(121 days)
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.
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.
Here's a breakdown of the acceptance criteria and study information for the STERIZONE® VP4 Sterilizer, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the demonstration of a sterility assurance level (SAL) of 10^-6, which is a standard for sterilization effectiveness. The "overkill" approach used in testing suggests that the device's performance exceeds this minimum requirement.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Sterility Assurance Level (SAL) | Demonstrated to achieve a SAL of 10^-6 |
| Safety Requirements | Complies with CSA C22.2 No 61010-1:2004, UL 61010-1:2004, FCC Part 18 / EN 55011, IEC 61326-1:2012, IEC 61010-1:2010, 61010-2-040:2005 |
| Software Performance | Verification and validation testing completed with no unresolved anomalies |
| RoHS Compliance | All components are RoHS compliant |
| New Pressure Transducer Functionality | Verified using the same test methods and acceptance criteria as the predicate device |
2. Sample Size for the Test Set and Data Provenance
- Sample Size: The test set for demonstrating sterilization efficacy consisted of a "representative sample of one or more device types and packaging, in seven separate validation loads." The details of these loads are provided in Table 1 (pages 2-3 and 5-6). For example:
- Load 1: General medical instruments (e.g., clamp, serrated surface, box-lock) – 11 lb load.
- Load 3: Three single-channel flexible endoscopes + eight general medical instruments – 23 lb load.
- Load 4: Up to 15 rigid or semi-rigid channeled instruments + two general medical instruments – 19 lb load.
- Load 7: General medical instruments – 75 lb load.
- Data Provenance: The document (page 4) states the applicant's name and address as TSO3 Inc., Quebec, QC, Canada. This indicates the testing and data likely originated from Canada, although the exact location of the testing facility is not specified. The study is prospective as it involves performance validation testing of the STERIZONE® VP4 Sterilizer to demonstrate its effectiveness.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The study focuses on the physical and biological efficacy of a sterilizer, not on interpretation by human experts. The "ground truth" for sterilization is typically established through standard microbiological methods (e.g., biological indicators, culturing) demonstrating the absence of viable microorganisms.
4. Adjudication Method for the Test Set
This is not applicable as the study does not involve subjective human assessment requiring adjudication. The assessment of sterilization efficacy is based on objective biological and physical measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret images or data, often with and without AI assistance. The STERIZONE® VP4 Sterilizer is a sterilization device, and its performance is evaluated by its ability to sterilize, not by human interpretation of its output.
6. Standalone Performance Study (Algorithm only without human-in-the-loop performance)
Yes, a standalone performance study was done. The document explicitly states: "The modified STERIZONE® VP4 Sterilizer underwent performance validation testing using the « overkill » approach to demonstrate the effectiveness of the process." This describes the algorithm (sterilization process) acting independently to achieve sterility. The efficacy is demonstrated by achieving a 10^-6 SAL, inherently a standalone performance metric.
7. Type of Ground Truth Used
The ground truth used for demonstrating sterilization efficacy is microbiological (biological indicators). The "overkill approach" and "achievement of a sterility assurance level (SAL) of 10^-6" directly refer to the statistical probability of a single viable microorganism remaining after sterilization, which is determined through testing with highly resistant bacterial spores (biological indicators).
8. Sample Size for the Training Set
This information is not explicitly provided in the document. The document describes verification and validation testing for the modified device, but does not detail a separate "training set" in the context of machine learning. The term "training set" is usually associated with AI/ML model development. While the device contains software, the efficacy testing described is typical for a medical device sterilizer, where robust physical and biological challenge tests are performed, rather than machine learning model training.
9. How the Ground Truth for the Training Set Was Established
As no explicit "training set" in the machine learning sense is described, this information is not applicable. The ground truth for the performance validation (test set equivalent) was established through microbiological methods using biological indicators to confirm sterility, typically following established standards for sterilization validation.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's seal, which includes an abstract image of a human figure in profile, repeated three times. The seal is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)
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.
| Validationload # | Load description | Load weight11Excluding the 25lb loading rack |
|---|---|---|
| 1 | Validation load #1 consisted of general medical instruments, representing thefollowing geometries:• Clamp• Serrated surface• Box-lock• Handle• Button• Pivot hinge• StopcockType of packaging used: wrapped plastic tray, including silicone mats and brackets,and PouchGeneral medical instruments were spread out over three trays, six pouches and onewrapped instrument. | 11 lb |
| 2 | Validation load #2 consisted of general medical instruments, representing thefollowing geometries:• Gliding mechanism• Hinges and screws• Serrated surface• Luer-lock• Spring• Rigid non-lumen scopesType of packaging used: wrapped plastic and aluminum tray, including silicone matsand brackets, rigid aluminum container and PouchGeneral medical instruments were spread out over one container, three trays, and sixpouches. | 20 lb |
Table 1. Description of the seven validation loads
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| Validationload # | Load description | Load weight1Excluding the 25lb loading rack |
|---|---|---|
| 3 | Validation load #3 consisted of three single channel flexible endoscopes(Ureteroscope) with inside diameter of 1.0 mm and length of 850 mm, packagedindividually in wrapped trays or containers, including appropriate silicone bracketsor 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 inthe presence of other packaged medical devices. Three double channel semi-rigidendoscopes (ureteroscope – 0.7 mm × 500 mm and 1.1 mm × 500 mm) werepackaged individually in wrapped trays or containers including appropriate siliconebrackets or mats. Additional rigid channeled instruments or stainless steel rigidlumens 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; oneUreteroscope with inside diameter of 1.0 mm and length of 850 mm, and aBronchoscope with inside diameter of 1.8 mm and length of 830 mm, and onedouble channel semi- rigid endoscope (ureteroscope – 0.7 mm × 500 mm and 1.1mm × 500 mm), packaged individually in wrapped trays or containers includingappropriate silicone brackets or mats. No additional item was added. | 21 lb |
| 6 | Validation load #6 consisted of general medical instruments, representing thefollowing geometries:• Distal end (swivel parts)• Hinge with screw• CannulaGeneral medical instruments packaged in one aluminum sterilization container. | 9 lb |
| 7 | Validation load #7 consisted of general medical instruments, representing thefollowing geometries:• Box-lock hinge• Pivot hinge• Luer-lockGeneral medical instruments, spread out over three aluminum sterilizationcontainers, 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: (418) 651-0003 ext. 287 FAX: (418) 653-5726 Email: ajokic@tso3.com
U.S. Contact
IM3, Inc. Contact: Thomas Richards, Ph.D. Phone: 503-415-0250 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.
| Validationload # | Load description | Load weight1 |
|---|---|---|
| 1Excluding 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 Stopcock Type of packaging used: wrapped plastic tray, including silicone mats andbrackets, and PouchGeneral medical instruments were spread out over three trays, six pouches and one wrapped instrument. | 11 lb |
| Validationload # | Load description | Load weight11Excluding the 25lb loading rack |
| 2 | Validation load #2 consisted of general medical instruments, representingthe following geometries:• Gliding mechanism• Hinges and screws• Serrated surface• Luer-lock• Spring• Rigid non-lumen scopesType of packaging used: wrapped plastic and aluminum tray, including siliconemats 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 appropriatesilicone brackets or mats. Eight general medical instruments, eachpackaged in a pouch, were added. | 23 lb |
| 4 | Validation load #4 consisted of up to 15 rigid or semi-rigid channeledinstruments in the presence of other packaged medical devices. Threedouble channel semi-rigid endoscopes (ureteroscope – 0.7 mm × 500 mmand 1.1 mm × 500 mm) were packaged individually in wrapped trays orcontainers including appropriate silicone brackets or mats. Additional rigidchanneled instruments or stainless steel rigid lumens were added to eachpackage. Two additional general medical instruments, each packaged in apouch, were added. | 19 lb |
| 5 | Validation load #5 consisted in two single channel flexible endoscopes; oneUreteroscope with inside diameter of 1.0 mm and length of 850 mm, and aBronchoscope with inside diameter of 1.8 mm and length of 830 mm, andone double channel semi- rigid endoscope (ureteroscope - 0.7 mm × 500mm and 1.1 mm × 500 mm), packaged individually in wrapped trays orcontainers including appropriate silicone brackets or mats. No additionalitem was added. | 21 lb |
| 6 | Validation load #6 consisted of general medical instruments, representingthe following geometries:• Distal end (swivel parts)• Hinge with screw• CannulaGeneral medical instruments packaged in one aluminum sterilizationcontainer. | 9 lb |
| 7 | Validation load #7 consisted of general medical instruments, representingthe following geometries:• Box-lock hinge• Pivot hinge• Luer-lockGeneral medical instruments, spread out over three aluminum sterilizationcontainers each weighting 25 lb. | 75 lb |
Table 1. Description of the seven validation loads
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TSO₃
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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.
| PREDICATESTERIZONE VP4K141163 | ModifiedSTERIZONEVP4 | |
|---|---|---|
| Intended Use | Terminal sterilization of reusablemedical devices in health carefacilities | Same |
| General Indications for Use | The STERIZONE® VP4 Sterilizer isintended for use in terminalsterilization of cleaned, rinsed, anddried metal and non-metal reusablemedical devices in healthcare | Same |
| Sterilant | Vaporized Hydrogen Peroxide/Ozone | Same |
| H2O2 Concentration byWeight | 50% | Same |
| Number of SterilizationCycles | 1 ("Cycle 1") | Same |
| Critical Process Parameters | Differential Chamber Pressure ( $Δ$ P)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.
| PREDICATESTERIZONE VP4K141163 | ModifiedSTERIZONEVP4 | |
|---|---|---|
| General Physical ProcessParameters | Wall temperature, vaporizationtemperature, exposure times, flowrates, ozone concentration,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.
§ 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).