The Verify® 270FP Challenge Pack is a test pack consisting of three emulating indicator inks situated on a test sheet surrounded by a steam penetration barrier, intended for use in SFPP (steam-flush pressure-pulse) and pre-vacuum steam sterilization. The Verify® 270FP Challenge Pack indicators change color from yellow to blue/purple when exposed to the following conditions at 270°F (132°C):

4 minute indicator SFPP and pre-vacuum steam sterilization for 4 minutes. .
10 minute indicator Pre-vacuum steam sterilization for 10 minutes. .
20 minute indicator Pre-vacuum steam sterilization for 20 minutes. ●

Device Description

The proposed Verify® 270FP Challenge Pack consists of three emulating indicator inks situated on a test sheet surrounded by a steam penetration barrier. The indicator inks on the proposed Verify® 270FP Challenge Pack test sheet change from yellow to blue/purple color when exposed to saturated steam at 270°F (132°C) for the following times.

4 minute indicator The 4 minute indicator ink on the Verify® 270FP . Challenge Pack can be used to monitor a 4 minute SFPP (steam-flush pressure-pulse) and pre-vacuum steam sterilization cycle.
10 minute indicator The 10 minute indicator ink on the Verify 270FP . Challenge Pack can be used to monitor a 10 minute pre-vacuum steam sterilization cycle.
20 minute indicator The 20 minute indicator ink on the Verify® 270FP . Challenge Pack can be used to monitor a 20 minute pre-vacuum steam sterilization cycle.

The process indicator outside of the packs undergoes a visual color change from pink to dark purple when exposed to steam in a temperature range of 250°F (121°C) to 275°F (135°C).

AI/ML Overview

The STERIS Verify® 270FP Challenge Pack is a chemical indicator used to monitor steam sterilization cycles. The provided text from the 510(k) summary describes its acceptance criteria and the studies conducted to demonstrate its performance.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (from ANSI/AAMI ISO 11140-1:2005 for Class 6 Indicators)	Reported Device Performance (Verify® 270FP Challenge Pack)
Color change from yellow to blue/purple when exposed to saturated steam at 270°F (132°C) for specified times	Demonstrated effective color change from yellow to blue/purple under the specified sterilization conditions.
4-minute indicator: Specifically designed to monitor 4-minute SFPP and pre-vacuum steam sterilization cycles.	Changes color when exposed to 270°F (132°C) for 4 minutes in SFPP and pre-vacuum steam sterilization.
10-minute indicator: Specifically designed to monitor 10-minute pre-vacuum steam sterilization cycles.	Changes color when exposed to 270°F (132°C) for 10 minutes in pre-vacuum steam sterilization.
20-minute indicator: Specifically designed to monitor 20-minute pre-vacuum steam sterilization cycles.	Changes color when exposed to 270°F (132°C) for 20 minutes in pre-vacuum steam sterilization.
Barrier material efficacy to allow steam penetration for indicating function	Efficacy of the barrier material demonstrated using a 16-towel test pack with biological indicators as a reference.

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

The document does not explicitly state the numerical sample size for the test set used for the performance testing of the emulating indicator inks or the barrier material. It mentions that "further testing was conducted to demonstrate the efficacy of the barrier material using a 16-towel test pack with biological indicators as a reference" and that "predicate test packs were included in this testing." This implies a comparative study but doesn't provide specific numbers for the Verify® 270FP Challenge Pack itself or the number of runs.

The data provenance is not explicitly stated regarding country of origin or whether it was retrospective or prospective. However, given that this is a 510(k) summary for a medical device submitted to the FDA (United States), it is highly probable that the testing was conducted under controlled laboratory conditions, likely in the United States, and was prospective in nature, specifically designed to meet regulatory requirements.

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

The document does not provide details about experts used to establish the ground truth in terms of human interpretation of the indicators. The acceptance criteria are based on objective color changes under specific physical conditions (temperature and time). The primary ground truth for the device's performance is the physical parameters of the sterilization cycles themselves, as measured by a resistometer to ANSI/AAMI/ISO 18472. The color change of the indicator is then assessed against these known physical conditions.

4. Adjudication Method for the Test Set

Not applicable. The performance of the chemical indicator is based on a clear, objective color change. It is not dependent on human adjudication in the way medical imaging interpretation might be. The color change "from yellow to blue/purple" is a binary outcome (changed/not changed) based on exposure to specific conditions, with the resistometer providing the definitive truth of those conditions.

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 or interpretive devices where human readers play a significant role in making decisions based on device output. For a chemical indicator, the output is a direct, objective color change, not subject to human interpretation variability in the same way.

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

Yes, the performance testing described is inherently a standalone assessment of the device (the chemical indicator). Its function is to change color in response to specific physical conditions, independent of human intervention once exposed to the sterilization cycle. The testing verifies this standalone performance against established standards.

7. The Type of Ground Truth Used

The ground truth used is primarily objective physical parameters and standards.

For the indicator inks: The ground truth is the defined conditions of saturated steam exposure (270°F for 4, 10, or 20 minutes) as measured by a resistometer conforming to ANSI/AAMI/ISO 18472. The specified color change is expected under these conditions.
For the barrier material: The ground truth is established by the performance of biological indicators within a 16-towel test pack, which are considered the gold standard for verifying sterilization efficacy.

8. The Sample Size for the Training Set

The document does not specify a "training set" sample size. This device is a passive chemical indicator, not an AI/ML algorithm that requires a training set. Its design and formulation are based on chemical principles to react to specific sterilization conditions.

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

Not applicable. As noted above, there is no "training set" for this type of device in the context of AI/ML. The device's performance is intrinsically linked to its chemical composition and physical design, which are developed and verified against known sterilization parameters and industry standards.

Summary

{0}------------------------------------------------

STERIS®

MAR | Q 2011

510(k) Summary For Verify® 270FP Challenge Pack

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

Contact:

Robert Sullivan Senior Director, Regulatory Affairs

Telephone: (440) 392-7695 Fax No: (440) 357-9198

Submission Date: March 10, 2011

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

{1}------------------------------------------------

K103053
p² of 3

1. Device Name

Indicator Pack Model:	Verify® 270FP Challenge Pack
Common Name:	Chemical Indicator
Classification Name:	Physical/chemical sterilization process indicator (21CFR 880.2800 (b), Product Code JOJ).

Predicate Device 2.

STERIS Verify® Challenge Pack (Model 270F 4) K073683 .
Getinge ChemSix Test Pack K080136 .

3. Device Description

4 minute indicator The 4 minute indicator ink on the Verify® 270FP . Challenge Pack can be used to monitor a 4 minute SFPP (steam-flush pressure-pulse) and pre-vacuum steam sterilization cycle.
10 minute indicator The 10 minute indicator ink on the Verify 270FP . Challenge Pack can be used to monitor a 10 minute pre-vacuum steam sterilization cycle.
20 minute indicator The 20 minute indicator ink on the Verify® 270FP . Challenge Pack can be used to monitor a 20 minute pre-vacuum steam sterilization cycle.

The process indicator outside of the packs undergoes a visual color change from pink to dark purple when exposed to steam in a temperature range of 250°F (121°C) to 275°F (135°C).

4. Intended Use

The Verify® 270FP Challenge Pack is a test pack consisting of three emulating indicator inks situated on a test sheet surrounded by a steam penetration barrier,

{2}------------------------------------------------

K103053

K103053/S001 STERIS Response to 3/10/11 Request for Clarification Verify 270FP Challenge Pack

intended for use in SFPP (steam-flush pressure-pulse) and pre-vacuum steam sterilization. The Verify® 270FP Challenge Pack indicators change color from yellow to blue/purple when exposed to the following conditions at 270°F (132°C):

4 minute indicator SFPP and pre-vacuum steam sterilization for 4 minutes. .
10 minute indicator Pre-vacuum steam sterilization for 10 minutes. .
20 minute indicator Pre-vacuum steam sterilization for 20 minutes. .

રાં Description of Safety and Substantial Equivalence

The proposed and predicate devices are all single use indicator test packs for use in steam sterilization cycles. The differences between the proposed Verify® 270FP Challenge Pack and predicate devices are limited to differences in design, materials and parameters of the sterilization cycles these indicator test packs are designed to monitor. These differences do not raise any new issues of safety or efficacy.

Performance Testing 6.

Performance testing was conducted to verify that the proposed emulating indicator inks within the test pack meet the requirements for Class 6 indicators as defined in ANSI/AAMI ISO 11140-1:2005 using a resistometer to ANSI/AAMI/ISO 18472.

Further testing was conducted to demonstrate the efficacy of the barrier material using a 16-towel test pack with biological indicators as a reference. The predicate test packs were included in this testing.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the seal is an abstract image of an eagle.

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

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

MAR 1 Q 2011

Re: K103053

Trade/Device Name: Verify® 270FP Challenge Pack Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: JOJ Dated: February 4, 2011 Received: February 7, 2011

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.

{4}------------------------------------------------

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/ucm115809.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 vou

Anthony 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

{5}------------------------------------------------

Indications for Use

510(k) Number (if known):

Device Name:

Verify® 270FP Challenge Pack

Indications For Use:

4 minute indicator SFPP and pre-vacuum steam sterilization for 4 minutes. .
10 minute indicator Pre-vacuum steam sterilization for 10 minutes. .
20 minute indicator Pre-vacuum steam sterilization for 20 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)

Page 1 of 1

Eldith S. (Clavis. William

(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control and Dental Devices,
510(k) Number: K103053

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).