLCD, Mini-Bio) provide fluorescent readout of SCBI at 60°C. Chemical indicators (CD42, CT40) provide visual color change (red-to-yellow or purple-to-green) to confirm exposure to sterilizing agent. Used in clinical settings to verify sterilization cycle completion. Healthcare providers use visual/fluorescent output to confirm sterilization efficacy; ensures processed items are safe for use.

Clinical Evidence

Bench testing only. Performance validated per ANSI/AAMI/ISO 11138-1:2017 (biological indicators) and ANSI/AAMI/ISO 11140-1:2014 (chemical indicators). Testing included viable spore population assay, resistance characteristics (D-value, survival/kill window), reduced incubation time validation, shelf-life studies, and biocompatibility. All tests passed.

Technological Characteristics

SCBI: Polypropylene tube, spore carrier, glass ampoule with culture medium. Chemical indicators: Plastic strips/tape with indicator ink. Sensing: Fluorescence (biological), colorimetric (chemical). Energy: 60°C/37°C incubation. Standards: ANSI/AAMI/ISO 11138-1:2017, ANSI/AAMI/ISO 11140-1:2014. Shelf life: 2 years (SCBI), 5 years (chemical indicators).

Indications for Use

Indicated for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes in the STERLINK™ FPS-15s Plus sterilizer (pouch plus and chamber modes).

Regulatory Classification

Identification

Biological sterilization process indicator: 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. Physical/chemical sterilization process indicator: 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.

Predicate Devices

• Terragene Bionova® SCBI (BT96); Terragene Bionova® Reader Incubators (IC10/20FRLCD, Mini-Bio); Terragene Chemdye® (CD42); Terragene Cintape® (CT40) (K212193)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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.<br>BVC-111, 125, Gwahak-ro,<br>Yuseong-gu, Daejeon, 34141,<br>Rep. of Korea (South Korea)<br>Tel: [phone] |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Candace Cederman |
| Address: | CardioMed Device Consultants LLC<br>3168 Braverton Street<br>Suite 200<br>Edgewater, MD 21037<br>Tel: [phone] |
| 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 Biological<br>Indicator 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);<br>Terragene Bionova® Reader Incubators<br>(IC10/20FRLCD, Mini-Bio);<br>Terragene Chemdye® (CD42);<br>Terragene Cintape® (CT40) | Same |
| 510(k) Number | - | K212193 |
| Manufacturer | Terragene® S. A. | Same |
| Device Classification<br>Name | Sterilization Process Indicator | Same |
| Classification Product<br>Code | FRC (biological indicators)<br>JOJ (chemical indicators) | Same |
| Regulation Number | 21 CFR 880.2800 | Same |
| Indications for Use | Terragene Bionova® SCBI (BT96) is a self-<br>contained biological indicator inoculated with<br>viable 106 Geobacillus stearothermophilus<br>bacterial spores and is intended for monitoring<br>the efficacy of vaporized hydrogen peroxide<br>sterilization processes. BT96 has Super Rapid<br>readout at 30 minutes at 60°C.<br><br>Terragene Bionova® Reader Incubators<br>(IC10/20FRLCD, Mini-Bio) incubate at 60°C<br>and 37°C and read the Terragene Bionova®<br>SCBI for fluorescent results at the times<br>prescribed in the User Manuals.<br><br>Terragene Chemdye® (CD42) is a chemical<br>process indicator intended for monitoring the<br>efficacy of vaporized hydrogen peroxide<br>sterilization processes. The chemical indicator<br>changes from red to yellow for CD42 to indicate<br>that 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.<br>Terragene Cintape® CT40 is a chemical process<br>indicator tape intended for monitoring the<br>efficacy of Vaporized Hydrogen Peroxide<br>sterilization processes. The indicating tape<br>changes from purple to green when exposure to<br>vaporized hydrogen peroxide. | Same | Self-<br>Contained<br>Biological<br>Indicator<br>(BT96) | Viable spore population assay | ANSI/AAMI/ISO 11138-1:2017 | Pass | | | | | | | | |
| Intended Use: Cycles | Vaporized Hydrogen Peroxide<br>Models Cycle BT96, CD42,<br>CT40 STERLINK™ FPS-15s<br>Plus - Pouch plus mode<br>STERLINK™ FPS-15s<br>Plus - Chamber mode | | | | | | Vaporized Hydrogen Peroxide<br>Models Cycle BT96, CD42,<br>CT40 STERLINK™ FPS-15s<br>Plus - Chamber mode | | | | | Resistance characteristics study | ANSI/AAMI/ISO 11138-1:2017 | Pass |
| Carrier and primary packaging<br>materials evaluation | ANSI/AAMI/ISO 11138-1:2017 | Pass | | | | | | | | | | | | |
| Holding time assessment | Guidance for Industry and FDA Staff -<br>Biological Indicator (BI) Premarket<br>Notification [510(k)] Submissions | Pass | | | | | | | | | | | | |
| Reduced incubation time validation<br>test | Guidance for Industry and FDA Staff -<br>Biological Indicator (BI) Premarket<br>Notification [510(k)] Submissions | Pass | | | | | | | | | | | | |
| | Recovery protocols: Recovery<br>medium test | ANSI/AAMI/ISO 11138-1:2017 | Pass | | | | | | | | | | | |
| Terragene Bionova® SCBI (BT96) | | | | Visual readout stability: Visual<br>inspection test | ANSI/AAMI/ISO 11138-1:2017 | Pass | | | | | | | | |
| Type of Biological<br>Indicator | Self-Contained | Same | | Shelf life study | ANSI/AAMI/ISO 11138-1:2017 | 2 years | | | | | | | | |
| Organism<br>Spore<br>Species<br>Strain | Geobacillus stearothermophilus ATCC 7953<br>spores inoculated on a strip (spore carrier) | Same | | Resistance Validation for Biological<br>Indicator | ISO 11138-1:2017 | Pass | | | | | | | | |
| Viable Spore<br>Population | ≥ 106 | Same | | BI & Test Pack Validation | Guidance for Industry and FDA Staff -<br>Biological Indicator (BI) Premarket<br>Notification [510(k)] Submissions | Pass | | | | | | | | |
| Resistance<br>characteristics | <i>D</i> -value<br>Survival time/Kill window | Same | Chemical<br>Indicator<br>(CD42,<br>CT40) | Performance characteristics obtained<br>from resistometer | Guidance for Industry and FDA Staff -<br>Premarket Notification [510(k)] Submissions<br>for Chemical Indicators<br>ANSI/AAMI/ISO 11140-1:2014 | Pass | | | | | | | | |
| Intended Sterilization<br>Cycles | STERLINK™ FPS-15s Plus – Pouch plus mode<br>(overall cycle: 14 minutes)<br>STERLINK™ FPS-15s Plus - Chamber mode<br>(overall cycle: 36 minutes) | STERLINK™ FPS-15s Plus - Chamber<br>mode (overall cycle: 36 minutes) | | Biocompatibility | Guidance for Industry and FDA Staff -<br>Premarket Notification [510(k)] Submissions<br>for Chemical Indicators<br>ANSI/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)] Submissions<br>for Chemical Indicators | 5 years | | | | | | | | |
| Intended Sterilization<br>Cycles | STERLINK™ FPS-15s Plus – Pouch plus mode<br>(overall cycle: 14 minutes)<br>STERLINK™ FPS-15s Plus - Chamber mode<br>(overall cycle: 36 minutes) | STERLINK™ FPS-15s Plus - Chamber<br>mode (overall cycle: 36 minutes) | | Chemical Indicator Validation | ANSI/AAMI/ISO 11140-1:2014 | Pass | | | | | | | | |
| Device design | Strip, Tape | Same | | | | | | | | | | | | |
| Color Change upon<br>Exposure to H2O2 | CD42: red to yellow<br>CT40: purple to green | Same | | | | | | | | | | | | |
| Recommended Storage<br>Conditions | Dry place, away from sunlight, at temperature<br>between 10-30°C, 30-80% relative humidity.<br>Do not wet. Do not store close to sterilizing<br>agents. | Same | | | | | | | | | | | | |
| Shelf Life | 5 years | Same | | | | | | | | | | | | |
| The subject and predicate devices are identical with respect to the organism, accessories, spore population, resistance<br>characteristics, culture conditions, carrier materials, packaging, storage conditions and claimed shelf life. The only<br>difference between the subject and predicate devices are the proposed indications for use, to label the indicators for<br>use 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.