The STERIZONE® VP4 Test Pack is intended to be used for routine monitoring of the STERIZONE® VP4 Sterilizer cycle (Cycle 1) and for the performance validation of the STERIZONE® VP4 Sterilizer system.

Device Description

The STERIZONE® VP4 Test Pack is a Process Challenge Device (PCD) designed to have greater resistance than the worst-case sterilization load of the STERIZONE® VP4 Sterilizer. The STERIZONE® VP4 Test Pack is intended to simulate products to be sterilized and to constitute a defined challenge to the sterilization process and used to assess the effective performance of the process.

The STERIZONE® VP4 Test Pack (subject device) is composed of a Self-contained Biological Indicator (the Terragene's Bionova® BT96), a 10 mL syringe and its plunger, and a diffusion restrictor. A STERIZONE® CI+ Chemical Indicator is also added, external to the syringe, to allow differentiating processed from unprocessed test packs. All components of the Test Pack are single-use, disposable items.

AI/ML Overview

The provided text describes the performance testing of the STERIZONE® VP4 Test Pack (subject device) which uses the Terragene Bionova® BT96 biological indicator, compared to a predicate device that used a different biological indicator. The goal was to demonstrate substantial equivalence.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

Test Name	Test Purpose	Test Acceptance Criteria	Subject Device Test Result
Half-cycle Survivability	Determine if the SCBI, when used within the Test Pack, can provide a resistance to the sterilization process that is equal to or greater than the most difficult item routinely processed in the sterilizer, per ISO 14937, ISO 11138-7 and the Guidance for Industry and Staff – Biological-Indicator (BI) Premarket Notification [510(k)] Submission.	The SCBI in the Test Pack must show growth at half-cycle in all the limit parameter loads tested.	The SCBI in the Test Pack showed growth at half-cycle in all the limit parameter loads tested.
Full cycle inactivation	Determine if the SCBI used within the Test Pack can repeatedly and consistently show an inactivation point in the second half of the sterilization cycle.	The SCBI in the Test Packs must demonstrate a survival ratio of 0% at least at the full cycle using the worst-case challenge load.	The SCBI in the Test Pack shows survival ratio of 0% in the second half of the sterilizer cycle, thus shows total inactivation by the end of a full cycle.
Increased resistance	Determine if the use of the Test Pack provides a greater challenge to the process than the BI itself, per Guidance for Industry and Staff - Biological-Indicator (BI) Premarket Notification [510(k)] Submission.	The SCBI in the VP4 Test Pack must show a higher survival ratio than its naked counterpart.	When exposed to the same partial cycles, the SCBI in the Test Pack showed growth while the naked SCBI was fully inactivated.

2. Sample size used for the test set and the data provenance:

The document does not explicitly state the numerical sample size for the test set (e.g., number of test packs, number of sterilization cycles). It mentions "all the limit parameter loads tested" for half-cycle survivability and "partial cycles" for increased resistance, implying multiple runs, but no specific number.

The data provenance is from bench testing ("Performance Testing - Bench") conducted by TSO3 Inc. (now part of Stryker) for this 510(k) submission. The location of the testing is not specified, but the submitter is TSO3 Inc. in Québec, Canada and Stryker in Portage, Michigan, USA. The nature of the study is prospective, as it's performance testing for a new device qualification.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. For biological indicators, the ground truth is typically established by the growth or non-growth of spores, which is a direct biological outcome, not subject to expert interpretation in the same way as, for example, a medical imaging diagnosis.

4. Adjudication method for the test set:

This information is not applicable and therefore not provided. The results of biological indicator testing (growth or no growth) are objective and do not require adjudication by multiple experts.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This information is not applicable as the device is a sterilization process indicator, not an AI-powered diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This information is not applicable. The device is not an algorithm, but a physical biological indicator used in a sterilization process. Its performance is inherent to its design and biological response, not an algorithm's output.

7. The type of ground truth used:

The ground truth used is biological growth/non-growth of Geobacillus stearothermophilus spores. This is a direct measure of the effectiveness of the sterilization process in inactivating microorganisms.

8. The sample size for the training set:

This information is not applicable. The STERIZONE® VP4 Test Pack is a physical device, not a machine learning model, so there is no training set in the context of AI/ML. The device's resistance characteristics are determined through experimental validation, not by "training" an algorithm.

9. How the ground truth for the training set was established:

This information is not applicable as there is no training set. The performance is assessed against established standards for biological indicators.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in two lines, with "FDA" being larger and bolder than the rest of the text.

March 24, 2021

TSO3 Inc., Now a part of Stryker Karan Modi, MS, RAC Staff Regulatory Affairs Specialist 1941. Stryker Wav Portage, Michigan 49002 USA

Re: K203560

Trade/Device Name: STERIZONE VP4 Test Pack Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC Dated: February 19, 2021 Received: February 23, 2021

Dear Karan Modi:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for Clarence W. Murray, III, PhD. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K203560

Device Name STERIZONE® VP4 Test Pack

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/1 description: The image shows a chemical structure diagram. The diagram includes the letters 'T' and 'S' on the left side. To the right of the letters, there is a chemical structure with an 'O' in the center and a subscript '3' at the bottom right.

K203560

1. Submitter

510(k) Owner:

TSO3 Inc., Now a part of Stryker 2505, avenue Dalton Québec (Québec) G1P 3S5 Canada

FDA Establishment Registration Number:

Contact Person:

3004148947

Karan Modi, MS, RAC Staff Regulatory Affairs Specialist Stryker Instruments 1941 Stryker Way Portage, Michigan 49002 USA P 269 888 0305 karan.modi@stryker.com

Date Submitted:

March 24, 2021

Subject Device Name 2.

Trade Name:	STERIZONE® VP4 Test Pack
Common Name:	Biological Indicator (Test Pack)
Classification:	Class II
Classification Product Code:	FRC
Classification Name:	Indicator, Biological Sterilization Process
Classification Regulation:	21CFR 880.2800
Review Panel:	General Hospital
Submission Type:	Traditional 510(k)

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Legally Marketed Predicate Device 3.

Predicate Device
STERIZONE® VP4 Test Pack	K141580
Reference Device
Terragene Bionova® SCBI (BT96)	K191021

4. Device Description

The STERIZONE® VP4 Test Pack cleared under K141580 contained a biological indicator (STERIZONE® BI+) which required 18 hours of incubation time. This Traditional 510(k) submission aims to qualify an additional biological indicator -Terragene's Bionova® BT96 (hereinafter referred to as "BT96") within the STERIZONE® VP4 Test Pack (hereinafter referred to as "Test Pack"). BT96 is a rapid biological indicator with 30 mins of incubation time and is cleared under K191021 for monitoring the effectiveness of sterilization processes that use vaporized hydrogen peroxide as the primary sterilant, including the STERIZONE® VP4 Sterilizer. The Test Pack with STERIZONE® BI+ cleared under K141580 will continue to be an option for customers to use.

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Image /page/5/Picture/1 description: The image shows a chemical structure diagram. The diagram includes the letters 'T' and 'S' on the left side. To the right of the letters, there is a chemical structure with 'O' and the number '3' at the bottom right.

5. Intended Use/Indications for use

Comparison of Technological Characteristics with the Predicate 6. Device

The following table identifies technological characteristics shared between the Predicate and Subject device:

Features	STERIZONE® VP4 Test Pack(Predicate Device- K141580)	STERIZONE® VP4 Test Pack (Subject Device)
Product description	A Self-contained BI, and a syringe with diffusion restrictor for holding the BI during the sterilization cycle, along with a process chemical indicator.	Same
Picture of the device	Image: STERIZONE VP4 Test Pack (Predicate Device- K141580)	Image: STERIZONE VP4 Test Pack (Subject Device)
Intended Use	Routine monitoring of the STERIZONE® VP4 Sterilizer cycle and performance validation of the STERIZONE® VP4 Sterilizer system	Same
Indications for Use	The STERIZONE® BI+ Self-contained Biological Indicator (SCBI) is intended for routine monitoring of the STERIZONE® VP4 Sterilizer, which offers a single pre-set sterilization cycle (“Cycle 1”). The SCBI should only be used in a Test Pack configuration to monitor Cycle 1. The SCBI placed within the STERIZONE® VP4 Test Pack monitors exposure to both vaporized hydrogen peroxide (H2O2 or VHP) and ozone (O3) which are both used in the STERIZONE® VP4 Sterilizer. The STERIZONE® VP4 Test Pack is intended to have equivalent to greater resistance than worst case devices and loads in any load configuration.	The STERIZONE® VP4 Test Pack is intended to be used for routine monitoring of the STERIZONE® VP4 Sterilizer cycle (Cycle 1) and for the performance validation of the STERIZONE® VP4 Sterilizer system.
Features	STERIZONE® VP4 Test Pack(Predicate Device- K141580)	STERIZONE® VP4 TestPack (Subject Device)
	The STERIZONE® VP4 Test Pack is a device composed ofthe STERIZONE® BI+ Self-contained Biological Indicator(TSO3 product code 42602, including crusher), a 10 mLsyringe and its plunger, and a diffusion restrictor (sold in theform of a kit - TSO3 product code: 44020). An externalSTERIZONE® CI+ Chemical Indicator (TSO3 product code43810) is also added to allow differentiating processed fromunprocessed test packs. All components of the Test Pack aresingle-use, disposable items.The STERIZONE® VP4 Test Pack is constructed by firstinserting the STERIZONE® BI+ Self-contained BiologicalIndicator inside the syringe, with the SCBI cap facing to theLuer-lock of the syringe. The plunger is then inserted to the10 mL mark of the syringe. The diffusion restrictor isscrewed to the Luer-lock of the syringe. The chemicalindicator is then inserted in the opening between the plungerand the syringe.The test pack is then placed within the load on the uppershelf of the STERIZONE® VP4 Sterilizer loading rack.After processing, the SCBI is retrieved from the test pack.The SCBI is intended to provide users with a means toassess spore kill by the STERIZONE® VP4 Sterilizer. A"no growth" result from the SCBI after 18 hours ofincubation indicates that the process achieved the conditionsnecessary to kill at least $1 \times 10^6$ viable spores of Geobacillusstearothermophilus (6 logs) on the SCBI inoculated stainlesssteel carrier.
Contraindication	Do not use in a system other than the STERIZONE® VP4 Sterilizer.Do not reuse any test pack component after it has been processed in the STERIZONE® VP4 Sterilizer.	Same
Sterilizer tobemonitoredby the testpack	STERIZONE® VP4 Sterilizer	Same
Biologicalindicator	STERIZONE® BI+ Self-contained Biological Indicator(K141580)	Terragene Bionova® SCBI(BT96) (K191021)
Features	STERIZONE® VP4 Test Pack(Predicate Device- K141580)	STERIZONE® VP4 TestPack (Subject Device)
	Geobacillus stearothermophilusATCC 7953 spores	Geobacillusstearothermophilus ATCC7953 spores
Holder	Syringe and plunger-10 mL Becton-Dickinson (BD) plastic syringe with Luer-Lok™ connector and its plunger	Same
Diffusionrestrictor	18 gauge (1.02 mm diameter),2-inch (50.8 mm) long polytetrafluoroethylene (PTFE)cannula with Luer-lock attachment	Same
ChemicalIndicator	STERIZONE® CI+ Chemical Indicator	Same
Resistancecharacteristics	Demonstrated to have equivalent or greater resistance thanthe worst case devices and loads in any load configuration.Demonstrated to be more resistant than the half-cycle,including exposure to hydrogen peroxide and ozone.	Same

Table 1. Comparison of the subject and the predicate (K141580) STERIZONE® VP4 Test Pack devices

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TSO₃

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$$\mathbb{S}^{\mathbb{S}}$$

The intended use of the modified device, as described in the labeling, has not changed as a result of the modification.

The STERIZONE® VP4 Test Pack components are identical to its original filing with the exception of the Self-Contained Biological Indicator.

Bionova® BT96 Super Rapid Readout Biological Indicator from Terragene -(K191021)
A diffusion restrictor (same as predicate): PTFE canula of 18 gauge and 2 inches -(5.1 cm) in length (with a Luer-lock connector) (K141580)
A plastic syringe (same as predicate): A 10 mL Becton Dickinson (BD) plastic syringe with Luer-Lok™ tip (K141580)
A chemical indicator (same as predicate): STERIZONE® CI+ Chemical Indicator -(K141580 and K141698)

The difference in the self-contained biological indicator between the subject and predicate device was considered in relation to the substantial equivalence determination:

The predicate Test Pack (PCD) contains the STERIZONE® BI+ Self-contained Biological Indicator (BI+) which was cleared under K141580. The subject Test Pack

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TSO₃

(PCD) contains the Bionova® BT96 Super Rapid Readout Biological Indicator from Terragene. The BT96 biological indicator is cleared for monitoring the effectiveness of STERIZONE® VP4 Sterilizer under K191021 and is therefore used in this submission as a reference device. Similar to the BI+, the BT96 is a self-contained biological indicator inoculated with at least 106 Geobacillus stearothermophilus viable bacterial spores. The qualification of BT96 as a biological challenge device for use within the Test Pack would provide a rapid readout option to the users. The BT96 biological indicator offers rapid readout (30 mins incubation time) compared to 18 hours with the current BI+.

7. Performance Testing - Bench

The performance of the subject STERIZONE® VP4 Test Pack (using BT96) was evaluated in accordance with FDA guidance document for Industry and FDA Staff, Biological Indicator (BI) Premarket Notification [510(k)] Submissions," issued on October 4, 2007. All results from testing meet the predetermined acceptance criteria.

The following performance data were provided in support of the substantial equivalence determination:

Test Name	Test Purpose	Test AcceptanceCriteria	Subject Device TestResult
Half-cycleSurvivability	Determine if the SCBI, when usedwithin the Test Pack, can provide aresistance to the sterilization processthat is equal to or greater than the mostdifficult item routinely processed in thesterilizer, per ISO 14937, ISO 11138-7and the Guidance for Industry and Staff– Biological-Indicator (BI) PremarketNotification [510(k)] Submission.	The SCBI in the TestPack must showgrowth at half-cyclein all the limitparameter loadstested.	The SCBI in the TestPack showed growth athalf-cycle in all the limitparameter loads tested.
Full cycleinactivation	Determine if the SCBI used within theTest Pack can repeatedly andconsistently show an inactivation pointin the second half of the sterilizationcycle.	The SCBI in the TestPacks mustdemonstrate asurvival ratio of 0%at least at the fullcycle using the worst-case challenge load.	The SCBI in the TestPack shows survivalratio of 0% in the secondhalf of the sterilizercycle, thus shows totalinactivation by the endof a full cycle.
Increasedresistance	Determine if the use of the Test Packprovides a greater challenge to theprocess than the BI itself, per Guidancefor Industry and Staff - Biological-Indicator (BI) Premarket Notification[510(k)] Submission.	The SCBI in the VP4Test Pack must showa higher survival ratiothannakeditscounterpart.	When exposed to thesame partial cycles, theSCBI in the Test Packshowed growth while thenaked SCBI was fullyinactivated.

Table 2. Summary of Nonclinical Testing:

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Traditional 510(k) – K203560 STERIZONE® VP4 Test Pack

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K203560 - 510(k) Summary

Conclusion 8.

The performance testing demonstrates that the subject STERIZONE® VP4 Test Pack is substantially equivalent to the identified predicate STERIZONE® VP4 Test Pack (K141580).

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).