BROWNE CIDEX OPA INDICATOR

K991709 · Albert Browne , Ltd. · JOJ · Oct 8, 1999 · General Hospital

Device Facts

• Record ID: K991709
• Device Name: BROWNE CIDEX OPA INDICATOR
• Applicant: Albert Browne , Ltd.
• Product Code: JOJ · General Hospital
• Decision Date: Oct 8, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

The Browne Cidex™ OPA Indicator (Browne OPA Indicator) is a concentration monitor for use in ortho-phthalaldehyde-containing germicide solutions with a minimum effective concentration of 0.3%. The Browne Cidex™ OPA Indicator is dedicated for use with Cidex™ OPA Solution.

Device Story

The Browne Cidex™ OPA Indicator is a disposable, non-sterile chemical indicator strip used to verify the concentration of ortho-phthalaldehyde in germicide solutions. The device consists of a polypropylene strip with an indicator pad impregnated with a chemical solution. When immersed in a germicide solution, the indicator pad reacts with the aldehyde moiety of the active ingredient. If the concentration is at or above the 0.3% MEC, the pad changes color from light blue to purple, providing a visual pass/fail result. It is intended for use by healthcare personnel to ensure the efficacy of germicide solutions prior to use. The device provides a simple, rapid visual assessment to confirm that the germicide is potent enough for its intended disinfection or sterilization application, thereby ensuring patient safety by preventing the use of sub-therapeutic germicide concentrations.

Clinical Evidence

Bench testing only. 180 indicators from 3 production lots were tested in 0.3% and 0.45% ortho-phthalaldehyde solutions. All 90 strips in 0.3% solution failed (light blue); all 90 strips in 0.45% solution passed (purple). Additional testing under simulated use (n=60) and worst-case conditions (contaminated with 5% serum, 5% salt, 5% sodium dodecyl sulfate) confirmed 100% accuracy in distinguishing between 0.3% (fail) and 0.45% (pass) concentrations. No false positives or false negatives were recorded.

Technological Characteristics

Polypropylene strip with an indicator pad impregnated with a chemical indicator solution. Mechanism: chemical reaction between indicator solution and aldehyde moiety of germicide. Non-sterile, disposable. Visual colorimetric readout (light blue to purple).

Indications for Use

Indicated for monitoring the concentration of ortho-phthalaldehyde-containing germicide solutions (specifically Cidex™ OPA Solution) to ensure the active ingredient meets the minimum effective concentration (MEC) of 0.3%.

Regulatory Classification

Identification

Biological sterilization process indicator: 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. Physical/chemical sterilization process indicator: 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.

Predicate Devices

• Browne GA Indicator (K922481)

Submission Summary (Full Text)

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8 1999

OCT

MDCI - NC

18

K 991709

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# 510(k) SUMMARY Browne Cidex™ OPA Indicator

## August 4, 1999

#### 1. SUBMITTER NAME AND ADDRESS

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

### 2. DEVICE NAME

Browne Cidex™ OPA Indicator Proprietary Name: ortho-Phthalaldehyde Concentration Indicator Common/Usual Name: Physical/Chemical Sterilization Process Indicator Classification Name:

### PREDICATE DEVICES 3.

Browne GA Indicator, subject of K922481

### 4. INTENDED USE

The Browne Cidex™ OPA Indicator (Browne OPA Indicator) is a concentration monitor for use in ortho-phthalaldehyde-containing germicide solutions with a minimum effective concentration of 0.3%.

The Browne Cidex™ OPA Indicator is dedicated for use with Cidex™ OPA Solution.

### DEVICE DESCRIPTION ട്.

The Browne OPA Indicator and the substantially equivalent device are chemical indicator strips intended to monitor the concentration of liquid chemical germicides. The devices indicate, via a color change, if the concentration of the

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active ingredient exceeds the MEC (minimum effective concentration) for the solution.

The Browne OPA 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 light blue to purple in Cidex™ OPA Solution with an ortho-phthaladehyde concentration greater than the MEC for the solution.

#### 6. TECHNOLOGICAL CHARACTERISTICS

The technological characteristics of the Browne GA Indicator, subject of K922481, are equivalent to that of the Browne OPA Indicator described in this Both devices are non-sterile, disposable strips containing an submission. indicator pad impregnated with an indicator solution which changes color in a liquid chemical germicide at the appropriate concentration of the active ingredient.

The mechanism of action for the color change is identical for the proposed and predicate devices. The active ingredient of the indicator solution in both devices interacts with the aldehyde moiety of the active ingredient of the germicide solution to produce a color change at the appropriate concentration of the germicide active ingredient. The indicator solution of the proposed device changes color from light blue to purple, while that of the Browne GA Indicator, subject of K922481, changes color from yellow to purple,

### 7. PERFORMANCE TESTING

Performance testing was conducted on 180 Browne OPA Indicators from 3 production lots in Cidex™ OPA solutions containing 0.3% and 0.45% orthophthaladehyde. Testing was performed according to the Instructions for Use. All 90 strips tested in the 0.3% solution were a light blue or light blue with purple mottling color, indicating a FAIL. All 90 strips tested in the 0.45% solution were a purple color, indicating a PASS.

Additional testing was conducted to evaluate the performance of the Browne OPA Indicator in Cidex™ OPA Solutions containing 0.3% or 0.45% orthophthalaldehyde using three production lots of strips under conditions of simulated

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use. All 30 of the indicators tested in the 0.3% ortho-phthaladehyde solution showed a FAIL condition. All 30 of the indicators tested in the 0.45% solutions showed a PASS condition. No false positives or false negatives were recorded.

The performance of the Browne OPA Indicator was also evaluated under conditions selected to simulate a worst case condition for the germicide solution. The indicators were tested in Cidex™ OPA solution containing 0.3% and 0.45% ortho-phthalaldehyde at the end of it's use life and contaminated with 5% serum, 5% salt, and 5% sodium dodecyl sulfate. An unadulterated solution was included as a control. For each of the contaminants tested, all of the indicator strips exhibited a FAIL condition in the 0.3% Cidex™ OPA solution and a PASS in the 0.45% solution.

The data shows that the Browne OPA Indicator is an effective monitor for the 0.3% MEC Cidex™ OPA Solution.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling a symbol. The symbol is a stylized caduceus, which is a traditional symbol of medicine, with three intertwined snakes around a staff. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 8 1999

Albert Browne Ltd. c/o Cynthia J.M. Nolte, Ph.D., RAC Staff Consultant Medical Device Consultants, Inc. 49 Plain Street North Attleboro, MA 02760

Re : K991709

> Browne Cidex® OPA Indicator Trade Name: Regulatory Class: II Product Code: JOJ September 15, 1999 Dated: Received: September 16, 1999

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 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 The general controls provisions of the Act 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory 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

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obligation you might have under sections 531 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 findinq 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 yitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

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

Enclosure

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K991709 510(k) Number (if known): _

Device Name: Browne Cidex™ OPA Indicator

Indications For Use:

The Browne Cidex™ OPA Indicator is a concentration monitor for use in orthophthalaldehyde-containing germicide solutions with a minimum effective concentration of 0.3%.

The Browne Cidex™ OPA Indicator is dedicated for use with Cidex™ OPA Solution.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Qun S. Lin

(Division Sign-Off Division of Dental, Infection Cor and General Hospit 510(k) Numb

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use X

Albert Browne Ltd. Browne Cidex™ OPA Indicator 510(k) 5/17/99