MODIFIED BROWNE PACKAGING AND LABEL STEAM PROCESS INDICATOR

K032801 · Albert Browne , Ltd. · JOJ · Oct 17, 2003 · General Hospital

Device Facts

• Record ID: K032801
• Device Name: MODIFIED BROWNE PACKAGING AND LABEL STEAM PROCESS INDICATOR
• Applicant: Albert Browne , Ltd.
• Product Code: JOJ · General Hospital
• Decision Date: Oct 17, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

The Modified Browne Packaging and Label Steam Process Indicator (Modified Packaging and Label Steam Indicator) is a process indicator which undergoes a visual color change when exposed to steam in a temperature range of 121°C to 135°C (250°F to 275°F).

Device Story

Chemical process indicator; consists of indicator ink applied to substrates (labels, tapes, tags, paper) via flexographic printing. Input: exposure to steam (121°C–135°C). Transformation: chemical reaction induces visual color change from pink to dark purple. Output: visual color change on packaging/labels. Used in clinical/healthcare settings to confirm steam exposure. Benefits: provides immediate visual verification of steam exposure for sterilized items.

Clinical Evidence

Bench testing only. Device demonstrated conformance to ANSI/AAMI ST60 requirements for Class I process indicators. Performance verified in 132°C, 134°C, and 135°C steam sterilization cycles.

Technological Characteristics

Class I chemical process indicator. Materials: indicator ink on clay-coated label stock or steam-sterilizable paper. Principle: chemical reaction causing color change (pink to dark purple) upon steam exposure. Temperature range: 121°C to 135°C. Manufacturing: flexographic printing.

Indications for Use

Indicated for use as a steam sterilization process indicator to provide visual confirmation of exposure to steam in the temperature range of 121°C to 135°C. Not intended to verify specific sterilization parameters.

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

• Browne Packaging and Label Steam Process Indicator (K992767)

Submission Summary (Full Text)

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OCT 1 7 2003

## Special 510(K) Summary Albert Browne Ltd. Modified Browne Packaging and Label Steam Process Indicator

- Albert Browne Ltd. 1. SUBMITTED BY: Chancery House 190 Waterside Road Hamilton Industrial Park · Leicester LE5 1QZ United Kingdom
- CONTACT PERSON: Alan Charlton Chancery House 190 Waterside Road Hamilton Industrial Park Leicester LE5 1QZ United Kingdom

September 8, 2003 DATE PREPARED:

- Modified Browne Packaging and Label Steam Process 2. DEVICE NAME: Indicator
CLASSIFICATION NAME: Physical/chemical sterilization process indicator

- CLASSIFICATION STATUS: Physical/chemical process indicators are classified as Class II under Sterilization process indicator in 21 CFR 880.2800 (Product Code JOJ) by the General Hospital and Personal Use Devices Panel
#### 3. PREDICATE DEVICE

Browne Packaging and Label Steam Process Indicator (K992767)

K032801

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#### INTENDED USE 4.

The Modified Browne Packaging and Label Steam Process Indicator (Modified Packaging and Label Steam Indicator) is a process indicator which undergoes a visual color change when exposed to steam in a temperature range of 121°C to 135°C (250°F to 275°F).

#### 5. DEVICE DESCRIPTION

Like the parent Browne Packaging and Label Steam Indicator, the proposed Modified Packaging and Label Indicator consists of indicator ink applied to a suitable substrate using a flexographic printing method. When exposed to steam in the temperature range of 121°C to 135°C (250°F to 275°F), the indicator changes color. The parent indicator changed color from pink to purple. The color change for the proposed indicator is from pink to dark purple. Neither the proposed or parent indicator is intended to indicate that specific sterilization parameters have been met, but simply that the indicator has been exposed to a steam process.

#### TECHNOLOGICAL CHARACTERISTICS 6.

The technological characteristics of the proposed Modified Packaging and Label Steam Indicator and the parent indicator are identical. The proposed and predicate devices consist of indicator ink applied to a substrate. The indicator ink changes color to confirm exposure to steam.

The Modified Packaging and Label Steam Indicator consists of indicator ink applied using a flexographic printing method to packaging material, self-adhesive labels, tapes, tags, inserts, etc. The indicator ink composition for the proposed Modified Packaging and Label Indicator was modified to make the ink compatible with multiple substrates and improve the intensity of the visual color change.

The substrates used to support the indicator ink are identical for the proposed and predicate devices. The substrates for both the proposed and parent indicators are clay-coated label stock (some containing permanent or peelable adhesive and a siliconized backing) and steam-sterilizable paper.

The composition of the indicator ink used for the proposed Modified Packaging and Label Indicator was modified to make the ink compatible with multiple substrates and increase the intensity of the color change. The chemical reaction that induces the indicator ink to change color is identical for the parent and proposed indicators. The

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effective temperature range of the proposed device was expanded to include a 135°C steam sterilization cycle.

#### 7. PERFORMANCE TESTING

Albert Browne Ltd. has performed testing which demonstrates that the Modified Browne Packaging and Label Steam Indicator conform to the applicable requirements of ANSI/AAMI ST60 for Class I process indicators for steam sterilization. Additional testing showed that the indicator performed as designed in 132°C, 134°C, and 135°C sterilization cycles.

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Image /page/3/Picture/1 description: The image is a circular seal for the U.S. Department of Health & Human Services. The seal features the department's name encircling an emblem. The emblem is a stylized eagle with its wings spread, symbolizing protection and service. The overall design is simple and professional, reflecting the department's role in public health and welfare.

### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 7 2003

Albert Browne Limited C/O Dr. Cynthia J.M. Nolte Ph.D. Staff Consultant Medical Device Consultants, Incorporated 49 Plain Street North Attleboro, Massachusetts 02760

Re: K032801

Trade/Device Name: Modified Browne Packaging and Label Steam Process Indicator Regulation Number: 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: JOJ Dated: September 8, 2003 Received: September 22, 2003

Dear Dr. Nolte:

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 -Dr. Nolte

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), 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

Sincerely vours.

Susan Runnerfz

Chip Line, Ph.D.

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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# KO32801

510(k) Number (if known):

Device Name: Modified Browne Packaging and Label Steam Process Indicator

Indications for Use:

The Modified Browne Packaging and Label Steam Process Indicator is a process indicator which undergoes a visual color change when exposed to steam in a temperature range of 121°C to 135°C (250°F to 275°F).

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Pat. Atty. Steven Spencer Chang, Inc., 10/17/03

(Division Sign-Off) Division of Anesthesiology, General Hospital, n Control. Dental

510(k) Number: F-032801

Prescription Use

OR

Over-The-Counter Use

(Per 21 CFR 801.109)

Albert Browne Ltd. Special 510(k) Modified Packaging and Label Steam Indicator September 8, 2003