(102 days)
The STERIZONE® VP4 Sterilizer is intended for use in terminal sterilization of cleaned, rinsed, and nonmetal 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, 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 lb, inclusive of the containers/packaging weight but excluding the 25 1b loading rack.
The STERIZONE® VP4 Sterilizer is a versatile low temperature sterilizer using two sterilants (vaporized hydrogen peroxide [H₂O₂] and ozone [O₃]) in a multi-phase process to sterilize reusable medical instruments up to a maximum load of 75 lb. In contrast to the sterilization processes using H2O2 only and having multiple cycles, the STERIZONE® VP4 Sterilizer enables the sterilization of a wider range of instruments and load configuration with only one preset cycle. The dynamic system to distribute the sterilant ensures an adequate supply of the sterilant through multiple successive pulsed injections that adapt to the different load conditions (size, weight and temperature). The STERIZONE® VP4 Sterilizer offers a unique preset sterilization cycle (Cycle 1) to sterilize a wide range of loads consisting of general instruments, flexible endoscopes with one channel, double channels and multi-channels, and devices with rigid and semi-rigid channels, including rigid endoscopes with single or double channels.
This document is a 510(k) premarket notification for the STERIZONE® VP4 Sterilizer, specifically addressing an air vent option (K173694) in comparison to a previously cleared version (K153689). The primary focus of the document is to demonstrate substantial equivalence, rather than providing a detailed report of the original validation study for the sterilizer's efficacy.
Therefore, many of the requested details about a study proving the device meets acceptance criteria, such as specific performance metrics, sample sizes for test/training sets, expert qualifications, and ground truth establishment, are not explicitly provided for the overall sterilizer efficacy. The document focuses on showing that the change (air vent option) does not negatively impact performance or safety.
However, based on the provided text, here is an attempt to address your questions where information is available:
1. A table of acceptance criteria and the reported device performance
The document primarily discusses sterilization efficacy as the overarching performance goal. The "acceptance criteria" for sterilization efficacy is implicitly achieving sterilization, meaning a biological indicator showing no growth. The reported "device performance" is that sterilization efficacy was demonstrated.
| Acceptance Criteria (Implicit for Sterilization Efficacy) | Reported Device Performance |
|---|---|
| Sterilization of medical devices (no microbial growth) | Sterilization efficacy was demonstrated |
| Residual sterilants within acceptable limits | Residual sterilants within clearance criteria (for the air vent change) |
The document outlines the types of devices and loads used in validation studies but doesn't provide specific numerical outcomes for sterilization efficacy (e.g., Sterility Assurance Level, or SAL, achieved). It states that the device is "intended for use in terminal sterilization of cleaned, rinsed, and nonmetal reusable medical devices."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The 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 specific number of individual devices or biological indicators within each load is not detailed in this summary.
- Data Provenance: Not explicitly stated as retrospective or prospective, but validation studies for medical devices are typically prospective. The company (TSO3 Inc.) is based in Quebec, Canada, suggesting the studies could have been performed there or internationally.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. For sterilization efficacy, the "ground truth" is typically established by the growth or non-growth of biological indicators (e.g., spore strips) after exposure to the sterilization process, followed by incubation. This is a scientific and microbiological assessment, not usually based on expert consensus in the way image interpretation might be.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable in the context of sterilization efficacy studies as described. The outcome (sterile or not sterile) is determined by objective microbiological testing methods using biological indicators, not human adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The STERIZONE® VP4 Sterilizer is a medical device for sterilization, not an AI-assisted diagnostic tool or an imaging device. Therefore, MRMC studies are not relevant to its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable to a physical sterilizer device. Its performance is inherent to its mechanical and chemical processes, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For sterilization efficacy, the ground truth is established by biological indicator (BI) testing. This involves placing a known quantity of highly resistant microorganisms (e.g., Geobacillus stearothermophilus spores) in challenge devices within the sterilization load. After the sterilization cycle, these BIs are retrieved and incubated. No growth of the test organism indicates successful sterilization (a negative BI result).
Additionally, physicochemical monitoring, such as chemical indicators (CIs) or physical parameters measured by the device itself, would also be used as part of the total validation of the sterilization process.
8. The sample size for the training set
Not applicable. This document describes the validation of a physical sterilizer, not a machine learning algorithm.
9. How the ground truth for the training set was established
Not applicable. This document describes the validation of a physical sterilizer, not a machine learning algorithm.
Additional Information from the Document Regarding the Validation Study:
- Validation Loads: Nine distinct validation loads were used, described in Table 1 (pages 3, 4, 7). These loads varied in terms of medical instrument geometries (e.g., clamp, serrated surface, hinged, lumens, scopes), packaging types (wrapped plastic tray, aluminum tray, pouch, rigid containers), and total weight. They included both general medical instruments and flexible and rigid endoscopes with varying channel diameters and lengths.
- Load Conditions: The load to be processed must be maintained between 20℃ to 26℃ (68°F to 78°F). Total load weight shall not exceed 75 lb, inclusive of containers/packaging, but excluding the 25 lb loading rack.
- Sterilization Method: Uses hydrogen peroxide and ozone, forming hydroxyl radicals.
- Cycle: A single pre-set cycle ("Cycle 1").
- The overall conclusion is that the updated device (with the air vent option) is "substantially equivalent" to the predicate device, implying that the established sterilization efficacy of the predicate is maintained.
- Biocompatibility testing was also performed, verifying that residual sterilants were within acceptable criteria, demonstrating biological safety.
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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.
March 13, 2018
TSO3, Inc. % Cynthia Pritchard CEO BioTechnology Transfer, LLC 1016 Tobiano Lane Raleigh, North Carolina 27614
Re: K173694
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 2, 2018 Received: February 15, 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 manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
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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 mediation-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,
Michael J. Ryan -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) K173694
Device Name
STERIZONE® VP4 Sterilizer
Indications for Use (Describe)
The STERIZONE® VP4 Sterilizer is intended for use in terminal sterilization of cleaned, rinsed, and nonmetal 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, 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 lb, inclusive of the containers/packaging weight but excluding the 25 1b loading rack.
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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| Validationload # | Load description | Loadweight¹ |
|---|---|---|
| 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, includingsilicone 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 aluminum containerand PouchGeneral medical instruments were spread out over onecontainer, three trays, and six pouches. | 20 lb |
| 3 | Validation load #3 consisted of three single channel flexibleendoscopes (Ureteroscope) with inside diameter of 1.0 mmand length of 850 mm, packaged individually in wrappedtrays or containers, including appropriate silicone bracketsor mats. Eight general medical instruments, each packagedin a pouch, were added. | 23 lb |
| Validationload # | Load description | Loadweight1 |
| 4 | Validation load #4 consisted of up to 15 rigid or semi-rigidchanneled instruments in the presence of other packagedmedical devices. Three double channel semi-rigidendoscopes (ureteroscope – 0.7 mm × 500 mm and 1.1 mm× 500 mm) were packaged individually in wrapped trays orAdditional rigid channeled instruments or stainless steelrigid lumens were added to each package. Two additionalgeneral medical instruments, each packaged in a pouch,were added. | 19 lb |
| 5 | Validation load #5 consisted in two single channel flexibleendoscopes; one Ureteroscope with inside diameter of 1.0mm and length of 850 mm, and a Bronchoscope with insidediameter of 1.8 mm and length of 830 mm, and one doublechannel semi- rigid endoscope (ureteroscope - 0.7 mm ×500 mm and 1.1 mm × 500 mm), packaged individually inwrapped trays or containers including appropriate siliconebrackets or mats. | 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 aluminumsterilization 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 threealuminum sterilization containers, each weighting 25 lb. | 75 lb |
| 8 | Validation load #8 consisted of two double-channel flexibleendoscopes (Ureteroscope) with inside diameter of 1 mmand lengths of 850 and 989 mm; and one single-channelflexible endoscopes (Ureteroscope) with inside diameter of1 mm and length of 850 mm, packaged individually inwrapped plastic sterilization trays, including appropriatesilicone brackets or mats. | 16 lb |
| Validationload # | Load description | Loadweight1 |
| 9 | Validation load #9 consisted of one multi-channel flexibleendoscope, with no more than 4 channels (VideoColonoscope), with inside diameters of 1.2 or more andlengths of 1955 mm or less, or 1.45 or more and lengths of3500 mm or less; packaged in aluminium sterilizationcontainer. | 17 lb |
Table 1. Description of the nine validation loads
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1Excluding the 25-lb loading rack
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Image /page/6/Picture/0 description: The image shows a logo with the letters 'TSO' in blue, followed by a chemical structure in gray. The 'T' is separate, while the 'S' and 'O' are connected. The chemical structure appears to be a simplified representation of a molecule, with circles connected by lines. The number '3' is written as a subscript to the 'O'.
510(k) Summary K173694
| GeneralInformation: | Owner's Name:Address: | TSO3 Inc.TSO3 Inc.2505, Avenue DaltonQuebec, QC G1P 3S5, Canada |
|---|---|---|
| Contact Person: | Alexandre JokicTSO3, Inc. Director Regulatory Affairs andQuality Assurance | |
| Address: | TSO3 Inc.2505, Avenue DaltonQuebec, QC G1P 3S5, Canada | |
| Telephone:Fax Number: | 418-651-0003 ext. 287418-653-5726 | |
| Subject Device: | Trade Name:Common Name:Product Code:FDA Regulation:Device Classification: | STERIZONE® VP4 SterilizerDual sterilant sterilizerPJJ21 CFR 880.6860Class II |
| Predicate Device: | Trade Name:Common Name:Product Code:FDA Regulation:Device Classification:Premarket Notification: | STERIZONE® VP4 SterilizerDual sterilant sterilizerPJJ21 CFR 880.6860Class IIK153689 |
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Image /page/7/Picture/0 description: The image shows a logo with the letters 'TSO' in blue, followed by a chemical structure in gray. The 'O' in 'TSO' is also part of the chemical structure. A small '3' is located at the bottom right of the logo, also in gray. The logo appears to represent a company or organization related to chemistry or science.
The STERIZONE® VP4 Sterilizer is intended for use in terminal sterilization of Indications for Use: 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 lb, inclusive of the containers/packaging weight but excluding the 25-lb loading rack.
| Validationload # | Load description | Loadweight |
|---|---|---|
| 1 | Validation load #1 consisted of general medicalinstruments, representing the following geometries:• Clamp• Serrated surface• Box-lock• Handle• Button• Pivot hinge• StopcockType of packaging used: wrapped plastic tray, includingsilicone mats and brackets, and Pouch. General medicalinstruments were spread out over three trays, sixpouches and one wrapped instrument. | 11 lb |
| 2 | Validation load #2 consisted of general medicalinstruments, representing the following geometries:• Gliding mechanism• Hinges and screws• Serrated surface• Luer-lock• Spring• Rigid non-lumen scopesType of packaging used: wrapped plastic and aluminumtray, including silicone mats and brackets, rigid aluminumcontainer and Pouch. General medical instruments werespread out over one container, three trays, and sixpouches. | 20 lb |
| 3 | Validation load #3 consisted of three single-channelflexible endoscopes (Ureteroscope) with inside diameterof 1.0 mm and length of 850 mm, packaged individuallyin wrapped trays or containers, including appropriatesilicone brackets or mats. Eight general medicalinstruments, 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 inwrapped trays or containers including appropriatesilicone brackets or mats. Additional rigid channelinstruments or stainless steel rigid lumens were added toeach package. Two additional general medicalinstruments, each packaged in a pouch, were added. | 19 lb |
| 5 | Validation load #5 consisted in two single channel flexibleendoscopes; one Ureteroscope with inside diameter of1.0 mm and length of 850 mm, and a Bronchoscope withinside diameter of 1.8 mm and length of 830 mm, andone double channel semi- rigid endoscope (ureteroscope– 0.7 mm × 500 mm and 1.1 mm × 500 mm), packagedindividually in wrapped trays or containers includingappropriate silicone brackets or mats. No additional itemwas added. | 21 lb |
| 6 | Validation load #6 consisted of general medicalinstruments, representing the following geometries:• Distal end (swivel parts)• Hinge with screw• CannulaGeneral medical instruments packaged in one aluminumsterilization container. | 9 lb |
| 7 | Validation load #7 consisted of general medicalinstruments, representing the following geometries:• Box-lock hinge• Pivot hinge• Luer-lockGeneral medical instruments, spread out over threealuminum sterilization containers, each weighting 25 lb | 75 lb |
| 8 | Validation load #8 consisted of two double-channelflexible endoscopes (Ureteroscope) with inside diameterof 1 mm and lengths of 850 and 989 mm; and one single-channel flexible endoscopes (Ureteroscope) with insidediameter of 1 mm and length of 850 mm, packagedindividually in wrapped plastic sterilization trays,including appropriate silicone brackets or mats. | 16 lb |
| 9 | Validation load #9 consisted of one multi-channel flexibleendoscope, with no more than 4 channels (VideoColonoscope), with inside diameters of 1.2 mm or moreand lengths of 1955 mm or less, or inside diameters of1.45 mm or more and lengths of 3500 mm or less;packaged in aluminum sterilization container. | 17 lb |
Table 1: Description of the validation loads
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Image /page/8/Picture/0 description: The image shows a logo for an organization or company. The logo consists of the letters "TSO" in blue, with the "O" stylized to resemble a chemical structure. To the right of the "O" is a small "3" in blue, likely indicating a chemical formula. Above the "SO" portion of the logo is a gray chemical structure, further emphasizing the scientific or chemical nature of the organization.
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Image /page/9/Picture/0 description: The image shows a logo with the letters 'TS' in blue, followed by a stylized chemical structure in gray. The chemical structure appears to represent a molecule with three oxygen atoms, indicated by the subscript '3' next to the 'O'. The overall design is clean and modern, suggesting a company or organization related to science, technology, or chemistry.
4Excluding the 25-lb loading rack
Device The STERIZONE® VP4 Sterilizer is a versatile low temperature sterilizer Description: using two sterilants (vaporized hydrogen peroxide [H₂O₂] and ozone [O₃]) in a multi-phase process to sterilize reusable medical instruments up to a maximum load of 75 lb. In contrast to the sterilization processes using H2O2 only and having multiple cycles, the STERIZONE® VP4 Sterilizer enables the sterilization of a wider range of instruments and load configuration with only one preset cycle. The dynamic system to distribute the sterilant ensures an adequate supply of the sterilant through multiple successive pulsed injections that adapt to the different load conditions (size, weight and temperature). The STERIZONE® VP4 Sterilizer offers a unique preset sterilization cycle (Cycle 1) to sterilize a wide range of loads consisting of general instruments, flexible endoscopes with one channel, double channels and multi-channels, and devices with rigid and semi-rigid channels, including rigid endoscopes with single or double channels.
Technological Characteristics Comparison Table
| Device TradeName | Predicate STERIZONE VP4 SterilizerK153689 | STERIZONE VP4Sterilizer(with air ventoption) K173694 |
|---|---|---|
| Device Class | Class II | Same |
| Product Code /Regulation | PJJ | Same |
| Regulation Name | Dual sterilant sterilizer | Same |
| Indications forUse | Terminal sterilization of reusable medical devicesin health care facilities | Same |
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Image /page/10/Picture/0 description: The image shows a logo with the letters 'TSO' in blue, followed by a stylized molecular structure in gray. The '3' is in gray and smaller, positioned as a subscript to the 'O'. The logo appears to represent a company or organization related to science or technology, possibly in the fields of chemistry or engineering.
| Inner Diameter | Lumen Length | Inner Diameter | Lumen Length | ||
|---|---|---|---|---|---|
| Single Channel Flexible Endoscope | ≥ 1mm | ≤ 850 mm | Same | Same | |
| Single & Double Channel Flexible Endoscope | ≥ 1 mm | ≤ 989 mm | Same | Same | |
| Multi-channel Flexible Endoscope (colonoscope – the FDA considers this a 4-channel device) | ≥ 1.2 mm≥ 1.45 mm | ≤ 1955 mm≤ 3500 mm | Same | Same | |
| Rigid Single & Double Channel Endoscope | ≥ 0.7 mm | ≤ 500 mm | Same | Same | |
| Sterilant | Vaporized Hydrogen Peroxide/Ozone | Same | |||
| H2O2Concentration byWeight | 50% | Same | |||
| Number ofSterilizationCycles | 1 ("Cycle 1") | Same | |||
| Critical ProcessParameters | Differential Chamber Pressure (ΔP) and Load Temperature | Same | |||
| General PhysicalProcessParameters | Wall temperature, vaporization temperature, exposure times, flow rates, ozone concentration, component temperatures | Same | |||
| Chamber Volume | 125L | Same | |||
| Software Control | Omron PLC | Same | |||
| Ventilation gas | ≥94% oxygen | Ambient air | |||
| Componentchanges | NA | Installation kit [filter: valve] |
Cycle Process Parameters Comparison Table
| Device Trade Name | PredicateSTERIZONE® VP4SterilizerK153689 | STERIZONE®VP4 Sterilizer(Air ventoption) | ||
|---|---|---|---|---|
| Phase | Cycle Steps | Controlled parameter | Value | Value |
| Pre-conditioning | Pressure | 1 Torr | Same | |
| Phase 1 | Dynamic H2O2exposure | Differential pressure of125-280 Solutionvaporizedand injected | 19 Torr | Same |
| H2O2 reduction: | Ozone injection | 2 mg/L | Same | |
| Ozone dwell | 5 min. | Same |
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Image /page/11/Picture/0 description: The image shows a logo with the letters 'TS' in blue, followed by 'O3' in a lighter gray color. The 'S' and 'O' are stylized with rounded corners, giving them a modern look. Above the 'O3' is a graphic of three circles connected by lines, also in gray, resembling a molecular structure or a network. The overall design is clean and simple, suggesting a technology or science-related company.
| Evacuation | Pressure | 1 Torr | Same | ||
|---|---|---|---|---|---|
| Phase 2 | Dynamic H2O2exposure | Differential pressure of125-280 Solutionvaporizedand injected | 19 Torr | Same | |
| H2O2 reduction: | Ozone injection | 2 mg/L | Same | ||
| Ozone dwell | 5 min. | Same | |||
| Evacuation | Pressure | 1 Torr | Same | ||
| Ventilation | depressurization | Atmosphericpressure usingpressurized O2 | Atmosphericpressure usingambient air |
Labeling: There has been no change to the intended use. There have been no changes to warnings, contraindications, or precautions in comparison to the device cleared in K153689. The mode of operation remains the same. This new feature does not impact the device usability in any way. Statement on These changes do not in any way alter the fundamental scientific technology upon which the device is based. The operating principle has Fundamental Technology: not changed. The sterilizer incorporates the same basic design. The sterilization cycle is identical to that of the predicate. The software has not changed. The only changes made are mechanical component changes, to allow the use of ambient air, instead of pressurized oxygen, for final ventilation of the chamber. Biocompatibility The purpose of the biocompatibility testing was to provide evidence of the biological safety of materials commonly found in medical devices after being processed in the STERIZONE® VP4 Sterilizer. Materials were tested in accordance with ISO 10993-1:2009 (Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process) to determine which tests are necessary to
demonstrate biocompatibility of the patient-contacting materials present in the finished device.
- Cytotoxicity (in vitro)
- Sensitization reactivity
- Hemocompatibility
- Irritation (Ocular) ● Acute systemic toxicity
● Intracutaneous This design change did not in any way impact the biocompatibility of the materials of the sterilized devices, since the materials sterilized, and the sterilant residuals, have not changed.
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Image /page/12/Picture/0 description: The image shows the logo for TSO3. The logo features the letters 'TSO' in blue, with the 'O' stylized to resemble a chemical structure. To the right of the 'O', there is a gray chemical structure. Below the 'O', there is a small subscript '3' in gray.
| Microbiological,Functional andCompatibilityTestingSafety Testing | Verification test results demonstrated that residual sterilants presenton the selected materials were within the acceptance criteria alreadycleared for the STERIZONE® VP4 sterilizer.The STERIZONE® VP4 Sterilizer has been designed, constructed andtested to meet the safety and performance requirements of applicableNorth American safety codes and international standards. TheSTERIZONE® VP4 Sterilizer complies with the applicable portions of thefollowing standards:• IEC 61010-1 2004 Safety requirement for measurement, controland laboratory use - Part 1: General• IEC 61010-2-040 2005 Safety requirement for measurement,control and laboratory use Part 2 particular requirements forsterilizers and washer-disinfectors used to treat medical materials• IEC 61326-1: 2012 Electrical equipment for measurement, controland laboratory use - EMC requirements - Part 1: Generalrequirements• Federal Communication Commission (FCC) Part 18 / EN 55011 |
|---|---|
| Risk Management | There was one potential risk [sterilant residual levels] identified due tothe change of gas for final ventilation. However, verification testingshowed that residuals were within acceptance criteria for previouslycleared versions of the STERIZONE VP4. All potential hazards and failuremodes identified during the design and development processes wereaddressed and did not impact the existing labeling. The riskmanagement activities included application FMEA, design FMEA andmanufacturing process FMEA. |
| Conclusion | The results of the verification/validation tests and the risk analyses havedemonstrated that the STERIZONE® VP4 Sterilizer (air vent option;K173694) is substantially equivalent to the STERIZONE® VP4 Sterilizer(K153689) |
§ 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).