BROWNE MVI STEAM INDICATOR

K971369 · Albert Browne , Ltd. · JOJ · Jan 29, 1998 · General Hospital

Device Facts

• Record ID: K971369
• Device Name: BROWNE MVI STEAM INDICATOR
• Applicant: Albert Browne , Ltd.
• Product Code: JOJ · General Hospital
• Decision Date: Jan 29, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

The Browne MVI Steam Indicator is a sterilization process indicator designed to indicate, through a visible color change, when the device has been exposed to a steam sterilization process.

Device Story

The Browne MVI Steam Indicator is a paper strip featuring chemical indicator ink pads at both ends. It is used to monitor steam sterilization cycles in gravity and vacuum-assisted steam autoclaves. Upon exposure to steam at temperatures between 121-134°C, the ink undergoes a temperature-dependent chemical reaction, changing color from white to purple via a pink intermediate. This visual change confirms that the device has been exposed to the sterilization process. The device is intended for use by healthcare personnel in clinical settings to verify autoclave performance.

Clinical Evidence

Bench testing only. Performance evaluated in a BIER vessel/prototype conforming to ANSI/AAMI ST45-1992. Testing confirmed color change from white to purple (pink intermediate) in partial cycles at 121°C and 134°C. Development of end-point response required ≥7 minutes at 121°C and ≥3 minutes at 134°C.

Technological Characteristics

Paper strip with chemical indicator ink pads. Operates via temperature-dependent chemical reaction. Designed for gravity and vacuum-assisted steam autoclaves (121-134°C). Performance testing conducted per ANSI/AAMI ST45-1992.

Indications for Use

Indicated for use as a process indicator to confirm exposure to steam sterilization in autoclaves operating between 121-134°C.

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

• Strate-Line™ Sterilization Indicator Strip, Propper Manufacturing Co., Inc.

Submission Summary (Full Text)

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# 510(k) Summary Albert Browne Ltd. Browne MVI Steam Indicator 1136

#### 1. SUBMITTED BY

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

## CONTACT PERSON

Alan Charlton Chancery House 190 Waterside Road Hamilton Industrial Park Leicester LE5 1QZ

### DATE PREPARED

December 16, 1997

#### 2. DEVICE NAME

Browne MVI Steam Indicator

CLASSIFICATION NAME

Physical/chemical sterilization process indicator

CLASSIFICATION STATUS

Physical/chemical process indicator is classified as Class II under Sterilization process indicator in 21 CFR 880.2800 by the General Hospital and Personal Use Devices Panel.

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#### 3. PREDICATE DEVICE

Strate-Line™ Sterilization Indicator Strip, Propper Manufacturing Co., Inc.

#### 4. INTENDED USE

The Browne MVI Steam Indicator is a sterilization process indicator designed to indicate, through a visible color change, when the device has been exposed to a steam sterilization process.

#### DEVICE DESCRIPTION 5.

The Browne Steam Indicator is a paper strip with indicator ink pads on each end which is used to monitor steam sterilization cycles. The indicator ink changes color from white to purple through a pink intermediate in a steam autoclave working at 121-134°C.

#### 6. TECHNOLOGICAL CHARACTERISTICS

The Browne MVI Steam Indicator consists of a paper strip with chemical indicator ink pads located on each end. The device is designed to monitor steam sterilization processes in gravity and vacuum-assisted steam autoclaves with a working range of 121-134°C. The color change in both devices is produced by a temperaturedependent chemical reaction.

#### 7. PERFORMANCE TESTING

All performance testing was conducted in a BIER vessel/prototype which conforms to the performance requirements for BIER/Steam vessels described in ANSI/AAMI ST45-1992.

Testing was conducted to evaluate the performance of the strips in partial cycles at 121°C and 134°C. The data showed that the strips changed color from white to purple with a pink intermediate. The time required for complete development of an end point response was ≥7 minutes at 121°C and ≥3 minutes at 134°C. The data demonstrates that the device can be used for the confirmation of exposure to a steam sterilization process in a steam autoclave with a working range of 121-134°C.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. In the center of the seal is a stylized image of an eagle with three stripes representing the three levels of government: federal, state, and local.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 9 1998

Albert Browne Ltd. C/O Ms. Mary McNamara-Cullinane Staff Consultant Medical Device Consultants 49 Plain Street North Attleboro, Massachusetts 02760

Re : K971369 Trade Name: Browne MVI Steam Chemical Indicator Requlatory Class: II Product Code: JOJ Dated: December 17, 1997 Received: December 18, 1997

Dear Ms. McNamara-Cullinane:

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 of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labelinq, 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. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Druq 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

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Page 2 - Ms. McNamara-Cullinane

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 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic 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 M. Hlatowski

Timol Elly A Directbr 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): _

Chemical Device Name: Browne MVI Steam Indicator

Indications For Use:

The Browne MVI Steam Indicator is a process indicator designed to indicate, through a white to purple color change, when the device has been exposed to a steam sterilization process in a working range of 121-134°C.

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| (Division Sign-Off Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---------------------------------------------------------------------------|---------------------------|
| Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | K971369 |
| Prescription Use | OR Over-The-Counter Use X |
| (Per 21 CFR 801.109) | |

Additional Information - K971369 Browne MVI Steam Indicator