STERITEC CROSS-CHECKS EO GAS STERILIZATION INTEGRATOR

K982547 · Steritec Products Mfg Co, Inc. · JOJ · Oct 8, 1998 · General Hospital

Device Facts

• Record ID: K982547
• Device Name: STERITEC CROSS-CHECKS EO GAS STERILIZATION INTEGRATOR
• Applicant: Steritec Products Mfg Co, Inc.
• Product Code: JOJ · General Hospital
• Decision Date: Oct 8, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

The Steritec Cross-Checks EO Integrators are designed to provide an integrated response to EO gas sterilization in hospital sterilizers. Color change to brown is complete between 30 and 45 minutes exposure to EO gas mixture of 88/12 with gas concentration of 600 mg/L, temperature at 130 F and Relative Humidity at 45%.

Device Story

SteriTec CROSS-CHECKS EO Gas Sterilization Integrator is a chemical indicator used in hospital sterilizers to monitor EO gas sterilization cycles. The device provides a visual color change (to brown) when exposed to specific parameters of EO gas concentration (600 mg/L), temperature (130 F), and relative humidity (45%) over a 30-45 minute duration. It serves as a process integrator to confirm that sterilization conditions have been met. It is intended for use by hospital staff to verify the effectiveness of the sterilization process for medical instruments.

Clinical Evidence

Bench testing only. The device was evaluated in parallel tests against biological indicators (EZTEST, ATTEST, STS Spore Strips) and compared against the predicate (Surgicot 2) and the Sterigage EO Integrator. Results indicated the device surpassed the performance of the biological indicators and the predicate device across four parameters of the ethylene oxide sterilization process.

Technological Characteristics

Chemical integrator for EO gas sterilization. Operates via colorimetric change (to brown) in response to specific EO gas concentration, temperature, and humidity. Standalone device; no software or electronic components.

Indications for Use

Indicated for use in hospital sterilizers to provide an integrated response to ethylene oxide (EO) gas sterilization processes.

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.

Predicate Devices

• SURGICOT 2 EO Gas Indicator Strip (K800029 and K800029A)

Reference Devices

• EZTEST
• ATTEST
• STS Spore Strips
• Sterigage EO Integrator

Submission Summary (Full Text)

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OCT 8 1998

CROSS-CHECKS EO Gas Sterilization Integrator 510(k) Premarket Notification K982547 SteriTec Products Mfg. Co., Inc.

# 510(k) PREMARKET NOTIFICATION

# SUMMARY

SUBMITTER:

Image /page/0/Picture/5 description: The image shows a handwritten string of characters and numbers. The string begins with the letter 'K', followed by the number '98'. After '98', the numbers '2547' are written. A line is drawn underneath the numbers, possibly indicating a signature or underlining.

STERITEC PRODUCTS MFG. CO., INC. 680 Atchison Way - Suite 600 Castle Rock, CO. 80104 [phone] [phone] Fax

Establishment Registration Number: 2028456

November 19, 1996 Date Summary was Prepared Date of First Revison February 7, 1997 November 5, 1997 Date of Second Revision Date of Third Revision July 15, 1998

# TOM ROLL

Printed name of person required to submit 510(k)

Tom Selleck

Signature of person required to submit 510(k)

### PRESIDENT

Title of person submitting 510(k)

| Proprietary Name: | SteriTec CROSS-CHECKS EO Gas Sterilization Integrator |
|----------------------|-----------------------------------------------------------------------------------------------------------------------|
| Common/ Usual Name: | Ethylene Oxide Gas Sterilization Process Integrator |
| Classification Name: | Sterilization Chemical Integrator |
| Classification: | FDA has classified Physical/Chemical Indicators in Class II<br>under Classification Number 80JOJ, Regulation 880.2800 |

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CROSS-CHECKS EO Gas Sterilization Integrator 510(k) Premarket Notification-K982547 SteriTec Products Mfg. Co., Inc.

# 510(k) Summary - continued

#### Identification of Predicate device:

The SteriTec CROSS-CHECKS EO Gas Sterilization Integrator is a chemical integrator equivalent in construction and performance to the predicate device. Since it is equivalent in construction and performance to the SURGICOT 2 EO Gas Indicator Strip, (FDA 510(k) # K800029 and K800029A) manufactured by SURGICOT of Research Triangle Park, North Carolina (Predicate device), it will perform in the same safe and effective manner as the predicate device as demonstrated in performance tests.

#### Description of 510(k) submission device:

#### Intended Use:

The Steritec Cross-Checks EO Integrators are designed to provide an integrated response to EO gas sterilization in hospital sterilizers.Color change occurs between 30 and 45 minutes exposure to EO gas mixture of 88/12 with gas concentration of 600 mg/L, temperature at 130 F and Relative Humidity at 45%.

#### Comparison to Predicate Device:

Compared to the predicate device our performance data shows the Cross-Checks EO to be substantially equivalent.

#### Performance Testing:

The SteriTec CROSS-CHECKS EO Gas Sterilization Integrator performance was determined in parallel tests against several biological indicators, (EZTEST, ATTEST, and STS Spore Strips) and in a separate test against the predicate device as well as the Sterigage EO Integrator. The Cross-Checks EO Integrators surpassed the performance of the biologicals for each of the four parameters used in the ethylene oxide sterilization process. In addition, the Cross-Checks EO Integrators surpassed the performance of the Surgicot 2 EO Integrator (the predicate) as well as the Sterigage EO indicator when tested on a side by side basis by an independent laboratory. In both tests , each parameter for EO gas sterilzation was varied while holding the balance of parameters constant.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure, with three profiles overlapping to create a sense of depth and community. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the figure, with "DEPARTMENT OF HEALTH & HUMAN" on the left side and "SERVICES - USA" on the right side.

OCT 8 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Tom Roll ·President SteriTec Products Mfg., Co., Incorporated 680 Atchison Way - Suite 600 Castle Rock, Colorado 80104

Re : K982547 Trade Name: SteriTec CROSS-CHECKS EO Gas Sterilization Inteqrator Regulatory Class: II Product Code: JOJ Dated: July 16, 1998 Received: July 21, 1998

Dear Mr. Roll:

We have reviewed your Section 510 (k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the qeneral 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations,

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Page 2 - Mr. Roll

This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. 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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Page _ 1 of _ 1 _ _ 1 _ _

510(k) Number (if known):_____K982547

Device Name:___Cross-Checks EO Integrator

Indications For Use:

Steritec Cross-Checks EO Integrators are designed to provide an integrated response to EO gas sterilization in hospital sterilizers. Color change to brown is complete between 30 and 45 minutes exposure to EO gas mixture of 88/12 with gas concentration of 600 mg/L, temperature at 130 F and Relative Humidity at 45%.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use Use (Per 21 CFR 801.109)

OR

Over-The-Counter X

(Optional Format 1-2-96)

Clins S. Cin
(Division Sign-Off)

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