(245 days)
Autoclave Indicator Tape is designed for use by a health care provider to demonstrate that the unit or load has been exposed to a steam sterilization process and to distinguish between processed units or loads. After steam sterilization, the chemical indicator lines will show a visual color change from yellow to Black. This is a single use, disposable device(s), and provided non-sterile.
The Autoclave Indicator Tape can be used in the following steam sterilization cycles:
-
Gravity: 121°C, 30 minutes
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Vacuum assisted (pre-vacuum): 134°C, 4 minutes
EO Indicator Tape is designed for use by a healthcare provider to demonstrate that the unit or load has been exposed to an EO gas sterilization process and to distinguish between processed units or loads. The chemical indicator lines turn from Orange to Green when exposed to EO gas sterilization conditions. This is a single use, disposable device(s), and provided non-sterile.
The EO Indicator Tape can be used in the following EO sterilization cycle:
55°C, 762mg/l EO, 40~80%RH, 4 hours exposure
Autoclave Indicator Tape is a single chemical indicator designed for steam sterilizing monitoring. The diagonal strips are printed along the length of the tape using chemical indicator ink. During the sterilization cycle, the initial yellow color of the indicator ink on the autoclave indicator tape changes to Black. If no color change occurs, it may indicate that the autoclave indicator tape was not exposed to the sterilization process due to equipment malfunctions or procedural errors during the sterilization process. This is a single use, disposable device(s), and provided non-sterile.
EO Indicator Tape is single chemical indicator designed for use in ethylene oxide sterilizing processes. The diagonal strips are printed along the length of the tape using chemical indicator ink. During the sterilization cycle, the initial orange color of the indicator ink on the EO indicator tape changes to green. If no color change occurs, it may indicate that the EO indicator tape was not exposed to the sterilization process due to equipment malfunctions or procedural errors during the sterilization process. This is a single use, disposable device(s), and provided non-sterile.
1. Table of Acceptance Criteria and Reported Device Performance:
Autoclave Indicator Tape
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Steam process indicator performance test (ISO 11140-1:2014 Type 1) | 121°C for 10 minutes: black | PASS |
| 121°C for 2 minutes: no color change or color markedly different compared to black | PASS | |
| 134°C for 2 minutes: black | PASS | |
| 134°C for 0.3 minutes: no color change or color markedly different compared to black | PASS | |
| 140°C for 30 minutes Dry heat: no color change | PASS | |
| Hospital steam sterilizer testing | Color change from yellow to black | PASS |
| Biocompatibility and ink transfer test (ISO 11140-1:2014, ISO 10993-5, -10, -23) | Individual components should not create biocompatibility issues. No ink transfer observed on unprocessed and steam processed indicators. Subject device is non-toxic, non-irritant, or non-sensitizing. | PASS |
| End point stability and shelf life study | 9 months postexposure signal color retention. Meet specifications after real-time 24 months shelf-life exposure. | PASS |
| Offset/transference (ISO 11140-1: 2014) | The Autoclave indicator tapes shall not offset or bleed, penetrate the substrate to which it is applied, or materials in which it is in contact before, during, or after the steam sterilization cycles for which it is designed. | PASS |
| Adhesion test | ≥3.8 N/19mm | PASS |
EO Indicator Tape
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| ISO 11140-1:2014 testing for Type 1 indicator | 54°C, RH 60%, EO 600mg/l, 2 min: no color change or color markedly different compared to green | PASS |
| 54°C, RH 60%, EO 600mg/l, 20 min: green color | PASS | |
| 60°C, RH ≥85%, EO - none, 90 min: no change | PASS | |
| Hospital EO sterilizer testing | Color change from orange to green. | PASS |
| Biocompatibility and ink transfer test (ISO 11140-1:2014, ISO 10993-5, -10, -23) | Individual components should not create biocompatibility issues. No ink transfer should be observed on unprocessed and EO processed indicators. The subject device is non-toxic, non-irritant, or non-sensitizing. | PASS |
| End point stability and shelf-life study | 9 months postexposure signal color retention. Meet specifications after real-time 18 months shelf-life exposure. | PASS |
| Offset/transference (ISO 11140-1: 2014) | The EO indicator tapes shall not offset or bleed, penetrate the substrate to which it is applied, or materials in which it is in contact before, during, or after the EO sterilization cycles for which it is designed. | PASS |
| Adhesion test | ≥3.8 N/19mm | PASS |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes used for each specific test within the non-clinical testing. However, the tests are performed according to recognized international standards (ISO 11140-1:2014, ISO 10993 series) and FDA guidance, which typically involve specific sample sizes to ensure statistical validity.
The data provenance is not specified beyond "non-clinical testing" conducted by the applicant, Jiangmen New Era External Use Drug Co., Ltd. Given the nature of these tests (e.g., sterilization cycle performance, biocompatibility, adhesion), they are most likely conducted in a controlled laboratory environment. The document does not indicate if the data is retrospective or prospective, but performance testing for regulatory submission is typically prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This section is not applicable. The tests performed are objective chemical and physical performance tests against established international standards and regulatory guidance, rather than subjective evaluations that would require expert human interpretation to establish ground truth.
4. Adjudication Method for the Test Set:
This section is not applicable. The tests performed are objective, with clearly defined pass/fail criteria based on physical and chemical reactions or measurements. There is no indication of an adjudication method being necessary for these types of tests.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study was done. The submission focuses on non-clinical performance testing of the sterilization indicators themselves, not on their use by human readers in a diagnostic capacity or with AI assistance.
6. Standalone Performance Study:
Yes, a standalone performance study (algorithm only without human-in-the-loop performance) was done. The entirety of the "Summary of Non-Clinical Testing" section describes the standalone performance of the Autoclave Indicator Tape and EO Indicator Tape against established standards and criteria for their chemical indicator function. The device itself is the "algorithm" in this context, where it is designed to change color based on exposure to specific sterilization conditions. The tests evaluate this color change and other physical properties directly.
7. Type of Ground Truth Used:
The ground truth used for these studies is based on:
- Established International Standards: ISO 11140-1:2014 for chemical indicators for sterilization.
- Regulatory Guidance: FDA guidance for industry and FDA staff, "Premarket Notification [510(k)] Submissions for Chemical Indicators."
- Defined Physical and Chemical Parameters: Specific temperature, time, and concentration parameters for steam and EO sterilization cycles that should induce a color change, and absence of color change under non-sterilizing conditions or dry heat.
- Biocompatibility Standards: ISO 10993-5, ISO 10993-10, and ISO 10993-23 for evaluating biological effects of medical devices.
- Material Science Specifications: Criteria for adhesion, offset/transference, and shelf-life.
8. Sample Size for the Training Set:
This information is not provided. The document describes premarket notification (510(k)) testing, which evaluates the final device product against performance criteria. It does not detail any "training set" in the context of machine learning, as these are chemical indicators, not AI/ML-based devices. The "training" for such devices is inherent in the chemical formulation and manufacturing process development.
9. How the Ground Truth for the Training Set Was Established:
This section is not applicable as the device is not an AI/ML-based system requiring a training set with established ground truth in that context. The "ground truth" for the development of these chemical indicators would have been established through extensive chemical research, formulation, and iterative testing to achieve the desired color change properties in response to specific sterilization parameters, guided by the ISO standards and regulatory requirements.
§ 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).