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 pcroxide 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 is a through-put process indicator tape to be used with ASP's STERRAD® Sterilization Systems. The STERRAD® Sterilization System utilizes hydrogen peroxide gas plasma to achieve rapid, low temperature sterilization of medical devices.

STERRAD® SealSure™ Chemical Indicator Tape is not intended to imply that sterilization has been achieved or to assure that the sterilization cycle has been completed. Rather, it provides a visual indication that hydrogen peroxide, an essential ingredient in the operation of the STERRAD® Sterilization Process, is present in the sterilization chamber.

STERRAD® SealSure™ Chemical Indicator Tape functions by means of a chemical reaction. Exposure of the chemical indicator to the STERRAD® Sterilizer cycle results in a recognizable color change from red to yellow. The gold (or lighter) STERRAD logos and chemical indicator square indicate that the load has been exposed to hydrogen peroxide.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information based on the provided 510(k) summary:

Acceptance Criteria and Reported Device Performance

The device is a chemical indicator tape, and the key performance aspects relate to its stability (shelf life) and adhesive properties. The document describes the acceptance criteria implicitly by stating what was tested and what the studies "support."

Acceptance Criteria Category	Specific Acceptance Criteria (Inferred from Study Purpose)	Reported Device Performance (Supports/Confirms)
Unopened Package Shelf Life	The tape should maintain its color and functionality for the specified shelf life when unopened.	Supports an extension of the unopened package shelf life to 22 months.
Opened Package Shelf Life	The tape should maintain its color and functionality for the specified shelf life once opened.	Supports an extension of the opened package shelf life to 5 months.
Adhesion Strength (Preprocessing)	The tape should have adequate adhesive properties before processing.	Confirms adequate pre-processing adhesive properties to support an extension of the product to 22 months.
Adhesion Strength (Post-processing)	The tape should have adequate adhesive properties after processing (exposure to sterilization cycle).	Confirms adequate post-processing adhesive properties to support an extension of the product to 22 months.

Study Information:

Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify the exact number of samples (e.g., rolls of tape, individual pieces of tape) used for the stability or adhesion studies. It only refers to "samples of SealSure Chemical Indicator Tape."
- Data Provenance: The studies were conducted by Advanced Sterilization Products (ASP), a division of Johnson & Johnson Medical, Inc. The exact country of origin of the data is not explicitly stated, but the company address is Irvine, California, suggesting the studies were likely conducted in the US. The studies are prospective, as they involve testing the product over time (shelf-life studies) and assessing its properties under controlled conditions.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable for this type of device. The ground truth for chemical indicator tapes is typically established by physical/chemical properties (color change, adhesion strength) rather than expert interpretation of images or other subjective data. No experts are mentioned in this context.
Adjudication method for the test set:
- Not applicable. Adjudication methods are typically used for subjective assessments (e.g., medical image interpretation) where multiple readers might have differing opinions. For physical/chemical properties like color change and adhesion, the assessment is typically objective and involves quantitative measurements against defined specifications.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for medical imaging AI systems where human readers interpret cases. The STERRAD® SealSure™ Chemical Indicator Tape is a physical chemical indicator, not an AI system or device requiring human interpretation in a comparative reader study.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical chemical indicator, not an algorithm. Therefore, "standalone" algorithm performance is not a relevant concept for this product.
The type of ground truth used:
- The ground truth is based on physical and chemical properties of the tape:
  - Color and Functionality: The ability of the chemical indicator to undergo a recognizable color change from red to yellow (or gold/lighter) upon exposure to hydrogen peroxide. This is an objective, observable chemical reaction.
  - Adhesion Strength: Measured physical properties of the tape's adhesive, likely against predefined specifications for tack, peel strength, etc.
The sample size for the training set:
- Not applicable. This device is a physical chemical indicator tape, not a machine learning or AI model. Therefore, there is no "training set" in the context of data used to train an algorithm. The product development process would have involved formulation and manufacturing process development, but not algorithm training.
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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ADVANCED STERILIZATION PRODUCTS®

a Johnson of chinen company REGULATORY AFFAIRS DEPARTMENT

K040742
510(k) Summary

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

Advanced Sterilization Products A Division of Johnson & Johnson Medical, Inc. 33 Technology Drive Irvine, CA 92618

Contact Person

Kevin Corrigan, R.A.C. Manager of Regulatory Affairs Tel: (949) 453-6410 Fax: (949) 789-3900

Natalie Bennington, R.A.C. Senior Regulatory Affairs Specialist Tel: (949) 453-6482 Fax: (949) 789-3900

Submission Date

March 22, 2004

Trade Name

STERRAD® SealSure™ Chemical Indicator Tape

Common Name

Chemical Sterilization Process Indicator

Classification Name

Class II

Legally Marketed Equivalent Device Name(s)

STERRAD® SealSure™ Chemical Indicator Tape, K022441, October 8, 2002.

DIVISION OF ETHICON, INC. . 33 TECHNOLOCY DRIVE . IRVINE, CA 92618 . (949) 581-5799 . FAX (949) 789-3908

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Description of Device

Statement of Intended Use

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

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.

Description of Modification

The modification is to the methods used to test the product for final release. Additionally, the labeling for the device was modified to reflect this release testing and to extend the shelf life of the device.

Summary of Nonclinical Tests

Unopened package shelf life stability studies were conducted on samples of SealSure Chemical Indicator Tape to assess the color and functionality throughout the shelf life of the product. Based upon the results obtained, the study supports an extension of the unopened package shelf life to 22 months.

Opened package shelf life stability studies were conducted on samples of SealSure Chemical Indicator Tape to assess the color and functionality throughout the shelf life of the product. Based upon the results obtained, the study supports an extension of the opened package shelf life to 5 months.

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Special 510(k) Advanced Sterilization Products

Adhesion Strength studies were conducted on samples of SealSure Chemical Indicator Tape to assess the adhesive properties of the tape at the labeled shelf life for the product. Based upon the results obtained, the study confirms that the tape has adequate preprocessing and post-processing adhesive properties to support an extension of the product to 22 months.

Substantial Equivalence

The modified STERRAD® SealSure Chemical Indicator Tape has the following similarities to that which previously received 510(k) clearance:

has the same intended use, .
. have the same indicated use,
. use the same operating principle,
incorporate the same design, .
. uses the same fundamental scientific technology,
. incorporate the same materials and construction and
is packaged using the same materials and processes. .

In summary, the STERRAD® SealSure Chemical Indicator Tape described in this submission is substantially equivalent to the predicate device.

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three wings.

APR - 2 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Advanced Sterilization Products Mr. Kevin Corrigan Manager of Regulatory Affairs A Division of Johnson & Johnson Medical, Incorporated 33 Technology Drive Irvine, California 92618

Re: K040742

Trade/Device Name: Modification to Sterrad® SealSure™ Chemical Indicator Tape Regulation Number: 880.2800 Regulation Name: Sterilization Process Indication Regulatory Class: II Product Code: JOJ Dated: March 22, 2004 Received: March 23, 2003

Dear Mr. Corrigan:

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 - Mr. Corrigan

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 (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.

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 vour device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-5618. 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 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.gov/cdrh/dsma/dsmamain.html

Sincercly yours,

Susan Runne

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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Image /page/5/Picture/0 description: The image shows a logo with the letters "ASP" inside of a rounded rectangle. The letters are stylized, with the "A" being a triangle and the "S" and "P" being connected. To the right of the logo are the letters "A".

ADVANCED STERILIZATION PRODUCTS® a Johnona Johnson company REGULATORY AFFAIRS DEPARTMENT

Indications for Use

510(k) Number:

K040742

STERRAD® SealSure™ Chemical Indicator Tape

Indications For Use:

Device Name

Prescription Use

Over-the-Counter Use X'

(Optional Format 1-2-96)

Susan Runo

Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Device

510(k) Number: K0110742

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).