STEAM STERILIZATION INTERGRATOR

K012195 · Dana Products, Inc. · JOJ · May 7, 2002 · General Hospital

Device Facts

• Record ID: K012195
• Device Name: STEAM STERILIZATION INTERGRATOR
• Applicant: Dana Products, Inc.
• Product Code: JOJ · General Hospital
• Decision Date: May 7, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

Dana Steam Sterilization Integrators are intended to monitor critical parameters in steam sterilization cycles in bealthcare facilities. The critical parameters for which the integrators will respond are time and temperature (when steam is present). The end point is determined by the migration of the steam sensitive dye to an area marked safe on the indicator. The integrators are intended to be used in 30 minute gravity cycles at 250 degrees F and 3 minute gravity and pre- vacuum cycles at 270 degrees F.

Device Story

Dana Steam Sterilization Integrator; chemical indicator device used in healthcare facilities to monitor steam sterilization cycles. Device monitors critical parameters: time, temperature, and presence of steam. Principle of operation: migration of steam-sensitive dye across indicator strip to 'safe' zone. Provides visual confirmation of sterilization cycle completion. Used by healthcare personnel to verify sterilization efficacy; output affects clinical decision-making regarding instrument sterility and patient safety.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Chemical sterilization process indicator. Employs steam-sensitive dye migration technology. Designed for specific cycle parameters: 30 minutes at 250°F (gravity) and 3 minutes at 270°F (gravity/pre-vacuum).

Indications for Use

Indicated for monitoring critical parameters (time, temperature, presence of steam) in steam sterilization cycles within healthcare facilities. Used in 30-minute gravity cycles at 250°F and 3-minute gravity/pre-vacuum cycles at 270°F.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## MAY 0 7 2002

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

Re: K012195

Trade/Device Name: Dana Steam Sterilization Intergrator Regulation Number: 880.2800 (b) Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: JOJ Dated: March 30, 2002 Received: April 2, 2002

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.

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

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.

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## Page 2 - Mr. Bala

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); 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.

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrh/dsma/dsmamain.html

Sincerely yours,

Klichrist

Timothy . 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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K012195 510(k) Number (if known):

Steam Sterilization Integrator Device Name:

Indications For Use:

Dana Steam Sterilization Integrators are intended to monitor critical parameters in steam sterilization cycles in bealthcare facilities. The critical parameters for which the integrators will respond are time and temperature (when steam is present). The end point is determined by the migration of the steam sensitive dye to an area marked safe on the indicator. The integrators are intended to be used in 30 minute gravity cycles at 250 degrees F and 3 minute gravity and pre- vacuum cycles at 270 degrees F.

(Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

Olin S. Lim

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