The Browne GA Indicator for Cidex Plus™ 28 Day Solution (Browne Cidex Indicator) is a concentration monitor for use in glutaraldehyde-containing germicide solutions with a minimum effective concentration of 2.1%.

The Browne GA Indicator for Cidex Plus™ 28 Day Solution is dedicated for use only with Cidex Plus™ 28 Day Solution.

Device Description

The Browne Cidex Indicator and the substantially equivalent devices are chemical indicator strips intended to monitor the concentration of glutaraldehyde solutions. The devices indicate, via a color change, if the glutaraldehyde concentration exceeds the MEC of the specific germicide solution they were designed to monitor.

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Browne GA Indicator for Cidex Plus™ 28 Day Solution

1. Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
100% failure rate in solutions containing 2.1% glutaraldehyde (indicating a FAIL condition for solutions at or below MEC)	100% failure rate observed in solutions containing 2.1% glutaraldehyde. All 20 indicators tested showed a FAIL condition.
Identification of a PASS condition for solutions with glutaraldehyde concentration ≥2.4%.	17 out of 20 indicators (85%) tested in 2.4% solutions showed a PASS condition.
No false positives (i.e., not indicating a PASS when glutaraldehyde is ≤2.1%)	"No false positives were recorded."
Performance not affected by detergent, organic, and inorganic contaminants over the 28-day reuse period.	"The performance of the Cidex Plus™ 28 Day Solution Test Strips is not affected by the presence of detergent, organic and inorganic contaminants over the 28 day reuse period."

2. Sample Size Used for the Test Set and Data Provenance

Manufacturing Lots Test: 5 manufacturing lots of test strips were used for testing in Cide Plus™ 28 Day Solution.
Simulated Use Test: 20 indicators (samples) were tested by ten individuals. This means each individual tested 2 strips (one in 2.1% and one in 2.4% solution).
Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. Given the context of a 510(k) submission to the FDA, it is highly likely a prospective study conducted by the manufacturer, Albert Browne Ltd., which is based in the United Kingdom.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document does not mention the use of experts to establish ground truth for the test set.
The ground truth was established by preparing solutions with known glutaraldehyde concentrations (2.1% and 2.4%).

4. Adjudication Method for the Test Set

None specified. The ground truth was based on the known glutaraldehyde concentrations of the solutions. For the "simulated use" test, the document states "Three of the 20 indicators tested in the 2.4% solution were incorrectly reported as failures. These false negatives were attributed to user inexperience." This implies the actual glutaraldehyde concentration was the definitive truth, and user readings were compared against it.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. The study evaluated the device's performance directly against known concentrations and in a "simulated use" scenario with individual users, rather than comparing human readers with and without AI assistance. The device is the monitoring tool; there's no AI component mentioned in this context.

6. Standalone Performance Study (Algorithm Only)

Yes, a standalone study was done. The initial performance testing involved "5 manufacturing lots of test strips" in solutions with known glutaraldehyde concentrations. This represents the device (test strip) functioning on its own, independent of a human reader's interpretation for the initial characterization. The human "simulated use" test was a secondary validation of user interpretation.

7. Type of Ground Truth Used

Known chemical concentration. The ground truth for the test set was established by using Cidex Plus™ 28 Day Solution with precisely known glutaraldehyde concentrations (2.1% and 2.4%).

8. Sample Size for the Training Set

The document does not explicitly mention a separate "training set" as would be typical for algorithmic or AI device development. The performance testing described appears to be the entire validation for this type of chemical indicator. For such a simple chemical indicator, extensive "training" in the AI sense is not applicable. The device's inherent chemical properties define its response. The performance data presented is for validation.

9. How Ground Truth for the Training Set Was Established

As a training set is not explicitly mentioned or applicable in the AI sense for this device, a method for establishing its ground truth is also not applicable/not described. The device's "ground truth" is based on the chemical reaction characteristics of glutaraldehyde which lead to the color change.

Summary

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DEC 7 1998

510(k) SUMMARY Browne GA Indicator for Cidex Plus™ 28 Day Solution October 8, 1998

981054

SUBMITTER NAME AND ADDRESS 1.

Mr. Alan Charlton Albert Browne Ltd. Chancery House 190 Waterside Road Hamilton Industrial Park Leicester LE5 1QZ United Kingdom

2. DEVICE NAME

Browne GA Indicator for Cidex Plus™ 28 Day Solution Proprietary Name: Common/Usual Name: Glutaraldehyde Concentration Indicator Physical/Chemical Sterilization Process Indicator Classification Name:

PREDICATE DEVICES 3.

Browne GA Indicator, subject of K922481 Cold Sterilog Glutaraldehyde Monitor, subject of K924681

INTENDED USE 4.

The Browne GA Indicator for Cidex Plus™ 28 Day Solution is dedicated for use only with Cidex Plus™ 28 Day Solution.

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5. DEVICE DESCRIPTION

TECHNOLOGICAL CHARACTERISTICS 6.

The technological characteristics of the Cold Sterilog Glutaraldehyde Monitor and Browne GA Indicator are similar to that of the Browne Cidex Indicator described in this submission. All three devices are non-sterile, disposable strips containing an indicator pad impregnated with an indicator solution which changes color at a glutaraldehyde concentration above the MEC of the liquid chemical germicide it is designed to monitor.

The mechanism of action for inducing a color change are identical for the Browne Cidex Indicator and the Browne GA Indicator, subject of K922481. Glutaraldehyde reacts with sodium sulfite in the test strip to form a sulfite addition product and an equivalent amount of base (STEP 1). If sufficient glutaraldehyde is present, the increase in pH causes a colour change in the pH indicator (STEP 2).

STEP 1

HCO(CH), CHO + 2Na,SO2 2H,O + glutaraldehyde sodium sulfite water (CH2),(CH(SO2Na)OH), 2NaOH T + sulfite addition product sodium hydroxide

STEP 2

NaOH + pH sensitive dye -> -> red color dye

The indicator color is dependent on the glutaraldehyde concentration of the germicide solution, and the time after exposure when the results of the test are read, as described in Table 1.

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Time(minutes)	Glutaraldehyde Concentration (%)
	≤2.1	2.2-2.3	≥2.4
<1	Yellow, Red/Yellow	Yellow, Red/Yellow	Red
1-2	Yellow, Red/Yellow	Yellow, Red/Yellow,Red	Red
>2	Yellow, Red/Yellow	Yellow, Red/Yellow	Red

Table 1. Color Development for the Cidex Plus™ 28 Day Solution Indicator

During the first 60 seconds after the test strip has been dipped into the Cidex Plus™ 28 Day Solution, following the procedure described in the Instructions for Use, the yellow test strip will begin to develop a red color.

At 60 seconds (1 minute), the strip will exhibit a uniform red color (except for the top 2 mm of the strip) if the concentration of glutaraldehyde is ≥2.4%. The strip will appear patchy red/yellow or yellow if the solution contains ≤2.1% glutaraldehyde. In the range of 2.2-2.3% glutaraldehyde, the strip may appear yellow, red/yellow or red.

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.

After 120 seconds (2 minutes) the color of the strip regresses toward the original yellow color. The rate of regression is dependent on the glutaraldehyde concentration of the Cidex Plus™ 28 Day Solution being tested.

The indicator solution of the proposed device changes color from yellow to red to indicate a PASS, while that of the Browne GA Indicator, subject of K922481, changes color from yellow to purple to indicate a PASS. The choice of colors for these indicators does not represent a difference in the mechanism of action for the color change.

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PERFORMANCE TESTING 7.

The performance characteristics of Cidex Plus™ 28 Day Solution Test Strips were established by testing 5 manufacturing lots of test strips in Cidex Plus™ 28 Day Solution with 2.1% and 2.4% glutaraldehyde. The test strip shows a 100% failure rate in solutions containing 2.1% glutaraldehyde when the testing was performed according to the Instructions for Use. The performance of the Cidex Plus™ 28 Day Solution Test Strips is not affected by the presence of detergent, organic and inorganic contaminants over the 28 day reuse period.

Testing was also conducted to evaluate the performance of the Browne Cidex Indicator in Cidex Plus™ 28 Day Solutions containing 2.1 or 2.4% glutaraldehyde under conditions of simulated use. Ten individuals who had not used the test strip previously were instructed to test the strips, following the Instructions for Use. All 20 of the indicators tested in the 2.1% solution showed a FAIL condition. Seventeen of the 20 indicators tested in the 2.4% solutions showed a PASS condition. Three of the 20 indicators tested in the 2.4% solution were incorrectly reported as failures. These false negatives were attributed to user inexperience.

No false positives were recorded, indicating that the Browne Cidex Indicator can accurately identify Cidex 28 Day Plus™ Solutions which are at or below the MEC of 2.1%. The false negatives would have caused the user to discard the solution unnecessarily. No disinfection procedure would have been compromised.

The data shows that the Browne Cidex Indicator is an effective monitor for the 2.1% MEC Cidex 28 Day Plus™ Solution.

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Image /page/4/Picture/2 description: The image shows a logo for the Department of Health. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three curved lines that are parallel to each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

7 1998 DEC

Albert Browne Ltd. C/O Cynthia J.M. Nolte, Ph.D. Associate Consultant Medical Device Consultants, Incorporated 49 Plain Street North Attleboro, Massachusetts 02760

K981054 Re : Browne GA Indicator for Cidex Plus™ 28 Day Trade Name: Solution Regulatory Class: II Product Code: JOJ Dated: October 8, 1998 Received: October 9, 1998

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 The general controls controls provisions of the Act. 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. ਕਿ 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 Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (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 the promotion and 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/dsmamajn.html".

Sincerely yours,

Timothy A. Ulatowski

Directdt 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): K981054

Device Name: Browne GA Indicator for Cidex Plus™ 28 Day Solution

Indications For Use:

The Browne GA Indicator for Cidex Plus™ 28 Day Solution is a concentration monitor for use in glutaraldehyde-containing germicide solutions with a minimum effective concentration of 2.1%.

The Browne GA Indicator for Cidex Plus™ 28 Day Solution is dedicated for use with Cidex Plus™ 28 Day Solution.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Chim S. Lin

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number

510(k) Number K981054

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use X

Browne GA Indicator for Cidex Plus™ 28 Day Solution 10/8/98 Additional Information - K981054

CONFIDENTIAL Page A-1

Regulation Number and Section

§ 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).