(196 days)
Not Found
No
The device is a simple chemical indicator tape that changes color based on temperature and moisture, with no mention of AI/ML in the description, intended use, or performance studies.
No.
This device is a process indicator tape used to confirm sterilization conditions within medical equipment, not to treat a patient directly.
No
Explanation: This device is a process indicator tape used to confirm whether sterilization conditions have been met. It does not diagnose any medical condition or disease.
No
The device is a physical tape with chemical indicators, not a software program.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body for the purpose of providing information for the diagnosis, treatment, or prevention of disease.
- Device Function: The Process Indicator Tape for Steam Sterilization is used to indicate whether sterilization conditions have been met for medical devices or other items being sterilized. It does not interact with human specimens or provide information for diagnosis or treatment of a patient.
- Intended Use: The intended use clearly states it's for holding sterilization packs together and indicating processed items based on temperature and moisture levels during sterilization cycles.
- Anatomical Site/Patient Age: The "Not Applicable" for Anatomical Site and Indicated Patient Age Range further supports that it's not used on or in relation to a patient's body.
Therefore, this device falls under the category of a sterilization process indicator, not an In Vitro Diagnostic.
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
JOJ
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.
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)
- ANSI/AAMI/ISO 11140-1 - 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: Passed
- Biocompatibility/Leach Off Testing: Passed
- Endpoint Stability: Passed
- Shelf Life: 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
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.
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.
Not Found
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).
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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
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Indications for Use
510(k) Number (if known) K140940
Device Name
Process Indicator Tape for Steam Sterilization
Indications for Use (Describe)
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.
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)
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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 Vertu | |
| Montreal, QC, Canada H4N 1E8 | |
| Contact Person: | Howard Cohen |
| President | |
| Canadian Technical Tape, Ltd. | |
| 514-334-1510 | |
| 514-745-0764 | |
| hcohen@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:
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.
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 steam | |
| sterilization | Process indicator tape for steam | |
| sterilization | ||
| 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). | ||
| Indicator Agent | Sulfur, lead carbonate hydroxide | |
| and magnesium oxide | Sulfur, lead carbonate hydroxide | |
| and magnesium oxide | ||
| Sterilization | ||
| Method | The tape is intended for use as a steam | |
| sterilization cycle process indicator in | ||
| gravity discharge and pre-vacuum | ||
| steam sterilizers. | The tape is intended for use as a steam | |
| sterilization cycle process indicator in | ||
| gravity discharge and pre-vacuum | ||
| steam sterilizers. | ||
| Endpoint | ||
| Specifications | 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 |
| Indications for use | SteriTec Autoclave and Blue | |
| Autoclave Tapes are for use holding | ||
| sterilization packs together and as | ||
| process indicators in gravity steam | ||
| sterilizers operating at 121° C and pre- | ||
| vacuum steam sterilizers operating at | ||
| 132-134° C. The white indicator | ||
| stripes on the tape turn black when | ||
| 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 4 | ||
| minutes. The indicator stripes turn | ||
| dark brown/black when exposed to | ||
| steam sterilization conditions, thus, | ||
| providing an indication of processed | ||
| items. | ||
| 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 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 | 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.