(226 days)
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 STERIZONE® VP4 Sterilization chamber has a capacity of 4.4 cu. ft. (125 liters). It requires oxygen (94% pure and greater), electricity and the 125-280 Solution™ containing 50% hydrogen peroxide by weight. Both hydrogen peroxide and ozone are used in a multiphase process.
The STERIZONE® VP4 Sterilizer is equipped with a factory-programmed control system offering a unique sterilization cycle.
Processed medical instruments are ready to use immediately after the cycle ends; no aeration is required.
Polypropylene non-woven wrapping material, non-woven polyethylene (Tyvek™) with polyester/LDPE transparent film pouches, and vaporized hydrogen peroxide compatible aluminium containers using disposable polypropylene filters, are used as packaging for medical devices to be sterilized. Plastic and metal trays are also suitable packaging means when combined with polypropylene wraps.
A self-contained biological indicator containing spores of G. stearothermophilus, incorporated into a test pack, is recommended to monitor cycle performance.
The STERIZONE® VP4 Sterilizer could be installed as a free standing unit or recessed behind the wall.
No exhaust gas ventilation duct is required as long as the room is adequately ventilated.
The document is a 510(k) premarket notification for the STERIZONE® VP4 Sterilizer, which is intended for terminal sterilization of reusable medical devices in healthcare facilities. It provides information regarding the device's indications for use, its sterilization process, safety and effectiveness testing, and a comparison to predicate devices to establish substantial equivalence.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The document presents "Performance Requirements for Effectiveness" and "Performance Requirements for Safety" for the STERIZONE® VP4 Sterilizer, along with the results.
| Performance Requirements for Effectiveness | Results |
|---|---|
| 1. Effective to sterilize medical devices inoculated with 10^6 microorganism at the half-cycle conditions (Half-cycle validation testing) | Met requirements |
| 2. Effective to sterilize medical devices inoculated with 10^6 microorganism in the presence of organic and inorganic matter at the complete cycle (Simulated-use testing) | Met requirements |
| 3. Sterilize medical devices in real life conditions (In-use testing) | Met requirements |
| 4. Pass the AOAC Sporicidal Screening Test | Met requirements |
| 5. Sterilize effectively on non-woven polyethylene sterilization pouches, rigid aluminum containers and wrapped trays | Met requirements |
| 6. Sterilization efficacy is repeatable | Met requirements |
| Performance Requirements for Safety | Results |
| 1. Sterilant is not toxic for users and patients | Met requirements |
| 2. Most of the materials used in the manufacturing of medical devices are compatible with the hydrogen peroxide-ozone sterilization process | Met requirements |
| 3. Sterilizer complies with electrical safety standards UL 61010-1, CAN/CSA 61010-1, EN/IEC 61010-1 and 61010-2-040 | Met requirements |
| 4. Sterilizer complies with EMI/EMC requirements of FCC 47CFR, part 18, subpart B, and IEC 613261 | Met requirements |
| 5. A Fault Tree Analysis and Mitigation (FTA-MIT) analysis have been preformed on the sterilizer and potential hazards were identified and mitigations were implemented among the control software safeties and design features | Met requirements |
| 6. A Failure Mode Effects and Criticality Analysis (FMECA) was done for each component of the sterilizer and safeties were included in the design of the device according to the findings of this study (built-in safeties) | Met requirements |
| 7. The amount of hydrogen peroxide and ozone remaining on containers and pouches immediately after cycle is not significant | Met requirements |
| 8. There are no toxic residue or by-products residues remaining in/on medical product after the sterilization cycle is completed. After the cycle is completed, medical devices are cool to touch and ready to use immediately (no aeration is required) | Met requirements |
| 9. The sterilization process is safe from an occupational safety point of view | Met requirements |
2. Sample Size Used for the Test Set and Data Provenance:
The "Effectiveness" validation was demonstrated using a "representative sample of one or more device types and packaging, in seven separate validation loads" (Table 1 and 2, pages 2-3 and 7-8). Each load contained various medical instruments representing different geometries and packaging types. The specific number of individual devices or biological indicators within each load is not explicitly stated as a "sample size" in the way it might be for a clinical trial. Instead, the "overkill" approach mentions inoculating medical devices with 10^6 microorganisms, implying a high concentration of test organisms rather than a large count of unique physical samples being tested. This type of testing is generally prospective, designed specifically for validation. The country of origin of the data is not explicitly stated, but the applicant's address is in Quebec, Canada, suggesting Canadian provenance for at least some of the underlying work.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This type of sterilization efficacy testing does not typically rely on human expert consensus for "ground truth" in the same way as, for example, image interpretation. The ground truth for sterilization is established through microbiological testing (e.g., demonstrating the eradication of 10^6 microorganisms, achieving a sterility assurance level (SAL) of 10^-6), and chemical analysis for residue. The document does not specify the number or qualifications of experts involved in analyzing these microbiological and chemical results, as these are standardized laboratory procedures.
4. Adjudication Method for the Test Set:
Not applicable in the context of sterilization device validation. Adjudication methods like "2+1" are used in studies involving subjective human interpretation, such as clinical image reading. Sterilization efficacy is determined by objective microbiological and chemical tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret outputs, often looking at how AI assistance changes their performance. For a sterilizer, the focus is on the device's inherent ability to achieve sterility, not on human interpretation of data.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Yes, the effectiveness testing describes the standalone performance of the STERIZONE® VP4 Sterilizer. The entire study focuses on the device's ability to sterilize medical devices on its own, independent of human intervention during the sterilization cycle once initiated. The "half-cycle validation testing," "simulated-use testing," and "in-use testing" all evaluate the device's performance directly.
7. The Type of Ground Truth Used:
The primary ground truth used for effectiveness testing is microbiological efficacy, specifically demonstrating a sterility assurance level (SAL) of 10^-6, which means a probability of one non-sterile item in a million. This is achieved through controlled inoculation of medical devices with a known quantity (10^6) of highly resistant microorganisms (e.g., Geobacillus stearothermophilus spores) and verifying their eradication after sterilization. Secondary ground truths include chemical analysis to ensure the absence of toxic residues and by-products.
8. The Sample Size for the Training Set:
This document does not describe a "training set" in the context of machine learning. The STERIZONE® VP4 Sterilizer is not an AI/ML device in the sense of requiring a training set of data for an algorithm to learn from. The "training" for a sterilization device would be the engineering design, development, and iterative testing that precedes the final validation studies.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as the device is not an AI/ML device that requires a training set and corresponding ground truth. The "ground truth" during the development and design phases would be based on established principles of microbiology, chemistry, and engineering for effective and safe sterilization.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around an emblem. The emblem consists of a stylized human figure with three faces, representing the department's focus on health and human well-being.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 17, 2014
TSO3 Inc. C/O Thomas Richards, Ph.D. Consultant IM3, Inc. 512F NE 81st Street, Suite110 Vancouver, WA 98665
Re: K141163
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: December 8, 2014 Received: December 10, 2014
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.
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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,
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
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Indications for Use
510(k) Number (if known) K141163
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 lbs loading rack.
| Validationload # | Load description | Load weight11Excluding the 25lb 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 PouchGeneral 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 PouchGeneral medical instruments were spread out over one container, three trays, and six pouches. | 20 lb |
Table 1. Description of the seven validation loads
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| Validationload # | Load description | Load weight1Excluding the 25Ib loading rack1 |
|---|---|---|
| 3 | Validation load #3 consisted of three single channel flexible endoscopes(Ureteroscope) with inside diameter of 1.0 mm and length of 850 mm, packagedindividually in wrapped trays or containers, including appropriate silicone bracketsor 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 inthe presence of other packaged medical devices. Three double channel semi-rigidendoscopes (ureteroscope - $0.7 mm \times 500 mm$ and $1.1 mm \times 500 mm$ ) werepackaged individually in wrapped trays or containers including appropriate siliconebrackets or mats. Additional rigid channeled instruments or stainless steel rigidlumens 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; oneUreteroscope with inside diameter of 1.0 mm and length of 850 mm, and aBronchoscope with inside diameter of 1.8 mm and length of 830 mm, and onedouble channel semi- rigid endoscope (ureteroscope - $0.7 mm \times 500 mm$ and $1.1 mm \times 500 mm$ ), packaged individually in wrapped trays or containers includingappropriate silicone brackets or mats. No additional item was added. | 21 lb |
| 6 | Validation load #6 consisted of general medical instruments, representing thefollowing geometries:• Distal end (swivel parts)• Hinge with screw• CannulaGeneral medical instruments packaged in one aluminum sterilization container. | 9 lb |
| 7 | Validation load #7 consisted of general medical instruments, representing thefollowing geometries:• Box-lock hinge• Pivot hinge• Luer-lockGeneral medical instruments, spread out over three aluminum sterilizationcontainers, 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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Image /page/4/Picture/0 description: The image shows a chemical structure. The structure contains the letters 'Ts' on the left side. To the right of 'Ts' is a chemical structure with a benzene ring and three oxygen atoms. The number '3' is located at the bottom right of the structure.
510(k) Summary
Applicant's Name and Address
TSO3 Inc. 2505, avenue Dalton Quebec, QC G1P 3S5 Canada
Contact Person, Telephone, FAX
Marc Chaunet, Director of Regulatory Affairs Phone: (418) 653-0003 ext. 242 Fax: (418) 653-5726 E-mail: mchaunet@tso3.com
U.S. Contact
IM3, Inc. Contact: Thomas Richards, Ph.D. Phone: 503-415-0250 Email: tomami20x@gmail.com
Summary Date December 12, 2014
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)
STERRAD® 100NX® Sterilizer with DUO Cycle (K111377) Amsco® V-PRO® maX Low Temperature Sterilization System (K131120)
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Image /page/5/Picture/0 description: The image shows a chemical structure diagram. The diagram depicts a central sulfur atom (S) bonded to three oxygen atoms (O), forming an SO3 group. The 'T' next to the sulfur atom is not clearly defined in the image, but it may represent a functional group or a placeholder for a larger molecule. The overall structure suggests a sulfur-containing compound, possibly an intermediate or a fragment of a larger molecule.
Process description
The STERIZONE® VP4 Sterilizer offers a single pre-set sterilization cycle designed for the sterilization of general instruments, single channel flexible endoscopes, rigid and semi-rigid channeled devices including single channel and double channel rigid endoscopes.
The STERIZONE® VP4 Sterilizer uses dual sterilants, vaporized hydrogen peroxide (H202) and ozone (O3), in a multiphase process.
Upon loading the medical devices into the sterilization chamber and closure of the door, the chamber is subjected to a vacuum of 1 Torr (referred to as pre-conditioning step). The first cycle phase (Phase 1) is initiated with the Dynamic H2O2 exposure step. During this step, a 50 weight-percent hydrogen peroxide solution (referred to as 125-280 Solution™) is injected at a fixed injection rate in vapor form into the sterilization chamber through a continuous micropulsed injection until a differential pressure set point of 19 Torr is reached (i.e., the actual chamber pressure is 20 Torr, less the initial vacuum of 1 Torr, which is equivalent to a "differential pressure" or "AP" of 19 Torr). The total amount of hydrogen peroxide introduced into the sterilization chamber and thus the duration of the injection varies depending on load composition (e.g. surface area), weight and temperature.
The second step of the cycle phase is the H2O2 Reduction Step. During this step, a set concentration of ozone is injected into the chamber and reacts with residual hydrogen peroxide to form hydroxyl radicals.
During the second cycle phase (Phase 2), the same sequence is repeated, including the Dynamic H2O2 exposure and H2O2 reduction steps. The full Cycle is then completed with an evacuation and ventilation, through a catalytic converter, to the atmosphere, at which point the chamber door can be safely opened.
The cycle process parameters are summarized in Table 1.
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| Hydrogen peroxide exposure | Ozone exposure | ||||||
|---|---|---|---|---|---|---|---|
| Hydrogenperoxide solution | Chamberdifferentialpressureset point | Time | Sterilantinjected | Vaporizer /Chambertemperature | O3injection | O3dwell | Nb ofphases |
| 125-280 Solution™(H2O2 50 wt%) | 19 Torr | 210-600sec* | 8.4-24 g* | 120°C /41 ± 3°C | 2 mg/L | 5 min | 2 |
Table 1. STERIZONE® VP4 Sterilizer – Cycle process parameters
- Vaporized hydrogen peroxide injection/exposure time (Dynamic H2O2 exposure step) varies with load composition and conditions. The quantity of vaporized hydrogen peroxide injected is directly related to the time required to reach a pressure differential of 19 Torr in the chamber, for load temperature ranging from 20℃ to 26℃. If the H2O2 injection time is less than 210 seconds, or greater than 600 seconds, the cycle will abort.
Intended 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 dual sterilants 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 2. 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.
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Image /page/7/Picture/0 description: The image shows a chemical structure diagram. The diagram depicts a molecule with the abbreviation 'Ts' on the left, followed by a sulfur atom (S) connected to three oxygen atoms (O). The oxygen atoms are arranged in a triangular shape around the sulfur atom, suggesting a sulfonate group. The 'Ts' likely represents a tosyl group, a common protecting group in organic chemistry.
| Validationload # | Load description | Loadweight1 |
|---|---|---|
| 1Excludingthe 25 lbloadingrack | ||
| 1 | Validation load #1 consisted of general medical instruments, representing thefollowing geometries:Clamp Serrated surface Box-lock Handle Button Pivot hinge Stopcock Type of packaging used: wrapped plastic tray, including silicone mats andbrackets, and PouchGeneral medical instruments were spread out over three trays, six pouches and onewrapped instrument. | 11 lb |
| 2 | Validation load #2 consisted of general medical instruments, representing thefollowing 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 matsand brackets, rigid aluminum container and PouchGeneral medical instruments were spread out over one container, three trays, and sixpouches. | 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, packagedindividually in wrapped trays or containers, including appropriate siliconebrackets 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 channeledinstruments in the presence of other packaged medical devices. Three doublechannel semi-rigid endoscopes (ureteroscope – 0.7 mm × 500 mm and 1.1 mm ×500 mm) were packaged individually in wrapped trays or containers includingappropriate silicone brackets or mats. Additional rigid channeled instruments orstainless steel rigid lumens were added to each package. Two additional generalmedical instruments, each packaged in a pouch, were added. | 19 lb |
| 5 | Validation load #5 consisted in two single channel flexible endoscopes; oneUreteroscope with inside diameter of 1.0 mm and length of 850 mm, and aBronchoscope with inside diameter of 1.8 mm and length of 830 mm, and onedouble channel semi- rigid endoscope (ureteroscope - 0.7 mm × 500 mm and1.1 mm × 500 mm), packaged individually in wrapped trays or containersincluding appropriate silicone brackets or mats. No additional item was added. | 21 lb |
| Validationload # | Load description | Loadweight11Excludingthe 25 lbloadingrack |
| 6 | Validation load #6 consisted of general medical instruments, representing thefollowing geometries:• Distal end (swivel parts)• Hinge with screw• CannulaGeneral medical instruments packaged in one aluminum sterilization container. | 9 lb |
| 7 | Validation load #7 consisted of general medical instruments, representing thefollowing geometries:• Box-lock hinge• Pivot hinge• Luer-lockGeneral medical instruments, spread out over three aluminum sterilizationcontainers, each weighting 25 lb. | 75 lb |
Table 2. Description of the seven validation loads
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Description of Device
The STERIZONE® VP4 Sterilization chamber has a capacity of 4.4 cu. ft. (125 liters). It requires oxygen (94% pure and greater), electricity and the 125-280 Solution™ containing 50% hydrogen peroxide by weight. Both hydrogen peroxide and ozone are used in a multiphase process.
The STERIZONE® VP4 Sterilizer is equipped with a factory-programmed control system offering a unique sterilization cycle.
Processed medical instruments are ready to use immediately after the cycle ends; no aeration is required.
Polypropylene non-woven wrapping material, non-woven polyethylene (Tyvek™) with polyester/LDPE transparent film pouches, and vaporized hydrogen peroxide compatible aluminium containers using disposable polypropylene filters, are used as packaging for medical devices to be sterilized. Plastic and metal trays are also suitable packaging means when combined with polypropylene wraps.
A self-contained biological indicator containing spores of G. stearothermophilus, incorporated into a test pack, is recommended to monitor cycle performance.
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The STERIZONE® VP4 Sterilizer could be installed as a free standing unit or recessed behind the wall.
No exhaust gas ventilation duct is required as long as the room is adequately ventilated.
Effectiveness
The STERIZONE® VP4 Sterilizer performance validation testing was performed 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 106 at the complete cycle.
This process has been demonstrated to be effective for terminal sterilization of packaged reusable medical devices.
Safety
The 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 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: 2012
- . International Electrotechnical Commission (IEC) Standard 61010-1 :2001, 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.
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Image /page/10/Picture/0 description: The image shows a chemical structure diagram. The diagram depicts a TsO3 molecule, with 'Ts' representing a tosyl group attached to a sulfur atom (S). The sulfur atom is bonded to three oxygen atoms (O3). The structure is presented in a simplified, two-dimensional format, commonly used in chemical notation.
To ensure optimum performance, the user must ensure the materials, instruments and devices to be sterilized are thoroughly cleaned and dried, that the instrument manufacturer's instructions are followed, and that each sterilization load is monitored with biological and chemical sterilization process indicators.
The software controls of the STERIZONE® VP4 Sterilizer have been designed providing safeguards that only intended operating cycles function to completion. Process parameters falling outside acceptable range will cancel the cycle and provide appropriate information identifying the source of the problem detected.
The following Table 3 summarizes the safety and effectiveness testing performed for the STERIZONE® VP4 Sterilizer.
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Table 3. Summary of Safety and Effectiveness testing performed for the STERIZONE® VP4 Sterilizer
| Performance Requirements for Effectiveness | Results | |
|---|---|---|
| 1 | Effective to sterilize medical devices inoculated with 106 microorganism at the half-cycle conditions (Half-cycle validation testing) | Met requirements |
| 2 | Effective to sterilize medical devices inoculated with 106 microorganism in the presence of organic and inorganic matter at the complete cycle (Simulated-use testing) | Met requirements |
| 3 | Sterilize medical devices in real life conditions (In-use testing) | Met requirements |
| 4 | Pass the AOAC Sporicidal Screening Test | Met requirements |
| 5 | Sterilize effectively on non-woven polyethylene sterilization pouches, rigid aluminum containers and wrapped trays | Met requirements |
| 6 | Sterilization efficacy is repeatable | Met requirements |
| Performance Requirements for Safety | ||
| 1 | Sterilant is not toxic for users and patients | Met requirements |
| 2 | Most of the materials used in the manufacturing of medical devices are compatible with the hydrogen peroxide-ozone sterilization process | Met requirements |
| 3 | Sterilizer complies with electrical safety standards UL 61010-1, CAN/CSA 61010-1, EN/IEC 61010-1 and 61010-2-040 | Met requirements |
| 4 | Sterilizer complies with EMI/EMC requirements of FCC 47CFR, part 18, subpart B, and IEC 613261 | Met requirements |
| 5 | A Fault Tree Analysis and Mitigation (FTA-MIT) analysis have been preformed on the sterilizer and potential hazards were identified and mitigations were implemented among the control software safeties and design features | Met requirements |
| 6 | A Failure Mode Effects and Criticality Analysis (FMECA) was done for each component of the sterilizer and safeties were included in the design of the device according to the findings of this study (built-in safeties) | Met requirements |
| 7 | The amount of hydrogen peroxide and ozone remaining on containers and pouches immediately after cycle is not significant | Met requirements |
| 8 | There are no toxic residue or by-products residues remaining in/on medical product after the sterilization cycle is completed. After the cycle is completed, medical devices are cool to touch and ready to use immediately (no aeration is required) | Met requirements |
| 9 | The sterilization process is safe from an occupational safety point of view | Met requirements |
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Substantial equivalence
The STERIZONE® VP4 Sterilizer ("VP4") is substantially equivalent to the STERRAD® 100NX® Sterilizer with DUO Cycle (K111377) and STERIS (Amsco®) V-PRO® maX Low Temperature Sterilization System (K131120). Table 4 summarizes the general specifications, indications, and overall technological characteristics for both the VP4 and predicate devices.
Table 4. General comparison of technical specifications, technology, and indications for the subject device and predicate devices.
| Subject Device:STERIZONE® VP4 | Predicate Device:STERRAD 100NXK111377 | Predicate Device:STERIS V-PRO maXK131120 | |
|---|---|---|---|
| Intended Use | Terminal sterilization of reusable medical devices in health care facilities | Same | Same |
| GeneralIndications forUse | The STERIZONE® VP4Sterilizer is intended foruse in terminalsterilization of cleaned,rinsed, and dried metaland non-metal reusablemedical devices in healthcare facilities. | The STERRAD® 100NX®Sterilizer is designed forsterilization of both metaland nonmetal medicaldevices at lowtemperatures. TheSTERRAD sterilizationprocess is a multiphasesterilization process thatutilizes a combination ofexposure to hydrogenperoxide vapor andplasma to safely sterilizemedical instruments andmaterials without leavingtoxic residue. | The Amsco V-PRO maXLow TemperatureSterilization System, withVAPROX® HC Steriant, isa vaporized hydrogenperoxide sterilizerintended for use in theterminal sterilization ofcleaned, rinsed, and driedreusable metal and non-metal medical devicesused in health carefacilities. |
| Sterilant | Vaporized HydrogenPeroxide / Ozone | Vaporized HydrogenPeroxide | Vaporized HydrogenPeroxide |
| H2O2Concentration byWeight | 50% | 59-94%Depending on Cycle | 59% |
| Post H2O2injection step | Ozone injection / Dwell | Air pulse / Dwell / Plasma | Air pulse / Dwell |
| Number Pulses | 2 | 2 | 4 |
| Subject Device:STERIZONE® VP4Image: STERIZONE VP4 | Predicate Device:STERRAD 100NXK111377Image: STERRAD 100NX | Predicate Device:STERIS V-PRO maXK131120Image: STERIS V-PRO maX | |
| Dimensions | H: 75.5 in (191.8 cm)W: 30.5 in (77.5 cm)D: 48.6 in (123.5 cm) | H: 70.5 in (179.1 cm)W: 30.5 in (77.5 cm)D: 40.0 in (102 cm) | H: 75.1 in (190.8 cm)W: 33.0 in (83.8 cm)D: 37.6 in (95.4 cm) |
| Weight | 1,245 lb (565 kg) | 938-1,006 lb (425-457 kg) | 788-910 lb (357-413 kg) |
| Chamber Volume | 125 L | 152 L | 136 L |
| EquipmentOperatingTemperature | 20-26 °CSame as Load Temp | 18-35 °C (64-95 °F) | 5-40°C (41-104 °F) |
| Chamber (Wall)Temperature | 41 °C | <55 °C | 50 °C |
| Load Temperature | 20-26 °C | Not Specified | Not Specified |
| H2O2 VaporizerTemperature | 120 °C (under vacuum) | 75 °C (under vacuum) | 60 °C (under vacuum) |
| Number of Pre-ProgrammedCycles | 1 | 4• Standard• Flex Scope• Express• DUO | 3• Non Lumen• Lumen• Flexible |
| Key CriticalProcessParameters | Differential ChamberPressure (△P) & LoadTemperature | H2O2 Dose & ExposureTime | H2O2 Dose & ExposureTime |
| Use of Pre-Conditioning Step | YES | YES | YES |
| Use of SecondaryStep to RemoveResidual H2O2(technology) | YES(ozone, acts as a sterilant) | YES(plasma) | NO |
| Use of AerationStep | YES | YES | YES |
| Feature | STERIZONE® VP4 | STERRAD® 100NX®(K111377) | Amsco® V-PRO® maX(K131120) |
| Intendeduse | Terminal sterilization of reusable medical devices in health care facilities | Terminal sterilization of reusable medical devices in health care facilities | Terminal sterilization of reusable medical devices in health care facilities |
| Labeling/Indicationsfor 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. | 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. | 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. |
| Lumenclaims* | |||
| I.D.(mm) | Lumen(mm) | ||
| Rigid | ≥ 0.7 | ≤ 500 | |
| Double Rigid | ≥ 0.7 | ≤ 500 | |
| Flexible | ≥ 1 | ≤ 850 | |
| I.D.(mm) | Lumen(mm) | ||
| Rigid | ≥ 0.7 | ≤ 500 | |
| Flexible | ≥ 1 | < 875* | |
| I.D.(mm) | Lumen(mm) | ||
| Single Rigid | ≥ 0,77 | ≤ 500 | |
| Double rigid | ≥0,77 | ≤500 | |
| Flexible | ≥ 1 | ≤ 1050 |
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Image /page/14/Picture/0 description: The image shows a chemical structure. The structure contains the letters 'TS' followed by a chemical symbol with an 'O' and a subscript '3'. The chemical structure is drawn in black and white.
The performance characteristics and intended use of the STERIZONE® VP4 Sterilizer are the same as for the STERRAD® 100NX® Sterilizer (K111377) and the Amsco® V-PRO® maX Low Temperature Sterilization System (K131120) (Table 5).
Table 5. Comparison between the intended use and claims for the STERIZONE® VP4 Sterilizer, the STERRAD® 100NX® Sterilizer and the Amsco® V-PRO® Sterilizer
*Lumen claims for the DUO Cycle of the STERRAD® 100NX Sterilizer.
Therefore, based on the foregoing information, the STERIZONE® VP4 Sterilizer is substantially equivalent to the STERRAD® 100NX® Sterilizer (K111377) and to the Amsco V-PRO® maX Low Temperature Sterilization System (K131120) with respect to intended use, mode of action, performance and safety characteristics.
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Image /page/15/Picture/0 description: The image shows a chemical structure. The structure contains the letters 'TS' followed by 'O' with a subscript '3'. The 'O' is connected to a ring-like structure. The image is in black and white.
In particular, all three devices require only exposure to vaporized H2O2 to achieve a sterility assurance level (SAL) of 10t. However, only the STERIZONE® VP4 and the STERRAD® 100NX® Sterilizers incorporate a subsequent step intended to reduce residual hydrogen peroxide (ozone and plasma respectively). The STERIZONE® VP4 Sterilizer is a dual sterilization system that uses ozone which reacts with residual hydrogen peroxide to form hydroxyl radicals.
The differences between the subject device and predicates are not critical to the intended use of the device and do not raise new questions of safety and effectiveness when the device is used as labeled.
Conclusion
The STERIZONE® VP4 Sterilizer is as safe and as effective and is substantially equivalent to the identified predicates.
§ 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).