STERIZONE STERILIZER

K141163 · Tso3, Inc. · PJJ · Dec 17, 2014 · General Hospital

Device Facts

• Record ID: K141163
• Device Name: STERIZONE STERILIZER
• Applicant: Tso3, Inc.
• Product Code: PJJ · General Hospital
• Decision Date: Dec 17, 2014
• 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 seven separate validation loads, as described in Table 1. The load to be processed should be maintained between 20℃ to 26℃ (68°F to 78°F). Total load weight shall not exceed 75 lbs. inclusive of the containers/packaging weight but excluding the 25 lbs loading rack.

Device Story

STERIZONE® VP4 is a low-temperature sterilizer for reusable medical devices; uses dual sterilants (vaporized 50% hydrogen peroxide and ozone) in a multiphase process. Input: cleaned/dried medical devices in compatible packaging (polypropylene wraps, Tyvek pouches, or aluminum containers). Operation: vacuum pre-conditioning; dynamic H2O2 exposure; ozone injection to react with residual H2O2 forming hydroxyl radicals; evacuation/ventilation via catalytic converter. Used in healthcare facilities; operated by staff. Output: sterile, ready-to-use instruments; no aeration required. Benefits: rapid turnaround; no toxic residues. Safety features: factory-programmed control system; cycle aborts if parameters (pressure/time) fall outside range; fault tree analysis/FMECA implemented for control redundancies.

Clinical Evidence

Bench testing only. Efficacy validated using seven representative loads (up to 75 lbs) including rigid/flexible endoscopes and general instruments. Achieved SAL 10^-6 using overkill approach. Simulated-use testing confirmed efficacy in presence of organic/inorganic matter. Safety testing confirmed no toxic residues, compliance with electrical (UL/CSA 61010-1) and EMC (FCC/IEC 61326) standards, and successful Fault Tree/FMECA analysis.

Technological Characteristics

Chamber volume 125L. Sterilants: 50% H2O2 solution and Ozone. Process: multiphase, vacuum-based, catalytic converter for exhaust. Materials: compatible with polypropylene, Tyvek, aluminum. Connectivity: standalone. Standards: UL 61010-1, CSA C22.2 No 61010-1, IEC 61010-1/2-040, IEC 61326, FCC Part 18. Software: factory-programmed control system with cycle monitoring and abort logic.

Indications for Use

Indicated for terminal sterilization of cleaned, rinsed, and dried metal and non-metal reusable medical devices in health care facilities, including instruments with diffusion-restricted spaces (hinged forceps/scissors) and rigid/flexible channeled devices.

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

• STERRAD® 100NX® Sterilizer with DUO Cycle (K111377)
• Amsco® V-PRO® maX Low Temperature Sterilization System (K131120)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around an emblem. The emblem consists of a stylized human figure with three faces, representing the department's focus on health and human well-being.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 17, 2014

TSO3 Inc. C/O Thomas Richards, Ph.D. Consultant IM3, Inc. 512F NE 81st Street, Suite110 Vancouver, WA 98665

Re: K141163

Trade/Device Name: STERIZONE® VP4 Sterilizer Regulation Number: 21 CFR 880.6860 Regulation Name: Ethylene Oxide Gas Sterilizer Regulatory Class: II Product Code: PJJ Dated: December 8, 2014 Received: December 10, 2014

Dear Dr. Richards:

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. 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.

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Page 2 - Dr. Richards

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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# Indications for Use

510(k) Number (if known) K141163

#### 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 seven separate validation loads, as described in Table 1. The load to be processed should be maintained between 20℃ to 26℃ (68°F to 78°F). Total load weight shall not exceed 75 lbs. inclusive of the containers/packaging weight but excluding the 25 lbs loading rack.

| Validation<br>load # | Load description | Load weight1<br>1Excluding the 25<br>lb loading rack |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|
| 1 | Validation load #1 consisted of general medical instruments, representing the following geometries: Clamp Serrated surface Box-lock Handle Button Pivot hinge Stopcock Type of packaging used: wrapped plastic tray, including silicone mats and brackets, and Pouch<br>General medical instruments were spread out over three trays, six pouches and one wrapped instrument. | 11 lb |
| 2 | Validation load #2 consisted of general medical instruments, representing the following geometries: Gliding mechanism Hinges and screws Serrated surface Luer-lock Spring Rigid non-lumen scopes Type of packaging used: wrapped plastic and aluminum tray, including silicone mats and brackets, rigid aluminum container and Pouch<br>General medical instruments were spread out over one container, three trays, and six pouches. | 20 lb |

# Table 1. Description of the seven validation loads

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| Validation<br>load # | Load description | Load weight1<br><span style="font-size: smaller;">Excluding the 25<br/>Ib loading rack1</span> |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| 3 | Validation load #3 consisted of three single channel flexible endoscopes<br>(Ureteroscope) with inside diameter of 1.0 mm and length of 850 mm, packaged<br>individually in wrapped trays or containers, including appropriate silicone brackets<br>or mats. Eight general medical instruments, 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<br>the presence of other packaged medical devices. Three double channel semi-rigid<br>endoscopes (ureteroscope - $0.7 mm \times 500 mm$ and $1.1 mm \times 500 mm$ ) were<br>packaged individually in wrapped trays or containers including appropriate silicone<br>brackets or mats. Additional rigid channeled instruments or stainless steel rigid<br>lumens were added to each package. Two additional general medical instruments,<br>each packaged in a pouch, were added. | 19 lb |
| 5 | Validation load #5 consisted in two single channel flexible endoscopes; one<br>Ureteroscope with inside diameter of 1.0 mm and length of 850 mm, and a<br>Bronchoscope with inside diameter of 1.8 mm and length of 830 mm, and one<br>double channel semi- rigid endoscope (ureteroscope - $0.7 mm \times 500 mm$ and $1.1 mm \times 500 mm$ ), packaged individually in wrapped trays or containers including<br>appropriate silicone brackets or mats. No additional item was added. | 21 lb |
| 6 | Validation load #6 consisted of general medical instruments, representing the<br>following geometries:<br>• Distal end (swivel parts)<br>• Hinge with screw<br>• Cannula<br>General medical instruments packaged in one aluminum sterilization container. | 9 lb |
| 7 | Validation load #7 consisted of general medical instruments, representing the<br>following geometries:<br>• Box-lock hinge<br>• Pivot hinge<br>• Luer-lock<br>General medical instruments, spread out over three aluminum sterilization<br>containers, each weighting 25 lb. | 75 lb |

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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Image /page/4/Picture/0 description: The image shows a chemical structure. The structure contains the letters 'Ts' on the left side. To the right of 'Ts' is a chemical structure with a benzene ring and three oxygen atoms. The number '3' is located at the bottom right of the structure.

### 510(k) Summary

#### Applicant's Name and Address

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

### Contact Person, Telephone, FAX

Marc Chaunet, Director of Regulatory Affairs Phone: [phone] ext. 242 Fax: [phone] E-mail: [e-mail]

### U.S. Contact

IM3, Inc. Contact: Thomas Richards, Ph.D. Phone: [phone] Email: [e-mail]

Summary Date December 12, 2014

Trade Name STERIZONE® VP4 Sterilizer

#### Common Name

Vaporized Hydrogen Peroxide Sterilizer

### Classification Name

Sterilizer, Chemical Class II (as per 21CFR, part 880.6860 equivalent device) Product code: PJJ

#### Legally Marketed Equivalent Device Name(s)

STERRAD® 100NX® Sterilizer with DUO Cycle (K111377) Amsco® V-PRO® maX Low Temperature Sterilization System (K131120)

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Image /page/5/Picture/0 description: The image shows a chemical structure diagram. The diagram depicts a central sulfur atom (S) bonded to three oxygen atoms (O), forming an SO3 group. The 'T' next to the sulfur atom is not clearly defined in the image, but it may represent a functional group or a placeholder for a larger molecule. The overall structure suggests a sulfur-containing compound, possibly an intermediate or a fragment of a larger molecule.

### Process description

The STERIZONE® VP4 Sterilizer offers a single pre-set sterilization cycle designed for the sterilization of general instruments, single channel flexible endoscopes, rigid and semi-rigid channeled devices including single channel and double channel rigid endoscopes.

The STERIZONE® VP4 Sterilizer uses dual sterilants, vaporized hydrogen peroxide (H202) and ozone (O3), in a multiphase process.

Upon loading the medical devices into the sterilization chamber and closure of the door, the chamber is subjected to a vacuum of 1 Torr (referred to as pre-conditioning step). The first cycle phase (Phase 1) is initiated with the Dynamic H2O2 exposure step. During this step, a 50 weight-percent hydrogen peroxide solution (referred to as 125-280 Solution™) is injected at a fixed injection rate in vapor form into the sterilization chamber through a continuous micropulsed injection until a differential pressure set point of 19 Torr is reached (i.e., the actual chamber pressure is 20 Torr, less the initial vacuum of 1 Torr, which is equivalent to a "differential pressure" or "AP" of 19 Torr). The total amount of hydrogen peroxide introduced into the sterilization chamber and thus the duration of the injection varies depending on load composition (e.g. surface area), weight and temperature.

The second step of the cycle phase is the H2O2 Reduction Step. During this step, a set concentration of ozone is injected into the chamber and reacts with residual hydrogen peroxide to form hydroxyl radicals.

During the second cycle phase (Phase 2), the same sequence is repeated, including the Dynamic H2O2 exposure and H2O2 reduction steps. The full Cycle is then completed with an evacuation and ventilation, through a catalytic converter, to the atmosphere, at which point the chamber door can be safely opened.

The cycle process parameters are summarized in Table 1.

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| Hydrogen peroxide exposure | | | | Ozone exposure | | | |
|------------------------------------|--------------------------------------------------|-----------------|-----------------------|---------------------------------------|-----------------|-------------|-----------------|
| Hydrogen<br>peroxide solution | Chamber<br>differential<br>pressure<br>set point | Time | Sterilant<br>injected | Vaporizer /<br>Chamber<br>temperature | O3<br>injection | O3<br>dwell | Nb of<br>phases |
| 125-280 Solution™<br>(H2O2 50 wt%) | 19 Torr | 210-600<br>sec* | 8.4-24 g* | 120°C /<br>41 ± 3°C | 2 mg/L | 5 min | 2 |

### Table 1. STERIZONE® VP4 Sterilizer – Cycle process parameters

* Vaporized hydrogen peroxide injection/exposure time (Dynamic H2O2 exposure step) varies with load composition and conditions. The quantity of vaporized hydrogen peroxide injected is directly related to the time required to reach a pressure differential of 19 Torr in the chamber, for load temperature ranging from 20℃ to 26℃. If the H2O2 injection time is less than 210 seconds, or greater than 600 seconds, the cycle will abort.

### 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 dual sterilants 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 seven separate validation loads, as described in Table 2. 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 lbs, inclusive of the containers/packaging weight but excluding the 25 lbs loading rack.

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Image /page/7/Picture/0 description: The image shows a chemical structure diagram. The diagram depicts a molecule with the abbreviation 'Ts' on the left, followed by a sulfur atom (S) connected to three oxygen atoms (O). The oxygen atoms are arranged in a triangular shape around the sulfur atom, suggesting a sulfonate group. The 'Ts' likely represents a tosyl group, a common protecting group in organic chemistry.

| Validation<br>load # | Load description | Load<br>weight1 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|
| | | 1Excluding<br>the 25 lb<br>loading<br>rack |
| 1 | Validation load #1 consisted of general medical instruments, representing the<br>following geometries:<br>Clamp Serrated surface Box-lock Handle Button Pivot hinge Stopcock Type of packaging used: wrapped plastic tray, including silicone mats and<br>brackets, and Pouch<br>General medical instruments were spread out over three trays, six pouches and one<br>wrapped instrument. | 11 lb |
| 2 | Validation load #2 consisted of general medical instruments, representing the<br>following geometries:<br>Gliding mechanism Hinges and screws Serrated surface Luer-lock Spring Rigid non-lumen scopes Type of packaging used: wrapped plastic and aluminum tray, including silicone mats<br>and brackets, rigid aluminum container and Pouch<br>General medical instruments were spread out over one container, three trays, and six<br>pouches. | 20 lb |
| 3 | Validation load #3 consisted of <b>three</b> single channel flexible endoscopes<br>(Ureteroscope) with inside diameter of 1.0 mm and length of 850 mm, packaged<br>individually in wrapped trays or containers, including appropriate silicone<br>brackets or mats. Eight general medical instruments, each packaged in a pouch,<br>were added. | 23 lb |
| 4 | Validation load #4 consisted of up to <b>15</b> rigid or semi-rigid channeled<br>instruments in the presence of other packaged medical devices. Three double<br>channel semi-rigid endoscopes (ureteroscope – 0.7 mm × 500 mm and 1.1 mm ×<br>500 mm) were packaged individually in wrapped trays or containers including<br>appropriate silicone brackets or mats. Additional rigid channeled instruments or<br>stainless steel rigid lumens were added to each package. Two additional general<br>medical instruments, each packaged in a pouch, were added. | 19 lb |
| 5 | Validation load #5 consisted in <b>two</b> single channel flexible endoscopes; one<br>Ureteroscope with inside diameter of 1.0 mm and length of 850 mm, and a<br>Bronchoscope with inside diameter of 1.8 mm and length of 830 mm, and <b>one</b><br>double channel semi- rigid endoscope (ureteroscope - 0.7 mm × 500 mm and<br>1.1 mm × 500 mm), packaged individually in wrapped trays or containers<br>including appropriate silicone brackets or mats. No additional item was added. | 21 lb |
| Validation<br>load # | Load description | Load<br>weight1<br>1Excluding<br>the 25 lb<br>loading<br>rack |
| 6 | Validation load #6 consisted of general medical instruments, representing the<br>following geometries:<br>• Distal end (swivel parts)<br>• Hinge with screw<br>• Cannula<br>General medical instruments packaged in one aluminum sterilization container. | 9 lb |
| 7 | Validation load #7 consisted of general medical instruments, representing the<br>following geometries:<br>• Box-lock hinge<br>• Pivot hinge<br>• Luer-lock<br>General medical instruments, spread out over three aluminum sterilization<br>containers, each weighting 25 lb. | 75 lb |

# Table 2. Description of the seven validation loads

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### Description of Device

The STERIZONE® VP4 Sterilization chamber has a capacity of 4.4 cu. ft. (125 liters). It requires oxygen (94% pure and greater), electricity and the 125-280 Solution™ containing 50% hydrogen peroxide by weight. Both hydrogen peroxide and ozone are used in a multiphase process.

The STERIZONE® VP4 Sterilizer is equipped with a factory-programmed control system offering a unique sterilization cycle.

Processed medical instruments are ready to use immediately after the cycle ends; no aeration is required.

Polypropylene non-woven wrapping material, non-woven polyethylene (Tyvek™) with polyester/LDPE transparent film pouches, and vaporized hydrogen peroxide compatible aluminium containers using disposable polypropylene filters, are used as packaging for medical devices to be sterilized. Plastic and metal trays are also suitable packaging means when combined with polypropylene wraps.

A self-contained biological indicator containing spores of G. stearothermophilus, incorporated into a test pack, is recommended to monitor cycle performance.

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The STERIZONE® VP4 Sterilizer could be installed as a free standing unit or recessed behind the wall.

No exhaust gas ventilation duct is required as long as the room is adequately ventilated.

## Effectiveness

The STERIZONE® VP4 Sterilizer performance validation testing was performed using the « overkill » approach to demonstrate the effectiveness of the process. Testing on directly inoculated medical devices was conducted employing half-cycle to demonstrate achievement of a sterility assurance level (SAL) of 106 at the complete cycle.

This process has been demonstrated to be effective for terminal sterilization of packaged reusable medical devices.

# Safety

The 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 STERIZONE® VP4 Sterilizer complies with the applicable portions of the following standards:

- Canadian Standard Association (CSA) Standard C22.2 No 61010-1: 2004 .
- Underwriters Laboratory Standard UL 61010-1: 2004
- Federal Communication Commission (FCC) Part 18 / EN 55011 ●
- International Electrotechnical Commission (IEC) Standard IEC 61326: 2012
- . International Electrotechnical Commission (IEC) Standard 61010-1 :2001, 61010-2-040: 2005

A Fault Tree Analysis and Mitigation (FTA-MIT) and a Failure Mode Effects and Criticality Analysis (FMECA) 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.

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Image /page/10/Picture/0 description: The image shows a chemical structure diagram. The diagram depicts a TsO3 molecule, with 'Ts' representing a tosyl group attached to a sulfur atom (S). The sulfur atom is bonded to three oxygen atoms (O3). The structure is presented in a simplified, two-dimensional format, commonly used in chemical notation.

To ensure optimum performance, the user must ensure the materials, instruments and devices to be sterilized are thoroughly cleaned and dried, that the instrument manufacturer's instructions are followed, and that each sterilization load is monitored with biological and chemical sterilization process indicators.

The software controls of the STERIZONE® VP4 Sterilizer have been designed providing safeguards that only intended operating cycles function to completion. Process parameters falling outside acceptable range will cancel the cycle and provide appropriate information identifying the source of the problem detected.

The following Table 3 summarizes the safety and effectiveness testing performed for the STERIZONE® VP4 Sterilizer.

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# Table 3. Summary of Safety and Effectiveness testing performed for the STERIZONE® VP4 Sterilizer

| | Performance Requirements for Effectiveness | Results |
|---|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|
| 1 | Effective to sterilize medical devices inoculated with 106 microorganism at the half-cycle conditions (Half-cycle validation testing) | Met requirements |
| 2 | Effective to sterilize medical devices inoculated with 106 microorganism in the presence of organic and inorganic matter at the complete cycle (Simulated-use testing) | Met requirements |
| 3 | Sterilize medical devices in real life conditions (In-use testing) | Met requirements |
| 4 | Pass the AOAC Sporicidal Screening Test | Met requirements |
| 5 | Sterilize effectively on non-woven polyethylene sterilization pouches, rigid aluminum containers and wrapped trays | Met requirements |
| 6 | Sterilization efficacy is repeatable | Met requirements |
| | Performance Requirements for Safety | |
| 1 | Sterilant is not toxic for users and patients | Met requirements |
| 2 | Most of the materials used in the manufacturing of medical devices are compatible with the hydrogen peroxide-ozone sterilization process | Met requirements |
| 3 | Sterilizer complies with electrical safety standards UL 61010-1, CAN/CSA 61010-1, EN/IEC 61010-1 and 61010-2-040 | Met requirements |
| 4 | Sterilizer complies with EMI/EMC requirements of FCC 47CFR, part 18, subpart B, and IEC 613261 | Met requirements |
| 5 | A Fault Tree Analysis and Mitigation (FTA-MIT) analysis have been preformed on the sterilizer and potential hazards were identified and mitigations were implemented among the control software safeties and design features | Met requirements |
| 6 | A Failure Mode Effects and Criticality Analysis (FMECA) was done for each component of the sterilizer and safeties were included in the design of the device according to the findings of this study (built-in safeties) | Met requirements |
| 7 | The amount of hydrogen peroxide and ozone remaining on containers and pouches immediately after cycle is not significant | Met requirements |
| 8 | There are no toxic residue or by-products residues remaining in/on medical product after the sterilization cycle is completed. After the cycle is completed, medical devices are cool to touch and ready to use immediately (no aeration is required) | Met requirements |
| 9 | The sterilization process is safe from an occupational safety point of view | Met requirements |

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## Substantial equivalence

The STERIZONE® VP4 Sterilizer ("VP4") is substantially equivalent to the STERRAD® 100NX® Sterilizer with DUO Cycle (K111377) and STERIS (Amsco®) V-PRO® maX Low Temperature Sterilization System (K131120). Table 4 summarizes the general specifications, indications, and overall technological characteristics for both the VP4 and predicate devices.

### Table 4. General comparison of technical specifications, technology, and indications for the subject device and predicate devices.

| | Subject Device:<br>STERIZONE® VP4 | Predicate Device:<br>STERRAD 100NX<br>K111377 | Predicate Device:<br>STERIS V-PRO maX<br>K131120 |
|---------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Terminal sterilization of reusable medical devices in health care facilities | Same | Same |
| General<br>Indications for<br>Use | The STERIZONE® VP4<br>Sterilizer is intended for<br>use in terminal<br>sterilization of cleaned,<br>rinsed, and dried metal<br>and non-metal reusable<br>medical devices in health<br>care facilities. | The STERRAD® 100NX®<br>Sterilizer is designed for<br>sterilization of both metal<br>and nonmetal medical<br>devices at low<br>temperatures. The<br>STERRAD sterilization<br>process is a multiphase<br>sterilization process that<br>utilizes a combination of<br>exposure to hydrogen<br>peroxide vapor and<br>plasma to safely sterilize<br>medical instruments and<br>materials without leaving<br>toxic residue. | The Amsco V-PRO maX<br>Low Temperature<br>Sterilization System, with<br>VAPROX® HC Steriant, is<br>a vaporized hydrogen<br>peroxide sterilizer<br>intended for use in the<br>terminal sterilization of<br>cleaned, rinsed, and dried<br>reusable metal and non-<br>metal medical devices<br>used in health care<br>facilities. |
| Sterilant | Vaporized Hydrogen<br>Peroxide / Ozone | Vaporized Hydrogen<br>Peroxide | Vaporized Hydrogen<br>Peroxide |
| H2O2<br>Concentration by<br>Weight | 50% | 59-94%<br>Depending on Cycle | 59% |
| Post H2O2<br>injection step | Ozone injection / Dwell | Air pulse / Dwell / Plasma | Air pulse / Dwell |
| Number Pulses | 2 | 2 | 4 |
| | Subject Device:<br>STERIZONE® VP4<br>Image: STERIZONE VP4 | Predicate Device:<br>STERRAD 100NX<br>K111377<br>Image: STERRAD 100NX | Predicate Device:<br>STERIS V-PRO maX<br>K131120<br>Image: STERIS V-PRO maX |
| Dimensions | H: 75.5 in (191.8 cm)<br>W: 30.5 in (77.5 cm)<br>D: 48.6 in (123.5 cm) | H: 70.5 in (179.1 cm)<br>W: 30.5 in (77.5 cm)<br>D: 40.0 in (102 cm) | H: 75.1 in (190.8 cm)<br>W: 33.0 in (83.8 cm)<br>D: 37.6 in (95.4 cm) |
| Weight | 1,245 lb (565 kg) | 938-1,006 lb (425-457 kg) | 788-910 lb (357-413 kg) |
| Chamber Volume | 125 L | 152 L | 136 L |
| Equipment<br>Operating<br>Temperature | 20-26 °C<br>Same as Load Temp | 18-35 °C (64-95 °F) | 5-40°C (41-104 °F) |
| Chamber (Wall)<br>Temperature | 41 °C | <55 °C | 50 °C |
| Load Temperature | 20-26 °C | Not Specified | Not Specified |
| H2O2 Vaporizer<br>Temperature | 120 °C (under vacuum) | 75 °C (under vacuum) | 60 °C (under vacuum) |
| Number of Pre-<br>Programmed<br>Cycles | 1 | 4<br>• Standard<br>• Flex Scope<br>• Express<br>• DUO | 3<br>• Non Lumen<br>• Lumen<br>• Flexible |
| Key Critical<br>Process<br>Parameters | Differential Chamber<br>Pressure (△P) & Load<br>Temperature | H2O2 Dose & Exposure<br>Time | H2O2 Dose & Exposure<br>Time |
| Use of Pre-<br>Conditioning Step | YES | YES | YES |
| Use of Secondary<br>Step to Remove<br>Residual H2O2<br>(technology) | YES<br>(ozone, acts as a sterilant) | YES<br>(plasma) | NO |
| Use of Aeration<br>Step | YES | YES | YES |
| Feature | STERIZONE® VP4 | STERRAD® 100NX®<br>(K111377) | Amsco® V-PRO® maX<br>(K131120) |
| Intended<br>use | Terminal sterilization of reusable medical devices in health care facilities | Terminal sterilization of reusable medical devices in health care facilities | Terminal sterilization of reusable medical devices in health care facilities |
| Labeling/<br>Indications<br>for use | Sterilization of both metal and nonmetal medical devices. Sterilization of instruments which have diffusion-restricted spaces, such as hinged portions of forceps and scissors. Processing of medical devices having rigid and flexible channels with limitations in materials, dimensions and number of devices. | Sterilization of both metal and nonmetal medical devices. Sterilization of instruments which have diffusion-restricted spaces, such as hinged portions of forceps and scissors. Processing of medical devices having rigid and flexible channels with limitations in materials, dimensions and number of devices. | Sterilization of both metal and nonmetal medical devices. Sterilization of instruments which have diffusion-restricted spaces, such as hinged portions of forceps and scissors. Processing of medical devices having rigid and flexible channels with limitations in materials, dimensions and number of devices. |
| Lumen<br>claims* | | | |
| | | I.D.<br>(mm) | Lumen<br>(mm) |
| | Rigid | ≥ 0.7 | ≤ 500 |
| | Double Rigid | ≥ 0.7 | ≤ 500 |
| | Flexible | ≥ 1 | ≤ 850 |
| | | | |
| | | I.D.<br>(mm) | Lumen<br>(mm) |
| | Rigid | ≥ 0.7 | ≤ 500 |
| | Flexible | ≥ 1 | < 875* |
| | | | |
| | | I.D.<br>(mm) | Lumen<br>(mm) |
| | Single Rigid | ≥ 0,77 | ≤ 500 |
| | Double rigid | ≥0,77 | ≤500 |
| | Flexible | ≥ 1 | ≤ 1050 |

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Image /page/14/Picture/0 description: The image shows a chemical structure. The structure contains the letters 'TS' followed by a chemical symbol with an 'O' and a subscript '3'. The chemical structure is drawn in black and white.

The performance characteristics and intended use of the STERIZONE® VP4 Sterilizer are the same as for the STERRAD® 100NX® Sterilizer (K111377) and the Amsco® V-PRO® maX Low Temperature Sterilization System (K131120) (Table 5).

Table 5. Comparison between the intended use and claims for the STERIZONE® VP4 Sterilizer, the STERRAD® 100NX® Sterilizer and the Amsco® V-PRO® Sterilizer

*Lumen claims for the DUO Cycle of the STERRAD® 100NX Sterilizer.

Therefore, based on the foregoing information, the STERIZONE® VP4 Sterilizer is substantially equivalent to the STERRAD® 100NX® Sterilizer (K111377) and to the Amsco V-PRO® maX Low Temperature Sterilization System (K131120) with respect to intended use, mode of action, performance and safety characteristics.

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Image /page/15/Picture/0 description: The image shows a chemical structure. The structure contains the letters 'TS' followed by 'O' with a subscript '3'. The 'O' is connected to a ring-like structure. The image is in black and white.

In particular, all three devices require only e…