The Browne TST Single Use Bowie-Dick Type Test Pack is a chemical sterilization process monitor which demonstrates adequate air removal and steam penetration during a 132°C (270°F) or 134°C (273°F) autoclave processing cycle by means of a yellow to blue color change.

Device Description

The Browne TST Single Use Bowie Dick Type Test Pack is a paper sheet containing an indicator figure wrapped in multiple layers of paper which is designed to monitor air removal and steam penetration during a 132 °C (270°F) or 134°C (273°F) steam autoclave processing cycle with a hold time of 3-4 minutes. The device changes color from yellow to blue when air removal during the cycle is sufficient to allow complete, even, steam penetration.

AI/ML Overview

This document describes the Browne TST Single Use Bowie-Dick Type Test Pack, a chemical sterilization process monitor. Here's an analysis of the acceptance criteria and the study information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Implied)	Reported Device Performance
Air Removal & Steam Penetration during Autoclave Processing: Demonstrates adequate air removal and steam penetration during a 132°C (270°F) or 134°C (273°F) autoclave processing cycle.	The device changes color from yellow to blue when air removal during the cycle is sufficient to allow complete, even, steam penetration.
Temperature Depression Sensitivity: Detects a ≥2℃ temperature depression at 132°C (270°F) or 134°C (273°F) in a test cycle of 3-4 minutes duration.	Performance testing showed that the sensitivity of the Test Packs is sufficient to detect a ≥2℃ temperature depression at 132°C (270°F) or 134°C (273°F) in a test cycle of 3-4 minutes duration.
Performance in Loaded Chamber: Sensitivity of the Test Pack is not affected by the presence of a loaded chamber.	Additional testing conducted in a loaded chamber demonstrated that the sensitivity of the Test Pack was not affected by the presence of the load.
Color Change Mechanism: Yellow to blue color change.	Achieves a yellow to blue color change.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state the sample size used for the performance testing. It refers to "performance testing" and "additional testing" without quantifying the number of tests conducted.

The data provenance is not explicitly stated as country of origin, retrospective or prospective. However, the submitter is from the United Kingdom, and the device is being submitted to the FDA in the US, suggesting the testing likely occurred in a calibrated lab environment for regulatory submission. The testing appears to be prospective, demonstrating the device's function under specified conditions.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

The document does not mention the use of human experts to establish ground truth for this device. This is a chemical indicator, where the "ground truth" is determined by the known physical conditions within the autoclave (e.g., successful steam penetration, specific temperature depression). The color change of the indicator itself is the output, and its accuracy is validated against the controlled physical parameters, not against human interpretation of an image or condition.

4. Adjudication Method for the Test Set:

Not applicable. As described above, the "ground truth" for a chemical indicator is the physical state of the autoclave, not an interpretation by human experts that would require adjudication. The color change is a direct physical response.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers interpret medical images or data, and the AI's impact on their performance is evaluated. The Browne TST Single Use Bowie-Dick Type Test Pack is a chemical indicator, not a diagnostic imaging device.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done:

Yes, a standalone performance assessment was conducted. The performance testing described evaluates the device's ability to accurately reflect the autoclave conditions (air removal, steam penetration, temperature depression) independently. The color change is a direct output of the device's chemical properties reacting to the environment, not requiring human interpretation as part of its primary function.

7. The Type of Ground Truth Used:

The ground truth used is based on physical parameters and controlled conditions within an autoclave. This includes:

Adequate air removal and steam penetration: Established by controlling the autoclave cycle to ensure these conditions are met.
Specific temperature depression: Artificially creating a ≥2℃ temperature depression to test the device's sensitivity.
Loaded vs. Unloaded Chamber: Testing under both conditions to see if the device's performance is affected.

The color change of the indicator then correlates with these known physical states.

8. The Sample Size for the Training Set:

The concept of a "training set" is not applicable here. This device is a passive chemical indicator, not an AI/machine learning algorithm that requires training data. Its function is based on fixed chemical properties.

9. How the Ground Truth for the Training Set was Established:

Not applicable, as there is no training set for a chemical indicator.

Summary

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K 971971/
July 10, 1998

510(k) SUMMARY Browne TST Single Use Bowie-Dick Type Test Pack April 3, 1998

SUBMITTER NAME AND ADDRESS 1.

Mr. Alan Charlton Albert Browne Ltd. 190 Waterside Road Hamilton Industrial Park Leicester LE5 1QZ United Kingdom

DEVICE NAME 2.

Proprietary Name:	Browne TST Single Use Bowie-Dick Type Test Pack
Common/Usual Name:	Bowie-Dick Test
Classification Name:	Physical/Chemical Process Indicator

PREDICATE DEVICE 3.

Browne TST Single Use Bowie-Dick Type Test Pack, subject of K932057

4. INTENDED USE

5. DEVICE DESCRIPTION

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TECHNOLOGICAL CHARACTERISTICS 6.

The device is composed of an indicator sheet, containing the indicator ink figure. The indicator sheet is wrapped in layers of paper which serves as a barrier to steam penetration. The chemical composition of the ink controls the temperature required for a color change to occur in the presence of complete, even steam penetration. A circular process indicator is affixed to the test pack label which changes color from yellow to blue when exposed to steam.

PERFORMANCE TESTING 7.

Performance testing has been conducted which showed that the sensitivity of the Test Packs is sufficient to detect a ≥2℃ temperature depression at 132°C (270°F) or 134°C (273°F) in a test cycle of 3-4 minutes duration. The data supports the use of the Test Pack to monitor air removal during a steam autoclave processing cycle. Additional testing conducted in a loaded chamber demonstrated that the sensitivity of the Test Pack was not affected by the presence of the load.

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Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and features an eagle with its wings spread. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are written around the top of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 0 1998

Albert Browne Ltd. C/O Cynthia J.M. Nolte, Ph.D. Associate Consultant Medical Device Consultants, Incorporated 49 Plain Street North Attleboro, Massachusetts 02760

K971971 Re : Browne TST Single Use Bowie-Dick Type Test Trade Name: Pack Regulatory Class: II Product Code: JOJ Dated: June 8, 1998 Received: June 9, 1998

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 legally marketed predicate 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, 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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (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 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

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Page 2 - Dr. Nolte

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 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 premarket notification" (21CFR 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/dsma/dsmamaing.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 .

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510(k) Number (if known): K971971

Device Name: Browne TST Single Use Bowie-Dick Type Test Pack

Indications For Use:

The Browne TST Single Use Bowie-Dick Type Test is a chemical sterilization process monitor which demonstrates adequate air removal and steam penetration during a 132°C (270°F) or 134°C (273°F) autoclave processing cycle by means of a yellow to blue color change.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Olin S. Lin

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use X

Browne TST Single Use Bowie-Dick Type Test Additional Information - K971971

CONFIDENTIAL 4/3/98

Page A-1

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).