The proposed Verify Flash Integrator is a polypropylene strip with two 12 mm circular chemical indicator ink spots, one located on either side of a reference circle exhibiting the endpoint color.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that proves the Verify Flash Integrator device meets them, based on the provided text:

Acceptance Criteria and Device Performance for Verify Flash Integrator

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (ANSI/AAMI ST60-1996 Class 5 integrating indicators)	Reported Device Performance
Color change from yellow to blue/purple	Device changes color from yellow to blue/purple
Response to 270°F (132°C), 10 min. flash gravity steam sterilization	Performed as expected
Response to 270°F (132°C), 4 min. Express abbreviated prevacuum steam sterilization	Performed as expected

2. Sample Size for the Test Set and Data Provenance

The document does not explicitly state the specific "sample size" in terms of number of individual integrators tested. However, it indicates simulated use testing was conducted.

Sample Size: Not explicitly stated as a number of individual units.
Data Provenance: The testing was "simulated use testing", implying a laboratory or controlled environment rather than real-world patient data. The country of origin of the device manufacturer is the United Kingdom.

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

This information is not provided in the document. For a chemical indicator, "ground truth" would likely be established by objective measurements of temperature and exposure time, rather than expert interpretation of the indicator itself. The performance standard (ANSI/AAMI ST60-1996) would define the parameters for acceptance.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided. Adjudication methods like "2+1" or "3+1" are typically used for studies involving human interpretation (e.g., image analysis by radiologists) where discrepancies need to be resolved. For a chemical integrator that changes color, the outcome is objective (either it changes color appropriately or it doesn't) and would be assessed against the predefined physical parameters, not through expert consensus on its interpretation.

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 assesses how human performance improves with AI assistance compared to without it, which is not relevant for a standalone chemical sterility indicator.

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

Yes, a standalone performance assessment was effectively done. The "device" in this context (Verify Flash Integrator) operates entirely by itself (changes color based on conditions). The performance testing described is inherently a standalone assessment of the device's ability to meet its specifications without human interpretation as part of its functionality. Human observation is required to read the result, but the device's performance isn't dependent on human assistance during its operational phase.

7. The Type of Ground Truth Used

The ground truth used was based on objective physical parameters and established standards:

The specified temperature (132°C/270°F)
The specified exposure times (10 min. or 4 min.)
The requirements for Class 5 integrating indicators as defined in clauses 9.1 and 9.3 of ANSI/AAMI ST60-1996.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided. Chemical indicators are physical devices, not machine learning algorithms, and thus do not have "training sets" in the conventional sense. The design and formulation of the indicator would be developed and refined through R&D, but this isn't reported as a "training set."

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

This information is not applicable because there is no "training set" for this type of device. The "ground truth" for the device's development would have been established through chemical and physical principles and laboratory testing to achieve the desired color-change response to specific sterilization parameters.

Summary

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DEC 6 2005 510(k) Summary for Verify Flash Integrator

1. SPONSOR

Albert Browne Ltd., subsidiary of STERIS Corporation Chancery House 190 Waterside Road Hamilton Industrial Park Leicester LE5 1QZ United Kingdom

Contact:	Richard Bancroft
Telephone:	0116 276 8636

Date Prepared: December 1, 2005

2. DEVICE NAME

Proprietary Name:	Verify Flash Integrator
Common/Usual Name:	Chemical indicator
Classification Name:	Physical/chemical sterilization process indicator

3. PREDICATE DEVICE

TST Control Integrator for Steam Sterilizers (K002937) .

DEVICE DESCRIPTION 4.

The proposed Verify Flash Integrator is a polypropylene strip with two 12 mm circular chemical indicator ink spots, one located on either side of a reference circle exhibiting the endpoint color. The stated values for the two indicator inks printed on the Verify Flash integrator are provided in Table 1.

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Temp	Exposure Time
(°C/°F)	(Min.)
132/270	10
132/270	4

Table 1. Stated Values for Verify Flash Integrator Inks

ડ. INTENDED USE

The Verify Flash Integrator is an integrating integrator that changes color from yellow to blue/purple when exposed to the following conditions:

270°F (132°C), 10 min. flash gravity steam sterilization .
270°F (132°C), 4 min. Express abbreviated prevacuum steam sterilization .

TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.

The proposed Verify Flash Integrator and the predicate TST Control Integrator indicate exposure to critical combination(s) of temperature and exposure time through a visible color change in an indicator ink spot printed on polypropylene. Differences between the proposed and predicate integrators are limited to minor differences in the materials used for construction of the strip and the indicator ink composition.

7. PERFORMANCE TESTING

Data was provided that demonstrates that the Verify Flash Integrator meets the requirements for Class 5 integrating indicators as defined in clauses 9.1 and 9.3 of ANSI/AAMI ST60-1996 "Sterilization of health care products - Chemical indicators - Part 1: General Requirements" for 132°C sterilization cycles. Simulated use testing confirms that the Verify Flash Integrator performed as expected in a 10 min. gravity flash and the 4 min. Express abbreviated prevacuum steam sterilization cycles at 132°C.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized, curved lines that converge at the bottom, resembling a stylized human form.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 6 2005

Albert Browne Limited C/O Dr. Cynthia J. M. Nolte Senior Staff Consultant Medical Device Consultant, Incorporated 49 Plain Street North Attleboro, Massachusetts 02760-4153

Re: K051101

Trade/Device Name: Verify Flash Integrator Regulation Number: 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: JOJ Dated: November 22, 2005 Received: November 23, 2005

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 approval applisions 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 (1 wr 1, 1 may 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 Ecderal Register.

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Page 2 - Mr. Nolte

Please be advised that FDA's issuance of a substantial equivalence determination does not I lease be act rised that 12 a determination that your device complies with other requirements moun that + D + + any Federal statutes and regulations administered by other Federal agencies. or the rece of unly 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 and ifing (21 ever forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirents as bet form 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 premarket notification. - In 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), n for accented 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 maj count 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,

Sitta G. Michael MD.

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

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510(k) Number: K051101

Device Name: Verify Flash Integrator

Indications For Use:

The Verify Flash Integrator is an integrating integrator that changes color from yellow to blue/purple when exposed to the following conditions:

270°F (132°C), 10 min. flash gravity steam sterilization .
270°F (132°C), 4 min. Express abbreviated prevacuum steam sterilization .

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-the-Counter Use X (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Shule H. Murphy, M.D. 12/6/65

alson General Hus; mtrol, Danusi Devices

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).