Terragene® Bionova® Photon Process Challenge Device with unique-point integrator (PCD225-2);Terragene® Bionova® Photon Process Challenge Device with moving-front integrator (PCD225-C)

K242453 · Terragene S.A. · FRC · Dec 12, 2024 · General Hospital

Device Facts

• Record ID: K242453
• Device Name: Terragene® Bionova® Photon Process Challenge Device with unique-point integrator (PCD225-2);Terragene® Bionova® Photon Process Challenge Device with moving-front integrator (PCD225-C)
• Applicant: Terragene S.A.
• Product Code: FRC · General Hospital
• Decision Date: Dec 12, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

Terragene® Bionova® Photon Process Challenge Device with unique-point integrator (PCD225-2) provides a defined challenge resistance against the claimed cycles shown below and demonstrated resistance equivalence to the ANSI/AAMI 16 towel pack. The device is intended for routine monitoring of the following steam sterilization processes: Gravity-displacement Steam Sterilization Cycles 132 °C, 25 minutes 132 °C, 15 minutes 132 °C, 10 minutes 135 °C, 10 minutes Dynamic-air-removal Steam Sterilization Cycles 132 °C, 4 minutes 135 °C, 3 minutes Bionova® Photon Process Challenge Device with moving-front integrator (PCD225-C) provides a defined challenge resistance against the claimed cycles shown below and demonstrated resistance equivalence to the ANSI/AAMI 16 towel pack. The device is intended for routine monitoring of the following steam sterilization processes: Gravity-displacement Steam Sterilization Cycles 132 °C, 25 minutes 132 °C, 15 minutes 132 °C, 10 minutes 135 °C, 10 minutes Dynamic-air-removal Steam Sterilization Cycles 132 °C, 4 minutes 135 °C, 3 minutes Terragene® Bionova® Photon Auto-reader Incubator (BPH) incubates at 60°C and reads the Terragene® Bionova® Photon Biological Indicator (BT225) which is a 7-second readout Self-Contained Biological Indicator (SCBI) inoculated with a minimum of 10^6 viable Geobacillus stearothermophilus bacterial spores.

Device Story

Disposable process challenge device (PCD) for steam sterilization monitoring; contains Bionova® Photon Biological Indicator (BT225) and chemical integrator (Type 5) within porous card stack; mimics ANSI/AAMI 16-towel pack challenge. Input: steam sterilization cycle conditions. Operation: SCBI contains Geobacillus stearothermophilus spores and growth medium; upon activation (crushing ampoule), culture medium contacts spores. Non-enzymatic fluorescence detection: ANS molecules bind to hydrophobic cavities in spore-associated proteins; fluorescence signal increases if sterilization fails. Output: 7-second fluorescent result via Bionova® Photon Auto-reader Incubator (BPH); optional visual color change confirmation. Used by healthcare personnel to verify sterilizer performance; provides immediate feedback on sterilization failure; ensures patient safety by confirming effective sterilization of medical instruments.

Clinical Evidence

Bench testing only. No clinical data required. Performance verified through comparison studies against standalone indicators, AAMI 16-towel test packs, and predicate devices across complete and incomplete steam sterilization cycles. All tests passed.

Technological Characteristics

Porous card stack containing SCBI and Type 5 chemical integrator; cardboard box with Type 1 process indicator. SCBI contains Geobacillus stearothermophilus spores (min 10^6). Fluorescence detection via ANS-spore protein binding (non-enzymatic). Incubation at 60°C. Complies with ISO 11140-1:2014 for chemical indicators. Shelf life 18 months.

Indications for Use

Indicated for routine monitoring of steam sterilization processes (gravity-displacement and dynamic-air-removal) in healthcare facilities. Used with Terragene® Bionova® Photon Auto-reader Incubator (BPH) for 7-second readout of Geobacillus stearothermophilus spore-based biological indicators.

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® PCD (PCD224-2); Terragene Bionova® PCD (PCD224-C) (K191021)

Submission Summary (Full Text)

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December 12, 2024

Terragene S.A. Hernando Carrizo Quality and Process Manager Ruta Nacional Nº 9, km 280 Parque Industrial Micropi Alvear, Santa Fe 2130 Argentina

Re: K242453

Trade/Device Name: Terragene® Bionova® Photon Process Challenge Device with unique-point integrator (PCD225-2);Terragene® Bionova® Photon Process Challenge Device with moving-front integrator (PCD225-C) Regulation Number: 21 CFR 880.2806 Regulation Name: Biological sterilization indicator with indirect growth detection Regulatory Class: Class II Product Code: FRC Dated: November 13, 2024 Received: November 13, 2024

Dear Hernando Carrizo:

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

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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.

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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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 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

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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).

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Digitally signed by PAULO LARANJEIRA -S Date: 2024.12.12 10:22:58 -05'00'

for: Christopher Dugard Assistant Director DHT4C: Division of Infection Control 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

Submission Number (if known)

K242453

Device Name

Terragene® Bionova® Photon Process Challenge Device with unique-point integrator (PCD225-2); Terragene® Bionova® Photon Process Challenge Device with moving-front integrator (PCD225-C)

Indications for Use (Describe)

Terragene® Bionova® Photon Process Challenge Device with unique-point integrator (PCD225-2) provides a defined challenge resistance aqainst the claimed cycles shown below and demonstrated resistance equivalence to the ANSI/AAMI 16 towel pack. The device is intended for routine monitoring of the following steam sterilization processes:

· Gravity-displacement Steam Sterilization Cycles

132 °C, 25 minutes

132 °C, 15 minutes

132 °C, 10 minutes

135 °C, 10 minutes

· Dynamic-air-removal Steam Sterilization Cycles

132 °C, 4 minutes

135 °C, 3 minutes

Bionova® Photon Process Challenge Device with moving-front integrator (PCD225-C) provides a defined challenge resistance against the claimed cycles shown below and demonstrated resistance equivalence to the ANSI/AAMI 16 towel pack. The device is intended for routine monitoring of the following steam sterilization processes:

· Gravity-displacement Steam Sterilization Cycles

132 °C, 25 minutes

132 °C, 15 minutes

132 °C, 10 minutes

135 °C, 10 minutes

· Dynamic-air-removal Steam Sterilization Cycles

132 °C. 4 minutes

135 °C. 3 minutes

Terragene® Bionova® Photon Auto-reader Incubator (BPH) incubates at 60°C and reads the Terragene® Bionova® Photon Biological Indicator (BT225) which is a 7-second readout Self-Contained Biological Indicator (SCBI) inoculated with a minimum of 10° viable Geobacillus stearothermophilus bacterial spores.

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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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# Terragene®

# 510(k) Summary for

# Terragene® Bionova® Photon Process Challenge Device with uniquepoint integrator (PCD225-2); Terragene® Bionova® Photon Process Challenge Device with moving-front integrator (PCD225-C) K242453

#### Sponsor Information:

Terragene S.A. Ruta Nacional Nº 9, km 280 Parque Industrial Micropi Alvear Santa Fe 2130 Argentina

Contact: Mr. Hernando Carrizo Quality and Process Manager Phone Number: [phone] Email: hernando.carrizo(@terragene.com

#### Date of Summary: 11 December 2024

#### 1. Device Name and Classification:

| Common or Usual Name: | Biological Indicator (BI) Challenge Pack |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Proprietary Name: | Terragene® Bionova® Photon Process Challenge Device with<br>unique- point integrator (PCD225-2); Terragene® Bionova®<br>Photon Process Challenge Device with moving- front integrator<br>(PCD225-C) |
| Classification Name: | Indicator, Biological Sterilization Process |
| Device Classification: | Class II, 21 CFR 880.2800 |
| Product Code: | FRC |

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### 2. Predicate Device:

Terragene Bionova® PCD (PCD224-2); Terragene Bionova® PCD (PCD224-C), K191021

# 3. Description of Device:

Bionova® Photon Process Challenge Devices consist of a disposable pre-assembled package as outlined in ANSI/AAMI ST79:2017 which contain a Bionova® Photon Biological Indicator (BT225), a Record Card and a chemical integrator that gives instant visible indication that sterilizing conditions have been reached. Each Bionova® Photon PCD consists of a stack of porous cards holding a Self-Contained Biological Indicator (SCBI) that contains a population of Geobacillus stearothermophilus ATCC®7953 spores on a carrier as well as growth indicator medium contained in a glass ampoule. Each SCBI has a process indicator on the label that changes from pink to brown when exposed to steam. These PCDs present a challenge to the sterilization process equivalent to the 16-towel process challenge device (PCD) recommended by the Associate for the Advancement of Medical Instrumentation (AAMI).

# 4. Indications for Use

Terragene® Bionova® Photon Process Challenge Device with unique-point integrator (PCD225-2) provides a defined challenge resistance against the claimed cycles shown below and demonstrated resistance equivalence to the ANSI/AAMI 16 towel pack. The device is intended for routine monitoring of the following steam sterilization processes:

| Cycle Type | Exposure<br>Temperature | Exposure Time |
|----------------------|-------------------------|---------------------------|
| Dynamic-air-removal | 132°C | 4 minutes |
| Dynamic-air-removal | 135°C | 3 minutes |
| Gravity-displacement | 132°C | 25, 15, and 10<br>minutes |
| Gravity-displacement | 135°C | 10 minutes |

Bionova® Photon Process Challenge Device with moving-front integrator (PCD225-C) provides a defined challenge resistance against the claimed cycles shown below and demonstrated resistance equivalence to the ANSI/AAMI 16 towel pack. The device is intended for routine monitoring of the following steam sterilization processes:

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| Cycle Type | Exposure<br>Temperature | Exposure Time |
|----------------------|-------------------------|---------------------------|
| Dynamic-air-removal | 132°C | 4 minutes |
| Dynamic-air-removal | 135°C | 3 minutes |
| Gravity-displacement | 132°C | 25, 15, and 10<br>minutes |
| Gravity-displacement | 135°C | 10 minutes |

Terragene® Bionova® Photon Auto-reader Incubator (BPH) incubates at 60°C and reads the Terragene® Bionova® Photon Biological Indicator (BT225) which is a 7-second readout Self-Contained Biological Indicator (SCBI) inoculated with a minimum of 10% viable Geobacillus stearothermophilus bacterial spores.

# 5. Comparison of Technological Characteristics with the Predicate Device

Both the submission and predicate challenge packs are designed to increase resistance beyond that measured with a standalone BI and both represent a challenge to the sterilization process equivalent to the AAMI reference PCD. The subject and predicate devices have the same intended use. The only difference between the Indication for Use statements is that the subject devices add the indication that they are to be used in conjunction with Terragene® Bionova® Photon Auto-reader incubator.

The differences in technological characteristics between the submission and predicate challenge pack are illustrated in the Device Comparison Table (Table 1).

| Feature | Subject Devices:<br>(K242453) | Predicate Devices:<br>(K191021) | Comparison |
|---------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Single Use biological indicator<br>process challenge<br>device | Single Use biological indicator<br>process challenge<br>device | Identical |
| | Subject Devices:<br>(K242453) | Predicate Devices:<br>(K191021) | Comparison |
| Feature | Terragene® Bionova® Photon<br>Process Challenge Device with<br>unique-point integrator<br>(PCD225-2) and Bionova®<br>Photon Process Challenge<br>Device with moving-front<br>integrator (PCD225-C)<br>provide a defined challenge<br>resistance against the claimed<br>cycles shown below and<br>demonstrated resistance<br>equivalence to the<br>ANSI/AAMI 16 towel pack.<br>The devices are intended for<br>routine monitoring of the<br>following steam sterilization<br>processes:<br>Dynamic-air-removal 132°C<br>4 minutes<br>Dynamic-air-removal 135°C<br>3 minutes<br>Gravity-displacement<br>132°C 25, 15, and 10<br>minutes<br>Gravity-displacement<br>135°C 10 minutes<br>Terragene® Bionova® Photon<br>Auto-reader Incubator (BPH)<br>incubates at 60°C and reads<br>the Terragene® Bionova®<br>Photon Biological Indicator<br>(BT225) which is a 7-second<br>readout Self-Contained<br>Biological Indicator (SCBI)<br>inoculated with a minimum of<br>106 viable <i>Geobacillus<br/>stearothermophilus</i> bacterial<br>spores. | Terragene Bionova® PCD<br>(PCD224-C, PCD224-2)<br>provides a defined challenge<br>resistance against the claimed<br>cycles shown below and<br>demonstrated resistance<br>equivalence to the<br>AAMI/ANSI 16 towel pack.<br>The device provides routine<br>monitoring and sterilizer<br>qualification testing steam<br>sterilization processes.<br><br>Terragene Bionova® Reader<br>Incubators (IC10/20FRLCD,<br>Mini-Bio) incubate at 60° C<br>and 37° C and read the<br>Terragene Bionova® SCBI for<br>fluorescent results at the times<br>prescribed in the User<br>Manuals. | Similar. The differences<br>between the Indications<br>for Use include: the<br>subject devices are not<br>intended to be used for<br>qualification and are to<br>be used in conjunction<br>with the Terragene®<br>Bionova® Photon<br>Auto-reader Incubator. |
| Feature | Subject Devices:<br>(K242453) | Predicate Devices:<br>(K191021) | Comparison |
| General design | Porous cards holding a Self-contained Biological Indicator<br>and a Chemical Integrator<br>(Type 5) according to ISO 11140-1: 2014). The system<br>also contains a Self-adhesive<br>record card where sterilization<br>cycle may be written and is<br>contained in a cardboard box<br>with a Process Indicator (Type<br>1) according to ISO 11140-1:<br>2014). | Porous cards holding a Self-contained Biological Indicator<br>and a Chemical Integrator<br>(Type 5) according to ISO 11140-1: 2014). The system<br>also contains a Self-adhesive<br>record card where sterilization<br>cycle may be written and is<br>contained in a cardboard box<br>with a Process Indicator (Type<br>1) according to ISO 11140-1:<br>2014). | Identical |
| Biological indicator | Terragene® Bionova® Photon<br>Biological Indicator (BT225)<br>106 Geobacillus<br>stearothermophilus spores | Terragene® Bionova® SCBI<br>(BT224)<br>106 Geobacillus<br>stearothermophilus spores | Different. The subject<br>device contains a<br>different biological<br>indicator with indirect<br>growth detection. |
| Biological Indicator<br>Incubation temperature | 60 ± 2°C | 60 ± 2°C | Identical |
| Biological Indicator<br>Readout time | 7-second final fluorescent<br>result in Terragene®<br>Bionova® Photon Auto-reader<br>Incubator (BPH) | 20-minute fluorescent result in<br>Bionova® Auto-reader<br>Incubator | Different. The subject<br>device has a shorter<br>readout time in a different<br>incubator. |
| | Subject Devices:<br>(K242453) | Predicate Devices:<br>(K191021) | |
| Feature | | | Comparison |
| Biological Indicator<br>Mechanism of Action | Upon the SCBI activation<br>(the ampoule contained in<br>the SCBI is crushed), the<br>culture medium soaks the<br>carrier and ANS comes into<br>contact with the spores (and<br>their outer proteins). In non-<br>sterilized SCBIs or after<br>unsuccessfully sterilization<br>processes, the ANS<br>molecules bind to the<br>hydrophobic cavities in<br>structurally intact spore-<br>associated proteins,<br>significantly increasing its<br>fluorescence signal, detected<br>by the Auto-reader. The<br>presence of fluorescence<br>upon incubation in the Auto-<br>reader indicates a<br>sterilization process failure.<br>Optionally, a visual color<br>change confirmation can be<br>performed. | In those SCBIs exposed to<br>an inefficient sterilization<br>cycle, the active α-<br>glucosidase enzymes, which<br>are naturally located in<br>different regions of the<br><i>Geobacillus<br/>stearothermophilus</i> spore<br>structure, catalyze the<br>breakdown of the non-<br>fluorescent α-MUG<br>substrate, releasing a<br>fluorescent by-product,<br>detected by the Auto-reader.<br>The presence of fluorescence<br>upon incubation in the Auto-<br>reader indicates a<br>sterilization process failure.<br>Optionally, a visual color<br>change confirmation can be<br>performed. | Different. The subject<br>device contains a<br>biological indicator with<br>a different fluorophore.<br>The fluorescence readout<br>does not depend on an<br>enzymatic reaction. |
| Biological Indicator<br>Resistance Characteristics | D-value132 °C ≥ 10 secs<br>Z-value132 °C ≥ 10 °C<br>Survival Time132 °C [ $log_{10}$<br>nominal population - 2) x D-<br>value132 °C] ≥ 1 min<br><br>D-value135 °C ≥ 8 secs<br>Z-value135 °C ≥ 10 °C<br>Survival Time135 °C [ $log_{10}$<br>nominal population - 2) x D-<br>value135 °C] ≥ 40 secs | D-value132 °C ≥ 10 secs<br>Z-value132 °C ≥ 10 °C<br>Survival Time132 °C [ $log_{10}$<br>nominal population - 2) x D-<br>value132 °C] ≥ 1 min<br><br>D-value135 °C ≥ 8 secs<br>Z-value135 °C ≥ 10 °C<br>Survival Time135 °C [ $log_{10}$<br>nominal population - 2) x D-<br>value135 °C] ≥ 40 secs | Identical |
| Chemical Integrator | Integron® IT26-C chemical<br>integrator (PCD225-C)<br>Bionova® PCDB1-2-RC<br>Chemical integrator<br>(PCD225-2) | Integron® IT26-C chemical<br>integrator (PCD224-C)<br>Bionova® PCDB1-2-RC<br>Chemical integrator<br>(PCD224-2) | Identical |
| Chemical Integrator<br>Endpoint Specifications<br>(Minimum Stated Values) | 121°C: 16.5 minutes<br>132°C: 2.0 minutes<br>135°C: 1.2 minutes | 121°C: 16.5 minutes<br>132°C: 2.0 minutes<br>135°C: 1.2 minutes | Identical |
| | Subject Devices:<br>(K242453) | Predicate Devices:<br>(K191021) | |
| Feature | | | Comparison |
| Chemical Integrator Color<br>Change | Integron® IT26-C chemical<br>integrator (PCD225-C):<br>The extent of migration of<br>the dark bar along the<br>ACCEPT/REJECT zone<br>indicates whether<br>sterilization conditions were<br>met or not.<br>Bionova® PCDB1-2-RC<br>Chemical integrator<br>(PCD225-2): turns from<br>purple to green when<br>sterilization conditions were<br>met. | Integron® IT26-C chemical<br>integrator (PCD224-C):<br>The extent of migration of<br>the dark bar along the<br>ACCEPT/REJECT zone<br>indicates whether<br>sterilization conditions were<br>met or not.<br>Bionova® PCDB1-2-RC<br>Chemical integrator<br>(PCD224-2): turns from<br>purple to green when<br>sterilization conditions were<br>met. | Identical |
| Mechanism to distinguish<br>processed and unprocessed<br>challenge pack | External Chemical Process<br>Indicator that turns from<br>light blue to dark grey/black<br>upon steam exposure | External Chemical Process<br>Indicator that turns from<br>light blue to dark grey/black<br>upon steam exposure | Identical |
| Resistance Comparison to<br>the AAMI ST79 16 Towel<br>PCD | Equivalent in resistance to<br>the AAMI ST79 16 Towel<br>PCD | Equivalent in resistance to<br>the AAMI ST79 16 Towel<br>PCD | Identical |
| Shelf life | 18 months | 24 months | Different. The subject<br>device has a shorter shelf<br>life. |
| Accessories | Terragene® Bionova®<br>Photon Auto-reader<br>Incubator (BPH) | Bionova® Auto-reader<br>Incubator | Different. The subject<br>device has a different<br>incubator. |

#### Table 1: Device Comparison Table

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#### 6. Nonclinical Comparison to the Predicate Device

The differences between the submission and predicate device have been evaluated through performance tests for the Terragene® Bionova® Photon Process Challenge Device with unique-point integrator (PCD225-2); Terragene® Bionova® Photon Process Challenge Device with moving-front integrator (PCD225-C).

Performance of the Terragene® Bionova® Photon Process Challenge Device with unique- point integrator (PCD225-2); Terragene® Bionova® Photon Process Challenge Device with movingfront integrator (PCD225-C) were verified through the following tests:

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| Test Performed | Device<br>Description | Applicable<br>Standards | Purpose | Acceptance<br>Criteria | Results |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Performance<br>study<br>comparison of<br>Bionova®<br>Photon Process<br>Challenge<br>Devices to the<br>standalone<br>biological and<br>integrator<br>indicators | Terragene®<br>Bionova® Photon<br>Process Challenge<br>Device with<br>unique- point<br>integrator<br>(PCD225-2) and<br>Terragene®<br>Bionova® Photon<br>Process Challenge<br>Device with<br>moving-front<br>integrator<br>(PCD225-C). | FDA Guidance for<br>Industry and FDA<br>Staff, Biological<br>Indicator (BI)<br>Premarket<br>Notification<br>[510(k)]<br>Submissions,<br>October 4, 2007 and<br>FDA Guidance for<br>Industry and FDA<br>Staff on Premarket<br>Notification<br>[510(k)]<br>Submissions for<br>Chemical<br>Indicators,<br>December 19, 2003. | Demonstrate<br>that the<br>Bionova®<br>Photon Process<br>Challenge<br>Devices provide<br>a greater<br>challenge to the<br>steam<br>sterilization<br>process than the<br>SCBI and<br>chemical<br>integrator<br>themselves. | Bionova®<br>Photon Process<br>Challenge<br>Devices<br>(PCD225-2 and<br>PCD225-C)<br>provide a greater<br>challenge than<br>the Bionova®<br>Photon BT225<br>SCBI and<br>Bionova®<br>PCDBI-2-RC<br>/Integron® IT26-<br>C chemical<br>integrator<br>themselves. | Passed |
| Performance<br>study<br>comparison of<br>Bionova®<br>Photon Process<br>Challenge<br>Devices to the<br>AAMI<br>16-Towel Test<br>Pack | Terragene®<br>Bionova® Photon<br>Process Challenge<br>Device with<br>unique- point<br>integrator<br>(PCD225-2) and<br>Terragene®<br>Bionova® Photon<br>Process Challenge<br>Device with<br>moving-front<br>integrator<br>(PCD225-C). | FDA Guidance for<br>Industry and FDA<br>Staff, Biological<br>Indicator (BI)<br>Premarket<br>Notification<br>[510(k)]<br>Submissions,<br>October 4, 2007 and<br>ANSI/AAMI<br>ST79:2017,<br>Comprehensive<br>guide to steam<br>sterilization and<br>sterility assurance<br>in health care<br>facilities. | Demonstrate<br>that the<br>performance of<br>Bionova®<br>Photon Process<br>Challenge<br>Devices is<br>comparable to<br>the performance<br>of the user-<br>assembled test<br>pack described<br>in ANSI/AAMI<br>ST79:2017. | The response of<br>Bionova®<br>Photon BT225<br>SCBI and<br>Bionova®<br>PCDBI-2-RC<br>/Integron® IT26-<br>C chemical<br>integrators inside<br>the Bionova®<br>Photon Process<br>Challenge<br>Devices<br>(PCD225-2 and<br>PCD225-C)<br>should be<br>equivalent to the<br>performance of<br>the same<br>indicators in the<br>16-towel<br>ANSI/AAMI<br>ST79:2017 user-<br>assembled test<br>pack for steam<br>sterilization<br>processes. | Passed |
| Performance<br>study of the<br>chemical<br>integrators in<br>the Bionova®<br>Photon Process<br>Challenge<br>Devices | Terragene®<br>Bionova® Photon<br>Process Challenge<br>Device with<br>unique- point<br>integrator<br>(PCD225-2) and<br>Terragene® | FDA Guidance for<br>Industry and FDA<br>Staff on Premarket<br>Notification<br>[510(k)]<br>Submissions for<br>Chemical<br>Indicators, | Compare the<br>performance of<br>the Bionova®<br>PCDBI-2-RC<br>/Integron®<br>IT26-C<br>chemical<br>integrators | Chemical<br>integrators<br>within the<br>Bionova®<br>Photon PCD<br>should show pass<br>results under<br>passing | Passed |
| compared to<br>AAMI<br>reference<br>biological<br>indicator test<br>packs | Bionova® Photon<br>Process Challenge<br>Device with<br>moving-front<br>integrator<br>(PCD225-C). | December 19, 2003. | within the<br>Bionova®<br>Photon Process<br>Challenge<br>Devices to the<br>Bionova®<br>Photon BT225<br>Biological<br>Indicator inside<br>the AAMI<br>standard test<br>packs. | conditions while<br>under failing<br>conditions, the<br>chemical<br>integrators<br>should show fail<br>results. These<br>results should be<br>consistent with<br>the outcome of<br>the Bionova®<br>Photon BT225<br>Biological<br>Indicator within<br>the standard test<br>packs. | |
| Performance<br>study<br>comparison of<br>Bionova®<br>Photon Process<br>Challenge<br>Devices to the<br>predicate<br>devices in<br>claimed cycles | Terragene®<br>Bionova® Photon<br>Process Challenge<br>Device with<br>unique- point<br>integrator<br>(PCD225-2) and<br>Terragene®<br>Bionova® Photon<br>Process Challenge<br>Device with<br>moving-front<br>integrator<br>(PCD225-C). | FDA Guidance for<br>Industry and FDA<br>Staff, Biological<br>Indicator (BI)<br>Premarket<br>Notification<br>[510(k)]<br>Submissions,<br>October 4, 2007 and<br>FDA Guidance for<br>Industry and FDA<br>Staff on Premarket<br>Notification<br>[510(k)]<br>Submissions for<br>Chemical<br>Indicators,<br>December 19, 2003. | Compare the<br>performance of<br>the Bionova®<br>Photon Process<br>Challenge<br>Devices<br>(PCD225-2 and<br>PCD225-C) to<br>the predicate<br>devices<br>(PCD224-2 and<br>PCD224-C) in<br>claimed cycles<br>(complete and<br>incomplete<br>cycles). | Bionova®<br>Photon Process<br>Challenge<br>Devices<br>(PCD225-2 and<br>PCD225-C)<br>should<br>demonstrate<br>equivalent<br>performance to<br>the Bionova®<br>PCD224-2 and<br>PCD224-C. | Passed |
| Performance<br>Study for<br>Bionova®<br>Photon Process<br>Challenge<br>Devices in<br>claimed cycles | Terragene®<br>Bionova® Photon<br>Process Challenge<br>Device with<br>unique- point<br>integrator<br>(PCD225-2) and<br>Terragene®<br>Bionova® Photon<br>Process Challenge<br>Device with<br>moving-front<br>integrator<br>(PCD225-C). | FDA Guidance for<br>Industry and FDA<br>Staff, Biological<br>Indicator (BI)<br>Premarket<br>Notification<br>[510(k)]<br>Submissions,<br>October 4, 2007 and<br>FDA Guidance for<br>Industry and FDA<br>Staff on Premarket<br>Notification<br>[510(k)]<br>Submissions for<br>Chemical<br>Indicators,<br>December 19, 2003. | Verify the<br>performance of<br>the Bionova®<br>Photon Process<br>Challenge<br>Devices<br>(PCD225-2 and<br>PCD225-C) in<br>claimed<br>sterilization<br>cycles, both for<br>complete cycles<br>(PASS<br>CONDITION)<br>and for<br>incomplete<br>cycles (FAIL<br>CONDITION). | Bionova®<br>Photon Process<br>Challenge<br>Devices<br>(PCD225-2 and<br>PCD225-C)<br>perform as<br>intended in<br>claimed cycles. | Passed |

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# 7. Clinical Comparison to the Predicate Device

Clinical testing was not required for this submission.

#### 8. Conclusion

Based on the intended use, technological characteristics, and non-clinical performance data, the submission device, the Terragene® Bionova® Photon Process Challenge Device with unique- point integrator (PCD225-2); Terragene® Bionova® Photon Process Challenge Device with moving- front integrator (PCD225-C), are as safe and as effective as the legally marketed predicate device, Terragene Bionova® PCD (PCD224-C, PCD224-2) cleared per K191021, Class II (21 CFR 880.2800), product code FRC.