DANA EMULATING INDICATOR

K100891 · Dana Products, Inc. · JOJ · Jan 13, 2011 · General Hospital

Device Facts

• Record ID: K100891
• Device Name: DANA EMULATING INDICATOR
• Applicant: Dana Products, Inc.
• Product Code: JOJ · General Hospital
• Decision Date: Jan 13, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

Dana Emulating Indicator is for use in 4 minute 270°F (132°C) pre-vacuum steam sterilization process. When exposed to steam sterilization temperature and time the dark bar will travel along the window and enter the accept area giving an indication that steam sterilization conditions were met.

Device Story

Dana Emulating Indicator is a chemical sterilization process indicator used in hospital pre-vacuum steam sterilizers. It functions by monitoring critical parameters of temperature (270°F/132°C) and time (4 minutes). The device features a visual indicator where a dark bar travels along a window into an 'accept' area upon exposure to the specified steam sterilization conditions. This provides immediate visual confirmation to healthcare personnel that the sterilization cycle parameters were achieved. It is intended for over-the-counter use.

Clinical Evidence

Bench testing only.

Technological Characteristics

Chemical sterilization process indicator; visual color-change/movement mechanism; designed for 270°F (132°C) pre-vacuum steam sterilization cycles; non-electronic; passive indicator.

Indications for Use

Indicated for use in 4 minute 270°F (132°C) pre-vacuum steam sterilization processes to indicate that sterilization conditions were met.

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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Mr. Harry Bala President Dana Products, Incorporated 7 Corey Drive South Barington, Illinois 60010

JAN 1 3 2011

Re: K100891

Trade/Device Name: Dana Emulating Indicator Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: JQJ Dated: January 6, 2011 Received: January 10, 2011

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, 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 the submit and the submit of the submit of the submit of the subject of Register.

and the comments of the comments of the comments of

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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 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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/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/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 yours,

James J. Roberts

for

Anthony D. Watson, B.S., M.S., M.B.A. Director

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

Enclosure

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K100891

## Indications for Use

510(k) Number (if known): Device Name: Dana Emulating Indicator

JAN 1 3 2011

Indications For Use:

Dana Emulating Indicator is for use in 4 minute 270°F (132°C) pre-vacuum steam sterilization process. When exposed to steam sterilization temperature and time the dark bar will travel along the window and enter the accept area giving an indication that steam sterilization conditions were met.

Critical Parameters in a standard hospital pre-vacuum steam sterilizer

Temperature : 270°F (132°C) Time: 4 Minutes

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

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

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| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|-------------|
| Division of Anesthesiology, General Hospital | |
| Infection Control, Dental Devices | |
| 510(k) Number: | K100891 |
| | Page 1 of 1 |
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