BROWNE MVI ETHYLENE OXIDE INDICATOR

K991418 · Albert Browne , Ltd. · JOJ · Jun 10, 1999 · General Hospital

Device Facts

• Record ID: K991418
• Device Name: BROWNE MVI ETHYLENE OXIDE INDICATOR
• Applicant: Albert Browne , Ltd.
• Product Code: JOJ · General Hospital
• Decision Date: Jun 10, 1999
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

The Browne MVI Ethylene Oxide Indicator (Browne MVI EO Indicator) is a process indicator designed to indicate, through a visible color change, when the device has been exposed to an ethylene oxide sterilization process.

Device Story

Browne MVI EO Indicator is a paper strip featuring indicator ink pads at both ends. Designed for monitoring ethylene oxide sterilization cycles. Principle of operation: active ingredient in ink reacts with ethylene oxide, inducing a pH-dependent color shift from orange to red. User compares color of exposed ink pads against a provided reference spot. Used in clinical or industrial sterilization settings to verify exposure to sterilization process. Provides visual confirmation of cycle exposure; assists healthcare providers in ensuring sterilization efficacy.

Clinical Evidence

Bench testing only. Device conforms to ANSI/AAMI ST60-1996 requirements for chemical indicators. Data provided to support a 2-year shelf life.

Technological Characteristics

Paper strip substrate with pH-sensitive indicator ink. Color change mechanism: chemical reaction between active ingredient and ethylene oxide. Conforms to ANSI/AAMI ST60-1996. No electronic components, software, or energy sources.

Indications for Use

Indicated for use as a physical/chemical process indicator to monitor ethylene oxide sterilization cycles by providing a visible color change upon exposure.

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

• Gas-Chex® Sterilization Indicator Strips, Propper Mfg. Corp.

Submission Summary (Full Text)

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# 510(k) SUMMARY ALBERT BROWNE LTD. BROWNE MVI ETHYLENE OXIDE INDICATOR 141

#### 1. SUBMITTED BY

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

### CONTACT PERSON

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

### DATE PREPARED

April 22, 1999

#### 2. DEVICE NAME

Browne MVI Ethylene Oxide Indicator

CLASSIFICATION NAME

Physical/chemical sterilization process indicator

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### CLASSIFICATION STATUS

Physical/chemical process indicators are classified as Class II (Product Code 80JOJ) in 21 CFR 880.2800 by the General Hospital and Personal Use Devices Panel.

#### 3. PREDICATE DEVICE

Gas-Chex® Sterilization Indicator Strips, Propper Mfg. Corp.

#### 4. INTENDED USE

The Browne MVI Ethylene Oxide Indicator (Browne MVI EO Indicator) is a process indicator designed to indicate, through a visible color change, when the device has been exposed to an ethylene oxide sterilization process.

#### 5. DEVICE DESCRIPTION

The Browne MVI EO Indicator is a paper strip with indicator ink pads on each end which is used to monitor ethylene oxide sterilization cycles. The indicator ink changes color from orange to red after exposure to an ethylene oxide sterilization process. After inclusion in an ethylene oxide sterilization cycle, the color of the indicator ink pads is compared to a reference spot which matches the red color of the exposed strip.

#### Q. TECHNOLOGICAL CHARACTERISTICS

The color change in both the proposed and predicate devices is produced by interaction of the active ingredient with ethylene oxide which induces a change in the color of a pH indicator dye.

#### 7. PERFORMANCE TESTING

The Browne MVI EO Indicator conforms to the applicable requirements of ANSI/AAMI ST60-1996 "Sterilization of health care products - Chemical indicators - Part 1: General requirements". Data was also included to support a 2 year shelf life for the device.

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Image /page/2/Picture/1 description: The image is a black and white seal for the U.S. Department of Health & Human Services. The seal is circular with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 0 1999

Albert Browne Limited c/o Cynthia J.M. Nolte, Ph.D., RAC Associate Consultant Medical Device Consultants, Incorporated 49 Plain Street North Attleboro, Massachusetts 02760

K991418 Re : Trade Name: Browne MVI Ethylene Oxide Indicator Requlatory Class: II Product Code: JOJ Dated: April 22, 1999 Received: April 23, 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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ಡ 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 regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Dr. Nolte

this response to your premarket notification Please note: submission does not affect any 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 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 [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 ene regaration Chorozon" (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 (800) 638-204% 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 Radiological Health

Enclosure

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510(k) Number (if known):

Device Name: _Browne MVI Ethylene Oxide Indicator

Indications For Use:

The Browne MVI Ethylene Oxide Indicator is a process indicator designed to indicate, The Drowne FAVI Hange, when the device has been exposed to an ethylene oxide sterilization process.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

K991418
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number

Prescription Use **__** OR Over-The-Counter Use ✓

(Par 21 CEP 801 100)

(Per 21 CFR 801.109)

4/22/99

(Optional Format 1-2-96)