BROWNE TST SINGLE USE BOWIE-DICK TYPE TEST PACK

K971971 · Board of Directors, Albert Browne , Ltd. · JOJ · Jul 10, 1998 · General Hospital

Device Facts

• Record ID: K971971
• Device Name: BROWNE TST SINGLE USE BOWIE-DICK TYPE TEST PACK
• Applicant: Board of Directors, Albert Browne , Ltd.
• Product Code: JOJ · General Hospital
• Decision Date: Jul 10, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

The Browne TST Single Use Bowie-Dick Type Test Pack is a chemical sterilization process monitor which demonstrates adequate air removal and steam penetration during a 132°C (270°F) or 134°C (273°F) autoclave processing cycle by means of a yellow to blue color change.

Device Story

Device is a single-use chemical sterilization process monitor; consists of indicator sheet with ink figure wrapped in multiple paper layers. Used in steam autoclaves (132°C/134°C) to verify air removal and steam penetration. Principle of operation: chemical ink changes color from yellow to blue upon exposure to sufficient steam penetration. Sensitivity detects ≥2°C temperature depression. Used by sterile processing staff in clinical settings. Provides visual confirmation of sterilization cycle efficacy; ensures equipment safety; aids in clinical decision-making regarding instrument sterility.

Clinical Evidence

Bench testing only. Testing demonstrated sensitivity to detect ≥2°C temperature depression at 132°C or 134°C in 3-4 minute cycles. Performance confirmed in both empty and loaded autoclave chambers.

Technological Characteristics

Indicator sheet with chemical ink figure; wrapped in multiple paper layers acting as steam barrier. Circular process indicator on label. Color change (yellow to blue) triggered by specific temperature and steam penetration conditions. Standalone, non-electronic, passive chemical indicator.

Indications for Use

Indicated for use as a chemical sterilization process monitor to verify adequate air removal and steam penetration in 132°C or 134°C steam autoclave cycles. Suitable for use in healthcare facilities performing steam sterilization.

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 TST Single Use Bowie-Dick Type Test Pack (K932057)

Submission Summary (Full Text)

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K 971971/
July 10, 1998

# 510(k) SUMMARY Browne TST Single Use Bowie-Dick Type Test Pack April 3, 1998

#### SUBMITTER NAME AND ADDRESS 1.

Mr. Alan Charlton Albert Browne Ltd. 190 Waterside Road Hamilton Industrial Park Leicester LE5 1QZ United Kingdom

#### DEVICE NAME 2.

| Proprietary Name: | Browne TST Single Use Bowie-Dick Type Test Pack |
|----------------------|-------------------------------------------------|
| Common/Usual Name: | Bowie-Dick Test |
| Classification Name: | Physical/Chemical Process Indicator |

#### PREDICATE DEVICE 3.

Browne TST Single Use Bowie-Dick Type Test Pack, subject of K932057

#### 4. INTENDED USE

The Browne TST Single Use Bowie-Dick Type Test Pack is a chemical sterilization process monitor which demonstrates adequate air removal and steam penetration during a 132°C (270°F) or 134°C (273°F) autoclave processing cycle by means of a yellow to blue color change.

#### 5. DEVICE DESCRIPTION

The Browne TST Single Use Bowie Dick Type Test Pack is a paper sheet containing an indicator figure wrapped in multiple layers of paper which is designed to monitor air removal and steam penetration during a 132 °C (270°F) or 134°C (273°F) steam autoclave processing cycle with a hold time of 3-4 minutes. The device changes color from yellow to blue when air removal during the cycle is sufficient to allow complete, even, steam penetration.

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## TECHNOLOGICAL CHARACTERISTICS 6.

The device is composed of an indicator sheet, containing the indicator ink figure. The indicator sheet is wrapped in layers of paper which serves as a barrier to steam penetration. The chemical composition of the ink controls the temperature required for a color change to occur in the presence of complete, even steam penetration. A circular process indicator is affixed to the test pack label which changes color from yellow to blue when exposed to steam.

### PERFORMANCE TESTING 7.

Performance testing has been conducted which showed that the sensitivity of the Test Packs is sufficient to detect a ≥2℃ temperature depression at 132°C (270°F) or 134°C (273°F) in a test cycle of 3-4 minutes duration. The data supports the use of the Test Pack to monitor air removal during a steam autoclave processing cycle. Additional testing conducted in a loaded chamber demonstrated that the sensitivity of the Test Pack was not affected by the presence of the load.

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Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and features an eagle with its wings spread. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are written around the top of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 0 1998

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

K971971 Re : Browne TST Single Use Bowie-Dick Type Test Trade Name: Pack Regulatory Class: II Product Code: JOJ Dated: June 8, 1998 Received: June 9, 1998

Dear Dr. Nolte:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Dr. Nolte

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address

"http://www.fda.gov/cdrh/dsma/dsmamaing.html".

Sincerely yours,

Timothy A. Ulatowski

Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure .

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510(k) Number (if known): K971971

Device Name: Browne TST Single Use Bowie-Dick Type Test Pack

Indications For Use:

The Browne TST Single Use Bowie-Dick Type Test is a chemical sterilization process monitor which demonstrates adequate air removal and steam penetration during a 132°C (270°F) or 134°C (273°F) autoclave processing cycle by means of a yellow to blue color change.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Olin S. Lin

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use X

Browne TST Single Use Bowie-Dick Type Test Additional Information - K971971

CONFIDENTIAL 4/3/98

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