VERIFY DRY HEAT LABEL

K053479 · Albert Browne , Ltd. · JOJ · Jul 18, 2006 · General Hospital

Device Facts

• Record ID: K053479
• Device Name: VERIFY DRY HEAT LABEL
• Applicant: Albert Browne , Ltd.
• Product Code: JOJ · General Hospital
• Decision Date: Jul 18, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Indications for Use

The Verify® Dry Heat Label is a process indicator that undergoes a visual color change from amber to black when exposed to dry heat in a temperature range of 160°C to 180°C.

Device Story

Verify® Dry Heat Label is a chemical process indicator; consists of indicator ink applied to a substrate via rotary screen printing. Used in dry heat sterilization environments; applied to packaged goods prior to processing. Upon exposure to dry heat (160°C–180°C), ink undergoes irreversible color change from amber to black. Provides visual confirmation of exposure to the process; does not verify sterilization efficacy. Used by healthcare personnel in clinical settings to distinguish processed from unprocessed items.

Clinical Evidence

Bench testing only. Testing demonstrated conformance to ANSI/AAMI ST60 requirements for Class I process indicators and verified performance in dry heat sterilization cycles between 160°C and 180°C.

Technological Characteristics

Class I chemical process indicator; indicator ink applied to substrate via rotary screen printing. Operates via thermal-sensitive chemical reaction. Complies with ANSI/AAMI ST60 standards.

Indications for Use

Indicated for use as a process indicator to provide visual confirmation of exposure to dry heat sterilization cycles (160°C to 180°C). Not intended to verify 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

• Dry Heat Sterilization Indicator Tape (K890758)

Submission Summary (Full Text)

{0}------------------------------------------------

K053479

# 510(k) Summary for

### Verify® Dry Heat Label

#### 1. SUBMITTER NAME AND ADDRESS

JUL 1 8 2006

Richard Bancroft Albert Browne Ltd., a Subsidiary of STERIS Corporation Chancery House 190 Waterside Road Hamilton Industrial Park Leicester LE5 1QZ United Kingdom

Contact: Richard Bancroft Telephone number: 44 116 276 8636

Date Prepared: March 21, 2006

#### 2. DEVICE NAME

| Proprietary Name: | Verify® Dry Heat Label |
|----------------------|---------------------------------------------------|
| Common/Usual Name: | Chemical indicator |
| Classification Name: | Physical/Chemical Sterilization Process Indicator |

#### 3. PREDICATE DEVICES

- Dry Heat Sterilization Indicator Tape (SPS Medical Supply Corp., K890758) .
#### 4. INTENDED USE

The Verify® Dry Heat Label is a process indicator that undergoes a visual color change from amber to black when exposed to dry heat in a temperature range of 160°C to 180°C.

{1}------------------------------------------------

#### న. DEVICE DESCRIPTION

The proposed Verify® Dry Heat Label consists of indicator ink applied to a substrate using a rotary screen printing method. When exposed to dry heat in the temperature range of 160°C to 180°C the indicator ink changes color from amber to black. The indicator is not intended to indicate that specific sterilization parameters have been met, but simply that the indicator has been exposed to a dry heat process.

#### 6. TECHNOLOGICAL CHARACTERISTICS

The technological characteristics of the Verify® Dry Heat Label indicator and the predicate device are similar. Both the proposed and predicate devices consist of indicator ink applied to a substrate that can be applied to packaged goods prior to dry heat sterilization.

#### 7. PERFORMANCE TESTING

Albert Browne Ltd. has performed testing which demonstrates that the Verify® Dry Heat Label conforms to the applicable requirements of ANSI/AAMI ST60 for Class I process indicators for dry heat sterilization. Additional testing showed that the indicator performed as designed in dry heat sterilization cycles in the range of 160°C to 180°C.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 8 2006

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

Re: K053479

Trade/Device Name: Verify® Dry Heat Label Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: JOJ Dated: July 3, 2006 Received: July 3, 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.

{3}------------------------------------------------

### Page 2 - Ms. 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,

Chiu-Li Lu, 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

{4}------------------------------------------------

## Indications for Use

510(k) Number (if known):

Device Name: VERIFY® Dry Heat Label

Indications for Use:

The Verify® Dry Heat Label is a process indicator that undergoes a visual color The Venty - Dry Heat Labor is a process manufacts.
change from amber to black when exposed to dry heat in a temperature range of 160°C to 180°C.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use_ × (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)

Shala M. Mingleur, 40 7/18/04

on Sign-Off)
In of Anesthesiology, General Hospital,
In of Anesthesiology, General Devices Devices in of Ambol, Dental Number

Page 1 of 1