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.
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.

Device Description

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.
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.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the Browne MVI Steam Indicator, based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria (Stated Goal)	Reported Device Performance
Indicate, through a visible color change (white to purple with a pink intermediate), when the device has been exposed to a steam sterilization process.	Strips changed color from white to purple with a pink intermediate.
Monitor steam sterilization processes in gravity and vacuum-assisted steam autoclaves with a working range of 121-134°C.	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.
Time required for complete development of an end point response at 121°C.	≥7 minutes at 121°C.
Time required for complete development of an end point response at 134°C.	≥3 minutes at 134°C.

Study Details

The provided text describes performance testing, but it does not detail a study in the sense of a formal clinical trial with human subjects or a comparison to an established gold standard in a real-world setting. Instead, it describes laboratory testing of the device's functional performance.

Here's a breakdown of the requested information based on the available text:

Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify the exact number of Browne MVI Steam Indicator strips (sample size) used for testing. It states "Testing was conducted to evaluate the performance of the strips..." implying multiple strips were tested.
- Data Provenance: The testing was conducted "in a BIER vessel/prototype which conforms to the performance requirements for BIER/Steam vessels described in ANSI/AAMI ST45-1992." This indicates a controlled laboratory environment, not a retrospective or prospective study from a specific country of origin in a clinical setting.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. The "ground truth" here is the observed color change of the indicator strips in response to defined steam sterilization conditions. The assessment of color change is a direct observation of the device's function, not an interpretation by experts in the typical sense of medical imaging or diagnostic devices.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not provided. Given the nature of a chemical indicator (a direct color change), a formal adjudication method like those used for expert consensus on medical images is unlikely to have been applied. The "ground truth" is likely the direct observation of the color change itself under controlled conditions.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. An MRMC comparative effectiveness study was not done. This device is a passive chemical indicator, not an AI-powered diagnostic tool requiring human interpretation and comparison with human readers.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, in essence. The performance testing described is for the device (chemical indicator) alone, without human intervention or interpretation beyond observing the color change. There is no algorithm involved; it's a chemical reaction.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth is the physical state of the steam sterilization process (i.e., exposure to specific temperatures and times) and the observed physical change of the device (color change from white to purple/pink). It's based on the intrinsic chemical reaction of the indicator.
The sample size for the training set:
- This concept is not applicable. The Browne MVI Steam Indicator is a chemical indicator, not a machine learning model, so there is no "training set."
How the ground truth for the training set was established:
- This concept is not applicable, as there is no training set for this type of device.

Summary

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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.

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 (301) 594-4618. 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" (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) 638-2041 or (301) 443-6597 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.

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

(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

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).