The Albert Browne Ltd. VERIFY® STEAM and EO Load Record Card 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) or an ethylene oxide sterilization process.

Device Description

The proposed VERIFY® STEAM and EO Load Record Card is a 5"x3" card containing space for recording information regarding the load to be processed and two indicator ink strips applied to the card using a rotary screen printing method. The indicator ink strips are steam and ethylene oxide-sensitive indicators that change color following exposure to the appropriate sterilant.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Albert Browne Ltd. VERIFY® STEAM and EO Load Record Card:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
For Steam Sterilization:
Visual color change when exposed to steam (121°C to 135°C)	Undergoes a visual color change from Blue to Black when exposed to steam in a temperature range of 121°C to 135°C (250°F to 275°F).
Indicator inks and substrate perform as intended.	The indicator inks (identical to K060103) and substrate perform as intended based on testing provided in K060103.
For Ethylene Oxide (EO) Sterilization:
Visual color change when exposed to an ethylene oxide process.	Undergoes a visual color change from Orange to Red when exposed to an ethylene oxide sterilization process.
Indicator inks and substrate perform as intended.	The indicator inks (identical to K991418) and substrate perform as intended based on testing provided in K991418.
Overall performance under "in use conditions"	Albert Browne Ltd. has performed testing which demonstrates that the indicators perform as intended under in use conditions. (Specific results for "in use conditions" are not detailed in this summary, but the overall statement implies satisfactory performance).
Manufacturing process (rotary screen printing) performs as intended	The printing process used for application of the indicator inks to the substrate is identical to that used for the predicate devices (K991418 and K060103), implying consistent manufacturing quality.

Explanation of Implied Acceptance Criteria: The document primarily focuses on demonstrating substantial equivalence to predicate devices, rather than explicitly stating quantitative acceptance criteria. Therefore, the acceptance criteria are inferred from the device's intended use and the performance characteristics described for both the proposed and predicate devices. The core criterion is the reliable and accurate visual color change upon exposure to the specified sterilization processes within the defined temperature ranges.

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

The provided 510(k) summary does not explicitly state the sample size used for the test set.

Data Provenance: The studies referenced (K991418 and K060103) were conducted by Albert Browne Ltd., a UK-based company. This suggests the data provenance is likely from United Kingdom laboratories/facilities. The studies were retrospective in the sense that the results from previous submissions were used to support the current device. However, the current submission also states that Albert Browne Ltd. performed additional testing for "in use conditions," which would be more prospective.

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

The document does not provide information on the number or qualifications of experts used to establish ground truth for the test set. Given that the device is a chemical indicator with a clear visual output, ground truth would likely be established through physical/chemical laboratory testing and adherence to recognized standards, rather than expert interpretation of complex images or clinical outcomes.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method. For a chemical indicator with a distinct color change, adjudication (in the sense of resolving conflicting interpretations) is usually not applicable. The assessment would likely involve objective observation of the color change against a reference and/or instrumental analysis to confirm the chemical reaction, rather than subjective human interpretation requiring consensus.

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 used for diagnostic imaging devices where human readers interpret medical images, often with and without AI assistance, to assess the impact of AI on diagnostic accuracy. The VERIFY® STEAM and EO Load Record Card is a chemical process indicator, not a diagnostic imaging device.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

The concept of "standalone performance" for this device is not directly applicable in the way it is used for AI algorithms. The device itself is standalone in its function as a chemical indicator. Its performance is evaluated by observing the chemical reaction (color change) to a sterilization process. There is no "algorithm" in the conventional AI sense for this mechanical/chemical device. The performance data comes from laboratory tests validating the chemical reaction to sterilant exposure.

7. The Type of Ground Truth Used

The ground truth used for this device would be based on physical and chemical validation against established sterilization parameters. This means:

Known sterilization conditions: Exposing the indicators to precisely controlled steam (at specified temperature and time) or ethylene oxide (at specified concentration, humidity, temperature, and time) processes.
Failure conditions: Exposing the indicators to suboptimal or failed sterilization cycles to ensure they do not change color or show an inappropriate change.
Reference standards: Comparing the observed color change to a known standard representing a successful sterilization.

Essentially, the "ground truth" is the objective physical and chemical reality of whether adequate sterilization conditions were met.

8. The Sample Size for the Training Set

The concept of a "training set" is not directly applicable to this device. This product is a chemical indicator, not an AI/machine learning algorithm that requires data for training. The performance of the indicator is based on its inherent chemical properties, validated through laboratory experiments, not on a machine-learning model trained on data.

9. How the Ground Truth for the Training Set Was Established

As stated above, there is no "training set" in the context of AI/machine learning for this device. The chemical properties of the indicator inks were developed and tested based on established scientific principles of chemical reactions to heat, steam, and ethylene oxide. The ground truth for their performance was established through rigorous physical and chemical laboratory testing as described in point 7.

Summary

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510(k) Summary

AUG 2 5 2006

Albert Browne Ltd. VERIFY® STEAM and EO Load Record Card

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: August 10, 2006

DEVICE NAME: 2. VERIFY® STEAM and EO Load Record Card 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 DEVICES

Browne MVI Ethylene Oxide Indicator (K991418) .
Albert Browne, Ltd. VERIFY® STEAM Value Indicators (K060103) ●
Steam/EO Record Card (K000502) ●

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4. INTENDED USE

The Albert Browne Ltd. VERIFY® STEAM and EO Load Record Card contains 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) or an ethylene oxide sterilization process.

5. DEVICE DESCRIPTION

6. TECHNOLOGICAL CHARACTERISTICS

The indicator inks and substrate used for the manufacture of the proposed VERIFY® STEAM and EO Load Record Card are identical to those described in K991418 and K060103 for the Browne MVI Ethylene Oxide Indicator and Albert Browne, Ltd. VERIFY® STEAM Value Indicators, respectively. The printing process used for application of the indicator inks to the substrate is also identical for the proposed and predicate devices. A tabular comparison of the proposed and predicate devices is provided on the following page.

7. PERFORMANCE TESTING

Testing was provided in K991418 and K060103 to validate the indicator inksubstrate combinations for use in confirming exposure to ethylene oxide and steam sterilization processes, respectively. Albert Browne Ltd. has performed testing which demonstrates that the indicators perform as intended under in use conditions.

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TechnologicalCharacteristics	VERIFY®STEAM and EO Load Card(proposed)	BrowneMVI Ethylene Oxide Indicator(K991418)	VERIFY®STEAM Value Indicators(K060103)	SteriTec Products, Inc.Steam/EO Record Card(K000502)
Intended Use		Confirm exposure to a sterilant	Confirm exposure to a sterilant through a visible color change
Sterilization Processes	• Steam• EO	EO	Steam	• Steam• EO
Color change	• Blue to black (steam)• Orange to red (EO)	Orange to red	Blue to black	• Blue to black (steam)• Yellow to brown (EO)
Materials of Construction	• Steam and EO-sensitive indicator inks1• paper substrate2	• EO-sensitive indicator ink• paper substrate	• Steam-sensitive indicator ink• paper substrate	• Steam and EO-sensitive indicator inks• Unknown substrate
Disposable	Yes	Yes	Yes	Yes
Sterile	No	No	No	No

omparison Chart for Determination of Substantial Equivaler

$\underset{O}{\overset{O}{||}}$
Ethylene oxide

The steam and EO-sensitive indicator inks are identical to the inks described and tested in K060103 and K991418.

19 ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name in a circular arrangement around a stylized caduceus symbol. The caduceus is a symbol of medicine and health, and it is often used to represent healthcare organizations. The seal is a symbol of the department's mission to protect the health of all Americans and to provide essential human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Albert Browne Limited C/O Dr. Cynthia J. M. Nolte Senior Staff Consultant Medical Device Consultants, Incorporated 49 Plain Street North Attleboro, Massachusetts 02760

AUG 2 5 2006

Re: K061738

Trade/Device Namc: Albert Browne Ltd. VERIFY STEAM and EO Load Record Card Regulation Number: 880.2800 Regulation Name: Sterilization Process Indication Regulatory Class: II Product Code: JOJ Dated: August 10, 2006 Received: August 11, 2006

Dear Dr. 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 - Dr. 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 vour 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,

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): K061738

Device Name: Albert Browne Ltd. VERIFY® STEAM and EO Load Record Card

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

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

The Course of Children Children Children Children

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Shady H. Murphy KD 8/24/01

Anesthesiology, General Hosp. al Control, Dantal Devices

umber: K 061738

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).