(176 days)
No
The device is a chemical indicator that changes color based on a chemical reaction, not through AI/ML processing. The description focuses on chemical and physical properties and performance testing related to sterilization exposure.
No
The device is a chemical indicator used to determine if medical devices have been exposed to a sterilization process, not to treat a condition or disease.
No
This device is a chemical indicator used to verify that medical devices have been exposed to a sterilization process, not to diagnose a medical condition in a patient. It distinguishes between processed and unprocessed items.
No
The device is a physical chemical indicator strip made of polymeric material with indicator ink, a reference color, and a varnish coating. It functions through a chemical reaction resulting in a color change, not through software processing.
Based on the provided text, the STERIZONE® CI+ Chemical Indicator is not an In Vitro Diagnostic (IVD).
Here's why:
- Definition of IVD: An In Vitro Diagnostic device is a medical device intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological state, state of health, or disease or congenital abnormality.
- Intended Use: The STERIZONE® CI+ Chemical Indicator is intended to distinguish between processed and unprocessed packaged medical devices after sterilization. It does not examine specimens from the human body to provide information about a person's health.
- Function: Its function is to indicate whether a sterilization process has occurred, not to diagnose or monitor a medical condition.
Therefore, while it is a medical device used in a healthcare setting, it falls under the category of a sterilization process indicator, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The STERIZONE® CI+ Chemical Indicator is a single-use process indicator intended to distinguish between processed and unprocessed packaged medical devices to be sterilized using the STERIZONE® VP4 Sterilizer. The device is intended for use only with the STERIZONE® VP4 Sterilizer, which has a single sterilization cycle ("Cycle 1"). Critical process parameters for Cycle 1 are summarized in Table 1.
The red stripe chemical indicator is located above the peach-colored stripe labeled as the "REFERENCE". After exposure to the Cycle 1 of the STERIZONE® VP4 Sterilizer, the chemical indicator color changes from red to peach-Reference color (or lighter).
Product codes
JOJ
Device Description
The STERIZONE® CI+ Chemical Indicator (CI+) is a Class 1 process indicator that conforms to ANSI/AAMI/ISO 11140-1: 2005(R)2010, and is intended to only be used with the STERIZONE® VP4 Sterilizer. The single pre-set cycle (Cycle 1) of the STERIZONE® VP4 Sterilizer utilizes vaporized hydrogen peroxide and ozone in a multiphase process, to rapidly sterilize a variety of reusable medical devices.
The CI+ chemical indicator consists of a polymeric material strip on which an indicator ink, a reference color and a varnish coating have been deposited. The CI+ provides a visual indication that a sterilization load has been exposed to the STERIZONE® VP4 Sterilizer Cycle 1. The indicator works by means of a chemical reaction, which results is a recognizable color change from red to peach (or lighter).
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)
Performance testing was conducted to demonstrate the functionality of the STERIZONE® CI+ Chemical Indicator and general conformance with the requirements for Class 1 vaporized hydrogen peroxide sterilization indicators as detailed in ANSI/AAMI/ISO 11140-1:2005(R)2010.
Summary of nonclinical tests performed to demonstrate Safety and Effectiveness of the STERIZONE® CI+ Chemical Indicator:
- CI+ Functionality - Passed
- Shelf-life - Passed
- Endpoint color stability - Passed
- ISO 11140-1 compliance - Passed
- Biocompatibility - Passed
Overall Performance Conclusions: Performance tests demonstrate that the STERIZONE® CI+ Chemical Indicator is suitable to distinguish between processed and unprocessed packaged medical devices to be sterilized using Cycle 1 of the STERIZONE® VP4 Sterilizer. The STERIZONE® CI+ Chemical Indicator is as safe and as effective as the Verify® V-PRO Chemical Indicator (Version 1A) (K091174).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, composed of three human profiles facing right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
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 Richard, Ph.D. Consultant IM3. Inc. 512F NE 81st Street. Suite 101 Vancouver, WA 98665
Re: K141698
Trade/Device Name: STERIZONE® CI+ Chemical Indicator Regulation Number: 21 CFR 880.2800 Regulation Name: Chemical Sterilization Process Indicator Regulatory Class: II Product Code: JOJ Dated: November 14, 2014 Received: November 17, 2014
Dear Dr. Richard:
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 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
2
Indications for Use
510(k) Number (if known) K141698
Device Name STERIZONE® CI+ Chemical Indicator
Indications for Use (Describe)
The STERIZONE® CI+ Chemical Indicator is a single-use process indicator intended to distinguish between processed and unprocessed packaged medical devices to be sterilized using the STERIZONE® VP4 Sterilizer. The device is intended for use only with the STERIZONE® VP4 Sterilizer, which has a single sterilization cycle ("Cycle 1"). Critical process parameters for Cycle 1 are summarized in Table 1.
The red stripe chemical indicator is located above the peach-colored stripe labeled as the "REFERENCE". After exposure to the Cycle 1 of the STERIZONE® VP4 Sterilizer, the chemical indicator color changes from red to peach-Reference color (or lighter).
Table 1. STERIZONE® VP4 Sterilizer - Cycle 1 process parameters
| Hydrogen peroxide exposure | Ozone exposure | ||||||
|---|---|---|---|---|---|---|---|
| Hydrogen | |||||||
| peroxide solution | Chamber | ||||||
| differential | |||||||
| pressure | |||||||
| set point | Time | Sterilant | |||||
| injected | Vaporizer set | ||||||
| point / | |||||||
| Chamber | |||||||
| temperature | O3 | ||||||
| injection | O3 | ||||||
| dwell | Nb of | ||||||
| phases | |||||||
| 125-280 Solution™ | |||||||
| (H2O2 50 wt%) | 19 Torr | 210-600 | |||||
| sec* | 8.4-24 g* | 120°C / | |||||
| 41 ±3°C | 2 mg/L | 5 min | 2 |
- Vaporized hydrogen peroxide injection/exposure time (Dynamic HoOs 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°C to 26°C. If the H₂O₂ injection time is less than 210 seconds, or greater than 600 seconds, the cycle will abort.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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Image /page/4/Picture/0 description: The image shows a chemical structure. The structure contains the letters T and S. There is also a subscript number 3 in the bottom right corner of the image.
5.0 510(k) Summary
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
December 10, 2014
5.2. Name of the device
Trade Name
STERIZONE® CI+ Chemical Indicator
Common Name
Chemical sterilization process indicator
Classification Name (if known)
Indicator, Physical/Chemical 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: JOJ
5.3. Legally Marketed Equivalent Device Name(s)
Verify® V-PRO Chemical Indicator (Version 1A) (K091174)
5
Description of device 5.4.
The STERIZONE® CI+ Chemical Indicator (CI+) is a Class 1 process indicator that conforms to ANSI/AAMI/ISO 11140-1: 2005(R)2010, and is intended to only be used with the STERIZONE® VP4 Sterilizer. The single pre-set cycle (Cycle 1) of the STERIZONE® VP4 Sterilizer utilizes vaporized hydrogen peroxide and ozone in a multiphase process, to rapidly sterilize a variety of reusable medical devices.
The CI+ chemical indicator consists of a polymeric material strip on which an indicator ink, a reference color and a varnish coating have been deposited. The CI+ provides a visual indication that a sterilization load has been exposed to the STERIZONE® VP4 Sterilizer Cycle 1. The indicator works by means of a chemical reaction, which results is a recognizable color change from red to peach (or lighter).
5.5. Indication for use
The STERIZONE® CI+ Chemical Indicator is a Class 1 process indicator intended to distinguish between processed and unprocessed packaged medical devices to be sterilized using the STERIZONE® VP4 Sterilizer. The device is intended for use only with the STERIZONE® VP4 Sterilizer, which has a single sterilization cycle ("Cycle 1"). Critical process parameters for Cycle 1 are summarized in Table 1.
The red stripe chemical indicator is located above the peach-colored stripe labeled as the "REFERENCE". After exposure to the Cycle 1 of the STERIZONE® VP4 Sterilizer, the chemical indicator color changes from red to peach-Reference color (or lighter).
| Hydrogen peroxide exposure | Ozone exposure | ||||||
|---|---|---|---|---|---|---|---|
| Hydrogen | |||||||
| peroxide solution | Chamber | ||||||
| differential | |||||||
| pressure | |||||||
| set point | Time | Sterilant | |||||
| injected | Vaporizer set | ||||||
| point / | |||||||
| Chamber | |||||||
| temperature | O3 | ||||||
| injection | O3 | ||||||
| dwell | Nb of | ||||||
| phases | |||||||
| 125-280 Solution™ | |||||||
| (H2O2 50 wt%) | 19 Torr | 210-600 | |||||
| sec* | 8.4-24 g* | 120°C / | |||||
| 41 ±3°C | 2 mg/L | 5 min | 2 |
Table 1. STERIZONE® VP4 Sterilizer – Cycle 1 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°C to 26°C. If the H₂O₂ injection time is less than 210 seconds, or greater than 600 seconds, the cycle will abort.
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Image /page/6/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 sulfur atom (S) bonded to three oxygen atoms (O). The subscript '3' indicates that there are three oxygen atoms in the molecule. The diagram is rendered in black and gray, with the 'TS' and the sulfur atom in black, and the oxygen atoms in gray.
5.6. Assessment of performances data
5.6.1. Summary of nonclinical performance tests
Performance testing was conducted to demonstrate the functionality of the STERIZONE® CI+ Chemical Indicator and general conformance with the requirements for Class 1 vaporized hydrogen peroxide sterilization indicators as detailed in ANSI/AAMI/ISO 11140-1:2005(R)2010.
Table 2. Summary of nonclinical tests performed to demonstrate Safety and Effectiveness of the STERIZONE® CI+ Chemical Indicator
| Test | Result | |
|---|---|---|
| 1 | CI+ Functionality | Passed |
| 2 | Shelf-life | Passed |
| 3 | Endpoint color stability | Passed |
| 4 | ISO 11140-1 compliance | Passed |
| 5 | Biocompatibility | Passed |
5.7. Substantial equivalence
The STERIZONE® CI+ Chemical Indicator is substantially equivalent to the Verify® V-PRO Chemical Indicator (K091174). The CI+ and predicate device are both single-use process indicators intended to monitor sterilization cycles that utilize vaporized hydrogen peroxide as a primary sterilant. Furthermore, the CI+ and predicate device are identical in design, both utilizing a dye, which when exposed to hydrogen peroxide, changes color. The difference in endpoint color change between exposed and non-exposed indicators is minor, and does not raise different questions of safety and effectiveness.
Table 3. Comparison between the STERIZONE® CI+ Chemical Indicator and the Verify® V-PRO Chemical Indicator (K091174)
| Feature | STERIZONE®
CI+ Chemical Indicator | Verify® V-PRO Chemical
Indicator (Version 1A)
(K091174) |
|-------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Single use sterilization process
indicator | Single use sterilization process
indicator |
| Indications for use | The STERIZONE® CI+ Chemical
Indicator is a single-use process | A process indicator intended to
distinguish between processed and |
| Feature | STERIZONE®
CI+ Chemical Indicator | Verify® V-PRO Chemical
Indicator (Version 1A)
(K091174) |
| | indicator intended to distinguish
between processed and unprocessed
packaged medical devices to be
sterilized using Cycle 1 of the
STERIZONE® VP4 Sterilizer. | unprocessed units when placed
within sterilization wraps, trays or
pouches to indicate, through a
visible change from magenta to
yellow, when the device has been
exposed to a V-PRO 1 Low
Temperature Sterilization process
(Lumen Cycle) or V-PRO 1 Plus
Low Temperature sterilization
process (Lumen and Non-Lumen
cycle). |
| Endpoint
specifications -
Distinctive Color
Change | Red stripe changes to 'peach'
(reference) stripe or a lighter color
when exposed to the STERIZONE®
VP4 Sterilizer. | Magenta spot changes to yellow
(reference) when exposed to the
Amsco V-PRO 1 or V-PRO 1 Plus
Low Temperature Sterilization
system |
| Indicator agent | Rosolic acid base
Image: Rosolic acid base chemical structure
| Pararosaniline base1
Image: Pararosaniline base chemical structure |
| Substrate | Polymer (Polypropylene) | Polymer (Polypropylene) |
| Technology
features | The molecule structure comprises
three conjugated rings.
Chromophore functional group is
associated with the molecule. The
energy difference between two
different molecular orbitals in the
chromophore is within the visible
spectrum. If the bond is broken due
to H2O2 exposure, the color
changes. | Same |
| Feature | STERIZONE®
CI+ Chemical Indicator | Verify® V-PRO Chemical
Indicator (Version 1A)
(K091174) |
| Principles of
operation | Redox Reaction. C=C and C=O are
the two double bonds present in the
chromophore of the molecule. The
initial color is affected by the C=O
group, which is part of the overall
conjugated system. When exposed
to H2O2, the C=C is broken due to
the action of HO2- (H2O2 anion).
This results in a color change. | Redox Reaction. C=C and C=N are
the two double bonds present in the
chromophore of the molecule. The
initial color is affected by the C=N
group, which is part of the overall
conjugated system. When exposed
to H2O2, the C=C is broken due to
the action of HO2- (H2O2 anion).
This results in a color change. |
| Sterilization
method and cycles | STERIZONE® VP4 Sterilizer
utilizes both vaporized hydrogen
peroxide and ozone in a single pre-
set cycle (Cycle 1), which is
intended for general instruments,
single-channel flexible endoscopes,
and rigid-channel devices including
single-channel and double-channel
rigid endoscopes. | V-PRO 1 Low Temperature
Sterilization process utilizes
vaporized hydrogen peroxide in
multiple cycle configurations
(Lumen Cycle and Non-Lumen
Cycle), which are intended for
different medical devices. |
| Dedicated Use | Yes, in the STERIZONE® VP4
Sterilizer | Yes, in the V-PRO® Sterilization
system |
| CI can be used both
internally (within
package) and
externally | Yes | Yes |
| Ease of Results
Interpretation | Reference color for end point is a
stripe identified “REFERENCE”.
No external color reference is
required. | Reference color for end point is a
yellow colored spot printed aside of
the indicator ink spot. No external
color reference is required. |
| Storage Conditions | Dry area, ambient temperature of
15° to 30° C | Temperature: 6° to 30° C
RH: 30 to 60% |
| Picture of the
device
Unprocessed | Image: STERIZONE CI+ Chemical Indicator Unprocessed | Image: Verify V-PRO Chemical Indicator Unprocessed |
| Processed | Image: STERIZONE CI+ Chemical Indicator Processed | Image: Verify V-PRO Chemical Indicator Processed |
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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 'T' and 'S' connected to a circle with the number '3' as a subscript. The circle is connected to the 'S' in the diagram. The diagram is a simplified representation of a chemical compound.
SECTION 5 – 510(k) SUMMARY K141698
¹ US Patent 2009/0023217, assigned to Steris, describes the use of pararosaniline base (a triphenylmethane dye) as an indicator agent for exposure to hydrogen peroxide.
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Image /page/8/Picture/0 description: The image shows a chemical structure diagram. The diagram includes the letters 'T' and 'S', with 'O' and '3' also visible. The diagram appears to represent a chemical compound or molecule, with the letters and numbers indicating the elements and their quantities within the structure.
SECTION 5 – 510(k) SUMMARY
9
$$\mathbb{S}^{\mathbb{S}}$$
SECTION 5 – 510(k) SUMMARY K141698
Overall Performance Conclusions 5.8.
Performance tests demonstrate that the STERIZONE® CI+ Chemical Indicator is suitable to distinguish between processed and unprocessed packaged medical devices to be sterilized using Cycle 1 of the STERIZONE® VP4 Sterilizer. The STERIZONE® CI+ Chemical Indicator is as safe and as effective as the Verify® V-PRO Chemical Indicator (Version 1A) (K091174).
Both the subject and predicate indicators have the same intended use, technical characteristics and performance. Based on the non-clinical performance testing data the subject device has proven to be as safe and effective as the predicate device (V-PRO Chemical Indicator (Version 1A) (K091174), when monitoring the Cycle 1 sterilization process for the STERIZONE VP4 Sterilizer.