(77 days)
No
The device is a simple chemical indicator tape that changes color based on temperature and moisture exposure, with no mention of AI or ML in the description or performance studies.
No
The device is a process indicator tape used to confirm steam sterilization conditions have been met, not to treat or diagnose a medical condition.
No
This device is a process indicator tape used to confirm exposure to steam sterilization conditions, not to diagnose a medical condition in a patient.
No
The device description clearly indicates it is a physical tape made of saturated crepe paper with printed indicator lines, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to hold sterilization packs together and provide an indication that the packs have been exposed to steam sterilization conditions. This is a process indicator for sterilization, not a diagnostic test performed on biological samples.
- Device Description: The device is a tape with indicator stripes that change color based on exposure to steam, moisture, and temperature. This mechanism is related to monitoring a sterilization process, not analyzing biological specimens.
- Lack of Biological Sample Interaction: IVDs are designed to be used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. This device does not interact with any biological samples.
- Focus on Sterilization Process: The performance studies and testing described are all related to the effectiveness of the tape as a sterilization process indicator (e.g., resistometer testing, in-use testing in sterilizers, shelf life, adhesion). They do not involve any diagnostic performance metrics.
Therefore, the Canadian Technical Tape, Ltd. LF Process Indicator Steam Sterilization Tape is a sterilization process indicator, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
JOJ
Device Description
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.
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
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.
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 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.
Summary of Nonclinical Testing:
- 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. Results: 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. Results: 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. Results: 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. Results: Passed.
- Endpoint Stability - ANSI/AAMI/ISO 11140-1 and FDA Chemical Indicator Guidance Document: End Point Stability was tested in accordance with ISO 11140-1, section 6.1.2. Results: 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. Results: 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 the PSTC-101 and PSTC-131 International Tape Standards. Results: Passed.
- Post Processing Visual Adhesive Test for Wrapped Packages: Test performed in response to a request from the FDA in the predicate K140940 clearance. Results: Passed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
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).
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).
0
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
1
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
2
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)
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.
| 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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3
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 Cohen |
| President | |
| 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):
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.
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.
4
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 indicator
lines. Provided in natural and blue
in widths of approximately 0.5",
0.75" and 1" (12mm, 18mm and
24mm). | Crepe paper printed with indicator
lines. Provided in natural and blue
in widths of approximately 0.5",
0.75" and 1" (12mm, 18mm and
24mm). | Crepe paper printed with indicator
lines. Provided in natural in widths
of 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) |
| Sterilization
Method
(Steam) | Gravity 121°C 30 minutes
Pre-vacuum 132°C 4 minutes
Gravity 135°C 3 minutes | Gravity 121°C 30 minutes
Pre-vacuum 132°C 4 minutes
Gravity 135°C 3 minutes | Gravity 121°C 30 minutes
Pre-vacuum 132°C 4 minutes
Gravity 135°C 3 minutes |
| Endpoint
Specifications | 121° C for 10 minutes
132-135° C for 2 minutes. | 121° C for 10 minutes
132-135° C for 2 minutes. | 121° C for 10 minutes
132-135° C for 2 minutes. |
| Shelf-life | 3 years | 3 years | 3 years |
| Indications for Use | 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. | 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 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. | SteriTec Green Tape can be used in
121°C gravity sterilizers for 30
minutes or pre-vacuum sterilizers
operating at 132°C for 4 minutes and
135°C for 3 minutes. Stripes turn
black after exposure to steam
sterilization conditions, thus
providing identification of processed
items. |
| Performance
Standards | ANSI/AAMI/ISO 11140-1:2014 | ANSI/AAMI/ISO 11140-
1:2005(R) 2010 | ANSI/AAMI/ISO 11140-
1:2005(R) 2010 |
5
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 Process | ||
| Indicator - ANSI/AAMI/ISO 11140-1 | Pass and fail testing in a steam resistometer according | |
| to Table 2 of ISO 11140-1:2014 | 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 | 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 | 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. | Passed | |
| Endpoint Stability - ANSI/AAMI/ISO 11140-1 and | ||
| FDA Chemical Indicator Guidance Document | End Point Stability was tested in accordance with ISO | |
| 11140-1, section 6.1.2. | 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 | 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 | |
| the PSTC-101 and PSTC-131 International Tape | ||
| Standards | Passed | |
| Post Processing Visual Adhesive Test for Wrapped | ||
| Packages | Test performed in response to a request from the FDA in | |
| the 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.