The Canadian Technical Tape, Ltd. LF Process Indicator Steam Sterilization Tape is indicated for use in holding sterilization packs together and can be used in gravity sterilizers operating at 121°C for 30 minutes or pre-vacuum sterilizers operating at 132°C for 4 minutes and 135°C for 3 minutes. The indicator stripes turn dark brown/black when exposed to steam sterilization conditions, thus providing an indication of processed items.

Device Description

The process indicator tape distinguishes between items processed in both gravity discharge and pre-vacuum steam sterilization cycles. The tape is made of a saturated crepe paper printed with green indicator lines that turn to dark brown/black when proper levels of moisture and temperature have been achieved. The tape adheres on contact and stays in place through live steam pressure.

AI/ML Overview

This looks like a 510(k) summary for a medical device, specifically a steam sterilization tape. I will extract the requested information based on the provided document.

1. Table of Acceptance Criteria and Reported Device Performance:

Test	Acceptance Criteria (from regulation/guidance)	Reported Device Performance
Performance Testing for a Class 1 Steam Process Indicator - ANSI/AAMI/ISO 11140-1	Pass and fail testing in a steam resistometer according to Table 2 of ISO 11140-1:2014 (Specific details not provided in the summary)	Passed
Resistometer Performance Testing for a Class 1 Steam Process Indicator - FDA Chemical Indicator Guidance Document	Pass and fail testing in a steam resistometer according to the requirements in Table 3 of the FDA guidance document on Chemical Indicators (Specific details not provided in the summary)	Passed
In Use Testing in FDA 510k Cleared Steam Sterilizers - FDA Chemical Indicator Guidance Document	Pass and fail testing in cleared healthcare steam sterilizers according to the requirements in section VII "Performance Characteristics" of the FDA guidance document on Chemical Indicators (Specific details not provided in the summary)	Passed
Biocompatibility/Leach Off Testing - FDA Chemical Indicator Guidance Document	Cytotoxicity Testing to the requirements in section VIII "Biocompatibility" of the FDA guidance document on Chemical Indicators and Leach Off test in accordance with ISO 11140-1, section 6.4.2. (Specific details not provided in the summary)	Passed
Endpoint Stability - ANSI/AAMI/ISO 11140-1 and FDA Chemical Indicator Guidance Document	Tested in accordance with ISO 11140-1, section 6.1.2. (Specific criteria for stability not provided in the summary)	Passed
Shelf Life - ANSI/AAMI/ISO 11140-1 and FDA Chemical Indicator Guidance Document	Pass and fail testing in a steam resistometer according to Table 2 of ISO 11140-1:2014 was performed in order to satisfy section X “Shelf Life” of the FDA guidance document on Chemical Indicators (Specific details not provided in the summary)	Passed
Pressure Sensitive Tape Council (PSTC) International Standards Test for Tape Adhesion - PSTC-101 and PSTC-131 Sterilization Tape Standards	Internal tape adhesion test performed in accordance with PSTC-101 and PSTC-131 International Tape Standards (Specific criteria not provided in the summary)	Passed
Post Processing Visual Adhesive Test for Wrapped Packages	Test performed in response to a request from the FDA in the predicate K140940 clearance (Specific criteria not provided in the summary)	Passed

2. Sample Size Used for the Test Set and Data Provenance:

The document states, "The non-clinical testing that has been performed on multiple lots of indicators and each was found to meet all predetermined acceptance criteria." However, it does not provide specific numerical sample sizes for the test set or the provenance (country of origin, retrospective/prospective) of the data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

The document does not mention the use of experts to establish ground truth for the testing. The tests conducted are for a physical/chemical indicator, where the "ground truth" is determined by the physical/chemical reaction itself under controlled steam sterilization conditions, as defined by the referenced standards (ANSI/AAMI/ISO 11140-1 and FDA Guidance).

4. Adjudication Method for the Test Set:

Not applicable, as expert adjudication is not described or required for this type of device testing based on the provided document. The outcome is a binary "Pass" or "Fail" based on objective chemical/physical reaction, likely visually assessed against predefined color change criteria.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

A MRMC comparative effectiveness study was not done. This type of study is typically for evaluating diagnostic algorithms where human readers interpret medical images or data. The device here is a physical/chemical process indicator.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Yes, the testing described is a standalone performance evaluation of the device (the chemical indicator tape) itself. The "Perfomance Standard Testing" and "Summary of Nonclinical Testing" sections detail tests conducted directly on the tape samples in controlled environments (e.g., steam resistometer, cleared healthcare steam sterilizers) without human interpretation in the loop as part of the primary outcome measurement. The "indication of processed items" is a direct physical transformation of the tape.

7. Type of Ground Truth Used:

The ground truth used is based on defined physical/chemical conditions (e.g., exposure to specific temperatures and times in a steam sterilizer) as mandated by the referenced international standards (ANSI/AAMI/ISO 11140-1) and FDA guidance documents. The "trigger" for the indicator to turn dark brown/black is the achievement of specific moisture and temperature levels.

8. Sample Size for the Training Set:

Not applicable. This device is a physical/chemical indicator, not a machine learning or AI-based algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for this type of device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an abstract symbol that resembles a stylized human figure.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 28, 2016

Canadian Technical Tape, Ltd. % Gary Socola President Highpower Validation and Testing Lab Services Inc. 125 Highpower Rd. Rochester, New York 14623

Re: K161024

Trade/Device Name: Canadian Technical Tape, Ltd. LF Process Indicator Steam Sterilization Tape Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: JOJ Dated: May 31, 2016 Received: June 1. 2016

Dear Gary Socola:

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.

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

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the quality systems (OS) 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 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

Enclosure

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Indications for Use

510(k) Number (if known) K161024

Device Name

Canadian Technical Tape, Ltd. LF Process Indicator Steam Sterilization Tape

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CER 801 Subpart D)	☐ Over-The-Counter Use (21 CER 801 Subpart C)

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510(K) SUMMARY

SUBMITTER INFORMATION:

Canadian Technical Tape, Ltd.
455 Côte-Vertu Blvd.
Montreal, Qubec, Canada
H4N 1E8
Phone:	(800) 334-1567
Fax:	(800) 334-1029
Contact Person:	Howard CohenPresident
Date of Summary:	June 28th, 2016

DEVICE INFORMATION:

Device Trade Name:	Canadian Technical Tape, Ltd. LF Process Indicator Steam Sterilization Tape
Common Name:	Lead Free Process Indicator Tape
Device Classification:	Indicator, Physical/Chemical Sterilization Process
Device Class:	Class II, 21 CFR § 880.2800(b)
Product Code:	JOJ

PREDICATE DEVICE:

Canadian Technical Tape, Ltd. Process Indicator Tape for Steam Sterilization (K140940)

REFERENCE 510K DEVICE:

SteriTec Green Tape (K122555)

DEVICE DESCRIPTION (MODEL 143 & MODEL 144):

INTENDED USE:

A physical/chemical sterilization process indicator is a single use device intended to be used by a health care provider to distinguish between sterilization processed and unprocessed units.

INDICATIONS FOR USE (IFU):

The Canadian Technical Tape, Ltd. LF Process Indicator Steam Sterilization Tape is indicated for use in holding sterilization packs together and can be used in gravity sterilizers operating at 121℃ for 30 minutes or pre-vacuum sterilizers operating at 132°C for 4 minutes and 135°C for 3 minutes. The indicator stripes turn dark brown/black when exposed to steam sterilization conditions, thus providing an indication of processed items.

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PERFORMANCE STANDARD TESTING:

Testing was performed in accordance with ANSI/AAMI/ISO 11140-1:2014 - Sterilization of health care products - Chemical indicators - Part 1: General requirements and the Guidance for Industry and FDA Staff Premarket Notification [510(k)] Submissions for Chemical Indicators.

SUBSTANTIAL EQUIVALENCE DISCUSSION:

The subject device has the same Indications for Use, intended use, technical characteristics and functional characteristics as the predicate device K140940. They provide a visual indication that packages have been exposed to the steam sterilization process. Each are made with the exact same manufacturing process.

COMPARISON OF THE PROPOSED DEVICE TO THE PREDICATE

ELEMENT	SUBJECT DEVICE	CANADIAN TAPE PREDICATE(K140940)	STERITEC REFERENCE(K122555)
Intended Use	Process Indicator Tape	Process Indicator Tape	Process Indicator Tape
Device Design	Crepe paper printed with indicatorlines. Provided in natural and bluein widths of approximately 0.5",0.75" and 1" (12mm, 18mm and24mm).	Crepe paper printed with indicatorlines. Provided in natural and bluein widths of approximately 0.5",0.75" and 1" (12mm, 18mm and24mm).	Crepe paper printed with indicatorlines. Provided in natural in widthsof approximately 0.5", 0.75" and 1”(12mm, 18mm and 24mm).
Indicator Agent	Steam Indicator Ink(not made from lead)	Steam Indicator Ink(made from lead)	Steam Indicator Ink(not made from lead)
SterilizationMethod(Steam)	Gravity 121°C 30 minutesPre-vacuum 132°C 4 minutesGravity 135°C 3 minutes	Gravity 121°C 30 minutesPre-vacuum 132°C 4 minutesGravity 135°C 3 minutes	Gravity 121°C 30 minutesPre-vacuum 132°C 4 minutesGravity 135°C 3 minutes
EndpointSpecifications	121° C for 10 minutes132-135° C for 2 minutes.	121° C for 10 minutes132-135° C for 2 minutes.	121° C for 10 minutes132-135° C for 2 minutes.
Shelf-life	3 years	3 years	3 years
Indications for Use	The Canadian Technical Tape,Ltd. LF Process Indicator SteamSterilization Tape is indicated foruse in holding sterilization packstogether and can be used in gravitysterilizers operating at 121°C for 30minutes or pre-vacuum sterilizersoperating at 132°C for 4 minutes and135°C for 3 minutes. The indicatorstripes turn dark brown/black whenexposed to steam sterilizationconditions, thus providing anindication of processed items.	The Process Indicator Tape forSteam Sterilization is indicated foruse in holding sterilization packstogether and can be used in gravitysterilizers operating at 121°C for 30minutes or pre-vacuum sterilizersoperating at 132°C for 4 minutes and135°C for 3 minutes. The indicatorstripes turn dark brown/black whenexposed to steam sterilizationconditions, thus providing anindication of processed items.	SteriTec Green Tape can be used in121°C gravity sterilizers for 30minutes or pre-vacuum sterilizersoperating at 132°C for 4 minutes and135°C for 3 minutes. Stripes turnblack after exposure to steamsterilization conditions, thusproviding identification of processeditems.
PerformanceStandards	ANSI/AAMI/ISO 11140-1:2014	ANSI/AAMI/ISO 11140-1:2005(R) 2010	ANSI/AAMI/ISO 11140-1:2005(R) 2010

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510(K) SUMMARY

SUMMARY OF NONCLINICAL TESTING:

The non-clinical testing that has been performed on multiple lots of indicators and each was found to meet all predetermined acceptance criteria.

Test	Description	Results
Performance Testing for a Class 1 Steam ProcessIndicator - ANSI/AAMI/ISO 11140-1	Pass and fail testing in a steam resistometer accordingto Table 2 of ISO 11140-1:2014	Passed
Resistometer Performance Testing for a Class 1Steam Process Indicator - FDA Chemical IndicatorGuidance Document	Pass and fail testing in a steam resistometer accordingto the requirements in Table 3 of the FDA guidancedocument on Chemical Indicators	Passed
In Use Testing in FDA 510k Cleared SteamSterilizers - FDA Chemical Indicator GuidanceDocument	Pass and fail testing in cleared healthcare steamsterilizers according to the requirements in section VII"Performance Characteristics" of the FDA guidancedocument on Chemical Indicators	Passed
Biocompatibility/Leach Off Testing - FDA ChemicalIndicator Guidance Document	Cytotoxicity Testing to the requirements in section VIII"Biocompatibility” of the FDA guidance document onChemical Indicators and Leach Off test in accordancewith ISO 11140-1, section 6.4.2.	Passed
Endpoint Stability - ANSI/AAMI/ISO 11140-1 andFDA Chemical Indicator Guidance Document	End Point Stability was tested in accordance with ISO11140-1, section 6.1.2.	Passed
Shelf Life - ANSI/AAMI/ISO 11140-1 and FDAChemical Indicator Guidance Document	Pass and fail testing in a steam resistometer accordingto Table 2 of ISO 11140-1:2014 was performed inorder to satisfy section X “Shelf Life” of the FDAguidance document on Chemical Indicators	Passed
Pressure Sensitive Tape Council (PSTC) InternationalStandards Test for Tape Adhesion - PSTC-101 andPSTC-131 Sterilization Tape Standards	Internal tape adhesion test performed in accordance withthe PSTC-101 and PSTC-131 International TapeStandards	Passed
Post Processing Visual Adhesive Test for WrappedPackages	Test performed in response to a request from the FDA inthe predicate K140940 clearance	Passed

CONCLUSION:

The Canadian Technical Tape, Ltd. LF Process Indicator Steam Sterilization Tape is substantially equivalent to the predicate device, as the devices are identical, share a common manufacturer, and share common intended use. The tape meets the performance claims for a type 1 process indicator according to ANSI/AAMI/ISO 11140-1:2014.

Regulation Number and Section

§ 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).