← Product Code [JOJ](/productcode/JOJ) · K141698 # STERIZONE CHEMICAL INDICATOR (K141698) _Tso3, Inc. · JOJ · Dec 17, 2014 · General Hospital · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K141698 ## Device Facts - **Applicant:** Tso3, Inc. - **Product Code:** [JOJ](/productcode/JOJ.md) - **Decision Date:** Dec 17, 2014 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.2800 - **Device Class:** Class 2 - **Review Panel:** General Hospital ## 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). ## Device Story STERIZONE® CI+ is a single-use Class 1 chemical process indicator; used to verify exposure of packaged medical devices to the STERIZONE® VP4 Sterilizer Cycle 1. Device consists of a polypropylene strip with indicator ink, reference color, and varnish coating. Principle of operation: redox reaction; hydrogen peroxide (H2O2) anion (HO2-) breaks C=C bonds in the rosolic acid-based chromophore, causing a visual color change from red to peach (or lighter). Used in clinical settings where STERIZONE® VP4 sterilization occurs. Healthcare providers place the indicator inside or outside device packaging; visual inspection of the color change confirms the load has undergone the sterilization cycle. Benefits include simple, rapid verification of processing status, ensuring processed and unprocessed items are distinguished. ## Clinical Evidence Bench testing only. Testing demonstrated conformance with ANSI/AAMI/ISO 11140-1:2005(R)2010. Tests included CI+ functionality, shelf-life, endpoint color stability, and biocompatibility. All tests passed. ## Technological Characteristics Class 1 chemical indicator; polypropylene substrate. Indicator agent: rosolic acid-based ink. Sensing principle: redox reaction (H2O2-induced bond cleavage in chromophore). Form factor: strip with indicator and reference color zones. Storage: dry, 15-30°C. Conforms to ANSI/AAMI/ISO 11140-1:2005(R)2010. ## Regulatory Identification Biological sterilization process indicator: 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. Physical/chemical sterilization process indicator: 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. ## Predicate Devices - Verify® V-PRO Chemical Indicator (Version 1A) ([K091174](/device/K091174.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ 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}------------------------------------------------ This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ 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. {6}------------------------------------------------ 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 | {7}------------------------------------------------ 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. {8}------------------------------------------------ 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. --- **Source:** [https://fda-staging.innolitics.com/device/K141698](https://fda-staging.innolitics.com/device/K141698) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com