DANA REUSABLE BOWIE TEST PACK FOR DANA BOWIE DICK INDICATORS

K120592 · Dana Products, Inc. · JOJ · Feb 27, 2013 · General Hospital

Device Facts

• Record ID: K120592
• Device Name: DANA REUSABLE BOWIE TEST PACK FOR DANA BOWIE DICK INDICATORS
• Applicant: Dana Products, Inc.
• Product Code: JOJ · General Hospital
• Decision Date: Feb 27, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

The Dana Reusable Bowie Dick Type Test Pack, when used with a Dana Bowie Dick indicator, is designed for testing the air removal efficiency of pre-vacuum steam sterilizers. The indicator will demonstrate complete dye migration when proper sterilization conditions are met and proper vacuum is achieved. If there is inadequate vacuum such that would result in a 2°C (+1°-0°C) temperature difference between the center of the ANSVAAMI/ISO 11140-5:2007 Standard Test Pack and the drain temperature at the beginning of the final minute of a three and a half minute cycle, the indicator will demonstrate incomplete dye migration (incomplete color change in the indicator window). The test parameters used for validating this device were 134℃ for 3.5 minutes with a 2 minute dry time.

Device Story

Device consists of a reusable test pack and chemical indicator used to verify performance of pre-vacuum steam sterilizers. Operates by monitoring air removal efficiency; inadequate vacuum results in insufficient steam penetration, detected by the indicator. Indicator shows complete dye migration (color change) when sterilization conditions are met; incomplete migration indicates failure. Used by healthcare personnel to ensure sterilizer functionality. Provides visual confirmation of sterilization parameters (134°C for 3.5 minutes).

Clinical Evidence

Bench testing only. Validation performed using test parameters of 134°C for 3.5 minutes with a 2-minute dry time, confirming indicator response to temperature differentials as defined by ANSI/AAMI/ISO 11140-5:2007 standards.

Technological Characteristics

Reusable test pack and chemical indicator. Sensing principle: chemical dye migration responsive to steam penetration and temperature. Designed for 134°C, 3.5-minute sterilization cycles. Complies with ANSI/AAMI/ISO 11140-5:2007 standards for test packs.

Indications for Use

Indicated for testing air removal efficiency of pre-vacuum steam sterilizers in clinical or healthcare 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.

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

## February 27, 2013

Mr. Harry Bala President Dana Products, Incorporated 7 Corey Drive SOUTH BARRINGTON IL 60010

Re: K120592

Trade/Device Name: Dana Reusable Bowie Dick Type Pack and Dana Bowie Dick Indicators Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: JOJ Dated: February 15, 2013 Received: February 19, 2013

Dear Mr. Bala:

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. Iisting 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. Bala

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 devicerelated 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportalProblem/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 yours.

Image /page/1/Picture/6 description: The image contains a signature or handwritten text that is difficult to decipher due to its stylized and cursive nature. The text appears to be overlaid on top of some graphic elements, including what looks like a stylized letter or symbol on the left and a triangular shape on the right. The overall impression is that of a personalized autograph or a logo with a handwritten component.

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

## K120592

510(k) Number (if known):

Device Name: Dana Reusable Bowie Dick Type Test Pack and Dana Bowie Dick Indicators

Indications For Use:

The Dana Reusable Bowie Dick Type Test Pack, when used with a Dana Bowie Dick indicator, is designed for testing the air removal efficiency of pre-vacuum steam sterilizers. The indicator will demonstrate complete dye migration when proper sterilization conditions are met and proper vacuum is achieved. If there is inadequate vacuum such that would result in a 2°C (+1°-0°C) temperature difference between the center of the ANSVAAMI/ISO 11140-5:2007 Standard Test Pack and the drain temperature at the beginning of the final minute of a three and a half minute cycle, the indicator will demonstrate incomplete dye migration (incomplete color change in the indicator window). The test parameters used for validating this device were 134℃ for 3.5 minutes with a 2 minute dry time.

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elizabeth F. Claverie2013.02.25 17:26:13 -05'00'Page 1 of 1

sthesiology, General Hospital

**510(k) Number:*****_****_*