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

270°F (132°C), 3 min. flash gravity steam sterilization .
270°F (132°C), 10 min. flash gravity steam sterilization .

Device Description

The proposed Albert Browne, Ltd. Verify Gravity Flash Integrator is a 22 mm x 143 mm strip with two 12 mm circular chemical indicator ink spots, one located on either side of a reference circle exhibiting the endpoint color. The proposed integrator can be used to monitor 3 min. and 10 min. 132°C gravity flash steam sterilization cycles.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Albert Browne Ltd. Verify Gravity Flash Integrator, based on the provided text:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Device meets 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 the 3 min. indicator ink printed on the polypropylene substrate.	The performance testing for the 3 min. indicator ink was repeated using the Verify Gravity Flash Integrator and confirmed to meet the requirements for Class 5 integrating indicators as defined in clauses 9.1 and 9.3 of ANSI/AAMI ST60-1996.
Device performs as expected in 132°C 3 min. gravity flash steam sterilization cycles.	"Simulated use testing submitted in K060066 confirms that the Verify Gravity Flash Integrator performed as expected 132°C 3 min. gravity in flash steam sterilization cycles."

Note: The 10 min. indicator ink's performance was not re-evaluated as it was identical to the predicate device's ink and was covered by previous 510(k) submissions (K051101 and K002937).

Study Information

Here's the detailed information about the study as requested:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document does not specify the sample size for the test set.
- The document does not explicitly state the country of origin of the test data (though the sponsor is UK-based) nor whether it was retrospective or prospective. It refers to "simulated use testing," which implies prospective testing in a controlled environment.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- This information is not provided in the document. For chemical indicators, the ground truth is typically assessed by objective color change against a reference, rather than expert interpretation in the same way a medical image would be.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not provided in the document. Given the objective nature of a chemical indicator color change, formal adjudication methods like 2+1/3+1 are less applicable than for subjective interpretations.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. This device is a chemical indicator, not an AI-assisted diagnostic tool for human readers.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This device is a standalone chemical indicator. Its performance is evaluated intrinsically based on its color-change properties when exposed to specific sterilization conditions. There is no "algorithm only" performance separate from the physical indicator itself. The "testing for the 3 min. indicator ink was repeated" and "simulated use testing" represent this standalone performance evaluation.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for this device is based on objective physical/chemical criteria related to sterilization effectiveness. Specifically, the indicator must meet the requirements for Class 5 integrating indicators as defined in clauses 9.1 and 9.3 of ANSI/AAMI ST60-1996. This standard likely specifies the precise chemical exposure conditions required to elicit the expected color change. "Simulated use testing" would involve controlled sterilization cycles known to achieve (or not achieve) specified sterilization parameters.
The sample size for the training set:
- This device does not involve a "training set" in the context of machine learning or AI. It's a chemical indicator, and its performance is based on its physical/chemical properties.
How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device.

Summary

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K060066 page 1 of 2

510(k) Summary for Albert Browne Ltd., Verify Gravity Flash Integrator

MAR 2 4 2006

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: March 13, 2006

2. DEVICE NAME

Proprietary Name:	Albert Browne, Ltd. Verify Gravity Flash Integrator
Common/Usual Name:	Chemical indicator
Classification Name:	Physical/chemical sterilization process indicator

3. PREDICATE DEVICE

Verify Flash Integrator (K051101) .
TST Control Integrator for Steam Sterilizers (K002937) .

4. DEVICE DESCRIPTION

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K060066 page 2 of 2

5. INTENDED USE

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

. 270°F (132°C), 3 min. flash gravity steam sterilization
270°F (132°C), 10 min. flash gravity steam sterilization .

6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

The proposed Albert Browne, I.td. Verify Gravity Flash Integrator (Verify Gravity Flash Integrator) is printed with two chemical indicator inks with stated values of 3 min. and 10 min. at 132°C. The 10 min. integrator ink printed on the proposed Verify Gravity Flash Integrator is identical to the 10 min. ink printed on the predicate Verify Flash Integrator. The 3 min. integrator ink printed on the proposed Verify Gravity Flash Integrator is identical to the indicator ink printed on the predicate TST Control Integrator. The differences between the proposed and predicate devices are limited to minor differences in substrates and configuration that do not raise any new issues of safety and effectiveness.

7. PERFORMANCE TESTING

The performance of both the 3 min. and 10 min. indicator inks used in the proposed Verify Gravity Flash Integrator was evaluated in the 510(k) premarket notifications for the predicate devices (K002937 and K051101). However, the substrates are slightly different for the proposed Verify Gravity Flash Integrator and predicate TST Control Integrator. Therefore, the performance testing for the 3 min. indicator ink was repeated using the Verify Gravity Flash Integrator. Performance testing was conducted to verify that the 3 min. indicator ink printed on the polypropylene substrate meets the requirements for Class 5 integrating indicators as defined in clauses 9.1 and 9.3 of ANSVAAMI ST60-1996 "Sterilization of health care products - Chemical indicators - Part 1: General Requirements". Simulated use testing submitted in K060066 confirms that the Verify Gravity Flash Integrator performed as expected 132°C 3 min. gravity in flash steam sterilization cycles.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the department's name around the perimeter. Inside the circle is a stylized image of four human profiles facing to the right, with flowing lines representing hair or movement. The profiles are simple and abstract, creating a sense of unity and forward motion.

MAR 2 4 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K060066

Trade/Device Name: Albert Browne Ltd., Verify Gravity Flash Integrator Regulation Number: 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: JOJ Dated: March 13, 2006 Received: March 15, 2006

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 approvisions 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 cither class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 writ), it inches an 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 -- Dr. Nolte

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 mean that or any Federal statutes and regulations administered by other Federal agencies. or the For of 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 insing (s as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as lectronic 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 premiumes actived.com - a 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), rryou decire of the Office of Compliance at (240) 276-0120. Also, please note the regulation cntitled, "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 oveans 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,

C. R.

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: K060066

Device Name: Albert Browne Ltd., Verify Gravity Flash Integrator

Indications for Use:

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

270°F (132°C), 3 min. flash gravity steam sterilization .
270°F (132°C), 10 min. flash gravity steam sterilization .

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

Over-The-Counter Use __ × (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Shule A. Murphy, MD 3/23/04

General Hospital,

K chloril

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).