INSTANT READOUT CHEMICAL INTEGRATOR CHALLENGE PACK, MODEL LT- 105

K080136 · Steritec Products, Inc. · JOJ · Aug 15, 2008 · General Hospital

Device Facts

• Record ID: K080136
• Device Name: INSTANT READOUT CHEMICAL INTEGRATOR CHALLENGE PACK, MODEL LT- 105
• Applicant: Steritec Products, Inc.
• Product Code: JOJ · General Hospital
• Decision Date: Aug 15, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

The SteriTec Instant Readout Chemical Integrator Chailenge Pack is a steam sterilization process challenge device that meets the FDA Chemical Indicator Guidelines performance requirements for chemical integrator test packs. The Integrator Challenge Pack monitors pre-vacuum steam sterilizers operating at 132°C (270°F) or 135°C (275°F). When exposed to steam sterilization conditions the Instant Readout Chemical Integrator card gives an integrated response by changing from purple to green. The integrator card inside the test pack also meets emulator performance standards according to ISO 11140-1:2005.

Device Story

Device is a steam sterilization process challenge device (PCD) used to monitor pre-vacuum steam sterilizers. It consists of an integrator card housed within a test pack. During sterilization cycles at 132°C or 135°C, the integrator card undergoes a chemical reaction, changing color from purple to green to indicate exposure to sterilization conditions. Used in hospital settings to verify sterilizer performance. Provides immediate visual confirmation to healthcare personnel regarding the adequacy of the sterilization process.

Clinical Evidence

No clinical data. Bench testing only, confirming performance against ISO 11140-1:2005 emulator standards and FDA Chemical Indicator Guidelines for pre-vacuum steam sterilization cycles at 132°C and 135°C.

Technological Characteristics

Chemical integrator test pack; colorimetric indicator (purple to green); meets ISO 11140-1:2005 emulator standards; designed for pre-vacuum steam sterilization at 132°C/135°C.

Indications for Use

Indicated for use as a steam sterilization process challenge device to monitor pre-vacuum steam sterilizers operating at 132°C (270°F) or 135°C (275°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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#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## AUG 1 5 2008

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

Re: K080136

Trade/Device Name: Instant Readout Chemical Integrator Challenge Pack, Model No.: I.T 105 Regulation Number: 21 CFR 880.2800 Regulation Name: Chemical Indicator Regulatory Class: II Product Code: JOJ Dated: August 05, 2008 Received: August 12, 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 adultcration.

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 (OS) regulation (21 CFR Part 820): and if annlicable, 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.

Cler

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): K080136

Device Name: SteriTec Instant Readout Chemical Integrator Challenge Pack, Model No.: LT 105

#### Indications For Use:

The SteriTec Instant Readout Chemical Integrator Chailenge Pack is a steam sterilization process challenge device that meets the FDA Chemical Indicator Guidelines performance requirements for chemical integrator test packs. The Integrator Challenge Pack monitors pre-vacuum steam sterilizers operating at 132°C (270°F) or 135°C (275°F). When exposed to steam sterilization conditions the Instant Readout Chemical Integrator card gives an integrated response by changing from purple to green. The integrator card inside the test pack also meets emulator performance standards according to ISO 11140-1:2005.

#### Critical Parameters in hospital steam sterilizers

| Temperature/<br>Sterilizer Type | Indicator "A” | Indicator "B" | Indicator "C" |
|---------------------------------|---------------|---------------|---------------|
| 132°C (270°F)/<br>Pre-Vacuum | 4 minutes | 10 minutes | 20 minutes |
| 135°C (275°F)/<br>Pre-Vacuum | 3 minutes | 8 minutes | 16 minutes |

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

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

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

Sharla H. Murphy, MD

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

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510(k) Number:

K 080136