ALBERT BROWNE LTD. VERIFY STEAM VALUE INDICATORS

K060103 · Albert Browne , Ltd. · JOJ · Mar 7, 2006 · General Hospital

Device Facts

• Record ID: K060103
• Device Name: ALBERT BROWNE LTD. VERIFY STEAM VALUE INDICATORS
• Applicant: Albert Browne , Ltd.
• Product Code: JOJ · General Hospital
• Decision Date: Mar 7, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

The VERIFY® STEAM Value Indicators are process indicators that undergo a visual color change when exposed to steam in a temperature range of 121℃ to 135℃ (250°F to 275°F).

Device Story

VERIFY® STEAM Value Indicators consist of indicator ink applied to substrates including packaging materials, self-adhesive labels, tapes, tags, and inserts. Device functions as a physical/chemical process indicator; ink undergoes visual color change upon exposure to steam within 121°C–135°C range. Used in clinical or healthcare settings to confirm sterilization process exposure. Healthcare personnel visually inspect the indicator to verify that the item has been processed through a steam sterilization cycle. Benefits include providing immediate visual confirmation of steam exposure for sterilized items.

Clinical Evidence

Bench testing only. Device conforms to ANSI/AAMI ST60 requirements for Class I process indicators. Additional testing confirmed performance under in-use conditions across all compatible substrates.

Technological Characteristics

Indicator ink applied to substrates (packaging, labels, tapes, tags, inserts). Chemical reaction induces color change upon steam exposure. Designed for 121°C–135°C range. Conforms to ANSI/AAMI ST60 standards for Class I process indicators.

Indications for Use

Indicated for use as a process indicator to confirm exposure to steam sterilization in the temperature range of 121°C to 135°C (250°F to 275°F).

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

• Modified Browne Packaging and Label Steam Process Indicator (K032801)

Submission Summary (Full Text)

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# Special 510(k) Summary Albert Browne Ltd. VERIFY® STEAM Value Indicators

K060103

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

Telephone: [phone]

DATE PREPARED: January 11, 2006

- 2. DEVICE NAME: VERIFY® STEAM Value Indicators
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

- Modified Browne Packaging and Label Steam Process Indicator (K032801) .

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#### INTENDED USE র্ব .

The VERIFY® STEAM Value Indicators are process indicators that undergo a visual color change when exposed to steam in a temperature range of 121℃ to 135℃ (250°F to 275°F).

#### ഗ് DEVICE DESCRIPTION

Similar to the parent Modified Browne Packaging and Label Steam Process Indicator, the proposed VERIFY® STEAM Value Indicators consists of indicator ink applied to a suitable substrate, i.e. packaging material, self-adhesive labels, tapes, tags, inserts, etc. Modifications to the parent indicator to produce the proposed VERIFY® STEAM Value Indicators included changes to the indicator ink composition, modification to the process used for application of the indicator ink to the substrates, and minor changes to the suite of compatible substrates. The modifications to the indicator ink composition were made to produce two variants with different color change schemes and improve the "printability" of the ink.

#### 6. TECHNOLOGICAL CHARACTERISTICS

Both the proposed and predicate devices consist of indicator ink applied to a substrate. The indicator ink changes color to confirm exposure to steam. The substrates used to support the indicator ink are similar for the proposed and predicate devices. Changes were made to the indicator ink formulation to produce two different color change schemes and improve the "printability" of the ink. However, the chemical reaction that induces the indicator ink to change color is identical for the parent and proposed indicators.

#### 7. PERFORMANCE TESTING

Albert Browne Ltd. has performed testing which demonstrates that the VERIFY® STEAM Value Indicators conform to the applicable requirements of ANSI/AAMI ST60 for Class I process indicators for steam sterilization. Additional testing confirmed that the indicators performed as designed under in use conditions using all of the compatible substrates.

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MAR 7

2006

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three overlapping wings, symbolizing health, human services, and well-being. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Albert Browne Limited C/O Ms. Cynthia J.M. Nolte Medical Device Consultants 49 Plain Street North Attleboro, Massachusetts 02760

Re: K060103

Trade/Device Name: Albert Browne Limited VERIFY® STEAM Value Indicators Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization process indicator Regulatory Class: II Product Code: JOJ Dated: February 27, 2006 Received: March 1, 2006

Dear Ms. 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 - Ms. Cynthia J.M. 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 (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 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/industry/support/index.html.

Sincerely yours,

Susan Phono
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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## Indications for Use

510(k) Number (if known): Kaown 3

Device Name: Albert Browne Ltd. VERIFY® STEAM Value Indicators

Indications for Use:

The Albert Browne Ltd. VERIFY® STEAM Value Indicators are process indicators that undergo a visual color change when exposed to steam in a temperature range of 121°C to 135°C (250°F to 275°F).

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use X (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Shula H. Murphy 3/7/66

Radiology, General Hospital
National Dental Devices
Koloa 3