MODIFICATION TO STERRAD SEALSURE CHEMICAL INDICATOR TAPE

K040742 · Advanced Sterilization Products · JOJ · Apr 2, 2004 · General Hospital

Device Facts

• Record ID: K040742
• Device Name: MODIFICATION TO STERRAD SEALSURE CHEMICAL INDICATOR TAPE
• Applicant: Advanced Sterilization Products
• Product Code: JOJ · General Hospital
• Decision Date: Apr 2, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

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.

Device Story

STERRAD® SealSure™ Chemical Indicator Tape is a process indicator tape used by healthcare providers to secure non-woven sterilization packs and wraps. The tape functions via a chemical reaction triggered by exposure to hydrogen peroxide gas plasma within STERRAD® Sterilization Systems. Upon exposure, the indicator changes color from red to gold (or lighter), providing a visual signal that the load has been exposed to hydrogen peroxide. It does not confirm sterilization or cycle completion. The device is used in clinical settings to differentiate between processed and unprocessed loads by comparing the tape color to provided comparator bars. The modification in this submission involves updated release testing methods and extended shelf life (22 months unopened; 5 months opened).

Clinical Evidence

No clinical data. Bench testing only. Stability studies confirmed color functionality and adhesive properties for an extended shelf life of 22 months (unopened) and 5 months (opened).

Technological Characteristics

Chemical indicator tape; color-changing chemical reaction (red to gold) upon exposure to hydrogen peroxide gas plasma. Used for securing non-woven sterilization packs. No electronic components or software.

Indications for Use

Indicated for use by healthcare providers to secure non-woven sterilization packs and wraps processed in STERRAD® hydrogen peroxide gas plasma sterilization systems; serves as a process indicator to differentiate between processed and unprocessed loads.

Regulatory Classification

Identification

Biological sterilization process indicator: 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. Physical/chemical sterilization process indicator: 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.

Predicate Devices

• STERRAD® SealSure™ Chemical Indicator Tape (K022441)

Submission Summary (Full Text)

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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: [phone] Fax: [phone]

Natalie Bennington, R.A.C. Senior Regulatory Affairs Specialist Tel: [phone] Fax: [phone]

### 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 . [phone] . FAX [phone]

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# Description of Device

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.

# 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 [phone]. 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 [phone] or [phone] 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

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.

Prescription Use

OR

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