The Browne Packaging and Label Steam Process Indicator is a process indicator which undergoes a visual color change when exposed to steam in a temperature range of 121°C to 134°C (250°F to 273°F).

Device Description

The Packaging and Label Steam Indicator is a chemical indicator consisting of indicator ink applied to a suitable substrate. The indicator ink changes color from pink to purple in a steam autoclave in a temperature range of 121°C to 134°C (250°F to 273°F).

The purpose of this submission is to:
. Replace the process indicator on the outer wrapper of the Browne TST Single Use Bowie Dick Type Test Pack (Browne Bowie Dick Test Pack, K971971) with the Packaging and Label Steam Indicator;
Market the Packaging and Label Steam Indicator, consisting of indicator ink . printed onto clay-coated label stock with permanent or peelable adhesive and a siliconized backing.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Browne Packaging and Label Steam Process Indicator:

Upon reviewing the provided 510(k) summary, it's important to note that this document describes a physical/chemical sterilization process indicator (Class II), not a diagnostic medical device that would typically involve a "device performance" metric like sensitivity or specificity. Therefore, many of the requested categories in your prompt that pertain to diagnostic performance (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance) are not directly applicable or reported in the context of this type of device submission.

The "device performance" for this process indicator is its ability to reliably change color when exposed to specific steam sterilization conditions and to maintain its properties over its shelf life.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria (if available)	Reported Device Performance
Visual Color Change	Changes color as designed	Changes color from pink to purple when exposed to steam in a temperature range of 121°C to 134°C (250°F to 273°F).
Conformity to Standard	Conforms to ANSI/AAMI ST60 requirements for Class I process indicators for steam sterilization.	Testing demonstrated conformity to applicable requirements of ANSI/AAMI ST60.
Response Time	(Implicitly, to confirm adequate exposure within a given cycle)	Changed color after approximately 2.5 minutes exposure to a 132°C autoclave processing cycle.
Shelf Life	Two-year shelf life	Data was provided to support a two-year shelf life.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not explicitly stated in the provided document. The term "testing" is used generally.
Data Provenance: Not explicitly stated, but the manufacturer is Albert Browne Ltd., located in the United Kingdom. Given the nature of a product test, it can be inferred that the testing was conducted prospectively on samples of the device being submitted.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable in the context of this device. The "ground truth" for a chemical indicator is the physical state of the indicator itself (color change) after being subjected to a defined physical environment (steam sterilization cycle). This is a direct physical observation, not an interpretation requiring expert consensus.

4. Adjudication method for the test set

Not applicable. As noted above, the outcome (color change) is an objective physical observation, not a subjective interpretation requiring adjudication among experts.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a chemical process indicator, not a diagnostic device involving human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is a physical chemical indicator, not an algorithm or AI system.

7. The type of ground truth used

The ground truth used is the physical state determined by exposure to known sterilization parameters. For example:

Exposure to a 132°C autoclave for 2.5 minutes should result in a color change.
Exposure to conditions below the threshold (e.g., lower temperature, shorter time) should not result in a complete color change.
The color change observed is the direct physical "truth" of the indicator's performance under those conditions.

8. The sample size for the training set

Not applicable. This is a physical chemical indicator, not a machine learning model that requires a training set.

9. How the ground truth for the training set was established

Not applicable. See point 8.

Summary

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ABBREVIATED 510(K) SUMMARY ALBERT BROWNE LTD. BROWNE PACKAGING AND LABEL STEAM PROCESS INDICATOR

K992767

1. Albert Browne Ltd. SUBMITTED BY: Chancery House 190 Waterside Road Hamilton Industrial Park Leicester LE5 1QZ United Kingdom
- CONTACT PERSON: Alan Charlton Chancery House 190 Waterside Road Hamilton Industrial Park Leicester LE5 1QZ United Kingdom

November 8, 1999 Date Prepared:

1. Browne Packaging and Label Steam Process Indicator DEVICE NAME: Physical/chemical sterilization process indicator Classification Name: Classification Status: Physical/chemical process indicators are classified as
- Class II under Sterilization process indicator in 21 CFR 880.2800 by the General Hospital and Personal Use Devices Panel.

3. PREDICATE DEVICE

3M Autoclave Tape, 3M Health Care (K932129)

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INTENDED USE 4.

The Browne Packaging and Label Steam Process Indicator (Packaging and Label Steam Indicator) is a process indicator which undergoes a visual color change when exposed to steam in a temperature range of 121°C to 134°C (250°F to 273°F).

5. DEVICE DESCRIPTION

The purpose of this submission is to:

. Replace the process indicator on the outer wrapper of the Browne TST Single Use Bowie Dick Type Test Pack (Browne Bowie Dick Test Pack, K971971) with the Packaging and Label Steam Indicator;
Market the Packaging and Label Steam Indicator, consisting of indicator ink . printed onto clay-coated label stock with permanent or peelable adhesive and a siliconized backing.

6. TECHNOLOGICAL CHARACTERISTICS

The technological characteristics of the Packaging and Label Steam Indicator and the 3M Autoclave Tape are similar. The proposed and predicate devices consist of indicator ink applied to a substrate. The indicator ink changes color to confirm exposure to steam. The proposed device changes color from pink to purple and the predicate device changes color from off white to brown.

The predicate device is composed of indicator ink applied to a paper substrate. The Packaging and Label Steam Indicator consists of indicator ink applied using a printing method to steam sterilizable paper or clay-coated label stock.

Browne Packaging and Label Steam Process Indicator 11/8/99 Additional Information - K992767

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7. PERFORMANCE TESTING

Albert Browne Ltd. has performed testing which demonstrates that the Browne Packaging and Label Steam Indicator conform to the applicable requirements of ANSI/AAMI ST60 for Class I process indicators for steam sterilization. Additional testing showed that the indicator changed color after approximately 2.5 minutes exposure to a 132°C autoclave processing cycle. Data was provided to support a two-year shelf life.

Browne Packaging and Label Steam Process Indicator 11/8/99 い Additional Information - K992767

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Image /page/3/Picture/2 description: The image shows a logo for the Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized lines that resemble a person or a bird.

JAN 1 0 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Cynthia J.M. Nolte, Ph.D., RAC Staff Consultant Medical Device Consultants, Incorporated 49 Plain Street North Attleboro, MA 02760

K992767 Re : Browne Packaging and Label Steam Process Trade Name: Indicator Class: II Product Code: JOJ Dated: November 8, 1999 Received: November 9, 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 qeneral 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. A 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 requlatory action. In addition, FDA may publish further announcements concerning your device in

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Page 2 & Dr. Nolte

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 obligation you might have 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 requlation (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" (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.fdaf.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski
Director

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): K992767

Device Name: Browne Packaging and Label Steam Process Indicator

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Olin S. Lakin
(Division Sign Off)

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

Prescription Use

Over-The-Counter Use

(Per 21 CFR 801.109)

Albert Browne Ltd. 8/16/99 Packaging and Label Steam Indicator 510(k)

CONFIDENTIAL Page vii

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).