(48 days)
Not Found
Not Found
No
The device is a simple chemical indicator strip that changes color based on exposure to ethylene oxide. There is no mention of any computational or analytical components that would suggest the use of AI or ML.
No
The device is an indicator for a sterilization process, not a device used for therapy.
No
Explanation: The device is an ethylene oxide indicator used to confirm exposure to a sterilization process. It does not diagnose any medical condition or disease.
No
The device description clearly states it is a paper strip with indicator ink pads, which are physical components, not software.
Based on the provided information, the Browne MVI Ethylene Oxide Indicator is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to indicate exposure to an ethylene oxide sterilization process through a color change. This is a process monitoring tool for sterilization equipment, not a diagnostic test performed on biological samples (in vitro).
- Device Description: The device is a paper strip with indicator ink. It monitors the sterilization process itself, not a biological condition or substance.
- Lack of Biological Sample Interaction: IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment. This device does not interact with any biological samples.
- Performance Standards: The device conforms to standards related to chemical indicators for sterilization, not standards for diagnostic tests.
In summary, the Browne MVI Ethylene Oxide Indicator is a sterilization process indicator, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
80JOJ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Gas-Chex® Sterilization Indicator Strips
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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 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
1
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.
2
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.
3
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 (301) 594-4692. 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 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 (301) 443-6597 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
4
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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
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)