The Process Indicator Tape for Steam Sterilization is indicated for use in holding sterilization packs together and can be used in gravity sterilizers operating at 121ºC for 30 minutes or pre-vacuum sterilizers operating at 132ºC for 4 minutes and 1359C for 3 minutes. The indicator stripes turn dark brown black when sterilization conditions, thus providing an indication of processed items.

Device Description

The process indicator tape distinguishes between items processed and unprocessed in both gravity discharge and pre-vacuum steam sterilization cycles. The tape is made of a saturated crepe paper printed with white 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

Here's a breakdown of the acceptance criteria and the study information based on the provided document:

This document is a 510(k) summary for a "Process Indicator Tape for Steam Sterilization" (K140940). It focuses on demonstrating substantial equivalence to a predicate device rather than a ground-up performance study for a novel device. Therefore, some of the requested information (like effect size of human readers with AI or training set details) is not applicable or provided.

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (from Performance Standard Testing & Summary of Nonclinical Testing)	Reported Device Performance
ANSI/AAMI/ISO 11140-1:2005(R) 2010 - Performance Testing for a Class 1 Steam Process Indicator	Passed
FDA Chemical Indicator Guidance Document - Resistometer Performance Testing for a Class 1 Steam Process Indicator	Passed
In Use Testing - Steam Gravity and Pre-Vacuum 510 K Cleared Sterilizers (indicating color change)	Passed (stripes turn dark brown/black when exposed to steam sterilization conditions)
Biocompatibility/Leach Off Testing	Passed
Endpoint Stability	Passed
Shelf Life (3 years)	Passed
PSTC-101 and PSTC-131 - Pressure Sensitive Tape Council (PSTC) International Standards Test for Tape Adhesion	Passed
Post Processing Visual Adhesive Test for Wrapped Packages	Passed
Intended Use: Distinguish between sterilization processed and unprocessed units.	Device successfully turns dark brown/black, providing an indication of processed items.
Device Design: Crepe paper printed with indicator lines.	Matches predicate description.
Indicator Agent: Sulfur, lead carbonate hydroxide, and magnesium oxide.	Matches predicate description.
Sterilization Method Compatibility: Gravity discharge and pre-vacuum steam sterilizers.	Matches predicate description.
Endpoint Specifications: 121° C for 10 minutes; 132-135° C for 2 minutes.	Matches predicate description.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: The document does not specify exact sample sizes for each test listed (e.g., number of tape strips tested for performance, number of sterilization cycles). It generally states "Testing was performed in accordance with..." and reports "Passed" for each category.
Data Provenance: The document does not explicitly state the country of origin of the data. The submitting company, Canadian Technical Tape, Ltd., is located in Montreal, QC, Canada. The testing likely occurred in a laboratory setting. No information is provided on whether it was retrospective or prospective, but given the nature of product performance testing, it would be prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device is a chemical process indicator where the "ground truth" is determined by the physical/chemical reaction (color change) under specified sterilization conditions, as measured against established performance standards (ANSI/AAMI/ISO 11140-1). There is no mention of human expert interpretation being part of establishing the ground truth for the test results.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. As noted above, the "ground truth" is based on objective chemical/physical reactions conforming to standards, not human interpretation requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This document describes a chemical indicator, not an AI-powered diagnostic or assistive device for human readers. There is no AI involved.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a standalone device in the sense that its function (color change) is inherent to the product itself, not an algorithm. Its performance is purely standalone (tape changing color or not changing color).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth is established by the physical/chemical reaction of the indicator agent in response to specific sterilization conditions (temperature, time, steam presence), as defined by the performance standards (ANSI/AAMI/ISO 11140-1:2005(R) 2010). The endpoint specification (e.g., 121°C for 10 minutes) dictates the conditions under which the indicator is expected to change color, and the absence of these conditions where it should not.

8. The sample size for the training set

Not applicable. This is a manufactured product (chemical indicator tape), not an AI/machine learning model that requires a training set. The "training" in this context would be the product development and formulation to achieve the desired chemical reaction.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for an AI model. The chemical formulation and manufacturing process are developed to meet the established performance standards, where the ground truth is the chemical reaction under specified sterilization conditions.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an abstract image of an eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top of the seal in a circular fashion. The seal is black and white.

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

October 27, 2014

Canadian Technical Tape, LTD C/O Mr. Gary Socola Official Correspondent President Highpower Validation Testing and Lab Services 125 Highpower Road Rochester, NY 14623

Re: K140940

Trade/Device Name: Process Indicator Tape for Steam Sterilization Regulation Number: 21 CFR 880.2800 Regulation Name: Physical/Chemical Sterilization Process Indicator Regulatory Class: Class II Product Code: JOJ Dated: September 19, 2014 Received: September 23, 2014

Dear Mr. 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

{1}------------------------------------------------

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 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/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 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 vours.

Susan Runno DDS, MA

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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K140940

Device Name

Process Indicator Tape for Steam Sterilization

Indications for Use (Describe)

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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 Druq 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."

{3}------------------------------------------------

12140940

510K SUMMARY 3.0

Submission Date:	April 8, 2014
Summary Date:	October 15th, 2014
Submitter Information:
Company Name:	Canadian Technical Tape, Ltd.
Company Address:	Canadian Technical Tape, Ltd.455 Côte VertuMontreal, QC, Canada H4N 1E8
Contact Person:	Howard CohenPresidentCanadian Technical Tape, Ltd.514-334-1510514-745-0764hcohen@cttgroup.com
Device Information:
Trade Name:	Process Indicator Tape for Steam Sterilization
Common Name:	Process Indicator Tape
Classification Name:	Physical/Chemical Sterilization Process Indicator
Product Code:	JOJ
Device Class:	Class II, 21 CFR 880.2800(b)
Predicate Devices:	Sterilization Process Indicator Tapes Model CI122 &CI123 (K001649) SteriTec Products, Incorporated

Device Description:

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.

{4}------------------------------------------------

Indications for Use:

The Process Indicator Tape for Steam Sterilization is indicated for use in holding sterilization packs together and can be used in gravity sterilizers operating at 121°C for 30 minutes or prevacuum 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.

Performance Standard Testing:

Testing was performed in accordance with ANSI/AAMI/ISO 11140-1:2005(R) 2010 -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.

Characteristic	Predicate Device:	Proposed Device:
Intended Use	Process indicator tape for steamsterilization	Process indicator tape for steamsterilization
Device Design	Crepe paper printed with indicatorlines. Provided in natural and blue inwidths of approximately 0.5", 0.75"and 1" (12mm, 18mm and 24mm).	Crepe paper printed with indicatorlines. Provided in natural and blue inwidths of approximately 0.5", 0.75"and 1" (12mm, 18mm and 24mm).
Indicator Agent	Sulfur, lead carbonate hydroxideand magnesium oxide	Sulfur, lead carbonate hydroxideand magnesium oxide
SterilizationMethod	The tape is intended for use as a steamsterilization cycle process indicator ingravity discharge and pre-vacuumsteam sterilizers.	The tape is intended for use as a steamsterilization cycle process indicator ingravity discharge and pre-vacuumsteam sterilizers.
EndpointSpecifications	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
Indications for use	SteriTec Autoclave and BlueAutoclave Tapes are for use holdingsterilization packs together and asprocess indicators in gravity steamsterilizers operating at 121° C and pre-vacuum steam sterilizers operating at132-134° C. The white indicatorstripes on the tape turn black whenindication of processed items.	The Process Indicator Tape for SteamSterilization is indicated for use inholding sterilization packs togetherand can be used in gravity sterilizersoperating at 121°C for 30 minutes orpre-vacuum sterilizers operating at132°C for 4 minutes and 135°C for 4minutes. The indicator stripes turndark brown/black when exposed tosteam sterilization conditions, thus,providing an indication of processeditems.
Performance	ANSI/AAMI ST-60	ISO 11140-1:2005, ANSI/AAMI/ISO
Standards		11140-1:2005(R)2010

Comparison of the Proposed Device to the Predicate Device:

{5}------------------------------------------------

The proposed device is an identical product to the predicate device and both are manufactured by Canadian Technical Tape, Ltd.

Summary of Nonclinical Testing:

Test	Results
ANSI/AAMI/ISO 11140-1 - Performance Testing for a Class 1 SteamProcess Indicator	Passed
FDA Chemical Indicator Guidance Document - Resistometer PerformanceTesting for a Class 1 Steam Process Indicator	Passed
In Use Testing - Steam Gravity and Pre-Vacuum 510 K Cleared Sterilizers	Passed
Biocompatibility/Leach Off Testing	Passed
Endpoint Stability	Passed
Shelf Life	Passed
PSTC-101 and PSTC-131 - Pressure Sensitive Tape Council (PSTC)	Passed
International Standards Test for Tape Adhesion
Post Processing Visual Adhesive Test for Wrapped Packages	Passed

Conclusion:

The Process Indicator Tape for Steam Sterilization is substantially equivalent to the predicate device. The tape meets the performance claims for a class 1 process indicator according to ANSI/AAMI/ISO 11140-1:2005 (R) 2010 and raises no issues related to safety or effectiveness.

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).