Terragene® Bionova® Self-Contained Biological Indicator (BT95), Terragene® Bionova® Self-Contained Biological Indicator (BT96), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40)

K231383 · Terragene S.A. · FRC · Sep 18, 2024 · General Hospital

Device Facts

• Record ID: K231383
• Device Name: Terragene® Bionova® Self-Contained Biological Indicator (BT95), Terragene® Bionova® Self-Contained Biological Indicator (BT96), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40)
• Applicant: Terragene S.A.
• Product Code: FRC · General Hospital
• Decision Date: Sep 18, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

Terragene® Bionova® SCBI (BT95, BT96) is a self-contained biological indicator inoculated with a minimum of 10º viable Geobacillus stearothermophilus bacterial spores and is intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes in the following systems: - Sterrad® 100S Sterilization System. - Sterrad® 100NX Sterilization System (Standard and Express cycles). - V-Pro® maX Low Temperature Sterilization System (Non Lumen and Flexible cvcles). - Sterizone® VP4 Sterilizer ( cycle 1 ). - LowTem Crystal 120 Sterilizer (Standard cycle). BT95 has rapid readout at 2 hours at 60 ℃ while BT96 has super rapid readout at 30 minutes at 60 ℃. Terragene® Chemdye® (CD42) is a chemical process indicator intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes in the following systems: - Sterrad® 100S Sterilization System. - Sterrad® 100NX Sterilization System (Standard and Express cycles). - V-Pro® maX Low Temperature Sterilization System (Non Lumen, Lumen and Flexible cycles). - Sterizone® VP4 Sterilizer ( cycle 1 ). - LowTem Crystal 120 Sterilizer (Standard cycle). 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 in the following systems: - Sterrad® 100S Sterilization System. - Sterrad® 100NX Sterilization System (Standard and Express cycles). - V-Pro® maX Low Temperature Sterilization System (Non Lumen and Flexible cycles). - Sterizone® VP4 Sterilizer ( cycle 1 ). - LowTem Crystal 120 Sterilizer (Standard cycle). The indicating tape changes from purple to green when exposure to vaporized hydrogen peroxide.

Device Story

Device suite monitors vaporized hydrogen peroxide sterilization efficacy. Includes self-contained biological indicators (BT95, BT96) containing Geobacillus stearothermophilus spores; chemical process indicator (CD42); and chemical process indicator tape (CT40). Biological indicators provide rapid (2 hours) or super-rapid (30 minutes) readout at 60°C to confirm spore inactivation. Chemical indicators provide visual color change (red to yellow for CD42; purple to green for CT40) upon exposure to sterilization conditions. Used in clinical settings to verify sterilization cycle performance. Healthcare providers observe color changes or biological readout to ensure sterilization efficacy, directly impacting clinical decision-making regarding instrument sterility and patient safety.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Biological indicators contain Geobacillus stearothermophilus spores. Chemical indicators utilize color-changing reactive chemistry. Indicators are designed for vaporized hydrogen peroxide sterilization environments. No software or electronic components.

Indications for Use

Indicated for monitoring vaporized hydrogen peroxide sterilization efficacy in healthcare facilities using specified sterilization systems (Sterrad, V-Pro, Sterizone, LowTem). Applicable to professional and over-the-counter use.

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)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".

September 18, 2024

Terragene SA % Raymond Kelly Consultant Licensale Inc 3422 Leonardo Lane New Smyrna Beach, Florida 32168

Re: K231383

Trade/Device Name: Terragene® Bionova® Self-Contained Biological Indicator (BT95), Terragene® Bionova® Self-Contained Biological Indicator (BT96), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40)

Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization process indicator Regulatory Class: Class II Product Code: FRC Dated: September 16, 2024 Received: September 16, 2024

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 (the 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 available 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.

{1}------------------------------------------------

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).

Sincerelv.

Stephen A. Digitally signed by stephen A. Anisko -S Date: 2024.09.18 Anisko -S 16:46:42 -04'00'

for: Christopher Dugard Assistant Director DHT4B: Division of Infection Control

{2}------------------------------------------------

and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

# Indications for Use

#### 510(k) Number (if known) K231383

#### Device Name

Terragene® Bionova® Self-Contained Biological Indicator (BT95), Terragene® Biological Indicator (BT96), Terragene® Chemical Process Indicator (CD42), Terragene® Chemical Process Indicator Tape (CT40)

#### Indications for Use (Describe)

Terragene® Bionova® SCBI (BT95, BT96) is a self-contained biological indicator inoculated with a minimum of 10º viable Geobacillus stearothermophilus bacterial spores and is intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes in the following systems:

- · Sterrad® 100S Sterilization System.
- · Sterrad® 100NX Sterilization System (Standard and Express cycles).
- · V-Pro® maX Low Temperature Sterilization System (Non Lumen and Flexible cvcles).
- · Sterizone® VP4 Sterilizer ( cycle 1 ).
- · LowTem Crystal 120 Sterilizer (Standard cycle).

BT95 has rapid readout at 2 hours at 60 ℃ while BT96 has super rapid readout at 30 minutes at 60 ℃.

Terragene® Chemdye® (CD42) is a chemical process indicator intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes in the following systems:

- · Sterrad® 100S Sterilization System.
- · Sterrad® 100NX Sterilization System (Standard and Express cycles).
- · V-Pro® maX Low Temperature Sterilization System (Non Lumen, Lumen and Flexible cycles).
- · Sterizone® VP4 Sterilizer ( cycle 1 ).
- · LowTem Crystal 120 Sterilizer (Standard cycle).

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 in the following systems:

- · Sterrad® 100S Sterilization System.
- · Sterrad® 100NX Sterilization System (Standard and Express cycles).
- · V-Pro® maX Low Temperature Sterilization System (Non Lumen and Flexible cycles).
- · Sterizone® VP4 Sterilizer ( cycle 1 ).
- · LowTem Crystal 120 Sterilizer (Standard cycle).

The indicating tape changes from purple to green when exposure to vaporized hydrogen peroxide.

- 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

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."