(32 days)
The Bismuth Process Indicator Steam Sterilization Tape is in holding sterilization packs together and can be used in gravity sterilizers operating at 121°C for 30 minutes; 132 °C for 10 minutes; 132 °C for 15 minutes; 135 ℃ for 3 minutes and 135 ℃ for 10 minutes or pre-vacuum sterilizers operating at 132℃ for 3 minutes; 132 °C for 4 minutes; 134 °C for 3 minutes and 135°C for 3 minutes. The indicator lines turn dark brown/black when exposed to steam sterilization conditions, thus providing an indication of processed items.
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 beige 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.
The provided text describes the acceptance criteria and study results for the Intertape Polymer Inc., Type 1 Bismuth Process Indicator Steam Sterilization Tape. This device is a chemical indicator designed to distinguish between sterilized and unsterilized items.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally qualitative "Passed" or "Failed" based on visual change or adherence.
| Test | Description | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Performance Testing for a Type 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 | Pass - Visual Change as specified by manufacturer. Fail - No change or a change that is markedly different from change specified by the manufacturer. | Passed |
| Resistometer Performance Testing for a Type 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 | Pass - Visual Change as specified by manufacturer. Fail - No change or a change that is markedly different from change specified by the manufacturer. | 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 | Pass - Visual Change as specified by manufacturer. Fail - No change or a change that is markedly different from change specified by the manufacturer. | 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. | Biocompatibility - None of the cultures treated with the test article show greater than a Mild reactivity (Grade 2). Leach Off - The indicator agent shall not offset or bleed to the substrate to which it is applied, or materials in which it is in contact. | 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. | Post processing, the endpoint color change shall remain unchanged for a period of not less than six months from the date of use, when stored under the conditions specified by the manufacturer. | 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 | Pass - Visual Change as specified by manufacturer. Fail - No change or a change that is markedly different from change specified by the manufacturer. | 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 | The average force and displacement values (in Newtons) of five tests shall meet the manufacturers' internal specification. | Passed |
| Post Processing Visual Adhesive Test for Wrapped Packages | Test performed in response to a request from the FDA in the predicate K140940 clearance | All test samples shall demonstrate proper adhesion by not lifting from sterilization wrap after steam sterilization and proper drying time. | Passed |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state a specific numerical "sample size" for the various tests. However, it indicates that testing was performed "in accordance with" established standards (ANSVAAMI/ISO 11140-1:2014, FDA Chemical Indicator Guidance Document, PSTC-101 and PSTC-131) which would specify the number of samples or replicates required for each test. For example, the PSTC adhesion test specifies "five tests".
The data provenance is not explicitly detailed in terms of country of origin or whether it was retrospective or prospective. It is implied that the testing was conducted by or on behalf of Intertape Polymer Inc. for regulatory submission to the FDA. The nature of these tests (performance, shelf-life, biocompatibility in controlled environments) suggests they are prospective laboratory and in-use studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not applicable and not provided. The "ground truth" for a chemical indicator like this is a direct physical or chemical change (color change due to exposure to steam sterilization conditions, or physical adherence). It does not involve human interpretation or expert consensus in the way a diagnostic imaging AI would, where radiologists establish ground truth for image classification. The "ground truth" is based on the physical parameters of the sterilization cycle and the expected reaction of the chemical indicator.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. As explained above, the assessment of the chemical indicator's performance is based on direct physical observation (color change, adhesion) relative to defined standards and manufacturer specifications, not subjective human opinion 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 device is a chemical process indicator, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is entirely irrelevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a physical/chemical indicator, not a software algorithm. Its "standalone performance" is its inherent reaction to steam sterilization conditions, which is what the performance testing evaluated.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The ground truth used is primarily based on controlled physical and chemical conditions (e.g., specific temperatures, times, and steam exposure levels in resistometers and actual sterilizers) as defined by established international and FDA standards (ANSVAAMI/ISO 11140-1:2014, FDA Chemical Indicator Guidance Document, PSTC standards). The expected "truth" is a specific visual change (dark brown/black color) upon exposure to these conditions and maintained physical properties (adhesion, lack of bleeding).
8. The sample size for the training set:
Not applicable. This device is a hardware chemical indicator, not a machine learning or AI 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.
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August 2, 2019
Intertape Polymer Inc. % Gary Socola President Highpower Validation Testing & Lab Service's Inc. 125 Highpower Road Rochester, New York 14623
Re: K191741
Trade/Device Name: Intertape Polymer Inc., Type 1 Bismuth Process Indicator Steam Sterilization Tape Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: JOJ Dated: June 28, 2019 Received: July 1, 2019
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For Elizabeth Claverie, M.S. Assistant Director for THT4B2 Acting Assistant Director for THT4B1 DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K191741
Device Name
Intertape Polymer Inc., Type I Bismuth Process Indicator Steam Sterilization Tape
Indications for Use (Describe)
The Bismuth Process Indicator Steam Sterilization Tape is in holding sterilization packs together and can be used in gravity sterilizers operating at 121°C for 30 minutes; 132 °C for 10 minutes; 132 °C for 15 minutes; 135 ℃ for 3 minutes and 135 ℃ for 10 minutes or pre-vacuum sterilizers operating at 132℃ for 3 minutes; 132 °C for 4 minutes; 134 °C for 3 minutes and 135°C for 3 minutes. The indicator lines 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 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) SUMMARY
SUBMITTER INFORMATION:
(K191741 Page 1 of 3)
| Address: | Intertape Polymer Group100 Paramount Dr Suite 300Sarasota, FL, US 34232 |
|---|---|
| Phone: | 618-303-2423 |
| Fax: | 514-745-0764 |
| Contact Person: | Michael BryantUS Agent |
| Date of Summary: | July 31st, 2019 |
DEVICE INFORMATION:
| Device Trade Name: | Intertape Polymer Inc.,Type 1 Bismuth Process Indicator Steam Sterilization Tape |
|---|---|
| Common Name: | Process Indicator |
| Device Classification: | Indicator, Physical/Chemical Sterilization Process |
| Device Class: | Class II, 21 CFR § 880.2800(b) |
| Product Code: | JOJ |
PREDICATE DEVICE:
Cantech, Intertape Polymer Inc., Ltd. Process Indicator Tape for Steam Sterilization (K140940 and K161024) (Formerly Canadian Technical Tape)
DEVICE DESCRIPTION (MODEL 146 & MODEL 147):
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 beige 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 Bismuth Process Indicator 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; 132 °C for 10 minutes; 132 °C for 15 minutes; 135 °C for 3 minutes and 135 °C for 10 minutes or prevacuum sterilizers operating at 132°C for 3 minutes; 134 °C for 4 minutes; 134 °C for 3 minutes; 134 °C for 4 minutes and 135°C for 3 minutes. The indicator lines turn dark brown/black when exposed to steam sterilization conditions, thus providing an indication of processed items.
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510(K) SUMMARY
PERFORMANCE STANDARD TESTING:
(K191741 Page 2 of 3)
Testing was performed in accordance with ANSVAAMI/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.
TECHNOLOGICAL CHARACTERISTICS:
Shown below is the comparison of the proposed device with the predicate device and reference device.
COMPARISON OF THE PROPOSED DEVICE TO THE PREDICATE
| ELEMENT | SUBJECT DEVICE(K191741) | CANTECH PREDICATE DEVICE(K140940) | CANTECH REFERENCE DEVICE(K161024) |
|---|---|---|---|
| Intended Use | Process Indicator Tape | Process Indicator Tape | Process Indicator Tape |
| 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 withindicator lines. Provided innatural and blue in widths ofapproximately 0.5", 0.75" and1" (12mm, 18mm and 24mm). | Crepe paper printed with indicatorlines. Provided in natural and bluein widths of approximately 0.5",0.75" and 1" (12mm, 18mm and24mm). |
| IndicatorAgent | Steam Indicator Ink(made from Bismuth) | Steam Indicator Ink(made from Lead) | Steam Indicator Ink(made from Copper) |
| SterilizationMethod(Steam) | Gravity121°C @ 30min132°C @ 3min132°C @ 10min132°C @ 15min135°C @ 3min135°C @ 10minPre-vacuum132°C @ 3min132°C @ 4min134°C @ 3min134°C @ 4min135°C @ 3min | Gravity121°C @ 30 minutes135°C @ 3 minutesPre-vacuum132°C @ 4 minutes | Gravity121°C @ 30 minutes135°C @ 3 minutesPre-vacuum132°C @ 4 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 | 2 years | 3 years | 3 years |
| Indicationsfor Use | The Bismuth Process Indicator SteamSterilization Tape is indicated for use inholding sterilization packs together and canbe used in gravity sterilizers operating at121°C for 30 minutes; 132 °C for 3minutes; 132 °C for 10 minutes; 132 °C for15 minutes; 135 °C for 3 minutes and 135°C for 10 minutes or pre-vacuum sterilizersoperating at 132°C for 3 minutes; 132 °Cfor 4 minutes; 134 °C for 3 minutes; 134 °Cfor 4 minutes and 135°C for 3 minutes. Theindicator lines turn dark brown/black whenexposed to steam sterilization conditions,thus providing an indication of processeditems. | The Process Indicator Tape forSteam Sterilization is indicatedfor use in holding sterilizationpacks together and can be used ingravity sterilizers operating at121°C for 30 minutes or pre-vacuum sterilizers operating at132°C for 4 minutes and 135°Cfor 3 minutes. The indicatorstripes turn dark brown/blackwhen exposed to steamsterilization conditions, thusproviding an indication ofprocessed items. | 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 minutesand 135°C for 3 minutes. Theindicator stripes turn darkbrown/black when exposed tosteam sterilization conditions, thusproviding an indication ofprocessed items. |
| PerformanceStandards | ANSI/AAMI/ISO 11140-1:2014 | ANSI/AAMI/ISO 11140-1:2005 | ANSI/AAMI/ISO 11140-1:2014 |
Comparison conclusion: The subject device has the same Indications for Use, intended use, technical characteristics and functional characteristics as the predicate device and reference device.
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510(K) SUMMARY
SUMMARY OF NONCLINICAL TESTING:
(K191741 Page 3 of 3)
The non-clinical testing that has been performed has been found to meet all predetermined acceptance criteria.
| Test | Description | Acceptance Criteria | Results |
|---|---|---|---|
| Performance Testing for aType 1 Steam ProcessIndicator -ANSI/AAMI/ISO 11140-1 | Pass and fail testing in a steamresistometer according to Table 2of ISO 11140-1:2014 | Pass - Visual Change as specified bymanufacturer.Fail - No change or a change that ismarkedly different from changespecified by the manufacturer | Passed |
| Resistometer PerformanceTesting for a Type 1Steam Process Indicator -FDA Chemical IndicatorGuidance Document | Pass and fail testing in a steamresistometer according to therequirements in Table 3 of the FDAguidance document on ChemicalIndicators | Pass - Visual Change as specified bymanufacturer.Fail - No change or a change that ismarkedly different from changespecified by the manufacturer | Passed |
| In Use Testing in FDA510k Cleared SteamSterilizers - FDAChemical IndicatorGuidance Document | Pass and fail testing in clearedhealthcare steam sterilizersaccording to the requirements insection VII "PerformanceCharacteristics" of the FDAguidance document on ChemicalIndicators | Pass - Visual Change as specified bymanufacturer.Fail - No change or a change that ismarkedly different from changespecified by the manufacturer | Passed |
| Biocompatibility/LeachOff Testing - FDAChemical IndicatorGuidance Document | Cytotoxicity Testing to therequirements in section VIII"Biocompatibility” of the FDAguidance document on ChemicalIndicators and Leach Off test inaccordance with ISO 11140-1,section 6.4.2. | Biocompatibility - None of thecultures treated with the test articleshow greater than a Mild reactivity(Grade 2).Leach Off - The indicator agent shallnot offset or bleed to the substrate towhich it is applied, or materials inwhich it is in contact. | Passed |
| Endpoint Stability -ANSI/AAMI/ISO 11140-1and FDA ChemicalIndicator GuidanceDocument | End Point Stability was tested inaccordance with ISO 11140-1,section 6.1.2. | Post processing, the endpoint colorchange shall remain unchanged fora period of not less than six monthsfrom the date of use, when storedunder the conditions specified by themanufacturer. | Passed |
| Shelf Life -ANSI/AAMI/ISO 11140-1and FDA ChemicalIndicator GuidanceDocument | Pass and fail testing in a steamresistometer according to Table 2 ofISO 11140-1:2014 was performedin order to satisfy section X "ShelfLife" of the FDA guidancedocument on Chemical Indicators | Pass - Visual Change as specified bymanufacturer.Fail - No change or a change that ismarkedly different from changespecified by the manufacturer | Passed |
| Pressure Sensitive TapeCouncil (PSTC)International StandardsTest for Tape Adhesion -PSTC-101 and PSTC-131Sterilization TapeStandards | Internal tape adhesion test performedin accordance with the PSTC-101and PSTC-131 International TapeStandards | The average force and displacementvalues (in Newtons) of five tests shallmeet the manufacturers' internalspecification. | Passed |
| Post Processing VisualAdhesive Test forWrapped Packages | Test performed in response to arequest from the FDA in thepredicate K140940 clearance | All test samples shall demonstrateproper adhesion by not lifting fromsterilization wrap after steamsterilization and proper drying time | Passed |
CONCLUSION:
Based on the conclusions drawn from the nonclinical tests demonstrates that the Intertape Polymer Inc., Type 1 Bismuth Process Indicator Steam Sterilization Tape is as safe, as effective, and performs as well as or better than the legally marketed predicate device.
§ 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).