(288 days)
Dana Emulating Indicator is for use in 4 minute 270°F (132°C) pre-vacuum steam sterilization process. When exposed to steam sterilization temperature and time the dark bar will travel along the window and enter the accept area giving an indication that steam sterilization conditions were met. Critical Parameters in a standard hospital pre-vacuum steam sterilizer Temperature : 270°F (132°C) Time: 4 Minutes
Not Found
The provided text is a decision letter from the FDA regarding a 510(k) premarket notification for a medical device called "Dana Emulating Indicator." It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain the information requested regarding acceptance criteria and the study that proves the device meets those criteria, specifically:
- A table of acceptance criteria and the reported device performance: This information is not present in the FDA letter. The letter only refers to "indications for use" as stated in the enclosure, but the details of performance criteria and actual test results are absent.
- Sample size and data provenance: Not mentioned.
- Number of experts and qualifications: Not mentioned.
- Adjudication method: Not mentioned.
- MRMC comparative effectiveness study: Not mentioned.
- Standalone performance: Not mentioned.
- Type of ground truth: Not mentioned.
- Sample size for training set: Not applicable for this type of device (it's a physical indicator, not an AI/software device).
- Ground truth for training set: Not applicable.
The "Indications for Use" section (page 2) describes what the device is intended to do and the specific parameters it's designed to monitor in a sterilization process:
Device Name: Dana Emulating Indicator
Indications For Use: "Dana Emulating Indicator is for use in 4 minute 270°F (132°C) pre-vacuum steam sterilization process. When exposed to steam sterilization temperature and time the dark bar will travel along the window and enter the accept area giving an indication that steam sterilization conditions were met."
Critical Parameters:
- Temperature: 270°F (132°C)
- Time: 4 Minutes
While these are the conditions the device is designed to indicate, the document does not provide the specific performance acceptance criteria (e.g., how accurate is the "dark bar travel" or what tolerance it has) nor does it provide a study report demonstrating its performance against such criteria. This kind of detail would typically be found in the actual 510(k) submission document or a separate test report, not in the FDA's decision letter.
§ 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).