CROSS-CHECKS EO GAS STERILIZATION MONITOR

K952244 · Steritec Products Mfg Co, Inc. · JOJ · Aug 5, 1996 · General Hospital

Device Facts

• Record ID: K952244
• Device Name: CROSS-CHECKS EO GAS STERILIZATION MONITOR
• Applicant: Steritec Products Mfg Co, Inc.
• Product Code: JOJ · General Hospital
• Decision Date: Aug 5, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

SteriTec CROSS-CHECKS EO gas process indicator monitoring strips are a yellow to brown chemical indicator strip that changes color during Ethylene Oxide (EO) processing. They indicate that the item has been processed in Ethylene Oxide.

Device Story

Chemical indicator strip; monitors Ethylene Oxide (EO) sterilization cycles. Input: exposure to EO gas environment. Transformation: chemical reaction causing color change from pale yellow/brown to a different state. Output: visual color change on strip. Used in sterilization facilities; operated by sterilization technicians. Provides visual confirmation of processing; assists in quality control for sterilized items; ensures items have undergone EO exposure.

Clinical Evidence

Bench testing only. Independent laboratory testing performed to verify performance and safety, demonstrating equivalence to the predicate device.

Technological Characteristics

Chemical indicator strip; color-changing reagent sensitive to Ethylene Oxide gas. Form factor: strip. No electronic components, software, or energy source.

Indications for Use

Indicated for use as a chemical process indicator to monitor Ethylene Oxide (EO) sterilization processing for items undergoing sterilization.

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

Submission Summary (Full Text)

{0}

AUG - 5 1996

SteriTec Products Mfg. Co., Inc.
CROSS-CHECKS EO Chemical Process Indicator
FDA 510(k) Application
May 27, 1996
Page 18

K 952244

# 510(k) SUMMARY

## SUBMITTER:

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

- Establishment Registration Number: 2028456

- Date Summary Summary was Prepared May 27, 1996

- **TOM ROLL**
Printed name of person required to submit 510(k)


- Signature of person required to submit 510(k)

- **PRESIDENT**
Title of person submitting 510(k)

Proprietary Name: CROSS-CHECKS EO
Common/Usual Name: EO Process Indicator
Classification Name: Process indicator
Classification:

FDA has classified Physical/Chemical Sterilization Indicators in Class II under Classification Number 80JOJ, Regulation Number 880.2800.

{1}

FROM : SteriTec Prod.
PHONE NO. : 303 660 4213
P04

SteriTec Products Mfg. Co., Inc.
CROSS-CHECKS EO Chemical Process Indicator
FDA 510(k) Application
May 27, 1996
Page 1

## 510(k) Summary - continued

### Identification of Predicate device:

The SteriTec CROSS-CHECKS EO gas process indicator strip product is similar in design, composition and function to the:

Surgicot 2® EO Gas Indicator, chemical indicator strip, which was marketed prior to May 28, 1976.

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

#### Product Description:

SteriTec CROSS-CHECKS EO process indicators are a pale yellow to brown chemical indicator strip that changes color during ethylene oxide processing.

#### Intended use:

SteriTec CROSS-CHECKS EO gas process indicator monitoring strips are a yellow to brown chemical indicator strip that changes color during Ethylene Oxide (EO) processing. They indicate that the item has been processed in Ethylene Oxide.

#### Comparison to Predicate devices:

The basic formula and concept of chemical Ethylene Oxide process indicators has not changed dramatically since they were invented in the fifties and sixties.

#### Laboratory testing

Laboratory tests were performed to substantiate and verify that the performance of the submitted SteriTec product performed safely and effectively as described and is equivalent to the predicate competitive product. These tests were performed by an independent testing laboratory.

#### Conclusion:

Results of performance testing indicate that the submitted product, SteriTec CROSS CHECKS EO, performed in a safe and effective manner equivalently to the Surgicot 2® predicate device.