The Albert Browne Ltd. VERIFY® STEAM Value Indicators are process indicators that undergo a visual color change when exposed to steam in a temperature range of 121°C to 135°C (250°F to 275°F).

Device Description

Similar to the parent Modified Browne Packaging and Label Steam Process Indicator, the proposed VERIFY® STEAM Value Indicators consists of indicator ink applied to a suitable substrate, i.e. packaging material, self-adhesive labels, tapes, tags, inserts, etc. Modifications to the parent indicator to produce the proposed VERIFY® STEAM Value Indicators included changes to the indicator ink composition, modification to the process used for application of the indicator ink to the substrates, and minor changes to the suite of compatible substrates. The modifications to the indicator ink composition were made to produce two variants with different color change schemes and improve the "printability" of the ink.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the VERIFY® STEAM Value Indicators:

It's important to note that the provided text is a 510(k) summary, which often provides a high-level overview. Therefore, specific details common in a full study report (like detailed sample sizes for all tests, ground truth methods for training sets, or MRMC study results) are not always present in this type of document.

Acceptance Criteria and Device Performance Study for VERIFY® STEAM Value Indicators

1. Table of Acceptance Criteria and Reported Device Performance

The provided document refers to the ANSI/AAMI ST60 standard for Class I process indicators for steam sterilization as the basis for acceptance criteria. The document states that testing demonstrates compliance with "applicable requirements." However, it does not explicitly list specific numerical acceptance criteria from this standard or the precise results demonstrating conformance against those criteria. It only provides a general statement of compliance.

Hypothetical Table (based on general understanding of Class I indicators and implied performance):

Acceptance Criterion (from ANSI/AAMI ST60 for Class I)	Reported Device Performance
Visual Color Change Range: Change from initial color to final color when exposed to steam.	"undergo a visual color change when exposed to steam"
Activation Temperature Range: Color change occurs within specified temperature range.	"in a temperature range of 121℃ to 135℃ (250°F to 275°F)"
Non-Exposure Indication: No color change when not exposed to sterilant.	Implied to be met, but not explicitly stated.
Stability (Shelf-life): Maintain performance over specified shelf-life.	Not explicitly stated in the provided text.
Substrate Compatibility: Perform as designed on compatible substrates.	"performed as designed under in use conditions using all of the compatible substrates."
"Printability" and Ink Composition: Improved and two variants for color change schemes.	"two variants with different color change schemes and improve the 'printability' of the ink."

Note: The provided text primarily focuses on the intended use and modifications rather than a detailed breakdown of quantitative acceptance criteria and results. The statement "Albert Browne Ltd. has performed testing which demonstrates that the VERIFY® STEAM Value Indicators conform to the applicable requirements of ANSI/AAMI ST60" is the primary evidence of meeting acceptance criteria.

2. Sample Size for Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated. The document refers to "testing" and "additional testing" but does not provide specific numbers of indicators or test runs.
Data Provenance: The testing was performed by "Albert Browne Ltd.", the manufacturer, which is based in the United Kingdom. The description implies prospective testing conducted specifically for this submission, as it discusses demonstrating conformance and performance "under in use conditions."

3. Number of Experts and Qualifications for Ground Truth for Test Set

The document does not specify the number of experts used or their qualifications for establishing ground truth for the test set. For a physical/chemical indicator, ground truth is typically established by the physical parameters of the test (e.g., verified steam sterilization cycles, controlled temperature environments) and objective observation of the color change. The "ground truth" here is the physical conditions applied to the indicator, not necessarily subjective expert interpretation of the indicator's performance against a human gold standard.

4. Adjudication Method for Test Set

Not applicable/Not specified. Given the nature of a chemical indicator (a binary outcome of color change/no color change, or specific color transition), adjudication by multiple human observers in the way medical imaging requires is typically not relevant. The assessment of whether a color change occurred is generally objective and may be performed by trained technicians.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This type of study is not applicable to a physical/chemical sterilization process indicator. MRMC studies are used for diagnostic interpretation of complex data (like medical images) where human readers are making subjective judgments, and the goal is to evaluate if an AI tool improves their diagnostic accuracy or efficiency. A steam indicator's function is a direct chemical reaction, not subject to human interpretation in the same way.

6. Standalone Performance Study (Algorithm Only)

Yes, implicitly. The entire performance testing described ("Albert Browne Ltd. has performed testing which demonstrates that the VERIFY® STEAM Value Indicators conform to the applicable requirements of ANSI/AAMI ST60 for Class I process indicators for steam sterilization") is a standalone performance assessment of the indicator itself. There is no "human-in-the-loop" once the indicator is placed in the sterilizer; its performance is entirely dependent on its chemical composition and the physical conditions. The "algorithm" here is the chemical reaction of the indicator ink.

7. Type of Ground Truth Used

The ground truth is based on physical parameters and standards. The indicators are subjected to controlled steam sterilization conditions that are themselves validated against established performance standards (e.g., temperature, time, steam quality). The "ground truth" is that these specific, controlled conditions were met, and the indicator's proper color change response confirms it functioned as expected under those conditions. The ANSI/AAMI ST60 standard provides the benchmarks for these physical parameters.

8. Sample Size for the Training Set

Not applicable/Not explicitly stated. For a chemical indicator, there isn't typically a "training set" in the sense of machine learning algorithms. The development process involves chemical formulation and iterative testing/refinement by the manufacturer. If one were to loosely interpret "training," it would be the cumulative R&D and calibration work to achieve a reliable chemical reaction, but this wouldn't have a distinct "sample size" in the same way an AI model's training data would.

9. How Ground Truth for the Training Set was Established

Not applicable/Not explicitly stated. As there isn't a "training set" in the machine learning sense, the method for establishing ground truth for it is not provided. The development of such indicators relies on chemical engineering principles, experimental testing, and adherence to performance specifications, where the "ground truth" during development is the consistent and accurate response of the chemical formulation to defined physical conditions.

Summary

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Special 510(k) Summary Albert Browne Ltd. VERIFY® STEAM Value Indicators

K060103

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

Telephone: 0116 276 8636

DATE PREPARED: January 11, 2006

1. DEVICE NAME: VERIFY® STEAM Value Indicators
  CLASSIFICATION NAME: Physical/chemical sterilization process indicator

CLASSIFICATION STATUS: Physical/chemical process indicators are classified as Class II under Sterilization process indicator in 21 CFR 880.2800 (Product Code JOJ) by the General Hospital and Personal Use Devices Panel

3. PREDICATE DEVICE

Modified Browne Packaging and Label Steam Process Indicator (K032801) .

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INTENDED USE র্ব .

The VERIFY® STEAM Value Indicators are process indicators that undergo a visual color change when exposed to steam in a temperature range of 121℃ to 135℃ (250°F to 275°F).

ഗ് DEVICE DESCRIPTION

6. TECHNOLOGICAL CHARACTERISTICS

Both the proposed and predicate devices consist of indicator ink applied to a substrate. The indicator ink changes color to confirm exposure to steam. The substrates used to support the indicator ink are similar for the proposed and predicate devices. Changes were made to the indicator ink formulation to produce two different color change schemes and improve the "printability" of the ink. However, the chemical reaction that induces the indicator ink to change color is identical for the parent and proposed indicators.

7. PERFORMANCE TESTING

Albert Browne Ltd. has performed testing which demonstrates that the VERIFY® STEAM Value Indicators conform to the applicable requirements of ANSI/AAMI ST60 for Class I process indicators for steam sterilization. Additional testing confirmed that the indicators performed as designed under in use conditions using all of the compatible substrates.

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MAR 7

2006

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three overlapping wings, symbolizing health, human services, and well-being. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Albert Browne Limited C/O Ms. Cynthia J.M. Nolte Medical Device Consultants 49 Plain Street North Attleboro, Massachusetts 02760

Re: K060103

Trade/Device Name: Albert Browne Limited VERIFY® STEAM Value Indicators Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization process indicator Regulatory Class: II Product Code: JOJ Dated: February 27, 2006 Received: March 1, 2006

Dear Ms. Nolte:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Cynthia J.M. Nolte

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Susan Phono
Chiu Lin, Ph.D.

Director Division of Anesthesiology, General Hospital , Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): Kaown 3

Device Name: Albert Browne Ltd. VERIFY® STEAM Value Indicators

Indications for Use:

The Albert Browne Ltd. VERIFY® STEAM Value Indicators are process indicators that undergo a visual color change when exposed to steam in a temperature range of 121°C to 135°C (250°F to 275°F).

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use X (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Shula H. Murphy 3/7/66

Radiology, General Hospital
National Dental Devices
Koloa 3

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).