STERI-PAK LF BOWIE-DICK TEST PACK

K990246 · Steritec Products Mfg Co, Inc. · JOJ · Jun 10, 1999 · General Hospital

Device Facts

• Record ID: K990246
• Device Name: STERI-PAK LF BOWIE-DICK TEST PACK
• Applicant: Steritec Products Mfg Co, Inc.
• Product Code: JOJ · General Hospital
• Decision Date: Jun 10, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

The Steri-Pak LF Bowie Dick Test Pack manufactured by SteriTec Products Mfg. Co., Inc. is designed to detect the presence of residual air in prevacuum steam sterilizers operating at 132 °C. It is designed to be used for daily Bowie Dick testing of hospital sterilizers as described in AAMI/ANSI ST46 section 7.7. It contains no Lead.

Device Story

Disposable test pack for daily monitoring of prevacuum steam sterilizers; detects residual air, inadequate steam penetration, and vacuum pump failures. Input: steam and air environment within sterilizer chamber. Operation: stack of 25 porous blotter paper layers with bottom plastic laminate; contains steam-sensitive ink indicator sheet. Output: visual color change (black for successful test, lighter blue center for air presence). Used in hospital sterilization departments; operated by sterile processing staff. Benefits: ensures sterilizer performance and patient safety by verifying effective steam penetration.

Clinical Evidence

Bench testing only. Laboratory tests compared the subject device to the predicate to confirm performance in detecting residual air in prevacuum steam sterilizers.

Technological Characteristics

Disposable test pack; 3" x 5/4" x 2" dimensions; 25 layers of porous blotter paper; plastic laminated bottom layer; steam-sensitive ink indicator; lead-free; compliant with AAMI/ANSI ST46 section 7.7.

Indications for Use

Indicated for daily monitoring of prevacuum steam sterilizers to detect residual air, inadequate steam penetration, and vacuum pump failures in hospital settings.

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

• SteriTec Steri-Pak Bowie Dick Test Pack (K982188)

Submission Summary (Full Text)

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JUN 10 1999

# 510(k) SUMMARY 990246

# SUBMITTER:

STERITEC PRODUCTS MFG. CO., INC. 680 Atchison Way - Suite 600 Castle Rock, CO. 80104 [phone] [phone] Fax

Establishment Registration Number:

2028456

Date Summary was Prepared:

January 20, 1999

TOM ROLL Printed name of person required to submit 510(k)

Tom Roll

Signature of person required to submit 510(k)

PRESIDENT Title of person submitting 510(k)

| Proprietary Name: | Steri-Pak LF Bowie-Dick Test Pack |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common/ Usual Name: | Disposable Bowie-Dick Test Pack |
| Classification Name: | Physical/Chemical Sterilization Indicator |
| Classification: | The Steri-Pak LF Bowie-Dick Test Pack for use in prevacuum steam sterilizers is a disposable "Physical/Chemical sterilization indicators" test pack for the daily monitoring of prevacuum steam sterilizers to detect air leaks, inadequate steam penetration, and vacuum pump failures. It contains no Lead. It falls under the FDA classification of Indicator, Physical/Chemical Sterilization Process in Class II under Regulation Number 880.2800. |
| Predicate Device: | SteriTec Steri-Pak Bowie Dick Test Pack 510(k) 982188 |

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# 510(k) Summary - continued

#### Description of 510(k) Submission Device:

# Intended use/Device Description:

The Steri-Pak LF Bowie-Dick Test Pack is designed specifically for daily monitoring of pre-vacuum steam sterilizers to detect the presence of residual air. The test pack is approximately 3%" x 5/4" x2/" in size consisting of a stack of 25 layers of porous blotter paper with a plastic laminated layer at the bottom. Embedded within the pack is an indicator sheet with steam sensitive ink printed on it. The indicator sheet changes to black during a typical Bowie-Dick test and will have a lighter, blue color in the center if a significant amount of air is present during the test.

#### Comparison to Predicate Device:

Laboratory tests show the Steri-Pak LF Bowie-Dick Test Pack and the above named predicate device have the same intended use in that they are disposable chemical indicator test packs designed specifically for daily monitoring of pre-vacuum steam sterilizers to detect the presence of residual air.

# Summary of Performance Testing:

Based on the results of laboratory tests, the Steri-Pak LF Bowie-Dick Test Pack is substantially equivalent to the SteriTec Steri-Pak Bowie Dick Test Pack 510(k) 982188.

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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three swooping lines forming its body and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 0 1999

Mr. Lon Bruso Vice President SteriTec Products Manufacturing Company, Incorporated 680 Atchison Way - Suite 600 Castle Rock, Colorado 80104

Re : K990246 Trade Name: Steri-Pak LF Bowie-Dick Test Pack Requlatory Class: II Product Code: JOJ Dated: March 29, 1999 Received: March 30, 1999

Dear Mr. Bruso:

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 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, ਰ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug 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.

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Page 2 - Mr. Bruso

this response to your premarket notification Please note: submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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" (21 CFR 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 (800) 638-20,41 or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.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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Page _ 1______________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known): ___________________

Device Name:__Steri-Pak LF Bowie Dick Test Pack

Indications For Use:

The Steri-Pak LF Bowie Dick Test Pack manufactured by SteriTec Products Mfg. Co., Inc. is designed to detect the presence of residual air in prevacuum steam sterilizers operating at 132 °C. It is designed to be used for daily Bowie Dick testing of hospital sterilizers as described in AAMI/ANSI ST46 section 7.7. It contains no Lead.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | | OR | Over-The-Counter Use | √ |
|----------------------|--|----|--------------------------|---|
| (Per 21 CFR 801.109) | | | (Optional Format 1-2-96) | |

| | K990246 |
|---------------|----------------------------------------|
| | (Division Sign-Off) |
| | Division of Dental, Infection Control, |
| | and General Hospital Devices |
| 510(k) Number | |