(37 days)
The Browne Sporicidin Phenol Indicator For Sporicidin Sterilizing and Disinfecting Solution (Browne Sporicidin Phenol Indicator) is a phenol concentration monitor for use in phenol-containing germicide solutions with a minimum effective concentration of 1.3% phenol.
The Browne Sporicidin Phenol Indicator is dedicated for use with Sporicidin Sterilizing and Disinfecting Solution.
The Browne Sporicidin Phenol Indicator and the substantially equivalent device are chemical indicator strips intended to monitor the concentration of the active ingredient of a liquid chemical germicide. The devices indicate, via a color change, if the concentration of the active ingredient exceeds the MEC for the solution.
The Browne Sporicidin Phenol 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 yellow to green in liquid chemical germicides with a phenol concentration above the MEC of 1.3%.
The Browne Sporicidin Phenol 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.
Here's an analysis of the provided text regarding the Browne Sporicidin Phenol Indicator device:
Acceptance Criteria and Study to Prove Device Meets Criteria
1. Table of Acceptance Criteria and Reported Device Performance
The core acceptance criterion for this device is its ability to accurately indicate whether the concentration of phenol in Sporicidin Sterilizing and Disinfecting Solution is at or above the Minimum Effective Concentration (MEC) of 1.3%. The device is designed to show a color change from yellow to green when the phenol concentration is sufficient, and remain yellow or partially yellow/green when it is not.
| Acceptance Criteria (What the device should do) | Reported Device Performance |
|---|---|
| 1. Indicate sufficient phenol concentration: The device should accurately register a "PASS" (green color) when the phenol concentration is at or above the MEC of 1.3%. Specifically, it should indicate sufficient concentration at ≥1.6% phenol. | 1. Consistent PASS at sufficient concentration: When tested in Sporicidin Solution with 1.6% phenol, the indicators showed the expected color change. The document states that at 60 seconds (1 minute), the strip exhibits a uniform green color if the concentration is ≥1.6%. The performance testing states "No false positives were recorded in any of the testing conducted." This implies that it correctly identified sufficient phenol. |
| 2. Indicate insufficient phenol concentration: The device should accurately register a "FAIL" (yellow or parchy green/yellow color) when the phenol concentration is at or below the MEC of 1.3%. | 2. Consistent FAIL at insufficient concentration: The test indicators showed a 100% failure rate in the 1.3% solution when testing was performed according to the Instructions for Use. This means it consistently showed a "FAIL" when the phenol was at the MEC, correctly indicating it needed to be discarded. |
| 3. Reliability and Consistency: The device should provide stable and consistent readings within the specified read window (1-2 minutes). | 3. Stable Read Window: The color of the strip is stable from 60 to 120 seconds (1 to 2 minutes), and a reading must be taken during this period for accuracy. Regression toward yellow occurs after 120 seconds. |
| 4. Minimal false negatives in ideal conditions: Under standard use and clean conditions, the device should not falsely indicate a "FAIL" when the solution is actually at or above MEC. | 4. False negatives observed under specific conditions: "Some false negatives were observed." Crucially, the frequency of false negatives increased "when the indicators were tested in the presence of high levels of detergent and salt contaminants, or when testing was performed by inexperienced users." This suggests that under ideal conditions (i.e., clean solution and experienced users), false negatives would be minimal or none, aligning with the 100% failure rate in the 1.3% solution (which is a correct failure). The observation of false negatives appears to be tied to user error or contaminated solution, rather than an inherent flaw in the indicator chemistry itself. The report clarifies, "The false negatives reported would have caused the user to discard the solution unnecessarily. No disinfection procedure would have been compromised," implying that these false negatives err on the side of caution. |
| 5. No false positives: The device should never falsely indicate a "PASS" when the solution is below the MEC. | 5. No false positives recorded: "No false positives were recorded in any of the testing conducted." This is a strong positive performance indicator. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the specific number of individual test strips used in the "Performance Testing." It refers to "test indicators" without specifying a count.
- Data Provenance: The document does not specify the country of origin of the data. It appears to be from internal testing conducted by the manufacturer, Albert Browne Ltd., located in the United Kingdom. However, the testing was done for a US FDA 510(k) submission. The data is retrospective as it pertains to testing performed prior to the submission date (December 1998 / February 1999).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
The document does not mention the use of experts to establish ground truth for the test set. Given the nature of the device (a chemical indicator with a clear, objective color change based on a known chemical concentration), the "ground truth" for the test was the known, precisely prepared chemical concentrations of phenol in the Sporicidin Sterilizing and Disinfecting Solution (1.6% and 1.3%). The assessment of the color change itself would be subjective to the human eye, but the underlying ground truth is the chemical concentration.
4. Adjudication Method for the Test Set
The document does not specify an adjudication method (like 2+1, 3+1, none) for interpreting the results of the color change. The description implies that the observation of the color (yellow, green/yellow, green) directly determines the outcome against predefined criteria. The mention of "inexperienced users" causing more false negatives suggests that user interpretation is a factor, but a formal adjudication process (e.g., multiple readers resolving discrepancies) is not described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study typically evaluates the performance of human readers (e.g., radiologists) with and without AI assistance on complex diagnostic tasks. The Browne Sporicidin Phenol Indicator is a simple chemical indicator, not an AI-powered diagnostic tool, and its assessment does not involve human interpretation in a comparative reader study context.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
While this isn't an "algorithm" in the modern AI sense, the device's chemical reaction and color change are its "standalone" function. The core performance testing (100% failure rate at 1.3% phenol, no false positives) reflects the standalone chemical performance of the indicator strip in response to specific phenol concentrations. Human observation is required to read the result, but the chemical reaction itself happens independently. The document describes the chemical mechanism (STEP 1 & STEP 2) as its inherent standalone function.
7. The Type of Ground Truth Used
The ground truth used was known, precisely controlled chemical concentrations of phenol in the Sporicidin Sterilizing and Disinfecting Solution. The testing was performed at a known 1.6% phenol concentration (expected PASS) and a known 1.3% phenol concentration (expected FAIL/MEC).
8. The Sample Size for the Training Set
This concept does not strictly apply to this device. As a chemical indicator, there isn't a "training set" in the machine learning sense. The chemical formulation of the indicator pad is developed and validated through chemical and manufacturing processes, not by training an algorithm on a dataset. The "development" and "optimization" of the chemical components would be analogous to training, but no specific dataset size is provided.
9. How the Ground Truth for the Training Set Was Established
Similarly, without a "training set" in the conventional AI/machine learning context, there's no ground truth established in that manner. The ground truth for the development of the indicator's chemistry would have been based on established chemical principles and controlled experiments to ensure the indicator reacted specifically and consistently to the target phenol concentrations. This involves standard chemical laboratory practices to ensure the dye changes color at the desired pH, which is, in turn, produced by the reaction with phenol.
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FEB 4 1995
510(k) SUMMARY BROWNE SPORICIDIN PHENOL 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 LE5 1QZ United Kingdom
-
- DEVICE NAME
| Proprietary Name: | Browne Sporicidin Phenol Indicator for SporicidinSterilizing and Disinfecting Solution |
|---|---|
| Common/Usual Name: | Browne Sporicidin Phenol Indicator |
| Classification Name: | Physical/Chemical Sterilization Process Indicator |
PREDICATE DEVICES 3.
Browne GA Indicator (K922481)
INTENDED USE 4.
The Browne Sporicidin Phenol Indicator for Sporicidin Sterilizing and Disinfecting Solution (Browne Sporicidin Phenol Indicator) is a phenol concentration monitor for use in phenol-containing germicides with a minimum effective concentration (MEC) of 1.3% phenol.
The Browne Sporicidin Phenol Indicator is dedicated for use with Sporicidin Sterilizing and Disinfecting Solution.
Browne Sporicidin Phenol Indicator Additional Information - K984613
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5. DEVICE DESCRIPTION
The Browne Sporicidin Phenol Indicator and the substantially equivalent device are chemical indicator strips intended to monitor the concentration of the active ingredient of a liquid chemical germicide. The devices indicate, via a color change, if the concentration of the active ingredient exceeds the MEC for the solution.
The Browne Sporicidin Phenol 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 yellow to green in liquid chemical germicides with a phenol concentration above the MEC of 1.3%.
The Browne Sporicidin Phenol 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.
TECHNOLOGICAL CHARACTERISTICS ર્ણ
The technological characteristics of the Browne GA Indicator are similar to that of the Browne Sporicidin Phenol Indicator described in this submission. Both devices are non-sterile, disposable strips containing an indicator pad impregnated with an indicator solution which changes color in a germicide solution at the appropriate concentration of the active ingredient of the liquid chemical germicide,
The mechanism of action for inducing a color change is identical for the Browne Sporicidin Phenol Indicator and the Browne GA Indicator. The active ingredient of the indicator solution in both devices interacts with the active ingredient in the germicide solution to produce a hydroxyl ion which ionizes a pH-sensitive dye.
In the proposed device, the phenol component of the Sporicidin Sterilizing and Disinfecting Solution reacts with the active ingredient in the indicator solution of the test strip to form a diazo addition product (STEP 1). If sufficient phenol is present, the increase in pH causes a color change in the pH indicator dye (STEP 2).
Browne Sporicidin Phenol Indicator Additional Information - K984613
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$$\forall \mathcal{A} \forall \emptyset \forall \mathcal{P}$$
| STEP 1 | ||||||
|---|---|---|---|---|---|---|
| ArOH | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | Ar'N, | t | ArN=NAr' | + NaOH | |
| phenol | active ingredientindicator solution | diazo additionproduct | ||||
| STEP 2 | ||||||
| NaOH | + | pH sensitive dye | green color dye |
The indicator color is dependent on the phenol concentration of the germicide solution, and the time after exposure when the results of the test are read, as described in the Table A-1 below.
Table A-1. Color Development for the Sporicidin Phenol Indicator Strip
| Time(minutes) | Phenol Concentration (%) | ||
|---|---|---|---|
| ≤1.3 | 1.4-1.5 | ≥1.6 | |
| <1 | yellow, green/yellow | ||
| 1-2 | yellow | yellow, green/yellow,green | green |
| >2 | yellow, green/yellow |
During the first 60 seconds after the test strip has been dipped into the Sporicidin Sterilizing and Disinfecting Solution, the yellow test strip will begin to develop a green color.
At 60 seconds (1 minute), the strip will exhibit a uniform green color (except for the top 2 mm of the strip) if the concentration of phenol in the Sporicidin Sterilizing and Disinfecting Solution is ≥1.6%. The strip will appear parchy green/yellow or yellow if the solution contains 51.3% phenol. In the concentration range of 1.4-1.5% phenol, the strip may appear yellow, green/yellow or green.
Browne Sporicidin Phenol Indicator Additional Information - K984613
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. the . word wise the child the sell to
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From 60 to 120 Seconds (1 to 2 minutes) the color of the strip is stable. A color reading must be taken during this time period for the results to accurately reflect the phenol concentration of the Sporicidin Sterilizing and Disinfecting Solution.
After 120 seconds (2 minutes) the color of the strip regresses toward the original yellow color. The rate of regression is dependent on the phenol concentration of the Sporicidin Sterilizing and Disinfecting Solution.
The indicator solution of the proposed device changes color from yellow to green to indicate a PASS, while that of the Browne GA Indicator changes color from yellow to purple to indicate a PASS. The difference in colors chosen for these indicators does not represent a difference in the mechanism of action for the production of a color change.
PERFORMANCE TESTING 7.
The performance characteristics of the Browne Sporicidin Phenol Indicator were established by testing indicators in Sporicidin Sterilizing and Disinfecting Solution containing 1.6% and 1.3% phenol. The test indicators showed a 100% failure rate in the 1.3% solution when the testing was performed according to the Instructions for Use. Some false negatives were observed. The frequency of false negatives increased when the indicators were tested in the presence of high levels of detergent and salt contaminants, or when testing was performed by inexperienced users.
No false positives were recorded in any of the testing conducted. The false negatives reported would have caused the user to discard the solution unnecessarily. No disinfection procedure would have been compromised.
The data demonstrates that the Browne Sporicidin Phenol Indicator is an effective monitor for the phenol component of the Sporicidin Sterilizing and Disinfecting Solution with a phenol MEC of 1.3%.
Browne Sporicidin Phenol Indicator Additional Information - K984613
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Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing.
FEB 4 1999 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Albert Browne Ltd. C/O Cynthia J.M. Nolte, Ph.D. Associate Regulatory Consultant Medical Device Consultants, Incorporated 49 Plain Street 02760 North Attleboro, Massachusetts
Re : K984613 Browne Sporicidin Phenol Indicator Trade Name: for Sporicidin Sterilizing and Disinfecting Solution Requlatory Class: II Product Code: JOJ December 28, 1998 Dated: December 29, 1998 Received:
Dear Dr. Nolte:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਉ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
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Page 2 - Dr. Nolte
through 542 of the Act for devices under the Electronic chrough Jr. Or on Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA debelibed is possible equivalence of your device to a legally marketed predicate device results in a classification for your marketed predicate acits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on compreadios as (advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address
"http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Direc Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): _ 1984613
Browne Sporicidin Phenol Indicator For Sporicidin Sterilizing and Device Name: Disintecting Solution
Indications For Use:
The Browne Sporicidin Phenol Indicator For Sporicidin Sterilizing and Disinfecting Solution (Browne Sporicidin Phenol Indicator) is a phenol concentration monitor for use in phenol-containing germicide solutions with a minimum effective concentration of 1.3% phenol.
The Browne Sporicidin Phenol Indicator is dedicated for use with Sporicidin Sterilizing and Disinfecting Solution.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Qian S. Lin
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices C 98 Ub 510(k) Number
Prescription Use (Per 21 CFR 801.109)
OR Over-The-Counter Use X
§ 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).