EMU-GRAPH EMULATOR, MODEL CI 131

K072408 · Steritec Products Mfg Co, Inc. · JOJ · Apr 30, 2008 · General Hospital

Device Facts

• Record ID: K072408
• Device Name: EMU-GRAPH EMULATOR, MODEL CI 131
• Applicant: Steritec Products Mfg Co, Inc.
• Product Code: JOJ · General Hospital
• Decision Date: Apr 30, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

SteriTec Emu-Graph is a steam sterilization emulator for use in a pre-vacuum steam sterilization process at 132°C (270° F) or 135° C (275° F). When exposed to the sterilization process, the 2 MIN and 4 MIN indicator bars will turn from purple to green giving an integrated response and visible indication that the sterilization parameters have been met. If only the 2 MIN indicator bar turns green and the 4 MIN indicator bar displays an incomplete color change, insufficient sterilization conditions occurred.

Device Story

Emu-Graph Emulator (Model CI 131) is a chemical sterilization process indicator used in hospital pre-vacuum steam sterilizers. Device consists of indicator bars that undergo a color change (purple to green) when exposed to specific steam sterilization conditions (temperature and time). Operator (hospital staff) places device in sterilizer; visual inspection of indicator bars post-cycle confirms whether sterilization parameters (2 MIN and 4 MIN thresholds) were achieved. If 4 MIN bar fails to turn green, sterilization is deemed insufficient. Provides immediate visual feedback to ensure sterilization efficacy for medical instruments.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Chemical sterilization indicator; color-changing ink (purple to green) responsive to steam, temperature, and time. Form factor: indicator strip/card. Designed for pre-vacuum steam sterilization at 132°C/135°C. No software or electronic components.

Indications for Use

Indicated for use as a steam sterilization emulator in pre-vacuum steam sterilizers at 132°C or 135°C to monitor sterilization parameters. No specific patient population or contraindications provided.

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

APR 30 Zuur

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

Re: K072408

Trade/Device Name: Emu-Graph Emulator, Model No .: CI 131 Regulation Number: 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: JOJ Dated: April 10, 2008 Received: April 14, 2008

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/industry/support/index.html.

Sincerely yours,

Sydite y. Micham Oms

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 (if known): K072408

Device Name: Emu-Graph Emulator, Model No .: CI 131

Indications for Use:

SteriTec Emu-Graph is a steam sterilization emulator for use in a pre-vacuum steam Sterried Ema Staph is a otoan at 132°C (270° F) or 135° C (275° F). When exposed stemization proodse open the 2 MIN and 4 MIN indicator bars will turn from purple to green giving an integrated response and visible indication that from purple to groom grining an t. If only the 2 MIN indicator bar turns green and the 4 MIN indicator bar displays an incomplete color change, insufficient sterilization conditions occurred.

Critical Parameters in a standard hospital pre-vacuum steam sterilizer

| Temperature | 4 MIN Indicator |
|---------------|-----------------|
| 132°C (270°F) | 4 minutes |
| 135°C (275°F) | 3 minutes |

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Shili A. Murphy, MD

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

510(k) Number. K072408

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