(316 days)
Steam Dot Blu ° Process Indicator is a chemical sterilization indicator intended to be used by a health care provider with sterilization wraps, containers, cassettes, pouches or other packaging materials to distinguish between processed and unprocessed units.
The indicator changes color from blue to pink when exposed to steam sterilization conditions at 121°C in gravity displacement and 132°C, 134°C and 135°C in pre-vacuum cycles.
The performance of the Steam Dot-Blu® Process Indicator meets the requirements of ANSI/AAMI/ISO 11140-1:2005 for process (Class 1) indicators.
No lead or heavy metals or their compounds are added in the production of the indicator.
Steam Dou Blu® Process Indicator is a single use chemical sterilization indicator for steam sterilizers. It complies with the requirements established in the FDA guidance document "Premarket Notification [510(k)] Submissions for Chemical Indicators," issued on December 19, 2003 and "ANSI/AAMVISO 11140-1:2005, Sterilization of health care products - Chemical indicators - Part 1: General requirements" standard for process indicators.
Steam Dot Blu® Process Indicator is designed to be used in 121°C gravity and in 132°C, 134°C and 135°C pre-vacuum steam sterilization cycles. During sterilization cycles the indicator change color from blue to pink. The color change after processing is stable. No lead or heavy metals or their compounds are added in the production of the indicator.
The provided text describes a chemical sterilization indicator, the "Steam Dot Blu® Process Indicator," and a study demonstrating its performance. However, there are aspects of the requested information that are not fully available in the provided document, particularly regarding specifics of a medical device study (e.g., sample sizes of test sets, number of experts, adjudication methods, MRMC studies, standalone performance, training sets). This is because the device is a chemical indicator, not an AI/software medical device.
Response based on the provided text:
The device described is a chemical sterilization indicator, not an AI or software-driven medical device. Therefore, many of the typical elements of a study for an AI medical device (like test set sample sizes, expert ground truth, adjudication methods, MRMC studies, or training sets) are not applicable or detailed in the provided 510(k) summary for this type of product. The study performed is a performance verification against an established standard for chemical indicators.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from ANSI/AAMI/ISO 11140-1:2005 for Class 1 Process Indicators) | Reported Device Performance |
|---|---|
| Color Change: Must change color when exposed to sterilization conditions. | Indicator changes color from blue to pink when exposed to steam sterilization conditions. The color change is stable after processing. |
| Steam Sterilization Conditions: | Blue to pink color change observed at: |
| - 121°C gravity displacement cycles | - 121°C gravity displacement cycles |
| - 132°C pre-vacuum cycles | - 132°C pre-vacuum cycles |
| - 134°C pre-vacuum cycles | - 134°C pre-vacuum cycles |
| - 135°C pre-vacuum cycles | - 135°C pre-vacuum cycles |
| Lead/Heavy Metals: No lead or heavy metals or their compounds added. | No lead or heavy metals or their compounds are added in the production of the indicator. |
| Compliance: Meets requirements of ANSI/AAMI/ISO 11140-1:2005 (Class 1). | The performance meets the requirements of ANSI/AAMI/ISO 11140-1:2005 for process (Class 1) indicators. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a "sample size" in the context of individual units tested. Instead, it refers to the device being tested according to the requirements of the ANSI/AAMI/ISO 11140-1:2005 standard. This standard prescribes the methods and stringency for testing chemical indicators.
- Data Provenance: The testing was conducted according to the FDA recognized consensus standard ANSI/AAMI/ISO 11140-1:2005. The specific country of origin for the data is not mentioned, but the submission is for a US market authorization (510(k)). The testing described would be considered experimental validation against a standard, not retrospective or prospective data collection in the context of clinical studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Not applicable in this context. For a chemical indicator, "ground truth" is established by the physical and chemical properties of the indicator and its performance against the specified physical conditions (temperature, steam, time) defined by the international standard. There are no human "experts" establishing a subjective ground truth for the color change. The standard itself specifies the acceptable performance.
4. Adjudication Method
- Not applicable in this context. Since there's no subjective interpretation or expert consensus needed for the chemical color change, no adjudication method (like 2+1, 3+1) is described or required. The performance is objectively measured against the standard.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. This is not an AI medical device or an imaging device requiring human interpretation; thus, an MRMC study is not relevant or described. The device's function is a direct chemical reaction.
6. Standalone (Algorithm Only) Performance Study
- Yes (in principle, but interpreted differently). The "standalone" performance for this device refers to the indicator itself, without human interpretation beyond observing the color change. The study involves assessing the indicator's intrinsic ability to change color accurately under specified sterilization conditions, as per the ANSI/AAMI/ISO 11140-1:2005 standard. The device is the "algorithm" in a sense – a chemical reaction that visually signals a process outcome. Its performance is evaluated as a standalone unit.
7. Type of Ground Truth Used:
- Objective Standard/Physical Conditions: The ground truth is the precise physical conditions of steam sterilization (specific temperatures and states of steam, e.g., 121°C gravity, 132°C, 134°C, 135°C pre-vacuum cycles) as defined and established by the ANSI/AAMI/ISO 11140-1:2005 standard. The indicator is expected to react predictably to these defined conditions.
8. Sample Size for the Training Set
- Not applicable. This device is a chemical indicator, not an AI model that requires a "training set." Its design and formulation are based on chemical principles and engineering, not machine learning.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As a chemical indicator, there is no "training set" or corresponding ground truth establishment in the conventional sense for AI/machine learning. The device's operational characteristics are determined by its chemical composition and manufacturing process, which are designed to react to specific physical parameters (heat, steam) according to the established industry standards.
§ 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).