The Once-A-Day® Vertos™ Test Pack is an air removal indicator that is intended to be used by a health care provider as a standardized test pack, e.g., Bowie Dick Test Pack, to assess the ability of a pre-vacuum sterilizer to remove air and allow steam to penetrate into wrapped goods and porous loads operating at 134° C using a 3.5 minutes exposure time. The Once-A-Day® Vertos™ Test Pack is directed to be positioned on the lowest shelf over the chamber drain in an otherwise empty chamber. An unexposed test pattern is uniformly blue and a uniform pink test pattern represents an acceptable cycle. The Once-A-Day® Vertos™ Test Pack is not an indication that the sterilizer has reached the parameters for sterilization.

Device Description

The Once-A-Day® Vertos™ Test Pack is a Bowie & Dick type test for prevacuum steam sterilizers that complies with requirements of AAMI/ANSI/ISO 11140-1:2005 as class 2 indicator, which includes conformance with the labeling requirements and general requirements on the performance. The pack also complies with requirements of AAMI/ANSI/ISO 11140-5:2007, which includes the test format parameters, performance at 134° C for 3.5 min in Pass and Fail cycles, dry heat test parameters, ink transfer limitations, labeling requirements, and all normative described in annexes.

AI/ML Overview

The provided text is a 510(k) summary for the Once-A-Day® Vertos™ Test Pack, a chemical sterilization process indicator. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain detailed information about a specific study with acceptance criteria, test set sample size, expert qualifications, or adjudication methods in the way a clinical trial or AI performance study would. It focuses on the device's conformance to ISO standards.

Based on the provided text, here's what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that the device complies with specific ISO standards, which inherently include performance criteria. The performance is described in terms of color change.

Acceptance Criteria	Reported Device Performance
Conformance to AAMI/ANSI/ISO 11140-1:2005 as Class 2 indicator	Complies with requirements, including labeling and general performance.
Conformance to AAMI/ANSI/ISO 11140-5:2007	Complies with requirements, including test format, performance at 134°C for 3.5 min in Pass and Fail cycles, dry heat test parameters, ink transfer limitations, labeling, and normative annexes.
Unexposed test pattern color	Uniformly blue.
Acceptable cycle test pattern color	Uniformly pink.
Incomplete change in air removal indicator	Uneven color change (indicates inefficient air removal, air leak, or non-condensable gases).

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: This information is not provided in the document. The document states compliance with ISO standards, which would imply testing, but not the specific sample size used for those tests.
Data Provenance: This information is not provided. The testing would have been conducted by the manufacturer, but specific details on where or how are not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided. The device's performance is based on chemical reactions and color interpretation, likely validated against physical/chemical references as defined by the ISO standards, rather than expert human interpretation of complex medical images.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This information is not provided. Given the nature of a chemical indicator, adjudication methods typical for subjective human interpretation (like in imaging studies) are not applicable. The assessment would be objective, based on color change.

5. 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 conducted or described. This type of study is relevant for AI-assisted diagnostic tools, not for a chemical sterilization indicator. The device is not an AI product.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

This question is not applicable as the device is a chemical indicator, not an algorithm or AI system. Its performance is inherent to its physical and chemical properties. Operators simply observe the color change.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The ground truth for this device is based on physical and chemical parameters defined by international standards (AAMI/ANSI/ISO 11140-1:2005 and 11140-5:2007) for steam sterilization. This includes precisely defined "Pass" and "Fail" cycle conditions at specific temperatures and exposure times (e.g., 134°C for 3.5 minutes). The color change observed in the indicator is then correlated to these established physical parameters representing effective air removal and steam penetration.

8. The sample size for the training set:

This concept is not applicable as the device is not an AI or machine learning system that requires a training set.

9. How the ground truth for the training set was established:

This question is not applicable for the same reason as point 8.

Summary

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K082620

510(k) Summary

Submitted by Propper Manufacturing Company, Inc. 36-04 Skillman Avenue. Address: Long Island City, New York 11101 (800) 832-4300 or (718) 392-6650 Telephone: JUL - 8 2009 (718) 482-8909 Facsimile: Marian M. Schuman, Executive V.P. / General Counsel Contact Name:

Date Submitted: September 8, 2008

Once-A-Day® Vertos™ Test Pack Trade Name: Chemical Sterilization Process Indicator (Bowie & Dick Test Pack) Common Name:

Product Code / Regulation: JOJ / 21 C.F.R. 880.2800

Description: The Once-A-Day® Vertos™ Test Pack is a Bowie & Dick type test for prevacuum steam sterilizers that complies with requirements of AAMI/ANSI/ISO 11140-1:2005 as class 2 indicator, which includes conformance with the labeling requirements and general requirements on the performance. The pack also complies with requirements of AAMI/ANSI/ISO 11140-5:2007, which includes the test format parameters, performance at 134° C for 3.5 min in Pass and Fail cycles, dry heat test parameters, ink transfer limitations, labeling requirements, and all normative described in annexes.

Intended Use: The Once-A-Day® Vertos™ Test Pack is an air removal indicator that is intended to be used by a health care provider as a standardized test pack, e.g., Bowie Dick. Test Pack, to assess the ability of a pre-vacuum sterilizer to remove air and allow steam to penetrate into wrapped goods and porous loads operating at 134° C using a 3.5 minutes exposure time. The Once-A-Day® Vertos™ Test Pack is directed to be positioned on the lowest shelf over the chamber drain in an otherwise empty chamber. An inefficient air removal stage, an air leak, or non-condensable gases in the steam supply are some of the conditions that could cause an incomplete change in the air removal indicator, e.g., uneven color change. An unexposed test pattern is uniformly blue and a uniform pink test pattern represents an acceptable cycle. The Once-A-Day® Vertos™ Test Pack is not an indication that the sterilizer has reached the parameters for sterilization.

Substantial Equivalence:

The Once-A-Day® Vertos™ Test Pack is similar in intended use and operating characteristics to Propper's once-a-day® Bowie and Dick Test Pack, K961156. Substantial equivalence to the predicate

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device was evaluated according to the FDA guidance document "Premarket Notification [510(k)] Submissions for Chemical Indicators," issued on December 19, 2003.

. :

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a stylized emblem. The emblem consists of a symbol with three abstract shapes, possibly representing human figures or elements of health and well-being. The text is in a sans-serif font and is arranged to follow the curve of the circle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Marian M. Schuman Executive Vice President/General Counsel Propper Manufacturing Company, Incorporated 36-04 Skillman Avenue Long Island City, New York 11101

JUL - 8 2009

Re: K082620

Trade/Device Name: Once-A-Day® Vertos™ Test Pack Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: JOJ Dated: June 12, 2009 Received: June 16, 2009

Dear Ms, Schuman:

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 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 - Ms. Schuman

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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Anthony D. Watson (or

Susan Runner, D.D.S., M.A. Acting 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): K082620

Device Name: Once-A-Day® Vertos™ Test Pack

Intended Use:

The Once-A-Day® Vertos™ Test Pack is an air removal indicator that is intended to be used by a health care provider as a standardized test pack, e.g., Bowie Dick Test Pack, to assess the ability of a pre-vacuum sterilizer to remove air and allow steam to penetrate into wrapped goods and por ous loads operating at 134° C using a 3.5 minutes exposure time. The Once-A-Day® Vertos™ Test Pack is directed to be positioned on the lowest shelf over the chamber drain in an otherwise empty chamber. An unexposed test pattern is uniformly blue and a uniform pink test pattern represents an acceptable cycle. The Once-A-Day® Vertos™ Test Pack is not an indication that the sterilizer has reached the parameters for sterilization.

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)

Shule A. Murphy, MD

(Division Sign-Off)

Page I of I

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K082620

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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).