(121 days)
STERIZONE® VP4 Sterilizer (K141163)
Not Found
No
The document describes a sterilization device and its modifications, focusing on chemical processes, physical parameters (temperature, weight), and software changes for maintenance and compliance. There is no mention of AI or ML in the intended use, device description, or performance studies.
No.
This device is a sterilizer intended for use in the terminal sterilization of reusable medical devices, not for diagnosing, treating, or preventing disease in a patient.
No
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. While it contains software, it is not a software-only medical device.
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 "terminal sterilization of cleaned, rinsed, and dried metal and non-metal reusable medical devices in health care facilities." This describes a process for making medical devices sterile for patient use, not a test performed on biological samples to diagnose a condition.
- Device Description: The description details a sterilizer using hydrogen peroxide and ozone, a process for disinfecting and sterilizing equipment. It doesn't mention any components or functions related to analyzing biological samples.
- 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.)
- Providing diagnostic information
- Using reagents or assays for testing
Therefore, the STERIZONE® VP4 Sterilizer is a medical device used for sterilization, not 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 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 seven 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 (comma separated list FDA assigned to the subject device)
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, single-channel flexible endoscopes, and rigid-channel devices including single-channel and double-channel rigid endoscopes.
The VP4 has been modified in order to make it compliant with the European Directive on the Restriction Of use of certain Hazardous Substances also known as « RoHS ». In addition, device software has been modified to include a maintenance mode, among other small changes. Finally, a new sensor has been adopted for monitor and control of chamber pressure.
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
All RoHS-compliant components have undergone verification testing using the exact same test methods and acceptance criteria as used in the predicate device. The use of a new pressure transducer to monitor and control chamber pressure was verified using the same test methods and acceptance criteria as used in the predicate device.
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. Testing on directly inoculated medical devices was conducted employing half-cycle to demonstrate achievement of a sterility assurance level (SAL) of 10-6.
This process has been demonstrated to be effective for terminal sterilization of packaged reusable medical devices.
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.
STERIZONE® VP4 Sterilizer (K141163)
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's seal, which includes an abstract image of a human figure in profile, repeated three times. The seal is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 24, 2016
TSO3 Inc. c/o Thomas Richards, Ph.D. Consultant IM3, Inc. 7720 NE Hwy 99, Suite D #110 Vancouver, Washington 98665
Re: K153392
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 22, 2016 Received: February 24, 2016
Dear Dr. Richards:
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.
1
Page 2 - Dr. Richards
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 (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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Teiashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known)
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 seven 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.
| 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 |
Table 1. Description of the seven validation loads
3
| Validation
load # | Load description | Load weight1
Excluding the 25
lb loading rack |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| 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 |
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 Tel: (418) 651-0003 ext. 287 FAX: (418) 653-5726 Email: ajokic@tso3.com
U.S. Contact
IM3, Inc. Contact: Thomas Richards, Ph.D. Phone: 503-415-0250 Email: tomami20x @ gmail.com
Submission Date
November 20, 2015
Trade Name
STERIZONE® VP4 Sterilizer
Common Name
Vaporized Hydrogen Peroxide Sterilizer
Classification Name
Sterilizer, Chemical Class II (as per 21CFR, part 880.6860 equivalent device) Product Code: PJJ
Legally Marketed Equivalent Device Name(s)
STERIZONE® VP4 Sterilizer (K141163)
5
Image /page/5/Picture/1 description: The image shows a chemical structure diagram. The diagram depicts a molecule with the abbreviation "Ts" connected to an "S" atom, which is further bonded to three oxygen atoms. The oxygen atoms are enclosed in parentheses with a subscript "3", indicating that there are three of them.
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, single-channel flexible endoscopes, and rigid-channel devices including single-channel and double-channel rigid endoscopes.
The VP4 has been modified in order to make it compliant with the European Directive on the Restriction Of use of certain Hazardous Substances also known as « RoHS ». In addition, device software has been modified to include a maintenance mode, among other small changes. Finally, a new sensor has been adopted for monitor and control of chamber pressure.
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 seven 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 |
Table 1. Description of the seven validation loads
6
TSO₃
7
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.
All RoHS-compliant components have undergone verification testing using the exact same test methods and acceptance criteria as used in the predicate device. The use of a new pressure transducer to monitor and control chamber pressure was verified using the same test methods and acceptance criteria as used in the predicate device.
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.
8
Effectiveness
The modified STERIZONE® VP4 Sterilizer underwent performance validation testing using the « overkill » approach to demonstrate the effectiveness of the process. Testing on directly inoculated medical devices was conducted employing half-cycle to demonstrate achievement of a sterility assurance level (SAL) of 10-6.
This process has been demonstrated to be effective for terminal sterilization of packaged reusable medical devices.
Substantial equivalence
The modified STERIZONE® VP4 Sterilizer is substantially equivalent to the predicate STERIZONE® VP4 Sterilizer (K141163). The design, materials, and functions of the sterilizers Changes to software and device components do not affect performance are identical. specifications or raise different questions regarding safety and effectiveness. A comparison between the two devices is provided in Table 2.
| | PREDICATE
STERIZONE VP4
K141163 | Modified
STERIZONE
VP4 |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| Intended Use | Terminal sterilization of reusable
medical devices in health care
facilities | Same |
| General 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 healthcare | 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 ( $Δ$ P)
and Load Temperature | Same |
Table 2. Comparison Table between Modified and Predicate Devices.
9
Image /page/9/Picture/7 description: The image contains a chemical structure diagram. The diagram depicts a molecule with the abbreviation 'Ts' connected to a sulfur atom (S). The sulfur atom is further bonded to three oxygen atoms, represented as 'O3'. The structure suggests a chemical compound containing a tosyl group (Ts) attached to a sulfur trioxide moiety.
| | PREDICATE
STERIZONE VP4
K141163 | Modified
STERIZONE
VP4 |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| General Physical Process
Parameters | Wall temperature, vaporization
temperature, exposure times, flow
rates, ozone concentration,
component temperatures | Same |
| Chamber Volume | 125L | Same |
| Software Control | PLC | Same |
The predicate device has been modified by manufacturing all device components from RoHS compliant materials, upgrade of the software to include a maintenance mode among other functions, and use of a single pressure transducer to monitor and control chamber pressure. Verification testing has been completed on all modified components using the exact same methods and acceptance criteria as completed on the predicate device. Software verification and validation testing confirms that the modified device will perform as intended under the specified use conditions. Electrical safety, EMC and microbiology testing has been completed on the modified device confirming that it is both as safe and as effective as the predicate device.
Conclusion
The performance testing demonstrates that the STERIZONE® VP4 Sterilizer is substantially equivalent to the identified predicate devices.