(187 days)
The STERIZONE® BI+ Self-contained Biological Indicator (SCBI) is intended for routine monitoring of the STERIZONE® VP4 Sterilizer, which offers a single pre-set sterilization cycle ("Cycle 1"). The SCBI should only be used in a Test Pack configuration to monitor Cycle 1. The SCBI placed within the STERIZONE® VP4 Test Pack monitors exposure to both vaporized hydrogen peroxide (H2O2 or VHP) and ozone (O3) which are both used in the STERIZONE® VP4 Sterilizer. The STERIZONE® VP4 Test Pack is intended to have equivalent to greater resistance than worst case devices and loads in any load configuration.
The STERIZONE® BI+ Self-contained Biological Indicator (TSO3 product code 42602) consists of at least 106 Geobacillus stearothermophilus viable spores, known to be the reference microorganism for the STERIZONE® VP4 Sterilizer sterilization process, grouped on a stainless steel carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization. The presence of G. stearothermophilus spores is detected by a visual color change (media turns yellow). The yellow color change indicates bacterial growth. No change of color indicates that the process achieved the conditions necessary to kill at least 1 × 106 viable spores of G. stearothermophilus (6 logs) on the SCBI inoculated stainless steel carrier. The final readout of a negative result (media remains purple) is made after 18 hours of incubation when using a dry-bath type incubator.
The STERIZONE® VP4 Test Pack is a device composed of the STERIZONE® BI+ Selfcontained Biological Indicator (TSO3 product code 42602, including crusher), a 10 mL syringe and its plunger, and a diffusion restrictor (sold in the form of a kit - TSO3 product code: 44020). A STERIZONE® CI+ Chemical Indicator (TSO3 product code 43810) is also added, external to the syringe, to allow differentiating processed test packs. All components of the Test Pack are single-use, disposable items.
The provided document describes the STERIZONE® BI+ Self-contained Biological Indicator and STERIZONE® VP4 Test Pack and includes a summary of nonclinical performance tests.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Requirement (Acceptance Criteria) | Reported Device Performance |
|---|---|
| Viable population assay | Passed (Within specification) |
| Growth inhibition by carrier and pack materials | Passed (No inhibition induced) |
| Reduced incubation time validation | Passed (18 hours using a dry-bath type incubator adjusted to 55 – 60 °C) |
| Effect of sterilization process on recovery media | Passed (No effect) |
| Stability of biological read | Passed (Stable for 7 days) |
| Positive Controls | Passed (Viability demonstrated) |
| Stability (shelf life) evaluation | Passed (Ongoing stability evaluation) |
| BI validation in the STERIZONE® VP4 process | Passed |
| Test Pack performance evaluation in the STERIZONE® VP4 Sterilizer process | Passed (Demonstrated to have equivalent to greater resistance than the worst case devices and loads in any load configuration; Demonstrated to be more resistant than the full half-cycle, including exposure to hydrogen peroxide and ozone) |
| Safe for use (Safety Requirement) | Passed (No safety issue) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for each of the nonclinical tests. It only lists the tests performed and their results. The data provenance is not specified (e.g., country of origin, retrospective/prospective). These were likely laboratory-based studies conducted by the manufacturer, TSO3 Inc., in Québec, Canada.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The tests performed are objective, laboratory-based assays (e.g., population counts, growth inhibition) that do not typically rely on human expert consensus for ground truth establishment in the way clinical diagnostic devices might.
4. Adjudication Method for the Test Set
This information is not applicable and is not provided in the document. The tests are scientific measurements or observations with clear pass/fail criteria, not subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic devices where human readers interpret medical images or data. The STERIZONE® BI+ Biological Indicator is a sterilization process indicator evaluated through laboratory performance tests.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
The device itself is a physical biological indicator, not a software algorithm. Therefore, the concept of "standalone (algorithm only)" is not applicable. The performance evaluation is based on the biological and chemical responses of the indicator to sterilization conditions.
7. The Type of Ground Truth Used
The ground truth for these nonclinical tests is based on established scientific principles and standards for biological indicators and sterilization efficacy.
- Viable population assay: Ground truth is the measured number of viable spores, compared against a specified range (e.g., $\ge1 \times 10^6$ viable spores).
- Growth inhibition: Ground truth is the observation of microbial growth/no growth in the presence/absence of carrier materials and pack materials.
- Reduced incubation time/stability of biological read/positive controls: Ground truth is the presence or absence of spore growth within specified timeframes or under specific conditions.
- BI validation in the STERIZONE® VP4 process & Test Pack performance evaluation: Ground truth is the kill of a specified log reduction of Geobacillus stearothermophilus spores (6 logs) under defined sterilization conditions (half-cycle vs. full cycle).
8. The Sample Size for the Training Set
The document does not describe a "training set" in the context of machine learning or AI. The tests described are validation tests for the physical device's performance characteristics. Development and optimization of the biological indicator would have involved internal testing, but this is not detailed as a "training set."
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" in the AI/ML sense, this question is not applicable. The device's performance is established through direct physical and biological testing against known sterilization challenges, rather than through a learning algorithm trained on data.
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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, Suite 101 Vancouver, WA 98665
Re: K141580
Trade/Device Name: Sterizone® BI+ Self-Contained Biological Indicator, Sterizone VP4 Test Pack Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC Dated: November 14, 2014 Received: November 17, 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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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 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 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 Keith Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K141580
Device Name STERIZONE® BI+ Self-contained Biological Indicator STERIZONE® VP4 Test Pack
Indications for Use (Describe)
The STERIZONE® BI+ Self-contained Biological Indicator (SCBI) is intended for routine monitoring of the STERIZONE® VP4 Sterilizer, which offers a single pre-set sterilization cycle ("Cycle 1"). The SCBI should only be used in a Test Pack configuration to monitor Cycle 1. The SCBI placed within the STERIZONE® VP4 Test Pack monitors exposure to both vaporized hydrogen peroxide (H2O2 or VHP) and ozone (O3) which are both used in the STERIZONE® VP4 Sterilizer. The STERIZONE® VP4 Test Pack is intended to have equivalent to greater resistance than worst case devices and loads in any load configuration.
STERIZONE® VP4 Test Pack is a device composed of the STERIZONE® BI+ Self-contained Biological Indicator (TSO3 product code 42602, including crusher), a 10 mL syringe and its plunger, and a diffusion restrictor (sold in the form of a kit - TSO3 product code: 44020). An external STERIZONE® CI+ Chemical Indicator (TSO3 product code 43810) is also added to allow differentiating processed from unprocessed test packs. All components of the Test Pack are single-use, disposable items.
The STERIZONE® VP4 Test Pack is constructed by first inserting the STERIZONE® BI+ Selfcontained Biological Indicator inside the syringe, with the SCBI cap facing to the Luer-lock of the syringe. The plunger is then inserted to the 10 mL mark of the syringe. The diffusion restrictor is screwed to the Luer-lock of the syringe. The chemical indicator is then inserted in the opening between the plunger and the syringe.
The test pack is placed within the load on the upper shelf of the STERIZONE® VP4 Sterilizer loading rack.
After processing, the SCBI is retrieved from the test pack. The SCBI is intended to provide users with a means to assess spore kill by the STERIZONE® VP4 Sterilizer. A "no growth" result from the SCBI after 18 hours of incubation indicates that the process achieved the conditions necessary to kill at least 1 × 10° viable spores of Geobacillus stearothermophilus (6 logs) on the SCBI inoculated stainless steel carrier.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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$$\mathbf{^{\hat{G}}}$$
5.1. Applicant's Name and Address and submission date
Applicant's Name and Address
TSO3 Inc., 2505, avenue Dalton, Québec (Quebec) Canada G1P 3S5
TSO3 Contact Person, Telephone, FAX
Marc Chaunet, Director of Regulatory Affairs Tel : (418) 651-0003 ext.242 FAX : (418) 653-5726 E-mail: mchaunet(@tso3.com
U.S. Contact
Contact: Thomas Richards, Ph.D. of IM3, Inc. Phone: 503-415-0250 Email: tomami20x@gmail.com
Submission Date
November 13, 2014
5.2. Name of the device
Trade Name
STERIZONE® BI+ Self-contained Biological Indicator STERIZONE® VP4 Test Pack
Common Name
Biological Indicator (Test Pack)
Classification Name (if known)
Indicator, Biological Sterilization Process
Regulatory Class
Class II under Sterilization Process Indicator in 21 CFR 880.2800 (b) by the General Hospital and Personal Use Devices Panel. Product code: FRC
5.3. Legally Marketed Equivalent Device Name(s)
STERRAD® CYCLESURE® 24 Biological Indicator (K123017)
STERRAD® 100NX DUO Cycle Test Pack (K111391)
Verify® V24 Self-contained Biological Indicator (K090514)
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Image /page/4/Picture/1 description: The image shows a chemical structure diagram. The diagram depicts a molecule with the letters 'TS' on the left side, followed by 'O' with a subscript of '3' on the right side. The oxygen atoms are connected to the sulfur atom, forming a tetrahedral arrangement.
5.4. Description of device
The STERIZONE® BI+ Self-contained Biological Indicator (TSO3 product code 42602) consists of at least 10° Geobacillus stearothermophilus viable spores, known to be the reference microorganism for the STERIZONE® VP4 Sterilizer sterilization process, grouped on a stainless steel carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization. The presence of G. stearothermophilus spores is detected by a visual color change (media turns yellow). The yellow color change indicates bacterial growth. No change of color indicates that the process achieved the conditions necessary to kill at least 1 × 10 viable spores of G. stearothermophilus (6 logs) on the SCBI inoculated stainless steel carrier. The final readout of a negative result (media remains purple) is made after 18 hours of incubation when using a dry-bath type incubator.
The STERIZONE® VP4 Test Pack is a device composed of the STERIZONE® BI+ Selfcontained Biological Indicator (TSO3 product code 42602, including crusher), a 10 mL syringe and its plunger, and a diffusion restrictor (sold in the form of a kit - TSO3 product code: 44020). A STERIZONE® CI+ Chemical Indicator (TSO3 product code 43810) is also added, external to the syringe, to allow differentiating processed test packs. All components of the Test Pack are single-use, disposable items.
5.5. Statement of Intended use
The STERIZONE® BI+ Self-contained Biological Indicator (SCBI) is intended for routine monitoring of the STERIZONE® VP4 Sterilizer, which offers a single pre-set sterilization cycle ("Cycle 1"). The SCBI should only be used in a Test Pack configuration to monitor Cycle 1. The SCBI placed within the STERIZONE® VP4 Test Pack monitors exposure to both vaporized hydrogen peroxide (H2O2 or VHP) and ozone (O3) which are both used in the STERIZONE® VP4 Sterilizer The STERIZONE® VP4 Test Pack is intended to have equivalent to greater resistance than worst case devices and loads in any load configuration.
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SECTION 5 - 510(k) SUMMARY
Image /page/5/Picture/1 description: The image shows a chemical structure diagram. The diagram depicts a molecule with the letters 'T' and 'S' on the left side, followed by 'O' with a subscript '3' on the right side. The 'O' atoms are connected to the 'S' atom, forming a tetrahedral arrangement.
The STERIZONE® VP4 Test Pack is a device composed of the STERIZONE® BI+ Selfcontained Biological Indicator (TSO3 product code 42602, including crusher), a 10 mL syringe and its plunger, and a diffusion restrictor (sold in the form of a kit - TSO3 product code: 44020). A STERIZONE® CI+ Chemical Indicator (TSO3 product code 43810) is also added, external to the syringe, to allow differentiating processed test packs. All components of the Test Pack are single-use, disposable items.
The STERIZONE® VP4 Test Pack is constructed by first inserting the STERIZONE® BI+ Selfcontained Biological Indicator inside the syringe, with the SCBI cap facing to the Luer-lock of the syringe. The plunger is then inserted to the 10 mL mark of the syringe. The diffusion restrictor is screwed to the Luer-lock of the syringe. The chemical indicator is then inserted in the opening between the plunger and the syringe.
The test pack is then placed within the load on the upper shelf of the STERIZONE® VP4 Sterilizer loading rack.
After processing, the SCBI is retrieved from the test pack. The STERIZONE® BI+ Selfcontained Biological Indicator (SCBI) is intended to provide users with a means to assess spore kill by the STERIZONE® VP4 Sterilizer. A "no growth" result from the STERIZONE® BI+ Self-contained Biological Indicator after 18 hours of incubation indicates that the process achieved the conditions necessary to kill at least 1 × 106 viable spores of Geobacillus stearothermophilus (6 logs) on the SCBI inoculated stainless steel carrier.
5.6. Substantial equivalence
The indicator organism, spore population and physical construction of the STERIZONE® BI+ Self-contained Biological Indicator are similar to the predicate devices for the proposed device (Table 1).
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Image /page/6/Picture/6 description: The image shows a chemical structure diagram. The diagram depicts a molecule with the formula TSO3. The letters 'TS' are prominently displayed on the left side of the diagram, followed by the letter 'O' and the number '3' as a subscript, indicating the presence of three oxygen atoms. The oxygen atoms are arranged in a triangular configuration on the right side of the diagram.
The performance characteristics and intended use of the STERIZONE® BI+ Self-contained Biological Indicator are the same as for the STERRAD® CYCLESURE® 24 Self-contained Biological Indicator (K123017) and to the Verify® V24 Self-contained Biological Indicator (K090514) (Table 1).
Table 1. Comparison between the intended use and claims for the STERIZONE® BI+ Self-contained Biological Indicator, and the STERRAD® CYCLESURE® 24 Self-contained Biological Indicator and to the Verify® V24 Self-contained Biological Indicator
| Features | STERIZONE® BI+ Self-contained BiologicalIndicator | STERRAD® CycleSure®24 Biological Indicator(K123017) | Verify® V24 Self-contained BiologicalIndicator (K090514) |
|---|---|---|---|
| Picture of thedevice | Image: STERIZONE® BI+ Self-contained Biological Indicator | Image: STERRAD® CycleSure® 24 Biological Indicator (K123017) | Image: Verify® V24 Self-contained Biological Indicator (K090514) |
| Type of BI | Self-contained BI | Self-contained BI | Self-contained BI |
| Organism:Spore species& Strain | GeobacillusstearothermophilusATCC 7953 | GeobacillusstearothermophilusATCC 7953 | GeobacillusstearothermophilusATCC 7953 |
| Viable sporepopulation | Equal or greater than 1×106 | Equal or greater than 1×106 | Equal or greater than 1×106 |
| Intended Use | Sterilization processindicator | Sterilization processindicator | Sterilization processindicator |
| Indications forUse | The STERIZONE® BI+Self-contained BiologicalIndicator is intended toprovide users with a meansto assess spore kill by theSTERIZONE® VP4Sterilizer. | The STERRAD®CycleSure® BiologicalIndicator is intended to beused as a standard methodfor frequent monitoring ofthe STERRAD® Sterilizercycles. | The Verify® V24 Self-contained BiologicalIndicator is intended to beused as a standard methodfor frequent monitoring ofthe Amsco® V-PRO™ LowTemperature SterilizationSystem. |
| Intended Use• Method ofsterilization | STERIZONE® VP4Sterilizer | STERRAD® SterilizationSystemAll types of STERRAD®Sterilization Cycles, e.g:STERRAD® 100S,STERRAD® 50STERRAD® NX™STERRAD® 100NX™ | Amsco® V-PRO™ LowTemperature SterilizationSystem |
| •Primary | Hydrogen peroxide | Hydrogen peroxide | Hydrogen peroxide |
| Features | STERIZONE® BI+ Self-contained BiologicalIndicator | STERRAD® CycleSure®24 Biological Indicator(K123017) | Verify® V24 Self-contained BiologicalIndicator (K090514) |
| sterilizingagent | |||
| Resistancecharacteristics:• D-value | $ΔP_{VS280}$ = 0.65 TorrTime = 4.3 secondsDose = 0.39 mg/L | Specific to the utilizedresistometer and claimedsterilization system | Specific to the utilizedresistometer and claimedsterilization system |
| • Survival-killwindow | |||
| $ΔP_{VS280}$ = ≥ 1.28 and ≤ 11.0TorrTime = ≥ 6.1 and ≤ 102.5secondsDose = ≥ 0.69 and ≤ 15.61mg/L | |||
| CultureConditions | Crushable "onion skin"glass containing aproprietary formulatedsoybean digest base with abromocresol purple pHindicator. | Crushable glass containing aproprietary formulatedsoybean digest base with apH indicator. | Crushable glass containing aproprietary formulatedsoybean digest base with apH indicator. |
| Carriermaterials | Disc made of polished 316Stainless Steel (non-porouscarrier type) | Non-cellulosic dry sporestrip made of fiberglass | Bottom of polypropylenevial |
| Incubationtemperature | 55 - 60 °C | 55 - 60 °C | 55 - 60 °C |
| Incubationtime | 18 hours | 24 hours | 24 hours |
| • InoculatedcarrierPrimaryPack | Capsule: Flexiblepolypropylene vial to holdboth dry spore disc and theampoule medium.Cap: White polypropylene | Capsule: Flexible polymericvial to hold both dry sporestrip and the ampoulemedium.Cap: White polypropylene | Capsule: Flexiblepolypropylene vial directlyinoculated with spores andcontaining the ampoulemedium. |
| cap. The cap filter is Tyvek®1073B non-wovenpolyethylene | cap. The cap filter is madeof non-woven polyethylene. | Cap: Orange polymeric cap.The cap filter is made ofnon-woven polyethylene. | |
| StorageConditions | 15-30°C (59-86°F) | 2-25°C (35-77°F)under dry conditions | 21-25°C (70-77°F)40-60 % RH |
| Labeling | Instructions for use | Instructions for use | Instructions for use |
| Features | STERIZONE® BI+ Self-contained BiologicalIndicator | STERRAD® CycleSure®24 Biological Indicator(K123017) | Verify® V24 Self-contained BiologicalIndicator (K090514) |
| Carton label | Carton label | Carton label | |
| Shipping label | Shipping label | Shipping label | |
| Accessories | Activator (BI crusher) | Activator (BI crusher) | Activator (BI crusher) |
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Image /page/7/Picture/0 description: The image shows a chemical structure diagram. The diagram depicts a molecule with the letters 'TS' on the left, followed by a central sulfur atom bonded to three oxygen atoms, represented by 'O3'. The 'O' atoms are arranged in a triangular configuration around the sulfur atom.
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Image /page/8/Picture/1 description: The image shows a chemical structure diagram. The diagram depicts a molecule with the letters 'TS' on the left, followed by a central atom 'O' connected to three other 'O' atoms, represented as O3. The 'O' atoms are drawn with a lighter shade of gray compared to the 'TS' letters, indicating a different element or group within the molecule.
Table 2 summarizes the specific device configuration for rendering each of the aforementioned biological indicators into a corresponding "test pack" or a resistant challenge to sterilization. Each version of a test pack is constructed of a biological indicator, a chemical indicator, and a diffusion restrictor intended to increase resistance. The diffusion restrictor varies from a sealed pouch (STERIS® Verify – K090514) to a vial with a cap having a defined orifice (STERRAD® 100NX DUO Cycle Test Pack – K111391). The STERIZONE® VP4 Test Pack has equivalent to greater resistance than the worst case devices and loads in any load configuration, and is designed to be more resistant than the full half-cycle, including exposure to hydrogen peroxide and ozone. The predicate STERRAD Test Pack is claimed to be at least as resistant to the sterilization process as the biological model developed for the DUO Cycle.
Table 2. Comparison of the STERIZONE® VP4 Test Pack with the STERRAD® 100NX DUO Cycle Test Pack and the STERIS® Verify® V24 "Test Pack"
| Features | STERIZONE® VP4Test Pack | STERRAD® 100NX DUOCycle Test Pack(K111391) | STERIS® Verify® V24"Test Pack"(K090514) |
|---|---|---|---|
| Productdescription | A STERIZONE® BI+ Self-contained BI, and a syringewith diffusion restrictor forholding the BI during thesterilization cycle, alongwith a process chemicalindicator. | A STERRAD® CycleSure®Self-contained BI, and aSTERRAD® NX® TestVial with cap for holdingthe BI during thesterilization cycle. | A STERIS Verify® Self-contained BI, a Verify®chemical indicator strip, anda low-temperaturesterilization pouch1 |
| Picture of thedevice | Image: STERIZONE VP4 Test Pack | Image: STERRAD 100NX DUO Cycle Test Pack | Image: STERIS Verify V24 "Test Pack" |
| Indications forUse | The STERIZONE® VP4Test Pack is used for routinemonitoring of the | The STERRAD® 100NXDUO Cycle Test Pack isused for routine | The Verify® V24 Self-contained BiologicalIndicator is intended to be |
| Features | STERIZONE® VP4Test Pack | STERRAD® 100NX DUOCycle Test Pack(K111391) | STERIS® Verify® V24"Test Pack"(K090514) |
| STERIZONE® VP4Sterilizer cycle and for theperformance validation ofthe STERIZONE® VP4Sterilizer system usinghospital-defined loads. | monitoring of theSTERRAD 100NX DUOSterilization Cycle and isalso used for the periodictesting of a STERRAD100NX System DUOcycle, using hospital-defined loads containingdevices that do not exceedclaims of the cycle. TheSTERRAD 100NX DUOCycle Test Pack consistsof a STERRADCYCLESURE 24Biological Indicator, vialand cap to hold the BI. | used as a standard methodfor frequent monitoring ofthe Amsco® V-PRO™ LowTemperature SterilizationSystem. | |
| Intended UseMethod ofsterilization | STERIZONE® VP4Sterilizer | STERRAD® SterilizationSystem | Amsco® V-PRO™ LowTemperature SterilizationSystem |
| Sterilizingagent(s) | Hydrogen peroxide / ozone | Hydrogen peroxide | Hydrogen peroxide |
| Biologicalchallenge | STERIZONE® BI+ Self-contained BiologicalIndicator - Min. 1×106 | STERRAD® CycleSure®24 Self-containedBiological Indicator - Min.1×106 | STERIS Verify® V24 Self-contained BiologicalIndicator - Min. 1×106 |
| Geobacillusstearothermophilus ATCC7953 spores | Geobacillusstearothermophilus ATCC7953 spores | Geobacillusstearothermophilus ATCC7953 spores | |
| Holder | Syringe and plunger-10 mL Becton-Dickinson(B-D) plastic syringe withLuer-lock connector and itsplunger | STERRAD® NX® TestVial9.1 mL (0.558 in3)polyethylene vial | STERIS Low TemperatureSterilization Pouch |
| Diffusionrestrictor | 18 gauge (1.02 mmdiameter),2-inch (50.8 mm) longpolytetrafluoroethylene(PTFE) cannula with Luer-lok™ attachment | Polyethylene vial cap witha single orifice of 1.4-1.55mm diameter & 2.7 mmlength (i.e., thickness ofcap) | Sealed Pouch |
| Resistancecharacteristics | Demonstrated to haveequivalent to greaterresistance than the worstcase devices and loads inany load configuration. | The Test Pack is at least asresistant to the sterilizationprocess as the biologicalmodel developed for theDUO Cycle. | Specific to the claimedsterilization system |
| Features | STERIZONE® VP4Test Pack | STERRAD® 100NX DUOCycle Test Pack(K111391) | STERIS® Verify® V24"Test Pack"(K090514) |
| Demonstrated to be moreresistant than the full half-cycle, including exposure tohydrogen peroxide andozone. |
1 Use of a pouch can increase resistance so as to create a test pack.
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Image /page/9/Picture/0 description: The image shows a chemical structure with the letters 'T', 'S', and 'O' arranged in a specific configuration. The 'T' is on the left, followed by 'S', and then 'O' with a subscript '3'. The 'O' and subscript '3' are drawn with gray lines, while the 'T' and 'S' are drawn with black lines. The image appears to represent a chemical formula or abbreviation, possibly related to an organic compound or a chemical reaction.
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Image /page/10/Picture/0 description: The image shows a chemical structure diagram. The diagram depicts a molecule with the letters 'TS' on the left, followed by a central sulfur atom connected to three oxygen atoms (O3) on the right. The oxygen atoms are arranged in a triangular configuration around the sulfur atom.
Conclusion:
The STERIZONE® BI+ Self-contained Biological Indicator and STERIZONE® VP4 Test Pack are substantially equivalent to the STERRAD® CYCLESURE® 24 Self-contained Biological Indicator (K123017), to the STERRAD® 100NX DUO Cycle Test Pack (K111391), and to the Verify® V24 Self-contained Biological Indicator (K090514) with respect to intended use, indications for use, and critical technological characteristics. Overall, the subject device and predicate devices have identical intended use, and general indications for use, although the STERIZONE® VP4 Test Pack monitors exposure to both hydrogen peroxide and ozone whereas the predicate devices monitor only exposure to hydrogen peroxide. Additionally, all devices have the same general technological characteristics, and the same operating principles. Performance testing demonstrates that the STERIZONE® BI+ Self-contained Biological Indicator and STERIZONE® VP4 Test Pack are substantially equivalent to the identified predicate devices. Minor differences in technology between the subject devices and predicates do not raise new questions of safety and effectiveness when the devices are used as labeled.
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Image /page/11/Picture/1 description: The image shows a chemical structure. The structure is labeled with the letters "TSO" on the left side. To the right of the letters, there is a chemical structure with three oxygen atoms. The number 3 is written as a subscript to the right of the last oxygen atom.
5.7. Assessment of performances data
Summary of nonclinical performance tests 5.7.1.
The studies were conducted to confirm that the performance characteristics of the STERIZONE® BI+ Self-contained Biological Indicator are similar to the predicate devices (3).
Table 3. Summary of nonclinical tests performed to demonstrate Safety and Effectiveness
| Performance Requirements for Effectiveness | Results | |
|---|---|---|
| 1 | Viable population assay | PassedWithin specification |
| 2 | Growth inhibition by carrier and pack materials | PassedNo inhibition induced |
| 3 | Reduced incubation time validation | Passed18 hours using a dry-bath type incubatoradjusted to 55 – 60 °C |
| 4 | Effect of sterilization process on recovery media | PassedNo effect |
| 5 | Stability of biological read | PassedStable for 7 days |
| 6 | Positive Controls | PassedViability demonstrated |
| 7 | Stability (shelf life) evaluation | PassedOngoing stability evaluation |
| 8 | BI validation in the STERIZONE® VP4 process | Passed |
| 9 | Test Pack performance evaluation in theSTERIZONE® VP4 Sterilizer process | PassedDemonstrated to have equivalent to greaterresistance than the worst case devices andloads in any load configurationDemonstrated to be more resistant than the fullhalf-cycle, including exposure to hydrogenperoxide and ozone |
| Performance Requirements for Safety | ||
| 1 | Safe for use | PassedNo safety issue |
Overall Performance Conclusions 5.7.2.
Performance tests demonstrate that the STERIZONE® BI+ Self-contained Biological Indicator and STERIZONE® VP4 Test Pack are substantially equivalent to the predicate devices.
§ 880.2800 Sterilization process indicator.
(a)
Biological sterilization process indicator —(1)Identification. A biological sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization.(2)
Classification. Class II (performance standards).(b)
Physical/chemical sterilization process indicator —(1)Identification. A physical/chemical sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device.(2)
Classification. Class II (performance standards).