(187 days)
Not Found
No
The device is a biological indicator and test pack for monitoring sterilization, relying on the growth or lack of growth of microorganisms and a visual color change. There is no mention of AI or ML in the description of its function or performance evaluation.
No.
The device is a biological indicator and test pack used to monitor the effectiveness of a sterilizer, not to provide therapy or treatment to a patient.
No
The device is a biological indicator used to monitor the effectiveness of a sterilizer by assessing spore kill, not to diagnose a medical condition in a patient.
No
The device is a biological indicator and test pack, which are physical components used to monitor a sterilization process. The description details the physical composition of the device, including spores, a stainless steel carrier, a syringe, plunger, and diffusion restrictor. It does not describe a software application.
Based on the provided text, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is intended to "assess spore kill by the STERIZONE® VP4 Sterilizer." This assessment is performed by observing the growth or lack of growth of microorganisms (Geobacillus stearothermophilus) in the biological indicator.
- Mechanism of Action: The device works by detecting the presence of viable microorganisms through a visual color change in the media. A color change indicates bacterial growth, while no color change indicates that the sterilization process was effective in killing the spores. This is a diagnostic test performed in vitro (outside the body) to evaluate the effectiveness of a sterilization process.
- Device Description: The description explicitly states that "Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization." This directly links the biological response of the microorganisms to a diagnostic assessment of the sterilization process.
While the device is used to monitor a sterilization process, the core function described is the in vitro detection of microbial viability to determine the success of that process. This aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
FRC
Device Description
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.
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
Not Found
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 studies were conducted to confirm that the performance characteristics of the STERIZONE® BI+ Self-contained Biological Indicator are similar to the predicate devices.
Nonclinical tests performed to demonstrate Safety and Effectiveness:
- 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, and demonstrated to be more resistant than the full half-cycle, including exposure to hydrogen peroxide and ozone.
Safety requirement: Safe for use: Passed, no safety issue.
Overall Performance Conclusions: Performance tests demonstrate that the STERIZONE® BI+ Self-contained Biological Indicator and STERIZONE® VP4 Test Pack are substantially equivalent to the predicate 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
§ 880.2800 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).
0
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.
1
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
2
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.
3
$$\mathbf{^{\hat{G}}}$$
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)
4
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.
5
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).
6
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 Biological
Indicator | STERRAD® CycleSure®
24 Biological Indicator
(K123017) | Verify® V24 Self-
contained Biological
Indicator (K090514) |
|----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Picture of the
device | 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 | Geobacillus
stearothermophilus
ATCC 7953 | Geobacillus
stearothermophilus
ATCC 7953 | Geobacillus
stearothermophilus
ATCC 7953 |
| Viable spore
population | Equal or greater than 1×106 | Equal or greater than 1×106 | Equal or greater than 1×106 |
| Intended Use | Sterilization process
indicator | Sterilization process
indicator | Sterilization process
indicator |
| Indications for
Use | The STERIZONE® BI+
Self-contained Biological
Indicator is intended to
provide users with a means
to assess spore kill by the
STERIZONE® VP4
Sterilizer. | The STERRAD®
CycleSure® Biological
Indicator is intended to be
used as a standard method
for frequent monitoring of
the STERRAD® Sterilizer
cycles. | The Verify® V24 Self-
contained Biological
Indicator is intended to be
used as a standard method
for frequent monitoring of
the Amsco® V-PRO™ Low
Temperature Sterilization
System. |
| Intended Use
• Method of
sterilization | STERIZONE® VP4
Sterilizer | STERRAD® Sterilization
System
All types of STERRAD®
Sterilization Cycles, e.g:
STERRAD® 100S,
STERRAD® 50
STERRAD® NX™
STERRAD® 100NX™ | Amsco® V-PRO™ Low
Temperature Sterilization
System |
| •
Primary | Hydrogen peroxide | Hydrogen peroxide | Hydrogen peroxide |
| Features | STERIZONE® BI+ Self-
contained Biological
Indicator | STERRAD® CycleSure®
24 Biological Indicator
(K123017) | Verify® V24 Self-
contained Biological
Indicator (K090514) |
| sterilizing
agent | | | |
| Resistance
characteristics:
• D-value | $ΔP_{VS280}$ = 0.65 Torr
Time = 4.3 seconds
Dose = 0.39 mg/L | Specific to the utilized
resistometer and claimed
sterilization system | Specific to the utilized
resistometer and claimed
sterilization system |
| • Survival-kill
window | | | |
| | $ΔP_{VS280}$ = ≥ 1.28 and ≤ 11.0
Torr
Time = ≥ 6.1 and ≤ 102.5
seconds
Dose = ≥ 0.69 and ≤ 15.61
mg/L | | |
| Culture
Conditions | Crushable "onion skin"
glass containing a
proprietary formulated
soybean digest base with a
bromocresol purple pH
indicator. | Crushable glass containing a
proprietary formulated
soybean digest base with a
pH indicator. | Crushable glass containing a
proprietary formulated
soybean digest base with a
pH indicator. |
| Carrier
materials | Disc made of polished 316
Stainless Steel (non-porous
carrier type) | Non-cellulosic dry spore
strip made of fiberglass | Bottom of polypropylene
vial |
| Incubation
temperature | 55 - 60 °C | 55 - 60 °C | 55 - 60 °C |
| Incubation
time | 18 hours | 24 hours | 24 hours |
| • Inoculated
carrier
Primary
Pack | Capsule: Flexible
polypropylene vial to hold
both dry spore disc and the
ampoule medium.
Cap: White polypropylene | Capsule: Flexible polymeric
vial to hold both dry spore
strip and the ampoule
medium.
Cap: White polypropylene | Capsule: Flexible
polypropylene vial directly
inoculated with spores and
containing the ampoule
medium. |
| | cap. The cap filter is Tyvek®
1073B non-woven
polyethylene | cap. The cap filter is made
of non-woven polyethylene. | Cap: Orange polymeric cap.
The cap filter is made of
non-woven polyethylene. |
| Storage
Conditions | 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 Biological
Indicator | STERRAD® CycleSure®
24 Biological Indicator
(K123017) | Verify® V24 Self-
contained Biological
Indicator (K090514) |
| | Carton label | Carton label | Carton label |
| | Shipping label | Shipping label | Shipping label |
| Accessories | Activator (BI crusher) | Activator (BI crusher) | Activator (BI crusher) |
7
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.
8
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® VP4
Test Pack | STERRAD® 100NX DUO
Cycle Test Pack
(K111391) | STERIS® Verify® V24
"Test Pack"
(K090514) |
|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Product
description | A STERIZONE® BI+ Self-
contained BI, and a syringe
with diffusion restrictor for
holding the BI during the
sterilization cycle, along
with a process chemical
indicator. | A STERRAD® CycleSure®
Self-contained BI, and a
STERRAD® NX® Test
Vial with cap for holding
the BI during the
sterilization cycle. | A STERIS Verify® Self-
contained BI, a Verify®
chemical indicator strip, and
a low-temperature
sterilization pouch1 |
| Picture of the
device | Image: STERIZONE VP4 Test Pack | Image: STERRAD 100NX DUO Cycle Test Pack | Image: STERIS Verify V24 "Test Pack" |
| Indications for
Use | The STERIZONE® VP4
Test Pack is used for routine
monitoring of the | The STERRAD® 100NX
DUO Cycle Test Pack is
used for routine | The Verify® V24 Self-
contained Biological
Indicator is intended to be |
| Features | STERIZONE® VP4
Test Pack | STERRAD® 100NX DUO
Cycle Test Pack
(K111391) | STERIS® Verify® V24
"Test Pack"
(K090514) |
| | STERIZONE® VP4
Sterilizer cycle and for the
performance validation of
the STERIZONE® VP4
Sterilizer system using
hospital-defined loads. | monitoring of the
STERRAD 100NX DUO
Sterilization Cycle and is
also used for the periodic
testing of a STERRAD
100NX System DUO
cycle, using hospital-
defined loads containing
devices that do not exceed
claims of the cycle. The
STERRAD 100NX DUO
Cycle Test Pack consists
of a STERRAD
CYCLESURE 24
Biological Indicator, vial
and cap to hold the BI. | used as a standard method
for frequent monitoring of
the Amsco® V-PRO™ Low
Temperature Sterilization
System. |
| Intended Use
Method of
sterilization | STERIZONE® VP4
Sterilizer | STERRAD® Sterilization
System | Amsco® V-PRO™ Low
Temperature Sterilization
System |
| Sterilizing
agent(s) | Hydrogen peroxide / ozone | Hydrogen peroxide | Hydrogen peroxide |
| Biological
challenge | STERIZONE® BI+ Self-
contained Biological
Indicator - Min. 1×106 | STERRAD® CycleSure®
24 Self-contained
Biological Indicator - Min.
1×106 | STERIS Verify® V24 Self-
contained Biological
Indicator - Min. 1×106 |
| | Geobacillus
stearothermophilus ATCC
7953 spores | Geobacillus
stearothermophilus ATCC
7953 spores | Geobacillus
stearothermophilus ATCC
7953 spores |
| Holder | Syringe and plunger-
10 mL Becton-Dickinson
(B-D) plastic syringe with
Luer-lock connector and its
plunger | STERRAD® NX® Test
Vial
9.1 mL (0.558 in3)
polyethylene vial | STERIS Low Temperature
Sterilization Pouch |
| Diffusion
restrictor | 18 gauge (1.02 mm
diameter),
2-inch (50.8 mm) long
polytetrafluoroethylene
(PTFE) cannula with Luer-
lok™ attachment | Polyethylene vial cap with
a single orifice of 1.4-1.55
mm diameter & 2.7 mm
length (i.e., thickness of
cap) | Sealed Pouch |
| Resistance
characteristics | Demonstrated to have
equivalent to greater
resistance than the worst
case devices and loads in
any load configuration. | The Test Pack is at least as
resistant to the sterilization
process as the biological
model developed for the
DUO Cycle. | Specific to the claimed
sterilization system |
| Features | STERIZONE® VP4
Test Pack | STERRAD® 100NX DUO
Cycle Test Pack
(K111391) | STERIS® Verify® V24
"Test Pack"
(K090514) |
| | Demonstrated to be more
resistant than the full half-cycle, including exposure to
hydrogen peroxide and
ozone. | | |
1 Use of a pouch can increase resistance so as to create a test pack.
9
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.
10
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.
11
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 | Passed |
| Within specification | ||
| 2 | Growth inhibition by carrier and pack materials | Passed |
| No inhibition induced | ||
| 3 | Reduced incubation time validation | Passed |
| 18 hours using a dry-bath type incubator | ||
| adjusted to 55 – 60 °C | ||
| 4 | Effect of sterilization process on recovery media | Passed |
| No effect | ||
| 5 | Stability of biological read | Passed |
| Stable for 7 days | ||
| 6 | Positive Controls | Passed |
| Viability demonstrated | ||
| 7 | Stability (shelf life) evaluation | Passed |
| Ongoing stability evaluation | ||
| 8 | BI validation in the STERIZONE® VP4 process | Passed |
| 9 | 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 |
| Performance Requirements for Safety | | |
| 1 | Safe for use | Passed
No 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.