(115 days)
Not Found
No
The summary describes a biological and chemical indicator system for monitoring steam sterilization, with no mention of AI or ML technology in the device description, intended use, or performance studies.
No
This device is intended for monitoring steam sterilization processes of other medical devices, not for treating patients.
No
Explanation: The devices described are "Process Challenge Devices" and an "Auto-reader Incubator" used for monitoring steam sterilization processes, not for diagnosing medical conditions.
No
The device description clearly outlines physical components including a disposable pre-assembled package, porous cards, a Self-Contained Biological Indicator (SCBI) with spores and growth medium, a glass ampoule, a record card, and a chemical integrator. These are all hardware components.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is for "routine monitoring of the following steam sterilization processes." This is a quality control function for a sterilization process, not a diagnostic test performed on a biological sample from a patient.
- Device Description: The device contains a biological indicator (bacterial spores) and a chemical integrator. These are used to challenge and verify the effectiveness of a sterilization cycle, not to diagnose a condition or disease in a patient.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status
- Diagnosing, monitoring, or predicting a disease or condition
The device is clearly designed to assess the performance of a sterilization process, which falls under the category of a sterilization process indicator or monitoring device, not an IVD.
N/A
Intended Use / Indications for Use
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 10^6 viable Geobacillus stearothermophilus bacterial spores.
Product codes (comma separated list FDA assigned to the subject device)
FRC
Device Description
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance study comparison of Bionova® Photon Process Challenge Devices to the standalone biological and integrator indicators
Purpose: Demonstrate that the Bionova® Photon Process Challenge Devices provide a greater challenge to the steam sterilization process than the SCBI and chemical integrator themselves.
Results: Passed. Bionova® Photon Process Challenge Devices (PCD225-2 and PCD225-C) provide a greater challenge than the Bionova® Photon BT225 SCBI and Bionova® PCDBI-2-RC /Integron® IT26-C chemical integrator themselves.
Performance study comparison of Bionova® Photon Process Challenge Devices to the AAMI 16-Towel Test Pack
Purpose: Demonstrate that the performance of Bionova® Photon Process Challenge Devices is comparable to the performance of the user-assembled test pack described in ANSI/AAMI ST79:2017.
Results: Passed. The response of Bionova® Photon BT225 SCBI and Bionova® PCDBI-2-RC /Integron® IT26-C chemical integrators inside the Bionova® Photon Process Challenge Devices (PCD225-2 and PCD225-C) should be equivalent to the performance of the same indicators in the 16-towel ANSI/AAMI ST79:2017 user-assembled test pack for steam sterilization processes.
Performance study of the chemical integrators in the Bionova® Photon Process Challenge Devices compared to AAMI reference biological indicator test packs
Purpose: Compare the performance of the Bionova® PCDBI-2-RC /Integron® IT26-C chemical integrators within the Bionova® Photon Process Challenge Devices to the Bionova® Photon BT225 Biological Indicator inside the AAMI standard test packs.
Results: Passed. Chemical integrators within the Bionova® Photon PCD should show pass results under passing conditions while under failing conditions, the chemical integrators should show fail results. These results should be consistent with the outcome of the Bionova® Photon BT225 Biological Indicator within the standard test packs.
Performance study comparison of Bionova® Photon Process Challenge Devices to the predicate devices in claimed cycles
Purpose: Compare the performance of the Bionova® Photon Process Challenge Devices (PCD225-2 and PCD225-C) to the predicate devices (PCD224-2 and PCD224-C) in claimed cycles (complete and incomplete cycles).
Results: Passed. Bionova® Photon Process Challenge Devices (PCD225-2 and PCD225-C) should demonstrate equivalent performance to the Bionova® PCD224-2 and PCD224-C.
Performance Study for Bionova® Photon Process Challenge Devices in claimed cycles
Purpose: Verify the performance of the Bionova® Photon Process Challenge Devices (PCD225-2 and PCD225-C) in claimed sterilization cycles, both for complete cycles (PASS CONDITION) and for incomplete cycles (FAIL CONDITION).
Results: Passed. Bionova® Photon Process Challenge Devices (PCD225-2 and PCD225-C) perform as intended in claimed cycles.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.2800 Sterilization process indicator.
(a)
Biological sterilization process indicator —(1)Identification. A biological sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization.(2)
Classification. Class II (performance standards).(b)
Physical/chemical sterilization process indicator —(1)Identification. A physical/chemical sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device.(2)
Classification. Class II (performance standards).
0
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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
1
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
2
Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Image /page/2/Picture/2 description: The image shows the signature of Paulo Laranjeira. The text "Sincerely," is written above the name. The name is written in a large, bold font. The last name is followed by a dash and the letter S.
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
3
Indications for Use
Submission Number (if known)
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)
4
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5
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: +5493415587007 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 |
| unique- point integrator (PCD225-2); Terragene® Bionova® | |
| Photon Process Challenge Device with moving- front integrator | |
| (PCD225-C) | |
| Classification Name: | Indicator, Biological Sterilization Process |
| Device Classification: | Class II, 21 CFR 880.2800 |
| Product Code: | FRC |
6
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
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
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:
7
| Cycle Type | Exposure
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
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:
(K242453) | Predicate Devices:
(K191021) | Comparison |
|---------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Single Use biological indicator
process challenge
device | Single Use biological indicator
process challenge
device | Identical |
| | Subject Devices:
(K242453) | Predicate Devices:
(K191021) | Comparison |
| Feature | Terragene® Bionova® Photon
Process Challenge Device with
unique-point integrator
(PCD225-2) and Bionova®
Photon Process Challenge
Device with moving-front
integrator (PCD225-C)
provide a defined challenge
resistance against the claimed
cycles shown below and
demonstrated resistance
equivalence to the
ANSI/AAMI 16 towel pack.
The devices are intended for
routine monitoring of the
following steam sterilization
processes:
Dynamic-air-removal 132°C
4 minutes
Dynamic-air-removal 135°C
3 minutes
Gravity-displacement
132°C 25, 15, and 10
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
106 viable Geobacillus
stearothermophilus bacterial
spores. | Terragene Bionova® PCD
(PCD224-C, PCD224-2)
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 testing steam
sterilization processes.
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. | Similar. The differences
between the Indications
for Use include: the
subject devices are not
intended to be used for
qualification and are to
be used in conjunction
with the Terragene®
Bionova® Photon
Auto-reader Incubator. |
| Feature | Subject Devices:
(K242453) | Predicate Devices:
(K191021) | Comparison |
| General design | Porous cards holding a Self-contained Biological Indicator
and a Chemical Integrator
(Type 5) according to ISO 11140-1: 2014). The system
also contains a Self-adhesive
record card where sterilization
cycle may be written and is
contained in a cardboard box
with a Process Indicator (Type
- according to ISO 11140-1:
2014). | Porous cards holding a Self-contained Biological Indicator
and a Chemical Integrator
(Type 5) according to ISO 11140-1: 2014). The system
also contains a Self-adhesive
record card where sterilization
cycle may be written and is
contained in a cardboard box
with a Process Indicator (Type - according to ISO 11140-1:
2014). | Identical |
| Biological indicator | Terragene® Bionova® Photon
Biological Indicator (BT225)
106 Geobacillus
stearothermophilus spores | Terragene® Bionova® SCBI
(BT224)
106 Geobacillus
stearothermophilus spores | Different. The subject
device contains a
different biological
indicator with indirect
growth detection. |
| Biological Indicator
Incubation temperature | 60 ± 2°C | 60 ± 2°C | Identical |
| Biological Indicator
Readout time | 7-second final fluorescent
result in Terragene®
Bionova® Photon Auto-reader
Incubator (BPH) | 20-minute fluorescent result in
Bionova® Auto-reader
Incubator | Different. The subject
device has a shorter
readout time in a different
incubator. |
| | Subject Devices:
(K242453) | Predicate Devices:
(K191021) | |
| Feature | | | Comparison |
| Biological Indicator
Mechanism of Action | Upon the SCBI activation
(the ampoule contained in
the SCBI is crushed), the
culture medium soaks the
carrier and ANS comes into
contact with the spores (and
their outer proteins). In non-
sterilized SCBIs or after
unsuccessfully sterilization
processes, the ANS
molecules bind to the
hydrophobic cavities in
structurally intact spore-
associated proteins,
significantly increasing its
fluorescence signal, detected
by the Auto-reader. The
presence of fluorescence
upon incubation in the Auto-
reader indicates a
sterilization process failure.
Optionally, a visual color
change confirmation can be
performed. | In those SCBIs exposed to
an inefficient sterilization
cycle, the active α-
glucosidase enzymes, which
are naturally located in
different regions of the
Geobacillus
stearothermophilus spore
structure, catalyze the
breakdown of the non-
fluorescent α-MUG
substrate, releasing a
fluorescent by-product,
detected by the Auto-reader.
The presence of fluorescence
upon incubation in the Auto-
reader indicates a
sterilization process failure.
Optionally, a visual color
change confirmation can be
performed. | Different. The subject
device contains a
biological indicator with
a different fluorophore.
The fluorescence readout
does not depend on an
enzymatic reaction. |
| Biological Indicator
Resistance Characteristics | D-value132 °C ≥ 10 secs
Z-value132 °C ≥ 10 °C
Survival Time132 °C [ $log_{10}$
nominal population - 2) x D-
value132 °C] ≥ 1 min
D-value135 °C ≥ 8 secs
Z-value135 °C ≥ 10 °C
Survival Time135 °C [ $log_{10}$
nominal population - 2) x D-
value135 °C] ≥ 40 secs | D-value132 °C ≥ 10 secs
Z-value132 °C ≥ 10 °C
Survival Time132 °C [ $log_{10}$
nominal population - 2) x D-
value132 °C] ≥ 1 min
D-value135 °C ≥ 8 secs
Z-value135 °C ≥ 10 °C
Survival Time135 °C [ $log_{10}$
nominal population - 2) x D-
value135 °C] ≥ 40 secs | Identical |
| Chemical Integrator | Integron® IT26-C chemical
integrator (PCD225-C)
Bionova® PCDB1-2-RC
Chemical integrator
(PCD225-2) | Integron® IT26-C chemical
integrator (PCD224-C)
Bionova® PCDB1-2-RC
Chemical integrator
(PCD224-2) | Identical |
| Chemical Integrator
Endpoint Specifications
(Minimum Stated Values) | 121°C: 16.5 minutes
132°C: 2.0 minutes
135°C: 1.2 minutes | 121°C: 16.5 minutes
132°C: 2.0 minutes
135°C: 1.2 minutes | Identical |
| | Subject Devices:
(K242453) | Predicate Devices:
(K191021) | |
| Feature | | | Comparison |
| Chemical Integrator Color
Change | Integron® IT26-C chemical
integrator (PCD225-C):
The extent of migration of
the dark bar along the
ACCEPT/REJECT zone
indicates whether
sterilization conditions were
met or not.
Bionova® PCDB1-2-RC
Chemical integrator
(PCD225-2): turns from
purple to green when
sterilization conditions were
met. | Integron® IT26-C chemical
integrator (PCD224-C):
The extent of migration of
the dark bar along the
ACCEPT/REJECT zone
indicates whether
sterilization conditions were
met or not.
Bionova® PCDB1-2-RC
Chemical integrator
(PCD224-2): turns from
purple to green when
sterilization conditions were
met. | Identical |
| Mechanism to distinguish
processed and unprocessed
challenge pack | External Chemical Process
Indicator that turns from
light blue to dark grey/black
upon steam exposure | External Chemical Process
Indicator that turns from
light blue to dark grey/black
upon steam exposure | Identical |
| Resistance Comparison to
the AAMI ST79 16 Towel
PCD | Equivalent in resistance to
the AAMI ST79 16 Towel
PCD | Equivalent in resistance to
the AAMI ST79 16 Towel
PCD | Identical |
| Shelf life | 18 months | 24 months | Different. The subject
device has a shorter shelf
life. |
| Accessories | Terragene® Bionova®
Photon Auto-reader
Incubator (BPH) | Bionova® Auto-reader
Incubator | Different. The subject
device has a different
incubator. |
Table 1: Device Comparison Table
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10
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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
Description | Applicable
Standards | Purpose | Acceptance
Criteria | Results |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Performance
study
comparison of
Bionova®
Photon Process
Challenge
Devices to the
standalone
biological and
integrator
indicators | Terragene®
Bionova® Photon
Process Challenge
Device with
unique- point
integrator
(PCD225-2) and
Terragene®
Bionova® Photon
Process Challenge
Device with
moving-front
integrator
(PCD225-C). | FDA Guidance for
Industry and FDA
Staff, Biological
Indicator (BI)
Premarket
Notification
[510(k)]
Submissions,
October 4, 2007 and
FDA Guidance for
Industry and FDA
Staff on Premarket
Notification
[510(k)]
Submissions for
Chemical
Indicators,
December 19, 2003. | Demonstrate
that the
Bionova®
Photon Process
Challenge
Devices provide
a greater
challenge to the
steam
sterilization
process than the
SCBI and
chemical
integrator
themselves. | Bionova®
Photon Process
Challenge
Devices
(PCD225-2 and
PCD225-C)
provide a greater
challenge than
the Bionova®
Photon BT225
SCBI and
Bionova®
PCDBI-2-RC
/Integron® IT26-
C chemical
integrator
themselves. | Passed |
| Performance
study
comparison of
Bionova®
Photon Process
Challenge
Devices to the
AAMI
16-Towel Test
Pack | Terragene®
Bionova® Photon
Process Challenge
Device with
unique- point
integrator
(PCD225-2) and
Terragene®
Bionova® Photon
Process Challenge
Device with
moving-front
integrator
(PCD225-C). | FDA Guidance for
Industry and FDA
Staff, Biological
Indicator (BI)
Premarket
Notification
[510(k)]
Submissions,
October 4, 2007 and
ANSI/AAMI
ST79:2017,
Comprehensive
guide to steam
sterilization and
sterility assurance
in health care
facilities. | Demonstrate
that the
performance of
Bionova®
Photon Process
Challenge
Devices is
comparable to
the performance
of the user-
assembled test
pack described
in ANSI/AAMI
ST79:2017. | The response of
Bionova®
Photon BT225
SCBI and
Bionova®
PCDBI-2-RC
/Integron® IT26-
C chemical
integrators inside
the Bionova®
Photon Process
Challenge
Devices
(PCD225-2 and
PCD225-C)
should be
equivalent to the
performance of
the same
indicators in the
16-towel
ANSI/AAMI
ST79:2017 user-
assembled test
pack for steam
sterilization
processes. | Passed |
| Performance
study of the
chemical
integrators in
the Bionova®
Photon Process
Challenge
Devices | Terragene®
Bionova® Photon
Process Challenge
Device with
unique- point
integrator
(PCD225-2) and
Terragene® | FDA Guidance for
Industry and FDA
Staff on Premarket
Notification
[510(k)]
Submissions for
Chemical
Indicators, | Compare the
performance of
the Bionova®
PCDBI-2-RC
/Integron®
IT26-C
chemical
integrators | Chemical
integrators
within the
Bionova®
Photon PCD
should show pass
results under
passing | Passed |
| compared to
AAMI
reference
biological
indicator test
packs | Bionova® Photon
Process Challenge
Device with
moving-front
integrator
(PCD225-C). | December 19, 2003. | within the
Bionova®
Photon Process
Challenge
Devices to the
Bionova®
Photon BT225
Biological
Indicator inside
the AAMI
standard test
packs. | conditions while
under failing
conditions, the
chemical
integrators
should show fail
results. These
results should be
consistent with
the outcome of
the Bionova®
Photon BT225
Biological
Indicator within
the standard test
packs. | |
| Performance
study
comparison of
Bionova®
Photon Process
Challenge
Devices to the
predicate
devices in
claimed cycles | Terragene®
Bionova® Photon
Process Challenge
Device with
unique- point
integrator
(PCD225-2) and
Terragene®
Bionova® Photon
Process Challenge
Device with
moving-front
integrator
(PCD225-C). | FDA Guidance for
Industry and FDA
Staff, Biological
Indicator (BI)
Premarket
Notification
[510(k)]
Submissions,
October 4, 2007 and
FDA Guidance for
Industry and FDA
Staff on Premarket
Notification
[510(k)]
Submissions for
Chemical
Indicators,
December 19, 2003. | Compare the
performance of
the Bionova®
Photon Process
Challenge
Devices
(PCD225-2 and
PCD225-C) to
the predicate
devices
(PCD224-2 and
PCD224-C) in
claimed cycles
(complete and
incomplete
cycles). | Bionova®
Photon Process
Challenge
Devices
(PCD225-2 and
PCD225-C)
should
demonstrate
equivalent
performance to
the Bionova®
PCD224-2 and
PCD224-C. | Passed |
| Performance
Study for
Bionova®
Photon Process
Challenge
Devices in
claimed cycles | Terragene®
Bionova® Photon
Process Challenge
Device with
unique- point
integrator
(PCD225-2) and
Terragene®
Bionova® Photon
Process Challenge
Device with
moving-front
integrator
(PCD225-C). | FDA Guidance for
Industry and FDA
Staff, Biological
Indicator (BI)
Premarket
Notification
[510(k)]
Submissions,
October 4, 2007 and
FDA Guidance for
Industry and FDA
Staff on Premarket
Notification
[510(k)]
Submissions for
Chemical
Indicators,
December 19, 2003. | Verify the
performance of
the Bionova®
Photon Process
Challenge
Devices
(PCD225-2 and
PCD225-C) in
claimed
sterilization
cycles, both for
complete cycles
(PASS
CONDITION)
and for
incomplete
cycles (FAIL
CONDITION). | Bionova®
Photon Process
Challenge
Devices
(PCD225-2 and
PCD225-C)
perform as
intended in
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.