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 106 viable Geobacillus stearothermophilus bacterial spores.

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).

AI/ML Overview

Here's an analysis of the acceptance criteria and study information provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance

Test Performed	Acceptance Criteria	Reported Performance
Performance study comparison of Bionova® Photon Process Challenge Devices to the standalone biological and integrator indicators	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	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 compared to AAMI reference biological indicator test packs	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.	Passed
Performance study comparison of Bionova® Photon Process Challenge Devices to the predicate devices in claimed 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	Bionova® Photon Process Challenge Devices (PCD225-2 and PCD225-C) perform as intended in claimed cycles.	Passed

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific sample sizes (number of devices or test runs) used for each performance study. It only mentions "Performance study" in the test descriptions.
The data provenance is not specified (e.g., country of origin, retrospective or prospective).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The studies are related to the performance of sterilization indicators and likely involve laboratory testing rather than human expert interpretation of results for ground truth.

4. Adjudication Method for the Test Set

This information is not applicable as the studies involve objective physical and biological tests, not human interpretation that would require adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The device is a sterilization indicator, not a diagnostic imaging device that would typically involve human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the studies described are standalone performance tests of the device (Process Challenge Device and its components) in various sterilization cycle conditions. The device's performance (e.g., color change of chemical integrator, fluorescence of biological indicator) is directly observed and compared to established standards or other devices.

7. The Type of Ground Truth Used

The ground truth used for these studies is based on:

Established standards: Specifically, ANSI/AAMI ST79:2017 (Comprehensive guide to steam sterilization and sterility assurance in health care facilities) for comparison against the 16-towel test pack.
Known sterilization conditions: Labs would define "passing" and "failing" sterilization cycles for testing accuracy.
Performance of predicate device: The predicate device (K191021) served as a benchmark for equivalent performance.
Intrinsic BI and CI performance: The standalone biological and chemical indicators' known performance characteristics establish a baseline for comparison with the PCD.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical diagnostic tool (sterilization indicator), not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable, as there is no training set for this type of device.

Summary

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

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

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)

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

· 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}------------------------------------------------

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."

{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 withunique- 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:

4. Indications for Use

Cycle Type	ExposureTemperature	Exposure Time
Dynamic-air-removal	132°C	4 minutes
Dynamic-air-removal	135°C	3 minutes
Gravity-displacement	132°C	25, 15, and 10minutes
Gravity-displacement	135°C	10 minutes

{7}------------------------------------------------

Cycle Type	ExposureTemperature	Exposure Time
Dynamic-air-removal	132°C	4 minutes
Dynamic-air-removal	135°C	3 minutes
Gravity-displacement	132°C	25, 15, and 10minutes
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 indicatorprocess challengedevice	Single Use biological indicatorprocess challengedevice	Identical
	Subject Devices:(K242453)	Predicate Devices:(K191021)	Comparison
Feature	Terragene® Bionova® PhotonProcess Challenge Device withunique-point integrator(PCD225-2) and Bionova®Photon Process ChallengeDevice with moving-frontintegrator (PCD225-C)provide a defined challengeresistance against the claimedcycles shown below anddemonstrated resistanceequivalence to theANSI/AAMI 16 towel pack.The devices are intended forroutine monitoring of thefollowing steam sterilizationprocesses:Dynamic-air-removal 132°C4 minutesDynamic-air-removal 135°C3 minutesGravity-displacement132°C 25, 15, and 10minutesGravity-displacement135°C 10 minutesTerragene® Bionova® PhotonAuto-reader Incubator (BPH)incubates at 60°C and readsthe Terragene® Bionova®Photon Biological Indicator(BT225) which is a 7-secondreadout Self-ContainedBiological Indicator (SCBI)inoculated with a minimum of106 viable Geobacillusstearothermophilus bacterialspores.	Terragene Bionova® PCD(PCD224-C, PCD224-2)provides a defined challengeresistance against the claimedcycles shown below anddemonstrated resistanceequivalence to theAAMI/ANSI 16 towel pack.The device provides routinemonitoring and sterilizerqualification testing steamsterilization processes.Terragene Bionova® ReaderIncubators (IC10/20FRLCD,Mini-Bio) incubate at 60° Cand 37° C and read theTerragene Bionova® SCBI forfluorescent results at the timesprescribed in the UserManuals.	Similar. The differencesbetween the Indicationsfor Use include: thesubject devices are notintended to be used forqualification and are tobe used in conjunctionwith the Terragene®Bionova® PhotonAuto-reader Incubator.
Feature	Subject Devices:(K242453)	Predicate Devices:(K191021)	Comparison
General design	Porous cards holding a Self-contained Biological Indicatorand a Chemical Integrator(Type 5) according to ISO 11140-1: 2014). The systemalso contains a Self-adhesiverecord card where sterilizationcycle may be written and iscontained in a cardboard boxwith a Process Indicator (Type1) according to ISO 11140-1:2014).	Porous cards holding a Self-contained Biological Indicatorand a Chemical Integrator(Type 5) according to ISO 11140-1: 2014). The systemalso contains a Self-adhesiverecord card where sterilizationcycle may be written and iscontained in a cardboard boxwith a Process Indicator (Type1) according to ISO 11140-1:2014).	Identical
Biological indicator	Terragene® Bionova® PhotonBiological Indicator (BT225)106 Geobacillusstearothermophilus spores	Terragene® Bionova® SCBI(BT224)106 Geobacillusstearothermophilus spores	Different. The subjectdevice contains adifferent biologicalindicator with indirectgrowth detection.
Biological IndicatorIncubation temperature	60 ± 2°C	60 ± 2°C	Identical
Biological IndicatorReadout time	7-second final fluorescentresult in Terragene®Bionova® Photon Auto-readerIncubator (BPH)	20-minute fluorescent result inBionova® Auto-readerIncubator	Different. The subjectdevice has a shorterreadout time in a differentincubator.
	Subject Devices:(K242453)	Predicate Devices:(K191021)
Feature			Comparison
Biological IndicatorMechanism of Action	Upon the SCBI activation(the ampoule contained inthe SCBI is crushed), theculture medium soaks thecarrier and ANS comes intocontact with the spores (andtheir outer proteins). In non-sterilized SCBIs or afterunsuccessfully sterilizationprocesses, the ANSmolecules bind to thehydrophobic cavities instructurally intact spore-associated proteins,significantly increasing itsfluorescence signal, detectedby the Auto-reader. Thepresence of fluorescenceupon incubation in the Auto-reader indicates asterilization process failure.Optionally, a visual colorchange confirmation can beperformed.	In those SCBIs exposed toan inefficient sterilizationcycle, the active α-glucosidase enzymes, whichare naturally located indifferent regions of theGeobacillusstearothermophilus sporestructure, catalyze thebreakdown of the non-fluorescent α-MUGsubstrate, releasing afluorescent by-product,detected by the Auto-reader.The presence of fluorescenceupon incubation in the Auto-reader indicates asterilization process failure.Optionally, a visual colorchange confirmation can beperformed.	Different. The subjectdevice contains abiological indicator witha different fluorophore.The fluorescence readoutdoes not depend on anenzymatic reaction.
Biological IndicatorResistance Characteristics	D-value132 °C ≥ 10 secsZ-value132 °C ≥ 10 °CSurvival Time132 °C [ $log_{10}$nominal population - 2) x D-value132 °C] ≥ 1 minD-value135 °C ≥ 8 secsZ-value135 °C ≥ 10 °CSurvival Time135 °C [ $log_{10}$nominal population - 2) x D-value135 °C] ≥ 40 secs	D-value132 °C ≥ 10 secsZ-value132 °C ≥ 10 °CSurvival Time132 °C [ $log_{10}$nominal population - 2) x D-value132 °C] ≥ 1 minD-value135 °C ≥ 8 secsZ-value135 °C ≥ 10 °CSurvival Time135 °C [ $log_{10}$nominal population - 2) x D-value135 °C] ≥ 40 secs	Identical
Chemical Integrator	Integron® IT26-C chemicalintegrator (PCD225-C)Bionova® PCDB1-2-RCChemical integrator(PCD225-2)	Integron® IT26-C chemicalintegrator (PCD224-C)Bionova® PCDB1-2-RCChemical integrator(PCD224-2)	Identical
Chemical IntegratorEndpoint Specifications(Minimum Stated Values)	121°C: 16.5 minutes132°C: 2.0 minutes135°C: 1.2 minutes	121°C: 16.5 minutes132°C: 2.0 minutes135°C: 1.2 minutes	Identical
	Subject Devices:(K242453)	Predicate Devices:(K191021)
Feature			Comparison
Chemical Integrator ColorChange	Integron® IT26-C chemicalintegrator (PCD225-C):The extent of migration ofthe dark bar along theACCEPT/REJECT zoneindicates whethersterilization conditions weremet or not.Bionova® PCDB1-2-RCChemical integrator(PCD225-2): turns frompurple to green whensterilization conditions weremet.	Integron® IT26-C chemicalintegrator (PCD224-C):The extent of migration ofthe dark bar along theACCEPT/REJECT zoneindicates whethersterilization conditions weremet or not.Bionova® PCDB1-2-RCChemical integrator(PCD224-2): turns frompurple to green whensterilization conditions weremet.	Identical
Mechanism to distinguishprocessed and unprocessedchallenge pack	External Chemical ProcessIndicator that turns fromlight blue to dark grey/blackupon steam exposure	External Chemical ProcessIndicator that turns fromlight blue to dark grey/blackupon steam exposure	Identical
Resistance Comparison tothe AAMI ST79 16 TowelPCD	Equivalent in resistance tothe AAMI ST79 16 TowelPCD	Equivalent in resistance tothe AAMI ST79 16 TowelPCD	Identical
Shelf life	18 months	24 months	Different. The subjectdevice has a shorter shelflife.
Accessories	Terragene® Bionova®Photon Auto-readerIncubator (BPH)	Bionova® Auto-readerIncubator	Different. The subjectdevice has a differentincubator.

Table 1: Device Comparison Table

{8}------------------------------------------------

{9}------------------------------------------------

{10}------------------------------------------------

{11}------------------------------------------------

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:

{12}------------------------------------------------

Test Performed	DeviceDescription	ApplicableStandards	Purpose	AcceptanceCriteria	Results
Performancestudycomparison ofBionova®Photon ProcessChallengeDevices to thestandalonebiological andintegratorindicators	Terragene®Bionova® PhotonProcess ChallengeDevice withunique- pointintegrator(PCD225-2) andTerragene®Bionova® PhotonProcess ChallengeDevice withmoving-frontintegrator(PCD225-C).	FDA Guidance forIndustry and FDAStaff, BiologicalIndicator (BI)PremarketNotification[510(k)]Submissions,October 4, 2007 andFDA Guidance forIndustry and FDAStaff on PremarketNotification[510(k)]Submissions forChemicalIndicators,December 19, 2003.	Demonstratethat theBionova®Photon ProcessChallengeDevices providea greaterchallenge to thesteamsterilizationprocess than theSCBI andchemicalintegratorthemselves.	Bionova®Photon ProcessChallengeDevices(PCD225-2 andPCD225-C)provide a greaterchallenge thanthe Bionova®Photon BT225SCBI andBionova®PCDBI-2-RC/Integron® IT26-C chemicalintegratorthemselves.	Passed
Performancestudycomparison ofBionova®Photon ProcessChallengeDevices to theAAMI16-Towel TestPack	Terragene®Bionova® PhotonProcess ChallengeDevice withunique- pointintegrator(PCD225-2) andTerragene®Bionova® PhotonProcess ChallengeDevice withmoving-frontintegrator(PCD225-C).	FDA Guidance forIndustry and FDAStaff, BiologicalIndicator (BI)PremarketNotification[510(k)]Submissions,October 4, 2007 andANSI/AAMIST79:2017,Comprehensiveguide to steamsterilization andsterility assurancein health carefacilities.	Demonstratethat theperformance ofBionova®Photon ProcessChallengeDevices iscomparable tothe performanceof the user-assembled testpack describedin ANSI/AAMIST79:2017.	The response ofBionova®Photon BT225SCBI andBionova®PCDBI-2-RC/Integron® IT26-C chemicalintegrators insidethe Bionova®Photon ProcessChallengeDevices(PCD225-2 andPCD225-C)should beequivalent to theperformance ofthe sameindicators in the16-towelANSI/AAMIST79:2017 user-assembled testpack for steamsterilizationprocesses.	Passed
Performancestudy of thechemicalintegrators inthe Bionova®Photon ProcessChallengeDevices	Terragene®Bionova® PhotonProcess ChallengeDevice withunique- pointintegrator(PCD225-2) andTerragene®	FDA Guidance forIndustry and FDAStaff on PremarketNotification[510(k)]Submissions forChemicalIndicators,	Compare theperformance ofthe Bionova®PCDBI-2-RC/Integron®IT26-Cchemicalintegrators	Chemicalintegratorswithin theBionova®Photon PCDshould show passresults underpassing	Passed
compared toAAMIreferencebiologicalindicator testpacks	Bionova® PhotonProcess ChallengeDevice withmoving-frontintegrator(PCD225-C).	December 19, 2003.	within theBionova®Photon ProcessChallengeDevices to theBionova®Photon BT225BiologicalIndicator insidethe AAMIstandard testpacks.	conditions whileunder failingconditions, thechemicalintegratorsshould show failresults. Theseresults should beconsistent withthe outcome ofthe Bionova®Photon BT225BiologicalIndicator withinthe standard testpacks.
Performancestudycomparison ofBionova®Photon ProcessChallengeDevices to thepredicatedevices inclaimed cycles	Terragene®Bionova® PhotonProcess ChallengeDevice withunique- pointintegrator(PCD225-2) andTerragene®Bionova® PhotonProcess ChallengeDevice withmoving-frontintegrator(PCD225-C).	FDA Guidance forIndustry and FDAStaff, BiologicalIndicator (BI)PremarketNotification[510(k)]Submissions,October 4, 2007 andFDA Guidance forIndustry and FDAStaff on PremarketNotification[510(k)]Submissions forChemicalIndicators,December 19, 2003.	Compare theperformance ofthe Bionova®Photon ProcessChallengeDevices(PCD225-2 andPCD225-C) tothe predicatedevices(PCD224-2 andPCD224-C) inclaimed cycles(complete andincompletecycles).	Bionova®Photon ProcessChallengeDevices(PCD225-2 andPCD225-C)shoulddemonstrateequivalentperformance tothe Bionova®PCD224-2 andPCD224-C.	Passed
PerformanceStudy forBionova®Photon ProcessChallengeDevices inclaimed cycles	Terragene®Bionova® PhotonProcess ChallengeDevice withunique- pointintegrator(PCD225-2) andTerragene®Bionova® PhotonProcess ChallengeDevice withmoving-frontintegrator(PCD225-C).	FDA Guidance forIndustry and FDAStaff, BiologicalIndicator (BI)PremarketNotification[510(k)]Submissions,October 4, 2007 andFDA Guidance forIndustry and FDAStaff on PremarketNotification[510(k)]Submissions forChemicalIndicators,December 19, 2003.	Verify theperformance ofthe Bionova®Photon ProcessChallengeDevices(PCD225-2 andPCD225-C) inclaimedsterilizationcycles, both forcomplete cycles(PASSCONDITION)and forincompletecycles (FAILCONDITION).	Bionova®Photon ProcessChallengeDevices(PCD225-2 andPCD225-C)perform asintended inclaimed cycles.	Passed

{13}------------------------------------------------

{14}------------------------------------------------

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.

Regulation Number and Section

§ 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).