(37 days)
Not Found
No
The device is a chemical indicator strip that changes color based on glutaraldehyde concentration, which is a purely chemical reaction and does not involve AI or ML.
No
This device monitors the concentration of a glutaraldehyde-containing germicide solution, not for therapeutic use on a patient.
No
Explanation: This device is a chemical indicator used to monitor the concentration of glutaraldehyde in germicide solutions, not to diagnose a medical condition in a patient.
No
The device is described as a chemical indicator strip made of polypropylene with an indicator pad, which changes color. This is a physical device, not software.
Based on the provided text, the Browne Sporicidin Glutaraldehyde Indicator is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is used to monitor the concentration of glutaraldehyde in a germicide solution. This solution is used for sterilizing and disinfecting medical devices. While the device itself doesn't directly test a biological sample from a patient, it is used in vitro (outside the body) to assess the efficacy of a solution used on medical devices that will come into contact with patients.
- Device Description: It's a chemical indicator strip that reacts with the glutaraldehyde solution to provide information about its concentration. This is a common characteristic of IVD devices used for quality control or monitoring of substances used in healthcare settings.
- Performance Studies: The performance studies describe testing the indicator in the glutaraldehyde solution, which is an in vitro test.
While the device doesn't directly diagnose a disease or condition in a patient, it falls under the broader definition of an IVD because it provides information about a substance used in a healthcare context to ensure the safety and efficacy of medical procedures. It's a quality control tool for a germicide solution, which is a critical component of preventing infections in healthcare settings.
N/A
Intended Use / Indications for Use
The Browne Sporicidin Glutaraldehyde Indicator for Sporicidin Sterilizing and Disinfecting Solution (Browne Sporicidin Glutaraldehyde Indicator) is a glutaraldehyde concentration monitor for use in glutaraldehyde-containing germicide solutions with a minimum effective concentration (MEC) of 0.6% glutaraldehyde.
The Browne Sporicidin Glutaraldehyde Indicator is dedicated for use with Sporicidin Sterilizing and Disinfecting Solution.
Product codes
JOJ
Device Description
The Browne Sporicidin Glutaraldehyde Indicator for Sporicidin Sterilizing and Disinfecting Solution and the substantially equivalent device are chemical indicator strips intended to monitor the concentration of glutaraldehyde in glutaraldehydecontaining germicide solutions. The devices indicate, via a color change, if the germicide concentration exceeds the MEC for the solution.
The Browne Sporicidin Glutaraldehyde Indicator consists of a polypropylene strip with an indicator pad on one end. The indicator pad is impregnated with an indicator solution which changes color from tan to purple in liquid chemical germicides with a glutaraldehyde concentration above the MEC of 0.6%.
The Browne Sporicidin Glutaraldehyde Indicator and the predicate device have a 2-year shelf life from the date of manufacture in the unopened bottle. Containers of both devices have a 90 day in-use life.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The performance characteristics of the Browne Sporicidin Glutaraldehyde Indicator were established by testing indicators in Sporicidin Sterilizing and Disinfecting Solution containing 0.6% and 0.7% glutaraldehyde. False negatives were observed when the indicators were tested in the presence of high levels of sodium dodecyl sulfate.
No false positives were recorded in solutions containing 0.6% glutaraldehyde, when the testing was performed according to the Instructions for Use. The false negatives would have caused the user to discard the solution unnecessarily. No disinfection procedure would have been compromised.
The data demonstrates that the Browne Sporicidin Glutaraldehyde Indicator is an effective monitor for the glutaraldehyde component of the Sporicidin Sterilizing and Disinfecting Solution with a glutaraldehyde MEC of 0.6%.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
FEB 4 1999.
510(k) SUMMARY FOR BROWNE SPORICIDIN GLUTARALDEHYDE INDICATOR FOR SPORICIDIN STERILIZING AND DISINFECTING SOLUTION
SUBMITTER NAME AND ADDRESS 1.
Mr. Alan Charlton Albert Browne Ltd. Chancery House 190 Waterside Road Hamilton Industrial Park Leicester LES IQL United Kingdom
DEVICE NAME 2.
| Proprietary Name: | Browne Sporicidin Glutaraldehyde Indicator for
Sporicidin Sterilizing and Disinfecting Solution |
|----------------------|----------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Browne Sporicidin Glutaraldehyde Indicator |
| Classification Name: | Physical/Chemical Sterilization Process Indicator |
3. PREDICATE DEVICE
Browne GA Indicator (K922481, Albert Browne Ltd.)
INTENDED USE ব .
The Browne Sporicidin Glutaraldehyde Indicator for Sporicidin Sterilizing and Disinfecting Solution (Browne Sporicidin Glutaraldehyde Indicator) is a glutaraldehyde concentration monitor for use in glutaraldehyde-containing germicide solutions with a minimum effective concentration (MEC) of 0.6% glutaraldehyde.
The Browne Sporicidin Glutaraldehyde Indicator is dedicated for use with Sporicidin Sterilizing and Disinfecting Solution.
Browne Sporicidin Glutaraldehyde Indicator Additional Information - K984616
1/25/99
Page A-1
1
2 | | tan, purple/tan | |
During the first 60 seconds after the test strip has been dipped into the Sporicidin Sterilizing and Disinfecting Solution, the tan test strip will begin to develop a ourple color.
At 60 seconds (1 minute), the strip will exhibit a uniform purple color (except for the top 2 mm of the strip) if the concentration of glutaraldehyde is ≥0.7%. The strip will appear patchy purple/tan or tan if the solution contains