Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene Chemdye

K191021 · Terragene S.A. · FRC · Sep 13, 2019 · General Hospital

Device Facts

• Record ID: K191021
• Device Name: Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene Chemdye
• Applicant: Terragene S.A.
• Product Code: FRC · General Hospital
• Decision Date: Sep 13, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

Terragene Bionova® SCBI (BT224) is a self-contained biological indicator inoculated with viable 10 Geobacillus stearothermophilus bacterial spores and is intended for monitoring the efficacy of steam sterilization processes. On each Terragene Bionova® SCBI is a chemical process indicator that changes color from pink to brown when exposed to steam. Terragene Bionova® PCD (PCD224-C, PCD224-2) and Integron® PCD (PCD26-C, PCD26-2) provides a defined challenge resistance against the claimed cycles shown below and demonstrated resistance equivalence to the AAMI/ANSI 16 towel pack. The device provides routine monitoring and sterilizer qualification processes. Terragene Bionova® Reader Incubators (10/20FRLCD, 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 Bionova® SCBI (BT110) is a self-contained biological indicator inoculated with viable 106 Bacillus atrophaeus bacterial spores and is intended for monitoring the efficacy of ethylene oxide sterilization processes. The integrator Terragene Integron® IT12 is designed to chemically react over time with the critical parameters of ethylene oxide sterilization cycle within a specified tolerance. The integrating indicator strip is intended to be placed in each pack, pouch, container, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles: 55°C for 240 minutes, 600 mg/l, RH 60 %, SV37°C/75 min., SV54°C/30 min, SV55°C/28 min. Terragene Chemdye® CD16 is a chemical process indicator intended for monitoring the efficacy of ethylene oxide sterilization processes. The chemical indicator changes from purple/brown to green to indicate that the conditions of the cycle have been met. Terragene Bionova® SCBI (BT95, 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. BT95 is Rapid Readout while BT96 is Super Rapid Readout. BT95 has Ranid readout at 2 hours at 60° C while BT96 has Super Rapid readout at 30 minutes at 60° C. Terragene Chemdye® (CD40, CD42) is a chemical process indicator intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes. The chemical indicator changes from purple to green for CD40 and red to vellow for CD42 to indicate that the conditions of the cycle have been met. The integrator Terragene Integron® TT26-1YS is designed to chemically react over time with the critical parameters of steam sterilization cycle within a specified tolerance. The integrating indicator strip is intended to be placed in each pack, pouch, container, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles: Gravity Displacement: 121° C for 30 minutes, 132° C for 25 minutes, 135° C for 10 minutes; Dynamic Air Removal (Vacuum Assist): 132° C for 3 minutes. SV121° C/16.5 min., SV132° C/2.0 min, SV135° C/1.2 min. The integrator Terragene Integron® IT26-C is designed to chemically react over time with the critical parameters of steam sterilization cycle within a specified tolerance. The integrating indicator strip is intended to be placed in each pack, pouch, container, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles: Gravity Displacement: 121°C for 30 minutes, 132°C for 15 minutes, 135°C for 25 minutes, 135°C for 10 minutes; Dynamic Air Removal (Vacuum Assist): 132° C for 4 minutes, 135° C for 3 minutes. SV121° C/16.5 min., SV132° C/2.0 min, SV135° C/1.2 min.. Terragene Chemdye® CD29 is a chemical process indicator intended for monitoring the effication processes. The chemical indicator changes from yellow to dark brown/black to indicate that the conditions of the cycle have been met. Terragene Cintape® CT22 is a chemical process indicator tape intended for monitoring the efficacy of steam sterilization processes. The indicating tape changes from yellow to dark brown/black when exposure to steam. 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.

Device Story

System includes self-contained biological indicators (SCBI), chemical process indicators, chemical integrators, and reader incubators. SCBIs contain bacterial spores (Geobacillus stearothermophilus or Bacillus atrophaeus); reader incubators monitor fluorescence to detect spore viability post-sterilization. Chemical indicators/integrators change color upon exposure to specific sterilization parameters (steam, EO, VHP). Used in clinical settings to verify sterilizer performance; ensures sterilization cycle conditions met. Provides healthcare providers with visual or fluorescent confirmation of sterilization efficacy; facilitates patient safety by ensuring instruments are sterile.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

System comprises biological indicators (spore-based), chemical indicators (color-changing dyes), and electronic reader incubators. Reader incubators operate at 37°C and 60°C. Connectivity via reader units. Sterilization monitoring based on biological spore death and chemical reaction to critical parameters (time, temperature, concentration).

Indications for Use

Indicated for monitoring efficacy of steam, ethylene oxide, and vaporized hydrogen peroxide sterilization processes in healthcare settings. Used for routine monitoring and sterilizer qualification. Applicable to various sterilization cycles including gravity displacement and dynamic air removal.

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.

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 13, 2019

Terragene SA % Raymond Kelly Consultant Licensale Inc 68 Southwoods Terrace Southbury, Connecticut 06488

## Re: K191021

Trade/Device Name: Terragene Bionova® SCBI (BT95, BT96, BT110, BT224); Terragene Bionova® PCD (PCD224-C, PCD224-2); Terragene Bionova® Reader Incubators (IC10/20FRLCD, Mini-Bio); Terragene Integron® (IT12, IT26-1 YS, IT26-C, PCD26-C, PCD26-2); Terragene Chemdye® (CD16, CD29, CD40, CD42); Terragene Cintape® (CT22, CT40) Regulation Number: 21 CFR 880.2800

Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC Dated: August 13, 2019 Received: August 16, 2019

Dear Raymond Kelly:

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

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Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For Elizabeth Claverie, M.S. Assistant Director for THT4B2 Acting Assistant Director for THT4B1 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

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K191021

#### Device Name

Terragene Bionova® SCBI (BT95, BT110, BT224); Terragene Bionova® PCD (PCD224-C, PCD224-2); Terragene Bionova® Reader Incubators (IC10/20FRLCD, Mini-Bio); Terragene Integron® (IT12, IT26-1YS, IT26-C, PCD26-C, PCD26-2); Terragene Chemdye® (CD16, CD29, CD40, CD42); Terragene Cintape® (CT22, CT40)

#### Indications for Use (Describe)

Terragene Bionova® SCBI (BT224) is a self-contained biological indicator inoculated with viable 10 Geobacillus stearothermophilus bacterial spores and is intended for monitoring the efficacy of steam sterilization processes. On each Terragene Bionova® SCBI is a chemical process indicator that changes color from pink to brown when exposed to steam.

Terragene Bionova® PCD (PCD224-C, PCD224-2) and Integron® PCD (PCD26-C, PCD26-2) provides a defined challenge resistance against the claimed cycles shown below and demonstrated resistance equivalence to the AAMI/ANSI 16 towel pack. The device provides routine monitoring and sterilizer qualification processes.

Terragene Bionova® Reader Incubators (10/20FRLCD, 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 Bionova® SCBI (BT110) is a self-contained biological indicator inoculated with viable 106 Bacillus atrophaeus bacterial spores and is intended for monitoring the efficacy of ethylene oxide sterilization processes.

The integrator Terragene Integron® IT12 is designed to chemically react over time with the critical parameters of ethylene oxide sterilization cycle within a specified tolerance. The integrating indicator strip is intended to be placed in each pack, pouch, container, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles: 55°C for 240 minutes, 600 mg/l, RH 60 %, SV37°C/75 min., SV54°C/30 min, SV55°C/28 min.

Terragene Chemdye® CD16 is a chemical process indicator intended for monitoring the efficacy of ethylene oxide sterilization processes. The chemical indicator changes from purple/brown to green to indicate that the conditions of the cycle have been met.

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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K191021

#### Device Name

Terragene Bionova® SCBI (BT95, BT110, BT224); Terragene Bionova® PCD (PCD224-C, PCD224-2); Terragene Bionova® Reader Incubators (IC10/20FRLCD, Mini-Bio); Terragene Integron® (IT12, IT26-1YS, IT26-C, PCD26-C, PCD26-2); Terragene Chemdye® (CD16, CD29, CD40, CD42); Terragene Cintape® (CT22, CT40)

### Indications for Use (Describe)

Terragene Bionova® SCBI (BT95, 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. BT95 is Rapid Readout while BT96 is Super Rapid Readout. BT95 has Ranid readout at 2 hours at 60° C while BT96 has Super Rapid readout at 30 minutes at 60° C.

Terragene Chemdye® (CD40, CD42) is a chemical process indicator intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes. The chemical indicator changes from purple to green for CD40 and red to vellow for CD42 to indicate that the conditions of the cycle have been met.

The integrator Terragene Integron® TT26-1YS is designed to chemically react over time with the critical parameters of steam sterilization cycle within a specified tolerance. The integrating indicator strip is intended to be placed in each pack, pouch, container, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles: Gravity Displacement: 121° C for 30 minutes, 132° C for 25 minutes, 135° C for 10 minutes; Dynamic Air Removal (Vacuum Assist): 132° C for 3 minutes. SV121° C/16.5 min., SV132° C/2.0 min, SV135° C/1.2 min.

The integrator Terragene Integron® IT26-C is designed to chemically react over time with the critical parameters of steam sterilization cycle within a specified tolerance. The integrating indicator strip is intended to be placed in each pack, pouch, container, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles: Gravity Displacement: 121°C for 30 minutes, 132°C for 15 minutes, 135°C for 25 minutes, 135°C for 10 minutes; Dynamic Air Removal (Vacuum Assist): 132° C for 4 minutes, 135° C for 3 minutes. SV121° C/16.5 min., SV132° C/2.0 min, SV135° C/1.2 min..

| 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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

{4}------------------------------------------------

## DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K191021

#### Device Name

Terragene Bionova® SCBI (BT95, BT110, BT224); Terragene Bionova® PCD (PCD224-C, PCD224-2); Terragene Bionova® Reader Incubators (IC10/20FRLCD, Mini-Bio); Terragene Integron® (IT12, IT26-C, PCD26-C, PCD26-2); Terragene Chemdye® (CD16, CD29, CD40, CD42); Terragene Cintape® (CT22, CT40)

#### Indications for Use (Describe)

Terragene Chemdye® CD29 is a chemical process indicator intended for monitoring the effication processes. The chemical indicator changes from yellow to dark brown/black to indicate that the conditions of the cycle have been met.

Terragene Cintape® CT22 is a chemical process indicator tape intended for monitoring the efficacy of steam sterilization processes. The indicating tape changes from yellow to dark brown/black when exposure to steam.

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.

| Autoclave/Steam Cycles | | | |
|---------------------------------------------------------|------------|------------------------|------------|
| Gravity Displacement | | | |
| Models | 121° C | 132° C | 135°C |
| CD29, CT22, IT26-C, IT26-1YS | 30 minutes | 15 minutes, 25 minutes | 10 minutes |
| PCD26-C, PCD26-2 | 30 minutes | NA | NA |
| BT224, PCD224-2, PCD224-C | NA | 15 minutes, 25 minutes | 10 minutes |
| BT224, PCD224-2, PCD224-C | NA | 10 minutes | 10 minutes |
| Dynamic Air Removal (Vacuum Assist) | | | |
| Models | 121° C | 132° C | 135° C |
| BT224, PCD224-2, PCD224-C, CD29, CT22, IT26-C, IT26-1YS | NA | 4 minutes | 3 minutes |
| PCD26-C, PCD26-2 | NA | 4 minutes | NA |

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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

{5}------------------------------------------------

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

## 510(k) Number (if known) K191021

#### Device Name

Terragene Bionova® SCBI (BT95, BT96, BT110, BT224); Terragene Bionova® PCD (PCD224-C); Terragene Bionova® Reader Incubators (IC10/20FRLCD, Mini-Bio); Terragene Integron® (IT12, IT26-C, PCD26-C, PCD26-2); Terragene Chemdye® (CD16, CD29, CD40, CD42); Terragene Cintape® (CT22, CT40)

Indications for Use (Describe)

| Vaporized Hydrogen Peroxide | | | |
|-----------------------------------------------------|------------------------------------------|-----------------|-------------|
| Models | Cycles | | |
| BT95, BT96, CT40, CD42 | STERRAD 100S 54 minutes | | |
| | STERRAD Standard and Express cycles | | |
| | V-Pro Max and Sterizone VP4 | | |
| CD40 | STERRAD 100S 54 minutes | | |
| | STERRAD Standard and Express cycles | | |
| | V-Pro Max | | |
| Ethylene Oxide | | | |
| Models | Cycles | | |
| CD16, BT110, IT12 | 55° C for 240 minutes, 600 mg/L, RH 60 % | | |
| Fluorescence Read Time and pH Color Change | | | |
| Models | Fluorescence Read Time | pH Color Change | |
| BT224, PCD224-2, PCD224-C | 20 minutes | 48 hours | |
| BT96 | 30 minutes | 48 Hours | |
| BT95 | 2 Hours | 48 Hours | |
| BT110 | 4 hours | 48 Hours | |
| Minimum Stated Values (SV) for Chemical Integrators | | | |
| Autoclave/Steam Cycles | | | |
| Models | 121 °C | 132 °C | 135 °C |
| IT26-C, IT26-1YS | 16.5 minutes | 2.0 minutes | 1.2 minutes |
| Ethylene Oxide (600mg/L) | | | |
| Models | 37 °C | 54 °C | 55 °C |
| IT12 | 75 minutes | 30 minutes | 28 minutes |

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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov