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510(k) Data Aggregation
(77 days)
Canadian Technical Tape, LTd. LF Process Indicator Steam Sterilization Tape
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 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.
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.
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