Tyvek® Pouches and Rolls with STERRAD® Chemical Indicator are intended to be used to enclose medical devices that are to be terminally sterilized in the STERRAD® 100NX® Sterilizer and to indicate, by color change, that the pouch has been exposed to sterilant. After completion of the sterilization process, the pouch/roll maintains sterility until the seal of the pouch/roll is opened; in the United States, this is for a period of 30 days.

The pouches and rolls are printed with a chemical indicator bar which is a process indicator (ISO 11140-1:2005) that changes from red to yellow (or lighter) when exposed to hydrogen peroxide vapor during processing in the STERRAD® Sterilization Systems.

Device Description

The Tyvek® Pouch/Roll with STERRAD® Chemical Indicator is intended to be used to contain medical devices to be terminally sterilized in the STERRAD® Sterilization Systems. The medical devices are inserted into the pouch/roll, sealed, and then sterilized in the STERRAD® Sterilization System. After completion of the sterilization process, the pouch/roll maintains sterility of the enclosed medical devices until the seal is opened. The pouch/roll is printed with a chemical indicator bar that changes from red to yellow (or lighter) when exposed to hydrogen peroxide vapor during the sterilization process in the STERRAD® Sterilization Systems.

The proposed pouches are constructed from Tyvek®/plastic films, with the STERRAD® Chemical Indicator printed onto the Tyvek® film. The self-seal pouch permits sealing of the pouch without need of heat-sealing equipment, while the heat sealed pouches and rolls are heat sealed prior to processing in the STERRAD® Sterilization Systems.

The STERRAD® Chemical Indicator offers an additional way to verify processing in the sterilization cycle. The Chemical Indicator should be used in addition to, not in place of, the biological indicator. STERRAD® Chemical Indicators do not signify sterilization; they only indicate that the indicator has been exposed to the hydrogen peroxide. The color of the Chemical Indicator changes from red to yellow (or lighter) when exposed to hydrogen peroxide.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Tyvek® Pouch/Roll with STERRAD® Chemical Indicator:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a quantitative sense (e.g., "must achieve X% accuracy"). Instead, it outlines a series of performance tests that the device passed. The implicit acceptance criterion for each study is "Pass."

Study	Implicit Acceptance Criteria	Reported Device Performance
Sterilant Penetration	Pass	Passed
Package Integrity	Pass	Passed
Maintenance of Package Integrity	Pass	Passed
Material Compatibility	Pass	Passed
Chemical Indicator Functionality	Pass	Passed
End Point / Post Processing Color Stability	Pass	Passed
Shelf Life	Pass	Passed
Biocompatibility	Pass	Passed

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

The document does not specify the exact sample sizes used for each of the performance tests (e.g., how many pouches were tested for sterilant penetration, how many were tested for shelf life, etc.).

It also does not directly state the data provenance (e.g., country of origin). However, given the submission is to the U.S. FDA, it is highly probable the testing was conducted to U.S. standards or by labs that meet U.S. regulatory requirements. It is a prospective study in the sense that these tests were conducted specifically for this 510(k) submission to demonstrate the device's performance.

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

This information is not provided in the document. For a physical device like a sterilization pouch with a chemical indicator, "ground truth" for many of these tests (e.g., Sterilant Penetration, Package Integrity, Shelf Life, Biocompatibility) would typically be established by standardized laboratory methods and measurements rather than expert consensus on interpretation. For the chemical indicator's functionality and color stability, visual assessment would be involved, but the number and qualifications of individuals assessing the color change are not specified.

4. Adjudication Method for the Test Set:

This information is not provided. Given the nature of the tests (laboratory measurements and visual assessment against a defined color change), formal adjudication methods like 2+1 or 3+1 are less likely to be explicitly called out as they would be for image interpretation. The "Pass" result implies that the observations met the predefined criteria.

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 done. This type of study is relevant for AI-powered diagnostic/interpretive devices where human performance with and without AI assistance is being compared. The device in question is a sterilization pouch with a chemical indicator, not an AI-driven image analysis or diagnostic system.

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

Not applicable. As stated above, this is a physical device, not an algorithm. The chemical indicator's function is standalone in the sense that it changes color without human intervention during the sterilization process, but "standalone performance" in the context of AI refers to the algorithm's performance without a human in the loop, which doesn't apply here.

7. The Type of Ground Truth Used:

The ground truth for most of these tests would be established by:

Laboratory measurements and observations: For sterilant penetration, package integrity (e.g., burst strength, seal strength), material compatibility (e.g., degradation over time), and biocompatibility (e.g., toxicity tests). These are objective, quantitative or qualitative assessments based on established test methodologies.
Visual observation against defined criteria: For "Chemical Indicator Functionality" and "End Point / Post Processing Color Stability," the ground truth is whether the indicator changed from red to yellow (or lighter) as specified. This is a direct observation compared to a known expected outcome.
Time-based observation: For "Shelf Life" and "Maintenance of Package Integrity," the ground truth involves monitoring the device's characteristics over specific time periods under defined storage conditions.

8. The Sample Size for the Training Set:

Not applicable. This device does not involve a "training set" as it is not an AI/machine learning model. The chemical indicator's behavior is based on chemical reactions, not learned patterns from data.

9. How the Ground Truth for the Training Set was Established:

Not applicable. As there is no training set for this device, there is no ground truth to establish for it.

Summary

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510(k) Summary

OCT 1 5 2012

Applicant's Name, Address, Telephone, FAX, Contact Person Advanced Sterilization Products 33 Technology Drive Irvine, CA 92618

Establishment Registration Number: 2084725

Contact Person

Nancy Chu Manager, Regulatory Affairs (949) 453-6435 (Telephone) (949) 789-3900 (Fax)

Date: September 10, 2012

1. CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME

Classification Name:

Sterilization Wrap Sterilization Process Indicator Common/Usual Name: Sterilization Pouch / Roll with Chemical Indicator Product Classification: Class II Product Code: KCT / JOJ Classification Regulation:21 CFR 880.6850 21 CFR 880.2800 Proprietary Name: Tyvek® Pouch/Roll with STERRAD® Chemical Indicator

2. PREDICATE DEVICES

Tyvek® Pouch/Roll with STERRAD® Chemical Indicator, which is currently manufactured and distributed by Advanced Sterilization Products [510(k) Notification
K103210, cleared June 6, 2011) K103210, cleared June 6, 2011].

3. INDICATIONS FOR USE

Tyvek® Pouches and Rolls with STERRAD® Chemical Indicator are intended to be used to enclose medical devices that are to be terminally sterilized in the STERRAD® 100NX® Sterilizer and to indicate, by oolor change that the pouch has been exposed to steriliant. After completion of the sterlization process, the pouch has been exposed.
sterility until the seal of the pouchtroll is assembly of maintains sterility until the seal of the stermzadon process, the pouch/roll maintains
steriod of 30 days. period of 30 days.

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4. DESCRIPTION OF DEVICE

5. SUMMARY OF NONCLINICAL TESTS

Performance testing was conducted to show that the Tyvek® Pouch/Roll with STERRAD® Chemical Indicator maintains sterility until the seal of the pouch/roll is opened, after completion of the sterilization process, and that the STERRAD® Chemical Indicator changes from red to yellow (or lighter) when exposed to hydrogen . peroxide.

Study	Results
Sterilant Penetration	Passed
Package Integrity	Passed
Maintenance of Package Integrity	Passed
Material Compatibility	Passed
Chemical Indicator Functionality	Passed
End Point / Post Processing Color Stability	Passed
Shelf Life	Passed

Table 1: Pouch/Roll with Chemical Indicator Performance Tests

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Biocompatibility	Passed
------------------	--------

6. OVERALL PERFORMANCE CONCLUSIONS

The nonclinical studies demonstrate that the Tyvek® Pouch/Roll with STERRAD® Chemical Indicator performs as intended as a sterilization packaging system of medical devices that are being terminally sterilized in STERRAD® Sterilization Systems. The Chemical Indicator performs as intended for differentiating processed from unprocessed packages in the STERRAD® Sterilization Systems. These studies also show that the proposed pouches have the same intended use and met the same criteria as the predicate device (K103210) and are substantially equivalent.

®Tyvek is a registered trademark of Du Pont

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name in a circular arrangement around a stylized emblem. The emblem consists of a symbol that resembles a stylized caduceus or a representation of human figures, conveying the department's focus on health and human well-being.

Public Health Service

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

OCT 15 2012

Advanced Sterilization Products Ms. Nancy Chu Manager, Regulatory Affairs 33 Technology Drive Irvine, California 92618

Re: K112087

Trade/Device Name: Tyvek® Pouch/Roll with Sterrad® Chemical Indicator Regulation Number: 21 CFR 880.6850/880.2800 Regulation Name: Sterilization Wrap / Sterilization Process Indicator Regulatory Class: II Product Code: KCT/JOJ Dated: September 21, 2012 Received: September 24, 2012

Dear Ms. Chu:

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.

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Page 2- Ms. Chu

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 yours,

For

Anthony D. 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

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Indications for Use

510(k) Number (if known): K112087

Device Name:

Tyvek® Pouch/Roll with STERRAD® Chemical Indicator

Indications for Use

Tyvek is a registered trademark of Du Pont

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use V (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).

E. Mitchell P. Claire-Well

(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital
Division of Anesthesiology, General Devices Division of Anestheshology, "
Infection Control, Dental Devices

510(k) Number: K112087

Page 1 of 1

(Posted November 13, 2003)

Regulation Number and Section

§ 880.6850 Sterilization wrap.

(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(b)
Classification. Class II (performance standards).