(290 days)
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Not Found
No
The device description and performance studies indicate a chemical indicator that changes color based on temperature, not AI/ML processing.
No
This device is a sterilization process indicator, meaning it monitors the effectiveness of a sterilization process, but it does not directly treat or diagnose a medical condition in a patient.
No
This device is a sterilization process indicator that monitors the effectiveness of a steam sterilization process, not a diagnostic device for medical conditions.
No
The device is a physical paper strip with chemical indicator ink, not a software program.
Based on the provided text, the Browne MVI Steam Indicator is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to indicate exposure to a steam sterilization process through a color change. This is a process monitoring function, not a diagnostic test performed on biological samples.
- Device Description: The device is a paper strip with indicator ink. It monitors the physical conditions of a sterilization cycle (temperature and steam exposure), not biological markers or patient samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Diagnosing a disease or condition
- Providing information about a patient's health status
- Using imaging modalities for diagnostic purposes
- Mentioning anatomical sites or patient age ranges
The device is clearly designed to monitor the effectiveness of a sterilization process, which is a quality control measure for medical devices or other items being sterilized, not a diagnostic test for a patient.
N/A
Intended Use / Indications for 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.
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.
Product codes
JOJ
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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.
Key Metrics
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Predicate Device(s)
Strate-Line™ Sterilization Indicator Strip
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
0
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.
1
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.
2
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