(104 days)
Not Found
Not Found
No
The device is a simple paper strip with color-changing ink, and the description and performance studies do not mention any computational or learning-based components.
No
The device is a process indicator for monitoring steam autoclaves, not a device used for treating or diagnosing medical conditions in patients.
No
The device is a process indicator for steam autoclaves, distinguishing between processed and unprocessed units, not diagnosing medical conditions or diseases.
No
The device description clearly states it is a "paper strip with indicator ink pads," which is a physical hardware component, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Browne Steam Indicator Function: The Browne Steam Indicator is used to monitor the sterilization process within a steam autoclave. It indicates whether the necessary conditions (temperature and time) for sterilization have been met. It does not interact with or analyze any biological specimens from a patient.
The device's purpose is to ensure the effectiveness of a sterilization process for instruments or materials, not to diagnose or provide information about a patient's health.
N/A
Intended Use / Indications for Use
The Browne Steam Indicator is a process indicator to be used in a steam autoclave with a working range of 121-134°C to distinguish between processed and unprocessed units.
Product codes
JOJ
Device Description
The Browne Steam Indicator is a paper strip with indicator ink pads on each end. The indicator ink pads change color from white to black through a brown intermediate in a steam autoclave working at 121-134°C (250-273°F).
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
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 black with a brown intermediate. The time required for complete development of an end point response was >=8 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 processing cycle in a steam autoclave with a working range of 121-134°C. The performance of the Browne Steam Indicator was equivalent to that of the predicate device.
All strips used for testing were >=2 years from the date of manufacture, demonstrating that the 2-year expiration date is adequate to ensure accurate, reproducible performance.
Key Metrics
Not Found
Predicate Device(s)
3M Comply 1250 Steam Integrator 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
JUN 2 4 1997
510(k) Summary Albert Browne Ltd. Browne Steam Indicator
K970918
SUBMITTED BY 1.
Albert Browne Ltd. Chancery House Rosebery Road Anstey Leicester LE7 7EL United Kingdom
CONTACT PERSON
Alan Charlton Chancery House Rosebery Road Anstey Leicester LE7 7EL United Kingdom
DATE PREPARED
March 11, 1997
DEVICE NAME 2. .
Browne Steam Indicator
CLASSIFICATION NAME
Physical/chemical sterilization process indicator
Browne Steam Indicator Additional Information - K970918
Page B-1
1
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.
PREDICATE DEVICE 3.
3M Comply 1250 Steam Integrator Strips, 3M Health Care.
4. INTENDED USE
The Browne Steam Indicator is a process indicator to be used in a steam autoclave with a working range of 121-134°C to distinguish between processed and unprocessed units.
DEVICE DESCRIPTION ડ.
The Browne Steam Indicator is a paper strip with indicator ink pads on each end. The indicator ink pads change color from white to black through a brown intermediate in a steam autoclave working at 121-134°C (250-273°F).
TECHNOLOGICAL CHARACTERISTICS 6.
The Browne Steam Indicator consists of a paper strip with chemical indicator ink pads located on each end. The device is designed to be used 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 temperature-dependent chemical reaction.
PERFORMANCE TESTING 7.
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.
1 - 14 - 1
2
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 black with a brown intermediate. The time required for complete development of an end point response was ≥8 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 processing cycle in a steam autoclave with a working range of 121-134°C. The performance of the Browne Steam Indicator was equivalent to that of the predicate device.
All strips used for testing were ≥2 years from the date of manufacture, demonstrating that the 2-year expiration date is adequate to ensure accurate, reproducible performance.
Browne Steam Indicator Additional Information - K970918
స్టే
5/1/97
3
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 4 1997 Cynthia J.M. Nolte, Ph.D. ·Associate Consultant Medical Device Consultants, Incorporated 49 Plain Street North Attleboro, Massachusetts 02760-4153
Re : K970918 Trade Name: Browne Steam Indicator Regulatory Class: II Product Code: JOJ Dated: May 1, 1997 Received: May 2, 1997
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, qood 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. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (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. Please note: this response to your premarket notification 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.
4
Page 2 - Dr. Nolte
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) 594-4618. 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 qeneral 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 at (301) 443-6597.
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
5
510(k) Number (if known): K970918
Device Name: Browne Steam Indicator
Indications For Use:
The Browne Steam Indicator is a process indicator to be used in a steam autoclave with a The Drowne Decall Included in the first in distinguish between processed units.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Dovicoc
510(k) Number K970918
Prescription Use (Per 21 CFR 801.109) Over-The-Counter Use
Browne Steam Indicator Additional Information - K970918
5/1/97
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