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.

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 multi-channel devices), and rigid-channel devices (including single-channel and doublechannel rigid endoscopes).

Lumen claims for the VP4 have been expanded to include double and multiple-channel devices with no more than four channels.

AI/ML Overview

This document describes the STERIZONE® VP4 Sterilizer, a device for terminal sterilization of reusable medical devices. The primary purpose of the submission is to expand the lumen claims for flexible endoscopes.

Here's an analysis of the provided text for acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criterion for this device is the achievement of a sterility assurance level (SAL) of 10^-6. The reported device performance indicates that this SAL was achieved.

Acceptance Criteria	Reported Device Performance
Sterility Assurance Level (SAL) of 10^-6	Achieved (demonstrated through "overkill" approach and half-cycle testing on directly inoculated medical devices)

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

The test set consisted of nine separate validation loads, as described in Table 1 (pages 2-3 and 5-6). Each load contained a representative sample of one or more device types and packaging. The specific contents of each validation load are detailed, including various surgical instruments and different types of endoscopes (single-channel flexible, multi-channel flexible, rigid, and semi-rigid channeled instruments).

The data provenance is not explicitly stated as retrospective or prospective, nor is the country of origin of the data. However, given that this is a premarket notification to the FDA, it is highly likely that the data was generated prospectively as part of the device's validation testing. The applicant's address in Canada suggests the studies may have been conducted there or in collaboration with Canadian institutions, but this is not explicitly stated.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of device validation (sterilization) does not typically involve human experts establishing "ground truth" in the way that image interpretation for diagnostics would. Instead, the ground truth for sterilization effectiveness is established through microbiological testing. For this device, the "overkill" approach was used, involving directly inoculated medical devices. The performance is measured by the complete killing of highly resistant microorganisms (e.g., bacterial spores as biological indicators). Therefore, experts in microbiology and sterilization validation would design and oversee these tests, but the "truth" is an objective, measurable outcome (sterility). The document does not specify the number or specific qualifications of such experts, but it is implied that these studies were conducted by qualified personnel in accordance with established standards (ANSI/AAMI/ISO 14937).

4. Adjudication Method for the Test Set

Not applicable. As described above, the effectiveness of a sterilizer is determined by objective microbiological testing, not by expert adjudication of various interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. This is a sterilization device, not an imaging or diagnostic device that requires human interpretation. Therefore, an MRMC study is not relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Yes, the effectiveness testing described is a standalone performance evaluation of the STERIZONE® VP4 Sterilizer. The device's ability to sterilize medical instruments to a specified SAL is assessed independently of human intervention during the sterilization cycle itself. The testing focused purely on the physical and chemical processes of the sterilizer.

7. The Type of Ground Truth Used

The ground truth used is microbiological proof of sterility, specifically demonstrating a Sterility Assurance Level (SAL) of 10^-6. This is achieved by challenging the sterilizer with a high number of highly resistant microorganisms (typically bacterial spores as biological indicators) directly inoculated onto medical devices. The complete inactivation of these microorganisms after a half-cycle exposure ensures that a full cycle would achieve the required SAL.

8. The Sample Size for the Training Set

Not applicable in the conventional sense of machine learning. This device is a physical sterilizer and its performance is based on well-understood physical/chemical principles, not a machine learning model that requires a "training set." The "training" for such a device would be its engineering design and optimization, which is not described in terms of a data set.

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

Not applicable. As explained in point 8, there isn't a "training set" with associated ground truth in the context of this physical device. The device's design and parameters are established through engineering principles, scientific understanding of sterilization, and iterative testing/optimization based on microbiological efficacy.

Summary

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

June 30, 2016

TSO3 Inc. % Thomas Richards Consultant IM3, Inc. 7720 Ne Hwy 99. Suite D#110 Vancouver, Washington 98665

Re: K153689

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: May 31, 2016 Received: June 1, 2016

Dear Thomas 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.

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 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

Enclosure

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K153689

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. 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.

Table 1. Description of the nine validation loads

Validation load #	Load description	Load weight11Excluding the 25lb 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 PouchGeneral 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 PouchGeneral medical instruments were spread out over one container, three trays, and six pouches.	20 lb
3	Validation load #3 consisted of three single channel flexible endoscopes (Ureteroscope) with inside diameter of1.0 mm and length of 850 mm, packaged individually in wrapped trays or containers, including appropriate silicone brackets 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 the presence of other packaged medical devices. Three double channel semi-rigid endoscopes (ureteroscope – 0.7 mm × 500 mm and1.1 mm × 500 mm) were packaged individually in wrapped trays or containers including appropriate silicone brackets or mats. Additional rigid channeled instruments or stainless steel rigid lumens were added to each package. Two additional general medical instruments, each packaged in a pouch, were added.	19 lb

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Validation load	Load description	Load weight1
#		1Excluding the 25lb loading rack
5	Validation load #5 consisted in two single channel flexible endoscopes; one Ureteroscope with inside diameterof 1.0 mm and length of 850 mm, and a Bronchoscope with inside diameter of 1.8 mm and length of 830 mm,and one double channel semi- rigid endoscope (ureteroscope - 0.7 mm × 500 mm and 1.1 mm × 500 mm),packaged individually in wrapped trays or containers including appropriate silicone brackets or mats. Noadditional item was added.	21 lb
6	Validation load #6 consisted of general medical instruments, representing the following geometries:Distal end (swivel parts)Hinge with screwCannulaGeneral medical instruments packaged in one aluminum sterilization container.	9 lb
7	Validation load #7 consisted of general medical instruments, representing the following geometries:Box-lock hingePivot hingeLuer-lockGeneral medical instruments, spread out over three aluminum sterilization containers, each weighting 25 lb.	75 lb
8	Validation load #8 consisted of two double-channel flexible endoscopes (Ureteroscope) with inside diameterof 1 mm and lengths of 850 and 989 mm; and one single-channel flexible endoscopes (Ureteroscope) withinside diameter of 1 mm and length of 850 mm, packaged individually in wrapped plastic sterilization trays,including appropriate silicone brackets or mats.	16 lb
9	Validation load #9 consisted of one multi-channel flexible endoscope, with no more than 4 channels (VideoColonoscope), with inside diameters of 1.2 or more and lengths of 1955 mm or less, or 1.45 or more and lengthsof 3500 mm or less; packaged in aluminum sterilization container.	17 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 Phone: (418) 651-0003 ext. 287 Fax: (418) 653-5726 E-mail: ajokic@tso3.com

U.S. Contact

IM3, Inc. Contact: Thomas Richards, Ph.D. Phone: 503-415-0250 Email: tomami20x @ gmail.com

Submission Date

June 30, 2016

Trade Name

STERIZONE® VP4 Sterilizer

Common Name

Vaporized Hydrogen Peroxide Sterilizer

Classification Name

Ethylene Oxide Gas Sterilizer Class II (as per 21CFR, part 880.6860 equivalent device) Product Code: PJJ

Legally Marketed Equivalent Device Name(s)

STERIZONE® VP4 Sterilizer (K141163 and K153392)

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Image /page/5/Picture/1 description: The image shows a chemical structure diagram. The diagram depicts a central sulfur atom (S) bonded to three oxygen atoms (O), represented as O3. The letters 'TS' are positioned to the left of the sulfur atom. The diagram is presented in a minimalist style, with the chemical symbols clearly visible.

Device Description

Lumen claims for the VP4 have been expanded to include double and multiple-channel devices with no more than four channels.

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.

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

Validationload #	Load description	Load weight11Excluding the 25lb loading rack
1	Validation load #1 consisted of general medical instruments, representingthe following geometries:• Clamp• Serrated surface• Box-lock• Handle• Button• Pivot hinge• StopcockType of packaging used: wrapped plastic tray, including silicone mats andbrackets, and PouchGeneral medical instruments were spread out over three trays, six pouchesand one wrapped instrument.	11 lb
Validationload #	Load description	Load weight1Excluding the 25 lb loading rack
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 PouchGeneral medical instruments were spread out over one container, three trays, and six pouches.	20 lb
3	Validation load #3 consisted of three single channel flexible endoscopes (Ureteroscope) with inside diameter of 1.0 mm and length of 850 mm, packaged individually in wrapped trays or containers, including appropriate silicone brackets 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 the presence of other packaged medical devices. Three double channel semi-rigid endoscopes (ureteroscope - 0.7 mm × 500 mm and 1.1 mm × 500 mm) were packaged individually in wrapped trays or containers including appropriate silicone brackets or mats. Additional rigid channeled instruments or stainless steel rigid lumens were added to each package. Two additional general medical instruments, each packaged in a pouch, were added.	19 lb
5	Validation load #5 consisted in two single channel flexible endoscopes; one Ureteroscope with inside diameter of 1.0 mm and length of 850 mm, and a Bronchoscope with inside diameter of 1.8 mm and length of 830 mm, and one double channel semi- rigid endoscope (ureteroscope – 0.7 mm × 500 mm and 1.1 mm × 500 mm), packaged individually in wrapped trays or containers including appropriate silicone brackets or mats. No additional item was added.	21 lb
6	Validation load #6 consisted of general medical instruments, representing the following geometries: Distal end (swivel parts) Hinge with screw Cannula General medical instruments packaged in one aluminum sterilization container.	9 lb
7	Validation load #7 consisted of general medical instruments, representing the following geometries: Box-lock hinge Pivot hinge Luer-lock General medical instruments, spread out over three aluminum sterilization containers, each weighting 25 lb.	75 lb
8	Validation load #8 consisted of two double-channel flexible endoscopes (Ureteroscope) with inside diameter of 1 mm and lengths of 850 and 989 mm; and one single-channel flexible endoscopes (Ureteroscope) with inside diameter of 1 mm and length of 850 mm, packaged individually in wrapped plastic sterilization trays, including appropriate silicone brackets or mats	16 lb
Validationload #	Load description	Load weight11Excluding the 25lb loading rack
9	Validation load #9 consisted of one multi-channel flexible endoscope,with no more than 4 channels (Video Colonoscope), with inside diametersof 1.2 or more and lengths of 1955 mm or less, or 1.45 or more and lengthsof 3500 mm or less; packaged in aluminium sterilization container.	17 lb

Table 1. Description of the nine validation loads

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TSO₃

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Image /page/7/Picture/0 description: The image shows a chemical structure diagram. The diagram depicts a central sulfur atom (S) bonded to three oxygen atoms (O3). To the left of the sulfur atom is the letter T. The letters and atoms are arranged in a way that suggests a three-dimensional structure.

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.

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.

Effectiveness

The modified STERIZONE® VP4 Sterilizer underwent performance validation testing using the « overkill » approach to demonstrate the effectiveness of the process in accordance with

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TSO₃

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 be effective for terminal sterilization of packaged reusable medical devices.

Substantial equivalence

The STERIZONE® VP4 Sterilizer, with the expanded flexible lumen claims, is substantially equivalent to the predicate STERIZONE® VP4 Sterilizer (K141163). The design, materials, and functions of the sterilizers are identical. Furthermore, the intended use and general indications for use are identical. Changes to the lumen claims do not raise different questions regarding safety and effectiveness. A comparison between the two devices is provided in Table 2.

	PREDICATESTERIZONE® VP4 SterilizerK141163 and K153392		STERIZONE® VP4 Sterilizerwith expanded flexible lumenclaims
Intended Use	Terminal sterilization of reusable medical devices inhealth care facilities		Same
GeneralIndication forUse	Sterilization of both metal and nonmetal medicaldevices. Sterilization of instruments, which havediffusion-restricted spaces, such as hinged portions offorceps and scissors. Processing of medical deviceshaving rigid and flexible channels with limitations inmaterials, dimensions and number of devices.		Same
Lumen claims		Inner Diameter	Lumen Length	Inner Diameter	Lumen Length
	Single Channel FlexibleEndoscope	≥ 1mm	≤ 850 mm	Same	Same
	Single & DoubleChannel FlexibleEndoscope			≥ 1 mm	≤ 989 mm
	Multi-channel FlexibleEndoscope (Videocolonoscope/gastroscope- 4 channels total)			≥ 1.2 mm≥ 1.45 mm	≤ 1955 mm≤ 3500 mm
	Rigid Single & DoubleChannel Endoscope	≥ 0.7 mm	≤ 500 mm	Same	Same
Sterilant	Vaprorized Hydrogen Peroxide/Ozone			Same
H2O2Concentration byWeight	50%			Same
Number ofSterilizationCycles	1 ("Cycle 1")		Same

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

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Image /page/9/Picture/0 description: The image shows a chemical structure diagram. The diagram depicts a molecule with the letters 'TS' on the left, followed by 'O' with a subscript '3'. The 'O' and subscript '3' are enclosed in parentheses. The diagram is rendered in shades of gray, with the 'TS' portion being darker than the rest of the molecule.

Critical ProcessParameters	Differential Chamber Pressure (ΔP) and LoadTemperature	Same
General PhysicalProcessParameters	Wall temperature, vaporization temperature, exposuretimes, flow rates, ozone concentration, componenttemperatures	Same
Chamber Volume	125L	Same
Software Control	Omron PLC	Same

Conclusion

The STERIZONE® VP4 Sterilizer, with the expanded flexible lumen claims, is substantially equivalent to the identified predicate device, the STERIZONE® VP4 Sterilizer.

Regulation Number and Section

§ 880.6860 Ethylene oxide gas sterilizer.

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