STERIZONE(R) VP4 Sterilizer

K190260 · Tso3, Inc. · PJJ · Jul 19, 2019 · General Hospital

Device Facts

• Record ID: K190260
• Device Name: STERIZONE(R) VP4 Sterilizer
• Applicant: Tso3, Inc.
• Product Code: PJJ · General Hospital
• Decision Date: Jul 19, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

Self-contained, stand-alone sterilizer; uses vaporized hydrogen peroxide and ozone in a single, pre-set multiphase cycle. Process involves injecting vaporized hydrogen peroxide followed by ozone; reaction forms hydroxyl radicals for sterilization. Used in healthcare facilities for terminal sterilization of cleaned, rinsed, and dried metal and non-metal reusable medical devices, including rigid and flexible endoscopes. Device features an anodized 6061 aluminum hydrogen peroxide vaporization block and uses semiconductor-grade hydrogen peroxide solution. System monitors differential chamber pressure and load temperature. Healthcare providers load devices into trays/containers; system provides automated sterilization cycle. Benefits include effective terminal sterilization of complex medical instruments.

Clinical Evidence

Bench testing only. Validation performed per ANSI/AAMI/ISO 14937 using an overkill approach. Nine validation loads tested with various medical device geometries (clamps, hinges, flexible/rigid endoscopes) to demonstrate SAL of 10^-6. Residual H2O2 testing conducted under worst-case conditions. FMEA conducted to ensure safety and control redundancies.

Technological Characteristics

Dual sterilant (H2O2/Ozone); 125L chamber volume. Vaporization block: 6061 aluminum with anodized surface treatment. H2O2 solution: Semiconductor grade (50-50.8%). Control system: Omron PLC. Standards: CSA C22.2 No 61010-1, UL 61010-1, FCC Part 18, EN 55011, IEC 61326-1, IEC 61010-1:2010, IEC 61010-2-040.

Indications for Use

Indicated for terminal sterilization of cleaned, rinsed, and dried metal and non-metal reusable medical devices in health care facilities. Compatible with rigid/flexible endoscopes and general medical instruments.

Regulatory Classification

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.

Predicate Devices

• STERIZONE® VP4 Sterilizer (K173694)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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 ( <i>Select one or both, as applicable</i> ) | |
|-----------------------------------------------------------------------|---------------------------------------------------------------------------------|
| <input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | <input checked="" type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |

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| Validation<br>load # | Load description | Load weight<br>[Excluding the<br>25 lb loading<br>rack] |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|
| 1 | Validation load #1 consisted of general medical<br>instruments, representing the following geometries:<br>• Clamp<br>• Serrated surface<br>• Box-lock<br>• Handle<br>• Button<br>• Pivot hinge<br>• Stopcock<br>Type of packaging used: wrapped plastic tray, including<br>silicone mats and brackets, and Pouch<br>General medical instruments were spread out over three<br>trays, six pouches and one wrapped instrument. | 11 lb |
| 2 | Validation load #2 consisted of general medical<br>instruments, representing the following geometries:<br>• Gliding mechanism<br>• Hinges and screws<br>• Serrated surface<br>• Luer-lock<br>• Spring<br>• Rigid non-lumen scopes<br>Type of packaging used: wrapped plastic and aluminum<br>tray, including silicone mats and brackets, rigid aluminum<br>container and Pouch<br>General medical instruments were spread out over one<br>container, three trays, and six pouches. | 20 lb |
| 3 | Validation load #3 consisted of three single-channel<br>flexible endoscopes (Ureteroscope) with inside diameter<br>of 1.0 mm and length of 850 mm, packaged individually in<br>wrapped trays or containers, including appropriate<br>silicone brackets or mats. Eight general medical<br>instruments each packaged in a pouch were added. | 23 lb |
| Validation<br>load # | Load description | Load weight<br>[Excluding the<br>25 lb loading<br>rack] |
| 4 | Validation load #4 consisted of up to 15 rigid or semi-rigid<br>channeled instruments in the presence of other<br>packaged medical devices. Three double channel semi-rigid endoscopes (ureteroscope - 0.7 mm × 500 mm and<br>1.1 mm × 500 mm) were packaged individually in wrapped<br>trays or containers including appropriate silicone brackets<br>or mats. Additional rigid channel instruments or stainless<br>steel rigid lumens were added to each package. Two<br>additional general medical instruments, each packaged in<br>a pouch, were added. | 19 lb |
| 5 | Validation load #5 consisted in two single channel flexible<br>endoscopes; one Ureteroscope with inside diameter of<br>1.0 mm and length of 850 mm, and a Bronchoscope with<br>inside diameter of 1.8 mm and length of 830 mm, and one<br>double channel semi- rigid endoscope (ureteroscope - 0.7<br>mm × 500 mm and 1.1 mm × 500 mm), packaged<br>individually in wrapped trays or containers including<br>appropriate silicone brackets or mats. No additional item<br>was added. | 21 lb |
| 6 | Validation load #6 consisted of general medical<br>instruments, representing the following geometries:<br>Distal end (swivel parts) Hinge with screw Cannula General medical instruments packaged in one aluminum<br>sterilization container. | 9 lb |
| 7 | Validation load #7 consisted of general medical<br>instruments, representing the following geometries:<br>Box-lock hinge Pivot hinge Luer-lock General medical instruments, spread out over three | 75 lb |
| Validation<br>load # | Load description | Load weight<br>[Excluding the |
| | | 25 lb loading<br>rack] |
| 8 | Validation load #8 consisted of two double-channel<br>flexible endoscopes (Ureteroscope) with inside diameter of<br>1 mm and lengths of 850 and 989 mm; and one single-<br>channel flexible endoscopes (Ureteroscope) with inside<br>diameter of 1 mm and length of 850 mm, packaged<br>individually in wrapped plastic sterilization trays, including<br>appropriate silicone brackets or mats. | 16 lb |
| 9 | Validation load #9 consisted of one multi-channel flexible<br>endoscope, with no more than 4 channels (Video<br>Colonoscope), with inside diameters of 1.2 mm or more<br>and lengths of 1955 mm or less, or inside diameters of 1.45<br>mm or more and lengths of 3500 mm or less; packaged in<br>aluminum 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: [phone] ext. 252 Fax: [phone] E-mail: [e-mail]

# 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 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.

#### Indications for Use

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. 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.

| Validation<br>load # | Load description | Load weight<br>[Excluding the 25<br>lb loading rack] |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|
| 1 | Validation load #1 consisted of general medical<br>instruments, representing the following geometries:<br>• Clamp<br>• Serrated surface<br>• Box-lock<br>• Handle<br>• Button<br>• Pivot hinge<br>• Stopcock<br>Type of packaging used: wrapped plastic tray, including<br>silicone mats and brackets, and Pouch<br>General medical instruments were spread out over three | 11 lb |
| Validation<br>load # | Load description | Load weight |
| | | [Excluding the 25<br>lb loading rack] |
| 2 | Validation load #2 consisted of general medical<br>instruments, representing the following geometries:<br>• Gliding mechanism<br>• Hinges and screws<br>• Serrated surface<br>• Luer-lock<br>• Spring<br>• Rigid non-lumen scopes | 20 lb |
| | Type of packaging used: wrapped plastic and aluminum tray,<br>including silicone mats and brackets, rigid aluminum<br>container and Pouch | |
| | General medical instruments were spread out over one<br>container, three trays, and six pouches. | |
| 3 | Validation load #3 consisted of three single-channel<br>flexible endoscopes (Ureteroscope) with inside diameter<br>of 1.0 mm and length of 850 mm, packaged individually in<br>wrapped trays or containers, including appropriate<br>silicone brackets or mats. Eight general medical<br>instruments, each packaged in a pouch, were added. | 23 lb |
| 4 | Validation load #4 consisted of up to 15 rigid or semi-<br>rigid channeled instruments in the presence of other<br>packaged medical devices. Three double channel semi-<br>rigid endoscopes (ureteroscope – 0.7 mm × 500 mm and<br>1.1 mm × 500 mm) were packaged individually in<br>wrapped trays or containers including appropriate<br>silicone brackets or mats. Additional rigid channel<br>instruments or stainless steel rigid lumens were added to<br>each package. Two additional general medical<br>instruments, each packaged in a pouch, were added. | 19 lb |
| 5 | Validation load #5 consisted in two single channel flexible<br>endoscopes; one Ureteroscope with inside diameter of<br>1.0 mm and length of 850 mm, and a Bronchoscope with<br>inside diameter of 1.8 mm and length of 830 mm, and one<br>double channel semi- rigid endoscope (ureteroscope - 0.7<br>mm × 500 mm and 1.1 mm × 500 mm), packaged<br>individually in wrapped trays<br>or containers including appropriate silicone brackets or<br>mats. No additional item was added. | 21 Ib |
| Validation<br>load # | Load description | Load weight<br>[Excluding the 25<br>lb loading rack] |
| 6 | Validation load #6 consisted of general medical<br>instruments, representing the following geometries:<br>• Distal end (swivel parts)<br>• Hinge with screw<br>• Cannula<br>General medical instruments packaged in one aluminum<br>sterilization container. | 9 lb |
| 7 | Validation load #7 consisted of general medical<br>instruments, representing the following geometries:<br>• Box-lock hinge<br>• Pivot hinge<br>• Luer-lock<br>General medical instruments, spread out over three<br>aluminum sterilization containers, each weighting 25 lb. | 75 lb |
| 8 | Validation load #8 consisted of two double-channel<br>flexible endoscopes (Ureteroscope) with inside diameter<br>of 1 mm and lengths of 850 and 989 mm; and one single-<br>channel flexible endoscopes (Ureteroscope) with inside<br>diameter of 1 mm and length of 850 mm, packaged<br>individually in wrapped plastic sterilization trays,<br>including appropriate silicone brackets or mats. | 16 lb |
| 9 | Validation load #9 consisted of one multi-channel<br>flexible endoscope, with no more than 4 channels (Video<br>Colonoscope), with inside diameters of 1.2 mm or more<br>and lengths of 1955 mm or less, or inside diameters of<br>1.45 mm or more and lengths of 3500 mm or less;<br>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 Sterilizer<br>K173694 | Subject<br>STERIZONE VP4<br>K190260 | | | | | | | | | | | | | | | | | | | | | | | | | |
|----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|-----------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|
| Intended Use | Terminal sterilization of reusable medical devices in health care facilities | Same | | | | | | | | | | | | | | | | | | | | | | | | | |
| General<br>Indication for<br>Use | 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<br>≥ 1.45 mm ≤ 1955 mm<br>≤ 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 | | | | | | | | | | | | | | | | | | | | | | | | | |
| H2O2<br>Concentration<br>by Weight | 50% | Same | | | | | | | | | | | | | | | | | | | | | | | | | |
| Number of<br>Sterilization<br>Cycles | One (“Cycle 1”) | Same | | | | | | | | | | | | | | | | | | | | | | | | | |
| Critical Process<br>Parameters | Differential Chamber Pressure (ΔP) and Load Temperature | Same | | | | | | | | | | | | | | | | | | | | | | | | | |
| General<br>Physical<br>Process<br>Parameters | 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.

| Software<br>Control | Omron PLC | Same |
|----------------------------------|----------------------------------------------------|----------------------------------------------------------------------------------------------|
| H2O2<br>Vaporization<br>Block | 6061 Aluminum H2O2 Vaporization Block Non-anodized | 6061 Aluminum<br>H2O2 Vaporization<br>Block with<br>anodization surface<br>treatment |
| Hydrogen<br>Peroxide<br>Solution | Durox® Grade<br>H2O2 50-50.8%<br>Stabilizers | Semiconductor<br>Grade<br>H2O2 50-50.8%<br>Same stabilizers,<br>but a lower<br>concentration |

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).