STERRAD® SealSure™ Chemical Indicator Tape is a process indicator intended for use by health care providers to secure non-woven sterilization packs and wraps to be sterilized in the STERRAD® Sterilization System.

The color of the STERRAD® SealSure™ Chemical Indicator Tape changes from red to gold (or lighter) when exposed to hydrogen peroxide and is intended to differentiate between processed and unprocessed loads. Reference the color comparator bars on the package box label.

Device Description

STERRAD® SealSure™ Chemical Indicator Tape (Class A per EN867-1 and Class 1 ISO 11140-1) is a through-put process indicator tape to be used with ASP's STERRAD® Sterilization System. STERRAD® SealSure™ Chemical Indicator Tape offers an additional way to verify processing in the sterilization cycle. It should be used in addition to, not in place of, the biological indicator. STERRAD® SealSure™ Chemical Indicator Tape does not signify sterilization; it only indicates that the indicator has been exposed to hydrogen peroxide.

There are six rolls of STERRAD® SealSure™ Chemical Indicator Tape per box. Each roll contains 55 meters (60 yards) of indicator tape.

AI/ML Overview

The STERRAD® SealSure™ Chemical Indicator Tape is a process indicator designed to confirm exposure of medical devices to hydrogen peroxide within the STERRAD® Sterilization System. The device changes color from red to gold (or lighter) when exposed to hydrogen peroxide, differentiating between processed and unprocessed loads.

Here's an analysis of its acceptance criteria and the studies conducted:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Performance Metric	Reported Device Performance
Functionality: Color change (red to yellow/gold) at half-cycle conditions.	All tape samples changed from red to yellow at half-cycle conditions in each STERRAD® Sterilization System.
Resistance to Chemicals: Adequate resistance to various chemicals.	Demonstrated adequate resistance to chemicals, with the exception of organic solvents with high polarity and strong acids.
Differentiation of Processed vs. Unprocessed Loads: Ability to distinguish.	Ability to distinguish between a processed load and a load where the cycle was canceled prior to hydrogen peroxide exposure.
Shipping Stability: Maintenance of stability in a simulated shipping environment.	Maintained stability in a simulated shipping environment.
Shelf-Life Color Stability (Unopened Package): Pre-processed color and functionality, Post-processed color.	Pre-processed samples maintained pre-processing color and functionality at both ambient and accelerated aging conditions for four months. Post-processed tape samples retained their post-processing color after aging in both ambient and accelerated aging conditions for two months. (Note: functionality stability for post-processed tapes not explicitly mentioned here, but indicated for pre-processed).
Shelf-Life Color and Functionality Stability (Opened Package): Pre-processed color and functionality, Post-processed color.	Pre-processed tape samples' color and functionality stability were maintained in both simulated hospital sterilizer room and central supply storage room ambient conditions for one month. Post-processing color was stable for one month. (Note: pre-processed studies will continue for a total of two months).
Impact on Sterilization Efficacy: No significant effect on the performance of the STERRAD® Sterilization System when using an extreme amount of tape.	The effect on sterilization efficacy of each STERRAD® System was insignificant, regardless of using an extreme amount of chemical indicator tape on each validation tray. Complete inactivation of challenge microorganisms was achieved in each system.
Adhesion Strength and Stability: Meeting minimum adhesion requirements and maintaining them over time.	Meets minimum adhesion strength requirements. Stability testing demonstrated maintenance of minimum adhesion strength over three months in accelerated and room temperature aging environments.

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

The document does not explicitly state the specific numerical sample size for each test set (e.g., how many rolls of tape were tested for functionality, or how many trays were used for efficacy testing). It generally refers to "all tape samples," "each of the STERRAD® Sterilization Systems," and "an extreme amount of STERRAD® SealSure™ Chemical Indicator Tape on each validation tray."

The data provenance is not explicitly stated in terms of country of origin. Given the applicant is "Advanced Sterilization Products Division of Ethicon, Inc. 33 Technology Drive Irvine, CA 92618" in the United States, it is highly likely the studies were conducted in the US. The studies appear to be prospective as they describe controlled laboratory-style testing performed to validate the device prior to marketing.

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

The document does not mention the use of human experts to establish ground truth for the chemical indicator's performance. The ground truth for chemical indicators like this is typically based on the physical and chemical properties of the indicator itself, its interaction with the sterilant, and established industry standards (such as EN867-1 and ISO 11140-1, which are referenced). The "ground truth" here is objective chemical reaction and physical performance, not subjective interpretation.

4. Adjudication Method for the Test Set

Not applicable. The device's performance (color change, adhesion, resistance) is based on objective measurements and established chemical/physical criteria, rather than human interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically relevant for interpretative devices where human readers assess cases (e.g., radiology images) and compare their performance with and without AI assistance. The STERRAD® SealSure™ Chemical Indicator Tape is an objective process indicator, not an interpretative device.

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

The studies described are inherently "standalone" in the sense that the device's performance (color change, adhesion, etc.) is tested directly without human interpretation in the loop. The "algorithm" here is the chemical reaction of the indicator itself.

7. The Type of Ground Truth Used

The ground truth used for these studies is based on:

Objective Chemical Reaction: The known and expected color change in response to hydrogen peroxide exposure.
Physical Properties: Measurable characteristics like adhesion strength, stability over time, and resistance to chemical degradation.
Microbiological Efficacy (for impact on sterilizer): The complete inactivation of challenge microorganisms, which is a definitive, objective measure of sterilization success.
Industry Standards: Compliance with standards like Class A per EN867-1 and Class 1 ISO 11140-1 provides a framework for defining acceptable performance.

8. The Sample Size for the Training Set

Not applicable. This device is a passive chemical indicator, not an AI or machine learning algorithm that requires a "training set." Its function is based on a predetermined chemical formulation.

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

Not applicable, as there is no training set for this device.

Summary

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K022441 510(k) SUMMARY

Applicant's Name, Address, Telephone, FAX, Contact Person

Advanced Sterilization Products Division of Ethicon, Inc. 33 Technology Drive Irvine, CA 92618

Contact Person

Natalie Bennington Senior Regulatory Affairs Specialist Tel: (949) 453-6482 Fax: (949) 789-3900

September 12, 2002

This summary of 510(k) substantial equivalence information is being submitted in accordance with the requirements of 21 CFR §807.92.

CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME

Common/Usual Name: Chemical Indicator Product Classification: Physical / Chemical Sterilization Process Indicator, Class II Proprietary Name: STERRAD® SealSure™ Chemical Indicator Tape

PREDICATE DEVICE

The predicate device is the STERRAD® Chemical Indicator Tape for use in the STERRAD® Sterilization Systems, currently manufactured and distributed by Advanced Sterilization Products.

INDICATIONS-FOR-USE

DEVICE DESCRIPTION

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KO 22441

There are six rolls of STERRAD® SealSure™ Chemical Indicator Tape per box. Each roll contains 55 meters (60 yards) of indicator tape.

COMPARISON TO THE PREDICATE DEVICE

STERRAD® SealSure™ Chemical Indicator Tape for use in the STERRAD® Sterilization System is substantially equivalent to STERRAD® Chemical Indicator Tape also for use in the STERRAD® Sterilization System. These devices are intended for use by health care providers to secure non-woven sterilization wraps used on medical devices to be sterilized in the STERRAD® Sterilization System and to differentiate processed items. In addition, both of these devices share similar design and appearance.

VALIDATION STUDIES

1. Functionality Study of the STERRAD® SealSure™ Chemical Indicator Tape in STERRAD® Sterilization Systems The functionality of STERRAD® SealSure™ Chemical Indicator Tape was tested in each of the STERRAD® Sterilization Systems. Functionality was verified as all tape samples
  changed from red to yellow at half-cycle conditions.
1. Effects of Chemicals, Air Plasma and Shipping Temperature on STERRAD® SealSure™ Chemical Indicator Tape for use in the STERRAD® Systems The effects of chemicals, air plasma and shipping temperature on STERRAD® SealSure™ Chemical Indicator Tape for use in the STERRAD® Sterilization Systems were tested.
  The test results demonstrated that STERRAD® SealSure™ Chemical Indicator Tape has adequate resistance to chemicals, with exception of organic solvents with high polarity as well as strong acids. STERRAD® SealSure™ Chemical Indicator Tape also has the ability to distinguish between a processed load vs. a load in which the cycle was cancelled prior to exposure to the hydrogen peroxide. Lastly, it was shown that STERRAD® SealSure™ Chemical Indicator Tape maintained its stability in a simulated shipping environment.

Color and Functionality Studies of Pre and Post-processing STERRAD® SealSure™ Chemical Indicator Tape Samples (Unopened Package) Shelf life color stability studies were conducted for both pre-processed and post-processed

samples of STERRAD® SealSure™ Chemical Indicator Tape. In addition, a functionality stability study was also performed on the pre-processed samples.

The test results demonstrated that the pre-processed samples maintained the pre-processing color and functionality at both ambient and accelerated aging conditions for four months. In addition, the post-processed tape samples retained their post-processing color after aged in both ambient and accelerated aging conditions for two months.

1. Color and Functionality Stability Studies of Pre and Post-processing STERRAD® SealSure™ Chemical Indicator Tape Samples (Opened Package)
  The color and functionality stability of opened-package STERRAD® SealSure™ Chemical Indicator Tape samples stored in two ambient conditions were tested. The first ambient

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KO22441

condition was used to simulate a hospital's sterilizer room and the other was used to simulate the storage room of the central supply area (CS Department).

The stability of post-processed tape samples stored in a storage room condition was also evaluated.

The results of this study demonstrated that the color and functionality stability of the preprocessed tape samples were maintained in each ambient condition for one month. In addition, the post-processing color was stable for one month. The pre-processed color and functionality stability studies will continue for a total of two months.

1. Efficacy Testing of STERRAD® Sterilization System with excess amount of STERRAD® SealSure™M Chemical Indicator Tape
  The efficacy of using an extreme amount of STERRAD® SealSure™ Chemical Indicator Tape on each validation tray in each of the STERRAD® Sterilization Systems was tested. Complete inactivation of challenge microorganisms in the defined test configuration was achieved in each System.

The test results demonstrated that the effect on sterilization efficacy of each of the STERRAD® Systems is insignificant, regardless of using an extreme amount of chemical indicator tape on each validation tray.

6. Adhesion Strength and Stability of the STERRAD® SealSure™ Chemical Indicator Tape for use in the STERRAD® Systems

The adhesion strength and stability of STERRAD® SealSure™ Chemical Indicator Tape was tested.

The test results demonstrated that STERRAD® SealSure™ Chemical Indicator Tape meets the minimum adhesion strength requirements. Stability testing results also demonstrated the maintenance of the minimum adhesion strength over three months in accelerated and room temperature aging environments.

CONCLUSION

Results of the validation studies demonstrate that the STERRAD® SealSure™ Chemical Indicator Tape meet or exceed all functional requirements and support its suitability for use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird-like figure.

Public Health Service

Food and Drug Administration 200 Corporate Boulevard Rockville MD 20850

OCT 0 8 2002

Ms. Natalie Bennington Senior Regulatory Affairs Specialist Advanced Sterilization Products Division of Ethicon, Incorporated 33 Technology Drive Irvine, California 92618

Re: K022441
Trade/Device Name: STERRAD® Sealsure™ Chemical Indicator Tape Regulation Number: 21 CFR 880.2800 Regulation Name: Chemical Sterilization Process Indicator Regulatory Class: II Product Code: JOJ Dated: July 24, 2002 Received: July 25, 2002

Dear Ms. Bennington:

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 such 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. Bennington

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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic 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 legally marketed predicate 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division 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.qov/cdrh/dsma/dsmamain.html

Sincerely,

Timothy A. Ulatowski

Timothy A. Ulatowski 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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Image /page/5/Picture/0 description: The image shows a logo with the letters "ASP" inside of a rounded rectangle. The letters are white and the background is black. The "A" is shaped like a triangle, and the "S" and "P" are stylized.

ADVANCED STERILIZATION PRODUCTS a Johnon Johnion company

REGULATORY AFFAIRS DEPARTMENT

510(k) Number (if known): K022441

STERRAD® SealSure™ Chemical Indicator Tape Device Name:

Indications-For-Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use(PER 21 CFR 801.109)		OR	Over-The-Counter Use(Optional Format 1-2-96)
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DIVISION OF ETHICON, INC. • 33 TECHNOLOGY DRIVE • IRVINE, CA 92618 • (949) 581-5799 FAX (949) 789-3900
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices

510(k) Number:	K022441
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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).