(190 days)
Not Found
No
The document describes a sterilization device and its validation process, with no mention of AI or ML technologies.
No
The device is a sterilizer for medical devices, not a therapeutic device designed to treat a disease or condition in a patient.
No
The device is a sterilizer, meaning it cleans and sterilizes medical devices, rather than diagnosing medical conditions. Its function is to prepare re-usable medical equipment for safe use.
No
The device description clearly states it is a "self-contained stand-alone device" that uses "vaporized hydrogen peroxide and ozone in a multiphase process," indicating it is a physical sterilizer with hardware components, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
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 performed on medical devices themselves, not on biological samples from a patient to diagnose a condition.
- Device Description: The device is a sterilizer that uses hydrogen peroxide and ozone. This is a physical/chemical process for killing microorganisms, not a test performed on a sample.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's health
- Using reagents or assays to detect specific substances
- Outputting results related to a patient's condition
The STERIZONE® VP4 Sterilizer is a device used to prepare other medical devices for safe use, not a device used for diagnosis.
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 lbs 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, 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 (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.
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 10-6.
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.
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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, arranged in a way that resembles a bird in flight.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 30, 2016
TSO3 Inc. % Thomas Richards Consultant IM3, Inc. 7720 Ne Hwy 99. Suite D#110 Vancouver, Washington 98665
Re: K153689
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: May 31, 2016 Received: June 1, 2016
Dear Thomas 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.
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education 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,
Tejashri 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
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K153689
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 lbs 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 aluminum 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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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
U.S. Contact
IM3, Inc. Contact: Thomas Richards, Ph.D. Phone: 503-415-0250 Email: tomami20x @ gmail.com
Submission Date
June 30, 2016
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)
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 (O), represented as O3. The letters 'TS' are positioned to the left of the sulfur atom. The diagram is presented in a minimalist style, with the chemical symbols clearly visible.
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
Excluding 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 letters and atoms are arranged in a way that suggests a three-dimensional structure.
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
TSO₃
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 molecule with the letters 'TS' on the left, followed by 'O' with a subscript '3'. The 'O' and subscript '3' are enclosed in parentheses. The diagram is rendered in shades of gray, with the 'TS' portion being darker than the rest of the 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.