STERIZONE VP4 Sterilizer

K153392 · Ts03, Inc. · PJJ · Mar 24, 2016 · General Hospital

Device Facts

• Record ID: K153392
• Device Name: STERIZONE VP4 Sterilizer
• Applicant: Ts03, Inc.
• Product Code: PJJ · General Hospital
• Decision Date: Mar 24, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6860
• Device Class: Class 2

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 Ibs loading rack.

Device Story

Self-contained, stand-alone sterilizer for healthcare facilities. Uses vaporized hydrogen peroxide and ozone in a single pre-set multiphase cycle; ozone reacts with residual hydrogen peroxide to form hydroxyl radicals. Processes cleaned, rinsed, and dried metal/non-metal reusable medical devices, including flexible and rigid endoscopes. Operates via PLC-based software control. Modifications include RoHS-compliant components, updated software with maintenance mode, and a new pressure transducer for chamber monitoring. Performance verified via overkill approach to achieve 10^-6 sterility assurance level (SAL).

Clinical Evidence

Bench testing only. Effectiveness demonstrated using an 'overkill' approach on directly inoculated medical devices to achieve a sterility assurance level (SAL) of 10^-6. Seven validation loads were tested covering various instrument geometries and packaging types.

Technological Characteristics

Stand-alone sterilizer; 125L chamber volume. Sterilant: Vaporized hydrogen peroxide and ozone. PLC-based control system. RoHS-compliant materials. Pressure monitored via transducer. Standards: CSA C22.2 No 61010-1, UL 61010-1, FCC Part 18/EN 55011, IEC 61326-1, IEC 61010-1, IEC 61010-2-040.

Indications for Use

Indicated for terminal sterilization of cleaned, rinsed, and dried metal and non-metal reusable medical devices in healthcare facilities. Suitable for general instruments, single-channel flexible endoscopes, and rigid-channel devices (single/double-channel).

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 (K141163)

Submission Summary (Full Text)

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

March 24, 2016

TSO3 Inc. c/o Thomas Richards, Ph.D. Consultant IM3, Inc. 7720 NE Hwy 99, Suite D #110 Vancouver, Washington 98665

Re: K153392

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: February 22, 2016 Received: February 24, 2016

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,

Teiashri 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)

K153392

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 Ibs 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<br>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 silicone mats and brackets,<br>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<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 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 |

#### 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/>lb loading rack</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 × 500 mm and 1.1 mm × 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 × 500 mm and 1.1<br>mm × 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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## 510(k) Summary

## Applicant's Name and Address

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

## Contact Person, Telephone, FAX

Alexandre Jokic, Director, Regulatory Affairs and Quality Assurance Tel: [phone] ext. 287 FAX: [phone] Email: [e-mail]

## U.S. Contact

IM3, Inc. Contact: Thomas Richards, Ph.D. Phone: [phone] Email: tomami20x @ gmail.com

# Submission Date

November 20, 2015

#### 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)

STERIZONE® VP4 Sterilizer (K141163)

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Image /page/5/Picture/1 description: The image shows a chemical structure diagram. The diagram depicts a molecule with the abbreviation "Ts" connected to an "S" atom, which is further bonded to three oxygen atoms. The oxygen atoms are enclosed in parentheses with a subscript "3", indicating that there are three of them.

## 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, single-channel flexible endoscopes, and rigid-channel devices including single-channel and double-channel rigid endoscopes.

The VP4 has been modified in order to make it compliant with the European Directive on the Restriction Of use of certain Hazardous Substances also known as « RoHS ». In addition, device software has been modified to include a maintenance mode, among other small changes. Finally, a new sensor has been adopted for monitor and control of chamber pressure.

#### 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 seven 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 lbs, inclusive of the containers/packaging weight but excluding the 25 lbs loading rack.

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

Table 1. Description of the seven validation loads

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# Performance Data

## Safety

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:

- 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 61326-1: 2012
- . International Electrotechnical Commission (IEC) Standard 61010-1 :2010, 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.

All RoHS-compliant components have undergone verification testing using the exact same test methods and acceptance criteria as used in the predicate device. The use of a new pressure transducer to monitor and control chamber pressure was verified using the same test methods and acceptance criteria as used in the predicate device.

The software controls of the modified STERIZONE® VP4 Sterilizer have undergone verification and validation testing in accordance with FDA's Guidance entitled "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this sterilizer was considered "moderate risk". Testing was completed with no unresolved anomalies.

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# Effectiveness

The modified STERIZONE® VP4 Sterilizer underwent performance validation testing 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 10-6.

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

# Substantial equivalence

The modified STERIZONE® VP4 Sterilizer is substantially equivalent to the predicate STERIZONE® VP4 Sterilizer (K141163). The design, materials, and functions of the sterilizers Changes to software and device components do not affect performance are identical. specifications or raise different questions regarding safety and effectiveness. A comparison between the two devices is provided in Table 2.

| | PREDICATE<br>STERIZONE VP4<br>K141163 | Modified<br>STERIZONE<br>VP4 |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| Intended Use | Terminal sterilization of reusable<br>medical devices in health care<br>facilities | Same |
| General Indications for Use | The STERIZONE® VP4 Sterilizer is<br>intended for use in terminal<br>sterilization of cleaned, rinsed, and<br>dried metal and non-metal reusable<br>medical devices in healthcare | Same |
| Sterilant | Vaporized Hydrogen Peroxide/<br>Ozone | Same |
| H2O2 Concentration by<br>Weight | 50% | Same |
| Number of Sterilization<br>Cycles | 1 ("Cycle 1") | Same |
| Critical Process Parameters | Differential Chamber Pressure ( $Δ$ P)<br>and Load Temperature | Same |

Table 2. Comparison Table between Modified and Predicate Devices.

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Image /page/9/Picture/7 description: The image contains a chemical structure diagram. The diagram depicts a molecule with the abbreviation 'Ts' connected to a sulfur atom (S). The sulfur atom is further bonded to three oxygen atoms, represented as 'O3'. The structure suggests a chemical compound containing a tosyl group (Ts) attached to a sulfur trioxide moiety.

| | <i>PREDICATE</i><br>STERIZONE VP4<br>K141163 | Modified<br>STERIZONE<br>VP4 |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| General Physical Process<br>Parameters | Wall temperature, vaporization<br>temperature, exposure times, flow<br>rates, ozone concentration,<br>component temperatures | Same |
| Chamber Volume | 125L | Same |
| Software Control | PLC | Same |

The predicate device has been modified by manufacturing all device components from RoHS compliant materials, upgrade of the software to include a maintenance mode among other functions, and use of a single pressure transducer to monitor and control chamber pressure. Verification testing has been completed on all modified components using the exact same methods and acceptance criteria as completed on the predicate device. Software verification and validation testing confirms that the modified device will perform as intended under the specified use conditions. Electrical safety, EMC and microbiology testing has been completed on the modified device confirming that it is both as safe and as effective as the predicate device.

# Conclusion

The performance testing demonstrates that the STERIZONE® VP4 Sterilizer is substantially equivalent to the identified predicate devices.