STERITEC EMU-GRAPH, MODEL NO. CI 131/US

K040901 · Steritec Products, Inc. · JOJ · Sep 9, 2004 · General Hospital

Device Facts

• Record ID: K040901
• Device Name: STERITEC EMU-GRAPH, MODEL NO. CI 131/US
• Applicant: Steritec Products, Inc.
• Product Code: JOJ · General Hospital
• Decision Date: Sep 9, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

SteriTec Integraph-E is a steam sterilization integrator for use in a pre-vacuum steam sterilization process at 132°C (270° F) for 2 minutes or 4 minutes. When exposed to steam sterilization conditions Integraph-E strips give an integrated response and visible indication that sterilization were met by changing from a purple to green color.

Device Story

SteriTec Integraph-E is a chemical sterilization process indicator strip. It functions as a steam sterilization integrator designed for use in pre-vacuum steam sterilization cycles. The device is placed within the sterilization load. Upon exposure to specific steam sterilization conditions (132°C for 2 or 4 minutes), the indicator strip undergoes a chemical reaction that results in a visible color change from purple to green. This color change provides the operator with a visual confirmation that the required sterilization parameters were achieved. It is intended for use by healthcare personnel in clinical settings to verify the efficacy of the sterilization process for medical instruments.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Chemical sterilization process indicator strip. Operates via a chemical reaction triggered by steam, temperature, and time, resulting in a visual color change (purple to green). Form factor is a strip. No energy source required. Non-electronic, non-software device.

Indications for Use

Indicated for use as a steam sterilization integrator in pre-vacuum steam sterilization processes at 132°C (270°F) for 2 or 4 minutes to provide a visual indication of sterilization conditions.

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

SEP - 9 2004

Ms. Linda Nelson Regulatory Affairs Manager Steritec Products, Incorporated 599 Topeka Way, Suite 400 Castle Rock, Colorado 80109

Re: K040901

Trade/Device Name: SteriTec Integraph-E, Model No. CI 131/US Regulation Number: 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: JOJ Dated: June 25, 2004 Received: June 29, 2004

Dear Ms. Nelson:

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.

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Page 2 - Ms. Nelson

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); 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/dsma/dsmamain.html

Sincerely yours.

Chiu Lin, Ph.D.

Chiu Lin, Ph.D. 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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## Indications for Use

510(k) Number : K040901

Device Name: SteriTec Integraph-E, Model No.: Cl 131/US

## Indications For Use:

SteriTec Integraph-E is a steam sterilization integrator for use in a pre-vacuum steam sterilization process at 132°C (270° F) for 2 minutes or 4 minutes. When exposed to steam sterilization conditions Integraph-E strips give an integrated response and visible indication that sterilization were met by changing from a purple to green color.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Kein Muluy

(Division Sign-Off) Division of Anesthesiology, General Hospital. Infection Control, Dental De

510(k) Number: K040901