The Verify® 275F 3 Indicator is a chemical indicator intended for use by health care providers to accompany products being sterilized through a sterilization procedure. The Verify® 275F 3 Indicator is an emulating indicator intended for use in steam sterilization. The indicator changes color from yellow to blue/purple when exposed to 275°F (135°C) pre-vacuum sterilization cycles for 3 minutes as indicated in the following table:

MODEL	TEMPERATURE	STERILIZATION TYPE	TIME
Verify 275F 3	275°F (135°C)	Pre-vacuum steam	3 minutes

Device Description

The proposed Verify® 275F 3 Indicator consist of:

A 22 mm x 143 mm polypropylene strip with one 12 mm chemical indicator . ink spot.
The indicator ink spot is located on one end of the strip, adjacent to a reference block exhibiting the endpoint color. The indicator ink on the proposed Verify" 275F 3 Indicator changes from yellow to blue/purple color when the steam sterilization cvclc is complete.
The Verify® 275F 3 Indicator can be used to monitor 3 minute 275°F (135°C) prevacuum steam sterilization cycles.

AI/ML Overview

Here's an analysis of the provided text regarding the Verify® 275F 3 Indicator, focusing on acceptance criteria and the supporting study:

The provided document is a 510(k) summary for a premarket notification for a Class 6 chemical indicator. It describes the device, its intended use, and states that performance testing was conducted to verify that the device meets the requirements of ANSI/AAMI/ISO 11140-1:2005 for emulating (Class 6) steam indicators. However, the document does not provide specific details about the study methodology or the exact reported performance metrics that would typically be found in a comprehensive clinical or performance study report.

Based on the available information, here's the breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (as implied by the standard and intended use):

Performance Metric	Acceptance Criteria (Implicit from ANSI/AAMI/ISO 11140-1:2005 for Class 6)	Reported Device Performance
Color Change	Change from yellow to blue/purple	Changes from yellow to blue/purple when exposed to 275°F (135°C) pre-vacuum sterilization cycles for 3 minutes.
Compliance	Meets requirements for emulating [Class 6] steam indicators	Meets the requirements of ANSI/AAMI/ISO 11140-1:2005 for emulating [Class 6] steam indicators.

Important Note: The document states that the device "meets the requirements," but it does not quantitatively report the exact performance (e.g., specific time-temperature parameters at which the color change definitively occurs, the accuracy or precision of this change, or any statistical measures of performance). The acceptance criteria for Class 6 indicators in ANSI/AAMI/ISO 11140-1:2005 are complex, involving stated values (SV) for time at specific temperatures, and the indicator's response needs to be within certain limits of those SVs. These specific values are not provided in this 510(k) summary.

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

The document states: "Performance testing was conducted to verify that the proposed Verify® 275F 3 Indicator meet the requirements for emulating [Class 6] indicators as defined in ANSI/AAMI ISO 11140-1:2005 using a resistometer to ANSI/AAMI ST44."

Sample Size: Not specified. The document does not provide any details about the number of indicators tested.
Data Provenance: The testing was conducted by STERIS Corporation, presumably at their facilities. The country of origin for the data is not explicitly stated but would likely be the USA, given the company's location (Mentor, OH) and regulatory submission context. The study is prospective in nature, as it involves newly manufactured indicators undergoing controlled testing.

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

Not Applicable. For a chemical indicator, the "ground truth" is typically established by the physical parameters of the resistometer (e.g., temperature, time, steam quality) and the pre-defined, objective color change required by the standard. There is no mention of human expert assessment being used to establish the ground truth for the performance of the indicator itself, beyond potentially observing and verifying the color change against the reference block.

4. Adjudication Method

Not Applicable. As the ground truth is based on the physical parameters of the resistometer and the objective color change, there isn't a need for expert adjudication in the way it would be applied to, for example, image interpretation.

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

Not Applicable. This device is a chemical indicator, not an AI-assisted diagnostic tool for human interpretation. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to its evaluation.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, implicitly. The chemical indicator's performance is standalone in the sense that its color change is a physical/chemical reaction to a specific sterilization cycle. The testing described (using a resistometer to ANSI/AAMI ST44) measures the indicator's performance directly and objectively, independent of human interpretation for the primary result. The human element would come in simply observing whether the color change has occurred to confirm a passed cycle.

7. Type of Ground Truth Used

The ground truth used is based on controlled physical parameters and objective chemical reaction. Specifically:

The resistometer ensures precise control over the steam sterilization conditions (temperature, pressure, time).
The ANSI/AAMI ISO 11140-1:2005 standard defines the acceptable performance characteristics for Class 6 emulating indicators under these controlled conditions, including the expected color change.
The "endpoint color" reference block on the indicator itself serves as an objective visual ground truth for comparison.

8. Sample Size for the Training Set

Not Applicable. Chemical indicators are physical devices that react to specific conditions. They do not involve algorithms or machine learning that require a "training set" in the computational sense. The design and formulation of the chemical indicator are developed through R&D, not trained on data.

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

Not Applicable. As there is no training set, there is no ground truth established for it.

Summary

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KO71895

STERIS®

NOV 1 4 2007

510(k) Summary For Verify® 275F 3 Indicator

STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (216) 354-2600 Fax No: (216) 639-4459

Contact:

Jack Scoville Fellow, Regulatory Affairs

Telephone: 440 392 7330 Fax No: 440 397 9198

Submission Date:

July 06, 2007

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

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1. Device Name

Indicator:	Verify® 275F 3 Indicator.
Common Name:	Chemical Indicator.
Classification Name:	Physical/chemical sterilization process indicator (21CFR 880.2800 (b), Product Code JOJ).

2. Predicate Devices

3M SteriGage Chemical Indicators (K894399) .
DANA SteriScan Indicators (K012195) .
SteriTec Integraph (Cardinal Steam Integrators' ) (K960441) .
STERIS Verify Integrators (K902958, K002937) .
EZ Test Steam Biological Indicator (K963841) .

3. Device Description

The proposed Verify® 275F 3 Indicator consist of:

A 22 mm x 143 mm polypropylene strip with one 12 mm chemical indicator . ink spot.
The indicator ink spot is located on one end of the strip, adjacent to a reference block exhibiting the endpoint color. The indicator ink on the proposed Verify" 275F 3 Indicator changes from yellow to blue/purple color when the steam sterilization cvclc is complete.

The Verify® 275F 3 Indicator can be used to monitor 3 minute 275°F (135°C) prevacuum steam sterilization cycles.

4. Intended Use

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

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STERIS ABBREVIATED 510(k) PREMARKET NOTIFICATION VERIFY® 275F 3 INDICATOR

the Verify® 275F 3 Indicator 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 Verify" 275F 3 Indicator and the predicate device are limited to differences in design, matcrial, 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 Verify® 275F 3 Indicator mect the requirements for emulating [Class 6] indicators as defined in ANSI/AAMI ISO 11140-1:2005 using a resistometer to ANSI/AAMI ST44.

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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 features a stylized depiction of three human profiles facing right, arranged in a row. The profiles are simple and abstract, with flowing lines suggesting hair or movement. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 4 2007

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

Re: K071895

Trade/Device Name: Verify® 275F 3 Indicator Regulation Number: 880.2800 Regulation Name: Sterilization process Indicator Regulatory Class: II Product Code: JOJ Dated: October 25, 2007 Received: October 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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Page 2 - Mr. Scoville

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,

Chiu Lin, Ph.D.

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): K071895

Verify® 275F 3 Indicator Device Name:

Indications for Use:

MODEL	TEMPERATURE	STERILIZATION TYPE	TIME
Verify 275F 3	275°F (135°C)	Pre-vacuum steam	3 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)

Sheila A. Murphy, MD

logy Center
Neal Davis

K071895

Page	1 of 1
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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).