(293 days)
Not Found
No
The document describes a sterilization device using chemical processes (hydrogen peroxide and ozone) and does not mention any AI or ML components in its operation or description.
No
The device is a sterilizer intended for processing medical devices, not for diagnosing, treating, or preventing disease in a patient.
No
Explanation: The device is a sterilizer intended for terminal sterilization of medical devices, not for diagnosing medical conditions.
No
The device is a physical sterilizer that uses hydrogen peroxide and ozone, clearly indicating it is a hardware device, not software-only.
Based on the provided text, the STERIZONE® VP4 Sterilizer is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the "terminal sterilization of cleaned, rinsed, and dried metal and non-metal reusable medical devices in health care facilities." This is a process applied to medical devices themselves, not a test performed on biological samples to diagnose a condition.
- Device Description: The device is described as a "self-contained stand-alone device, using vaporized hydrogen peroxide and ozone in a multiphase process" for sterilization. This aligns with a sterilization device, not an IVD.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Testing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays for analysis
The STERIZONE® VP4 Sterilizer is a device used to make other medical devices safe for reuse, which falls under the category of a sterilization device, not an IVD.
N/A
Intended Use / Indications for Use
The STERIZONE® VP4 Sterilizer is intended for use in terminal sterilization of cleaned, rinsed, and dried metal and non-metal reusable medical devices in health care facilities.
The single pre-set cycle of the STERIZONE® VP4 Sterilizer uses hydrogen peroxide and ozone. The injection of vaporized hydrogen peroxide is followed by the injection of ozone, which reacts with residual hydrogen peroxide to form hydroxyl radicals.
Sterilization efficacy was demonstrated using a representative sample of one or more device types and packaging, in nine separate validation loads, as described in Table 1. The load to be processed should be maintained between 20℃ to 26℃ (68°F to 78°F). Total load weight shall not exceed 75 lbs, inclusive of the containers/packaging weight but excluding the 25 Ibs loading rack.
Product codes
PJJ
Device Description
The STERIZONE® VP4 Sterilizer (VP4) is a self-contained stand-alone device, using vaporized hydrogen peroxide and ozone in a multiphase process. The VP4 offers a single sterilization cycle intended for general instruments, flexible endoscopes (including single, dual, and multi-channel devices), and rigid-channel devices (including single-channel and doublechannel rigid endoscopes).
Lumen claims for the VP4 have been expanded to include double and multiple-channel devices with no more than four channels.
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
The modified STERIZONE® VP4 Sterilizer has been designed, constructed and tested to meet the safety and performance requirements of various North American safety codes and standards. The modified STERIZONE® VP4 Sterilizer complies with the applicable portions of the following standards:
- Canadian Standard Association (CSA) Standard C22.2 No 61010-1: 2004
- Underwriters Laboratory Standard UL 61010-1: 2004
- Federal Communication Commission (FCC) Part 18 / EN 55011
- International Electrotechnical Commission (IEC) Standard IEC 61326-1: 2012
- International Electrotechnical Commission (IEC) Standard 61010-1 :2010, 61010-2-040: 2005
A Fault Tree Analysis and Mitigation (FTA-MIT) and a Failure Mode Effects and Criticality Analysis (FMECA) has been conducted on the entire system of the STERIZONE® VP4 Sterilizer to ensure safety features and control redundancies have been implemented in the design and will be maintained during the manufacturing, installation, maintenance and servicing of the sterilizers.
The software controls of the modified STERIZONE® VP4 Sterilizer have undergone verification and validation testing in accordance with FDA's Guidance entitled "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this sterilizer was considered "moderate risk". Testing was completed with no unresolved anomalies.
The modified STERIZONE® VP4 Sterilizer underwent performance validation testing using the « overkill » approach to demonstrate the effectiveness of the process in accordance with ANSI/AAMI/ISO 14937. Testing on directly inoculated medical devices was conducted employing half-cycle to demonstrate achievement of a sterility assurance level (SAL) of 10 °. This process has been demonstrated to be effective for terminal sterilization of packaged reusable medical devices.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
May 9, 2018
TSO3, Inc. % Cynthia Pritchard CEO BioTechnology Transfer, LLC 1016 Tobiano Lane Raleigh, North Carolina 27614
Re: K172191
Trade/Device Name: STERIZONE VP4 Sterilizer Regulation Number: 21 CFR 880.6860 Regulation Name: Ethylene Oxide Gas Sterilizer Regulatory Class: II Product Code: PJJ Dated: March 16, 2018 Received: April 9, 2018
Dear Cynthia Pritchard:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good
1
manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Geeta K. Pamidimukkala -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K172191
Device Name STERIZONE® VP4 Sterilizer
Indications for Use (Describe)
The STERIZONE® VP4 Sterilizer is intended for use in terminal sterilization of cleaned, rinsed, and dried metal and non-metal reusable medical devices in health care facilities.
The single pre-set cycle of the STERIZONE® VP4 Sterilizer uses hydrogen peroxide and ozone. The injection of vaporized hydrogen peroxide is followed by the injection of ozone, which reacts with residual hydrogen peroxide to form hydroxyl radicals.
Sterilization efficacy was demonstrated using a representative sample of one or more device types and packaging, in nine separate validation loads, as described in Table 1. The load to be processed should be maintained between 20℃ to 26℃ (68°F to 78°F). Total load weight shall not exceed 75 lbs, inclusive of the containers/packaging weight but excluding the 25 Ibs loading rack.
Table 1. Description of the nine validation loads
| Validation load
| Load description | Load weight1
1Excluding the 25
lb loading rack |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|
| 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 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 |
3
| Validation load # | Load description | Load weight1 |
|---|---|---|
| 1Excluding the 25 lb loading rack | ||
| 5 | Validation load #5 consisted in two single channel flexible endoscopes; one Ureteroscope with inside diameter of 1.0 mm and length of 850 mm, and a Bronchoscope with inside diameter of 1.8 mm and length of 830 mm, and one double channel semi- rigid endoscope (ureteroscope – 0.7 mm × 500 mm and 1.1 mm × 500 mm), packaged individually in wrapped trays or containers including appropriate silicone brackets or mats. No additional item was added. | 21 lb |
| 6 | Validation load #6 consisted of general medical instruments, representing the following geometries: | |
| • Distal end (swivel parts) | ||
| • Hinge with screw | ||
| • 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 or more and lengths of 1955 mm or less, or 1.45 or more and lengths of 3500 mm or less; packaged in aluminium sterilization container | 17 lb |
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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4
510(k) Summary
Applicant's Name and Address
TSO3 Inc. 2505, avenue Dalton Quebec, QC G1P 3S5 Canada
Contact Person, Telephone, FAX
Alexandre Jokic, Director, Regulatory Affairs and Quality Assurance Phone: (418) 651-0003 ext. 287 Fax: (418) 653-5726 E-mail: ajokic@tso3.com
Date of Preparation May 7, 2018
Trade Name STERIZONE® VP4 Sterilizer
Common Name
Vaporized Hydrogen Peroxide Sterilizer
Classification Name
Ethylene Oxide Gas Sterilizer Class II (as per 21CFR, part 880.6860 equivalent device) Product Code: PJJ
Legally Marketed Equivalent Device Name(s)
STERIZONE® VP4 Sterilizer (K141163 and K153392) K141163 - Primary Predicate
5
Image /page/5/Picture/1 description: The image shows a chemical structure diagram. The diagram depicts a central sulfur atom (S) bonded to three oxygen atoms (O3). To the left of the sulfur atom is the letter T. The oxygen atoms are arranged around the sulfur atom, suggesting a trigonal pyramidal or similar geometry.
Device Description
The STERIZONE® VP4 Sterilizer (VP4) is a self-contained stand-alone device, using vaporized hydrogen peroxide and ozone in a multiphase process. The VP4 offers a single sterilization cycle intended for general instruments, flexible endoscopes (including single, dual, and multi-channel devices), and rigid-channel devices (including single-channel and doublechannel rigid endoscopes).
Lumen claims for the VP4 have been expanded to include double and multiple-channel devices with no more than four channels.
Indications for Use
The STERIZONE® VP4 Sterilizer is intended for use in terminal sterilization of cleaned, rinsed, and dried metal and non-metal reusable medical devices in health care facilities.
The single pre-set cycle of the STERIZONE® VP4 Sterilizer uses hydrogen peroxide and ozone. The injection of vaporized hydrogen peroxide is followed by the injection of ozone, which reacts with residual hydrogen peroxide to form hydroxyl radicals.
Sterilization efficacy was demonstrated using a representative sample of one or more device types and packaging, in nine separate validation loads, as described in Table 1. The load to be processed should be maintained between 20°C to 26°C (68°F to 78°F). Total load weight shall not exceed 75 lbs, inclusive of the containers/packaging weight but excluding the 25 lbs loading rack.
| Validation
load # | Load description | Load weight1
1Excluding the 25
lb loading rack |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|
| 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 |
| Validation
load # | Load description | Load weight1
1Excluding the 25
lb loading rack |
| 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 channeled instruments or stainless steel rigid lumens were added to each package. Two additional general medical instruments, each packaged in a pouch, were added. | 19 lb |
| 5 | Validation load #5 consisted in two single channel flexible endoscopes; one Ureteroscope with inside diameter of 1.0 mm and length of 850 mm, and a Bronchoscope with inside diameter of 1.8 mm and length of 830 mm, and one double channel semi- rigid endoscope (ureteroscope - 0.7 mm × 500 mm and 1.1 mm × 500 mm), packaged individually in wrapped trays or containers including appropriate silicone brackets or mats. No additional item was added. | 21 lb |
| 6 | Validation load #6 consisted of general medical instruments, representing the following geometries: Distal end (swivel parts) Hinge with screw Cannula General medical instruments packaged in one aluminum sterilization container. | 9 lb |
| 7 | Validation load #7 consisted of general medical instruments, representing the following geometries: Box-lock hinge Pivot hinge Luer-lock General medical instruments, spread out over three aluminum sterilization containers, each weighting 25 lb. | 75 lb |
| 8 | Validation load #8 consisted of two double-channel flexible endoscopes (Ureteroscope) with inside diameter of 1 mm and lengths of 850 and 989 mm; and one single-channel flexible endoscopes (Ureteroscope) with inside diameter of 1 mm and length of 850 mm, packaged individually in wrapped plastic sterilization trays, including appropriate silicone brackets or mats. | 16 lb |
| Validation
load # | Load description | Load weight1 |
| | | 1Excluding the 25
lb loading rack |
| 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
6
TSO₃
7
Image /page/7/Picture/0 description: The image shows a chemical structure diagram. The diagram depicts a central sulfur atom (S) bonded to three oxygen atoms (O3). To the left of the sulfur atom is the letter T. The diagram is rendered in black and gray, with the oxygen atoms and connecting lines appearing in gray.
Performance Data
Safety
The modified STERIZONE® VP4 Sterilizer has been designed, constructed and tested to meet the safety and performance requirements of various North American safety codes and standards. The modified STERIZONE® VP4 Sterilizer complies with the applicable portions of the following standards:
- Canadian Standard Association (CSA) Standard C22.2 No 61010-1: 2004 ●
- Underwriters Laboratory Standard UL 61010-1: 2004
- Federal Communication Commission (FCC) Part 18 / EN 55011
- International Electrotechnical Commission (IEC) Standard IEC 61326-1: 2012
- International Electrotechnical Commission (IEC) Standard 61010-1 :2010, 61010-2-040: 2005
A Fault Tree Analysis and Mitigation (FTA-MIT) and a Failure Mode Effects and Criticality Analysis (FMECA) has been conducted on the entire system of the STERIZONE® VP4 Sterilizer to ensure safety features and control redundancies have been implemented in the design and will be maintained during the manufacturing, installation, maintenance and servicing of the sterilizers.
The software controls of the modified STERIZONE® VP4 Sterilizer have undergone verification and validation testing in accordance with FDA's Guidance entitled "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this sterilizer was considered "moderate risk". Testing was completed with no unresolved anomalies.
Effectiveness
The modified STERIZONE® VP4 Sterilizer underwent performance validation testing using the « overkill » approach to demonstrate the effectiveness of the process in accordance with
8
Image /page/8/Picture/9 description: The image shows the chemical formula for a compound. The formula is represented as "TSO3". The letters are in bold, sans-serif font. The "3" in "O3" is a subscript, indicating the number of oxygen atoms in the molecule. There are some gray circles above the "SO" part of the formula.
ANSI/AAMI/ISO 14937. Testing on directly inoculated medical devices was conducted employing half-cycle to demonstrate achievement of a sterility assurance level (SAL) of 10 °.
This process has been demonstrated to be effective for terminal sterilization of packaged reusable medical devices.
Substantial equivalence
The STERIZONE® VP4 Sterilizer, with the expanded flexible lumen claims, is substantially equivalent to the predicate STERIZONE® VP4 Sterilizer (K141163). The design, materials, and functions of the sterilizers are identical. Furthermore, the intended use and general indications for use are identical. Changes to the lumen claims do not raise different questions regarding safety and effectiveness. A comparison between the two devices is provided in Table 2.
| | PREDICATE
STERIZONE® VP4 Sterilizer
K141163 and K153392 | | STERIZONE® VP4 Sterilizer
with expanded flexible lumen claims | | |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|------------------------------------------------------------------|-----------------------|------------------------|
| Intended Use | Terminal sterilization of reusable medical devices in health care facilities | | Same | | |
| General
Indication for
Use | Sterilization of both metal and nonmetal medical devices. Sterilization of instruments, which have diffusion-restricted spaces, such as hinged portions of forceps and scissors. Processing of medical devices having rigid and flexible channels with limitations in materials, dimensions and number of devices. | | Same | | |
| Lumen claims | | Inner Diameter | Lumen Length | Inner Diameter | Lumen Length |
| | Single Channel Flexible
Endoscope | ≥ 1mm | ≤ 850 mm | Same | Same |
| | Single & Double
Channel Flexible
Endoscope | | | ≥ 1 mm | ≤ 989 mm |
| | Multi-channel Flexible
Endoscope (Video
colonoscope/gastroscope
- 4 channels total) | | | ≥ 1.2 mm
≥ 1.45 mm | ≤ 1955 mm
≤ 3500 mm |
| | Rigid Single & Double
Channel Endoscope | ≥ 0.7 mm | ≤ 500 mm | Same | Same |
| Sterilant | Vaprorized Hydrogen Peroxide/Ozone | | | Same | |
| H2O2
Concentration by
Weight | 50% | | | Same | |
| Number of
Sterilization
Cycles | 1 ("Cycle 1") | | | Same | |
Table 2. General comparison of technical specifications, technology, and indications for use between the STERIZONE® VP4 Sterilizer and predicate device
9
Image /page/9/Picture/0 description: The image shows a chemical structure diagram. The diagram depicts a central 'S' atom bonded to three oxygen atoms, represented as 'O' with a subscript '3'. To the left of the 'S' atom is the letter 'T', which is part of the chemical formula. The chemical formula is likely an abbreviation for a more complex molecule.
| Critical 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 |
Conclusion
The STERIZONE® VP4 Sterilizer, with the expanded flexible lumen claims, is substantially equivalent to the identified predicate device, the STERIZONE® VP4 Sterilizer.