(104 days)
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.
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).
The Browne Steam Indicator is a physical/chemical sterilization process indicator. Its intended use is to distinguish between processed and unprocessed units in a steam autoclave operating within a range of 121-134°C.
Here's a breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance Statement |
|---|---|
| Color Change | The strips should change color from white to black through a brown intermediate. |
| Response Time at 121°C | The time required for complete development of an end-point response at 121°C should meet an undefined threshold for effective sterilization. |
| Response Time at 134°C | The time required for complete development of an end-point response at 134°C should meet an undefined threshold for effective sterilization. |
| Distinguish Processed/Unprocessed | The device should be able to confirm exposure to a processing cycle in a steam autoclave with a working range of 121-134°C. |
| Equivalence to Predicate Device | The performance of the Browne Steam Indicator should be equivalent to that of the predicate device (3M Comply 1250 Steam Integrator Strips). |
| Expiration Date Adequacy | The 2-year expiration date should be adequate to ensure accurate, reproducible performance. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the numerical sample size for the test set (i.e., how many strips were tested). It mentions that "All strips used for testing were ≥2 years from the date of manufacture," which implies a sample was used, but the quantity is not provided.
The data provenance is retrospective in the sense that the strips tested had already been manufactured and aged for at least two years. The testing itself would then be prospective on these aged strips.
The country of origin for the data is implicitly United States, as the testing was conducted for submission to the FDA. The manufacturer is based in the United Kingdom, but the testing environment (BIER vessel conforming to ANSI/AAMI ST45-1992) suggests adherence to US standards for medical device testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of device (chemical indicator for sterilization) does not typically involve human expert interpretation of results to establish ground truth in the same way an AI diagnostic imaging system would. The "ground truth" for these indicators is objective chemical color change based on exposure to specific conditions. Therefore, no experts were explicitly used in a consensus or adjudication process for establishing the ground truth of the color change. The color change itself, and its timing, are the measurable outcomes.
4. Adjudication Method
Not applicable. As described above, the "ground truth" for this device is based on objective chemical reactions and physical measurements (time to color change), not subjective interpretation requiring adjudication among experts.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC comparative effectiveness study is not applicable to a physical/chemical sterilization process indicator. This type of study is typically used for diagnostic or screening devices where human readers interpret output (e.g., medical images) and their performance is compared with and without AI assistance. This device's function is a direct chemical reaction.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in essence. The "performance testing" described is a standalone evaluation of the device's chemical reaction and color change properties under controlled conditions in a BIER vessel. There is no "human-in-the-loop" component to the inherent function of the indicator itself, only observation of its final state (color change or lack thereof). The device functions autonomously based on chemical properties.
7. The Type of Ground Truth Used
The ground truth used is objective physical/chemical reaction data. Specifically, it's the observed color change (from white to black through brown) and the measured time required for this change to reach an end-point response at specified temperatures (121°C and 134°C). The absence of the expected color change under specific conditions also serves as a ground truth for "unprocessed."
8. The Sample Size for the Training Set
Not applicable. This device is a physical/chemical indicator, not a machine learning or AI-based device that requires a training set. Its function is based on chemical engineering and physical properties, not on learned patterns from data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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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
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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.
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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
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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.
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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
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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
Page A-1
§ 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).