STERITEC GREEN CARD PACK BOWIE-DICK TEST MODEL BD 126

K122945 · Steritec Products Mfg Co, Inc. · JOJ · Apr 30, 2013 · General Hospital

Device Facts

• Record ID: K122945
• Device Name: STERITEC GREEN CARD PACK BOWIE-DICK TEST MODEL BD 126
• Applicant: Steritec Products Mfg Co, Inc.
• Product Code: JOJ · General Hospital
• Decision Date: Apr 30, 2013
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

SteriTec Green Card Pack Bowie-Dick Test is designed to detect the presence of residual air in pre-vacuum steam sterilizers operating at 132°C for 3.5 minutes. The indicator card within the Green Card Pack will demonstrate a uniform color change from purple to green when proper sterilization conditions are met and no air is present. If enough air is present to create a 2° C (+1°-0° C) temperature difference between the center of the towel pack, as identified in ANSI/AAMI/ISO 11140-5, and the drain temperature at the beginning of the final one minute of a three and half minute cycle the indicator card within the Green Card Pack will demonstrate a non-uniform color change.

Device Story

SteriTec Green Card Pack Bowie-Dick Test is a chemical indicator used to verify performance of pre-vacuum steam sterilizers. Device consists of an indicator card housed within a pack; placed in sterilizer chamber. During 132°C, 3.5-minute cycle, device monitors for residual air. If air is absent, indicator card undergoes uniform color change from purple to green. If residual air creates a 2°C temperature differential (per ANSI/AAMI/ISO 11140-5), card shows non-uniform color change. Healthcare personnel inspect card post-cycle to confirm sterilization conditions. Provides immediate visual feedback on sterilizer efficacy; helps ensure instrument sterility; prevents use of improperly sterilized equipment.

Clinical Evidence

Bench testing only. Performance validated against ANSI/AAMI/ISO 11140-5 standards for Bowie-Dick type tests to confirm color change response to specific temperature differentials caused by residual air.

Technological Characteristics

Chemical indicator card; color-changing ink (purple to green). Designed for 132°C, 3.5-minute pre-vacuum steam sterilization cycles. Complies with ANSI/AAMI/ISO 11140-5 specifications for Bowie-Dick test packs.

Indications for Use

Indicated for use in pre-vacuum steam sterilizers operating at 132°C for 3.5 minutes to detect residual air. Intended for use by healthcare personnel in clinical 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 Green Card Pack Bowie-Dick Test (K122945 is the subject device; no specific predicate name/number provided in text)

Submission Summary (Full Text)

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#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

# April 30, 2013

Mr. Jonathan Rutigliano Director of Regulatory Affairs and Quality Assurance Steritec Products Manufacturing Company, Incorporated 74 Inverness Drive East ENGLEWOOD CO 80112

Re: K122945

Trade/Device Name: SteriTec Green Card Park Bowie-Dick Test, Model BD 126 Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: JOJ Dated: April 16, 2013 Received: April 17, 2013

Dear Mr. Rutigliano:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 - Mr. Rutigliano

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

for

Theta

Euromitus

++

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, 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): ____________________________________________________________________________________________________________________________________________________

Device Name: SteriTec Green Card Pack Bowie-Dick Test, Model BD 126

Indications For Use:

SteriTec Green Card Pack Bowie-Dick Test is designed to detect the presence of residual air in pre-vacuum steam sterilizers operating at 132°C for 3.5 minutes. The indicator card within the Green Card Pack will demonstrate a uniform color change from purple to green when proper sterilization conditions are met and no air is present. If enough air is present to create a 2° C (+1°-0° C) temperature difference between the center of the towel pack, as identified in ANSI/AAMI/ISO 11140-5, and the drain temperature at the beginning of the final one minute of a three and half minute cycle the indicator card within the Green Card Pack will demonstrate a non-uniform color change.

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

Over-The-Counter Use × (21 CFR 801 Subpart C)

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# Concurrence of CDRH, Office of Device Evaluation (ODE)

Elizabeth F Claverie

Digitally signed by Elizabeth F. Claverie DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People. 0.9.2342.19200300.100.1.1=1300055864 , cn=Elizabeth F. Claverie
Date: 2013.04.30 14:19:44 -04'00"

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רועיוsion of Anesthesiology, General Hospital rection Control, Dental Devices

10(k) Number: K122945

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