The Verify® Steam Indicators are emulating indicators intended for use in steam sterilization. The Verify® Steam Indicators change color from yellow to blue/purple when exposed to the appropriate cycle temperature, type, and duration. The indicator models and their cycle temperatures, types, and times are:

MODEL	TEMPERATURE	STERILIZATION TYPE	TIME
Verify 250F 30	250°F (121°C)	gravity steam	30 minutes
Verify 270F 15	270°F (132°C)	gravity steam	15 minutes
Verify 270F 3-10	270°F (132°C)	gravity flash steam	3 or 10 minutes
Verify 270F 4	270°F (132°C)	Steam Flush Pressure Pulse(SFPP), pre-vacuum andExpress steam	4 minutes

Device Description

The proposed Verify® Steam Indicators consist of a 22mm x 143 mm strip (7/8" x 5.6") with a 12 mm circular chemical indicator ink spot (or two spots in the case of the 270°F 3-10 Indicator) located on one end, adjacent to a reference circle exhibiting the endpoint color. The indicator ink on the proposed Verify® Steam Indicators changes from yellow to blue/purple color when the steam sterilization cycle is complete.

The Verify® 250°F 30 Indicator can be used to monitor a 30 minute . 250°F/121°C gravity steam sterilization cycle.
The Verify® 270°F 15 Indicator can be used to monitor a 15 minute . 270°F/132°C gravity steam sterilization cycle.
The Verify® 270°F 3-10 Indicator can be used to monitor a 3 minute or10 . minute 270°F/132°C gravity flash steam sterilization cycle.
The Verify® 270°F 4 Indicator can be used to monitor a 4 minute . 270 F/132°C SFPP, pre-vacuum and Express steam sterilization cycle.

AI/ML Overview

Acceptance Criteria and Device Performance Study for Verify® Steam Indicators

This document summarizes the acceptance criteria and the performance study for the Verify® Steam Indicators, based on the provided 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

The Verify® Steam Indicators are intended to meet the requirements for emulating [Class 6] indicators as defined in ANSI/AAMI/ISO 11140-1:2005. While specific numerical acceptance criteria (e.g., color change within a certain percentage of exposure time) are not explicitly detailed in the provided text, the overall acceptance criterion is the successful color change from yellow to blue/purple when exposed to the proper time and temperature of the designated steam sterilization cycle, in accordance with the standard.

Acceptance Criterion (Implicit from ANSI/AAMI/ISO 11140-1:2005 for Class 6 Indicators)	Reported Device Performance (as stated in the document)
Emulate Class 6 Steam Indicators requirements	The performance of the Verify® Steam Indicators meets the requirements of ANSI/AAMI/ISO 11140-1:2005 for emulating [Class 6] steam indicators.
Specific Cycle Parameters for Color Change:	The indicators change color from yellow to blue/purple when exposed to the appropriate cycle temperature, type, and duration.
250°F 30 Indicator: 250°F (121°C) gravity steam, 30 minutes	Monitor a 30 minute, 250°F/121°C gravity steam sterilization cycle, changing from yellow to blue/purple.
270°F 15 Indicator: 270°F (132°C) gravity steam, 15 minutes	Monitor a 15 minute, 270°F/132°C gravity steam sterilization cycle, changing from yellow to blue/purple.
270°F 3-10 Indicator: 270°F (132°C) gravity flash steam, 3 or 10 minutes	Monitor a 3 minute or 10 minute 270°F/132°C gravity flash steam sterilization cycle, changing from yellow to blue/purple.
270°F 4 Indicator: 270°F (132°C) SFPP, pre-vacuum and Express steam, 4 minutes	Monitor a 4 minute, 270°F/132°C SFPP, pre-vacuum and Express steam sterilization cycle, changing from yellow to blue/purple.

2. Sample Size and Data Provenance

Test Set Sample Size: The document does not specify the exact sample size for the test set. It broadly states that "Performance testing was conducted."
Data Provenance: The document does not explicitly state the country of origin for the data or whether the study was retrospective or prospective. Given that STERIS Corporation is based in Mentor, OH, USA, and the 510(k) submission is to the FDA, it is likely the testing was conducted in the USA or under US regulatory guidelines. The testing appears to be prospective, as it was conducted to verify that the proposed indicators meet the requirements.

3. Number of Experts and Qualifications for Ground Truth

The document does not mention the use of experts to establish ground truth for the test set. The ground truth for chemical indicators typically relies on objective physical/chemical changes observable by trained personnel, often against a reference or standard, rather than expert interpretation of complex images or data.

4. Adjudication Method

As no experts are mentioned for establishing ground truth, there is no adjudication method described. The assessment of chemical indicator performance is usually a direct, objective observation of color change against a specified endpoint color (blue/purple in this case).

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

No MRMC comparative effectiveness study was done. Chemical indicators are read directly for color change, which is a straightforward observation, not requiring the same type of interpretative analysis as, for example, medical imaging.

6. Standalone Performance (Algorithm Only) Study

Yes, a standalone performance study was done. The "Performance Testing" section states: "Performance testing was conducted to verify that the proposed indicators meet the requirements for emulating [Class 6] indicators as defined in ANSI/AAMI ISO 11140-1:2005 using a resistometer to ANSVAAMI ISO 18472." This indicates that the performance of the indicators themselves (the "algorithm only" in a broader sense of device function) was tested against the standards without human interpretation as part of the core performance evaluation, although humans would visually confirm the color change.

7. Type of Ground Truth Used

The ground truth used is based on objective performance standards and physical/chemical properties. Specifically, the ground truth is established by the requirements of ANSI/AAMI/ISO 11140-1:2005 for emulating [Class 6] indicators, and the testing was conducted using a resistometer to ANSI/AAMI ISO 18472. This means the indicators were exposed to precisely controlled sterilization conditions (time, temperature, steam presence) and their color change was assessed against the expected outcome defined by these international standards.

8. Sample Size for the Training Set

The document does not describe a "training set" in the context of an algorithm or machine learning. For a chemical indicator, the manufacturing process and quality control would ensure consistency, but there isn't a "training set" as understood in AI studies. The development process would involve iterative design and testing to optimize the ink formulation and strip design to achieve the desired performance characteristics.

9. How Ground Truth for the Training Set Was Established

As there is no "training set" for an algorithm in this context, the question of how its ground truth was established is not applicable. The development of the chemical indicator itself would have relied on scientific principles of dye chemistry and material science, with iterative testing against known steam sterilization parameters to ensure the correct reaction.

Summary

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Image /page/0/Picture/0 description: The image shows the word "STERIS" in a bold, sans-serif font, with the registered trademark symbol next to it. Below the word is a graphic of several horizontal wavy lines stacked on top of each other. Underneath the graphic is the alphanumeric code "K070461" in a handwritten style.

510(k) Summary For Verify® Steam Indicators

. JUL 1 7 2007

STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 639-4459

Contact:

Richard Bancroft Development and Technical Service Director

Telephone: 011 44 116 2747337 Fax No: 011 44 116 2768639

Date Prepared:

June 12, 2007

STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600

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1. Device Name

Indicators Models:	Verify® 250°F 30 IndicatorVerify® 270°F 15 IndicatorVerify® 270°F 3-10 IndicatorVerify® 270°F 4 Indicator
Common Name:	Chemical Indicator
Classification Name:	Physical/chemical sterilization process indicator (21 CFR 880.2800 (b), Product Code JOJ).

2. Predicate Devices

. 3M SteriGage Chemical Indicators
. DANA SteriScan Indicators
. SteriTec Integraph (Cardinal Steam Integrators )
STERIS Verify Integrators ●

3. Device Description

The Verify® 250°F 30 Indicator can be used to monitor a 30 minute . 250°F/121°C gravity steam sterilization cycle.
The Verify® 270°F 15 Indicator can be used to monitor a 15 minute . 270°F/132°C gravity steam sterilization cycle.
The Verify® 270°F 3-10 Indicator can be used to monitor a 3 minute or10 . minute 270°F/132°C gravity flash steam sterilization cycle.
The Verify® 270°F 4 Indicator can be used to monitor a 4 minute . 270 F/132°C SFPP, pre-vacuum and Express steam sterilization cycle.

1 Cardinal is a private label brand produced by Steritec under K960441.

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4. Intended Use

The Verify® Steam Indicators are chemical indicators intended for use by health care providers to accompany products being sterilized through a sterilization procedure. The indicators change color from yellow to blue/purple when exposed to the proper time and temperature of the designated steam sterilization cycle. The performance of the Verify® Steam Indicators meets the requirements of ANSI/AAMI / ISO 11140-1:2005 for emulating [Class 6] steam indicators.

5. Description of Safety and Substantial Equivalence

The proposed and predicate devices are all single use indicators for use in steam sterilization cycles. The differences between the proposed bundled Verify® Steam Indicators and predicate devices are limited to differences in design, material, and parameters of the sterilization cycles these indicators are designed to monitor. These differences do not raise any new issues of safety and efficacy.

6. Performance Testing

Performance testing was conducted to verify that the proposed indicators meet the requirements for emulating [Class 6] indicators as defined in ANSVAAMI ISO 11140-1:2005 using a resistometer to ANSVAAMI ISO 18472.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and three human figures below it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

JUL 17 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. John Scoville Regulatory Affairs Sterilization Technology Steris Corporation 5960 Heisley Road Mentor, Ohio 44060

Re: K070461

Trade/Device Name: Verify® Steam Indicators Regulation Number: 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: JOJ Dated: June 22, 2007 Received: June 26, 2007

Dear Mr. Scoville:

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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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 vours.

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

K070461 510(k) Number (if known):

Device Name:

Verify® Steam Indicators

Indications For Use:

MODEL	TEMPERATURE	STERILIZATION TYPE	TIME
Verify 250F 30	250°F (121°C)	gravity steam	30 minutes
Verify 270F 15	270°F (132°C)	gravity steam	15 minutes
Verify 270F 3-10	270°F (132°C)	gravity flash steam	3 or 10 minutes
Verify 270F 4	270°F (132°C)	Steam Flush Pressure Pulse(SFPP), pre-vacuum andExpress steam	4 minutes

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

Over-The-Counter Use ___X (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Luke A Murphy /s
(Division Sign-Off)

Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number K070464

Page 1 of 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).