The STERIS STEAM n is a process indicator that undergoes a visual color change from a pink to copper color when exposed to the following steam sterilization cycle parameters:

121℃ (250°F), 30 min, steam sterilization gravity cycle ●
. 132°C (270°F), 15 min, steam sterilization gravity cycle
135℃ (275ºF), 10 min, steam sterilization gravity cycle ●
132°C (270°F), 4 min, steam sterilization dynamic air removal cycle .
135°C (275ºF), 3 min, steam sterilization dynamic air removal cycle .

Device Description

The proposed STERIS STEAM n is composed of a single ink printed on polyethylene terephthalate. The indicator inks change from pink to copper color when exposed to temperature ranges of 121℃ to 135℃ (250ºF to 275ºF).

AI/ML Overview

1. Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Standard ANSI/AAMI ISO 11140-1:2005 for Class 1 Indicators)	Reported Device Performance (STERIS STEAM π)
Change from pink to copper color when exposed to specified steam sterilization cycle parameters	Device changes from pink to copper color when exposed to the specified parameters.

2. Sample Size and Data Provenance:

The document does not explicitly state the sample size used for performance testing (test set) or the data provenance (country of origin, retrospective/prospective). It only mentions that "Performance testing was conducted to verify that the proposed STERIS STEAM π meets the requirements...".

3. Number of Experts and Qualifications:

Not applicable. The ground truth was established by physical/chemical changes measured against a standard, not by expert review.

4. Adjudication Method:

Not applicable. The ground truth was established by physical/chemical changes measured against a standard, not by human adjudication.

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

No, an MRMC comparative effectiveness study was not done. The device is a chemical indicator that undergoes a visual color change, not a diagnostic imaging device requiring human interpretation alongside AI.

6. Standalone Performance (Algorithm Only):

Yes, a standalone performance test was done. The device's performance was evaluated based on the visual color change from pink to copper when exposed to specific steam sterilization cycle parameters. This is an objective, standalone assessment of the indicator's function.

7. Type of Ground Truth Used:

The ground truth used was based on meeting the requirements for process [Class 1] indicators as defined in ANSI/AAMI ISO 11140-1:2005. This involves physical/chemical properties and their reaction to standardized sterilization conditions, confirmed using a resistometer to ANSI/AAMI ISO 18472.

8. Sample Size for the Training Set:

The document does not mention a "training set" in the context of machine learning or AI. As a chemical indicator, its design and performance are based on chemical formulations and physical properties rather than data-driven machine learning models requiring training data.

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

Not applicable. There is no training set for this type of device.

Summary

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JAN 1 1 2012

Image /page/0/Picture/2 description: The image shows the word "STERIS" in a bold, sans-serif font. To the right of the word STERIS is a registered trademark symbol. Below the word STERIS is a graphic of several horizontal lines that are curved in the middle.

510(k) Summary For STERIS STEAM π

STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 357-9198

Contact:

Bill Brodbeck Senior Manager, Regulatory Affairs Telephone: (440) 392-7690 Fax No: (440) 357-9198

Summary Date:

January 4, 2012

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

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1. Device Name

Indicators Models:	STERIS STEAM π
Common Name:	Chemical Indicator
Classification Name:	Physical/chemical sterilization process indicators(21 CFR 880.2800 (b), Product Code JOJ)

2. Predicate Device

Verify STEAM Value Indicators (K060103) .

3. Device Description

4. Intended Use

The STERIS STEAM n is process indicator that undergoes a visual color change from a pink to copper color when exposed to the following steam sterilization cycle parameters:

121℃ (250°F), 30 min, steam sterilization gravity cycle ●
. 132°C (270°F), 15 min, steam sterilization gravity cycle
135℃ (275°F), 10 min, steam sterilization gravity cycle ●
132°C (270°F), 4 min, steam sterilization dynamic air removal cycle .
135°C (275°F), 3 min, steam sterilization dynamic air removal cycle .

Description of Safety and Substantial Equivalence ട.

The proposed and predicate devices are both single use indicators for use in steam sterilization cycles. The differences between the proposed STERIS STEAM n Indicators and the predicate device are limited to differences in general design of the ink and material. However, these differences do not affect the intended use, performance characteristics, nor do the differences raise any new issues of safety and efficacy.

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6. Performance Testing

Performance testing was conducted to verify that the proposed STERIS STEAM π meets the requirements for process [Class 1] indicators as defined in ANSVAAMI ISO 11140-1:2005 using a resistometer to ANSVAAMI ISO 18472. The data provided by this testing demonstrates that the proposed STERIS STEAM π device is substantially equivalent to the predicate device.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular emblem with the department's name encircling a stylized image of an eagle. The eagle is depicted with three lines forming its body and wings, and two lines representing its legs and feet. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA".

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. Robert Sullivan Senior Director, FDA Regulatory Affairs STERIS Corporation 5960 Heisley Road Mentor, Ohio 44060

JAN 1 1 2012

Re: K112256

Trade/Device Name: STERIS STEAM π Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: JOJ Dated: January 4, 2012 Received: January 5, 2012

Dear Mr. Sullivan:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 - Mr. Sullivan

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm 115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Anthony D. Nutter

Anthony D. Watson, B.S., M.S., M.B.A. 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): K112256

STERIS STEAM T Device Name:

Indications for Use:

The STERIS STEAM n is a process indicator that undergoes a visual color change from a pink to brown color when exposed to the following steam sterilization cycle parameters:

121°C (250°F), 30 min, steam sterilization gravity cycle .
132°C (270°F), 15 min, steam sterilization gravity cycle .
135℃ (275℃F), 10 min, steam sterilization gravity cycle .
132°C (270°F), 4 min, steam sterilization dynamic air removal cycle ●
135℃ (275℃), 3 min, steam sterilization dynamic air removal cycle .

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)

Elishh P. Currie-Wells

(Division Sign-Off) (Division Sign-on)
Division of Anesthesiology, General Hospital Division of Control, Dental Devices

510(k) Number: K112256

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).