(196 days)
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.
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.
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.
§ 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).