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.

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the Browne Sporicidin Glutaraldehyde Indicator, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state formal "acceptance criteria" in a quantitative, pass/fail manner with specific numerical targets. Instead, it describes expected color changes at certain glutaraldehyde concentrations and the device's performance in terms of avoiding false positives and managing false negatives.

Acceptance Criteria (Implied)	Reported Device Performance
Positive Indicator (≥0.7% Glutaraldehyde): Uniform purple color within 1-2 minutes.	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%. From 60 to 120 seconds (1 to 2 minutes) the color of the strip is stable, and a reading must be taken during this time.
Below Minimum Effective Concentration (<0.6% Glutaraldehyde): Patchy purple/tan or tan color within 1-2 minutes.	The strip will appear patchy purple/tan or tan if the solution contains <0.6% glutaraldehyde. From 60 to 120 seconds (1 to 2 minutes) the color of the strip is stable, and a reading must be taken during this time.
Inconclusive/Borderline (0.61-0.69% Glutaraldehyde): Tan, purple/tan, or purple color within 1-2 minutes.	In the concentration range of 0.61-0.69%, the strip may appear tan, purple/tan or purple. From 60 to 120 seconds (1 to 2 minutes) the color of the strip is stable, and a reading must be taken during this time.
Avoidance of False Positives: No purple indication at or below MEC.	No false positives were recorded in solutions containing 0.6% glutaraldehyde, when the testing was performed according to the Instructions for Use.
Handling of False Negatives: If false negatives occur, they should not compromise disinfection.	False negatives were observed when the indicators were tested in the presence of high levels of sodium dodecyl sulfate. The false negatives would have caused the user to discard the solution unnecessarily. No disinfection procedure would have been compromised.
Overall Effectiveness: Effective monitoring of glutaraldehyde component.	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%.

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

Sample Size: The document does not specify the exact number of indicator strips or tests performed in the performance testing. It states that indicators were "tested in Sporicidin Sterilizing and Disinfecting Solution containing 0.6% and 0.7% glutaraldehyde."
Data Provenance: The document does not explicitly state the country of origin of the data. It appears to be a submission to the FDA (USA) from a UK-based company (Albert Browne Ltd.), so the testing likely occurred in the UK or under the company's oversight. The data is presented as retrospective for the purpose of this 510(k) submission, as it describes tests already performed to establish performance characteristics.

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

This information is not provided. The ground truth for the glutaraldehyde concentrations (0.6% and 0.7%) was likely established through chemical analysis or precise formulation of the Sporicidin Sterilizing and Disinfecting Solutions, rather than via expert consensus on visual assessment of the strips.

4. Adjudication Method for the Test Set

This information is not applicable/provided. The 'adjudication method' typically refers to how disagreements are resolved among multiple human readers when establishing ground truth for diagnostic studies. For a chemical indicator, the output is a direct color change, not subject to individual interpretation in the same way. The ground truth (glutaraldehyde concentration) would have been objectively measured.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This type of study is more relevant for diagnostic devices where human interpretation plays a significant role and the device aims to assist or replace human readers. The Browne Sporicidin Glutaraldehyde Indicator is a chemical indicator that produces a direct visual result.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done

Yes, this is essentially a standalone (algorithm only) study, though the "algorithm" is the chemical reaction and color change, not a digital one. The performance described is of the indicator strip itself, based on its chemical reactions to glutaraldehyde concentrations. The color change is a direct physical/chemical output, measured against known concentrations. Human interaction is limited to observing the color change at a specified time.

7. The Type of Ground Truth Used

The ground truth used was the known, chemically verified glutaraldehyde concentration in the Sporicidin Sterilizing and Disinfecting Solution (0.6% and 0.7%). This is a form of "reference standard" or "gold standard" established by precise chemical formulation or analysis.

8. The Sample Size for the Training Set

This document does not mention a 'training set.' Chemical indicators do not typically undergo a "training" phase like machine learning algorithms. Their performance is inherent to their chemical formulation. The testing described is a validation of the pre-designed chemical system.

9. How the Ground Truth for the Training Set was Established

As there is no explicit 'training set' for this chemical indicator in the conventional sense, this question is not applicable. The ground truth for the development of the indicator's chemistry would have been established through iterative chemical formulation and testing against known glutaraldehyde concentrations to achieve the desired color changes at specific thresholds. However, this development process is distinct from the regulatory "training set" concept for AI/ML devices.

Summary

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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 forSporicidin 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 is dedicated for use with Sporicidin Sterilizing and Disinfecting Solution.

Browne Sporicidin Glutaraldehyde Indicator Additional Information - K984616

1/25/99

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<984616

DEVICE DESCRIPTION ડે.

TECHNOLOGICAL CHARACTERISTICS રું.

The technological characteristics of the Browne GA Indicator are similar to that of the Browne Sporicidin Glutaraldehyde 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 glutaraldehyde concentration.

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

STEP 1

HCO(CH2)3CHOglutaraldehyde	+	2Na2SO3sodium sulfite	+	2H2Owater
→	(CH2)3(CH(SO3Na)OH)2sulfite addition product	+	2NaOHsodium hydroxide

Browne Sporicidin Glutaraldehyde Indicator 1/25/99 Additional Information - K984616

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K984616

STEP 2

NaOH + pH sensitive dye purple color dyc (proposed device)

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 the Table A-1 below.

Table A-1. Color Development for the Sporicidin Glutaraldehyde Indicator Strin

Time(minutes)	Glutaraldehyde Concentration (%)
	≤0.6	0.61-0.69	≥0.7
<1	tan, purple/tan	tan, purple/tan
1-2	tan, purple/tan	tan, purple/tan, purple	purple
>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 <0.6% glutaraldehyde. In the concentration range of 0.61-0.69, the strip may appear tan. purple/tan or purple.

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 glutaraldehyde concentration of the Sporicidin Sterilizing and Disinfecting Solution.

After 120 seconds (2 minutes) the color of the strip regresses toward the original tan color. The rate of regression is dependent on the glutaraldehyde concentration of the Sporicidin Sterilizing and Disinfecting Solution being tested.

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Performance Testing 7.

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 dodecy] 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 glutaraldchyde MEC of 0.6%.

1/25/99

Browne Sporicidin Glutaraldehyde Indicator Additional Information - K984616

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Image /page/4/Picture/10 description: The image shows a partial view of a document, likely an official one, featuring the emblem of a bird's head and neck on the left side. To the right of the emblem, the word "DEPARTMENT" is visible, suggesting the document belongs to a governmental department. The overall impression is that of an official document header.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 4 1999

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

Re: K984616 Browne Sporicidin Glutaraldehyde Indicator Trade Name: for Sporicidin Regulatory Class: II Product Code: JOJ December 28, 1998 Dated: Received: December 29, 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 controls provisions of the Act. The general controls provisions of the Act include requirements for annual reqistration, 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 Requlations, Title 21, Parts 800 to 895. ਜ 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 action. In addition, FDA may publish further announcements 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 requlations.

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 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 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/dsmama/n.html" .

Sincerely yours,

Timothy A. Ulatowski

Directør Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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510(k) Number (if known): Kg y 461

Browne Sporicidin Glutaraldehyde Indicator for Sporicidin Sterilizing and Device Name: Disinfecting Solution

Indications for Use:

The Browne Sporicidin Glutaraldehyde 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)

Qiu S. Lin

(Division Sign Off) Division of Dental, Infection Control, and General Hospital Devices 986 510(k) Number

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use $\underline{X}$

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).