The STERIZONE® VP4 Sterilizer is intended for use in terminal sterilization of cleaned, rinsed, and dried metal and non- metal reusable medical devices in health care facilities. The single pre-set cycle of the STERIZONE® VP4 Sterilizer uses hydrogen peroxide and ozone. The injection of vaporized hydrogen peroxide is followed by the injection of ozone, which reacts with residual hydrogen peroxide to form hydroxyl radicals. Sterilization efficacy was demonstrated using a representative sample of one or more device types and packaging, in nine separate validation loads, as described in Table 1 [refer to continuation pages 2 - 4 of this form]. The load to be processed should be maintained between 20℃ to 26℃ (68°F to 78°F). Total load weight shall not exceed 75 lb, inclusive of the containers/packaging weight but excluding the 25 lb loading rack.

Device Description

The STERIZONE® VP4 Sterilizer (VP4) is a self-contained stand-alone device, using vaporized hydrogen peroxide and ozone in a multiphase process. The VP4 offers a single sterilization cycle intended for general instruments, flexible endoscopes (including single, dual, and multichannel devices), and rigid-channel devices (including single-channel and double-channel rigid endoscopes). The changes to the sterilizer are component changes that were made to extend the of the hydrogen peroxide vaporization block. These changes include: 1] anodization of the hydrogen peroxide vaporization block, and 2] a reduction of the stabilizer concentration in the hydrogen peroxide solution.

AI/ML Overview

This document describes the non-clinical testing and validation of the STERIZONE® VP4 Sterilizer, specifically focusing on changes to the hydrogen peroxide vaporization block and the hydrogen peroxide solution. The primary goal of the study was to demonstrate that the modified device maintains the same safety and effectiveness as its predicate (K173694).

Here's an analysis based on the provided text:

1. Acceptance Criteria and Reported Device Performance:

The primary acceptance criterion is that the modified STERIZONE® VP4 Sterilizer achieves a Sterility Assurance Level (SAL) of 10⁻⁶ using an overkill approach. It also needed to meet various safety and performance standards.

Acceptance Criteria	Reported Device Performance
Achievement of a Sterility Assurance Level (SAL) of 10⁻⁶ for terminal sterilization of packaged reusable medical devices, demonstrated using an overkill approach and half-cycle testing.	"Sterility testing of directly inoculated medical devices was conducted employing an overkill approach in the modified sterilizers to demonstrate achievement of a sterility assurance level (SAL) of 10⁻⁶." "Testing on directly inoculated medical devices was conducted employing half-cycle to demonstrate achievement of a sterility assurance level (SAL) of 10⁻⁶." "This process has been demonstrated to achieve a sterility assurance level of 10⁻⁶ for terminal sterilization of packaged reusable medical devices."
Compliance with various North American safety codes and standards (CSA C22.2 No 61010-1, UL 61010-1, FCC Part 18 / EN 55011, IEC 61326-1, IEC 61010-1:2010, 61010-2-040).	"The modified STERIZONE® VP4 Sterilizer complies with the applicable portions of the following standards." (Followed by a list of standards).
All parameters of each part of the test series meeting acceptance criteria.	"In each case, all parameters of each part of the test series met acceptance criteria."
No impact on the biocompatibility of the materials of the sterilized devices due to changes.	"The modification did not in any way impact the biocompatibility of the materials of the sterilized devices, since the materials sterilant residuals, have not changed." "The verification tests performed to determine the concentration of post-sterilization H₂O₂ residuals on materials sterilized with the STERIZONE® VP4 Sterilizer equipped with the proposed anodized H₂O₂ vaporization block and the Semiconductor-grade H₂O₂ solution were tested under worst-case conditions."
Maintaining safety features and control redundancies as determined by a Failure Mode Effects Analysis (FMEA).	"A Failure Mode Effects Analysis (FMEA) has been conducted on the entire system of the STERIZONE® VP4 Sterilizer to ensure safety features and control redundancies have been implemented in the design and will be maintained during the manufacturing, installation, maintenance and servicing of the sterilizers."

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

Sample Size for Test Set: The sterilizer underwent "nine separate validation loads" as described in Table 1 (pages 3-4 and reiterated on page 7). Each load represented specific types of medical instruments, geometries, and packaging. The text does not specify the exact number of individual items or biological indicators within each load, but it refers to the use of "directly inoculated medical devices."
Data Provenance: The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective. However, based on the applicant's address (TSO3 Inc., Québec, QC G1P 3S5 Canada) and the FDA submission, the testing likely occurred in a controlled lab environment, most likely in Canada or the US, as part of a prospective validation study for regulatory submission.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This document is for a sterilizer device, not an AI or imaging device that requires diagnostic interpretation by human experts. Therefore, the concept of "experts establishing ground truth for a test set" in the context of radiological reads or similar scenarios is not applicable here.
The "ground truth" for a sterilizer's performance is established by microbiological testing (e.g., biological indicators, inoculated devices) and subsequent culturing to verify the absence of viable microorganisms. The expertise lies in microbiology, sterilizer validation, and engineering, rather than clinical interpretation.

4. Adjudication Method for the Test Set:

Not applicable as this is a sterilizer validation study, not a study involving human reader interpretation or adjudication of diagnostic findings. The results are quantitative (sterility assurance level) and determined by laboratory methods.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. This is a study on a sterilization device, not an AI-assisted diagnostic tool for human readers. No human readers are involved in the "performance" of the sterilizer itself.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance):

This concept is applicable to the STERIZONE® VP4 Sterilizer itself. The device performs its sterilization function autonomously once initiated. The validation studies performed were standalone performance studies of the device's ability to achieve sterility without human intervention in the sterilization process, only in its operation.
The study demonstrated the device's ability to achieve an SAL of 10⁻⁶ on its own.

7. Type of Ground Truth Used:

The ground truth for sterility was established through microbiological methods, specifically:
- Directly inoculated medical devices: Devices were purposely contaminated with known resistant microorganisms (likely bacterial spores, given the "overkill" approach for sterilization validation).
- Biological Indicators: Although not explicitly stated as "biological indicators," the "overkill approach" and "half-cycle testing" strongly imply the use of standardized biological indicators or highly resistant microbial challenges to demonstrate the SAL.
- Absence of viable microorganisms: The success criterion for sterility is the complete inactivation of these microbial challenges, confirming an SAL of 10⁻⁶.

8. Sample Size for the Training Set:

Not applicable. This is a physical device (sterilizer) undergoing validation, not an AI algorithm that requires a training set. The device's operation is based on established physical and chemical principles, not machine learning from data.

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

Not applicable, as there is no "training set" in the context of an algorithm. The device's design and operational parameters are based on scientific understanding of sterilization processes, extensive R&D, and adherence to relevant standards for medical device manufacturing and sterilization.

Summary

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

July 19, 2019

TSO3 Inc % Cynthia Pritchard CEO BioTechnology Transfer, LLC 1016 Tobiano Lane Raleigh, North Carolina 27614

Re: K190260

Trade/Device Name: STERIZONE® VP4 Sterilizer Regulation Number: 21 CFR 880.6860 Regulation Name: Ethylene Oxide Gas Sterilizer Regulatory Class: Class II Product Code: PJJ Dated: June 24, 2019 Received: June 25, 2019

Dear Cynthia Pritchard:

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

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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 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 (QS) 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 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 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 Elizabeth Claverie, M.S. Assistant Director for THT4B2 Acting Assistant Director for THT4B1 DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

Device Name

STERIZONE® VP4 Sterilizer

Indications for Use (Describe)

The STERIZONE® VP4 Sterilizer is intended for use in terminal sterilization of cleaned, rinsed, and dried metal and non- metal reusable medical devices in health care facilities.

The single pre-set cycle of the STERIZONE® VP4 Sterilizer uses hydrogen peroxide and ozone. The injection of vaporized hydrogen peroxide is followed by the injection of ozone, which reacts with residual hydrogen peroxide to form hydroxyl radicals.

Sterilization efficacy was demonstrated using a representative sample of one or more device types and packaging, in nine separate validation loads, as described in Table 1 [refer to continuation pages 2 - 4 of this form]. The load to be processed should be maintained between 20℃ to 26℃ (68°F to 78°F). Total load weight shall not exceed 75 lb, inclusive of the containers/packaging weight but excluding the 25 lb loading rack.

Type of Use ( Select one or both, as applicable )
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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Validationload #	Load description	Load weight[Excluding the25 lb loadingrack]
1	Validation load #1 consisted of general medicalinstruments, representing the following geometries:• Clamp• Serrated surface• Box-lock• Handle• Button• Pivot hinge• StopcockType of packaging used: wrapped plastic tray, includingsilicone mats and brackets, and PouchGeneral medical instruments were spread out over threetrays, six pouches and one wrapped instrument.	11 lb
2	Validation load #2 consisted of general medicalinstruments, representing the following geometries:• Gliding mechanism• Hinges and screws• Serrated surface• Luer-lock• Spring• Rigid non-lumen scopesType of packaging used: wrapped plastic and aluminumtray, including silicone mats and brackets, rigid aluminumcontainer and PouchGeneral medical instruments were spread out over onecontainer, three trays, and six pouches.	20 lb
3	Validation load #3 consisted of three single-channelflexible endoscopes (Ureteroscope) with inside diameterof 1.0 mm and length of 850 mm, packaged individually inwrapped trays or containers, including appropriatesilicone brackets or mats. Eight general medicalinstruments each packaged in a pouch were added.	23 lb
Validationload #	Load description	Load weight[Excluding the25 lb loadingrack]
4	Validation load #4 consisted of up to 15 rigid or semi-rigidchanneled instruments in the presence of otherpackaged medical devices. Three double channel semi-rigid endoscopes (ureteroscope - 0.7 mm × 500 mm and1.1 mm × 500 mm) were packaged individually in wrappedtrays or containers including appropriate silicone bracketsor mats. Additional rigid channel instruments or stainlesssteel rigid lumens were added to each package. Twoadditional general medical instruments, each packaged ina pouch, were added.	19 lb
5	Validation load #5 consisted in two single channel flexibleendoscopes; one Ureteroscope with inside diameter of1.0 mm and length of 850 mm, and a Bronchoscope withinside diameter of 1.8 mm and length of 830 mm, and onedouble channel semi- rigid endoscope (ureteroscope - 0.7mm × 500 mm and 1.1 mm × 500 mm), packagedindividually in wrapped trays or containers includingappropriate silicone brackets or mats. No additional itemwas added.	21 lb
6	Validation load #6 consisted of general medicalinstruments, representing the following geometries:Distal end (swivel parts) Hinge with screw Cannula General medical instruments packaged in one aluminumsterilization container.	9 lb
7	Validation load #7 consisted of general medicalinstruments, representing the following geometries:Box-lock hinge Pivot hinge Luer-lock General medical instruments, spread out over three	75 lb
Validationload #	Load description	Load weight[Excluding the
		25 lb loadingrack]
8	Validation load #8 consisted of two double-channelflexible endoscopes (Ureteroscope) with inside diameter of1 mm and lengths of 850 and 989 mm; and one single-channel flexible endoscopes (Ureteroscope) with insidediameter of 1 mm and length of 850 mm, packagedindividually in wrapped plastic sterilization trays, includingappropriate silicone brackets or mats.	16 lb
9	Validation load #9 consisted of one multi-channel flexibleendoscope, with no more than 4 channels (VideoColonoscope), with inside diameters of 1.2 mm or moreand lengths of 1955 mm or less, or inside diameters of 1.45mm or more and lengths of 3500 mm or less; packaged inaluminum sterilization container.	17 lb

Table 1. Description of the nine validation loads

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K190260

Image /page/6/Picture/1 description: The image shows a logo with the letters 'TS' in blue, followed by a stylized chemical structure in gray. The chemical structure appears to represent a sulfur trioxide molecule, with the 'S' and 'O3' parts of the molecule integrated into the logo design. The overall design is clean and modern, suggesting a company or organization related to chemistry or technology.

510(k) Summary

Applicant Name and Address

TSO3 Inc. 2505, avenue Dalton Québec, QC G1P 3S5 Canada

Contact Person, Telephone, Fax

Sandy Cliche, Director, Regulatory Affairs and Quality Assurance Phone: (418) 651-0003 ext. 252 Fax: (418) 653-5726 E-mail: scliche@tso3.com

Date of Preparation

24 June 2019

Trade Name STERIZONE® VP4 Sterilizer

Common Name

Dual Sterilant Sterilizer

Classification Name

Regulation Number and Regulation Description: 21 CFR 880.6860; Ethylene oxide gas sterilizer Product Code and Device Name: PJJ; Two or more sterilant sterilizer

Technical Method: Dual sterilant sterilizer using hydrogen peroxide and ozone as the sterilant

Legally Marketed Predicate Device Name

STERIZONE® VP4 Sterilizer (K173694)

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Image /page/7/Picture/0 description: The image shows a logo with the letters 'TSO' in a stylized font. The 'T' is in a light blue color, while the 'S' and 'O' are in a darker blue. To the right of the 'O', there is a small subscript '3'. Above the 'SO', there is a graphic of three interconnected circles in gray, resembling a molecular structure or a network symbol.

Device Description

The changes to the sterilizer are component changes that were made to extend the of the hydrogen peroxide vaporization block. These changes include: 1] anodization of the hydrogen peroxide vaporization block, and 2] a reduction of the stabilizer concentration in the hydrogen peroxide solution.

Indications for Use

Sterilization efficacy was demonstrated using a representative sample of one or more device types and packaging, in nine separate validation loads, as described in Table 1. The load to be processed should be maintained between 20°C to 26°C (68°F to 78°F). Total load weight shall not exceed 75 lb, inclusive of the containers/packaging weight but excluding the 25 lb loading rack.

Validationload #	Load description	Load weight[Excluding the 25lb loading rack]
1	Validation load #1 consisted of general medicalinstruments, representing the following geometries:• Clamp• Serrated surface• Box-lock• Handle• Button• Pivot hinge• StopcockType of packaging used: wrapped plastic tray, includingsilicone mats and brackets, and PouchGeneral medical instruments were spread out over three	11 lb
Validationload #	Load description	Load weight
		[Excluding the 25lb loading rack]
2	Validation load #2 consisted of general medicalinstruments, representing the following geometries:• Gliding mechanism• Hinges and screws• Serrated surface• Luer-lock• Spring• Rigid non-lumen scopes	20 lb
	Type of packaging used: wrapped plastic and aluminum tray,including silicone mats and brackets, rigid aluminumcontainer and Pouch
	General medical instruments were spread out over onecontainer, three trays, and six pouches.
3	Validation load #3 consisted of three single-channelflexible endoscopes (Ureteroscope) with inside diameterof 1.0 mm and length of 850 mm, packaged individually inwrapped trays or containers, including appropriatesilicone brackets or mats. Eight general medicalinstruments, each packaged in a pouch, were added.	23 lb
4	Validation load #4 consisted of up to 15 rigid or semi-rigid channeled instruments in the presence of otherpackaged medical devices. Three double channel semi-rigid endoscopes (ureteroscope – 0.7 mm × 500 mm and1.1 mm × 500 mm) were packaged individually inwrapped trays or containers including appropriatesilicone brackets or mats. Additional rigid channelinstruments or stainless steel rigid lumens were added toeach package. Two additional general medicalinstruments, each packaged in a pouch, were added.	19 lb
5	Validation load #5 consisted in two single channel flexibleendoscopes; one Ureteroscope with inside diameter of1.0 mm and length of 850 mm, and a Bronchoscope withinside diameter of 1.8 mm and length of 830 mm, and onedouble channel semi- rigid endoscope (ureteroscope - 0.7mm × 500 mm and 1.1 mm × 500 mm), packagedindividually in wrapped traysor containers including appropriate silicone brackets ormats. No additional item was added.	21 Ib
Validationload #	Load description	Load weight[Excluding the 25lb loading rack]
6	Validation load #6 consisted of general medicalinstruments, representing the following geometries:• Distal end (swivel parts)• Hinge with screw• CannulaGeneral medical instruments packaged in one aluminumsterilization container.	9 lb
7	Validation load #7 consisted of general medicalinstruments, representing the following geometries:• Box-lock hinge• Pivot hinge• Luer-lockGeneral medical instruments, spread out over threealuminum sterilization containers, each weighting 25 lb.	75 lb
8	Validation load #8 consisted of two double-channelflexible endoscopes (Ureteroscope) with inside diameterof 1 mm and lengths of 850 and 989 mm; and one single-channel flexible endoscopes (Ureteroscope) with insidediameter of 1 mm and length of 850 mm, packagedindividually in wrapped plastic sterilization trays,including appropriate silicone brackets or mats.	16 lb
9	Validation load #9 consisted of one multi-channelflexible endoscope, with no more than 4 channels (VideoColonoscope), with inside diameters of 1.2 mm or moreand lengths of 1955 mm or less, or inside diameters of1.45 mm or more and lengths of 3500 mm or less;packaged in aluminum sterilization container	17 lb

Table 1. Description of the nine validation loads

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Image /page/8/Picture/0 description: The image shows a logo for a company or organization, featuring the letters 'TS' in a dark blue color, followed by 'O' with a subscript '3' in a lighter blue. To the right of the 'O3', there is a stylized molecular structure in gray, with three circles connected by lines, resembling a chemical compound. The overall design is clean and modern, suggesting a focus on technology, science, or a related field.

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Image /page/9/Picture/0 description: The image shows a logo with the letters 'TSO' in a stylized font. The 'T' is in a dark teal color, while the 'S' and 'O' are in a lighter teal. To the right of the 'O', there is a graphic that resembles a chemical structure, with interconnected circles in gray. Below the 'O', there is a small subscript '3' in the same teal color as the 'S' and 'O'.

Technological Characteristics

A comparison between the subject and predicate devices is provided [Table 2].

Table 2: General comparison of technical specifications, technology, and indications for use between the STERIZONE® VP4 Sterilizer and the predicate device

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Image /page/10/Picture/0 description: The image shows a logo with the letters 'TS' in blue, followed by a stylized chemical structure in gray and blue. The chemical structure appears to represent a sulfur trioxide molecule (SO3), with the 'O3' part of the formula written as a subscript to the 'S'. The overall design is clean and modern, suggesting a company or organization related to chemistry or technology.

	Predicate STERIZONE VP4 SterilizerK173694	SubjectSTERIZONE VP4K190260
Intended Use	Terminal sterilization of reusable medical devices in health care facilities	Same
GeneralIndication forUse	See Above	Same
Lumen claims
	Inner Diameter Lumen Length Single Channel Flexible Endoscope ≥ 1mm ≤ 850 mm Single & Double Channel Flexible Endoscope ≥ 1 mm ≤ 989 mm Multi-channel Flexible Endoscope (Video colonoscope/gastroscope – 4 channels total) ≥ 1.2 mm≥ 1.45 mm ≤ 1955 mm≤ 3500 mm Rigid Single & Double Channel Endoscope ≥ 0.7 mm ≤ 500 mm		Inner Diameter Lumen Length Same Same Same Same Same Same Same Same
Sterilant	Vaporized Hydrogen Peroxide/Ozone	Same
H2O2Concentrationby Weight	50%	Same
Number ofSterilizationCycles	One (“Cycle 1”)	Same
Critical ProcessParameters	Differential Chamber Pressure (ΔP) and Load Temperature	Same
GeneralPhysicalProcessParameters	Wall temperature, vaporization temperature, exposure times, flow rates, ozone concentration, component temperatures	Same

Chamber Volume	125L	Same
----------------	------	------

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Image /page/11/Picture/0 description: The image shows a logo with the letters 'TS' in blue, followed by a stylized chemical structure in gray and blue. The chemical structure appears to represent a sulfur-oxygen compound, possibly a sulfonate or sulfate group, with the subscript '3' indicating the number of oxygen atoms. The overall design is clean and modern, suggesting a company or organization involved in chemistry, science, or technology.

SoftwareControl	Omron PLC	Same
H2O2VaporizationBlock	6061 Aluminum H2O2 Vaporization Block Non-anodized	6061 AluminumH2O2 VaporizationBlock withanodization surfacetreatment
HydrogenPeroxideSolution	Durox® GradeH2O2 50-50.8%Stabilizers	SemiconductorGradeH2O2 50-50.8%Same stabilizers,but a lowerconcentration

The proposed changes to the sterilizer were for component changes. These changes were made to extend the use life of the hydrogen peroxide vaporization block. These changes include: 1] anodization of the hydrogen peroxide vaporization block, and 2] a reduction of the stabilizer concentration in the hydrogen peroxide solution.

Summary of Non-Clinical Testing:

Description of performance testing:

The modified STERIZONE® VP4 Sterilizer has been designed, constructed and tested to meet the safety and performance requirements of various North American safety codes and standards. The modified STERIZONE® VP4 Sterilizer complies with the applicable portions of the following standards:

O Canadian Standard Association (CSA) Standard C22.2 No 61010-1
O Underwriters Laboratory Standard UL 61010-1
Federal Communication Commission (FCC) Part 18 / EN 55011 O
International Electrotechnical Commission (IEC) Standard IEC 61326-1 O
International Electrotechnical Commission (IEC) Standard 61010-1 :2010, 61010-2-040 O

Sterility testing of directly inoculated medical devices was conducted employing an overkill approach in the modified sterilizers to demonstrate achievement of a sterility assurance level (SAL) of 10th. In each case, all parameters of each part of the test series met acceptance criteria.

The modification did not in any way impact the biocompatibility of the materials of the sterilized devices, since the materials sterilant residuals, have not changed. The verification tests performed to determine the concentration of post-sterilization H₂O₂ residuals on materials sterilized with the STERIZONE® VP4 Sterilizer equipped with the proposed anodized H₂O₂ vaporization block and the Semiconductor-grade H₂O₂ solution were tested under worst-case conditions.

A Failure Mode Effects Analysis (FMEA) has been conducted on the entire system of the STERIZONE® VP4 Sterilizer to ensure safety features and control redundancies have been implemented in the design and will be maintained during the manufacturing, installation,

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maintenance and servicing of the sterilizers. No changes to the user manual, labeling, or software were required.

Description of the Sterilization Validation Activities:

The modified STERIZONE® VP4 Sterilizer underwent performance validation testing using the "overkill" approach to demonstrate the effectiveness of the process in accordance with ANSI/AAMI/ISO 14937. Testing on directly inoculated medical devices was conducted employing half-cycle to demonstrate achievement of a sterility assurance level (SAL) of 10-°. This process has been demonstrated to achieve a sterility assurance level of 10t for terminal sterilization of packaged reusable medical devices.

Performance Testing Conclusion:

New test data have been generated in accordance with the FDA Sterilizer Guidance documents and applicable standards, to ensure that the sterilizer performance and other specifications meet TSO3 acceptance criteria.

Conclusion

The conclusion drawn from the non-clinical tests demonstrates that the STERIZONE® VP4 Sterilizer is as safe, as effective and performs as well as or better than the legally marketed predicate device (K173694).

Regulation Number and Section

§ 880.6860 Ethylene oxide gas sterilizer.

(a)
Identification. An ethylene gas sterilizer is a nonportable device intended for use by a health care provider that uses ethylene oxide (ETO) to sterilize medical products.(b)
Classification. Class II (performance standards).