(102 days)
No
The document does not mention AI, ML, or related concepts. The description of the "dynamic system" adapting to load conditions suggests a rule-based or algorithmic control system, not necessarily AI/ML.
No
The device is a sterilizer intended for cleaning medical devices, not for treating patients or therapeutic purposes.
No
This device is a sterilizer, not a diagnostic device. Its intended use is for terminal sterilization of medical devices, which means it cleans and decontaminates them, rather than diagnosing a condition or disease.
No
The device description clearly outlines a physical sterilizer unit that uses hydrogen peroxide and ozone, indicating it is a hardware device with integrated software for control.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "terminal sterilization of cleaned, rinsed, and nonmetal reusable medical devices in health care facilities." This describes a process for making medical devices safe for reuse, not a test performed on biological samples to diagnose a condition.
- Device Description: The device is described as a "low temperature sterilizer using two sterilants (vaporized hydrogen peroxide [H₂O₂] and ozone [O₃]) in a multi-phase process to sterilize reusable medical instruments." This further reinforces its function as a sterilization device.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The device's purpose is to sterilize medical instruments, which is a crucial step in infection control within healthcare settings, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The STERIZONE® VP4 Sterilizer is intended for use in terminal sterilization of cleaned, rinsed, and nonmetal reusable medical devices in health care facilities.
Product codes (comma separated list FDA assigned to the subject device)
PJJ
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care facilities.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
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).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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) |
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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) |