(503 days)
STERRAD® Chemical Indicator
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No
The device is a simple chemical indicator strip that changes color based on exposure to ozone. There is no mention of any computational analysis, algorithms, or learning processes.
No.
This device is a chemical indicator used to determine if items have been exposed to a sterilization process, not to treat a condition or disease.
No
Explanation: The device is a chemical indicator used to differentiate between unprocessed and processed items in a sterilizer. It indicates the presence of ozone, not the sterility or a diagnosis of any condition. Its purpose is to monitor a sterilization process, not to diagnose a patient.
No
The device is a physical chemical indicator strip with ink and a clear finish, not a software program.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to indicate whether an item has been processed in a specific sterilization cycle (TSO3 Model 125L Sterilizer) by changing color in the presence of ozone. It is used with items being sterilized, not to diagnose a condition or analyze a biological sample.
- Device Description: The description reinforces its function as a process indicator for sterilization, not a diagnostic tool.
- Lack of Biological Sample Analysis: IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze any biological samples.
- Focus on Sterilization Process: The performance studies and overall description are focused on the device's ability to react to the sterilization process (ozone exposure, effects of other sterilization methods, stability).
Therefore, the TSO3 Chemical Indicator is a sterilization process indicator, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The TSO3 Chemical Indicator is a process indicator intended for use by healthcare providers to accompany sterilization packs, containers, or trays intended to be sterilized in the TSO, Model 125L Sterilizer. It is intended to differentiate between unprocessed items and processed items. The color of the TSO; Chemical Indicator changes from a red to lighter than the peach reference color when exposed to ozone, a critical component of the TSO3 Model 125L Sterlizer sterilization process.
Product codes (comma separated list FDA assigned to the subject device)
JOJ
Device Description
The TSO1 Chemical Indicator is a process indicalor strip intended to be used in the TSO--125L Ozone Sterilizer. The TSO3-125L Ozone Sterilizer uses Ozone vapor at low temperature and high humidity to destroy both spore-forming and nonspore-forming microorganisms. The routine use of CI's is considered to complement the employment of a biological indicator monitoring program. The TSO3 Chemical Indicator can be used to identify that an item has been processed through the TSO:-125L Ozone Sterilizer and that the Ozone was present. It does not imply that terminal sterilization occurred or to assure that the sterilization cvcle has been completed.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
healthcare providers
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing to support a substantial equivalence decision include the following : Incremental exposures to ozone - For the CI to reach its end point, the ozone dose injected into the sterilization chamber (ozone concentration) must be at least 70 mg/L. Tests were conducted to determine the effect of acid and basic vapors and solutions on the color stability of the Chemical Indicators. Generally, with the exception of liquids and very strong alkaline vapors, the color stability was not effected. The effect of UV exposure on color stability of the TSO3 Chemical Indicator was evaluated for pre and post exposure to ozone. Unprocessed CIs were exposed to UV for 15, 30, 45 and 60 days. The unprocessed CI's color was not affected by UV exposure. The color of the CI is stable to UV up to 2 months after being processed in a partial sterilization cycle. A slight color difference is observed for Cls processed to a partial sterilization cycle when exposed to UV between 3 to 12 months. The effects of other sterilization processes on the color stability of the TSO3 Chemical Indicator were evaluated: CIs were processed to an EtO sterilization cycle and the CI color is not affected by EtO sterilization process. CIs were also processed to 2 different (liquid and porous load) Steam sterilization cycles. Results indicate that the CI color is effected by a liquid cycle in an autoclave but not affected by a porous load cycle. Cytotoxicity tests were conducted to determine if residues could be released by the CI when exposed to the sterilization cycle. Cl's were processed in contact with polymer (LDPE), Stainless Steel coupons and medical grade silicone inside a sterilization pouch. Results showed that the CI does not induce cytotoxicity.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
STERRAD® Chemical Indicator
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.
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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).
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§ 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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TSO3 Chemical Indicator 510(k) Summary - K021161
Applicant's Name and Address
TSO3 Inc. 2505, Dalton Avenue Sainte-Foy (Québec) GIP 385
Phone : (418) 651-0003 (418) 653-5726 Fax : Email :info@tso3.com
Contact United States Agent
Charles O. Hancock, RAC 33 Black Watch Trail Fairport, New York 14450
Phone 585-223-1850 Fax : 585-223-6855 Email : chancock(@frontiernet.net
Submission Date
April 5, 2002
Trade Name
TSO3 Chemical Indicator
Common Name
Chemical sterilization process indicator
Classification Name
Physical/chemical process indicator is classified as Class II under Sterilization Process Indicator in 21 CFR 880.2800 by the General Hospital and Personal Use Devices Panel.
Legally Marketed Equivalent Device Name(s)
STERRAD® Chemical Indicator
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INDICATIONS-FOR-USE
The TSO3 Chemical Indicator is a process indicator intended for use by healthcare providers to accompany sterilization packs, containers, or trays intended to be sterilized in the TSO, Model 125L Sterilizer. It is intended to differentiate between unprocessed items and processed items. The color of the TSO; Chemical Indicator changes from a red to lighter than the peach reference color when exposed to ozone, a critical component of the TSO3 Model 125L Sterlizer sterilization process.
Description of Device
The TSO1 Chemical Indicator is a process indicalor strip intended to be used in the TSO--125L Ozone Sterilizer. The TSO3-125L Ozone Sterilizer uses Ozone vapor at low temperature and high humidity to destroy both spore-forming and nonspore-forming microorganisms. The routine use of CI's is considered to complement the employment of a biological indicator monitoring program. The TSO3 Chemical Indicator can be used to identify that an item has been processed through the TSO:-125L Ozone Sterilizer and that the Ozone was present. It does not imply that terminal sterilization occurred or to assure that the sterilization cvcle has been completed.
The Indicator Strip
The TSO3 Chemical Indicator is comprised of a paper strip upon which a reactant chemical indicator ink is printed which is then overcoated with a clear finish to prevent the indicator ink from being damaged by handling or abrasion before, during or after use. The imprint consists of a red indicating ink circle located within a peach colored reference square. When the color of the indicator circle has changed to a color lighter than that of the surrounding peach colored reference square, the appropriate exposure to Ozone has taken place.
Packaging
The TSO3 Chemical Indicator strips are packaged in rolls of 1000 indicators adhesively affixed to the roll to be peeled off for use. The rolls are packaged 2 per box for distribution.
Performance testing
The TSO3 Chemical Indicator is intended for one time, single use by health care workers to differentiate processed from unprocessed items.
Performance testing to support a substantial equivalence decision include the following :
Incremental exposures to ozone - For the CI to reach its end point, the ozone dose injected into the sterilization chamber (ozone concentration) must be at least 70 mg/L.
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TSO
Effects of other chemicals on the TSO3 Chemical Indicator color pre and post exposure to ozone :
Tests were conducted to determine the effect of acid and basic vapors and solutions on the color stability of the Chemical Indicators. Generally, with the exception of liquids and very strong alkaline vapors, the color stability was not effected.
The effect of UV exposure on color stability of the TSO3 Chemical Indicator was evaluated for pre and post exposure to ozone. Unprocessed CIs were exposed to UV for 15, 30, 45 and 60 days. The unprocessed CI's color was not affected by UV exposure. The color of the CI is stable to UV up to 2 months after being processed in a partial sterilization cycle. A slight color difference is observed for Cls processed to a partial sterilization cycle when exposed to UV between 3 to 12 months.
The effects of other sterilization processes on the color stability of the TSO3 Chemical Indicator were evaluated:
CIs were processed to an EtO sterilization cycle and the CI color is not affected by EtO sterilization process.
CIs were also processed to 2 different (liquid and porous load) Steam sterilization cycles. Results indicate that the CI color is effected by a liquid cycle in an autoclave but not affected by a porous load cycle.
Cytotoxicity tests were conducted to determine if residues could be released by the CI when exposed to the sterilization cycle. Cl's were processed in contact with polymer (LDPE), Stainless Steel coupons and medical grade silicone inside a sterilization pouch. Results showed that the CI does not induce cytotoxicity.
Conclusion
The results of the performance studies with the TSO, Chemical Indicator demonstrated that the TSO3 Chemical Indicator is appropriate for its intended use.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 7 2003
Technologies of Sterilization with Oxone, TSO3 Incorporation C/O Mr. Charles O. Hancock, RAC President Charles O. Hancock Associates, Incorporated 33 Black Watch Trail Fairport, New York 14450-3701
Re: K021161
Trade/Device Name: TOS3 Chemical Sterilization Process Indicator Regulation Number: 880.2800 (b) Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: JOJ Dated: August 18, 2003 Received: August 20, 2003
Dear Mr. Hancock:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Hancock
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Susan Renner
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indication for Use Statement 510(k) Number K021161
Device Name : TSO3 Chemical Indicator
Indications for Use :
The TSO3 Chemical Indicator is a process indicator intended for use by health carc providers to accompany sterilization packs, containers, or trays to be sterilized in the TSO3 Model 125L Ozone Sterilizer. It is intended to differentiate between unprocessed items and processed items.
The color of the TSO3 Chemical Indicator changes from a red to lighter than the peach reference color when exposed to ozone, a critical component of the TSO3 Model 125L Sterilizer sterilization process.
Olin S. Lim
(Division Sign-O Division of Anesthesiology, General Hospital. Infection Control, Dental
510(k) Number: K021161
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. (