(71 days)
The EO Chex Indicator Tape for Ethylene Oxide gas sterilization is designed to secure wrapped packs by a health care provider. EO Chex indicator tape demonstrates that the packs have been exposed to an EO gas sterlization process, and to distinguish between processed and unprocessed packs. The EO process indicator turns from pink to orange-brown when exposed to EO gas sterilization conditions, thus providing an indication of processed items.
The EO Chex indicator tape can be used in the following EO sterilization cycles:
- 38°C, 736 mg/L EO, 40-80% RH, 4.5 hours exposure
- 38°C, 759 mg/ L EO, 40-80% RH, 4.5 hours exposure
- 54℃, 600 mg/ L EO, 40-60% RH, 45 min or longer
- 55°C, 736 mg/ L EO, 40-80% RH, 1 hour exposure
- 55°C, 759 mg/ L EO, 40-80% RH, 1 hour exposure
The EO Chex "1" indicator tape is a single-use, beige color pressure-sensitive adhesive tape with pink stripes that can be used to secure packages for Ethylene Oxide Gas (EO) sterilization.
The pink stripes are process chemical indicators for monitoring of exposure to Ethylene Oxide sterilization. After sterilization exposure the pink stripes turn to orange-brown.
The EO Chex indicator tape is made in rolls ¾ inch and 1 inch wide and 55-60 yards long. Each roll has a core with 3-inch internal diameter that allows for use with any standard tape dispenser.
The indicator responds to the critical parameters of an EO sterilization cycle: exposure time, temperature, relative humidity, and concentration of Ethylene Oxide gas. During EO sterilization process indicator ink chemicals react forming an orange-brown compound. The degree of the reaction depends on the sterilization exposure. When the parameters achieve the required level, the indicator ink chemistry changes color from pink to orange-brown. If the parameters do not achieve the required level, the indicator color remains as any shade of pink.
This FDA 510(k) summary describes the acceptance criteria and the study proving the device (EO Chex™ Indicator Tape) meets these criteria. Since this is for a physical/chemical sterilization process indicator, the "study" is a series of non-clinical performance tests rather than a clinical trial with human subjects. Thus, many of the typical questions for AI medical devices (e.g., sample size for test set, number of experts, MRMC studies) are not applicable.
Here's the breakdown based on the provided text:
Acceptance Criteria and Reported Device Performance
The core acceptance criterion for the EO Chex™ Indicator Tape is its conformance to the ANSI/AAMI/ISO 11140-1:2014 standard for Type 1 process indicators, along with successful performance in typical EO sterilization cycles, biocompatibility, endpoint stability, shelf-life, and adhesive tests.
Table of Acceptance Criteria and Reported Device Performance:
| Test | Purpose | Acceptance Criteria | Reported Device Performance (Result) |
|---|---|---|---|
| Performance testing in BIER vessel (ANSI/AAMI/ISO 11140-1:2014 for Type 1 Indicator) | To demonstrate conformance to the requirements specified in ISO 11140-1:2014 for process indicators. | Specific Pass Conditions: |
- 37°C, RH 60%, EO 600mg/L, 25 min: orange-brown
- 54°C, RH 60%, EO 600mg/L, 20 min: orange-brown
Specific Fail Conditions (no color change or markedly different): - 37°C, RH 60%, EO 600mg/L, 3 min
- 54°C, RH 60%, EO 600mg/L, 2 min
- 60°C, RH ≥85%, EO - none, 90 min | Passed |
| Testing in EO cycles typical for healthcare use | To demonstrate that EO Chex indicator tape achieves specified end color in typical cycles. | Color change from pink to orange-brown (in specified cycles: 38°C, 736 mg/L EO, 40-80% RH, 4.5 hrs; 38°C, 759 mg/L EO, 40-80% RH, 4.5 hrs; 54°C, 600 mg/L EO, 40-60% RH, 45 min+; 55°C, 736 mg/L EO, 40-80% RH, 1 hr; 55°C, 759 mg/L EO, 40-80% RH, 1 hr). | Passed |
| Biocompatibility study and ink transfer test | To demonstrate that the indicator does not create biocompatibility issues for healthcare professionals and patients; and to confirm no ink transfer. | Evaluation of individual components for biocompatibility and indicators with similar formulation with long history on the market.
Ink Transfer Requirement (ISO 11140-1:2014, 6.2.2): No ink transfer should be observed on unprocessed and EO processed samples. | Passed |
| End point stability and shelf-life study | To confirm acceptable stability of color after processing (passed/failed conditions) and to demonstrate performance parameters are met throughout the declared shelf-life using real-time exposure. | Endpoint Stability: EO Chex indicator tape processed in Pass and Fail cycles at various time points after production and at the end of shelf-life should demonstrate stable color for 180 days.
Shelf-Life: Met specifications after 24 months of real-time shelf-life exposure. | Passed |
| Adhesive test healthcare applications | To evaluate if the adhesive is suitable for its function and does not deteriorate during the sterilization process. | The test is considered a pass if at least 95% of the indicators at different stages of shelf life remain on surfaces of sterilization packaging materials before and after EO processing. | Passed |
Study Details (Non-Clinical Performance Testing):
This section addresses the specific points requested, noting their applicability to a physical/chemical indicator.
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Sample size used for the test set and the data provenance:
- The document does not explicitly state the numerical sample size for each test (e.g., number of indicator strips tested). However, the testing was conducted according to specified industrial standards (ANSI/AAMI/ISO 11140-1:2014), which implicitly define the required sample sizes and methodologies for such performance evaluations.
- Data Provenance: Not explicitly stated, but typical for 510(k) submissions, the testing would have been conducted by the manufacturer (Propper Manufacturing Co., Inc.) or a qualified testing lab, likely within the US, as the submitter is based in New York. The data is retrospective in the sense that it was collected prior to the 510(k) submission for the purpose of demonstrating substantial equivalence.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable in the context of this device. Ground truth for a chemical indicator is established by physical/chemical reactions under controlled conditions (e.g., color change based on precise exposure to sterilant). It does not involve expert human interpretation of complex data like medical images. The "ground truth" is defined by the physical/chemical properties and the specified color change according to the ISO standard.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This is not applicable as the evaluation relies on objective color change criteria and physical performance metrics rather than subjective human interpretation requiring adjudication.
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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:
- This is not applicable as the device is a chemical indicator, not an AI-assisted diagnostic tool or system that involves human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not applicable. The device is a physical indicator. Its "performance" is its ability to change color as designed, which is a standalone function in itself, but not an "algorithm."
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth is established by objective physical and chemical criteria, specifically:
- Defined color changes: Pink to orange-brown under specific EO sterilization conditions (Pass).
- Absence of color change or markedly different color: Under defined challenging or insufficient sterilization conditions (Fail).
- Adherence/physical integrity standards: For the adhesive and ink transfer.
- Biocompatibility standards: Related to material safety.
- These are based on the requirements of ANSI/AAMI/ISO 11140-1:2014 and the manufacturer's internal specifications derived from these standards.
- The ground truth is established by objective physical and chemical criteria, specifically:
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The sample size for the training set:
- This is not applicable. The device is a chemical indicator that operates based on material properties and chemical reactions. There is no "training set" in the machine learning sense. The development of the indicator chemistry and manufacturing process would involve internal R&D and optimization, but this is not analogous to training an AI model.
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How the ground truth for the training set was established:
- This is not applicable for the reasons stated above.
§ 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).