(293 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 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.
Here's a breakdown of the acceptance criteria and the study details for the STERIZONE® VP4 Sterilizer, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes the device's performance in terms of its ability to achieve sterility under various load conditions and its compliance with safety standards. The core acceptance criterion for effectiveness is demonstrating a Sterility Assurance Level (SAL) of 10⁻⁶.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance | Study Details/Evidence |
|---|---|---|---|
| Effectiveness (Sterilization) | Achievement of a Sterility Assurance Level (SAL) of 10⁻⁶ for packaged reusable medical devices. | Demonstrated achievement of SAL of 10⁻⁶ using the "overkill" approach. | Performance validation testing on directly inoculated medical devices employing half-cycle. |
| Efficacy for various device geometries and types (clamps, serrated, box-lock, hinges, scopes, cannulas, lumens, flexible endoscopes, multi-channel endoscopes). | Sterilization efficacy demonstrated across nine validation loads covering a wide range of instrument geometries and types. | Nine separate validation loads (Table 1) | |
| Efficacy for various packaging types (wrapped plastic trays, pouches, rigid aluminum containers). | Demonstrated efficacy with various packaging types. | Mentioned within the description of validation loads (Table 1) | |
| Operation within specified load temperature range for processed items. | Load to be maintained between 20°C to 26°C (68°F to 78°F). | Stated in "Indications for Use" and device description. | |
| Operation within specified total load weight. | Total load weight not to exceed 75 lbs (excluding 25 lbs loading rack). | Stated in "Indications for Use" and device description. | |
| Safety | Compliance with North American safety codes and standards. | Designed, constructed, and tested to meet safety and performance requirements of CSA Standard C22.2 No 61010-1, UL 61010-1, FCC Part 18 / EN 55011, IEC 61326-1, IEC 61010-1, IEC 61010-2-040. | Performance Data - Safety section. |
| Implementation of safety features and control redundancies. | Fault Tree Analysis and Mitigation (FTA-MIT) and Failure Mode Effects and Criticality Analysis (FMECA) conducted. | Performance Data - Safety section. | |
| Software controls verification and validation. | Software controls underwent V&V testing in accordance with FDA guidance for "moderate risk" software; no unresolved anomalies. | Performance Data - Safety section. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The test set for effectiveness involved nine separate validation loads. The specific number of individual medical devices or biological indicators within each load is implied to be sufficient to demonstrate SAL 10⁻⁶ for the represented device types and geometries, but a precise count of individual items is not given.
- Data Provenance: The document does not explicitly state the country of origin for the data or whether the study was retrospective or prospective. However, given that it's a 510(k) submission to the U.S. Food & Drug Administration (FDA) by a company (TSO3 Inc.) located in Quebec, Canada, it's reasonable to infer that the studies were conducted by or on behalf of TSO3 Inc., likely in Canada or a facility compliant with regulatory standards for such testing. The validation studies appear to be prospective, designed specifically to demonstrate the effectiveness of the sterilizer for the expanded claims.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not explicitly provided in the document. The determination of sterility (ground truth for effectiveness) in such studies is typically established through the "overkill" approach using biological indicators (BIs) with a known high resistance to the sterilization process. The expertise involved would be in microbiology and sterilization sciences, ensuring proper BI preparation, inoculation, exposure, and recovery methods that align with standards like ANSI/AAMI/ISO 14937. However, no specific number of experts or their qualifications are mentioned.
4. Adjudication Method for the Test Set:
This information is not applicable and therefore not provided. Sterilization validation studies using biological indicators do not involve human "adjudication" in the sense of multiple experts reviewing results like in diagnostic imaging studies. The outcome (sterility or growth) of biological indicators is a direct, objective measure interpreted by microbiological methods.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret results, sometimes with AI assistance. The STERIZONE® VP4 Sterilizer is a medical device for sterilization, which has objective performance metrics (sterility, safety) and does not involve human readers interpreting device output in a comparative effectiveness setting as described.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Yes, the effectiveness study of the STERIZONE® VP4 Sterilizer is inherently a standalone performance evaluation. The device's primary function is to perform sterilization independently. The "performance validation testing" described directly assesses the sterilizer's ability to achieve a Sterility Assurance Level (SAL) of 10⁻⁶ without human intervention or interpretation during the sterilization process itself. The study confirms that the sterilizer, as a standalone automated system, effectively sterilizes the specified medical devices.
7. The Type of Ground Truth Used:
The ground truth used for effectiveness was based on microbiological challenge testing, specifically:
- Biological Indicators (BIs): The "overkill" approach typically involves using biological indicators with a high concentration of resistant microorganisms (e.g., bacterial spores like Geobacillus stearothermophilus) placed in the most challenging locations within the test load.
- Achievement of SAL 10⁻⁶: The ground truth is confirmed by showing the complete inactivation of these highly resistant microorganisms, demonstrating a sterility assurance level of 1 viable microorganism in a million.
8. The Sample Size for the Training Set:
This information is not applicable and therefore not provided. The STERIZONE® VP4 Sterilizer is a physical device that performs a sterilization process, not an AI/machine learning algorithm that requires a "training set" of data in the computational sense. Its performance is validated through defined physical and microbiological challenges.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the reasons stated in point 8. The device's operational parameters and design are based on established scientific principles of sterilization, engineering, and validated through performance testing rather than training on a data set.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 9, 2018
TSO3, Inc. % Cynthia Pritchard CEO BioTechnology Transfer, LLC 1016 Tobiano Lane Raleigh, North Carolina 27614
Re: K172191
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: March 16, 2018 Received: April 9, 2018
Dear Cynthia Pritchard:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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 of medical device-related adverse events) (21 CFR 803); good
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manufacturing practice requirements as set forth in 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.
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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Geeta K. Pamidimukkala -S
for Tina Kiang, Ph.D. Acting 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
510(k) Number (if known) K172191
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 Ibs 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• 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 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 scopesType of packaging used: wrapped plastic and aluminum tray, including silicone mats and brackets, rigid aluminumcontainer 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 appropriatesilicone 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 otherpackaged 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 siliconebrackets or mats. Additional rigid channeled instruments or stainless steel rigid lumens were added to eachpackage. 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 25 lb loading rack | ||
| 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• CannulaGeneral 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-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 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 |
| 9 | Validation load #9 consisted of one multi-channel flexible endoscope, with no more than 4 channels (Video Colonoscope), with inside diameters of 1.2 or more and lengths of 1955 mm or less, or 1.45 or more and lengths of 3500 mm or less; packaged in aluminium 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
Date of Preparation May 7, 2018
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) K141163 - Primary Predicate
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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 (O3). To the left of the sulfur atom is the letter T. The oxygen atoms are arranged around the sulfur atom, suggesting a trigonal pyramidal or similar geometry.
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.
Indications for Use
The STERIZONE® VP4 Sterilizer is intended for use in terminal sterilization of cleaned, rinsed, and dried metal and non-metal reusable medical devices in health care facilities.
The single pre-set cycle of the STERIZONE® VP4 Sterilizer uses hydrogen peroxide and ozone. The injection of vaporized hydrogen peroxide is followed by the injection of ozone, which reacts with residual hydrogen peroxide to form hydroxyl radicals.
Sterilization efficacy was demonstrated using a representative sample of one or more device types and packaging, in nine separate validation loads, as described in Table 1. The load to be processed should be maintained between 20°C to 26°C (68°F to 78°F). Total load weight shall not exceed 75 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 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 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 weight1 |
| 1Excluding 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 diagram is rendered in black and gray, with the oxygen atoms and connecting lines appearing in gray.
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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Image /page/8/Picture/9 description: The image shows the chemical formula for a compound. The formula is represented as "TSO3". The letters are in bold, sans-serif font. The "3" in "O3" is a subscript, indicating the number of oxygen atoms in the molecule. There are some gray circles above the "SO" part of the formula.
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 lumen claims | ||||
|---|---|---|---|---|---|
| Intended Use | Terminal sterilization of reusable medical devices in health care facilities | Same | |||
| GeneralIndication forUse | 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. | 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 central 'S' atom bonded to three oxygen atoms, represented as 'O' with a subscript '3'. To the left of the 'S' atom is the letter 'T', which is part of the chemical formula. The chemical formula is likely an abbreviation for a more complex 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.
§ 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).