Who is the manufacturer of STERIZONE VP4 Sterilizer?

Tso3, Inc. filed the 510(k) submission for STERIZONE VP4 Sterilizer (K173694).

What is the FDA product code for STERIZONE VP4 Sterilizer?

PJJ. It is classified under 21 CFR 880.6860 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for STERIZONE VP4 Sterilizer?

510(k) clearance (submission type: Traditional).

What are the predicate devices for STERIZONE VP4 Sterilizer?

STERIZONE® VP4 Sterilizer (K153689).

Who can help prepare an FDA 510(k) submission like STERIZONE VP4 Sterilizer?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

STERIZONE VP4 Sterilizer

K173694 · Tso3, Inc. · PJJ · Mar 13, 2018 · General Hospital

Device Facts

Record ID	K173694
Device Name	STERIZONE VP4 Sterilizer
Applicant	Tso3, Inc.
Product Code	PJJ · General Hospital
Decision Date	Mar 13, 2018
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.6860
Device Class	Class 2

Intended Use

The STERIZONE® VP4 Sterilizer is intended for use in terminal sterilization of cleaned, rinsed, and nonmetal reusable medical devices in health care facilities.

Device Story

Low-temperature sterilizer using vaporized hydrogen peroxide and ozone; multi-phase process forms hydroxyl radicals for sterilization. Operates via single pre-set cycle; dynamic system adjusts sterilant distribution based on load size, weight, and temperature. Used in healthcare facilities; operated by facility staff. Input: cleaned/rinsed medical devices (up to 75 lb). Output: terminally sterilized instruments. Subject device introduces ambient air ventilation instead of pressurized oxygen. Healthcare providers use sterilized instruments for patient procedures; ensures device safety by eliminating microbial contamination.

Clinical Evidence

Bench testing only. Validation performed using nine representative loads covering various instrument geometries (clamps, hinges, lumens, endoscopes) and packaging types. Verification confirmed residual sterilant levels meet acceptance criteria and compliance with IEC 61010-1, IEC 61010-2-040, and IEC 61326-1 standards.

Technological Characteristics

Dual-sterilant (H2O2/O3) low-temperature sterilizer; 125L chamber volume. Uses Omron PLC for software control. Critical parameters: differential chamber pressure, load temperature, wall/vaporization temperatures, exposure times, flow rates, and ozone concentration. Ventilation via ambient air. Complies with IEC 61010-1, IEC 61010-2-040, IEC 61326-1, and FCC Part 18/EN 55011.

Indications for Use

Indicated for terminal sterilization of cleaned, rinsed, and dried metal and non-metal reusable medical devices in health care facilities, including general instruments, flexible endoscopes (single, double, and multi-channel), and rigid/semi-rigid channeled instruments.

Regulatory Classification

Identification

An ethylene gas sterilizer is a nonportable device intended for use by a health care provider that uses ethylene oxide (ETO) to sterilize medical products.

Predicate Devices

STERIZONE® VP4 Sterilizer (K153689)

Related Devices

K153689 — STERIZONE Sterilizer · Tso3, Inc. · Jun 30, 2016
K190260 — STERIZONE(R) VP4 Sterilizer · Tso3, Inc. · Jul 19, 2019
K212200 — STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM Cassette · Plasmapp Co,., Ltd. · Oct 22, 2021
K172191 — STERIZONE VP4 Sterilizer · Tso3, Inc. · May 9, 2018
K141163 — STERIZONE STERILIZER · Tso3, Inc. · Dec 17, 2014

Submission Summary (Full Text)

{0}------------------------------------------------ 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); {1}------------------------------------------------ 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 {2}------------------------------------------------ ## 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) | CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ | Validation load # | Load description | Load weight¹ | |----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------| | 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 Pouch General 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 Pouch General 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 | | Validation load # | Load description | Load weight1 | | 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 orAdditional 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. | 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 | | Validation load # | Load description | Load weight1 | | 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 | #### Table 1. Description of the nine validation loads {4}------------------------------------------------ {5}------------------------------------------------ 1Excluding the 25-lb loading rack {6}------------------------------------------------ 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 | General Information: | Owner's Name: Address: | TSO3 Inc. TSO3 Inc. 2505, Avenue Dalton Quebec, QC G1P 3S5, Canada | |-------------------------|----------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------| | | Contact Person: | Alexandre Jokic TSO3, Inc. Director Regulatory Affairs and Quality Assurance | | | Address: | TSO3 Inc. 2505, Avenue Dalton Quebec, QC G1P 3S5, Canada | | | Telephone: Fax Number: | 418-651-0003 ext. 287 418-653-5726 | | Subject Device: | Trade Name: Common Name: Product Code: FDA Regulation: Device Classification: | STERIZONE® VP4 Sterilizer Dual sterilant sterilizer PJJ 21 CFR 880.6860 Class II | | Predicate Device: | Trade Name: Common Name: Product Code: FDA Regulation: Device Classification: Premarket Notification: | STERIZONE® VP4 Sterilizer Dual sterilant sterilizer PJJ 21 CFR 880.6860 Class II K153689 | {7}------------------------------------------------ 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. | Validation load # | Load description | Load weight | |----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------| | 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 Pouch. General 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 Pouch. General 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 channel 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 | | 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 mm or more and lengths of 1955 mm or less, or inside diameters of 1.45 mm or more and lengths of 3500 mm or less; packaged in aluminum sterilization container. | 17 lb | Table 1: Description of the validation loads {8}------------------------------------------------ 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. {9}------------------------------------------------ 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 Trade Name | Predicate STERIZONE VP4 Sterilizer K153689 | STERIZONE VP4 Sterilizer (with air vent option) K173694 | |------------------------------|---------------------------------------------------------------------------------|------------------------------------------------------------------| | Device Class | Class II | Same | | Product Code / Regulation | PJJ | Same | | Regulation Name | Dual sterilant sterilizer | Same | | Indications for Use | Terminal sterilization of reusable medical devices in health care facilities | Same | {10}------------------------------------------------ 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 | | | H2O2 Concentration by Weight | 50% | | | Same | | | Number of Sterilization Cycles | 1 ("Cycle 1") | | | Same | | | Critical Process Parameters | Differential Chamber Pressure (ΔP) and Load Temperature | | | Same | | | General Physical Process Parameters | 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 | | | Component changes | NA | | | Installation kit [filter: valve] | | ### Cycle Process Parameters Comparison Table | Device Trade Name | | | Predicate STERIZONE® VP4 Sterilizer K153689 | STERIZONE® VP4 Sterilizer (Air vent option) | |-------------------|--------------------------|---------------------------------------------------------------------------|------------------------------------------------------|------------------------------------------------------| | Phase | Cycle Steps | Controlled parameter | Value | Value | | | Pre-conditioning | Pressure | 1 Torr | Same | | Phase 1 | Dynamic H2O2 exposure | Differential pressure of 125-280 Solution vaporized and injected | 19 Torr | Same | | | H2O2 reduction: | Ozone injection | 2 mg/L | Same | | | | Ozone dwell | 5 min. | Same | {11}------------------------------------------------ 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 H2O2 exposure | Differential pressure of 125-280 Solution vaporized and injected | 19 Torr | Same | | | | | H2O2 reduction: | Ozone injection | 2 mg/L | Same | | | | | Ozone dwell | 5 min. | Same | | | Evacuation | Pressure | 1 Torr | Same | | | | Ventilation | depressurization | Atmospheric pressure using pressurized O2 | Atmospheric pressure using ambient 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. {12}------------------------------------------------ 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 and Compatibility Testing Safety Testing | Verification test results demonstrated that residual sterilants present on the selected materials were within the acceptance criteria already cleared for the STERIZONE® VP4 sterilizer. The STERIZONE® VP4 Sterilizer has been designed, constructed and tested to meet the safety and performance requirements of applicable North American safety codes and international standards. The STERIZONE® VP4 Sterilizer complies with the applicable portions of the following standards: • IEC 61010-1 2004 Safety requirement for measurement, control and laboratory use - Part 1: General • IEC 61010-2-040 2005 Safety requirement for measurement, control and laboratory use Part 2 particular requirements for sterilizers and washer-disinfectors used to treat medical materials • IEC 61326-1: 2012 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: General requirements • Federal Communication Commission (FCC) Part 18 / EN 55011 | |----------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Risk Management | There was one potential risk [sterilant residual levels] identified due to the change of gas for final ventilation. However, verification testing showed that residuals were within acceptance criteria for previously cleared versions of the STERIZONE VP4. All potential hazards and failure modes identified during the design and development processes were addressed and did not impact the existing labeling. The risk management activities included application FMEA, design FMEA and manufacturing process FMEA. | | Conclusion | The results of the verification/validation tests and the risk analyses have demonstrated that the STERIZONE® VP4 Sterilizer (air vent option; K173694) is substantially equivalent to the STERIZONE® VP4 Sterilizer (K153689) |

STERIZONE VP4 Sterilizer

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Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

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Predicate Devices

Related Devices

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STERIZONE VP4 Sterilizer

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Device Story

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Related Devices

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