(84 days)
Albert Browne Ltd., GA Glutaraldehyde Concentration Monitor, Pymah Corporation Cold Sterilog Glutaraldehyde Monitor
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No
The device is a simple chemical indicator strip that changes color based on glutaraldehyde concentration, with no mention of AI or ML in its description or performance studies.
No.
This device is an indicator for monitoring the concentration of glutaraldehyde solutions, which are used to disinfect medical devices. It does not directly treat or diagnose a medical condition.
No
The device is a chemical indicator to monitor the concentration of glutaraldehyde, not to diagnose a medical condition in a patient.
No
The device description clearly states it is a "chemical indicator strip," which is a physical component, not software.
Based on the provided information, the Cottrell, Ltd., ProChek® G Glutaraldehyde Concentration Level Indicator is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "minimum effective concentration (MEC) monitor intended for use in 2-3.5% activated glutaraldehyde solutions." This indicates it's used to test a chemical solution outside of the human body to determine a specific characteristic (glutaraldehyde concentration).
- Device Description: The description details a "chemical indicator strip" that changes color based on the concentration of glutaraldehyde in the solution being tested. This is a classic example of an in vitro diagnostic test.
- Function: The device is designed to provide information about the quality or effectiveness of a glutaraldehyde solution, which is used for disinfection or sterilization of medical devices. This information is used to ensure the solution is at the proper concentration for its intended purpose, which directly relates to patient safety by ensuring proper disinfection/sterilization.
While the document doesn't explicitly use the term "In Vitro Diagnostic," the function and intended use of the device align perfectly with the definition of an IVD, which is a medical device used to perform tests on samples taken from the human body or on other materials (like chemical solutions used in healthcare) to provide information about a person's health or to monitor the effectiveness of a treatment or process. In this case, it's monitoring a process (disinfection/sterilization) that directly impacts patient health.
N/A
Intended Use / Indications for Use
The Cottrell, Ltd., ProChek® G Glutaraldehyde Concentration Level Indicator is a 1.5% minimum effective concentration (MEC) monitor intended for use in 2-3.5% activated glutaraldehyde solutions.
Product codes
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Device Description
The ProChek® G Glutaraldehyde Concentration Level Indicator is a chemical indicator strip with a minimum effective concentration of 1.5% glutaraldehyde designed to monitor solutions, containing up to 3.5% activated glutaraldehyde. The indicator pad changes from yellow to purple, indicating a pass, if the active glutaraldehyde concentration in the solution being tested is greater than or equal to 1.75%.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
This testing was performed to evaluate the permeability of the moisture proof containers used for shipping the ProChek® G Glutaraldehyde Concentration Level Indicator from Albert Browne Ltd. to Cottrell, Ltd. for packaging and labeling.
To test the permeability of the shipping containers, containers were filled with silica gel bags and sealed. The weight of each container was recorded immediately after sealing. After twelve hours, in a controlled environment of 65% humidity at 40°C, the containers were weighed and compared with the weights obtained at the time of sealing. None of the experimental containers used for shipping gained weight.
Testing demonstrates that the packaging modification does not impact the safety or effectiveness of the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Albert Browne Ltd., GA Glutaraldehyde Concentration Monitor, Pymah Corporation Cold Sterilog Glutaraldehyde Monitor
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
0
APR - 4 1996
510(k) SUMMARY ProChek® G Glutaraldehyde Concentration Level Indicator January 4, 1996
SUBMITTER NAME AND ADDRESS 1.
- 1.1 Submitter
APR - 4 1996
Cottrell, Ltd. 7399 South Tucson Way Englewood, CO 80112 Telephone # (800) THE-EDGE Telefax # (303) 799-9408 John Scoville, Director of Regulatory Affairs and Quality Assurance
2. DEVICE NAME
| Proprietary Name: | ProChek® G Glutaraldehyde Concentration Level Indicator |
|---|---|
| Common/Usual Name: | Glutaraldehyde Concentration Indicator |
| Classification Name: | Sterilization Process Indicator; Physical/Chemical Process |
| Indicator |
3. PREDICATE DEVICES
Albert Browne Ltd., GA Glutaraldehyde Concentration Monitor Pymah Corporation Cold Sterilog Glutaraldehyde Monitor
4. INTENDED USE
The Cottrell, Ltd., ProChek® G Glutaraldehyde Concentration Level Indicator is a 1.5% minimum effective concentration (MEC) monitor intended for use in 2-3.5% activated glutaraldehyde solutions.
ડ. DEVICE DESCRIPTION
The ProChek® G Glutaraldehyde Concentration Level Indicator is a chemical indicator strip with a minimum effective concentration of 1.5% glutaraldehyde designed to monitor
1
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solutions, containing up to 3.5% activated glutaraldehyde. The indicator pad changes from yellow to purple, indicating a pass, if the active glutaraldehyde concentration in the solution being tested is greater than or equal to 1.75%.
6. TECHNOLOGICAL CHARACTERISTICS
The technological characteristics of the Cottrell, Ltd. ProChek® G Glutaraldehyde Concentration Level Indicator are identical to those of the Albert Browne Ltd. GA Concentration Monitor. The proposed device is the same indicator, purchased in bulk from the manufacturer, and packaged and labeled by Cottrell, Ltd.
TESTING 7.
This testing was performed to evaluate the permeability of the moisture proof containers used for shipping the ProChek® G Glutaraldehyde Concentration Level Indicator from Albert Browne Ltd. to Cottrell, Ltd. for packaging and labeling.
To test the permeability of the shipping containers, containers were filled with silica gel bags and sealed. The weight of each container was recorded immediately after sealing. After twelve hours, in a controlled environment of 65% humidity at 40°C, the containers were weighed and compared with the weights obtained at the time of sealing. None of the experimental containers used for shipping gained weight.
Testing demonstrates that the packaging modification does not impact the safety or effectiveness of the device.